ML19309F919

Transcript of 800415 Briefing in Bethesda,Md Re Interim Actions on Performance Testing for Personnel Dosimetry. Pp 1-27

ML19309F919
Person / Time
Issue date:	04/15/1980
From:	NRC COMMISSION (OCM)
To:
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REF-10CFR9.7 NUDOCS 8005010646
Download: ML19309F919 (28)

Text

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BRIEFING ON INTERIM ACTIONS ON PERFORMANCE TESTING FOR PERSONNEL DOSIMETRY P l c, c e :

Bethesda, Maryland Date:

April 15,1980 Pages:

1 - 27 INTERNATIONAL VERBATIM REPORTERS, INC.

499 SOUTH CAPITCL STREET. S.W. SUITE 107 WASHINGTON, D. C. 20002

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UNITED STATES OF AMERICA 2

NUCLEAR REGULATORY COMMISSION f

___________________________.x In the Matter of:

4 BRIEFING ON INTERIM ACTIONS ON PERFORMANCE TESTING l

4 FOR PERSONNEL DOSIMETRY 7

________________'____________x 3

9 Room 550 to East-West Towers 4850 East West Highwa)

Bethesda, Maryland Tuesday, April 15, 1980 i

13 j

14 The Commission met, pursuant to notice, for 8

12 presentation of the above-entitled matter at 2:00 p.m.,

j id John F. Ahearne, Chairman of the Commission presiding.

17 18 BEFORE:

JOSEPH HENDRIE, Commissioner 0

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i STAFF ATTENDANCE I

Speaker:

R. Alexander 2

C. Goller l

2 R. Minogue I

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N. Dennis 3

I E. Hanrahan 4

4 Dr. Phillip Plato, University of Michigan i

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M. Ehrlich, National. Bureau of Standards l

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CHAIRMAN AHEARNE:

The Ccmmission starts its r

I afternoon agenda.

A Briefing on interim actions for improving 2

personnel dosimetry... Mr. Alexander, Kevin, senior officials s

of the agency.

I MR. CORNELL:

I'd like to refer to Carl Goller.

6 I

CHAIRMAN AHEARNE:

Thank you Kevin.

Mr. Dhairman 7

in response to Section 80 44 dated January 23, 1980, the Com-3

mission approved publication of advanced notice of rulemaking 9

on the certification of personnel dosimetry processes.

This to advance notice was published in the Federal Register on March l 11 l 28.

The advance notice addresses the problem of lack of con I-1:

j nistency and accuracy in dosimeter processing and invites com-

ments on how a test and certification program of dosimetry la processors should be established and conducted.

Subsequently' s

theCommissionrequestedabriefingtofocusonwhatmightbej done immediately or in the interim to ameliorate this problem:.

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I jg We suspect this request on the part of the Commission was the l'

19 result of a combination of concerns, particularly the per-i

o ceived seriousness of the problem and the relatively long i

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1 time it usually takes to complete an entire rulemaking pro-We will in the course of this briefing be speaking to !

cess.

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both of these points.

We welcome what has already been done, 24 what will be done and what else could be done on an interim basis to help this problem.

Bob Alexander, the chief of the

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Occupational Health Standards Branch in the Office of Standards Development will provide further briefing.

Bob.

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MR. ALEXANDER:

Thank you.

Mr. Chairman, we have two j

guests today, our contractor from the University of Michigan I

which conducted a pilot study that I'll talk about later is 6

here.

Dr. Phillip Plato and would be willing to answer any i

i questions you'might have and our other guest is the chairman 3

of the Health Physics Society Standards Committee that prepared t

9 the standard that we are using in this program, Dr. Greta I

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Ehrlich from the National Bureau of Standards.

This problem 4

11 has been around for quite awhile.

Battele, Northwest published 1

studies in 1967 and 1965 indicating a problem of consistency i

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and accuracy in the area of personnel dosimetry.

However, not Id l

much happened until...

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CHAIRMAN AHEARNE:

Were both of those studies focused on the processing..

MR. ALEXANDER:

They..

II CHAIRMAN AHEARNE:

Or were they focused on the in-II struments or what?

• 0 MR. ALEXANDER:

They focused simply on the results 21 that the processors obtained.

Badges were irradiated to known doses and sent to the processors...

2 CHAIRMAN AHEARNE:

One is focused upon...in both j

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cases what was done is focused on the processors.

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Now did anything happen?

There is an interim period there?

2 MR. ALEXANDER:

Not much.

I really know of very i

little of a constructive program that was started during that

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3 period.

Things started happening in 1973 and strangely enough I

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6 the states called our attention to the situation in 1973.

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7 CHAIPMAN AHEARNE:

Now were both studies done by the f

3 AEC?

9 MR. ALEXANDER:

The 1957 study was funded by the to AEC and the 1975 study was funded by the Bureau of Radiologicqtl i

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Health.

Things really started happening when the Health Physics 1

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Society standards committee published a standard to go by in i 13 this area.

A draft became available in November of 1973 and j 14 7

we in the next month held a public meeting in which all of I

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the processors and most of the...many of the users --principal to users--of dosimetry services were invited.

17 i-CHAIRMAN AHEARNE:

And you say that they were re-i ta I

quested to develop new standards?

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MR. ALEXANDER:

That -- feel free to correct me.

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you look back at the record, it appears to have been sort of I' 21 i

a consensus of many different state governements and Federal

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governments that a new standard was needed.

MS. EHRLICH:

That's right.

It started actually with the states.

The request came directly from the states,

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MR. ALEXANDER:

The pilot study--the public meeting 2

i was very well attended and people seemed to be very much in 2

l favor of a performance testing program to be conducted by the l

government, but they gave us one more.

They said you should 4

3 conduct a pilot study to make sure that standard is a good one 6

one that is stringent enough, but not so stringent that it puts i

7 everybody out of business.

So we accepted that advice and hel6 3

a pilot study which took considerable time.

We had to award I

9 the contract and then we had to get all the radiation equipment 10 l

and sources set up and then we had two rounds of testing for I

li the processors that took about two and a half years to complete.

I The pilot study was conducted by the University of Michigan j

I' 13 CHAIRMAN AHEARNE:

What part of the University?

l I4 MR. ALEXANDER:

The school of Public Health?

I 13 VOICE:

Yes f

I4 MR. ALEXANDER:

The School of Public Health, i

17 The participation was entirely voluntary.

We had 59 processors 18 to process about 90% of the dosimeters in our country, not all i

l 19 of_which incidentally are NRC licensees.

There are many otherf 20 people who wear those badges.

The processors were tested in 21 8 different radiation categories such as gamma radiation, 20 neutrons, and a combination of radiations.

The testing pro-f 1

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24 CHAIRMAN AHEARNE:

It covered all sources.

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MR. ALEXANDER:

Yes.

All significant types of expo-V N UM N

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The testing procedure...in 2

MR. COLLER:

Mr. Chairman, the various categories 2

l that were considered are these. It's the slide that we now l

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have displayed.

