ML23156A145

PRM-035-10A - 57FR21043 - American College of Nuclear Medicine; Receipt of an Amended Petition for Rulemaking

ML23156A145
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Issue date:	05/18/1992
From:	Chilk S NRC/SECY
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57FR21043, PRM-035-10A
Download: ML23156A145 (1)

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ADAMS Template: SECY-067 05/18/1992 PRM-035-10A-57FR21043 -AMERICAN COLLEGE OF NUCLEAR MEDICINE; RECEIPT OF AN AMENDED PETITION FOR RULEMAKING PRM-035-1 0A 57FR21043 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE:

PRM-035-l0A OPEN ITEM (Y/N) N RULE NAME:

AMERICAN COLLEGE OF NUCLEAR MEDICINE; RECEIPT OF AN AMENDED PETITION FOR RULEMAKING PROPOSED RULE FED REG CITE:

57FR21043 PROPOSED RULE PUBLICATION DATE:

05/18/92 NUMBER OF COMMENTS:

ORIGINAL DATE FOR COMMENTS:

I I

EXTENSION DATE:

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55 FINAL RULE FED. REG. CITE: 62FR04120 FINAL RULE PUBLICATION DATE: 01/29/97 NOTES ON:

STATUS OF RULE:

AMENDED PET. REQUESTED THAT ORIGINAL PET. BE EXPANDED TO CONSIDER ALLOWING USE OF AMOUNTS GREATER THAN 30 MILLICURIES IN DIAGNOSTIC STUDIES & TO ADD DEF. OF CONFINEMENT. SEE PR-20 & 35.

FILE ON Pl.

HISTORY OF THE RULE PART AFFECTED: PRM-035-l0A RULE TITLE:

PROPOSED RULE SECY PAPER:

FINAL RULE SECY PAPER:

AMERICAN COLLEGE OF NUCLEAR MEDICINE; RECEIPT OF AN AMENDED PETITION FOR RULEMAKING DATE PROPOSED RULE PROPOSED RULE SRM DATE:

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SIGNED BY SECRETARY:

05/12/92 FINAL RULE SRM DATE:

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DATE FINAL RULE SIGNED BY SECRETARY:

STAFF CONTACTS ON THE RULE I

I CONTACTl: MICHAEL T. LESAR CONTACT2:

MAIL STOP: T-6D59 MAIL STOP:

PHONE: 415-7163 PHONE:

DOCKET NO. PRM-035-lOA (57FR21043)

In the Matter of AMERICAN COLLEGE OF NUCLEAR MEDICINE; RECEIPT OF AN AMENDED PETITION FOR RULEMAKING DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 05/21/92 05/14/92 05/22/92 05/12/92 06/08/92 06/03/92 06/12/92 06/02/92 06/12/92 06/17/92 06/!9/92 06/23/92 06/03/92 06/12/92 06/16/92 06/12/92 07/01/92 06/29/92 07/02/92 06/29/92 07/02/92 06/29/92 07/06/92 06/29/92 07/06/92 06/29/92 07/06/92 06/29/92 07/06/92 06/29/92 07/06/92 06/29/92 07/06/92 06/30/92 PETITION FOR RULEMAKING SUBMITTED BY THE AMERICAN COLLEGE OF NUCLEAR MEDICINE (RICHARD A. WETZEL)

FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (STEVEN C. COLLINS) (

1)

COMMENT OF UNIVERSITY OF CINCINNATI MEDICAL CENTER (DR. HARRY R. MAXON III) (

2)

COMMENT OF DR. MARSHALL BRUCER (

3)

COMMENT OF MOBILE CARDIAC/PULMONARY TESTING (JOHN CARPENTER, DIRECTOR) (

4)

COMMENT OF CONFERENCE OF RADIATION CONTROL PRO DIR (AUBREY V. GODWIN, CHAIRPERSON) (

5)

COMMENT OF DAVID M. GARNER (

6)

COMMENT OF IRA D. GODWIN, M.D. (

7)

COMMENT OF KARL T. DOCKRAY, M.D. (

8)

COMMENT OF WILLIAM J. ELTON, M.D. (

9)

COMMENT OF KEVIN J. DONOHOE, M.D. (

10)

COMMENT OF J. ANTHONY PARKER, M.D., PH.D (

11)

COMMENT OF DR. GERALD M. KOLODNY, DIRECTOR (

12)

COMMENT OF W.J. STRADER, M.D. (

13)

COMMENT OF JULIAN R. KARELITZ, M.D. (

14)

COMMENT OF GERALDS. FREEDMAN, M.D., FACR (

15)

DOCKET NO. PRM-035-lOA (57FR21043)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 07/06/92 06/30/92 07/06/92 06/30/92 07/06/92 06/30/92 07/06/92 06/30/92 07/06/92 06/30/92 07/06/92 07/01/92 07/06/92 07/01/92 07/06/92 07/01/92 07/07/92 06/26/92 07/08/92 07/02/92 07/08/92 07/03/92 07/10/92 07/08/92 07/10/92 07/03/92 07/10/92 07/13/92 07/13/92 07/07/92 07/08/92 07/03/92 07/13/92 07/08/92 07/13/92 07/02/92 07/13/92 07/06/92 07/13/92 07/06/92 07/13/92 07/08/92 07/15/92 06/30/92 07/15/92 07/14/92 07/16/92 07/01/92 COMMENT OF NUCLEAR MEDICINE CONSULTANTS (DR. MALCOLM R. POWELL) (

