ML20141J135

From kanterella
Jump to navigation Jump to search
Responds to to Chairman Which Expressed Concerns Re Status of Rulemaking on Release of Patients Administered Radioactive Matl. Final Rule & Regulatory Guidance Scheduled for Submittal by June 1995
ML20141J135
Person / Time
Issue date: 02/10/1995
From: Beckjord E
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To: Marcus C
CALIFORNIA, UNIV. OF, LOS ANGELES, MEDICAL SCHOOL
Shared Package
ML20007J296 List: ... further results
References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-028, AE41-2-28, NUDOCS 9708150091
Download: ML20141J135 (1)


Text

, . . . .- .- . - . - . - - . - -

.~-m ',

% IFebruary 10l;1995'-

7

-(

A Carol- S. Marcus, Ph.D. , M.D.

' Director, Nuclear Med. Outpt. Clinic

[@

UCLA' School of Medicine Harbor - UCLA Medical Center Department of Radiology 1000 Carson Street Torrence, California 90509

Dear Dr. Marcus:

This is in response to your letter of January 24, 1995, to the Chairman expressing concern over the status of the rulemaking on " Release of Patients Administered Radioactive Material."

The-final rule and regulatory guidance are scheduled for submittal to the Executive Director of Operations by June 1995.

We are working on this rule as a high priority effort. Your comments along with others will be included in our resolution of the final rule.

. Sincerely,

/s/ Eric S. Beckjord Eric S. Beckjord, Director Office of Nuclear Regulatory Research Distribution:

RPHEB R/F JTaylor

, RES' Files JMilhoan TSpeis JBlaha LRiani RBernero, NMSS MBridgers (ED0 #62) RBangart, SP MFato (RES #950029) KCyr, OGC MFederline, NMSS/IMSS NAME,: g: *See previous concurrences

1. .... .. . ..., . .... ii..\.schnei.d\.csm-rpl.y.

. i. . i. .. .. epat DOCUM.ENT .s, . ..,, .is...i .ii.. . f. .i...... . . ...,. in 0FFICE: DRA/RPHEB C DRA/RPHEB C DRA/RPHEB C DD/DilA/R,ES SSchneidsr;ss*

NAME: KDragonette* DACoo1* FC$hdnzi DATE: -02/01/95 02/01/95- 02/02/95- 02/ /0/95

.PrA _

0FFICE: D/bRi/kkS D/RES [

NAME: [Sf8btris EBeckjord v

.. DATE: 02//d /95 02/1o/95

,C'i

' V 0FFICIAL RECORD COPY RES File Code No. 2-06 9708150091 970807 PDR PR 20 62FR4120 PDR

O

9%eae N' - DOCKETNUMBERe s RU lfz.

?e PROPOSED RULE rn mW 000/11ED WM L

I5'WRttm4 '

4809 Drummond Avenue US!!RC 5'1 LITit(L Chevy Chase, MD 208: 5 February 23, 1% M E' T'D L Dr. Ivan Selin, Chairman 8 U.S. Nuclear Regulatory Commission OfflLL 00CKEIlO a ~' *j W W - W O Washington, D.C. 20555 Rat Proposed Rule on~" Criteria'for the Release of Patients Administered Radioactive Material.""59 F.R.

30724 (June-15< 1994)-

Dear Chairman Selin:

-A recent letter to you, dated January 24, 1995, and now in the Public Document Room, deals ~with the pending rulemaking on patient release critoria. That letter, a copy of which is appended, raises-questions about the integrity of the current rulemaking, and'indeed places it under a cloud which only you are-

-in a position to dispel.