CEAIRMAN AHEARNE:

That's the draft standard and the 3

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--our study covered all of the elements of the draft standard? I 7

MR. ALEXANDER:

Yes. (Pause)

The testing procedure 3

l involved receiving a number of badges from each participant I

9 Dr.

irradiated those badges to known doses.

The accuraq f

cy of his work was attested to by the National Bureau of 10 Standards.

His radiations were within 2 percent of the actual 11 i

dose.

The badges were then sent to the processors to try to I:

determine the dose and then their results were sent back to the i

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University of Michigan where they were prepared against the i

l' statistical criteria of the standard.

The results were not

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!d extremely encouraging.

Many of the processors did rather poorly I

17 as we expected.

The standards came out very well.

Some changes la l

were indicated to be necessary.

Those have been made.

19 CHAIRMAN AHEARNE:

What?

How when you say they in-20 dicated the standard was generally acceptable it came out welli 21 What kind of criteria were you using to judge the acceptability I

of the standard?

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23 MR. ALEXANDER:

Well, the NRC staff pretty much lef t 24 that to the working group that had been established to develop l i

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the standard.

We didn't try to guide them in the words of the; 1

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l statistical criteria that should be used.

I It was rather obvious I

that these standards were too strict.

Some changes had been 1

i made in the standards to make it more reasonable.

I CHAIRMAN AHEARNE:

In what sense?

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l MR. ALEXANDER:

All right.

Could I have the backup l

0 viewgraph for those standards?

7 MR.' GOLLER':

Mr. Chairman as I understood the thrust i

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l of your first question, I think the ultimate answer to that is t

I that it was found that some processors were able to satisfy all i

10 parts of the standard so that the standard was achievable in U

all aspects.

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CHAIRMAN AHEARNE:

But then...

I MR. GOLLER:

And some processors were able to pass a 1 1

components of the standard.

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MR. ALEXANDER:

The statistical test was changed.

t4 The tolerance limits which were variable depending on the dose were changed to a constant.tich was independent of dose

,' so that you...all badges have to meet the same criteria even is for low doses as well as high doses.

The revised standard

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has been submitted back to the Health Physics Society to approve.

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An approval is expected this summer.

Those were the major I

changes that were made in the standard th -' we looked particularly l j

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CHAIRMAN AHEARNE:

The last item... cobalt cesium I

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A cobalt source was used in the pilot i

j study was called for in the standard.

That's a rather high i

energy proton above 1MEV that causes some secondary electron 4

difficulties at the point of the irradiation of the bags...

j interactions of protons with

.r.

Cesium is considerably e

6 softer gamma and considered to be more suitable for calibration 7

i of liigh energy protons.

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f CHAIRMAN AHEARNE:

(inaudible) 3 9

MR. ALEXANDER:

I just wanted to say that the

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though the study was conducted primarily to test the standard l

th,we were also looking at the performance of the processors and as you may be aware the performance of the processors doesi 1

13 n't look very good if you look at the first issue of the stan-

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dard as the crit 6ria.

If you look at the second issue of the I

te standard as the criteria the performance becomes somewhat bettdr id i

and if you look at it on the basis of just percentage badges t;

that got the dose right, it doesn't look nearly as bad as the i

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first issue of the standard made the situation look.

I CHAIRMAN AHEARNE:

What is that second percentage 19 j

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o that you cite?

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MR. ALEXANDER:

We have a backup viewgraph with that I

information.

Forexamplethatplusorminus50 percent..youl 22 use that as a tolerance limit.

In the first round of testing i

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77.6% of the badges came within plus or minus 50 percent and i

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n 86.4 percent came that close in the second round.

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i CHAIRMAN AHEARNE:

What was the differnce between l

j round 1 and round 2?

f MR ALEXANDER:

There were no differences in the i

4 radiation procedures I believe.

The difference was that the i

3 processors had an opportunity to improve their process before 6

they participated in the second round.

Unfortunately only a 7

very few did..

That as you can see.

I think considerable judg-i

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l ment is required in evaluating these data and saying how good i

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the American dosimetry processes really are.

A lot depends

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to on the criteria we use to evaluate them.

The..that's all I it wanted to say about the pilot study results. The regulatory 1:

action.

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CHAIRMAN AHEARNE:

Well let me ask another question.

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I have never studied the badges

..so I'm not...how accurate 12 I

te are the badges?

Because you are getting a testing by doing 14 an accurate measurement of the dose that's given to a badge.

I 17 Then you have a processor check the badge.

Whatarethenormak is tolerances that you'd expect from the badge manufacturer i

t9 MR. PLATO:

From the badge itself, not including i

o the processor?

l 31 COMMISSIONER HENDRIE:

Suppose the processor were 100 percent l

l MR. PLATO:

From my experience about a 10 percent

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variability is probably reasonable.

But given a large number,

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just in the way the badges are aanufactured, assembled and so i

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I CHAIRMAN AHEARNE:

Thank you.

MR. GOLLER:

I'd like to add to that.

That is some-3 what a function of the care that is taken in selecting the TRV l

6 chips that are used.

Some processors do this we, are aware l

I and some do not.

One of the objectives of this entire program 3

is to encourage real processors to do that.

To examine the l

9 chips that they receive and reject any defective ones.

Those i

10 processors that have done this have reported to us rejection II rates as high as 25 percent.

This is encompassed within the i

C program that we have underway and would be one of the ways of I

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--but only one of the ways of improving this dosimetry process!.

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CHAIRMAN AHEARNE:

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Carl in the sense that...are you saying that the processors l

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are the same as the manufacturers of the badges or are you II asking that II MR. GOLLER:

Well, either of the two could conduct I'

this quality program.

M CHAIRMAN AHEARNE:

Are you talking about the quality

• 1 program focused on manufacturers, as well as processors or?

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COMMISSIONER HENDRIE:

I think Carl is talking i

I in the word processor in this sense in the sense of the guy l

that assembles the badge.

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MR. GOLLER:

No.

In either one. The processor could!

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i the processor could so write in his specification and of course increasing price to him, purchase the badges from the manufac-turer of the badges, with that examination and additional l

QA already applied.

Alternately, he could apply it.

Another l

3 alternative might be the manufacture of the chips themselves.

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I don't think' that we would be specifying who would actually 3

do this.

It could be done anywhere in the line.

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l CHAIRMAN AHEARNE:

Now is your comment though that 10 you would hope to be able to decrease the plus or minus 10 11 percent or is your comment that there are some badges that clearly fall way outside the plus or minus 10 percent.

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i MR. ALEXANDER:

No these.

Many of these kits fall i

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way outside plus or minus.

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CHAIRMAN AHEARNE:

Not due to the quality.

I'm try-Id ing to draw a distinction between the quality processing of 1'

the badge.

18 MR. ALEXANDER:

We are talking about the materials l

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now.

