ML20147J316

Transcripts of Pub Meeting,Discussion of Status of S-3 Interim Rule.Pp.1-31

ML20147J316
Person / Time
Issue date:	12/14/1978
From:	Gilinsky V, Hendrie J, Kennedy R NRC COMMISSION (OCM)
To:
References
REF-10CFR9.7 NUDOCS 7812280048
Download: ML20147J316 (32)

Text

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O NU C1.! A R R E G U L AT C R Y CO MM I S S I O N-w IN THE M ATTER O F:

PUBLIC MEETING

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DISCUSSION OF STATUS OF S-3 INTERIM RULE Piece. Washington, D. C.

Octe - Thursday, 14 December 1978

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DISCLAIMER This is an unofficial transcript of a meeting of the United States

!!uclear Regula: ry Commission held on la noce-8.-, o,o in the Ccmmission's offices at 1717 H street, ii. W., Wasningt:n, D. C.

The meeting was open t.c public attandance and observation.

Th'i s transcript has not been reviewed, corrected, or editad, and it may contain inaccuracies.

. The transcript is intended solely for general informa'ticnal purposes.

As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the mat:ars discussed.

Excressiens of cpinien in this transcript do not necessarily reflect final detarminations or beliefs.

l10 pleading or other paper may be filed with the C:mmission in any proceeding as the result of or addressed to any statement or argument contained herein, except as the Ccmmission may authorize.

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UNITED STATES OF AMERICA i

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NUCLEAR REGULATORY COMMISSION I

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PUBLIC MEETING 4:

DISCUSSION OF STATUS OF S-3 INTERIM RULE l

5l I

6 Room'1130 7l 1717 H Street, N. W.

Washington, D. C.

8l Thursday, 14 December 1978 9l l

The Commission met, pursuant to notice, at 1:40 p.m.

10 BEFORE :

11,

I DR. JOSEPH M. HENDRIE, Chairman 12 '

VICTOR GILINSKY, Commissioner 13,

RICRARD T. KENNEDY, Commissioner 14 PETER A. BRADFORD, Commissioner 15 3

JOHN F. AHEARNE, Commissioner 16 '

PRESENT:

17 Messrs. Eilperin, Slaggie, and Sege.

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- _R O C_ _E _E _D _I _N G_ _S P

i 2l CEAIRMAN HENDRIE:

Why don't we come to order and t

' get started on this afternoon's meeting, some of which I hope 3

will come to tidier ends than this morning 's session.

I

$l The subject for this afternoon is a discussion of 6 l the status of the S-3 Interim Rule rule making, and the Office 7l of the General Counsel will assist us in this discussion.

Please go ahead.

3 COMMISSIONER KENNEDY:

What is the issue we are here 9

to discuss?

Maybe we could start with that?

10

)

I 11 i MR. SLAGGIE:

The point is well taken.

The real issue before the Commission today is whether to have an oral 12 j3 j presentation as part of the Commission's activities to making I its decision on the S-3 rule making.

y In the Ccmmission's Order of October 19 th that went 15 l

out to all the parties, it said -- you asked the parties to 16 1

make written comments to the Commission once they had seen the j7 jglreccmmendations.

The Order also caid that the Commission was 19 thinking about having up to three hours of oral presentations 20 ; but had not made up its mind, and wanted parties to give expres-i sions of interest to indicate what they might talk about.

21 i i

Well, the Hearing Board's recommendations came out on m,

i 23, 0ctober 26 th, and it really is maybe relevant to today's discus-24 sion to summarize the.a very briefly.

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25 The Hearing Board recommended that the Commissi n i

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f should adopt Table S-3 as modified by the staff, which was j

2; submitted as an appendix to the staff's final submission before 3]

the Hearing Board.

That is part of the recommendation.

l The second part would be, however, to add an explana ;

4 i

t ry narrative t that table as part of the final rule.

5 And third, the Hearing Board made a number of recom- !

6 l

mendations for the general update of the rule, as part of this ;

7 general update of WASH-1248.

So in'a sense, what they are 3

proposing or suggesting that the Commission should do before 9

next March 14th does not end the matter of what they think 10 1

ought to be done with regard to the fuel cycle rule.

ij 12 Okay, there were nine written comments that came i

in, including comments from the NRC staff.

Three of these j3 i

ja

. comments were very anti-Hearing Board reccmmendations.

NRDC l

15 and Marvin Lewis basically opposed the Hearing Board's recem-l 16 lmendation.

j7 They said that they had a number of objections with 18 lthe actual numbers in the table.

The NRDC was in favor of an 4

I 19 ' explanatory narrative, but felt that it should be more elaborate 20 and have a greater scope than the narrative that the Hearing i

Board has suggested.

21 COMMISSIONER AHEARNE:

Didn't they basically say 22 23 f that the Hearing. Board's position was -- should be thrown out, and the record used to write a narrative?

24 op.cerei neooners. Inc..

25 l MR. SLAGGIE:

At least, insofar as the numbers in t

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the table, yes.

They said:

This is totally inadequate, and I

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2 other language of that sort.

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MR. EILPERIN:

A lot of parties made the point that 4l they thought that the record has been developed sufficient to i

5 deal with the problem.

6 l' MR. SLAF'i!E :

The NRDC said that the Commission l

l 7

could expeditiously prepare what they would regard as an ade-ai quate rule based on the record that they now have.

9 Now the utility groups were, in the main, in favor l

10, of the Hearing Board's recommendation that you adopt a modified I

11 i Table S-3, but they weren' t so keen on the idea of this 12 '

explanatory narrative, i

13 j The Nuclear Regulatory Commissi'n Staff, as I under-o l

14 stand, our participation was naturally in f avor of the Board's 15 recommendation to adopt a table that they proposed.

As far as 16 an explanatory narrative goes, it is my understanding that the 17, staff's position is:

they f avor the idea of an explanatory la, narrative.

They are working on an explanatory narrative, a draft 19 of which would be available sometime in February, but it is not I

i their view that this narrative should be attached or made cart 20,

! of the rule right now; that ultimately that would be done, at 21 I

t 22 l the conclusion of the general update.

I 23 i Well, in the future there is some " grand finale" rule 24 q that will include a giant explanatory narrative, but the staff ACO-FM:graf Recorrert, Ific.1 25 ' does not advocate putting that narrative in right at the acment.

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in that sense, the staff is not entirely in 1

2 l agreement with the Hearing Board recommendations, as I under-stand the Hearing Board recommendations and as I understand the y

staff position.

4 5l Now with regard to oral argument, the parties have i

! said the Hearing Board recommendations are hopelessly.inade-6 1

1

.j 7l quate -- not " hopelessly," but they said " inadequate. "

They i

! said, "we want oral argument; we want to ccme in and make a 3

9' presentation."

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The State of New York, however, did not.

New York 10 l

said that the interim rule as proposed by the Hearing Board is j; ;

I 12 :

inadequate because there has been no demonstration that the i

model f acility for which the numbers are based are economically,

13 feasible.

That is the point that New York has made throughout 33 13 the proceeding and continues to make that point.

i 16 They say you cannot adopt a rule because the economic

'l feasibility has not been shown.

And, they say you cannot even

7 L continue to use an interim rule, for the same reason.

18 19 l They also say that they have said all that they have 20 !

to say -- you can read it in the record and in the report --

and they don't much want to come in and talk about i t, but they 21 will if you ask them to.

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i 73 ;

CCMMISSIONER AHEARNE:

They seem to go a little bit 24 f ur ther, don ' t they?

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In addition to concluding that the record doesn' t a

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i or Ithat the case has not been made that it is feasible,

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economically feasible, in fact they claim just the opposite:

2 that the record establishes that it is infeasible.

3 i

4l MR. SLAGGIE:

Yes; that's right.

That is correct.

COMMISSIONER AHEARNE:

And as Steve said, they also 5

say the record is adequate to support the case.

It is just l

6 that the conclusion is different.

7 MR. SLAGGIE:

They come up with a different conclu-8

! sion and they would, if you wanted to ask them questions, they 9

I 10 : would send somebody down.

But they were meaning about having 11, a 40 percent reduction in their staf f, and it is kind of a i

12 lhardship case, and so they want to know early if you want them to come down.

13 14 l Ohio and Wisconsin, I found, had a somewhat confusing i

1 15 comment.

Basically what they say is that socioeconomic impacts c

16 have been treated in a confusing fashion in the record.

The j7 l record is confused on socioeconcmic impacts.

i They seem to feel that the staf f 's treatment has not jg I

19 l been adequate.

They are not clear on whether this in any way l

20 l affects the rule, because it is not clear to them whether the t

! rule purports to address socioeconomic impacts, or whether this 21 is a matter like some other matters ' that can be considered in 22.

I 23 i the individual licensing.

24 ;

They wanted to come down and make 10-minute presen-c..se w i m omen.inc tLtions.

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The utility groups, with the exception of TVA --

i 2 iwell, TVA was a little unclear -- but two major utility groups h

3' said they did not see any need for oral argument; but if the a' Commission decides to have it, they definitely want to come down S' and speak at it.

6 TVA was a little ambiguous.

I could not tell whether 7

they were saying -- well, they certainly said "we see no need I

8 i for it, and we don't have anything to say," but it was not 9' clear whether, if we choose to have oral argument, they would i

10, want to come down and be a part of it.

11 l The NRC staf f, I believe, also -- although their 12 comments did not say they were opposed to oral argument -- in I

13 l the past they felt that it would not be useful, but they also I

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14 volunteered to answer Commission cuestions, and the staff said i

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15 i that if you have oral arguments, in effect, to let the people j

i 16 ccme down and get the problems off their' chests, that the staff 17 wants to talk for about 15 or 20 minutes in support of the 18 Hearing Board's recommendation.

l 19 i So that is the picture on the comments on oral I

20 l arguments.

21 l The OGC recommendation is that you have oral argu-l 22 l ments, based on these comments and based upon what we see as

-l 23 the general status of the whole rule making.

We think at this 24 l point, at least in our minds, the direction of what the esJecerti Aeoorters, Inc, ;

25 Ccmmission ought ultimately to do on this rule making is not i

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1 entirely clear.

2l There are a number of issues still hanging around.

3 One would be:

Well, are the numbers in this table presently 1

4l adequate?

And if not, well, which ones are and which ones i

5 aren't?

I I

There has been controversy about that.

There is 6l l

7! certainly a question about what this explanatory narrative l

8!

should contain, and procedurally when it should come in and how i

9 it should be treated.

t 10 l It is in a situation where, if you haven't made up 11 l your minds, if you haven't, about precisely what it is you want 12 l to do, that is a classic situation to have additional oral 13 presentation, have people come in and talk about it.

I 14 l Fur ther, it is a chance -- and maybe a last chance -

15 to hear a response to some of the criticisms that have been i

16 ;

taised about the Board's recommendations.

Il 17 We have these comments saying the Scard's recommen-13 ; dations are adequate for a variety of reasons.

But the 19 i parties who would disagree with those comments have not really i

i' 20 l had an opportunity t: come in and tell the Commission in detail 21 l

why they would disagree.

22 l So oral presentations would give you a chance to 23 l hear that.

2d i And finally, it seems at this point tha t the

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25 Commission's decision on this rule is bound to be controversial.

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i It is not going to be a feast of harmony at which everybody says 2l"weallsupport the decision."

There are people that are going i

3 i to say -- whichever way you go -- they are going to say "this is awful."

i 4l 5!

And my feeling, in circumstances like that is:

It l

6j is desirable to have everybody given a maximum reasonable 7

Opportunity to get his feelings off his chest in front of the 8 i body that is actually going to make the decision that ultimately i

l 9! maybe they are not going to like too much.

lo So summing these reasons together, we f eel oral argu-ments are a good idea.

We ha <e consulted with the Secretary's 11 i

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12 i Office, and tpparently January the 18th would be the first i

13 l time, reasonably, when every, body is going to be all together.

14 l We have suggested that you allow each party 20 15 minutes for presentation; if all 9 come in and talk the whole i

16 20 minutes, that is about 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />.

That would include time for 17 the Commissioners -- that will include questioning time.

COMMISSIONER GILINSKY:

Why did you reccmmend 19 l i

19 j letting TVA and not New York State --

l 20 j COMMISSIONER KENNEDY:

I would ask the same quescion.

I 21 MR. SLAGGIE:

Well, I got a ccament frem Commissioner 22 Kennedy on that.

The reason why we did it that was is :

Our l

23 '

impression was that New York State definitely did not want to l

2a come.

They would ccme if " told" to come, but they would prefer o ;c w.i n m ents,inc.

25 ~ to sit up in the World Trade Tower and not spend the day ccming l

7-9 jwb 111 down here.

l From what TVA said, we just couldn't tell whether 2l I

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they were saying "we have nothing to say," or whether they were W

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i saying "we have nothing to _ say, but if you are going to hear 3

fr m ther people who have nothing to say, we will want to come 5

i down and say it, too."

l 6

i i

i COMMISSIONER AHEARNE:

Was New York the only party 7

tha t raised the economic issue?

8, MR. SLAGGIE:

Yes.

New York raised the economic 9l l

feasiblity, 10,

r 11 l COMMISSIONER AREARNE:

Were they the only ones?

12 !

MR. SLAGGIE:

They were only one that stressed

! economic feasibility.

Chio and Wisconsin have supported New 13 l

ja j York, but they are off on a socioeconomic impact which is i

somewhat different.

15 t

16 So in response to Commissioner Kennedy's comments, t

; we thought, "well, we will just invite everybody."

Certainly we want to make it plain that certainly New York is welcome to jg

9 l come down if they want to speak, but they should not f eel that l

20 l they are being draggoned into coming down here if they don't want t

speak.

21 1

I 32 i COMMISSIONER AHEARNE:

Although I would certainly i,

23 llike to encourage them, since they did raise one issue that no i

24 one else was raising.

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SLAGGIE:

Well, that is the reason why you may l

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want to ask them directly.

You might want to say, "we have come down her* and talk about it."

2lquestionswewanttoaskyou; MR. EILPERIN:

One way of encouraging New York, one 3

3l1 way of assisting the other parties, because it is a rather huge record and a rather short presentation time -- we're talking 5

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about a total of 20 minutes per side, or at least that is what l is proposed -- but it is a proceeding which has gone on for a 7

i long time, covering a lot of subjects.

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j We think, although we haven' t proposed it in the paper 9

we think it best that there could be specific questions that the jo ij Commission might address to the parties.

CCMMISSIONER GILINSKY:

For individual participants?

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MR. EILPERIN:

Well, it depends.

I mean, if there g

ja j are some which are very peculiar to one party, if it is a i

15 question of some comments that New York made on economic f easi-16 bility, you might just ask them those questions, or list those

'I' questions in advance.

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COMMISSIONER KENNEDY:

Anyone would be free to c0mment I

19 l on anything.

We would just say these are particular questions I

20 l or New York.

I MR. EILPERIN:

Sure.

And there have been some 21 l t

i recent legal developments which one might want to speak to, like 22 l

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the promulgation of the new CEQ regulations.

Those regulations 24 ' deal with what impact statements are supposed to look like.

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One of the things it tal-ks about is the idea of having i

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a " worst case analysis."

It's very specific that, if the 2 h world is uncertain, not only do you include -- not only do you 1 include what you think a realistic estimate is of the environ-3 3l mental impact, but you list what you think the uncertainties l

t are, and you put in the worst case.

5 Those regulations, by their terms, are supposed to --

6 1

well, are effective July '79.

But if one can comply with them 7

gl earlier, it would, needless to say, be useful to comply with

! them earlier,

9 i

I ja '

So one set of questions that people might be asked ij l to address are questions about:

Where would one get the worst-i 12 ; case analysis?

And what is the risk of uncertainty?