To make clear.the different interests involved, the letter's author is a petitioner in the rulemaking,_whereas I am a commenter, acting in my_ private capacity as a member of the public, not'in my capacity as an NRC employee. (Because--in the past-I have been treated for thyroid cancer with iodine-131, and-might conceivably need to be treated with it again, the radiation doses that my family receives from me, if and when-I an-treated, could be affected by the; outcome of;this.rulemaking.) As-you know,_I:have_not partictpated in-any official capacity in-deliberations on-this rulemaking,-nor dofI-_ intend-to.' This letter, like-sy 1992 comments on the notice of the petition for-

--rulemaking-and my 1994 comments on the proposed-role (also-appended)i was written at home, on my own_ time, using my own computer, paper, envelopes, stamps, and so forth.

The gist of-my-comments, both on the notice of the filing of the petition for rulemaking and on the, proposed-rule, has been

- that31-131NisTatspecial1caseg becauseLof 7 thelepecialsdangers;it poseento(familylameberelandinambersiof(theipublic WlSsWera G .

States:madeithe same pointcin theiricomments ontthe:petitionXas1 JIEdescribed*in my comments:on:the~proposedirule.r 7

_I'did, however, recently send an electronic mail message-to two of my supervisors, referring to the rulemaking. I do not think Lit constitutes interference in the_ deliberative process, but I am attaching it anyway, in the interest.of. full. disclosure.

I D OUU\00\9- o vi: __-_- A

w ,

2 i

The January 28 letter makes representations about a private meeting with you in September, 1994. It appears to claim that in that meeting, the petitioner presented you with information-bearing on'the rulemaking; that you stated your agreement with her substantive positions; and that you yourself'criticised-the NRC staff handling of the rulemaking, saying that the staff "had not done its homework" and that errors would be corrected.

I do not for a moment mean to suggest that I take these representations at face value. Far from it. Over the past few years, I have probably read several dozen letters from the same source,-and have--learned to take them all with, to put it kindly, a grain of salt._'Butiunless:and,untilethey;are,refutodiJthey

cast 7doubtfon?thefrulemaking asiaJuhole,iand;jeopardiselit ilegally,3for!they'depictCa relationship; between the j reg 61stors andlthe
regulatedIthatris completelyJattodds:with1the$ars's-length regulationito7which NRC;is; committed.I If new information bearing on this rulemaking was presented to you, it mustebekplacedionrthe' docket;for all to see and respond to; if not, the allegation should be refuted.'

Likewise, if, as the letter appears to claim, you offered assurances as to the further handling of the rulemaking, that fact also-should be made-known on the rulemaking docket. But if, as seens'to me infinitely more-likely, no such assurances were.

given, thia vallegationdtoorshould*be*deniad, on the public docket.

"An inside job from the start" was the petitioner's unforgettable description,,in a 1992 letter sent'to:the docket of this_ proceeding, of an-earlier NRC rulemaking in which she was the petitioner. In--various letters to the NRC, the petitioner has complained of the fact that-in response to that 'inside job"-

rulemaking, the agency adopted a rule requiring the MRC to reveal any staff involvement in procuring or preparing a petition-for rulemaking nominally' submitted by a member of the public or the regulated industry. .The January 24,_1995,- letter now claims-that-the petitionsfor:rulemaking in this proceeding _was also requested by,the.NRC staff. This is-not a new assertion; previous letters to the NRC have also made'this claim about the current

.rulemaking, and have even identified by name the individual (no longer with NRC)..who allegedly' requested the petition.

  • If the Commission has decided to c.onsider new information, it might profitably inquire whether this rule comports with the new Basic Safety Standards for radiation protection which are now being adopted by the_ international community.

_ -- - - - - 1

)$$00 Y U. '

jy y M cI%.$ -

_ 3-If.this allegation is true,:then the NRC is required by its own rules to make this fact known. If it is false, on the other handi_-then the NRC owes it to_the public and to its own reputation to refute an allegation which could lead the public and a. reviewing court to view the NRC rulemaking process as corrupted. --If-the-issue is in doubt,-you have an Inspector

-General.to resolve just such questions.