CHAIRMAN AHEARNE:

I'm talking about the materials i

myself.

You say many would fall way outside that.

Do you have I

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any way or the study of any way of estimating how much of this' would do that?

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• 4 MR. ALEXANDER:

Our contractor gave us an estimate l

that as many as 25 percent of these chips would be outside of [

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Your contractor in Reston.

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MR. PLATO:

Well, from what we saw, a processor who very carefully screened his dosimeter..the sensitive A

element of the dosimeter, where it was film or thermoluminescedt l

material.

If he put forth a very good effort, stillaboutthel best he could do is somewhere on the order of 7 or 8 or 10 i

percent, right in there.

And if the processor doesn't screen the sensitive elements, in some cases, you see sensitive elements 9

I that don't respond to radiation at all.

I don't know what I

it's a factor of infinity.

CHAIRMAN AHEARNE:

In the results that you have thers it shows that you have 78-86 percent plus or minus 50.

How j

much of that is due do you think to faulty dosimeters and how much of that is due to bad reading and bad processing of the i

dosimeter?

Id i

MR. PLATO:

I suppose about the first 10 percent of t,e the 77.

That's probably about as good as you are going to get the dosimeter and the rest of that has something to do with l

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the processor's procedures.

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CHAIRMAN AHEARNE:

Then it could be either bad badge as well as bad reading practices?

MR. PLATO:

That's correct.

Including such things I

that have nothing to do with the physics of dosimetry, it's 4

I just that you incorrectly copy a number.

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CHAIREMI AHEARNE:

And there's a mixture...an unde-l termined mixture of those?

j MR. PLATO:

That's right.

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COMMISSIONER HENDRIE:

Is there a...With regard to the material variability including some of those that are well 3

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3 outside the range.

Is the distribution more or less symmetricil 7

l abodt the correct dose ~ or do you preferentially read those?

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MR. PLATO:

Yes, I've seen it go both ways.

Yes,

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I would think it is fairly normal to distribute it.

When you to consider all of the error.

11 COMM. HENDRIE:

In which case when you run 23,000 r;

badges why, those bummers that are giving you very anomalously i

g3 low dose are balanced by some bummers that are giving you i

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anomalously high' doses.

te MR... PLATO-With the one exception, the lowest dose '

!<6 you can report is 0 but there is no upper limit on the upper.

t-COMM. HENDRIE:

Hard to beat that.

13 MR. GOLLER:

I'm curious about what you meant I

t9 Commissioner about balance?

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o Well' so they are not balanced by the 21 standard.

The standard is on an absolute basis and a low i

l reading is just as bad as a high.

I COMMISSIONER HENDRIE:

In terms of this, for instance i

24 I'm looking at..trying to look at badge data cumulative expo sure at a station over a year or something like that.

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can say is that I pick up any badge :eading that has a swing 2

in it but this suggests it is fairly substantial.

But if the 9

1 error distribution is fairly symmetrical, it probably means the station man rem for the year is to first order, not MR. GOLLER:

As far as that consideration, yes 5

j there is balance obviously.

I MR. ALEXANDER:

We found that to be true for photons i

I I

but not for neutrons or beta particles.

The badges tended to I

underestimate the neutron dose and to overestimate the beta 10 dose. So what you say for photons is absolutely correct. Well II l

the regulatory action that the staff is planning concerns an 1:

amendment to part 20 which we will prepare to send to the IU Commission, which would state that personnel dosimetry results t

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would only be acceptable to the NRC if they are acquired by 13 a processor who has successfully passed the performance testing 14 l

program using this HPSSC standard.

I think the most difficult' problem we have in this program is the fact that the NRC's la l

authority extends only to our' licensees and not to the proces ;l U

sors who do the dosimetry.

So that's the reason for our IO The revision of the standard has been completed I'm informed 21 by Dr. Ehrlich the chairman and has been submitted to the 22 I

Health Physics Society for approval and that is expected i

23 in May.

After we have had a chance to analyze the comments j

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from the advance modus we hope to be able to come back to the Commission and discuss in more detail the alternative approaches

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that we can take to the operation of a test and certification 2

laboratory this summer.

Then we want to accelerate our 2

schedule for getting the rule in place.

This we intend I

4 to...the Commission willing... to publish the proposed rule 3

this fall and the effective rule the following summer to get l

6 the program into place.

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7 CEAIRMAN AHE'ARNE:

Why do you believe it would take 3

that long?

i 9

MR. GOLLER:

Actually as Bob indicated I

10 i

that schedule compared to the usual rulemaking process has 11 been considerably shortened.

COMMISSIONER HENDRIE:

Sounded precipitous to me.

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MR. GOLLER:

And I might add we had specifically la j

done that in response to the Commission's apparent concern i

13 about this problem and it's request for this briefing.

i I4 CHAIRMAN AHEARNE:

Done which?

i 17 MR. GOLLER:

Accelerated the schedule.

I 18 CHAIRMAN AHEARNE:

Can it be accelerated?

I 19 MR. GOLLER:

It can and we will certainly try, but 20 I think the one that's scheduled now indicated is an expeditedi i

21 optimistic schedule which we will try i

I CHAIRMAN AHEARNE$

But it has gone through as you i

22 pointed out at least the basic standard 24 MR. GOLLER:

The problem has been identified.

I 2

think we would just point out going back to 1967.

The stan-in,

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dard was discussed as to when should you in your briefings i

2 have a ----------and a lot of comment on it.

Alex then 2

I recommended it's gone through pilot study, revised standards s

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developed.

3 MR. GOLLER:

Well the advance notice went out the I

1 6

j very end of March and we certainly wanted to have the benefit 7

of the comments t

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CHAIRMAN AHEARNE:

Oh yes. I understand that.

MR. GOLLER:

So that I think to develop a proposed to rule by fall of 80 is optimistic but reasonable.

11 l

CHAIRMAN AHEARNE:

When did the advance notice...

12 when did they....when did the public comments end?

13 l

VOICES:

60 days...May 27.

14 CHAIRMAN AHEARNE:

May 27?

1.!

VOICE:

Yes.

!4 MR. GOLLER: Mr. Chairman, if I may.

This discussion 17 is focused on a technical question. And there's ancther aspect 18 to this rulemaking.

We are really hacking a lot of new ground 19 with this business of a certification program for processors 20 and many of the questions of advance notice really deals with 21 that issue...how the government should best come at a program.

of certification of processors and that's a relevant split 22

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between private industry and that's going to raise some very 2A complex issues and a very optimistic schedule, accelerated with those issues is not practical as indicated here.

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COMMISSIOliER HENDRIE:

It goes beyond the technical 2

i issues that we have been discussing.

l CHAIRMAN AHEARNE:

You just shot down; I was about 4

to say but since it seems to be a very technical rule that i

3 perhaps under the delegation of standards that it could be 1

6 handled that way but I think we just pointed out that it has 7

the nature of policy.

l 3

MR. MINOGUE:

I thick this is a general problem, i

9 Mr. Chairman.

A real tendency nowadays and a good tendency to to think in terms of programs of certification and use of 11 some of these third party systems.