16)

COMMENT OF DR. JOHN 8. SELBY, SR. (

17)

COMMENT OF DR. LARRY L. HECK (

18)

COMMENT OF DR. JAEKYEONG HEO (

19)

COMMENT OF K.C. KARVELIS, M.D., DIRECTOR (

20)

COMMENT OF DR. ROBERT J. GRIEP, DIRECTOR (

21)

COMMENT OF DR. MICHAELS. KIPPER (

22)

COMMENT OF DR. WIL 8. NELP (

23)

COMMENT OF DR. GAYLE F. BREWER (

24)

COMMENT OF JOHN B. EBY, 0.0. (

25)

COMMENT OF DR. VINCENT J. SEIWERT (

26)

COMMENT OF PAUL J. CHASE, D.O., FAOCR (

27)

COMMENT OF DR. LAWRENCE V. BASSO (

28)

COMMENT OF DR. JAMES S. ARNOLD (

29)

COMMENT OF DR. ANITA MOALLEM, SITE DIRECTOR (

30)

COMMENT OF DR. M. PUTERBAUGH, RSO (

31)

COMMENT OF DR. SYDNEY HEYMAN (

32)

COMMENT OF DR. JOHN E. D'ABREO (

33)

COMMENT OF OR. J.G. LLAURADO (

34)

COMMENT OF DR. ANIL K. SAIN (

35)

COMMENT OF DONALD F. DEVRIES, M.D. (

36)

COMMENT OF DR. JOHN V. CALCE (

37)

COMMENT OF DR. EUGENE L. SAENGER (

38)

COMMENT OF OR. JAMES T. DODGE (

39)

DOCKET NO. PRM-035-lOA (57FR21043)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 07/16/92 07/13/92 07/16/92 07/14/92 07/16/92 07/14/92 07/17/92 07/08/92 07/17/92 07/14/92 COMMENT OF DR. RONALD C. WALKER (

40)

COMMENT OF DR. DAVID M. SHEARER (

41)

COMMENT OF THOMAS W. MCCREARY III, M.D. (

42)

COMMENT OF DR. GEORGE L. COLVIN (

43)

COMMENT OF SAMUELE. FRIEDMAN, M.D. (

44) 07 /17 /92 07/10/92*

LTR FROM C.M. HARDIN, EXEC. DIRECTOR CRCPD TO 07/20/92 07/13/92 07/20/92 07/14/92 07/20/92 07/15/92 07/20/92 07 /17 /92 07/21/92 07 /17 /92 07/27/92 07 /17 /92 CHILK RE: CORRECTED COPY OF THEIR LTR OF 6/16/92 COMMENT NO. 5 COMMENT OF DR. HELEN H. KIM, PATHOLOGIST (

45)

COMMENT OF DR. HERBERT C. ALLEN, JR. (

46)

COMMENT OF AMERICAN COLLEGE OF RADIOLOGY (GARY W. PRICE, SENIOR DIRECTOR) (

47) 07/27/92 07/21/92 08/06/92 08/13/92 COMMENT OF DANIEL J. MACEY, PH.D., ET AL (

48)

COMMENT OF WILLIAM B. BASS, JR., RSO (

49)

COMMENT OFF. DEAVER THOMAS, M.D. (

50)

COMMENT OF J. HOLT ROSE, M.D. (

51)

COMMENT OF BRUCE F. BOWER, M.D. (

52) 08/17 /92 09/09/92 11/02/92 11/17 /92 11/18/92 12/07/92 08/13/92 09/04/92 10/31/92 11/09/92 11/17 /92 11/19/92 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (BRUCE F. BOWER, M.D.) (

53)

LTR FROM JOSEPH I. LIEBERMAN, UNITED STATES SENATE RE: LTR (ENCL.) FROM CONSTITUENTS SUPPORTING PETITION FOR RULEMAKING COMMENT OF MR. PETER CRANE (

54)

LTR MARCUS TO CHILK RESPONDING TO CRANE LETTER OF 10/31/92 LTR CRANE TO MARCUS RESPONDING TO HER LETTER OF 11/09/92 TO SECRETARY CHILK COMMENT OF AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (JEFFREY E. POTTRUFF) (

55)

oOCKETNUMBER O.,A...

PETITION RULE PRM 3f;J.

( 57 F-R. :2..J CJ'-/3)

AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE NW Chapter November 19, 1992 Charles A. Kelsey. Ph.D Chairman, AAPM Radiation Protection Committee Univereity of New Mexico Department of Rad1oloqy Albuquerque, NM 87131 Dear Or. Kelsey1

• 92 EC -7 P12 :Q6 On behalf of the Northwest Chapter of t~e AAPM, I wish to add our concern to those expressed by many other physicists regarding the decision of the Nuclear Regulatory Commission to lower the radiation dose limits to the ~eneral public from 500 to 100 mrem per year (Title 10. Part 20.1301). effective January 1994.

Since many states use the same dose l1m1 t for all radiation sources.

whether machine produced or radioactive materials, this rule will have a major impact on medical x-ray machines and the use of therapeutic isotopes.

Of particular concern to our membership. is the fact that existinq facilities are required to formally request exempt.ion, rather than beinc;i *grandfathex-ed" from meeting new standards.

Such existing facilit~es have already been reviewed by either federal or state regulators and have met accept.able design atandar~s established at that t1me.