I j3 l It is a troubling rule making, and I think to the l

yl extent that we can list some of those questions and give parties i

i j3 advance notice about what the Commission is thinking about, 16 that is all to the good.

ll COMMISSIONER GILINSKY:

Is there some reason why all j7 18 of the parties need to be allotted the same amount of time?

i j9 ; Will they be equally active participants?

l 20 l MR. EILPERIN:

I don't think there is any need for fearful symmetry.

I think the only party I believe that requested 21 22 l m re time than 20 minutes was NRDC, which asked for 30 minutes.

I No one else, I believe, asked for more than 20.

23 !

1 24 MR. SLAGGII:

No one else asked for as much as 20.

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CCMMISSIONER AHEARNE:

I guess.my reason on both of 25,

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7-12 jwb, 14 {

l those points would be -- I think particularly in the case of 3

1 2 l New York, my f eeling would be that we should ask them and i

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encourage them to participate, particularly to address the

,! economic feasibility issue in which they were unique in stressing that.

5 As f ar as the time goes --

6, I

7l COMMISSIONER KENNEDY:

Are we satisfied that we do i

not have enough information in the comments that they have g

-l made to be able to deal with that, rather than dragging them 9

down here for that specific purpose when they don't want to 10,

11 i come?

l CHAIRMAN HENDRIE:

If they didn ' t feel they wanted 12 i

13 j to raise it further, why it's not clear to me --

I COMMISSIONER KENNEDY:

I'm satisfied; I know what ja,

15 they're talking about and what they said.

I'm not sure what more I'm going to get out of this, except a bill from the 16 q

' government, which I will send to you.

17 COMMISSIONER AHEARNE:

Well, I would like to ask the 13 19 l staff to respond to New York's concerns and issues, because I

af ter all, New York is basically saying that they could not get 20 hold of the detailed backup information.

It was unavailable to 21 l!

,2 }, them.

l 23 h They challenge all of the calculations.

They claim il 24,

the calculations are wrong.

And they challenge -- well, they kc3 hctrti Reporters, irtC.

25 ' ought to have an opportunity to challenge the application.

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15j I'm now asking the staf f to respond.

I would like t

f fer New York a chance to comment on that, also.

They 2

' don't have to.

It is their choice.

3 3;

On the time, I guess I would initially conclude that l

5l the times the people have asked for, we ought to at least i

l 6l consider allocating to them, but I really doubt whether three hours is going to be the time that it will completed.

I think 7

I gl that probably is that the five of us sit mute, and I doubt tha t i

9l will happen.

I MR. SLAGGIE:

Well, we scheduled it for a morning, 10 1

Il i so it can go over into the afternoon.

COMMISSIONER KENNEDY:

These proceedings are rather 12,

i

! different from our Commission meetings, which do tend to run

3 on just a trifle.

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i 15 l These proceedings are, I think -- or at least they 3

! always have been in the past four years of the Commission, are 16 1

' very orderly proceedings, scheduled -- and with schedules j7 adhered to, except when specific additional allocations have 18

9 f been granted by the Chair at the time of the hearing itself.

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20 l But the parties all understand, in accordance with the rules of such proceedings, that they have 20 minutes, or 21

• 2 l whatever the allocated amount is, and that includes whatever a

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23. time is taken from them in questioning.

i 24 So if they don' t get a chance to say more than i

Wederal Aeoo,ters, Inc.

" good morning" when they are asked a question, they will never 25 !

7-14 jwb 16 i

get a chance to make their presentation unless they are granted, f 1

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then, specific permission by the Chair to do so.

Isn't that the way the proceedings normally have 3

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! operated?

3 I

MR. EILPERIN:

I think that is probably true.

I 5

6, think that the real ' question is :

How much time does the Commis-1 l sion think it should allocate in order to be able to ask them 7

I questions that it wants to ask?

g Oral argument is really primarily for the benefit, 9

I think, of the Commission, rather than for the benefit of the 10 ij ! parties.

I think the real question is just that the Commis-12

3 l sion has to be satisfied that it has asked the questions it i

i ja ' wants to ask.

i Three hour s is a while to spend on this subject.

15 ;

COMMISSIONER KENNEDY:

Not for this Commission.

I 16,

il j7l mean, that is one of the more =inor subjects.

Three days is

g j more like it.

MR.. EILPERIN:

Well, it is a question of how much 39 l

I 20 ! concentration and effort one might have to sit through and ask i

questions.

We thought that three hours was enough.

21 COMMISSIONER KENNEDY:

I would be prepared to vote 22 23, f r that, immediately.

COMMISSIONER GILINSKY:

Are we going to be hearing 24 s o.7.c m i meoo,ters. inc.

25 the same arguments over and over again?

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7-15 jwb 17l I

1 MR. EILPERIN:

I don' t think so.

The Sierra Club's j

basic argument that they advanced differed from New York.

It 2

differed from Ohio.

It differed from NRDC.

3 i

Each group did take a different tack.

Sierra Club 4

t I

i said:

Look, the only thing they could have in terms of exper-3l

.ience on reprocessing is West Valley.

So that is what you have 6

to put down as what you think the expected impacts are, 7

i There is no basis, really, for predicting a much gi 1 better job than that.

As Leo mentioned, they talked about 9

jo, econcmic feasibility.

NRDC, many of its comment subjects are 11 not covered by a rule.

J Part of it dealt with the relative certainties or 12 ;

1 j3 j uncertainties of waste disposal technology and how one predicts i

ja !

that.

i i

So I think that-you will have a number of subjects 15

! <6 covered by the parties.

And if something is repetitive, you

' can always interrupt and ask than to go on to something else.

j7 COMMISSIONER AEF.ARNE:

Well, if we are establishing jg

! the total time for the process in this, then I guess I would 19 :

1 have to be interested in more like six hours.

20 7j l COMMISSIONER BRADFORD :

Well, there is this to be I said for going beyond three:

And that is, that the parties in 22 23 i the questioning time probably assumed that what they had to 24 say would take 10 minutes or 15 minutes or whatever they asked Ace 41dertl Recorters, Inc.

25 :

for.

They may not have thought about it in terms of what would 4

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1 happen if they found themselves facing questions.

2 What one might be able to say in 10 minutes might i

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easily become 20 if there were questions.

4l COMMISSIONER GILINSKY:

Let's see.

If you add up i

Sj 20 minutes for each one, it is 20 x 9, and that's where you i

6! come out with your 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />.

1 7l MR. SLAGGIE:

If people actually talk that long.

i 8

New the Sierra Club said, "We want to talk 15 minutes." i 9

Of course, other people said, "We don't want to talk at all, 10 ! but we will."

11 l COMMISSIONER AHEARNE:

My only concern is that, if 12 we are really establishing the outer boundary and we are saying i

l 13 l now that that 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> is the total time, it is a su:ficiently i

la ! important issue, and it is sufficiently complex that I think 15 it inappropriate to put that kind of a restriction on it.

16,

COMMISSIONER GILINSKY:

We can always take as much

l 17 time as we want.

CCMMISSIONER AHEARNE:

But as Dick just poinced out, 19 this is a different framework.

4 20 t COMMISSIONER KENNEDY:

We have always gone over the 21 time, but only in a relatively small degree, simply because we 22 have tried to discipline ourselves in the proceeding in order to-

.d 4 7 23 conclude it.

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COMMISSIO.fER GILINS.<Y:

If you are following some 2

line of inquiry that you thought was 1,p o-ta nt, you c ould 3

continue it.

4 COMMISSIOJER XENNEDY:

Yes, we did so.

5 COMMISSIONER GILINSKY: I think it is us e f ul to ha ve 6

guidance for the carticipants.

7 COMMISSIO.lER AHEARNS: Certa inly. I think thr ee 3

hours is cuite fine for guidance to tne oeople that are 9

coming in to present.

And I think, c erta inly. I would ce 10 prepared not to o c.f f into i rre levent fields.

Su I

il que ss at tne moment I feel that I have to be the judge of 12 tnat for myself, whether or not it's relevant.

And I would 13 not want to, f rom scratch, on this serious an issue say tnat la if the particicants coming in plan on having two or two and 15 a half hours of total presentation t ime, wnat they feel is 16 really important to say and we're coing out and asking tnem 17 and we're offering then the copor. unity to come in and say 13 it, I think it's unrealistic to then, to start witn a very Il tight elimination of the cotential to cuestion them.

2)

COVMISSIOJER GILI.'ISKY: It sounded, t ho ug h.

like 21 they night not take all of that time, particularly if we 22 indica ted that argument shouldn't be repeated.

23 MR. SLACGIE Our draf t order has not set any time 24 for the whole thing.

It just says 20 minutes shall ce 25 allott ed for presentations. It doesn't say, and the case she'l ACE-FEDERAL REPORTERS, INC, (202)347-3700

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fall shut at the end of three hours if pecole talk for 20 2

minute s and you say, that's f asc inat inc, go on.

I see no 3

real problem with doing that.

4 Then you get to the next person that has 20 ninute s and 5

you've sa id, this is incredibly coring, be culet, mavbe 'you 6

would have to cut him o f f in 20.

7 But this is an accordian tyoe of arrangement. It could 3

certainly soill over into the af ternoon, if that aopears 7

desirable to the commission.

20 minutes is really more of, 10 I think, an indication to the carties of the length of Il presentation that they might have in alnd, rather than a 12 straight jacket on the anount of tine that the commission can 13 allow itself to hear from any one person or f rom everybody.

la COMMISSIOJER BR ADFORD:

Though no exoerienced 15 attorney would come in with 20 minutes' worth of things to 16 s ay and exoect not to be int e rr uo t ed.

17 MR. SLAGGIE: I would exoect not. Wnenever I have l3 to go through an oral argument, I nave 20 minutes of things 19 to say, just in case I have to fill up the 20 minutes.

20 (Laughter.)

21 CHAIRMAN HENDRIE: You expect to get your central 22 points acro ss first and get those made and then see where the 23 discussion goes.

24 MR. SLAGGIE: Mr. Elloerin k eep s ins is ting I try to 25 do that, but I don't eften succeed.

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MR. EILFERIN I think this shows the need f or some 2

questions to be prooounded ahead of time to the parties 3

because this isn't like the tyoical legal argument in a 4

court, wnere you are rather clear as to what the issues are 5

and you have a fairly decent expectation about what kincs of 6

questions ar.e going to be that you're going to get.

this is a very broad-ranging rule-mak ing.

It deals with.

e 3

needle ss to say, many dif ferent and discrete tecnnical 9

issues, as well as assorted legal issues.

And I tnink we will 10 just get better presentations and better orecaretion to the 11 extent that one can show one's cards ahead of tine in terms i

12 of the sort of questions we might ask.

13 COMMISSIO;iER 3R ADFORO: Your propos ition, John, as la I understand it, you did not oo lect to giving the parties 15 20 minutes es guidelines for then to shoot at, as long as it was u derstood that the thing mignt well soill over into the n

16 17 afternoon.

IS CO MM I SS IO.lE R AHEARNE: Rignt. I nave not nad tne iJ experience that Dick has on how tne gu ideline s In these 20 operate, and I just wanted to coint out in advence tnat I 21 did not think it.was aporopriate to cut us o.ff from asking 22 questions.

23 COMMI3SladER 3RADFORD2 It would satisfy your 24 concern, though, as long as San does not schedule anotner 25 meeting for 18007 ACE-FEDERAL REPORTERS, INC. (202)347-3700 4

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COMMISSIONER AHEARNE : I don't care what he 2

schedules in the af ternoon.

It would satisfy my purpose if 3

st least it was understood that we weren't, by vot ing for a

the 20 minutes each, say ing that, yes, we agreed that when 5

that came, the guillo tine struck and we would stop as king 6

questions'.

7 CHAIRMAN HENDRIE: I guess for myself, the 20 minutes 3

a party I think would be ample.

It suggests two people, that 9

they concentrate on the central points, that they would at 10 this final sta e in the rule-making, like to make to the 11 commiss ion and not go all over the map, which I'm sure the 12 parties will do Lt more t ime is allowed.

13 I have a notion you're going to find tnree hours long 14 enough to listen here.

13 One of the things I suggest tnat the c o m.m i ss ion ' a e p in c

16 mind is that this is a conclex subject, that for precisely 17 that reason, the commission estaclisned a board to ", ear it.

1:

.ne board worked long and hard on it.

17 What vould you guess at the number of cays they we re in 23 active session?

21 MR. SLA0GIE: Just for their recoc.mendations alone?

22 MR. EILPERIN: I think there were 17 hearing days.

23 CHAIRMAN HEMDRIE: And the coard then worked.

24 presumacly a number of additional days to form tne 25 reco.mnendations to gather things up.

And then, finally. to ACE-FEDERAL REPORTERS, INC, (202)347-3700

23 788.08.5 gsh I

form the recommendations which we have asked them to make.

2 So what I'm suggesting to the commiss ion is if tnere is 3

any con templa tion he re that commissioners are, in f ac t, going 4

to learn everything they want to know about the S-3 5

rule-making proceeding f rom tnese oral presentations, I 6

suggest to you that in that case, you are f ailing to consider 7

the record which has been made here painf ully and over many 3

months, and which has been ore sented and summarized f or you 9

by the board constituted nere.

10 COMMISSI0 DER AHEARNE: I wasn't trying to say that, 11 Joe.

It was just Leo's point tnat no ma tt er how we come 12 out, people are going to be very upset.

And I wanted to make 13 sure that I had an adequate ooportunity to at least ask i

14 some po'ssible questions. But no. I was not under the 15 impre ss ion ' tha t that was going to work out like that.

15 CHAIRi1Ali iENDRIE: Well, I make the.coint in 17 particular cecause parties who do not agree witn :ne boaro 13 recommendations are o'oviously going to make a oitch to you 17 here that you must disregaro all of that.

20 COMMISSIOJER AHE ARNE: I understand.

21 CHAIRMAN HENDRIE: And listen to what they tell you 22 here in their final briefs.

23 dell, I don't know that I an enthused about it. Sut if :ne 24 majority of the commission wish it. I will not ocject.

There

~

25 is a proposed crcer in hand from the counsel's o ffice.

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take it that people would like to -- what is it precisely 2

you would like to do wita regard to New York State?

3 COMMISSIONER KENNEDY 2 I gave them some lanouage 4

yesterday to simply change the f ootnote to say we invitec tne 5

partic ipation of New York State end TVA, should they choose 6

to attend, putting Jew York in the same category as TVA. If 7

they would like to attend, we would be delighted to have 3

then, of course, but not mandating the ir acpearance.

?

CHAIRMAN HENDRIE:

How does that strike you?

10 COMMISSI0 DER AHEARNE:

douldn't New Yo r k mo s t 11 likely. I guess, focus upon their issue, anyway, even if they 12 weren't asked to?

13 MR. 5LAGGIE:

I would think so.

14 COMMISSIONER AHEARNE: I would say it is not 13 nec e ssary.

I would agree with Dick.

16 CHAIRMAN HENDRIE: They could suit thems elve s, so to 17 speak.

13 COMM ISS IO NER AHE AR.'IE : Did you strike the teotnote?

Id CHAIRMAN HENDRIE: Yes.

I tnink the whole footnote 20 goes. Put New York in up above and then put an asterisk, and 21 then down below just say what is it?

22 COMMISSIONER KENNEDY : It just deletes that business 23 about the cor. mission does not consider it reouired, and 24 ther. puts New York in ene re in tne same category es TVA.

25 MR. EILPERid Another coint in the croposed order ACE-FEDERAL REPORTERS, INC. (202)347-3700

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'88e08.7 gsh I

as it is now notes that the time period of 20 minutes per 2

party includes time allotted f or cuestions by the commission.

3 If one just wants to read tnat, that's fine.

If one wants 4

to dele te the idea that that is the expected time, whatever.

5 COMMISSI0 DER AHEARNE: I would delete that.

6 CHAIRMAN HENDRIE:

Ifhich sentence is that?

7 MR. EILPERIN:

It is in the middle of page 2, af ter 8

the listing of the various parties. Then it goes on to say 9

the time period in which time allo tted for cuestions by tne 10 comm i ss io n.