But they all involve i:

some very complex policy issues.

13 CHAIRMAN AHEARNE:

I will take your word Bob based on 12 i

your long experience and the chairman's uh Joe's point about I

IJE being precipitous.

But it doesn't look too accelerated to me, 14 MR. GOLLER:

There's another nontechnical aspect to i

17 this Mr. Chairman that we should all be familiar with and that is that only 30. percent or less of the dosimeters being pro-la 19 cessed are actually for NRC licensees.

In the process of the 20 NRC taking these steps we will very likely be correcting this 21 l

problem which certainly exists for all those other dosimeters O

also and for other regulatory organizations.

I 1

\\

22 MR. ALEXANDER:

Let me speak to that.

The..back i

l l

24 af ter the standards graph first became available to us, many l

t 2

other agencies were interested in the problem and the NRC

[prygmumah VNffas h last as mswrge CMrT12. STWET. E e. Sffft :87

_ U -5

4 c

19 oncz.we.

i simply took the lead and we formed a policy committee in a formal 2

l way which involves i.11 of these other agencies and we meet 2

periodically to review the NRC progress and to give advice i

l to them and I thin). as a result of that effort when we come to 4

i 3

you with a proposed rule we will be able to say that we have 6

the concern of the staff people at the other agencies.

I I

7 CHAIRMAN AHEARNE:

Who are the other places involved?

3 l

MR. ALEXANDER:

The National Bureau of Standards, i

7 the Bureau of Radiological Health, Department of Labor, OSHA, i

i 10 l

Department of Energy, Department of Defense, EPA and represen-11 l

tatives of the states.

5'

!2 CHMN. AHEARNE:

How is that latter individual chosen?

i l

13 l

MR. ALEXANDER:

Greta, do you know how he is chosen?'

I4 i

MS. EHRLICH:

The organization...The Conference of i

13 Radiation controlled probably this approach and they selected. l l

I4 MR. ALEXANDER:

Now, getting to the interim actions f 17 the Commissioner has requested us to focus on, we feel that l

18 the foregoing actions, interim actions have already been taken i

l i

19 to effect improvement and we have some evidence that some l

t t

20 improvement has taken place.

The pilot study itself caused 21 many processors, unfortunately not all of them, but many of 22 them, to make improvements in their processing.

We asked our C

contractor to visit 8 of the largest commercial processors to 24 go over the process with them and try to point out to them i

i 2

why they did poorly in the test if they did poorly.

That was i.m no ve=n- % i=

me sente M sTearf. L e. surft ?st

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caar.wo. 20 l

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f done and a number of corrections were made as a result of I

that study.

We were very pleased with that.

We feel l

that the advanc.e notice of rulemaking which the Commission 3

l 4

i has just apprcived will do a great deal toward getting the t

a 1

l attention of the dosimetry processors and we had indications i

5 l

from our contractor that many of the processors did not take I

the pilot stddy seriously, did not really make an effort to i

3 I

be better in the second round, not believing that the govern-9 l

ment was really going to do something about this problem.

10 Now that the advance notice has been published, NRC has P

U l

[

stated to the world that action is going to be taken on this 12 problem, we feel that corrective measures would be taken very I 13 l

readily.

In this connection this week we are in the process l

U of mailing a letter to all of the licensees discussing with

{'e 8

them the causes of queer performance that were identified i

I0 in the pilot study and in the limited side visits and suggest-ing to them that they get busy making corrections before a i

I8 regulatory program is put into place.

Now with respect to the i

corrective interim actions to be taken, these are actions i

O that we have already decided to take.

Additional site visits 21 j

are in progress to all of the other processors, not just the I

l 8 big ones so that Dr. Pluto can work with them in identifying 23 I

their problems.

t CEMN. AHEARNE:

Do you know how many processors?

_e

~

MR. ALEXANDER:

Well there were 59 participants imn v

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21 Q

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t I

i so he has about 50 to go.

That project has already been i

funded.

Then we are planning a third round of testing.

9 i

l Now the principle reason for the third round of testing 4

i is to test the standard revisions because we don't like i

i e

the idea of coming to the commission with an untested 4

5 i

standard in any way and asking you to make it regulatory, i

7 This project 'has been accelerated at the time of supplemental I

3

{

funding was suggested.

We plan to do it in Fiscal year 80 9

j if these get started in FY 80 if the supplemental funds become 10 available.

If they don't become available then we plan to 11 conduct this as originally planned in FY 81.

1 I

CHMN. AHEARNE:

r So that whatever date that you have 13 i

i for the final completion is certainly tied i

14 l

MR. ALEXANDER:

Tied, proposed to the rule?

t ~e t

The way we are planning to do that is to have the third round i Id completed before we come to you asking you to make the rule 17 effective so that the result of the third round would be a la i

go - No go result sort of thing.

If we were satisfied with 19 I

them, we would be able to come to you and say we believe that i

.g the time has come for this regulation.

If not, they would have i

l to come to you and say that.

The third round of testing would!

~

l in no way slow down the regulatory process.

CHAIRMAN AHEARNE:

If the third round of testing i

3 i

shows that they are doing even worse than the first and second!

rounds does that lead you to conclude the standard is too tough i.m no v

n w i,.c

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pacz.sc.

r that its absolutely meaningless.If the third round of l

testing shows that they all did magnificently that leads you

.s 3

to conclude the standard isn't needed or it's not tough enough.

i MR. ALEXANDER.

I think that there is a very limited 3

probability that either one of those eventualities will take i

E1#"**

6 7

CHMN. AHEARNE:

Then if its clear l

g l

MR. ALEXANDER:

The only thing I'm really worried I

9 about Mr. Chairman is that one of these changes in the standard, f

will be something impractical and we want to identify that.

10 MR. MINOGUE:

Mr. Chairman, you need the CHMN. AHEARNE:.Well I was trying to see how

3 closely linked they are coupling everything.

i la MR. MINOGUE:

Well the standard should be seen I i

l think as the basis for the program.

It's a pre-g r

I to requisite.

l

!7 CHMN. AHEARNE:

Is the action to be taken in May i

i I

g on the standard to be one that is intended or is it on approva]i i

t

9 by the Health Physics Society?

l

.g MS. EHRLICH:

Final approval l

21 MR. ALEXANDER:

To continue, as a result of the n

communication from the Commission regarding the advance notice I i

of rulemaking and expre.ision of interest by the commmission 3

4 i

i y

in interim measures to take while waiting for the rule to 3

take place, we put ouz heads to work trying to think of additional

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71 I

things that we could do and came up with the idea of I

which we've adopted of holding a public meeting out of here, 3

but in this final meeting, the type that we 've of ten held i

4 in standards development..on the subject of personnel dosimetry 3

processes in which we would bring the processors together and 6

discuss problems and the lessons learned in the pilot studies '

7 and let them share what they've learned the new procedures that they've been able to take to solve their own problems in i

9 their own shops and we think that a workshop like that which f

is almost no expense to the government can be very effective 10 11 to these technical people.