~Over the years, the petitionar has sent countless letters that make adverse comments on NRC employees, named and unnamed, with direct and often-coarse attacks on their veracity, integrity, competence, and/or sanity.' In her letter of January-24,:1995,- the' petitioner goes one step further, and seeks to associate you personally with her criticisms of-the NRC staff.

I frankly doubt that the account c.:/ your comments is even remotely accurate. People tend to hear what they want to hear, and. strong feelings can cloud perceptions, so I am sure that you were either misunderstood or misrepresented. I hope that you will r.ake:this clear on the publicsdocket, and will do;so M iskly. It"iis ' difficult"enougCfor"public servants to endure

- abusive and unprofessional- distribes*, year af ter year, without Many of these letters, all on UCLA letterhead, and apparently prepared - with the aid of a secretary, were - written <

during- the _ petitioner's four years as a - member of ' the NRC's Advisory Committee on the Medical Uses of Isotopes. To the obvious question ---whether any.public funds,-Federalfor, State,. paid;for

= these letters - and - tho photocopied magazine cartoons that rather.

bizarrely often accompanied.them--- I have no answer.

The following_ extract is_from a letter sent to the NRC on January 24,;1992:

And out of that boredom and frustration (of the NRC, _over the decline of the nuclear power industry), I suppose, and not a small degree of personality disorder, arose the desire to practice medicine; and -pharmacy without a license. . . . The Commission, with its oversimplifications of medical and pharmacy practice, required willing_ pawns to do its work. A sort of Darwinian evolution took place 3 in which the scientifically unfit, a few individuals with very poor attitudes, and several cowards inherited the duty.... In order to support the Commission's desires, and advance their own power agendas, the present staff uses fraud in any_ convenient ' form. Data are misrepresented, ~ omitted, ignored, _ or. manufactured for convenience. ... The recent humiliation of NRC by staff of OMB when ' NRC's fraudalent ' version of the " Quality

_j

+ .

4 4

having to wonder even for,a fraction of a second whether their own ultimate supervisor, the agency Chairman, views them in the same--light.-

The petitioner's sense of urgency is understandable, with

-nominations for-new Commissioners now pending-before the Senate.

But-clearly petitioner wants more than just a rapid approval of-her petition. SMeriultimmtfobjective, =as:she:;has repeatedly made iclears is(to;end!alliortvirtually'all'NRC regulattentin*the -

ime$icallaree;' Apparently toward' theti andItho' petitioner ~' now-seeks to-depict the agency's leadership as having been brought-to heel by her superior knowledge and dominating will. Mistaken as the petitioner may be about the degree of her influence on the agency,-the NRC cannot remain silent without appearing to give credence to her claims.

--I wish to make clear that I am-not seeking to silence-the petitioner. I believe in the First Amendment and in the free

, flow of' ideas.

Accepting the. principle of freedom of speech means sometimes having'to listen to views expressed unpleasantly.

Management" rule was uncovered is astounding but predictable. Instead of NRC's upper management retracting- the material .and apologizing, a delegation of NRC staff and management went into frenzied, paroxysmal "superlying" to cover the original lying, and earned the contempt of all concerned. Some of the statements made in writing by NRCL staff - to justify- the Rule describes actual deaths of patients caused by physicians:which.in

' f act did not: occur. This would itself constitute a libel suit; but -in this case has no point; no damage will be

-done because no one believes the NRC.anyway. Pitiful, isn't<it? ... I do not believe that the Medical Use Program is compatible with. honesty, integrity, or even simple human. decency.

Hard as=it may be to believe, this rhetoric is temperate compared with'that of more recent-letters, the frequency and shrillness of

.which have been. increasing markedly. And what did-the NRC do that so-enraged the petitioner? .It promulgated'a modest rule designed to make; all'aedical= licensees follow the sensible radiation safety practices that 95 percent of them had already adopted on their own.