We feel that the new regulations should not subject exiting facilities to the additional effort and expense to meet future requirements.

Another concern from our members is the fact that NRC rules are frequently adopted by state regulatory agencies. as evidenced by CRCPO rules currently in draft form applying to the new Part 20 rules.

Again. al though only materials licenses are officially affected, the new regulations may affect all radiation facilities since tew states are willing to institute two standards of protection for the qeneral public.

Within the Northwest chapter's geographic region (Alaska, Idaho. Montana, Oregon and Washington) several states appear to be considering a~endment of theix-regulations to allow a aingle dose limit to the general public.

This will require a review of all existing shielding requirements, as well as new construction shielding.

The resulting expense of design review. potential redesign and construction modification will be significant and would appear to be inconsistent "11th national concern about increasing health care costs.

The Association's Scientific Journals are MEDICAL PHVSICS and PHYSICS IN MEOIC1Ne ANO 8101..0GY

U.S. NiJCLEAR REGULATORY COMMISSIOt-.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Copies Received --------

Add'I Copies Reproduced ~J-~-r--=--~ -

Special Distriootion fl.I. IJ>::J O Yl1 Pl.,r

Charlee Kelsey, Ph.O Page 2 Finally, the need for new p~otection limits is not clearly understood.

However, I do not wish to debate the motivations for lowering the general public dose limits in this letter.

The consensus of our chapter though, 1s to suggest that if the new dose limits are adopte~. then onl~* new or modified facilities should be required to meet the n~w standard.

We request that the expanded impact of this rule be evaluated further, and that the AAPM petition the NRC tor a rule chano* that is both responsible and reasonable tor the evaluation of ~adiation dose limits to the general public.

Respectfully Submitted, Jlt2 ~-~ff, H. S.

President, Northwest Chapter AAPM cc1 Secretary. U.S. Nuclea~ Regulatory Commission /

U.S. Nuclear Regulatory Commission, Region III U.S. Nuclear Regulatory Commission, Region V Washington Radiation Control Section or,gon Radiation Control Section Montana Radiation Control S@ction Alaska Radiation Control Section Idaho Radiation Control Section State of Washington DEPARTMENT OF HEALTH 1511 Third Avenue, Suite #700 Seattle, Washington 98101

Dr. Carol S. Marcus UCLA School of Medicine Department of Radiology 1000 Carson Street Torrance, CA 90509 DOCKET NUMBER PETITION RULE PRM

- / 0 A

(~7FR 1..IOL/3) 4809 Drummond Avenue Chevy Chase, MD 20815.92 NOV 18 A8 :27 November 17, 1992 Re:

Docket Nos. PRM-20-20, PRM-35-10, PRM-35-l0A

Dear Dr. Marcus:

I was gratified to learn, from your letter to Mr. Chilk of November 9, 1992, that you believe that "the concept of sending patients home with 400 mCi of NaI-131 was ludicrous."

Though my language was less vivid, that was of course the whole point of my comments of October 31, 1992.

Thank you for drawing my attention to my mistake in conflating your proposal to eliminate the 30 mCi standard with the ACNM's proposal to raise the 30 mCi limit to 400 mCi.

I sincerely regret the error, which appears in two places on p. 7 of my October 31, 1992, submission.

For the record, let me therefore make clear my acknowledgment that you neither proposed nor supported the ACNM position. (You are correct, by the way, in surmising that I was unaware of your written comments on the ACNM petition, but even if I had read them, I would not have realized, given the passage that you quote in your November 9 letter,that you thought the ACNM proposal "ludicrous.")

I am happy to have the opportunity to correct what was an injustice to you, and I will place this letter in the docket file and see that it is forwarded to all those who got copies of my earlier submission.

In every other particular, however, I stand by my October 31 submission.

I should add that I get no pleasure from placing details of my own medical history on the public record.

I did so in this case not because I regarded myself as a medical professional, but because I saw the NRC staff proceeding with consideration of an important public health and safety issue without having some crucial information at its disposal:

for example, on the issue of how patients feel after radioiodine treatment for thyroid illnesses.

I wish that when Judith Brown asked that question at the ACMUI meeting and Don Cool of the NRC staff was unable to answer it, you had contributed your experience of the numerous thyroid patients you have treated.

It is only when professionals whose experience encompasses many patients fail to speak out, leaving the NRC staff to make decisions in the dark, t hat individual patients may feel compelled to come forward, even at the cost of their own and their families' privacy.

cc: Docket file Commissioners ACMUI members

DOCKET NUMBER

. l PEilJION RULE PAM

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• DAV IS IRV INE

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• 92 NOV 17 November 9, 1992 Samuel Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Docketing and Service Branch Washington, DC 20555

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UCLA SCHOOL OF MEDICINE HARBOR - UCLA MEDICAL CENTER DEPARTMENT OF RADIOLOGY 1000 CARSON STREET TORRANCE, CALIFORNIA 90509

Subject:

Letter of Peter Crane dated 10/31/92 regarding PRM 20, PRM-35-10, PRM-35-l0A, and the 23 October 92 meeting of the ACMUI

Dear Mr. Chilk:

I am writing to correct the scientific mistakes and misunderstandings contained in Mr. Crane's letter of 31 Oct. 92, and to point out that certain opinions ascribed to me by Mr.

Crane are grossly inaccurate.