Turning now to some other interim II actions that we have considered but rejected as impractical and 13 inappropriate, these have to do with imposing as quickly as i

I4 l

possible quality assurance requirements on the processors.

l.5 Now, assurance to the current quality assurance to deal 16 with inhouse procedures that they might follow to check their :

i 17 own process as opposed to a testing program which involv es j

18 an outside testing lab.

Such court requirement could be 19 placed on the licensing by the various ways that NMSS and NMR f 20 have in dealing with their licenseees.

We should investigate i

21 l

possibility of imposing quality assurance programs on the l

processors themselves in a manner similar to the way I&E does '

22 22 quality assurance inspections where we have component manufac-Il turers who are not really our licensees.

There is some question 13 about the regulatory base with that approach.

And the third I

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l one, let me emphasize again we are not recommending an immediate I

i I

effective regulation which would impose a specified quality 2

assurance program.

That concludes our formal briefing.

4 COMMISSIONER HENDRIE:

In the course of your pilot 3

study in your contacts with some of the processors and so on,

(

I 6

what sense do you get from what I will characterize as more 7

progressive members of that group?

Do they sound like they are 3

going to drag foot, scream and holler, or are they going to i

9 move forward and pick up these leads and look for a certifying 10 laboratory.

What sense do you get from..I'd say the good side 11 of the industry.

i 12 MR. ALEXANDER:

'I think we can put that question to l

Dr. Pluto directly.

My impression as a regulator is that they 13 1.4 i

seem to be divided into two groups.

One group which is i

i I.!

very scientifically oriented, very health protection oriented ~

i 14 people who want to do a good job and who do a good job and 17 a few who don't do a very good job at all.

Is that about 18 right?

i I think the vast majority approve of thisl 19 DR. PLUTO:

20 and in fact, the hesitation has come in part because over the i

Il years, there have been a number of efforts at creating standards and implementing testing programs and I think some of the i

i U

hesitation by a lot of processors is this yet one more standard.

t 24 Why should we put any special effort on this and I think they i

15 are beginning to realize that this is the way things are moving.

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l COMM. HENDRIE:

This one, hopefully by virtue i

I I

of the testing grounds daat had been made and will be made 2

often have a better basis I would think than the results of I

4 l

the best intentions to me, working over a series of meetings I

I to try to evolve some standards.

4 MR. WEISS:

What I was going to say is that based i

7 on the past h'istory,- this standard now has with all of the l

3 ones back in 1963, an incentive.

It was never I

9 there before and it was a standard at the University of 10 l

Michigan.

The National Sanitation Foundation had a standard it It was well accepted.

It was sponsored by DHEW.

But there i

!2 was no incentive, no sanctions and people saw no need to pass is i

it and it kind of dropped by the wayside.

And now its down i

14 to four companies that participate in that program. And so i

I!

the standard that has been from has been the intent of sanctio s I

I to that we now have had and I think the majority of the job is 17 done once you get their interest and they start calibrating 18 l

and providing for it too.

i 19 COM!!. HENDRIE:

Well I should think the responsible 1

20 operators in the field would be grateful for a competent agree-Il ment with standards mandated by the government.

In effect, it C

allows them to do a quality job without the commercial risk 1

23 of being undercut by a sloppy operator who just runs a slapdash I

24 cheap operation and then offers it to a guy's customers.

If

~!

everybody has to tow a reasonable quality line, you can at i

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least work to that level and in effect you are commercially e

I protected.

n MR. WEISS:

And they think that they can pass and i

i j

they are not too sure about the others small guys can.

5 MR. ALEXANDER:

It's interesting.

I think that it 's.

I s

6 the largest problem dosimetry processor visited us out at I

Nicholson Lan'e a few months ago and encouraged us to not change I

}

the standard at all but to leave it exactly as it was.

He h saw all of b.s competition and he figured that he had a way to to

{

meet it and nobody else did.

II MR. MINOGUE:

One of the motives for publishing this II advance notice that way which is to deliver this message broadly l

IU l

COMM. HENDRIE:

I don't have any more questions.

N l

CEMN. AHEARNE:

Bob you mentioned that about 30 per,

l' cent of the dosimeters are from 14 MR. ALEXANDER:

Thirty percent or less.

i CHMN. AHEARNE:

Is there any other large bulk that la are regulated?

I U

MR. ALEXANDER:

Yes. I think the largest number of I

og people would be the users of X-ray machines which are generally U

regulated by the individual state.

They are a much larger I

l

~

group than our group, i

l CHMN. AHEARNE:

And, do you get the sense, that I gather you had sensed this original effort seemed to be precipitated by state request.

Do you think the states will

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follow the strictures that ------

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MR. ALEXANDER:

Absolutely.

The only way that would fal to happen is that if we just do a lousy job of it.

I I

f And don't really do anything that would be helpful.

Then i

e I think they will find another way.

But they are very in-l terested in this program.

I I

i CHMN. AREARNE: Well thank you all.

6 3

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INTERIMACTIONSFORIMPROVING PERSONNEL DOSIMETRY PERFORMANCE

=

b 6

)

OUTLINE l,

I.

Purpose of Briefing II. Statement of Problem III.

Status of NRC Efforts to Resolve Problem i

A.

Regulatory Action Completed B.

Regulatory Action Planned j

IV.

Interim Actions A.

Corrective Actions Taken l

B.

Corrective Actions To Be Taken l

C.

Other Possible Interim Actions Considered and Rejected 1

i i

4 0

i 4

STATERNT OF PROBLEM 0 FIRST BATTEU_E STUDY - 1967 9 SECOND BATTELLE STUDY - 1975 8 RESULTS INDICATED SIGNIFICANT PROBLEMS WIm CONSISTENCY AND ACCURACY OF DOSIMETER PROCESSING e

e

REGULATORYACTIONCUPLETED 0 HPSSC REQUESTED TO DEVELT NEW STANDARD - 1975 4 DRAFT STANDARD AVAILABLE lbVEMBER,1976 O PuBLIC MEETItE HELD DECEMBER, 1976 0 IDEA 0F PERFORMANCE IESTIE WEU. ACCEPTED 0 PILOT STUDY TO TEST STANDARD STRONGLY REC 0iMENDED 0 PILOT STUDY CONDUCTED 1977 - 1979 O

O

P_Il0TSTUDY

$ CONDUCTED BY THE UNIV. OF MICH. UNDER NRC CONTRACT

$ VOLUNTARY PARTICIPATION

$ CONFIDENTIALITY OF PROCESSOR PERFORMAtCE

$ 59 PROCESSORS PARTICIPATED 0 PARTICIPANTS PROCESS ABOUT W OF US PERSONNEL DOSIMETERS S 8 RADIATION CATEGORIES I TESTING PROCEDURE e

m 9

RESULTS OF THE PILOT STUDY

$ CONFIRMED lliE liPSSC/ ANSI STANDARD AS GENERALLY ACCEPTABLE '