1I I think there was some sentiment to striking that.

I2 COMM I SS [ 0.4E R AHE ARNE : Yes.

13 MR. SLAGGIE You certainly have tne discretion to 14 let people-talk on if you want. This gives you the opportunity 15 to cut them off if you want.

16 COMMI SS IO:4ER 3R ADFORD: Why do we care if ceople 17 yield their time to others?

13 COVMISSIOc;ER GILINSXY: I would think we want tnen 19 to.

23 COMMISSICelER KEh?4EDY: That depends upon wna t you 21 mean oy " yield."

22 CHAIRMAN HENDRIE: The intent was if somecody has 23 10 minutes' worth of stuff to say, that he doesn't get to 24 sell another ten minutes.

So somebody else can now have 30 25 minutes.

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COMMISSIONER AHEARNE: dhy?

2 CHAIRMAd.HENDRIE: Secause, presumably, if a party l

l 3

has 10 minutes' worth of things to say, wny, that's what we 1

1 4

ought to hear.

5 COMMISSIONER AHEARNE:

The problem that at least I l

6 tho ught I saw here was that you are treating all parties 7

equivalently as though the contentions thcy nao raised, or 3

the issues they wanted to bring about for us to consioer 9

again were equa.11y lengtny and equally significant and there 10 was really no difference.

11 And it was not clear to me from your summary whether that 1

12 was true.

In fact, I thought that it was not true.

13 MR. SLAGGIE: I think it is not true with respect, I

}

14 perhaps, to one or two of the comments.

But my feeling on 4

15 that was it is difficult and pernaps, in a sense, somewhat j

r 16 invidious at this point to try to make distinc tions ce: ween l

i 17 wne is more im po r ta n t and wno is less important, and it is 2

13 cerhaps worth sitting inrough a few extra minutes of l

17 somebcdy's comments that aren't so cogent.

I 20 00W4ISSIGAER AHEARNE: Except what you might end uo 1

i 21 doing is sitting through a f ew extra minutes of somebody's 22 comments who aren't so cogent and foreshortening others 23 who might be.

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24

'4R. SLAGGIE: dell, again, nobody reouests that even 25 as mucn as 20 minutes, with the exception of NROC.

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COMMI SSIONER AHE ARNE : do what you're bas ically 2

do ing is cutting 10 minutes off of them.

3 MR. SLA00IE: Yes.

I think, ho we ve r, that the d

inherent flexibility of the situation, and it is the 5

commission's discretion or authority to handle this.

And i

6 we said brief rebuttal statements mey be allowed.

7 Well, how brief is brief ?

That is certainly an ocportunity, S

if you want to hear more from any carticular party, to give f

9 them a chance to talk on as long as you care to hear from 10 them.

11 MR. EILPEdIN: O r if yo u wan t, you can specify that 12 NRDC gets 30 minutes on the theory ths; they are the only 13 people who asked for 30 minutes.

j IJ I think it is wholly within tne commi.ssion's discretion 15 whichever way they want to go.

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COMMISSIONER BRADFORD: I would be incl.ined to 17 strike that trading provision and le t them shoo if they can 13 p ic k i t up fron someone else.

19 CHAIRMAN HENDRIE: What is the orief recu.ttal 20 sta tement? ?lhat does that contemplate?

21 COMMISSIONER SRADFORD: I suspect if you give NRDC 22 30, some others who didn't want it earlier might af terwards.

23 CHAIRMAN HENDRIE: I suspect so. :co, and you might a

24 get some difficulty in trying to cut off 30-minute parties 25 versus 20-minute carties ve rsus I C-minute parties.

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COMMISSIOJER 3R ADFORD: But that problem does not 2

arise if one can yield pieces of his time to another.

3 CHAIR'4AN HENDRIE: Okay. Strike the no-yielding. Now a

what about rebuttal statements? I am against them.

5 COMMI SSI0 DER KENNEDY:

I su pport them.

You are going 6

to have flat-out statements which are going to be diametrically 7

ocposed, raised in f ront of you.

It might be well, at least, 3

to hear what each says about the other's statement in this 9

regard before you go away. Otherwise, you're go ing to ha v s

]

1 10 to figure it out for yourself, if you can.

11 CHAIRMAN HENDRIE: I'm not sure that rebuttal 12 statenents are going to haopen.

I'm not sure they're go ing 13 to be much help.

la COMMISSIONER KENNEDY: They turn out usually to be 15 of considerable helo.

16 MR. EILPERIN: I guess we patterned this in a way 17 af ter an oral argument in court, and typically, you are la allowed to yield some terribly snort, or reserve some shor:

19 period of time to just answer the more colicue 20 mis representations of the person who preceded you.

21 And it usua.11y comes down to a 2-minue clincher rather tnan 22 a repe tition of what one has already gone through.

23 I think what we had in mind was, we might allow the 24 parties some five minutes, at most, just to get one last 25 ditch effort at the fellow.

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CHAIRMAN 'iE lDRIEi Okay.

Otner comments on the i

2 order, draft order?

3 COMMISSIONER GILINSKY: Let's see, are we drafting 4

some cuestions?

5 MR. EILPERIN: That is the next que s t io n. We can 6

consult with various commissioner offices and come up with 7

a list of questions.to supplement this order.

S I don't think one necessarily has to hold uo the order, 9

but the questions for the parties snould get to them witnin, 10 certainly, a couple of weeks witnin advance of the j

11 arguments so they have some idea.

12 COMMISS IONER XENNEDY: I think that is a scod idea, 13 and the order does not have to wait, then.

la MR. EILPERIN: That's right.

15 COMMISSIONER AHEARNE: On receipt of those questions, 16 on speaking to the lawyers, would the pecole conclude that 17 those are the questions that they hed cest address, whenner 13 or not those are the questions they felt ougn: to be 19 acdressed?

20 COMMISSIONER 3R ADFORD:

It depends a little how 21 you phrase it. But prudence would dictate that you focus 22 on them. Now you can do any num' er of things.

You can say, o

23 we would be interested in having the State of New York, for 24 instance, could address its economic issues.

Yo u c an s a y 25 that these are the questions the conmission is expressly ACE-FEDERAL REPORTERS, INC. (202)347-3700 4

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30 79S.08.12 gsh I

interested in.

You might also pursue others, but you might 2

want to focus on these.

3 COMMI SSIOdER AHE ARNE : In your suggestion that we 4

draf t up some cuestions, are you saying that these, then, 5

should be, as far as we are concerned, the key unresolved 6

issues in our minds with regard to the board /s findings?

7 COMMISSIONER BRADFORD: Probably, but not 3

nec e ssarily.

You might have some key questions that, for 7

some reason, you didn' t feel the parties nad anything more 10 to say on what was in the re.

11 COMMISSIONER KENNEDY:

I wouldn't think so.

12 nec e ssar ily. I would agree with Peter.

They are questions 13 that you are going to want them to address.

And the more la of those you could tell them in advance, the more you could 15 be sure that A, they have thought about them long enough 15 to give you what you want, and 3, you're coing to get it.

17 COMMISSIONER AHEARNE: The order will go out anyway.

la MR. EILPERIN: The order will go out and we will 19 try to get the questions out the.first part of next week.

20 CHAIRMAN HENDRIE: Okay.

In order that we not have 21 to meet again, and since I think the language chances that 22 are needed in the order are clear enough and are agreed to 23 here. I will ask you, suo jec t to final reading of the 24 language, to vote approval of the draf t order as discussed 25 and amended.

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f38.CS.12 gsh I

( A show o f hands. )

2 CHAIRMAN HENDRIE:

30 o rde r e d.

3 COMMISSIONER KENNEDY :

When does this have to get 4

out to the Federal Register? The sooner it gets there, the 5

better, right?

6 MR. EILPERIN: We ll, it will be mclied to the 7

particular parties.

3 COMMISSIONER XENNEDY: It won't go in the Register?

9 MR. EILPERIN: No, I don't tnink so.

10 CHAIRMAN HENDRIE: And we understand also there will 11 be a draft question list circulated.

12 MR. SLAGGIE: I don't kno w it i t was clear. My 13 proposal on this, which I think Ste ve was making. is if the 14 commissioners' o f fices as well would suggest questions that 15 they feel are important, send these to the 0.ffice of General Cou sel.

n 15 17 And I would also like to ask the (lf fice of Policy 13 Evalua tion to do the sane thing, and then we will try to put 19 the se together to eliminate recetition and circulate a 20 revised letter.

21 CHAIRMAN HENDRIE: Sold.

22 (Whereupon, at 2:25 p.n.,

the hearin proceeded to 23 new subject matter.)

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l DISCLAIMER This is an unofficial transcript of a meeting of the United States

.luclear Regulatory Coma 1ssion held on 14 December

~978 in tha 1

Commission s or71ces at 1717 H Street, N. W., Wasnincton, D. C.

The meeting was open to public attendance and-observation.

This transcript

,\\

hao neu been reviewec, corrected, or edited, and it may contain inaccuracies.

The transcript is intended solely for general informa'tional c i

ns provided by 10 CrR 9.103, it is not part of the formal or info' urooses" ma'l or cegision or the matters discussed.

Expressions of opinion in recore l

this transcript do not necessarily reflect final determination's or bellers.

,,o pleading or other paper may be filed with the Co: mission in any proceeding as the result of or addressad to any statement or ar umen' contained herein, except as the Commission may authorize.

l uA D

y8122800 THIS DOCUMENT CONTAINS J

POOR QUAUTY PAGESj i

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2 1l UNITED STATES OF AMERICA I.

2 l; NUCLEAR REGULATORY COMMISSION i

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3' PUBLIC MEETING j

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AFFIRMATION SESSION 78-31 5

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Room 1130 1717 H Street, N. W.

7 Washington, D.

C.

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8 i Thursday, 14 December 1978 9l Th2 Commission met, pursuant to notice, at 2:25 p.m.

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10 '

BEFORE:

j l

11 l

DR. JOSEPH M. HENDRIE, Chairman l

i 12 VICTOR CILINSKY, Commissioner 13 RICHARD T.

KENNEDY, Commissioner 14 PETER A.

BRADFORD, Commissioner l

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15 ;l JOHN F. AHEARNE, Ccmrissioner 16 PREFENT:

I 17 !l Samuel Chilk, Secretary il n

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2 CHAIRMAN HENDRIE: Now, Sam, let us see if you i

3 can get a. thing affirmed here.

4 MR. CHILK This is SECY-78, s u bje c t to 10CFR, 5

Part 35, the calibration requirements.

The purpose is to 6

obtain commission approval for rule-making for calibrating 7

teletherapy units annually.

8 The staff recommends approval. Each of you approved.

]

9 Commissioner Kennedy, with a minor ravision, which was 10 circulated to your offices.

11 I ask for your affirmation.

12 (A chorus of eyes.)

13 CHAIRMAN HENDRIE: So ordered.

Do we have to do 14 anything on the agenda?

15 MR. CHILK: Yes, we have a vote or two.

16 (Whereupon, at 2:25 o.m.,

the hearing was ad journed, 17 to r convene subject to the call of the Chair.)

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IS 19 20 1

21 22 23 24 25 1

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7Cn03, NUCLEAR REGULATORY COMMISSION SECY-78-583 November 9, 1978 qg CONSENT CALENDAR ITEM For:

The Commissioners From:

Robert B. Minogue, Director, Office of tandards Development 4

Thru:

Executive Director for Operations

Subject:

EFFECTIVE AMENDMENTS TO 10 CFR PART 35:

TELETHERAPY CALIBRATION REQUIREMENT

Purpose:

To obtain Commission approval of a notice of effective rulemaking that would require medical licensees to calibrate their teletherapy units annually and perform monthly spot checks on those calibrations Category:

This paper covers a minor policy question.

Discussion:

On May 19,1977 NRC published in the Federal Register (42 FR 25743) proposed amendments that would require licensees to calibrate their teletherapy units annually and perform monthly spot checks on those l

calibrations (Enclosure 5). The comment period, originally set to close on July 5,1977, was extended to July 29, 1977 due to public interest.

Of the 59 comments received, 23 approved the rule; 7 approved most of the rule but objected to one section; 16 disapproved either the i

entire rule or a section of the rule; and 13 commented on, or ques-i tioned, one or more sections of the rule but were otherwise non-committal. lists the commenters' names and addresses, summarizes their comments and provides a staff analysis.

Most of the commenters who disapproved of the proposed rule ques-tioned either the need for the rule or whether NRC was the appro-priate federal agency to require calibrations of teletherapy units.

The staff agrees with those commenters who pointed out that the Riverside Hospital incident involving 400 patients was indeed iso-lated and that the NRC's efforts to alert licensees and check on licensee calibrations were successful.

However, the staff feels that Riverside shows the magnitude of the harm caused by one uncali-brated teletherapy unit.

The purpose of this rule is to ensure that teletherapy units remain properly calibrated throughout their useful lives.

Regarding the question of appropriate agency, NRC is the only federi agency with direct regulatory control over the human use of byprod-uct material in teletherapy units.

Food and Drug Administration rgg122800 O

Contact:

Ed Podolak, SD 443-5946

., s

'i The Commissioners 2

(FDA) regulations are directed primarily at the manufacture, distribution, and labeling of teletherapy units.

It will be some time before FDA develops specific regulations for teletherapy units.

The two agencies are working together to harmonize regula-tions for this and other medical devices incorporating radioactive material.

Finally, this teletherapy calibration rule is consistent with NRC's proposed policy that, "NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with them are inadequate."

The following changes from the rule as proposed are intended either to strengthen or to simplify the final rule:

(1)

A new performance standard for calibration of the beam output to "an accuracy within t 3%";

(2) A new requirement for full calibration following certain repairs of the teletherapy unit; (3) A new requirement that the calibration of the dosimetry system must be traceable to the National Bureau of Standards (NBS).

(4) The minimum training and experience of the " qualified expert" is now a part of the rule.

The licensees are responsible for the qualifications of their experts (I&E inspects against the standard in the rule).

(5) The misa.dministration reporting requirement is deleted in deference to the more general NRC proposed rule in 43FR29297(Enclosure 7).

Licensees will be given 180 days to come into compliance with this regulttion.

Also, previous calibrations of their teletherapy units, if conducted in accordance with the final regulation, will count toward the annual requirement.

The long lead time and recognizing past calibrations are necessary to minimize the logistics impact of requiring the dosimetry system to be traceable to NBS.

The Office of Inspection and Enforcement currently reviews the licensee's calibration records (where available) and conducts independent verification measurements on the licensee's teletherapy units during routine inspections.

The total cost to NRC of review-ing all licersees' calibration records during routine inspections is estimated to be 50 person-hours / year (Enclosure 6).

The effective rule sill not require any additional Commission resources.

The teletherapy calibration rule was coordinated with the Agreement States.

As they have done in the past with similar important mat-ters of public health and safety, we expect the Agreement States to adopt this requirement for their licensees.

The Office of Stat.e Programs will keep the Commission informed of the Agr ement States' progress in this area.

m

i

,s

,,4 The Comissioners 3

Recommendations:

The Commission:

1.

Approve a notice of a final rule (Enclosure 1) that would require medical licensees to calibrate their teletherapy units annually and perform monthly spot checks on those calibrations.

2.

Note:

a.

The amendment would be published in the Federal Register to be effective in 180 days; b.

All affected licensees and the appropriate congressional committees will be informed; c.

A public announcement such as Enclosure 2 will be issued when the final rule is filed with the Office of the Federal Register; d.

Clearance of the recordkeeping requirements by the General Accounting Office will be obtained prior to the effective date of the amendments; Coordination:

The Offices of Nuclear Materials Safety and Safeguards, Inspection and Enforcement, State Programs, General Counsel and Policy Evaluation, and the Division of Rules and Records concur in the recommendation of this paper.

The Office of the Executive Legal Director has no legal objection.

The draft public announcement was prepared by the Office of Public Affairs.