Fortunately my opinions are amply documented, in writing, in your office, so this should be quite straightforward.

I recommend that Mr. Crane review my Petition dated 12/26/90, my important Addendum of 6/12/92, and my comments of 3/14/92 concerning the ACNM Petition.

My Petition was written at the request of Hal Peterson, who was embarrassed at the uncorrected errors in 10 CFR Part 20, and who urged me to "write a Petition YESTERDAY".

At the time, the new Part 20 was supposed to go into effect 1 Jan 92, and we did not have many months to waste.

I argued at the time that I did not want to write another petition (I wonder why?), but he insisted it was the only option open, and that is how I spent Christmas Eve, 1990.

It was hastily done, and recommended honoring the methodology of NCRP no. 37, getting rid of the 30 mci rule" for all radionuclides other than I-131, and retaining the 5 msv maximum for members of the public from patient sources; this is in keeping with the most recent recommendations of NCRP, ICRP, and the IAEA.

I recommend that Mr. Crane review this literature as well, as NRC asserts frequently that it uses such sources for its standards.

Much later, after discussing the issues at leisure in much more detail with members of NCRP, ACNP, SNM, and NRC, I wrote an Addendum covering the "30 mCi" issue.

Due to the fact that the 11 30 mCi" value was embarrassingly based on a naive mistake by the AEC in the early 1950's and never fixed thereafter, and due also to the fact it is not mentioned anywhere in NCRP no. 37 (nor should it have been), I made a scientifically valid case for a "default value of I-131 patient discharge which came out to 33

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November 9, 1992 Samuel Chilk, Secretary Page mci.

However, there is excellent reason to raise that number, especially for athyreotic carcinoma patients with normal renal function.

NCRP no. 37 lists limits of 50 mci for certain home situations and 80 mci for even more restrictive home situations.

Mr. Crane should familiarize himself with these qualifiers, because he is obviously unfamiliar with these long-accepted concepts.

NCRP no. 37 is the law in California; the 11 30 mci rule" does not exist here.

We in California try to base our policies on scientifically valid health physics.

When the ACNM Petition was submitted, I used my comment opportunity to remind NRC that my Petition was drowning at the bottom of Mr. Roecklein's "in" pile, and that it needed resolution.

The concept of sending patients home with 400 mCi of NaI-131 was ludicrous.

Although I could theoretically concoct a situation where it could possibly be justified, there are not too many patients who would qualify as hermits in isolated areas.

In any case, I stated:

"The one aspect of the petition that causes me some concern is the claim of safety of an outpatient dose of 400 mci.

I have not reviewed data supporting this argument and would appreciate the opportunity to do so.

Although I'm sure that safety could be satisfied, it would appear to require some very specific circumstances".

As there are no data that could possibly support this except in highly unusual situations, the point is moot.

Mr. Crane should also know that I requested that ACNP (absolutely not related in any way whatsoever to ACNM), SNM, the American College of Radiology, and Jack Goodrich, M.D., past ACMUI member, make similar points in their comment letters.

I explained to the American Hospital Association that this was NOT a good way to save money, and made a presentation against the ACNM Petition at last Spring's CRCPD meeting at the request of Terry Frazee of the State of Washington.

I hope that NRC clearly understands that I am not now, nor have I ever been. a member of the ACNM nor an espouser of 400 mci I-131 doses dispensed to patients in an uncontrolled manner.

However, NRC's 11 30 mCi" rule is scientifically unfounded and constitutes bad physics, just as ACNM's claims are unsupported by scientific data.

All I am trying to do is challenge NRC to make an intellectually defensible, scientifically valid regulation based on best available scientific data and scientific judgment.

I urge NRC to entertain only scientific discussion, and eschew scientifically

November 9, 1992 Samuel Chilk, Secretary Page uninformed nuclear hysteria from any source.

NRC's independent status insures it does not have to honor outside opinion flawed by ignorance.

One would hope NRC would not have to honor inside opinion flawed by ignorance, either.

Mr. Crane asks NRC to regard him somehow as a knowledgeable professional on the subject of I-131 for thyroid cancer, based on his personal experience with the disease.

Having read Mr.

Crane's present missive, and a previous related document at the time the Commission signed the scientifically insupportable "Quality Management thing, let me assure you, as a knowledgeable professional on the subject of I-131 for thyroid cancer, that Mr.

Crane is well-qualified to be a patient, and nothing more.

For example, if Mr. Crane really had a partial thyroidectomy in 1973 and then 2 doses of 29.9 mci each 10 and 11 years later to ablate the remnant, it is no wonder he had recurrences, and it is surprising he isn't in malpractice court.

Knowing the excellence of NIH, however, I would tend to doubt the validity of his account.

As far as his story about his confinements, let me explain that one does not need "thick paper" on the floor, only absorbent material with a plastic backing.

As far as "smelling strongly of seaweed", this is pure confabulation.

In the first place we do not give iodine, we give iodide.

Iodide does not smell like seaweed.

Second, the mass of 150 mci of I-131 is (150) (131) (8) (24) (60) (60) (8.87x10*17 ) = 1.2 micrograms.

Normal stool contains 10-50 micrograms per day.

The average person contains 30,000 micrograms of the element iodine, and another microgram or so, even if converted to a volatile form, should not make his deodorant fail.

Mr. Crane's story about his contaminated computer case is indeed a physics first.