-Two organisations with which the petitioner is associated-challenged the: rule in court, and'despite the efforts of'an able

-lawyer, Sheldon' Trubatch, the D.C. Circuit rejected the challenge, 1

completely and crushingly.

. Presumably, . this would mean NRC's asking Congress to be

- relieved ~of its statutory duty to protect the public from the hasards associated with the medical uses of nuclear materials.

j u

~ .

I' 5

g~

Moreover, the NRC cannot-do its. job properly unless;it gets the views of-the affected public, including the-regulated-community, presentedLwith candor and frankness.- But there is all-the

' difference in the world between candor,;on the one hand, and ,

vituperative-personal abuse, on the other, and this petitioner has crossed that-line not once but many times.-

Purely as a= tactical matter, petitioner would help her own cause if she learned that if every letter contains the same-overheated rhetoric -- NRC actions are always " diabolical,"

" dastardly," or " venomous," the product of " perversions" and-

" personality disorders," etc., etc., -- the hyperbolic language loses its power to shock and instead becomes numbingly tedious.

In the end, the reader feels that he or she is reading

-essentially the same-letter for the twentieth or thirtieth time.

Small wonder that the letters are always from-petitioner alone, and.that more responsible members of the medical community seen in no hurry to associate themselves with petitioner's views.

Furthermore, the reasonable person will ask whether the petitioner's singular mode of expression does not suggest that the substance of the letters also leaves 1something to be. desired. -

And indeed, all too often, what the petitioner offers _is not balanced,--or complete, or accurate. _Let me_ offer just one a' example, on a subject I happen to know something about, and let the reader _ extrapolate-from it. Petitioner writes, in a docketed letter'of-January'12, 1995:

As NRC apparently does-not understand anything;about

" radiation risk" in nuclear medicine, let me-explain

.it. _In i terms of jsars of--life lost, which is the.

preferred,-sophisticated way of describing risk, the number of years c life lost from radiation accidents in nuclear medicine, after 59_ years and,approximately=a anarter of a bill'on radiopharmaceutical administrations,-as probably less than one. [ Emphasis .

in.the original.] ... All the Nal-131 events that NRC i crows about have not been= associated with any years of life lost. Patients at worst simply take_ synthetic tetraiodothyronine, and with the exception of certain i lawyers,_-are normal.

Petitioner-is, correct'that I-131 misadministrations-(about which the NRC has'never " crowed," needless to say) do not cause death.,,,These: events,can L.however,;have= serious; impacts-on them .

qual.ity;of life,cand"anyone whoathinks?that_thefsologconsequence? ,

of be'in( without a thyroid is the needL to take'a' daily-pill"of

v, .; .

?

, t.

6 synthetic-thyroid hormoneits-grossly--misinformisd;* '

<It is readily understandable that the petitioner wants the.

Commission to,believe'that-the " preferred,. sophisticated" way of-describing; risk-is to J1ook- only; at years 'of life"'lostt In that way,-the_ numerous misadministrations involving inadvertent overdoses-of I-131 become a non-problem. ~But does-the petitioner really believe that it will be as simple as taking a pill a day for the newborn Micronesian infant whose-thyroid was ablated

,(i.e.,; burned out by radiation)=because;hisanother wasigiven3a, gtherapeutic dose' of(1- 131Jatta Mawaii2 hospital without:firste

,being asked whethereshe<was= nursing? -What about the mother in

-Arizona, given a thousand-fold overdose of I-1317 Does'the petitioner not know that the normal thyroid dose varies from person to person, that patients often have difficulty achieving the correct dose, and"that both underdosing7and; overdosing of~

sthyroid< hormone-can<have-adverse' consequences? Has petitioner never looked at the Synthroid package insert, which discusses the possibility that long-term use of-the drug-leads to osteoporosis, and the special problems-presented-when the patient is diabetic?