Scheduling:

Affirmation at an open meeting.

l

~

, f.;

. :- b

'/ ru-;-

Robert B. Minogue, Director Office of Standards Development

Enclosures:

See next page

1 4

1 4

The Commissioners

Enclosures:

1.

Federal Register Notice of Effective Rule Making 2.

Draft Public Announcement 3.

Draft Congressional letter 4.

List of Commenters, Summary of Public Comments and Staff Analysis 5.

Proposed Teletherapy Calibration Rule (42 FR 25743) 6.

Justification Analysis for the Collection of Information Subject to GA0 clearance 7.

Proposed Misadministration Rule (43 FR 29297)

Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.c.b. Friday, November 24, 1978.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT November 16, 1978, with an information copy to the Office of the Secretary.

If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of November 27, 1978.

Please refer to the appropriate Weekly Commission Schedule, when published, for a specific date and time.

DISTRIBUTION Commissioners Commission Staff Offices Exec Dir for Operations Regional Offices Secretariat

~ _ _ _ _ _ _. _ _

4 B

6 1

e ENCLOSURE 1 Oe

l

[7590-01]

Title 10 - Energy CHAPTER I - NUCLEAR REGULATORY COMMISSION PART 35 - HUMAN USES OF BYPRODUCT MATERIAL Calibration of Teletherapy Units AGENCY:

U.S. Nuclear Regulatory Commission.

ACTION:

Final rule.

l

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations to require medical licensees to (1) calibrate each teletherapy unit annually and (2) perform monthly spot checks on those calibrations.

The annual full calibrations must be performed by a qualified expert.

The monthly spot checks need not be performed by a qualified expert but the results of the spot checks must be reviewed by a qualified expert on a timely basis.

The amendments will help ensure that a patient receives the pre-scribed radiation dose by requiring that teletherapy units are l

properly calibrated.

EFFECTIVE DATE:

The amendments become effective on

• Any full calibrations performed in accordance with the procedures in this amendment during the 365 days prior to the effective date of this amendment will count as the first full calibration.

• 180 days after FEDERAL REGISTER publication

[7590-01]

NOTE:

The Nuclear Regulatory Commission has submitted this rule to the Comptroller General for review under the Federal Reports Act, as amended, 44 U.S.C. 3512.

The date on which the rule becomes effective, unless advised to the contrary, accordingly reflects inclusion of the 45-day period which that statute allows for this review (44 U.S.C.

3512(c)(2)).

FOR FURTHER INFORMATION CONTACT:

Mrs. Patricia C. Vacca, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C.

l 20555 (301-427-4232).

SUPPLEMENTARY INFORMATION:

On May 19, 1977, the iRC published in the FEDERAL REGISTER (42 FR 25743) proposed amendments to its regulations pertaining to the human uses of byproduct materials including tele-therapy units.

The proposed aqenoments to 5 35.13 would have required teletherapy licensees to:

1.

Have a qualified expert perform full calibration measurements at least once each year; 2.

Perform spot-check measurements on their teletherapy units at least monthly; and 3.

Report to NRC if these measurements indicate that patients treated by teletherapy units received a radiation dose differing from the prescribed dose by more than 10 percent.

The public was invited to submit written comments and suggestions on the proposed amendments.

The comment period, originally set to close on July 5,1977, was extended to July 29, 1977, 2

Enclosu,re 1

[7590-01]

I.

Comments on Proposed Rule Fifty-nine comments were received.

Copies of the comments and a detailed analysis of the comments may be examined in the NRC Public Document Room at 1717 H Street, NW., Washington, D.C.

Approximately one-half of the commenters supported the proposed rule.

Of the j

remainder, approximately one-half disapproved of the proposed rule and the other half were non committal.

Virtually all of the com-menters offered helpful suggestions, most of which were accommodated as detailed in Section II below, " Summary of Major Changes in the Final Rule".

Most.of the commenters who disapproved of the proposed rule questioned either the need for a rule or whether NRC was the appro-priate federal agency to require calibrations of teletherapy units.

The Commission agrees with those commenters who pointed out that the Riverside Hospital incident involving 400 patients was an isolated case and that NRC's efforts to alert other licensees and check on their calibrations were successful.

However, the Commission believes that Riverside shows the magnitude of the harm caused by one uncalibrated teletherapy unit.

The purpose of this rule is to ensure that teletherapy units remain properly calibrated throughout their useful lives.

Those commenters who questioned whether NRC was the appropriate agency to require calibration of teletherapy units, pointed to potential conflicts with the Food and Drug Administration's (FDA) new authority 3

[7590-01]

l under the Medical Device Amendments of 1976.

Through the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended, NRC has direct regulatory control over the human use of byproduct material in teletherapy units.

NRC is the only Federal Agency with direct regulatory control over the use of byproduct material and, as such, is certainly an appropriate agency to require calibration of NRC regulated teletherapy units.

NRC is aware that its responsibilities and those of FDA do overlap in the area of medical devices.

NRC and FDA staff members have met on several occasions to coordinate the responsibilities of the two agencies.

It appears that it will be some time before the FDA has standards or guidelines in place for teletherapy calibration.

As they are developed, NRC will work closely with FDA to minimize overlapping regulation by the two agencies.

One commenter suggested that licensees be required to participate in calibration check programs such as those sponsored by FDA or the National Bureau of Standards.

The Commission encourages teletherapy licensees to participate in voluntary calibration check programs but will not require it.

Several commenters did not understand that a qualified expert need not actually perform the spot-check measurements.

The final rule states clearly that the qualified expert need not actually perform the spot check, but the results of the measurements must be reviewed by a qualified expert within 15 days.

4

[7590-01]

' There were numerous comments on the section of the proposed rule that would have required reporting to NRC, and to the patient's referring physician, certain misadministrations involving teletherapy units.

The misadministration reporting requirement in the proposed teletherapy calibration rule has been deleted from the final rule.

All comments received on this subject will be considered as comments on the more comprehensive proposed misadministration reporting requirement that was published in the Federal Register on July 7, 1978 (43 FR 29297), for public comment.

II.

Summary of Major Changes in the Final Rule NRC has decided to issue the final rule by adding 55 35.21-35.25, inclusive, to 10 CFR Part 35, rather than by amending 5 35.13 as proposed.

This change will make the final rule easier to read and understand.

It will also be clear that the rule pertains only to l

teletherapy units and not to other sealed sources.

As discussed in Section I above, the misadministration reporting requirement of the proposed rule has been deleted.

Section 35.21 on full calibration has been expanded to require full cale ation following any repair of the teletherapy unit that r

includes removal of the source or major repair of the components associated with the source exposure assembly and prior to treating humans.

In 5 35.21 the term "significant change," which related to the spot-check measurement and will trigger a recalibration, now reads " output differs by more than 5 percent."

Section 35.21 now 5

Enclos'ure 1

,o'

[7590-01]

I includes a performance standard of "to an accuracy within t 3 percent" for the calibration of teletherapy output.

Finally, i 35.21 now includes a requirement to correct the calibration of teletherapy output for physical decay at intervals not to exceed one month.

Under the effective rule, the licensee generally will not have to submit the training and experience of the qualified expert to NRC for evaluation.

Rather, 5 35.24 requires the licensee to determine, l

pursuant to the provisions of that section, if a person is an expert qualified by training and experience to calibrate teletherapy units.

The licensee will then keep records of that evaluation of the expert's training and experience for inspection by NRC.

A new requirement has been added to ensure that dosimetry systems used to calibrate the teletherapy units are also properly calibrated.

Section 35.23 requires that the dosimetry system used for full cali-brations has itself been calibrated by the National Bureau of Standards (NBS) or by one of three Regional Calibration Laboratories (RCL), who in their turn are directly " traceable" to NBS.

Alternatively, a dosimetry system used solely for spot-check measurements may be calibrated by direct intercomparison with a system calibrated by NBS or one of the RCLt.

III.

Final Rule Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Sections 552 and 553 of Title 5 of the United States Code, the following amendments to Title 10, Chapter I, Code of Federal Regulations, Part 35, are

~

published as a document subject to codification.

6

10 CFR Part 35 is amended by adding a new center heading and new 55 35.21-35.25, as follows:

SPECIAL REQUIREMENTS FOR TELETHERAPY LICENSEES 5 35.21 Requirement to perform full calibration measurements of teletherapy units.

(a) Any licensee authorized under 5 35.13 to use teletherapy units for treating humans shall cause full calibration measurements to be performed on each teletherapy unit:

(1)

Prior to the first use of the unit for treating humans; (2)

Prior to treating humans:

(i) Whenever spot-check measurements indicate that the output value differs by more than 5 percent from the value obtained at the last full calibration corrected mathematically for physical decay; (ii) Following replacement of the radiation source or following reinstallation of the teletherapy unit in a new location; (iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (3)

At intervals not exceeding one year.

(b)

Full calibration measurements required by paragraph (a) of this f

section shall include determination of:

7

7

[7590-01]

(1)

The exposure rate or dose rate to an accuracy within + 3 per-cent for the range of field sizes and for the range of distances (or for the axis distance) used in radiation therapy; (2)

The congruence between the radiation field and the field indicated by the light beam localizing device; 1

i (3)

The uniformity of tne radiation field and its dependence upon the orientation of the useful beam; (4) Timer accuracy; and (5) The accuracy of all distance measuring devices used for treating humans.

(c)

Full calibration measurements shall be made in accordance with the procedures recommended by the Scientific Committee on Radia-tion Dosimetry of the American Association of Physicists in Medicine (Physics in Medicine and Biology, Vol. 16, No. 3, 1971, pp. 379-396).I (d) The exposure rate or dose rate values determined in paragraph (b)(1) of this section shall be corrected mathematically for physical decay for intervals not exceeding one month.

I This incorporation by reference provision was approved by the Acting Director of the TDERAL REGISTER on August 6,1976.

Copies are avail-able for inspection or may be obtained from U.S. Nuclear Regulatory Commission, Public Document Room, 1717 H Street, NW., Washington, D.C.

20555.

8 Enclos'ure 1

[7590-01]

(e)

Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (d) of this section shall be performed by an expert qualified by training and experience in accordance with 1 35.24.

5 35.22 Requirement to perform periodic spot-check measurements of teletherapy units.

(a) Any licensee authorized under 9 35.13 to use teletherapy units for treating humans shall cause spot-check measurements to be performed on each teletherapy unit at intervals not exceeding one month.

(b)

Spot-check measurements required by paragraph (a) of this section shall include determination of:

(1)

Timer accuracy; (2)

The congruence between the radiation field and the field indicated by the light beam localizing device; (3) The accuracy of all distance measuring devices used for treating humans; (4)

The exposure rate, dose rate, or a quantity related in a known manner to these rates for one typical set of operating conditions; and (5) The difference between the measurement made in paragraph (b)(4) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

9

[7590-01]

(c)

Spot-check measurements required by paragraph (a) of this section shall be performed in accordance with procedures established by an expert qualified by training and experience in accordance with s 35.24.,

(A qualified expert need not actually perform the spot-check measure-ments.)

If a qualified expert does not perform the spot-check measurements, the results of the spot-check measurements shall be reviewed by a qualified expert within 15 days.

I 35.23 Requirement to calibrate instruments used for full calibration and spot-check measurements.

(a)

Full calibration measurements required by s 35.21 shall be per-formed using a dosimetry system that has been calibrated by the National Bureau of Standards or by a Regional Calibration Labora-tory accredited by the American Association of Physicists in Medicine.

The dosimetry system shall have been calibrated within the previous two years and after any servicing that may have affected system calibration.

(b)

Spot-check measurements required by 5 35.22 shall be performed using a dosimetry system that has been calibrated in accordance with paragraph (a) of this section.

Alternatively, a dosimetry system used solely for spot-check measurements may be calibrated by direct intercomparison with a system that has been calibrated in 10

[7590-01]

accordance with paragraph (a) of this section.

This alternative calibration method shall have been performed within the previous one year and after each servicing that may have affected system calibration.

Dosimetry systems calibrated by this alternative method shall not be used for full calibration measurements.

5 35.24 Qualified expert.

The licensee shall determine if a person is an expert qualified by training and experience to calibrate a teletherapy unit and establish procedures for (and review the results of) spot-check measurements.

The licensee shall determine that the qualified expert:

(a)

Is certified by the American Board of Radiology in Therapeutic Radiological Physics, Radiological Physics, Roentgen-Ray and Gamma-Ray Physics, or X-ray and Radium Physics; or 2

(b) Has the following minimum training and experience:

2Licensees that have their teletherapy units calibrated by persons who do not meet these criteria for minimum training and experience may request a license amendment excepting them from the requirements of 5 35.24 The request, accompanied by the appropriate amendment fee (5 170.31 of 10 CFR Part 170), should include the name of the proposed qualified expert, a description of his training and experience including information similar to that specified in 5 35.24(b), reports of at least one calibration and spot-check program based on measurements personally made by the proposed expert within the last 10 years, and written endorsement of the technical qualifications of the proposed expert from personal knowledge by a physicist certified by the American Board of Radiology in one of the specialities listed in 5 35.24(a).

The individual's qualifications will be evaluated by NRC's consultants in medical physics.

The amendment request should be addressed to:

License Management Branch, U.S. Nuclear Regulatory Commission, Washington, D.C.

20555.

11

[7590-01]

(1) A Master's or Doctor's degree in physics, biophysics, radio-logical physics or health physics; (2) One year of full-time training in therapeutic radiological physics; and

^

(3) One year of full-time experience in a radiotherapy facility including personal calibration and spot check of at least one teletherapy unit.

I 5 35.25 Records.

The licensee shall maintain, for inspection by the Commission, records of the measurements, tests, corrective actions, and instrument calibrations made under 55 35.21-35.23 and records of the licensee's evaluation of the qualified expert's training and experience made under 5 35.24.

(a)

Records of (1) full calibration measurements under 5 35.21 and (2) calibration of the instruments used to make these measurements under 5 35.23, shall be preserved for five years after completion of the full calibration.

(b)

Records of (1) spot-check measurements and corrective actions under 5 35.22 and (2) calibration of instruments used to make spot-check measurements under 5 35.23, shall be preserved for two years after completion of the spot-check measurements and corrective actions.

(c)

Records of the licensee's evaluation of the qualified expert's training and experience under 5 35.24 shall be preserved for 12

[7590-01]

five years after the qualified expert's last performance of a full calibration on the licensee's teletherapy unit.

(Sec. 161, Pub. L.83-703, 68 Stat. 948 (42 U.S.C. 2201): Sec. 201, Pub. L.93-438, 88 Stat.1243 (42 U.S.C. 5841)).

1

1978, Dated at Washington, D.C., this day of For the Nuclear Regulatory Commission.

i Samuel J. Chilk Secretary of the Commission 13

k e

4 e

l ENCLOSURE 2 t

y

f DRAFT PUBLIC ANN 0UNCEMENT NRC AMENDS REGULATIONS ON TELETHERAPY UNITS The Nuclear Regulatory Commission is amending its regulatio.is to require licensees using teletherapy units containing radioactive material for the treatment of cancer to have a qualified expert calibrate their teletherapy units to ensure that patients will receive the prescribed radiation dose.

The amendment requires NRC licensees to have a qualified expert perform full calibration measurements on-an annual basis and defines the qualifica-tion requirements of the expert performing the calibrations.

The amendment also requires the licensees to perform their own monthly spot-check measure-ments on the teletherapy units anc have the results of the spot checks reviewed by a qualified expert.

Also, originally proposed as part of the amendment to Part 35, there was a requirement for licensees to notify the NRC if their measurements indicated that patients treated with teletherapy units could have received radiation doses differing from the prescribed dose by more than 10 percent.

This requirement was deleted from the final rule because the Commission has published another proposed rule that would require all medical licensees, not just teletherapy licensees, to report certain misadministrations involv-ing the use of radioactive material.

The amendment results from an NRC investigation of an incident in which about 400 patients treated for cancer with a cobalt-60 teletherapy

unit received doses that exceeded prescribed doses by more than 10 percent l

l because the unit had not been properly calibrated.