0 INDICATED NECESSARY CHAtEES IN STANDARD

$ CONFIRMED SIGNIFICANT PROBLEMS WITH CONSISTEfEY AND ACCURACY OF DOSIMETER PROCESSITE O

e

REGULAT m Y ACTION PLN NED 8 REGULATORY REQUIREMENT FOR DOSIMETRY PROCESSOR CERTIFICATION 4 REVISION OF HPSSC STAf0ARD - SlmER 1980 (EVENTUAL ISSUE BY N6D 8 MEETING WIE CONISSION TO DISCUSS COMMENTS AND ISSUES - SUMMER 1980 8 PUBLICATION OF PROPOSED RULE - FALL 1980 8 PUBLICATION OF EFFECTIVE RULE - StmER 1981 G

9

CORRECTIVE INTERIM ACTIONS TAKEN 0 PILOT STUDY COMPLETED

- DISCOVERY OF PROBLEMS, VOLUNTARY CORRECTIONS

-DRAFTSTANDARDIESTEDANDEVALUATED

- IMPACT OF STANDARD 0 LIMITED SITE VISITS BY CONTRACTOR

-IDENTIFICATIONOFCAUSESFORPOORPERFORMANCE

-METHODSOFCORRECTION 8ADVANCENOTICEOFRULEMAKING

- PROPOSED RULE TO REQUIRE CERTIFICATION

-INDICATESADOPTIONOFREVISEDHPSSCSTANDARD

-IMPACTOFTHEADVANCENOTICE

.PROMOTEMANAGEMENTAPPROVALFOREXPENDITURES

. POSITIVE IMPACT ON THIRD ROUND OF TESTING

. INCREASE IMPACT OF ClRRENT SITE VISITS BY Ifl

$ LETTERS TO LICENSEES AND PROCESSORS

- TO ACCOMPANY ADVANCE NOTICE MAILING (VOLUNTARY ACTION)

- DISCUSS CAUSES OF POOR PERFORMANCE f

9

CORRECTIVE INTERIM ACTIONS IO dE IAKEN 0 ADDITIONAL SITE VISITS BY CONTRACTOR S THIRD ROUND OF IESTING

- SIGNIFICANT CHANGES IN THE STANDARD

- TEST THE REVISED STANDARD

- PERMIT ADOPTION OF BEST CRITERIA IF CHOICES ARISE

- ALLOW TEST OF PROCESSORS AFTER SITE VISITS 8 WCaKSHOP

-TECHNICALDOSIMETRYPROBLEMS

- ELEMENTS OF A QUALITY ASSURANCE PROGRAM

- C0fEENTS ON ADVANCE NOTICE e

F S

OTHER POSSIBLE INTERIM ACTIONS (CONSIDERED AND REJECTED)

I DOSIMETRY QA REQUIREMENTS 9 ON LICENSEES S LETTER, 4IECIRCULARORBULLETIN, O LICENSE AMENDMENT, OR IECH SPEC 9 ORDER SONPROCESSORS

$IMMEDIATELYEFFECTIVEREGULATION i

1 9

~

~

~

Federal Register / V:L 45. Nr 82 / Friday. March 28, 1980 / Proposed Rules 20493

-~

AcTices Advance notice of. Maa diferences between the dosameter to improve accuracy in personnel inadiation techniques used by the tester dosimetry.

^ and the calibration methoda used by the prae===a s; this possiblility is discussed aussesanv: Tests have indicated that a in the following paragraph. However, signiRenat percentage of penanel actualinaccuracies may arise because dos,imetry processors may not be ofinadequate quality controlin b-a-.with an appropriate desme.

dosimeter manufacturing orin a few of accuracy. Altematives for action to cases because of ineptitude on the part correct this situation are presented-of thiprocessor.nese diferent

. Interested persons are invited to submit problems would require diferent...

maa=+=*= on these alternatives.

,,guiga,,,,o that appropriate regulatory

- paise: t'a===* should be received by corrective action is very dep=ad==t on a

May 27.19e0..

better

'.; J:-e f the causes of the o

mooneesser t'-te or suggestions problem.

for con ideration in -a-ceian with.

Regarding the adoption of methods for these alternatives may be sent to the-

..c.1, this problem,it is evident

' - Secretary of the t'a==i==laa UA from at least two I g,d.st Nuclear Regulatory Commission.

eaa*id-ations that caution should be washington,D.C.20555. Attention: -

exercised.First. as previoulsy fiacir=*ing and Service Branch. Copies of. mentioned, the inena=iatent test ca===ats received may be =r=aila=d at measurements refer to diferences the Commission's Public Document between the amount of radiation Room.1717,H Street NW. Washington.. delivered to a dosimeter, under highly D.C.

controlled laboratory conditions, by the ron Puerrteen enronasattoes coerract:

Individuals conducting the test, and the Mr. Robert E. Alexander. OfBce of amount of radiation subsequently Standards Development. U.S. Nuclear reported by the processor.These tests l

Regulatory Co==le= Ion. Washington, do not necessarily measure the I

D.C.20555,301-443-5075.

difference between the radiation -

delivered to a' dosimeter worn by a surrtmeerrany neronesafiose Recent worker and the radiation subseouently l

tests indicate that a significant percentage of the personnel dosimetry reported by the processor. For example.

processors in the United States are not the radiatim source used by the bifm Jog with a degree of accuracy pmcassor to calibrate the dosimeter acceptable to the NRC when compared may emit radition of the same or very against a consensus standard prepamd similar quality as the radiation to which under the auspices of the American the worker is exposed, but may be quits National Standards Institute.' To the different from the radiation used by the extent that these test results are tester to irradiate the processor's test dosimeters.Thus, standardization of representative of routine field conditions, the results indicate that the calibration techniques among U.S.

dose received by occupationally

' Processors, which may be essential for exposed personnelmay often be achieving good performanca in a test conriderably differea' from the dose program, could in some cases produce reported by the dosimetry processor.

apparent improved accuracy while Where complete reliance for individual actually introducing greater errors in the personnel dose measurement process.*

• i dose dete9 mations is placed on ~

~

This consideration is an Integral part of personras dosimeters, control of individual radiation exposures may not the personnel dosimetry problem and must receive full consideration in be accomplished as well as is indicated,

• 'and compliance with regulatory dose corrective action planning.

i t

limits tasy not. in fact. be achieved. The Secondly, any regulatory action taken test results indicate that individual must be handled in a manner to ensure doses may be over or understated.

that sufBcient personneldosimetry

'Further, these incorrect measurements services remain available, could become a source of error when the Unnecessarily severe or improper.

dosimetry data are used in corrective action could reduce the epidemiological studies intended to number of available processors to the investigate the does-effect relationship.

extent that the dose determinations for

.10 CFR Part 20 he principalcauses of the some workers could be adversely inconsistent test measurements that affected.

l Advance Notice of Rulemaking on have been observed are not well l

Certification of Personnel Dosimetry understood. Here is some evidence that

• • For example, a pmcasser may calibrate beta d**'**'" * * ** *t a uramm fueuabncauan Processors the inconsistencies are due primarily to plant usans e uranium slatz the tester may use a

"""""8'"""**P"c'"'""!d**"

Aoemcv:U.S. Nuclear RegulatofY

• Ptiot study conducted for the NRC by the measure the workers doses accurately but could

&mmla= ion.