On the basis of my personal experience,-the experience of friends, and the many Marshallese thyroid patients whom I

  • It is fascinating, incidentally, to see how the petitioner's -

views have ; evolved, and become more radical, just since' the petition was filed.- The ' original petition asked that the 30-millicurie rule be= relaxed for all radiopharmaceuticals except I-131. Petitioner then" changed her mind, but-still described-as- -

" ludicrous" (in a 1992: letter) the idea that patients requiring 400 millicuries of I-131 could be treated as outpatients. 'Theweest

' calculations in rthe JJanuary L 24, 1995,: letteri appearo to . imply, however, = that : 31111-1311 patients - can be ' treated = as- outpatients,

?regardless of dose level.

  • On the other' side of the ledger, it is gratifying that the ~

petitioner appears to have become better informed about I-131

- therapy L in the course of-- the rulemaking. In the January 1995 letter, the petitioner stresses that the 30-millicurie rule leads physicians to administer therapy in " chunks" of 30 millicuries or'j below to. avoid hospitalizing patients. Yet in October 1992; when--

11 mentioned'having-received two 29.9 millicurie doses of I-131 as 4

, .an--NIH outpatient,'the petitioner's response, in a November 1992 hstter' to the docket, was to say that if this were true, it-would explain why I had had a recurrence of cancer, and it was surprising that I had not filed a malpractice suit -- but that it'was more s likely that I'was making it up. I take the petitioner's-January'

1995 letter as an implied retraction of the suggestion that I was -

fabricating-my own medical history in my 1992 comments.

7 encountered professionally in my tenure as an administrative judge with the Nuclear Claims Tribunal in the Republic of the l

Marshall Islands, I would suggest that the petitioner's view of risk is simplistic and tendentinus in the extreme. Perhaps the petitioner has never seen, as I have, people whose lives have been blighted (including children permanently retarded) because for one reason or another -- a lack of information, or the deficiency of the health care system -- they did not receive an adequate dose of thyroid hormone. Perhaps-the-petitioner-is>

unaware'of^theTtragicVcasetofathe late Senator John East of North Carolina, who, according to his wife, was driven to take his own life because of psychological effects resulting from his doctors' failure to prescribe the correct dose of synthetic thyroid hormone. Or does the petitioner really know all this, and choose not to shore the information with a Commission presumed not to know better?

It would be understandable if the petitioner's zeal to buffalo the NRC into surrendering its authority over the medical uses of nuclear materials had affected her ability or willingness to provide sound professional advice to NRC. Whatever the cause, however, the result is unfortunate. The petitioner, as a professional with many years of experience in the field of nuclear medicine, could be making a valuable contribution to the Commission's processes. But that is not the case today.

I should add that I am not offended that the petitioner has demanded my dismissal by NRC. Quite the contrary: I am one of those NRC employees who regard an "off-with-his-head" edict from the petitioner as a source both of mirth and even some modest pride that perhaps we have been doing something right.'

The Commission has probably figured out for itself by now why the petitioner is so violently abusive toward dedicated public servants such as Dr. Donna Beth Howe, Marjorie Rothschild, Dr. Patricia Holahan, Dr. Anthony Tse, James Lieberman, and Dr.

Carl Paperiello -- not because they are giving incorrect or unbalanced information to the Commission, but for precisely the contrary reason. It is just because they are rational, fair, and level-headed that the petitioner is so intent to neutralize them with attacks on their competence and motives calculated to make When the petitioner recently wrote to the. NRC demanding that a senior manager be 6 sent away for psychiatric treatment, the manager 6 taped the fatwa to his wall for M M its h uss,orous u rk e .

t;  ; .

8 them look like agenda-driven:ideologues.'

As the Commission considers what to do next,;-.I: respectfully, suggest.that=it" step back for:a moment;and.7 consider-how this 5rulemaking might' appear to an outside~ observer. For that purpose, it-might profitably consult with its Solicitor, John Cordes, who will have the job of defending,the Commission's rule in-. court if any petition for review is filed. He (and any other lawyer) will surely tell you that the Commission's_ technical:

judgments are_ entitled to utmost deference from reviewing courts, but that J procedural: defacts ; are anotherm story. At this point, the petitioner's;1sttersJhave raised a host of questions about the procedural regularity of:this_rulemaking.