Evidence obtained by the NRC indicated that a number of units in the United States had not been 3

calibrated for as long as five years.

At that time, the Commission took immediate action to assure that all teletherapy units licensed by the NRC were properly calibrated during the time required to implement these changes in its regulations.

The amendment to Part 35 of NRC regulations will become effective 180 days following publication in the Federal Register (FR

).

2 Er. closure 2

e 9

e i

l l

l l

l ENCLOSURE 3 I

• e

Draft Congressional Letter i

l Dear Enclosed for the information of the Subcommittee is a copy of a notice of rule making to amend 10 CFR Part 35 of the Commission's regulations.

The amendments of Section 35.13 would require tele-therapy licensees to perform periodic full calibration and spot-check measurements of each teletherapy unit used for treatment of patients.

The amendments are designed to ensure that teletherapy units are properly calibrated so that patients will receive the prescribed radiation dose.

The notice of rule making is being transmitted to the Office of the Federal Register and the amendments will become effective 180 days after publication.

A copy of the amendments will be sent to all teletherapy licensees.

Also enclosed is a copy of a public announcement to be released on this matter in the next few days.

Sincerely, Robert B. Minogue, Director Office of Standards Development

Enclosures:

1.

Federal Register Notice 2.

Public Announcement r h_ ---_-- _ --

-i---

8 e

g s

O e

1 1

1 i

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i ENCLOSURE 4

• e

LIST OF COMMENTERS,

SUMMARY

OF COMMENTS AND STAFF ANALYSIS LIST OF COMMENTERS l

l 1.

John R. Glover, Ph.D.

9.

Merle Loken, M.D., Ph.D.

Monmouth Medical Center University of Minnesota i

Long Branch, NJ Box 382 l

Mayo Memorial Building 2.

Mukund K. Kartha, Ph.D.

Minneapolis, MN 55455 Ohio State University Columbus, OH 10.

Boone M. Bowen P.O. Box 218 3.

Gordon L. Barclay, Consultant Huger, SC 29450 State of New York Department of Mental Hygiene 11.

Richard A. Rudman, M.D.

l Division of Research St. Mary's Hospital 44 Holland Avenue Centralia, IL 62801 Albany, NY 12229 12.

Hyman R. Senturia, M.D.

4.

C. H. Wang, M.D.

Department of Radiology Oakwood Hospital The Jewish Hospital of St. Louis Department of Radiology St. Louis, MO 18101 Oakwood Boulevard

Dearborn,

MI 48124 13.

Edwin Van Arsdale, R.T.(T.)

Department of Radiology 5.

Arthur B. Frazier, M.D.

University of South Alabama James A. Hancock, Jr.

Medical Center DePaul Hospital 2451 Fillingim Street 150 Kingsley Lane Mobile, Alabama 36617 Norfolk, VA 23505 14.

Rene J. Smith, Ph.D.

6.

Uthai Vincent Wilcox, II, M.D.

Veterans Administration Hospital Sibley Memorial Hospital East Orange, NJ 07019 Department of Radiology 5255 Loughboro Road, N.W.

15.

Benjamin Copleman, M.D.

Washington, DC 20016 466 New Brunswick Avenue Perth Amboy, NJ 08861 7.

Bruce B. Dicey, M.S.

147 Tildon Lane 16.

R. T. Collins, M.D.

Bolingbrook, IL 60439 St. Mary's Hospital Department of Radiology 8.

Ahren Jacobson Duluth, MN University of Louisville Louisville, KY 40201 17.

Randall W. Carter Emory University School of Medicine Woodruff Medical Center Administration Building 1440 Clifton Road, N.E.

Atlanta, GA 30322

~

1

18.

Frank Batley, M.D.

27.

William N. Brand, M.D.

Ohio State University Hospital Northwestern Memorial Hospital Columbus, Ohio Superior Street and Fairbanks Court 19.

J. W. Barber, M.D.

Chicago, IL 60611 Memorial Hospital of Laramie County 300 East 23rd 28.

James D. George Cheyenne, Wyoming 82001 1825 Lexington Avenue Great Lakes, IL 60088 20.

Juan V. Fayos, M.D.

University of Michigan 29.

Bernard Percarpio, M.D.

Medical Center Robert M. Quillin, M.S.

Ann Arbor, MI 48104 Robert Golden, M.S.

Department of the Army 21.

A. Curtis Hass, M.D.

Walter Reed Anny Medical Center Margaret and Howard Hall Washington, DC 20012 Radiation Center 60310th Street, S.E.

30.

Perry Sprawls, Ph.D., Chairman Cedar Rapids, IA 52403 Council of Medical Radiological Physicists of Georgia 22.

Patton H. McGinley, Ph.D.

P.O. Box AD Emory University Clinic Atlanta, GA 30322 1365 Clifton Road, N.E.

Atlanta, GA 30322 31.

Marshall S. Little 9808 Dameron Drive 23.

David S. Gooden, Ph.D.

Silver Spring, MD 20902 St. Francis Hospital Tulsa, OK 32.

Michael T. Gillin, Ph.D.

The Medical College of Wisconsin 24.

F. X. Masse Milwaukee County Medical Complex Tufts University School 8700 West Wisconsin Avenue of Medicine - New England Milwaukee, WI 53226 Medical Center Hospital 171 Harrison Avenue 32.

Lawrence E. Lee, M.D.

Boston, MA 02111 Trinity Lutheran Hospital 31st and Hyandotte Streets 25.

Robert H. Johnstone, Administrator Kansas City, M0 64108 Donald F. Loeffler, M.D.

Good Samaritan Hospital 34.

Ronald V. Scheele 703 Tyler Street 408-Brookridge l

Sandusky, OH 44870 Green Bay, WI 54301 26.

Andrew G. Bukovitz, M.S.

35.

J. M. Paul, Ph.D.

University Health Center Lewis A. Weiss Memorial Hospital of Pittsburgh 4646 Marine Drive 3601 5th Avenue Chicago, IL 60640 Pittsburgh, PA 15213 2

36.

John C. Villforth, President 45.

Q. E. Crews, Jr.

Health Physics Society Acting Commanding Officer Bureau.of Radiological Health National Naval Medical Center j

5600 Fishers Lane Bethesda, MD 20014 Rockville, MD 20852-46.

Michael S. Terpilak 37.. Richard C. Granke Secretary-Treasurer 1311 Downs Drive Americcn Board of Health Physics Silver Spring, MD 20904 1916 Grays Lake Drive Silver Spring, MD 20906 38.

Kenneth A. Wright, Chairman American Association of Physicists 47.

Lyle A. Carter, Chainnan in Medicine State and Federal Legislation irtiation. Therapy Committee Committee itessachusetts Institute.of Technology Health Physics Society H1gh Voltage Research Laboratory Battelle, Northwest Bldg. N P.O. Box 999 Cambridge, MA 02139 Richland, WA 99352 39.

Elmer H. Eisenhower, Chief 48.

Ernest O. Jones, Ph.D.

Office tf Radiation Measurement The University of Nebraska U.S. Department of Commerce Medical Center National Buredu of Standards 42nd and Dewey Avenue Washington, DC 20234 Omaha, NE 68105 40.

A. T. Tuma, M.D.

49.

Earle C. Gregg, Ph.D., Chairman 215 Oak NCRP Scientific Committee No. 3 Poplar Bluff, M0 National Council on Radiation Protection and Measurements 41.

Paul W. Earle, Vice President 7910 Woodmont Avenue, Suite 1016 American Hospital Association Washington, DC 20014 840 North Lake Shore Drive Chicago, IL 60611 50.

J. A. Ransohoff, President Neutron Products, Inc.

42.

Nathaniel Silon, M.D.

Dickerson, MD 20753 The Allentown Hospital Association 17th and Chew Streets 51.

Eugene L. Saenger, M.D.

Allentown, PA 18102 Radioisotope Laboratory Cincinnati General Hospital 43.

Joseph M. Murphy, M.D.

Cincinnati, OH 45267 The Greenwich Hospital Association Perryridge Road 52.

Ernest J. Clark

. Greenwich,'CT 06830 Brig Gen, USAF, MC Director of Professional Services 44.

Robert Loevinger, Chief Office of the Surgeon General Dosimetry Section Headquarters U.S. Air Force Center for Radiation Research Department of the Air Force L

U.S. Department-of Commerce Washington, DC 20314 National Bureau of Standards

. Washington, DC 20234 k

~

' 3 4

53.

Theodore A. Tristan, M.D.

Agreement States Tristan Associates 4518 Union Deposit Road 1.

R. H. Fetz Harrisburg, PA 17111 Georgia Department of Human Resources 54.

John C. Villforth, Director Bureau of Radiological Health 2.

Doyle Mills Food and Drug Administration

. Kentucky Department of Department of Health, Education, Human Resources

& Welfare Rockville, MD 20352 3.

Ronald J. Forsythe Mississippi State 55.

Jack Dobson, Ph.D.

Board of Health Technical Assistant to the i

American College of Radiology 4.

E. Ellis Simmons Radiotherapeutic Equipment Committee Nebraska Department of Health Safety Sciences Division of WSA, Inc 11772 Sorrento Valley Road 5.

Albert J. Hccle San Diego, CA 92121 Colorado Department of Health 56.

H. Glasser, President Nuclear Associates, Inc.

6.

Martin C. Wukasch 100 Voice Road Texas Department of Carle Place, NY 11514 Health Resources j

~ 57.

Cecil B. Brown, Supervisor 7.

D. A. Pickler Radioactive Materials Unit California Department Radiation Protection Branch of Health North Carolina State Department of Human Resources P.O. Box 12200 Raleigh, NC 27605 58.

George D. 0 liver, Jr., Ph.D.

St. John's Mercy Medical Center 615 South New Ballar Road St. Louis, Missouri 63141 59.

David D. Snellings, Jr., Director Division of Radiological Health Bureau of Environmental Health Services Arkansas Department of Health 4815 West Markham Street Little Rock, Arkansas 72201 4

SUMMARY

OF COMMENTS AND STAFF ANALYSIS Th'e comments can be divided as follows:

Number Category 4

Approved proposed rule change.

19 Approved proposed rule change and suggested improvements.

7 Approved most of proposed rule change but objected to one section.

16 Disapproved of entire proposed rule or the only section discussed in letter, 13 Questioned or commented on one or more sections of proposed rule change but were otherwise noncommittal.

The following is a summary of the comments received on the proposed rule change.

NEED FOR RULE CHANGE Comment #1 Six commenters believed that NRC had not adequately documented the need for the proposed rule change.

They do not believe that a significant number of teletherapy units deliver a radiation dose that differs from the prescribed dose by more than 10%.

One person asked for documentation of our statements that 'up to five years have elapsed since the last cali-bration of some units." These commenters said that the Riverside incident 5

does not constitute a significant number.

They said that the results of NRC's thermoluminescent dosimeter (TLD) program and follow-up ionization chamber measurements do not support NRC's rationale for the rule.

Several commenters believed that the proposed rule is not an appropriate response to the Riverside incident.

They said that Riverside was an isolated case.

Staff Response #1 At the time it prepared this proposed rule change, the staff had informa-tion from two sources on the accuracy of teletherapy calibration.

The first information pertained to the Riverside incident (SECY 75-371).

The second was a preprint of a National Bureau of Standards (f.N survey of '

cobalt-60 teletherapy units.I

~

Participants in the NBS study had been asked to deliver a prescribed 60 absorbed dose (300 rads) of Co gamma radiation to TLDs under specified conditions.

Ehrlich and Welter stated that differences of + 5% between the prescribed 300 rads and the average NBS dose interpretation were considered to be significant.

The results for 114 teletherapy units indicated that:

60 l Ehrlich, M. and G. Welter, " Nationwide Survey of Co Teletherapy Dosimetry." J. Research (July-August 1977).

6

25% of the units showed differences greater than 1 5%.

6% of the units showed differences greater than i 10%.

4% of the units showed differences greater than i 20%.

The staff was concerned about these results because it believed that many of the participants in the NBS study were larger, well-known institutions who would be likely to have a full-time medical physicist and who were interested in a third party check of their units.

The staff was also concerned about the accuracy of calibration of teletherapy units in smaller institutions or in institutions who had not participated in a third party check.

Because of these concerns:

(1) the staff proposed the teletherapy rule change, (2) I&E instituted a TLD program patterned on the NBS study and (3)

I&E supplemented their TLD program with follow-up ionization chamber measure-ments.

The results of I&E's program indicate that the calibration of 97.6%

of NRC-licensed teletherapy units is within 5% of the values supplied by the licensee's physicist.

The I&E's TLD program was intended to determine whether a licensee's tele-therapy. unit was accurately calibrated at the time he participated in the TLD program.

It was not intended to, and did not, determine the accuracy of calibration at any time prior to participation in the program.

It is not unreasonable to expect that many licensees checked their teletherapy 7

units in the wake of the publicity surrounding the Riverside incident and before participating in the I&E TLD program.

The staff believes that the Riverside incident points to the magnitude of the harm caused by one uncalibrated teletherapy unit.

The purpose of the rule is to help ensure that all NRC-regulated teletherapy units remain calibrated throughout their useful lives.

Comment #2 One commenter stated that the proposed rule would not ensure accurate calibration because the ohysicist might make a systematic error.

This commenter and several others suggested that an independent outside party check the calibration.

Staff Response #2 l

The staff believes that accurate calibration will result when well-qualified individuals follow the referenced protocol in Physics in Medicine and Bioloay.

The staff encourages licensees to participate in independent third party checks of their teletherapy units.

The proposed rule would not prevent this type of participation.

Comment #3 Several commenters expressed the opinion that the proposed rule change would not have prevented the Riverside incident.

They said that the physician had been certified by the American Board of Radiology (ABR) and that the 8

Enclosur,e 4

~_.

4.

physicist could have passed any of the Board certification examinations listed in Section 35~.13(b)(5).

Both individuals had been trained at well-known institutions by well-qualified professionals.

One organization exnressed the opinion that the Riverside problem resulted from falsification of data an'd records and that disciplinary action is more appropriate than the proposed rule.

Staff Response #3 The staff believes that the proposed rule would have prevented the Riverside incident if the physicist had calibrated the teletherapy unit in accordance with the procedures in the referenced protocol.

The record indicates that the authorized physician was certified by the ABR and met NRC's criteria for training and experience.

The physicist was not certified by the ABR in one of the specialities listed in Section 35.13(b)(5) of the proposed rule.

Since he had not taken the ABR certification examination, it is not known if he would have passed it and been certified.

NRC's investigation of the Riverside incident indicated that the incident was caused by improper calibration of the teletherapy unit, not falsi-fication of data and records.

NRC has no authority to take disciplinary action against the physicist.

9 e

Comment #4 Nine commenters pointed to the conflicting responsibilities of various governmental agencies.

They indicated that there should be a coordinated regulatory program for users of all teletherapy equipment (i.e., cobalt-60, cesium-137 and linear accelerators).

Several stated that the Food and Drug Administration (FDA) is the more appropriate Federal agency to regulate teletherapy equipment.

They referred NRC to FDA's Notice of Intent (42 FR 15428, March 22,1977) to develop standards and/or guidelines with regard to radiation therapy equipment.

Staff Response #4 The staff is aware of the overlapping responsibilities of various federal agencies (SECY-76-529).

NRC and FDA staff members have met on two occasions to discuss the responsibilities of the two agencies.

However, it appears that it will be some time before the standards and/or guidelines referenced i

in FDA's Notice of Intent are developed and published in effective form.

As they are developed, NRC will work closely with FDA to minimize overlapping regulation by the two agencies.

SUGGESTIONS IN LI__EU OF RULE Comment #5 Several commenters stated that the proposed regulation will not serve any purpose other than to increase paperwork.