".... radiation from stray drops of urine had probably penetrated the thick concrete walls of the bathroom and reached the case.

A month later, the case had cooled down to the point that I could collect it from Radiation Safety."

Quick, Mr. Bernero!

We need at least three contracts to starving DOE labs to understand this new phenomenon.

"Beta creep"?

Good God!

Have all our shielding calculations been for nought all these years?

My Uncle Joe Fertik, who designed the 14 foot concrete vault around the very first Oak Ridge reactor after W.W. II, died last year at 94, and never knew.

If a gamma ray sneaked through and hit the case it should last no more than about a picosecond at most.

A month?

Wow!

Mr. Crane makes some other interesting statements, quoting such incontrovertibly superb scientific sources as the New York Times

November 9, 1992 Samuel Chilk, Secretary Page for data on childhood thyroid cancer near Chernobyl.

I recommend that Mr. Crane read Hull AP: Post Chernobyl childhood cancers reported.

The Health Physics Newsletter, vol. 20, Nov. 1992, (cover story).

There are some interesting problems with Russian "data" at this point.

Mr. Crane's naivete' concerning the first Petition I wrote in June, 1989, with Mr. McElroy's help, is surprising.

Mr.

Cunningham instructed Mr. McElroy to help me write the Petition.

I didn't know how to write regulatory language, and it was Mr.

McElroy's job to help me do that.

NRC had written some very poor quality and dangerous regulations in 1987, and Mr. Cunningham realized that the language had to be fixed, and asked us to do it together.

It was an "inside" job from the start.

Mr. Cunningham gave us some very tough boundary conditions, but we did the best we could.

This was before NRC rammed through the petitioner's "Gag Rule" without opportunity for public comment.

If I were to write my own petition to change Part 35 today, with none of Mr.

Cunningham's constraints, I would get rid of nearly everything in it, and upgrade education and experience criteria for nuclear medicine physicians so that NRC stopped licensing incompetent physicians who don't even know what Part 20 is, let alone the basic science necessary to comply with it.

Nuclear Medicine would be subject to performance standards only.

The only reason we have completely prescriptive regulation is that performance standards require thorough understanding and judgment, and NRC itself cannot seem to rise to that level.

So yes, Mr. Crane, the staff "is passing judgment on a petition that the staff itself helped to write", and I did not "misspeak".

Mr. Crane is a lawyer.

It is not surprising that he is thoroughly unfamiliar with the areas of nuclear medicine, nuclear pharmacy, and basic nuclear sciences, because he has never had any education, training, or experience in these fields.

However, one may expect certain professional behavior from a lawyer.

For openers, one would expect him to read the obvious background material on a case, so that he would be aware of the facts.

It is well known that I do not deprive the NRC of my opinions on subjects involving my expertise, and a short search on Mr.

Crane's part would surely have yielded the facts he so desperately lacked.

Although he would not have understood my calculations, he could have asked an expert for some help.

He could even have called me!

He would, however, have been expected to understand the English.

It is not acceptable professional behavior for an NRC lawyer to attempt to deceive NRC about the opinions of an NRC advisor and consultant, refuse to even bother with the facts, and expect NRC licensees to continue to support him with User Fees.

I object to his continued employment at NRC.

November 9, 1992 Samuel Chilk, secretary Page In addition to being of no value as a nuclear expert, he is, in my opinion, behaving in an unacceptable manner for a lawyer.

Thank you for the opportunity to comment on this most informative comment letter.

Sincerely,

~

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

Director, Nuclear Med. Outpt. Clinic and Assoc. Prof. of Radiological Sciences UCLA cc:

Peter Crane Commissioner Ivan Selin Commissioner Gail de Planque Commissioner Forrest Remick Commissioner Kenneth Rogers Commissioner James Curtiss Hugh Thompson, Deputy EDO Robert Bernero Richard Cunningham John Glenn, Ph.D.

William Parler, Chief Counsel Joan McKeown Peter Almond, Ph.D.

Ted Webster, Ph.D.

Gerald Pohost, M.D.

Judy Brown Curtis Scribner, M.D.

Steve Collins Barry Siegel, M.D.

Mel Griem, M.D.

Dan Flynn, M.D.

Capt. Wm. Briner Mark Rotman Myron Pollycove, M.D.

CSM:sfd

To:

From:

Subject:

October 31, 1992 Secretary of the Commission U.S. Nuclear Regulatory Commission Attention:

Docketing and Service Branch Peter G. Crane /I'~

DOCKET NOS. PRM-2ol20, PRM-35-10, AND PRM-35-lOA (PATIENT RELEASE CRITERIA FOR PATIENTS TREATED WITH RADIOPHARMACEUTICALS)

The following are comments on the amended petition for rulemaking filed by the American College of Nuclear Medicine (ACNM), as noticed in the Federal Register with a request for comment. I realize that the Federal Register notice states that comments received after July 17, 1992, will be considered only if it is practical to do so.

I hope that the Commission will nevertheless elect to take my comments into account, because I believe my experience as a nuclear medicine patient, treated with a total of 760 millicuries of radioactive iodine as an inpatient and an outpatient, may be of some value in weighing the merits of the petition.

I apologize for the lateness of my comments.

I was living on an atoll in the Central Pacific at the time that the American College of Nuclear Medicine first proposed (on January 14, 1992) that the 30 millicurie limit be eliminated for putpatient treatments with radioiodine, and that "confinement" of patients be redefined to include "remaining in a private residence."