Finally, and perhaps unnecessarily, let me assure you that I i am_not taking part in this rulemaking for my own entertainment.-

If there is one thing-that all present and former cancer patients

-share, it is_a sense of how. precious and irretrievable time is.

Using my evenings and weekends to write-letters to the NRC docket is not a busman's holiday for me; I have many things that I would rather be'doing with my spare time, including working on history projects,-woodworking, and enjoying my family's company. But'thes.

issuenheresis of protectingany own fanily," families like minet )

and the^public~at large'from the" risks'associatedswithsI-131.o _

Q-Patientswhocome-homewith150ormore'aillicuriesofI-131Ein'(i their systems will= inevitably be delivering a, larger radiation _ ~

Mg_,

dosetoitheir' families"than~whentheycouldnotleaveradioactivyt$

i

-isolation,until:the levelsin their-bodies--dropped'below--30 r y5g m

'illicuries. Nor.is the hazard limited to patients' families.

,It also, affacts anyonexwho ytravelsrby[airplana'sor/ public4 O!

  • Although this is not dicactly relevant to the rulemaking,-I cannot help. observing that the failure of NRC leadership to speak up in defense-of the agency's abused-employees,-and to make clear that vilification of staff members will not.be tolerated, has had the effects that might be predicted: a lowering.of staff morale, and incitement of. the petitioner _ to progressively more inappropriate behavior. I should add that I am not looking for.any
defense
of me. personally;'for the purposes of this rulemaking, I

-am a member of the public rather than of the NRC,-and petitioner is welcome to say'whatever she cares to_about me. g

.Weialready know, from the comments filed by the Nationa Institutes of Health, that despite being warned of the radiation {

consequences to others, NIH patients from abroad who have received

'I-131 as outpatients commonly go directly to the airport and board {:

flights backihome. So far, none'of these patients has had more, than 30 millicuries of I-131.in his'or her system. But if you and 4 thei other Commissioners do what the petitioner now demands, the( ,

J .- . . . -

4 9

transportation:(and, as I-pointed-out:in my 1992 comments, anyone who might go to_a supermarket and bring home fruits or vegetables contaminated by the touch of a prematurely released I-131

-patient). The conscience of the-_ individual-patient is not an adequate substitute for long-standing and sensible regulatory measures, where the hasards of I-131 are concerned.

Protecting the health and safety of the public from

-radiation risks,-including those associated with the use of radiopharmaceuticals in medicine, is the NRC's statutory duty.

To yield-to the petitioner's. demands would be, I respectfully submit, an abdication of that duty. I hope that it will be 3 understood, therefore, that my participation in this rulemaking, I and my comments today, are a sign not of disloyalty to the NRC, which-I have served since 1975, but rather, on the deepest level, of my loyalty to it.

Sincerely, Peter-Crane Attachments: Petitioner's letter, January 24, 1995 Electronic Mail Message, January 10, 1995 Comments on Proposed Rule, August 25, 1994 cc: Docket File Commissioner Rogers Commiseioner de Planque next time you take a transoceanic flight, you-may unknowingly be i spending seven or more hours . sitting next to someone who has received.200 or 300 millicuries of I-131 only hours before. (If. ,

that happens, let us hope there is no turbulence, since the patient may well be nauseous already. Not only may you and others.around you get=a much larger dose of radiation, think of the person who handles the airsickness bag. ) Once you abolish the rule that keeps people with more than 30 millicuries of I-131 in radiological isolation, your and the public's . only protection will be :the'

~ altruism. of- the patient <. The altruistic patient will spend the money on a hotel room in crder to isolate himself or'herself while the bulk of the I-131 passes through the system and is eliminated.