Two of these commenters suggested that a committee of representatives of NRC, FDA, medical physicists and H

10

1 radiation therapy physicians make an extensive study of the " state-of-the-art" and prepare a set of standards by which to regulate all radiation therapy units including accelerators.

They recommended that NRC delay final action on this rule until the committee has concluded its work.

Staff Response #5 The Commission should not delay its action on this rule while a committee formulates another set of recommendations to add to the various voluntary standards now in place.

Comment #6 One person said, " Peer review, in all professions, has been the most effective and safe approach to avoiding unfortunate incidents... I strongly suggest that at licensed institutions, where only one internal qualified expert is available, the calibration must be reviewed by an outside qualified expert.

At institutions with more than one qualified expert, cross checking would serve the same purpose."

Staff Response #6 In the preamble to the final rule (Enclosure 1), the Commission encourages, but does not require, teletherapy licensees to particioate in voluntary calibration check programs.

11

~.

Comment #7 One individual suggested that although the proposed rule outlines good procedures, they would be better as guidelines in order to preserve pro-fessional relationships developed in radiotherapy.

Staff Response #7 j

The staff does not believe that this rule should adversely affect the professional relationships developed in radiotherapy.

The rule outlines the need to follow procedures that are considered to be good practice.

The referenced protocol allows the licensee's qualified expert to use professional judgement regarding the method of calibration.

The expert will also need to exercise professional judgment in establishing an appropriate spot check program.

Comment #8 Several comenters suggested that in lieu of this rule, NRC should continue its TLD program by sending TLDs to licensees at regular intervals.

This would ensure that units are properly calibrated and it would preclude miscalibration by a " qualified expert" whose abilities do not match his credentials.

Staff Response #8 The staff does not believe that I&E's TLD program should be continued on an indefinite basis.

There are several other formal programs to check teletherapy calibration (e.g., Center for Radiological Physics, Radiological PhysicsCenters).

These programs are conducted by well-qualified individuals 12

under the sponsorship of the American Association of Physicists in Medicine.

The staff believes that it is preferable for the medical community to sponsor these programs rather than to involve a federal regulatory agency.

Personnel from I&E's regional offices will, however, make confirmatory measurements on the output of teletherapy units as a regular part of their inspection of teletherapy licensees.

Comment #9 One physician said that problems experienced with cobalt-60 units have occurred because of inadequate testing under actual conditions of use prior to wide-scale marketing.

He said that NRC would provide a greater service to the country by requiring manufacturers of teletherapy units to " prove the reliability and accuracy of their equipment by appropriate l

and vigorous testing prior to permitting sale."

Staff Response #9 The staff does not believe that any, calibration problems with teletherapy units have been caused by inadequate testing of the unit by the manufacturer.

Prior to selling a new teletherapy unit, a manufacturer must submit to NRC (or an Agreement State, if he is located in one) descriptive information, drawings, specifications, and results of prototype testing on the unit.

These are evaluated by the staff.

If the staff finds that the unit meets the radiation safety recommendations in NCRP Report No. 33, " Medical X-Ray and Gamma Ray Protection for Energies Up to 10 MeV - Equipment Design and Use," the staff will issue a catalog sheet authorizing the unit to be l

13

licensed for use in medical facilities.

Part of the evaluation includes review of the manufacturer's quality control program to ensure that subse-quent units perform in the same manner as the prototype.

Under provisions of the Medical Device Amendments of 1976, FDA may be interested in these units for nonradiation safety-related matters (e.g.,

electrical, mechanical).

INTENTION OF RULE

_ Comment #10 One commenter pointed out that although Section 35.13(a)(2) refers to sealed sources and to teletherapy units, Sections 35.13(b)(1)-(7) are intended to refer to teletherapy units only.

Staff Response #10 The final rule is now a separate 55 35.21-35.25 and titled "Special Require-ments for Teletherapy Licensees."

FREQUENCY OF FULL CALIBRATION _

Comment #11 Several comenters said that after an initial calibration is completed and assured to be accurate, the physicist need only make spot checks.

Their recomended frequency of spot checks varied from daily to monthly (See also coments on spot checks).

Thus, they claim, requirements for frequent full 14

calibration are unwarranted because they lead to increased costs that are passed on to the patient.

One comenter suggested that full calibration be performed semiannually.

Staff Response #11 Full calibration of teletherapy units at least once each year is recommended on page 395 of the protocol referenced in 5 35.13(b)(3) of the proposed rule and by most of the other voluntary standards.

Coment #12 Any frequencies imposed as minimum requirements are in danger of being regarded as acceptable under all circumstances.

Staff Response #12 This is always a problem and real-life compromise with any rule making.

When NRC considers a new regulation, it tries to specify the minimum activities required to protect the public health and safety.

While some individuals may interpret minimum requirements as being acceptable under all circum-stances, licensees and their qualified experts should use their training and experience to determine whether minimum requirements are sufficient for their particular situation.

Comment #13 Although the frequency of full calibration and of spot checks as specified in the proposed rule are reasonable, they are not in direct agreement with 15 Enclosur'e 4

voluntary standards.

For example, NCRP says that recalibration is "not required so long as spot checks... indicated no significant change in the exposure rate or dose rate."

Staff Response #13 Voluntary standards do not agree with one.another in all aspects.

The final teletherapy rule tries to balance the recommendations of several voluntary organizations with the impact on teletherapy licensees.

Comment #14 Several commenters said that Section 35.13(b)(1)(ii) is not appropriate to teletherapy units because a radiation meter is not normally incorporated in these units.

They further stated that a significant change in output should be the basis for investigation, correction or recalibration, as appropriate, regardless of the duration of the change.

Others suggested that significant change be defined in terms of a 5% variation from the anticipated output.

Staff Reeponse #14 The staff accepts these coments and the final rule incorporates appropriate language.

J Comment #15 One commenter suggested that recalibration also be required "following any repair of the therapy device that includes removal of the source or major 16

.. \\

repair of the components associated with the source exposure assembly."

This additional requirement would provide compatibility with the require-ment to recalibrate following relocation of the teletherapy unit (see Section 35.13(b)(1)(iii) of the proposed rule).

The commenter said he can think of no changes that are likely to result from relocation that would not also result from major repair, particularly with source removal.

Staff Response #15 The staff believes that this suggestion would improve the rule and has made appropriate changes in the final rule.

DEFINITION OF FULL CALIBRATION Comment #16 Several commenters said that it would be very difficult to calibrate a teletherapy unit at each treatment distance used.

This is a particular problem with isocentric units.

The commenters stated that they calibrate their teletherapy units at several source-to-skin distances (SSD) that are routinely used for treating patients.

When an occasional patient is treated at an 550 s few centimeters different from these points, the commenters apply a simple inverse square correction.

They suggested that the rule be modified to require calibration for the " range of dictances used."

17

Staff Response #16 The staff believes that these comments are valid.

The final rule includes a requirement to calibrate for "the axis distance or for the range of distances used for radiation therapy."

i Comment #17 One commenter suggested adding a requirement that the calibrated output of a teletherapy unit be corrected for physical decay at intervals not exceeding one month.

Staff Response #17_

4 The staff believes that this suggestion is consistent with standard practice and has added appropriate language to the final rule.

Comment #18 One'commenter said that by al. lowing radiation output to be measured in air, the proposed rule ignores the important factors that influence the absorbed dose in the patient.

He suggested requiring that one set of measurements be made in an appropriate phantom.

Staff Response #18 The medical physics community is divided on whether radiation therapy units should be calibrated in air or in water or other appropriate phantom.

The staff does not believe that NRC should decide this tech-nical. issue.

The referenced protocol offers licensees the option of using either method.

18-

Coment #19 One group of commenters requested that NRC define the phrase " localizing device."

Staff Response #19 The staff understands that light localizing devices are used exclusively on radiation therapy units to indicate the radiation field and the final rule has been changed appropriately.

Comment #20 Three commenters requested that NRC define tolerance limits for congruence.

, Staff Response #20 page 394 of the referenced protocol gives tolerance limits for congruency between the radiation field and the field indicated by the light beam localizing device.

Comment #21_

Three commenters observed that Section 35.13(b)(2)(iii) of the proposed rule did not specify tolerance limit.s for radiation field uniformity or the locations at which measurements should be made to check the dependence of output with beam direction or orientation.

One individual observed that beam uniformity in air may differ from that in a phantom and requested a definition of acceptable beam flatness.

He then suggested that a perform-ance standard for manufacturers be established.

19 Enclosyre 4

Staff Response #22 The rule requires that the qualified expert determine the uniformity of the radiation field and its dependence on the direction of the useful beam.

The qualified expert using his professional judgment can then determine the extent to which these factors will affect the licensee's use of his teletherapy unit.

Comment #23 Several individuals suggested that the word " orientation" replace "direc-tion" in Section 35.13(b)(2)(iii).

i Staff Response #23 This suggested change has been made in the final rule.

Comment #24 One person suggested that the requirement to determine timer accuracy be expanded to include determination of net irradiation time (i.e., irradia-tion time corrected for time needed for source to come to "on" position and to return to "off" position).

Staff Respo'nse #24 The staff believes that determination of net irradiation time need not be specified because it is a basic part of the calibration technique.

It is analogous to making te:aperature and pressure corrections for R-chamber measurements, t

20 Enclosurs 4

l Coment #25 Two organizations commented that it would be desirable in Section 35.13 (b)(2) to confirm that calibration distances from the source agree with the distances used clinically (e.g., optical distance indicator).

l StaffReshonse#25 The staff believes this is a valuable suggestion and has added appropriate language to the final rule.

Coment #26 One comenter suggested that the rule require determination of the accuracy of backpointers.

Staff Response #26 Checking the accuracy of backpointers may be a good practice; however, the accuracy of backpointers does not affect calibration of the teletherapy device.

The staff does not believe that this suggestion should be implemented.

Coment #27 One organization suggested that to minimize the chance of gross calibration error the rule should require a redundancy check in the initial calibration of a teletherapy source (e.g. compare the source manufacturer's measurements of dose rate v_s,._ those of the qualified expert).

s 21

Staff Response #27 The staff does not believe that it is necessary to require a redundancy check.

A qualified expert may make this type of check if he wishes to do so.

The staff believes that a better way for a licensee to check the calibration of his teletherapy unit is to participate in a third-party evaluation (e.g., those sponsored by National Bureau of Standards, Bureau of Radiological Health, Center for Radiological Physics, Radiological Physics Centers).

The Supplementary Information preceding the final rule will encourage teletherapy licensees to participate in these programs.

Comment #28 One organization said that while it is appropriate to require full calibra-tion and spot-check measurements, "the issue of importance is whether the unit attains an adequate level of performance." They suggested adding a provision that "The full calibration and spot-check measurements should demonstrate an overall accuracy of the radiation dose delivered to a tissue equivalent or water phantom of 15%.

An alternative approach would be to state the overall accuracy of the 15% in a Regulatory Guide as the desired objective."

Staff Response #28 The referenced protocol discuss the uncertainties associated with various measurement techniques.

The final rule will have a performance standard that the calibration of the output be "within 13% of the true value."

22 Enclosur,e 4

PROTOCOL TO BE FOLLOWED FOR FULL CALIBRATION Comment #29 One commenter suggested that licensees be allowed to submit alternative calibration procedures for NRC's approval on an individual basis or that NRC list acceptable protocols in a licensing guide.

Another person thought that it would be difficult to change the referenced protocol and suggested adding the wording "... or such other calibration protocol as may be authorized from time to time by the Nuclear Regulatory Commission."

Staff Response #29 The protocol referenced in the rule allows licensees considerable latitude in selecting a procedure.

Comment #30 One person suggested that NRC substitute for the referenced protocol the International Commission on Radiation Units and Measurements (ICRU) Report Number 23, " Measurement of Absorbed Dose in a Phantom Irradiated by a Single Beam of X or Gamma Rays" and ICRU Report Number 24, " Determination of Absorbed Dose in a Patient Irradiated by Beams of X of Gamma Rays in Radiotherapy Procedures."

23

.w Staff Response #30 The protocol in the proposed rule is general enough to encompass the inter-national standards without deciding the controversy over measurements in air vs. phantom (see Staff Response #18).

SPECIFICATION OF_ SPOT CHECKS AND FREQUENCY OF MEASUREMENTS Comment #31 Nine commenters observed that monthly spot-check measurements only increase the cost of maintenance of the teletherapy unit and these costs are passed on to the patient.

These individuals were concerned about the availability of qualified physicists as well as the cost to smaller institutions to have consultant physicists make the monthly spot-check measurements.

Staff Response #31 These comments are based on a mistaken understanding of Section 35.13(b)(5).

The proposed rule stated that spot checks were to be performed and evaluated in accordance with procedures established by the qualified expert.

The qualified expert need not actually perform the measurements.

Comment #32 Commenters were divided about the need for spot checks and the frequency of performing them.

The comments ranged from "This single section of your proposed rule could suffice to assure quality and accuracy in treating patients" to opposition to spot checks because of unnecessary increases in 24

i costs for medical care.

The suggested frequency ror performing spot checks included daily, monthly, bimonthly, quarterly and semiannually.

Several commenters stated that many teletherapy licensees do not have the equipment necessary to make the measurements required in subparagraph (iii).

Purchasing and maintaining this type of equipment would increase the cost of medical care.

They were also concerned about the quality of measurements made with this equipment by inexperienced personnel.

Other commenters argued that monthly checks of the output of a teletherapy unit would only serve as check on the reproducibility of the instruments used for the measurements since cobalt-60 (.the main byproduct material used in teletherapy units) decays at a rate of about 1% per month.

Staff Response #32 The spot checks in the proposed rule and the monthly frequency are recom-mended in ANSI N449-1974 "American National Standard Guidelines for Main-taining Cobalt-60 and Cesium-137 Teletherapy Equipment." According to the standard the spot checks are used as constancy checks to verify the calibrated output of the teletherapy unit.

Comment #33 One individual suggested that NRC require antico111sion mechanisms to be tested as a part of the prescribed spot checks.

25

Staff Response #33 The staff believes that it is prudent to check anticollision mechanisms regularly.

However, it does not believe that these checks should be required by NRC because they do not pertain to calibration of teletherapy units nor are they related to radiation safety matters.

Comment #34 One person suggested expanding " timer accuracy" to include " net irradiation time."

Staff Response #34 See Staff Response #24.

I Comment #35 Several ccmmenters suggested that NRC define " localizing device."

Staff Response #35 The final rule has been changed appropriately.

DEFINITION OF QUALIFIED EXPERT:

RESPONSIBILITIES OF QUALIFIED EXPERT Comment #36 One organization questioned the purpose of submitting to NRC a statement of the qualified expert's training and experience.

It asked if NRC intended to disapprove individuals considered to be unqualified.

If that is the case, 26 L

the organization said that "such a provision should be directly required l

for issuance of a license."

Staff Response #36 The final rule has been changed to specify the minimum training and ' experience required of the qualified expert.

The licensee will be responsible for deter-mining that this expert is qualified and I&E will inspect against the minimum standard in the rule.

Comment #37 There were numerous comments on the definition of qualified expert.

(a) Two commenters said that the NRC should not evaluate the qualfications of medical physicists because voluntary accreditation programs exist.

One said that calibrations should be carried out only by physicists certified by the American Board of Radiology (ABR) and that NRC should not attempt to determine equivalence.

He stated that there are a sufficient number of certified physicists distributed throughout the country to i

calibrate teletherapy units.

(b) One commenter suggested that NRC review the qualifications of all

" qualified experts" and not accept certif1 cation by the American Board of Radiology as prima facie evidence of an individual,'s qualifications.

27 hu

_____b__._____.

(c) Two commenters suggested adding "or certified by the American Board of Health Physics."

(The American Board of Health Physics stated it did not have any comments to submit to NRC on the proposed rule.)

(d) One commenter suggested that the definition of qualified expert include individuals who are " eligible for certification by the American Board of Radiology."

(e) One commenter suggested that calibrations should be performed "by or under the supervision of the qualified expert."