Although I rejoined the NRC in May, 1992, I was not 1oll..'!>l'fl aware until October 30, 1992, when I first saw the transcript of

~meeting of the Advisory Committee on the Medical Uses of Isotopes, that such a proposal was under consideration.

I should emphasize that although I am now an employee of the Nuclear Regulatory Commission, I am submitting these comments in my capacity as a member of the public, rather than in my official role as Counsel for Special Projects in the Office of the General Counsel.

I am writing these comments at home, on my own time.

The ACNM proposes to allow patients to be treated with Iodine-131 in doses of up to 400 millicuries on an outpatient basis.

The argument is made that the increased dose to family members from the patient is compensated by the benefit to the family of having the patient at home.

It is further proposed that the definition of "confinement"

-- since at present, persons receiving doses in excess of 30 millicuries of I-131 must be confined until their activity level declines to prescribed levels -- be revised to include an instruction to remain at home.

The 30-millicurie limit would be abolished, and the dose to the maximally exposed member of the public would be increased from 1

100 millirem to 500 millirem.

My experience with I-131, as an outpatient and as an inpatient, began in 1973, when I had a partial thyroidectomy for papillary thyroid carcinoma.

I received diagnostic doses of I-131 -- in what amount I no longer recall -- at that time and in subsequent checkups.

In 1983 and 1984, as an outpatient, I was given two doses of 29.9 millicuries each to ablate (burn out) the thyroid remnant.

For several years after that, I was tested with diagnostic scans of either 5 or 10 millicuries of I-131.

In 1988, after a scan showed evidence of new growth, I received 100 millicuries as an inpatient.

In 1989, after another positive scan, I received 150 millicuries as an inpatient.

In 1990, I received two more treatments as an inpatient, each of 150 millicuries, and in June 1991, I had a fifth inpatient treatment, again of 150 millicuries.

All seven treatments were given at the National Institutes of Health.

Earlier this month, after a 10-millicurie diagnostic scan, I was pronounced free of any sign of suspect tissue.

Persons who have not had inpatient treatment with I-131 have no reason to be familiar with what it entails.

Because the patient becomes a radioactive source, emitting contamination through bodily fluids of all kinds, special precautions are taken.

The floor is covered with thick paper, fastened to the wall with duct tape, because the iodine exuded through the skin of the patient's feet will otherwise contaminate the floor.

All taps at the sink are covered with duct tape.

Male patients are instructed to urinate sitting down, in order to minimize the possibility of contamination, and patients are told to flush the toilet twice.

The patient is cautioned that any books he or she brings into the room will be have to be discarded or retained until their radioactivity has diminished to acceptable levels.

At mealtimes, the patient is allowed to open the door momentarily to take the tray off the proffered cart; after the meal, one deposits one's tray and its contents in the trash, to be disposed of as low-level waste.

Because the iodine in the patient is excreted through perspiration as well as through urine, the room tends to smell strongly of seaweed.

Except for the people from Radiation Safety who test the patient for radioactivity, and the people who collect the trash, no one enters the room.

As I developed experience with radioiodine treatments, I learned how to make conditions more livable.

By wearing rubber gloves at all times, I could keep my books from being contaminated.

On one occasion, however, when Radiation Safety was checking me and my belongings for release, I was told that while my laptop computer, borrowed from NRC, was clean, its case was not.

I expressed amazement; I had not touched the case since entering the room two days earlier, whereas I had been handling the computer, albeit with rubber gloves, extensively.

It was explained to me that the case was on the side of the room close 2

to the bathroom, and that radiation from stray drops of urine had probably penetrated the thick concrete walls of the bathroom and reached the case, A month later, the case had cooled down to the point that I could collect it from Radiation Safety, Under the regulations now in force, one cannot be released from inpatient confinement until the level of residual radioactivity in one's body is equivalent to that of someone who has received a 30-millicurie dose, Extensive advice is given as to precautions to be taken on returning home:

always flush twice, urinate sitting down, bathe frequently, minimize contact with and proximity to children, sleep apart from your spouse for a week, do not handle food that others will eat, etc.

I followed those instructions rigorously.

It was not that difficult to do so; I could understand the instructions and their rationale, my wife could serve the food, set the table, and make the children's lunches, and we had a bathroom in the basement that no one in the family but me ever used.

Even so, it is not easy to avoid physical contact with children who are used to hugs and kisses, especially when one of your first objectives is to preserve a sense of normality in the household, On one occasion, I had just returned from a one-or two-night stay in NIH thinking rather smugly that with various distractions, my wife and I had succeeded in keeping the children blissfully unaware that anything seriously out of the ordinary had occurred.

It took my daughter, then about 6 years old, only about 20 minutes to figure out that I was keeping my distance from her.

She burst into tears and asked me, "Daddy, will you still love me after you die?"

This from a child who has never heard the word "carcinoma or its equivalents spoken in front of her in reference to her father.

My family is fortunate:

we are a two-parent household, we have a spare bathroom and a spare bed, and we are educated enough to appreciate the significance of radiation protection guidance, But imagine the single parent who does not have anyone else to do the shopping, prepare the meals, set the table, make the sandwiches for the children's lunches, bathe the children, and so on.

Imagine also the mother, frightened at the diagnosis she has received, who wants only to hug her children to herself.

Imagine the family that lives in a small apartment, with one bathroom shared by all and no spare bed.