The patient who_ is a little less altruistic, or a little less well-to-do, will get on the plane, knowing that no one can tell that he or.she is a walking radioactive source.

.: . .. -e 10 James M. Taylor,< Executive Director for Operations Karen D. Cyr, General Counsel David A.-Williams, Inspector General

-Dr. Shirley A.-Jackson

> Mr. Dan Berkovitz Dr. Donna-Beth Howe Marjorie Rothschild, Esq.

Dr. Patricia Holahan Dr.-Anthony Tse James Lieberman, Esq.

Dr. Carl Paperiello Dr. Carol Marcus Public Document Room

~

M2 pyjyy A E- Al- +

SulglARY OFIPACKAGE STATMFIllAL RULDIAKINS?

3/30/95

1. Package out for office review.

. package includes FRN/RG

. RG - w/o BFI table; to be provided by ORISE

-2. Reg. Analysis to be completed.

3. ORISE/BFI -

. new born and 1 year old models

. full documentation provided

. provide internal dose calculations for commonly used radiopharmaceuticals

4. Regulatory Guide -

. no release table that includes biological elimination; see the first example in the guide. .

SUMMARY

OF NMSS REQUESTED CHANGES 10 5 35.75 FRN (3/30/95) 1.Page4(CH): Response to PRM-35-11 on page 32 was brought forward.

2.Page6(CH/TH): The number of patients breast feeding is given as 70,000; based on input from Sam Jones cnd modified by -

Steve / Stewart for the situation at hand.

3. Page 6 (CH/TH): A paragraph was added that briefly summarizes the regulatory guide and regulatory analysis.

4.Page7(CH/TH): Deleted sentence that referenced person who submitted one of the petitions.

5. Page 9 (TH): Regulatory guide approach based on NCRP 37 and values stated are conservative.
6. Page 11 (CH/TH): The commenter did use the word vomit.
7. Page 41 (CH/TH): Deleted sentence referring to " Doses are a measure of degree of protection." Also, the response was expanded.
8. Page 11 (CH/TH): The commenter did use the word " vomit." Also, the response was expanded.
9. Page 12 (TH): The response to the comment on the Agreement States was clarified and expanded.
10. Page 12 (CH/TH): The response to the comment on doses > 5 mSv was clarified and expanded,
11. Page 12 (CH/TH): The text describing the comments on "recordkeeping" was revised.
12. Page 14 (CH/TH): The response was considerably expanded. Reference to Drs. Pollycove and Siegel was included.
13. Page 14 (CH/TH): The first response on this page was considerably expanded.
14. Page 15 (CH/TH): The comment at the top of the page was deleted from the FRN.
15. Page 16 (CH/TH): The first response on this page was clarified and expanded.
16. Page 16 (CH/TH): The second response on this page was clarified and expanded. The 1979 Medical Policy statement is now discussed.

17.Page18(CH/TH): The response on confinement regarding NRC penalties was revised.

l l

l

. . - _ _ _ - - _ - - - _ a

18.Page19(CH):* The last sentence of the first response was not deleted, i.e., the reference to good health physics practice.

19.Page19(CH/TH): The response to confinement to one's home was clarified and expanded.

20.Page21(CH/TH): The response to boarding an airplane upon release was clarified and expanded.

21.Page22(CH/TH):* The response was reworded but the essence of the response did not changel i.e., case-specific calculations can be used again in identical situations.

The 24-hour voiding time assumption was not' considered too conservative-by the experts at ORISE.

Statement in the Regulatory Guide: "In those instances for which a case-specific calculation ' ,ies to more than one patient release, the calce' .on need not be performed again."

22.Page22(CH/TH): The coment in the first sentence of the second set of coments at the bottom of the page is inov addressed in the response.

23.Page24(CH/TH)* The response to the comment on "inc19iing a biological half-life release table" was no, revised.

24.Page25(CH/TH): The response to the coment on examples in the guide has be revised.