(f)

Several commenters asked NRC to prepare a set of guidelines to be met by the non-certified medical physicist.

Staff Response #37 See Staff Response #36.

MISADMINISTRATION FEPORTING REQUIREMENT This section has been deleted from the final rule because the Commission has approved publication of a proposed rule requiring all medical licensees (not just teletherapy licensees) to report certain misadministrations.

Comments received on the misadministration reporting requirement of the proposed teletherapy rule will be considered as comments on the new I

misadministration reporting proposal.

28

1 CALIBRATION OF D0SIMETRY SYSTEM Comment #38 Five commenters observed that another problem commonly encountered is the lack of calibration or recalibration of the dosimetry system used to cali-brate the teletherapy unit.

They recommended that the final rule specify where dosimetry systems may be calibrated (e.g., National Bureau of Standards, Radiological Physics Center) and the frequency of calibration.

They also suggested similar requirements for the instruments used for spot checks.

Staff Response #38 A new 5 35.23 was added to accommodate this comment.

OUTSIDE THE SCOPE OF THE RULE Comment #39 Several commenters discussed the manner in which NRC conducted its TLD program.

Staff Response #39 i

These comments were referred to I&E.

It should be noted that NMSS and I&E staff explained the NRC's TLD program at the August 1977 meeting of the American Association of Physicists in Medicine (AAPM) and at the December l

1977 meeting of the Radiological Society of North America.

The latter meeting was cosponsored by AAPM.

29

4 Comment #40 Several commenters suggested that NRC require teletherapy licensees to have a verification timer.

Most teletherapy units use a mechanical " count-down" timer. These commenters recommended a " count-up" timer to check on the accuracy of the preset treatnent time.

Staff Response #40 Use of a verification timer is a good idea and the staff would encourage licensees to have a "back-up" timer.

Although the staff does not believe that it would be appropriate to add this requirement to the final tele-therapy rule, it will consider this suggestion when revising the present teletherapy licensing guide.

(

Comment #41 One commenter observed that NRC does not have a radiotherapist on its Advisory Committee on the Medical Uses o' Isotopes and suggested that a radiotherapist be added.

l Staff Response #42 l

i

'Two radiotherapist-physicians have been added to the advisory comm ttee.

30

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$j PROPOSED RULES 25743 l

FOR FURTHER INFORMATION CON-TACT:

i Mrs. Patricia C. Vacca. Division of Fuel Cycle and Material Safety. OfHee of Nuclear Material Safety and Safe-guards. U.S. Nuclear Regulatory Com-3 mission. Washington, D.C. (301-427-l 4232).

SUPPLEMENTARY INFORMATION:

i Following its crganization under the Energy )teorganization Act of 1974 (Pub.

j lic law 93-438). the Nuclear Regulatory

. Commission (NRC) has stated its inten.

tion of reviewing those of its regula-tions and procedures pertaining to the licensing and regulation of nuclear fa.

1 cilities and materials that were origl-I nally promulgated by the Atomic Energy Commission with a view to considering what changes should be made. In this context the Commission is currently re-viewing its regulations pertaining to the i

human use of byproduct material in-cluding teletherapy units.'

Byproduct material licenses are issued on the basis that the licensee is quall-NUCt. EAR REGUI.ATORY fled by training and experience to use licensed material in such manner as to COMMISSION protect health and minimise danger to i

[10 CFR Port 35]

life or property. Implicit in the issuance of the license on that basis is the con.

HUMAN USES O.F BYPRODUCT MATERIAL capt that the licensee is expected to be Human Uses of Teletherepy Units aware of the accepted standards of prac-I tice in his particular area of usage and AGENCY: U.S. Nuclear Regulatory Com-to estabi1*h administrative procedures j

g,,3 g sufBelent to ensure that the licensed ACTION: Proposed rule.

- materialis used in accordance with NRC i

regulations and accepted standards of

SUMMARY

The Nuclear Regulatory P#*#U8'#

Commission is proposing to amend its In the area of teletherapy, existing q

1 regulations regarding human uses of by-standards include National Council on a

product (i.e., reactor produced) mate-Radiation Protection and Measurements l

rial.in teletherapy units. The proposed WCRP) Report No. 33. Medical X Ray

{

rule requires teletherapy licensees to:

and Gamma-Ray Protection for Ener-

1. Have a quallned expert perform full gles Up to 10 MeV-Equipment Design j

calibration measurements on each tele

• and Use. American National Standards therapy unit at 1, east once each yearl Institute. Inc. (ANSI) Publication N449-2.* Perform spot-check measurementa 1974. **Ouldelines for Maintaining Co-on the output of t, heir units at least balt-60 and Cesium-137-Teletherapy monthly; and Equipment" and the criteria for accredi-s

3. Report to the U.S. Nucles.r Reguis-tation of the Joint Committee on Hos-I tory Commission radiation doses that pital Accreditation.

diger from prescribed doses by more than Despite the existence and general ac-10 percent.

ceptance of these standards, recent evi-The proposed rule is needed to ensure dance indicates that a sign 1 Scant num- -

)

that teletherapy units are properly call-ber of teletherapy units may deliver a 1

brated. The proposed amendments are radiation dose that difers from the pre-designed to ensure that patienta can re-scribed dose by more than 10 percent.

l ceive the correct radiation dose and to (With proper calibration, the radiation '

1

. prevent recurrence of overexposure output of a teletherapy unit can be de-I events due to improperly calibrated tale. tennined with an uncertainty of less j

than 3 percent.) The evidence also indi-therapy unita, cates that up to Ave years has elapsed I

DATES: Comments must be received by since the last calibration of some tele.

3 July 5.1977*

therapy units.

ADDR N F4: Written comments or The Commission has conducted an in-suggestions for consideration in connec-vestigation of a recent incident in which tion with the proposed amendment apptcximately 400 patients treated for should be sent to the Secretary of the cancer with a cobalt-40 teletherapy unit Commission. U.S. Nuclear Regulatory received radiation doses that exceeded Commission. Washington. D.C. 20555, the prescribed doses by as much as 41

- Attention:

Docketing and Service percent. This incident occurred because Branch. Copies of comments received the radiation dose rate from the tele-j therapy unit had not been properly 1

. will be available for public inspection at the ' Commission's Public Document afte'r its investigation, the Com-Room.1717 H Street. NW., Washing-mission took actions to ensure that all ton, D.C. 20666.

teletherapy unita licensed by the NRC..

rm n m ENCLOStJRE 5

l

l 23744 PROPOSED RULES l

irere properly celibrated. The Commis.

(bi (1) Any licettee who is authorized required by paragraph ibl(4) of thl.s a6on beueves that these actions were ade. to use teletherapy units for human usa section shall be performed and evaluated tuate to prevent recurrence of overex. shall cause full calibration measure. in accordance with procedures estab-

> court events due to improperly call. ments on each teletherapy unit to be Itshed by the qualified expert. 'nte quali.

Brated units during the time required to performed:

fled expert shall review the results of Jnpl:m:nt necessary changes in its (la Prior to the first ute of the unit for spot. check measurements and shall rec.

regulations, treating humans; ommend corrective action when signin.

l Secause cf the events described above.

( til Whdnever the radiation meter or cant d1Nerences are noted.

eppears thr.t the Commission should other device related to radiation oukut (6) When measurements made pur. [

Apose such ct,ntrols as are necessary to shows a continued significant change in suant to paragraphs (blil) and (b> (4 I

maure that teletherapy units continue to its normal reading; of this section indicate that patients

( 111 Following replacement of the ra.

treated by teletherapy units may have p used in such mancer as to deliver diation source or following reinstallation received a radiation dose differing from odiation doses that are not significantly fifferent from the doses prescribed by the of the unit in a new location and prior to the prescribed dose by more than 10 per.

%vMan. Accordingly, the Commission the use of the unit for treating humans: cent, the licensee shall notify the appro.

b proposing an amendment to i 35.13 to liva At intervals not exceeding one priate Regions! OfHce of Inspection and Enforcement listed in Appendix D of 10 require that a qualified expert perform year.

- todic full calibration measurements (2) Pull calibration measurements CFR Part 20. and, where practicable, the et cAablish monthly doot. check proce. shall include determination of:

referring physicians of affected patients.

res in ace:rdance with accepted stand.

ill The exposure rate or dose rate for This notification shall be made within 24 stds Th3 proposed regulation defines the range of field sizes used and for each hours after the licensee's discovery that Lhe qualifications of the expert. the treatment distance used by radistion such misadministration is likely to have nessurements to be madir, tht frequency therapy:

occurred.

and circumstances under which the fili The congruence between the ra.

(7) The licensee shall maintain for measuremnits are to be performed and diation field and the field indicated by inspection by the Commission records of Ro procedures to be used. The proposed the localizing device when loca!! zing de.

the measurements made pursuant to smendment also requires that licensees vices are used:

paragraphs (b)(D and (b)(4) of this JEtify th? U.S. Nuclear Regulatory Com.

Itill The uniformity of the radiation section and of reports made to referring Eission chen their measurements indl. field and its dependence upon the direc. physicians pursuant to paragraph (b)(68 of this section, Eta titat patients treated with tele. tion of the useful beam:

herapy units may have received radia.

(iv) Timer accuracy.

(sec.161. Pub. t 83-703. es stat. 948 (42 los doses differing from the prescribed (3) Full calibration measuremehts Us.c. 220t t : sec. 201. Pub. t 93-438. 88 Stat.

lose by more than 10 percent, sha!! be made,in accordance with the 1243 f.42 (TE.c. ss41).)

Pursuint to the Atomic Energy Act of procedures recommended by the Scien.

054, as amended., the Energy Reorgani. tific Committee on Radiation Dosimetry daI o M*

77*

Dti:n Act af 1974, as amended and Sec. of the American Association of Physi.

ilons $52 and 353 of Title 5 of the United cists in Medicine (Physics m Medicine For the U.S. Nuclear Regulatory Com.

Btates Code, notice is hereby given that and Biology, Vol.16, No. 3,1971, pp. 379.-

mission.

W1:ption cf the following amendmept to 396).'

Saturr. J. Came.

10 CPR Part 35 is contemplated.

(4) Spot. check measurements shall be Secref ary for the Comntission.

In additiin to comments and sugges. performed at intervals not exceeding one

. Irn Doc.7't.14429 rued 5-18-77;8:45 aml 1Bns en the merits of the proposed month and shallinclude:

'mendments, the Nuclear Regulatory til Determination of timer accuracy; bemmission also wants to receive com.

(11) Determinattoit of congruency of

• Eents designed to clarify any possible the useful beam with the light localizer; smbiguities in the rule. All interested

( 111 ) Determination of the exposure f

persons who desire to submit written rate, dose rate or a quantity related in a somments or suggestions with regard to known manner to these rates for one Lhe proposed amendment should send typical set of machine operating condi.

$em to th3 Secretary of the Commission, tions:

%2. Nuclear Regulatory Commission, (ivl Comparison of the nicasurements 3ashin; ton, D.C.

20555. Attention: made in Section (iii) of this paragraph Docketing and Service Branch by July S, with values calculated from physical de.

3977. C pies of comments on the pro. cay of the radiation source.

mess' resnents re-posed am.ndment may be namined at (58 Calibration u

.he Commisalon's Public Document Room quired by paragraph (b)(1) of this sec. 31717 H Street, NW.. Washington, D.C.

tion shall be perform)d by a qualified 10855.

expert such as an individual certified by

1. Section 35.13 is amended to read the American Board of Radiology in

'D filhws:

Therapeutic Radiological Physics, Radio-logical Physics, Roentgen Ray and 3 35.13 Specific fleenses for human u c Gamma Ray Physics or X. ray and et byproduct material in seated Radium Physics or an individual who has equivalent qualifications, f A descrip.

f an An application for a specific !!. tion of the quallfled expert's training and

ense fit use of a sealed source for hu. Quallacations shall be submitted to the man use will be approved if:

Commission for review. If the qualifted (11 Th2 cpplicant satisfies the gen. expert is certified in one of the specialties Ea! requirements speciSed in i 30.33 of listed in this paragraph only a statement Lhis chapter; and of that fact and the date of certification (2) Th2 coplicant or. If the applica. is required.) Spot. check measurements b is made by an institution, the indl.

• ridual user, (1) has specialized training i This incorporation by reference provtston 9 the therapeutic use of the radioactive was approvect by the Acung Director of the fevica c:nsidered (teletherapy unit, beta Federal Register on August 8.1976. Coptes

"'*"*D

'*' '"'P**" " ** th* Unit *d toplicator, etc.), or has experience States Nuclear Regulatorr Commisaton. Pub.

Iquivalent to such training *. and (11) is a !!c Docurnent Room. 1717 H Street. NW.,

Washington D.C. 2osso.

ENCLOSURE 5

P90ERAL. RGOl$78R, VOL. 42, NO 97-THUR50AY, MAY 19,1977

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4 JUSTIFICATION ANALYSIS FOR THE COLLECTION OF INFORMATION SUBJECT TO GA0 CLEARANCE (VALUE IMPACT ASSESSMENT)

I.

NEED FOR THE REPORT The new amendments of 66 35.21-35.25 of 10 CFR Part 35 require teletherapy licensees to perform periodic full calibration and spot-check measurements on each teletherapy unit used to treat patients.

The amendments are designed to ensure that teletherapy units are properly calibrated so that patients will receive the prescribed radiation dose.

The amendments also require that teletherapy licensees maintain, for inspection by the Commission, records of these measurements and tests.

This recordkeeping requirement is needed to allow repre-sentatives of HRC's Office of Inspection and Enforcement to determine if a licensee has complied with the new requirements.

II.

COST OR BURDEN TO RESPONDENTS AND NRC FOR RECORDKEEPING AND REVIEW The amendment of 6 35.21 required yearly calibration of teletherapy units and weekly spot checks of the equipment.

There are an estimated 590 teletherapy units licensed by NRC.

1

~

A.

Cost to NRC Licensees for Yearly Calibration Recordkeeping

)

To prepare and maintain records of the results of a yearly calibration may require 1 person-hour.

This work would be done by a physicist.

590 NRC-licensed units x 1 person-hr = 590 person-hours year-unit year 590 person-hours x $30 cost

= $17,700/ year year person-hour B.

Cost to NRC Licensees for Monthly Spot Check Recordkeeping To prepare and maintain the results of monthly spot checks may require 0.15 person-hour per month.

This work would be done by a radiation therapy technologist.

590 NRC-licensed units x 0.15 person-hour x 12 months = 1062 person-hours month year year 1062 person-hours x $8 cost

= $8,496/ year year person-hour C.

Recordkeeping Cost to NRC Licensees for the Evaluation of Qualified Expert and the Biennial Calibration of Calibration Instruments To maintain records of the evaluation of the qualified expert and the biennial e

calibration of the instruments used to calibrate the teletherapy units would require.1 person-hour per year.

This work would be done by a clerk.

60 person-hours 590 NRC-licensed units x.1 person-hours

=

year year 60 person-hours x

$4 cost

= $240 year person-hour 2

j

D.

Total Cost to NRC Licensees for Recordkeeping Requirement Total cost of preparing and maintaining the records required by Section 35.25 is as follows:

590 + 1062 + 60 = 1712 person-hours year

$17,700 + $8,496 + $240 = $26,436 E.

Cost to NRC for Review of Licensee Records Teletherapy licensees are inspected at 3 year intervals.

To review the records required by Section 35.13 may require 0.25 person-hour.

This work would be done by an inspector of NRC's Office of Inspection and Enforcement.

590 NRC-licensed units x 0.33 fraction of units inspected x 0.25 person-hours year unit inspectq

= 49 person-hours year 49 person-hours x $12 cost

= $584 year person-hour F.

Cost to Other Organizations There are a similar number of teletherapy units in Agreement States.

Thus, the costs to Agreement State licensees and to the Agreement States will be similar to those for NRC licensees and for NRC.

-}

3

Estimates were based on conversations with NRC's medical physics consult-ants.and with NRC's Office of Inspection and Enforcement.