In short, there are cases where it may be better by far for children to be farmed out to a relative or a family friend for several days than to remain at home with a parent who is a radiological hazard.

Speaking from experience, it is not always easy to remember at all times to follow the radiation protection guidance one has been given.

Especially in the home, one tends to follow habit, and when a child reaches up to you for a goodnight kiss, one may kiss her without thinking about it.

But all my experience 3

involves being at home with an activity level in my body of 30 millicuries or less.

Can you imagine how much worse the problems would be, and how much more serious the unintended exposures, if a patient is at home with 300 millicuries of I-131 working its way through his or her system?

The transcript of the ACMUI meeting shows Ms. Brown, the patient's representative on ACHUI, asking -- with a common sense practicality that reflects credit both on her and on the Commission that decided to add such a representative to the Committee -- for "some basic information to follow the issue here.

Is the person that before this change would have been hospitalized and now is likely to be able to go home -- is that patient going to feel bad?

Is it someone who is likely to go home to bed, or is it someone who would have just been feeling fine in the hospital and feeling fine at home -- is it just that you don't want them to expose other people?"

(Transcript, pp.

471-72).

To this, Dr. Cool of the NRC staff replies, "I am not sure I am really in a position to address how they may feel."

It may strike some as anomalous that the staff, in the issues paper prepared for the ACMUI meeting, should justify its proposed elimination of the 30-millicurie limit in part by pointing to "the emotional benefit provided the patient when in the direct care of family members," while at the same time confessing ignorance as to whether patients physically "feel fine" or "feel bad.

Can an agency which exists to protect people from the harmful effects of radiation be unaware of patients' physical condition and yet offer opinions on their psychological state?

I, however, am in a position to address how they may feel."

Any patient being treated for carcinoma with a therapeutic dose of I-131, whether lt is 30 millicuries or 400, is already severely hypothyroid, having been removed from all thyroid medication several weeks in advance of the scan.

As a result, the person is physically in a state of extreme exhaustion.

(When President Bush was recovering from his I-131 treatment for Graves disease, and was hypothyroid from having his thyroid ablated, there was comment in the press as to his surprising breach of protocol in sitting down in the presence of the Queen of England.

Any veteran of I-131 treatments could have come up with the explanation:

he was too weak to stand up a moment longer.)

The patient's reflexes are slowed, making driving more hazardous.

Mental processes are also slowed down, and there is a loss of short-term memory.

All these factors make it less likely that a patient will remember and follow radiation protection guidance if treated as an outpatient, especially at the extremely high doses envisioned by the petition.

(To my knowledge, 400 millicuries is a massive dose, used only with advanced metastatic disease.

On one occasion, when I was in NIH, I was told of a patient who was hospitalized for eight days after a 300-millicurie dose.)

4

In addition, one of the most common effects of I-131 treatment is nausea.

(As one reads the transcript of the October 1992 ACMUI meeting, one finds frequent references to patients vomiting.)

As an inpatient, one is instructed to call the nurses' station at the first sign of nausea, so that appropriate medication may be given.

Vomiting presents problems for hospital Radiation Safety departments, because they must enter the radiologically contaminated room in order to clean up.

Consider, however, how much worse it would be if the patient is at home, vomiting, and unprotected family members, rather than Radiation Safety personnel with rubber gloves and other protective gear, are having to clean up, probably without thinking for a moment, under the stress of the situation, of the radiological implications.

There are other reasons to keep a patient hospitalized:

for example, to remind the patient to suck hard candies, in order to purge the salivary glands of radioiodine, Is the patient at home likely to remember that he or she is supposed to be sucking sourballs at frequent intervals?

I doubt it, The question is asked by Ms. Brown, the patients' representative on ACMUI, at p. 472 of the transcript, "if this is a guy who might just, not having taken an altruism test, would go down to the 7-11 and stand behind me and my kind and get a pack of cigarettes,"

I can speak to that.

Even though one is weak, it takes little effort to drive to a store, and one may do so either from necessity -- some patients must shop and prepare food for themselves -- or without thinking about the radiological consequences to others.

On one occasion, I was released from NIH after a treatment and decided to stop into a nearby toy store to pick up a homecoming present for my children.

Slap bracelets were the fad that winter, and I had handled the store's whole assortment before it suddenly hit me that I had contaminated them all.

Rather than have a child's contamination on my conscience, I bought 22 slap bracelets and kept them in a drawer for a month or two to cool down before giving them away.

But suppose it had never occurred to me, or suppose the product had been one costing not a dollar apiece but $50 apiece.

What then?

Suppose that the patient, full of 400 millicuries of I-131, stops by the grocery store, and, forgetting the fact that he or she is just out of the hospital, picks and chooses among the peaches and tomatoes as he or she has always done, leaving behind contaminated fruit and vegetables for the next shopper.

What about the patient, traveling home by public transportation, who cannot find a seat, and therefore spends half an hour or an hour exuding radioiodine onto the strap or pole of a subway or bus?

Has the staff thought about this at all when it speaks in the issues paper about the "infrequent nature of the exposure to members of the public"?

5

At p. 518 of the transcript, Dr. Siegel asks for a "worst case scenario,"

Dr. Marcus replies, on the following page, by describing the Arizona misadrninistration in which a woman received 100 millicuries of I-131 by mistake :

"what we had as worst-case situation where someone behaves normally -- kisses the children, kisses husband -- all this stuff,"

I believe that this understates the problem.