University of blichisan, fail the performance test.

20194

' Fodn. cal Register / Vol. 45. Nr. 62 / Friday. M rch 18, 1980 / Proposed Rulco One of the major sources of error in-discussions revealed general agreement this study, the UM submitted monthly personnel dosimetry is known to be the that a personnel dosimetry pmblem

, progress reports to the NRC.These potential difference between the actual does exist and that the problemis reports are available for inspection or dose received by the dosimeter and the suffidently broad in scope that it should copyingin the Commission's Public

- actual dose received by the wearer.

be addressed by the Federal Document Room.1717 H Street.NW.,

Such differences can forexample, be government.However many of the Washington D.C. Copies may also be due to shielding of the dosimeter by the.

attendees cautioned against precipitous obtained by contacting the Public

• body when the worker is not facing the action and strongly recanmanded a Document Room. (202) 634-3273. h source of radiation or due to different pilot study (1) to evaluate the drafi final report for the study.NUREC/CR-Irradiation of the part of the body on HPSSC/ ANSI =8madard and (2) to.

~ 1084.may be purchased froen National which the dosimeteris worn than'of provide processors the opportunity to

.,TachnicalInformation Service.

other parts of the body. nase. sources of take any nacaa== y corrective actions la Springfield. Vissinia 22181.

error are w~,.;.4 bet are not partof their operations prior to the h draft et==la d aHowed the &

J.. processing problem thatis implementatio i of new Federal proosetors to be tested in eight different being considered forcorrection.

regulations on the dosimetry radiados cetegoswe.h tersa-A FederalInteragency Policy -

p '== problem.nese

. " category" refers to the type of r=as.es.-

Committee on PersonnelDoeinstry reenmmandations were accepted and Performance has been formed to' guide the NuclearRegulatory Com=i-ion?

being measured.For example. Category and coordinate correction of the (NRC) subsequently issued e contract to I ls gamma radiation. Category 2 is high -

dosimetry processorperformance the University of'" ' * - - (UM) to energy X-radiation. Category 3 is low energy X. radiation, etc. Within each problem. Represented on this Committee conduct a two. year pilotitudy.& -

category of the draft standard were are: the Bureau of Radiological Health objectives of this study werer (HEW). the Department of Defense, the (1)To determinewhether the draft several dose ranges called intervals.ne Department of Energy,the HPSSC/ ANSI standard provides an consensus standard used in the pilot adequate and' study evaluated a processor's ability to EnvironmentalProtection Agency the National Bureau of Standards (NBS), the performance: practical test cf dosimetry

• consistently and accurately perform Nuclear Regulatory r%=d--6= the (2)Togiveprocessorsanc,,..; ;;r within a specific tolerance limit for each OccupationalSafety and Health.

. to correct any problems that are interval Failure to pass one interval Administration (DOL).and the uncovered:

within the category would cause a Conference of Radiation Control (3) To develop operationaland fail the Program Directors (States). Dosimetry administrative procedures to be used A

ladox.P was calcula processors and users haveindicated later by a ent testing laboratory, for each dosimeter as(reported does agreement that some correcstve action is ne stu y wascompleted December minus the delivered dose) divided by the appropriate. A woriang group of the 3L 1979.

MM h F himW i

Health Physics Society Standards Conditions of the cont'ract included a average Performanc= index. P. and its Committee (HPSSC) has developed and provision that any personnel dosimetry standard devianon.S wm calculated.

the American National Standards processor in the United States would be h draft standard incorpated a Institute (ANSI) has published a draft allowed to perdcipate in the study on a - statistical test.P + 2S equal to orless

. standard for doalmetr / performance strictly voluntary basis, provided only.

than a specific tolerance value.&

(N13.11. July 1978). This standard is that the dosimeters tested be restricted tolerance value for any given interval -

t considered to be the most ircportant to those used to provide the permanent was a function of the average delivered i

element in a corrective program. An.

record of occupational exposures.

dose and varied from 0.3 to 2.0. A industry committee (Personnel Processors were told that the UM would processor could only pass a given Dosimetry Overview Committee) has keep test results confidential (i.e., that category Iallintervals of a respective been formed to assist in ensuring that no organization other than the UM category vempassed..

aay proposed regulatory actionis would be able to associate specific At the e onclusion of the first round of effective and appropriate to the need.

results with the name of a processor),

testing. t! e results were examined by However, agreement has not been that all results would be published (in the NRC staff. by the Interagency Policy reached as to the specific action that.

coded form) that the UM would charge CommiNee on Personnel Dosimetry should be taken. Alternative corrective no fee for particfpation, that the new.

Performance, and by the industry's sctions under consideration are HPSSC/ ANSI standard would be used -

Personnel Dosimetry Overview discussed below, to evaluate their performance, that each Committee. The results Indicated poor

~

Recent Federal Gownment Action participant would be given the

. performance on the part of many opportunity to be tested twice and.

processors. Only 23% of the category Some time ago, on November 30 and would also begiven an opportunity to tests attempted by the processors were December 1.1976. the Nuclear discuss with UM personnel the possible passed, using the criteria in the HPSSC Regulatory Commission and other' reasons for any poor performance prior - ANSI standard. None of the processors Federal agencies conducted a public

. to the second round of tests, and that passed all of the tests attempted in the meeting at which the personnel the accuracy of the Irradiations first round but every category test was dosimetry performance problem was - provided by the UM would be verified passed by at least one processor.These discussed in an open forum by by the NBS, and that UM facilities and facts indicate that the standard is personneldosimetry processors, dosimetry users, and representatives of equipment would be open to inspection achievable and suggest that the problem by the participants prior to the may lie with the processor and/or with i

State governments and Federal beginning of the tests. An open heuse differences in irradiation techniques egencies. Other co-sponsors of this was conducted for the latter purpose by used by the UM and those used by the l

meeting were the Energy Research and the UM on April 20.1978. Fifty-nine processors during their calibration Development Administration (now the processors participated in the study:it is procedures.The participants' Department of Energy) and the Bureau believed that very few U.S. processors performance in the first round was also l

ofRadiologicalHealth hse did not participate. Dunna the course of evaluated used a simple percentage-