No pretests or surveys were used.

Tne proposed rule change published in May 1977 included a similar recordkeeping requirement.

NPC received 59 comments on the proposed rule.

No one commented on the recordkeeping requirement.

j 1

III. IDENTIFY AND EVALUATE ALTERNATIVE DATA SOURCES f

The only way NRC can be assured that the licensee is complying with the new regulation is to require the licensee to keep records of full calibration and spot-check measurements.

A possible alternative would be to require licensees to send copies of these records to NRC.

However, this alternative has been rejected because it would result in increased costs to the licensee (i.e., mailing costs) and to NRC (i.e., receiving and distributing mail).

NRC's costs for reviewing the information would also be increased.

Rather than. reviewing all of one licensee's records at a time, an NRC employee would have to locate each licensee's file, familiarize himself with the facility, unit and previous data, and then review the most recent data.

l L

4

There are no other alternative sources of data and the chosen alternative is in accordance with the recommendations of NRC's medical physics consultants.

IV.

VALUE IMPACT ASSESSMENT The value of the recordkeeping requirement is that it provides evidence that teletherapy units are properly calibrated and that patients can receive the prescribed radiation dose.

This information is of value to the licensees themselves, to regulatory agencies such as NRC and the Agreement States, and to the public, particularly those members of the public treated with a given teletherapy unit.

The principal benefit to be derived from the new calibration and spot-check requirement is to help ensure that patients receive the prescribed radiation dose.

Delivery of radiation doses that are greater than the prescribed optimal dose increases the morbidity of the treatment regime.

There is increased local damage to tissues near the treatment site, slower healing of these areas and increased residual damage.

Delivery of radiation doses that are less than the prescribed optimal dose may be expected to have an adverse effect on the control rate, either by recurrence of the tumor at the treatment site or by the appearance of metastases elsewhere in the body.

5

4.

3 A.

Benefit Considering Only NRC Licensees Assume:

590 NRC-licensed units 250 New patients treated per unit per year 0.03 Fraction of units delivering doses differing fron prescribed doses by more than 10%

$1,000 Charge per patient for each course of treatment (20-30 treatments) 590 NRC-licensed units x 250 New Patients = 147,500 New Patients per year Unit year 147,500 New Patients x $1,000 Cost

= $147,500,000 cost of treatment year patient per year 147,500 New Patients x 0.03 Fraction of

= 4425 Patient:; Receiving year Units Delivering Incorrect Oose Incorrect Dose As is seen from the above calculations, 147,500 new patients are treated each year with NRC-licensed teletherapy units at a cost of $147,500,000.

I It is estimated that 4425 of these patients receive doses that differ from the prescribed doses by more than 10%.

B.

Costs Considering Only NRC Licensees (Excluding Recordkeeping)

Annual. full calibrati6n costs are estimated as follows:

l.

I i.

6

4 Assume:

590 Units to be calibrated

$300 Calibration fee per unit (Includes equipment and equipment calibration costs)

Full calibration cost per year:

590 Units x $300 = $177,000 Full calibration cost per patient:

$177,000

= $1.20 147,500 Patients Spot-check measurements required by the new rule will be performed by the licensee's staff according to procedures established by the qualified expert.

Cost of monthly spot-checks may be estimated as follows.

Assume:

$20 Cost of performing monthly checks (Includes equipment and equipment calibration costs) 12 Sets of spot-check measurements per year 590 Units Cost for one year's monthly check measurement:

20 x 12 Monthly check x 590 Units = $141,600 Monthly check year Cost of monthly check measurements per patient:

$141,600

= $.96 147,500 Patients 7

,w Total yearly cost for all. required measurements:

$177,000 + $141,600 = $318,600 Total yearly cost of measurements per patient:

$1.20 + $.96 = $2.16 i

C.

Consultations Outside NRC As has been mentioned previously, the reporting requirements were

' discussed with NRC's medical physics consultants and there are no unresolved problems.

The consultants' comments have been included in the final rule.

The proposed rule had a similar recordkeeping requirement.

In addition to publishing the proposed rule in the Federal Register, NRC issued a public announcement and sent copies of the proposed rule to all teletherapy licensees and to various interested organizations.

NRC received no comments on the proposed recordkeeping requirement.

D.

Actual Cost of the Effective Rule Most NRC and Agreement States licensees (80%-90%) already perform the annual calibration of teletherapy units and a lesser (unknown)

-l 8

=-

,o percentage already. perform the spot-check at least monthly.

This.

regime is consistent with the voluntery standards.

1 The actual cost of the annual calibration requirement will be reduced by 80% and the cost of the spot-check will be reduced by an unknown amount:

$177,000 x (1.80) + $141,600 + $27,020 = $204,020 total actual cost to NRC and NRC licensees.

Thus, the total actual cost per year of the effective rule is estimated to be less than $204,000 to NRC and NRC licensees and a similar amount to the Agreement States and their licensees.

This is less than

$345 per teletherapy unit and $1.38 per patient.

Note that Inspection and Enforcement has in place a procedure for checking the calibration of teletherapy units as a part of their routine inspection program.

Because they consider this an essential part of the teletherapy inspection, they anticipate that the current level of inspection effort will not be affected by a Commission decision either to proceed with or withdraw the proposed licensee teletherapy cali-bration requirement.

Also, some of the Agreement States have similar programs in place but this will probably not be an area of required compatibility.

9

._...m

,c' TABLE 1:

COST VS. BENEFIT OF RECORD KEEPING REQUIREMENT Considering NRC Considering NRC Teletherapy Units and Agreement State.

Teletherapy Units

'Telethdrapy Units 590 1180 New Patients per Year 147,500 295,000 Cost of Treatment per Year

$147,500,000

$295,000,000 No. of Patients Receiving Incorrect Doses 4425 8850 Cost of Recordkeeping to licensees, NRC, Agreement States:

in' person-hours / year 1761 3522 in dollars

$27,020

$54,040 Actual cost of calibration and Spot-check to licensees'

$177,000

$354,000 Total actual cost of Effective Rule

$204,000

$408,000 l

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7 996 41]

health) penonnel were adequately the padentis a minori or the pauentis t

trained in the safe use d neoacun unconscious and incapable of mmpm NUCLEAR REOULAN materials. Because 5 years have handing the information. The licensee COMUS$40N elapsed since the AEC requirement would have the discretion or reporting was proposed. It is being withdrawn either to the pauent or to the ps.

[y Upon as]

and a new NRC proposed mi=adminia.

tient's responsible relative. The record MU41AN USE$ OF BYPt000Cf MAfstlAt tration recordkeeping and reporting or report which would be supplied to requirement. 30 CFR f 35.33, is being NRC would contain a brief description offered for public comment The NRC of the event, the effect on the patient.

88'*dadalesmeen seeerens R:,

~~

4,W rule reflects the public com. and the action taken to prevent recur.

I AGENCY: Nuclear Regulatory Com. ments on the AEC proposal, rence. The names of individuals would mission.

One purpose of the misadministra. be maintained in the licensee's record AGON: Proposed rule, tion reporting W4 mta is to snow but not reported to the NRC. A copy NRC to investigate the incident; deter. of the report to NRC would be fur.

SUMMARY

The Nuclear Regulatory mine if there was a violauon of NRC ninhad by the licaname to the pauent Commission is aanaisiacing amending regulations; evaluate the corrective. or the patient's responsible relauve if its Msuladons to requin Ucensees to action taken by the 11eanaae to mini. either had been notified previously.

(13 keep records of au miamAminist,s.

mise the chanen of recurreLos; and, if An example of the follow 4p action Mons of rascacun material or rag. there is a possibility of other Moensees NRC might take upon receipt of a mis.

suon from radoacun material, and making the same error, to allow NRC administrauon report was the NRC in.

(2) prompuy report potentlany dan, to begin generic correcuve action vestigauon of an incident were 400 ps.

which as a minimum, would inform tients treated for cancer with a cobalt.

serous minadministrauons to the NRC, to the patient's referring physi. other licensees of the potential prob. 60 teletherapy unit received radiation clan, and to the padent or the ps. lem. Another purpose is to inform the doses that exceeded the prescribed tient's responsible relative..

patient or the patient's responsible doses by as much as 41 percent. This DATES: Comment period expires do. relative so that corrective action can ' incident occurred because the,radi.

tober 5.1978.

be taken. On this point the Commis. atton dose rate from the teletherapy sion has expressed concern about the unit had not been properly deter.

ADDRESSES: Written comments or possibility of undue intrusion into the mined. Soon after its investigation.

suggesMons for considention in con. physician-patient relationablp. Conse. NRC acted to ensure that all telether.

neocon with the proposed amendment quantly, the Comminaion asks that spy unita licensed by it were properly should be submitted to the 8eentary commentors particularly focus on. calibrated. NRC also published in the of the Commiasion. U.S. Nuclear Reg. those poruona of the proposed amend. PEDERat. Rantarsa (43 FR 38743) a pro.

. ulatory Comminaion. Washington. D.C.

ments which deal with the manner in posed amendment to $38.13 requiring 20684. Attention: Docketing and Serv

• which referring physicians and their teletherapy, licensees routinely to cali.

los Branch. Copies of comments re. patients are informed of =i=Aminia.

brate and check their teletherapy de.

vices. The teletherapy caubration pro.

oeived may be examined at W Com* trations.

miasien's Pubue Document Room at Specificany. NRC's proposed 135.33 posal also included a specific misad.

5757 R Street NW., Washington D.C.

would require Ucensees to maintain for ministration reporting requirement inspection by the Commiasion. records that would be replaced by $38J3 (a POR FURTHER INFORMATION of au miandministntions of mom general proposaD. Comments re, CONTACT:

radiopharmaceuticals or radiation oeived in response to the earlier te.

Edward Podolak. Office of Stand. from teletherapy and brachytherapy latherapy Wdmiaiatration reporting ards Development. U.8. Nuclear Res. sources. Liaansass would also be re. requirement wUl be considered in con.

ulatory r*ammismian Washington, quired to report prompuy su misad. junction with the proposed rnlamak.

D.C. 20066, phone 301-4 minist'auons that involve a therapy ing.

M swam and thcee diagnostic misad.

In this ' newly proposed rule.

SUFFLEMENTART INFORMATION, ministrations that could cause a clini. 136.33(f) (4) and (m; define miandmin.

FoHowing its usanissuon under the 'cany detectable adverse effect on the istrations in part sa administrations Energy Rewganhatian Act of 1974 patient: (1) To the NRC. (2) to the ps.

differing from the total prescribed (Pub. L.93-438) NRC with a view to dent's referring physician, and (3) to dose or exposure by more than 10 per.

Whle changes, began revie%ng its the patient or the patient's responsi. cent for therapeutic procedures or 20 regulations and procedures about li' ble relative, unless the referring physt. percent from diagnostic procedures.

osasing and mgulation of nuclear fa* clan personauy informs the licensee These limita should not be viewed as cinues and materials Wnah pro. that in his medical judgment tening the normal cal!bration limita for these 1

tad he Atonnic Energy Coen* the patient or the patient's respons1 procedures but rather the points ble relative would be harmful to one where an error obviously has occurred.

On March 9.1973, the AEC pub. or the other, respectively.

The narrower tolerance for the thers.

Ilahed a proposed rule in the FEDEsAr.

It is expected that the licensee peutic procedures recognizes the Rasterna (38 FR 6399) that would would report to the patient's responal. greater risk to the patient from thers.

have M&W 11amammes to report to ble relative rather than the patient peutic mi=*Aministrauons.

the AEC and to the patient au misad. when, for example, the referring phy.

Pursuant to the Atomic Energy Act minist'ations of byproduct material sician ' tells the licensee that in his of 1954, as amended, the Energy Reor.

and also would have required Ucensees medical judgment informing the ps.

ganization Act of 1974, as amended.,,

to determine that paramedical (alued tient would be harmful to the patient; and section 553 of title 5 of the United PBERAL ESSISTER. V04. 48, NO.13f--PSIDAY, JULY y,19F8

...a 5

29298 PtoPCSED Rut.15 pacent's responsible relative shan not taken to prevent recurrence.

states Code, nodce is hereby s.17en that ib. In3 AEC prope.ed rul (33 defer ne.ded meetcai care for the p u) For this section. =--a-ini-a.

tion means the administration of:

FR 6399) is withdrawn.and adoption tient,Within 15 days acer the Ucene.

(1) A radiopharmaceutien& or rsdi.

(c) of, the foDowtar new amendments to se's discovery that the =hini="s-ation from a source other than the 10 CPR Part 35 la contemplatecL tion is Ukely to have occurred, the 11* one intendedt Anew I 38.33 la added to 10 CFR Part eensee shan make a wrttten noort to - (2) A r=hhaa=utical or radi.

38 to read as fonows:

the NRC Regional Office inittaur tele

• ation to the wrong padent:

gas.38 Escords and repares of =s a.w phoned, and furnish a copy of th*

(3) A radiophar=*a=utical or radi.

leeresloon.

report to the patient or the padent's ation by a route of admitLWtrar. ton i (a) When a mi=aA=Ini=* ration in.

we. r==pa==shl= rotative if 'either has noen other than that intended by the pre.

volves either a rifarnaart, previously notified umler paragraph serthing physician:

that could cause a r unicalty detectable (aX3) of this section.

(4) A ruarna=Ha done of a radiophar.,

adverse effect or therapy WGe (d) The written noort made under' maceutical differing fross the pre. i

.within 34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br /> after the Ita=n==='s paragraph (e) of this section shan in* scribed does by more than 30 percent *. '

disco,ery that the minadmini="suon clude the ths nante: a brief de. or is Ukely to have d the Ha====

sertption of the event

• the effect on (5) A therapeutic dose of a. radio-shan notify by teleph.ne:

the M ant' the aedon taken to pm. pham_.M or exposun from a rs.

H (1) The appropriate NRC Regional vent recurnacs and whether the & diatiour source such that the total Office. listed in appendix D of part 20 consee Informed the patient or the pa*

treatment dose or exposure differs of this chapter.

tient's responsible relativr. and if not. freun the prescribed dose or exposure (3) The pattant'anferring physiciaan why not However, the esport should by more than 10 percent.

(g) Aside from the notiffatfan re.

ami(3) The patient or the patient's re. not inciucle.the names of others in..

quirement, nothing in this section volved tn the misadmi'4stratisti, such spannihie relative, unless the referrh.g as the patient. physk!ans, and suisd than affect any rigitts or duties of,11-physician personaDy informs the,U.

consee that in his medical fnrMmant health N U oensees and physicians in relation to i tening the patient or ther padent's re.

(e) Each 11a=n==e shan maintain for each omer, patients or responsible rel. i sponsible relaufe would be harmful to S Fears for cammi==ian inspection reca attves.

one or the other, respectively.

. ords of all mimaananranscions of (seek 8L 141 Puh. I. 85 708. 88 Stat, 938

~ (b) If the referring physician. or the, radiopharmaceutiesla or resHaHan 94s (42 U 1LC. 2111. 2301P. Sec. 201. Puh. I.

paHant's responsible rviative is un. from teletherspy or brachytherapy as-438, as StaL L242 (42 U.S.C. 5s41).)

r.vailable within 24 h Jr a, 'he Ucensee sources. These records shall contain Dated a&. Washington.

D.C., this shan make the nr45 J.2.2 under the names of everyone involved in the 30th day of June IM3.

paragraphs (aX3) ot 'i '. et this sec. event (including the licensee. the au.

For The Nuclear Regulatory Com l tion as soon as pra,. sole after that thortsed userts)., allied health person.

min' inn-person beenman avaitain Attamnts to nel, the patient's referring physician,

%yg nottfy the referring. physician or the, the patient, and, where appropriate, g<h l CFR Doc.7& 18T38 Fug L't-a.Tt,268.eetl PEDERAL REGISTR. VOL. 43, NC.131-JtIDaY, JULY 7,1973 F

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