25.Page25(TH):* The essence of the response to the coment on "BFI information" in the guide has not been revised 26.Page26(CH/TH):* The response to the coment on " generally acceptable calculations" was not revised.

27.Page27(CH/TH): The responses to the first and second coments on

$. person-rem and hospital room costs, respectively, were revised.

28.Page28(CH/TH): " Coordination with Agreement States" - Sumary of last workshop included.

29.Page28(CH)* The format for the section " Discussion of the Final Rule Text" was not changed.

30. Page 34 (CH):* The issue of compatibility for Agreement States will be addressed by OSP upon their review of the package.

NN$ N ~

L j'( . y f AGENDA FOR MEETING ON PATIENT RELEASE KEY PARTICULARS KEY ROLES Date: Wednesday, Juna 28, 1995 Primary Facilitator: J. Glenn Start: 3:00 PM Secondary Facilitstors: All End: 4:00 PM Timekeeper: S. Jones Location: TWFN 7A3 Minute Takers: S. Jones & C. Haney PURPOSE OF MEETING: The purpose of this meeting is to discuss options to the Part 35.75 rule language to address the ED0's concerns.

DESIRED OUTCO'iF:

- Explore various options Reach concensus on the preferred option to present to the EDO Establish timetable for briefing RES and NMSS management EXPECTED PARTICIPANTS:

RES - John Glenn, Cathy Haney, Sam Jones, Steve McGuire, Stuart Schneider HMSS - Myron Pollycove, Larry Camper, Janet Schlueter, Trish Ho11ahan 3:00 - 3:10 Identification of E00's concerns - J. Glenn 3:10 - 3:20 Various options and technical basis - J. Glenn 3:20 - 3:40 Cost / benefit of options - S. McGuire and S. Schneider 3:40 - 3:50 Open discussion - All 3:50 - 4:00 Wrap-up - J. Glenn

\ l

p[f[JN g/v -

M 4C A

Xssue.

mpg q t4 Should 4 ht. d os. + o m in o rs be limtfed +o o, I re m ?

(Noh. : 4his issuc d oes n ot involve 3rca,1. reedig 2 xAntr.

theg orc alrea.Ig limtIca io 01 rem ta ut ra te po cx 3e.)

Optton_1 : Defend a. Irm ,tt of o,6 re m :

(%is n3eaus defendig +bc. currmt ewI< p,ee.3e 4 Al+<<noi e 3 in 4 4. Rej.

Analsis.)

y e NeeP 116, ScgP gu ,

IceP 6 0 , NRC Part .ao, awa E PA '.s A raft guidance allow 0,5 rem 4o ya m e.u b< r of +be- pblic <Y abtre cs x neca +6t cou j usti#g i+.

Staitve.lg feu pbice co m m eat.r o bj,cted to +1,cs appec ach, oPYI* h E ';"' IY ' d ** "'" "# +" O'I "'

  • C t his coaA be acco* Plishe d r ep latio n - Al+<rm+tve. 2 in tk. R win & curr<wr 3 Analy sc.r.)

A C R + Nc8 P Co m a, <.nt ag *ll I. m c + a e3 <. + a c h ild r ,n to 0.1 rem, 8 ND AN" uni t g'uJil[I'caf/6% ff/S~lJ b CXCf ed 0./ r em, NaY c est - e%c1tve .

  • The, c ore too yan risk /nuc+ dos 4_. may bc Severat dimes largse he cktIdun cowg+rra % odas, e be - ba se.c! hw(c + jdA <., a re to o compl/c,ted, mqw.,

diffccu lt,lic e nS ce. 's u rK + rec.<d- k'.e tp/wg m or.

. pRt woua 60 on n S S tL t.

m < " rig ht" s,dc of y a en,oy,w hecattr Sia bt liig . ih _-1 bc rvjv(ettlehJ.

- _ _ - _ . ]