~

~

Federal Register / Vol. 45. No. 82 / Friday March 28; 1980 / Proposed Rules 20495 passed basis (as opposed to the more After can=Maring this situation, the have been certlSed as welras those who complicated statistical formula of the Interagency Committee on Personnel

'have lost their certification: (4) would stan< lard). Again senerally poor Dosimetry Performance made the (except for one possibility noted below) l performance was indicated.Using a following reco====A=tions:

name the testing and certification simple 305 pass. fall criterion for each (1) ne actual causes of the poor laboratory (s) requimd to be used: (5)-

and every dosimeterin a category performance should be determined v<ith would stipulate that the laboratory (s) during the first round of tests, the a greater degree of certainty before would be monitored for technical weighted average of au the processors

"""*"" plans for corrective action:

competence by the National Bureau of reveals 7% of the category tests were (2) A notice should be published in the Standards: and (6) would specify the passed (Le all dosimeters tested in au Federal Register for the purpose of is.4. to be used for reinstating intervals of the category feu within the notifying alli---- ' dosimetry processors who have lost their 230% criterion). Using a 150% criterion ' processors and the public that the certifications and have appealed.

in the same manner. 21% of the category Federal Government la determined to

. Subsequently, other affected Federal tests wwe paned.Dus, the results

- take action as -==>y to correct the and State ag==ria= would be likely to.

using the draft standard are sindar to F

dosimetry problem.

. consider adopting similar agulations.

those using b 150% critwien.

Subsequently, the NRC staff Although it is estimated that only about authorized the UM to conduct a series of 15% of U.S. personnel occupationally l

It had been andcipated at the that site visits with eight of thelargest exposed to me.asurable In91 ring beginning of the pilot stud [poorly during ' procusars to try m detemine se l

radiadas (eg, above 30 mmas pw processors who performe the first round of testing would be able causes of pw performanca At the month) are engagedin NRC-licensed.

conclusion of these site visits, the UM activities, it should be recognized that

' to take corrective action prior to the personalpapand a reportwhich any NRC regulations in this area would second round and would improve their - indicates fw major cams:

affect a much large pawntagt his is puformance %e second-round results did indicate improvement over the first (1) Inadequate cahbradon sources, true because most canmweial (2) Variabilityin the processors serve customers other than round. Approximately35% of the thermoluminescent dosimeter chips.

NRClicensees, and anyimprovements category tests were passed.Using a (3) C!wical was, in &eir opwedons would be Ekely to simple 30% pass. fall criterion for each (4) Lack of effort on the part of the benefit all of their customers rather than dosimeter in a category during the processors to make the changes

-. just the NRC licensees.

second round of tests, the weighted necessary to pass the tests.

Several alternatives are possible as to average of all the processors reveals.

His report. dated May 1979. is '

the operation of the testing and 19% of the category tests were passed avaHable in b Comminion's Public.

certification laboratory (s):

(Le alldosimeters testedin allintervals Document Room in the !!!e on personnel (1) UnspecifiedLaboratory(s). This goh,'I f 50% crit dosimetry puformance testing.

alternative would require an onin the amendment to the NRC regulations as same ma mar. 32% of the category, tests Future Action described above but without naming the w"e pasud.

De pilot study was completed by the testing laboratory (s). The processors Processor performance was not based UM on December 31.1979. Future action and users would thereby be left to their on the percentage of dosimeters that will be based in part on the final report.

own initiatives to establish one or more individually passed the criteria set forth However. it is possible at this time to laboratories which would have to be in the standard. Of the 23.000 individual

dentify the following actions that the monitored by the NBS.%e NRC would dosimeters evaluated during the pilot NRC has under consideration.

have no control over the laboratory (s),

study.85% of the dosimeters tested except through regulations applying to passid round one of the tests and 90% of Prae===a Cetification its licensees. Howeyw. if it is stipulated the dosimeters passed in the second According to this plan.the NRC would that the licensee must obtain personnel round. Failure of the 15% and 10% of the issue new regulations stating that dosimetry results under conditions as dosimeters tested to meet minimum personnel dosimetry results would be described above (except for naming the tolerances established by the HPSSC/

acceptable only if provided by a testing and certification laboratory (s)).

ANSIin the standard is an processor who is certified by a testing NRClicensees could only use a unsatisfactory level of performance (Ls certifying) laboratory approved by, processor who complies with these when determininq individual dose or_specifted by, the NRC.

conditions, including monitoring by the assessments. In the pilot study for nose processors would have to NBS.

example,high doses (i.e 000 rads) obtain and maintain their certification (2)NRC.OpemtedLaboratory.His delivered to some of the test dosimeters by passing, at a specified frequency, alternative would also require an were actually undetected by some of the performance tests conducted by the amendment to the NRC regulations as processors.

certifying laboratory. The certifying described above,but the testing One proceesor, whose results la the laboratory (s) would use performance laboratory would be a Government first round were very poor, worked with criteria published by the American facility managed and operated by NRC UM personnel to identify and effect the National Standards Institute (ANSI) and employees. By charging an appropriate necessary changes in the process and referenced in the new regulations. nese testing fee, costs for establishing, then performed very well during the regulations: (1) Would adopt. possibly in maintaining, and operating the second round, passing all categories modified form, the final ANSI standa-d laboratory could be recovered.

attempted bat one. Another processor evolving from draft ANSI standard (3) NRC.ContmetedLaboratory.

passed all eight of the categories.These N13.11:(2) would specify how frequent.y Similar regulation amendments would facts provide rather strong indications processors would have to demonstrste, be needed for this alternative. but the that conformance with the standard is through testing. their ability to comply laboratory would be operated by an attainable, but that many processors with this standard: (3) would establish NRC contractor. using the contractor's have not made the necessary changes in the procedure to be used by the NRC to facilities. Funding would be provided by their operations.

let its licensees know which processors testing fees.

l l

20496 Federal Register / Vcl. 45. Ns. 62 / Frid y. March 28. 1980 / Proposed Rule _s_

(4) FedemiCovernment(non-NRC)

Opemtad Laborotory. Similar regulatio amendments would be needed for this citernative, but this testing laboratory would be operated by an agency of the Federal Government other than the NRC. preferably by one of the agencies cxperienced in laboratory testing work.

Existing expertise could be utilized, or qualified personnel could be employed.

The facilities would be Government-owned; funding would be provided by testing fees.

InvitationTo

-n-e r

Information perhining to the personnel dosimetry problem A_i==M in this notice is invited, including comments on the alternative solutions discribed, suggestions of other

- citernatives, and estimates of costs anticipated in the process modifications nicessary to permit successful passing of the ANSI standard criteria.

Comments should be received by May 27.1980.

Dated at Washington D.C., this 21st day of

. March 198(L For the Nuclear Regulatory Commission.

Willians 1. Dircks.

Actitig Executive Directorfor Opetutions.

gra on. seasis ru.d w-aa an I 58L1JNG Coot rS064NS 1

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