We have to consider contamination of food, contamination of the bathroom, the child who sits in a parent's lap (thereby receiving a dose from the patient's bladder), the child who crawls into bed with the patient at night and lies near the patient's thyroid, and a range of other possibilities.

I realize that the NRC staff's issue paper states that licensees would have to evaluate individual circumstances (including the presence of children in the home) before allowing the patient to be treated as an outpatient, but I question whether, in reality, a detailed and thoughtful evaluation of actual exposure pathways would *take place, if hospital personnel are under pressure to cut costs by minimizing in-patient I-131 treatments.

Of all the reasons offered by the staff in support of removing the 30 millicurie limit, the first one is the most revealing:

"the benefit afforded the patient in reduced hospital costs."

I am no expert on the financing of medical care in America, but it is my strong impression that very few patients pay their own bills in hospitals.

Rather, the bills are paid by insurance companies or by Federal or state bodies.

Hospitals are no longer reimbursed for their actual costs, but at the levels that various governmental authorities see fit to pay.

Thus to the extent that the hospital's cost exceeds the reimbursement, the hospital is out of pocket; and to the extent that the hospital can cut costs by turning inpatients into outpatients, the hospital standE to profit.

In short, I am prepared to agree with the NRC staff that cost is the primary justification for this proposed change, but I cannot see that cost to the patient plays much of a rol~.

In sum, I see no good reason for changing existing requirements.

The 30-millicurie level or equivalent is a known benchmark, Providjng latitude to hospitals to cut costs by turning highly radioactive patients loose on their families and the community at la~ge may provide health care providers with short-term economic benefits, but it carries serious risks to public health and safety, Confinement to one's own residence is not equivalent to confinement in radiological isolation; it is self-delusion to imagine otherwise.

Ironically, this proposal may well be contrary to the longer-term economic interests of the regulated community.

When there is a perception of a public health need and a regulatory vacuum, other agencies, Federal or state, step in, with 6

unpredictable results.

Moreover, giving discretion to hospitals as to whether to release patients with large amounts of radiopharmaceuticals in them is an invitation to lawsuits charging that they have exercised their discretion unwisely.

The following scenario for a lawsuit is not so very improbable:

"Hospital X, you elected to treat my ex-boyfriend with 400 millicuries of I-131 as an outpatient.

He then came and spent the night with me, without telling me about his treatment.

You should have known that he was dangerous and that his judgment was impaired.

I now have received a dose to my thyroid, I'm seeing a psychiatrist because of my fear of developing cancer, and I am suing you for x millions of dollars for the physical and psychological harm I have. suffered."

Stranger lawsuits than that are filed every day.

It is worth noting that Dr. Marcus, praising the NRC staff's proposed resolution of the outstanding medical issues, speaks of the "40-month gestation," and says that the staff's proposal "is far better than the petition Mr. McElroy help[~] me write."

Transcript, p. 363.

Given that Mr. McElroy was until recently a member of the NRC staff, could the staff clarify whether in this proposal it is passing judgment on a petition that the staff itself helped to write, or did Dr. Marcus misspeak?

It is a blessing, however, that we have a responsible ACMUI majority to speak up in opposition to the position espoused by Dr. Marcus and the NRC staff.

As one reads the transcript, the contrast is startling:

at the same time that Dr. Marcus is urging that patients with 400 millicuries be treated as outpatients, Dr. Siegel is worrying that there is a regulatory gap, in that patients with 5 millicuries are not being given guidance about protection for family members.

Transcript, p.

512.

I can vouch from recent experience for the validity of Dr.

Siegel's concern.

On October 6, 1992, I received a 10-millicurie diagnostic dose of I-131 at a well-known teaching hospital in the Washington area.

I asked the technologist specifically whether there were any precautions I should take with regard to my

family, The answer was "None -- though you might not want to get close to babies."

My own memory was hazy on radiation protection matters, and I was used to dealing with larger doses, so I was prepared to believe this; nevertheless, from what I thought was an excess of caution, I used the basement bathroom most of the time, washed my hands frequently, let my wife pour the children's milk at the dinner table, and so on.

FortunatelyJ my scan was negative, which means (I believe) that most o( the iodine was excreted fairly rapidly through my urine.

But I am sure that if I had been cautioned along the lines suggested by Dr. Siegel in the discussion beginning at p. 512, I would have been more circumspect than I was in physical contact with my children in the days following the administration of the dose.

Dr. Marcus and the NRC staff make the point (Transcript, p.

7

505) that raising exposure limits to family members fivefold --

to 500 millirem per year to a member of the family -- can be justified because, in Dr. Marcus's words, they "have some benefit to go with the risk."

Ever since Jimmy Carter quoted his daughter in a pre-election debate, people who quote their children on issues of public policy invite ridicule, but it's a risk I'm willing to take.

From years of experience, my children now know a lot about radioiodine and the precautions that go with it -- perhaps on some points more than the NRC staff -- so I described the issues at the dinner table last night, and the proposal to relax restrictions on exposure to family members.

The first question was, "Why?"

I said that people thought, among other things, that it was good for children to have their parents around.

My six-year-old son exclaimed, "Crazy!"

My eight-year-old daughter then clarified the point:

"It isn't crazy that it's good for children to have their parents around, but it is crazy for children to have their parents around if it's going to make them sick."

Doses of I-131 to parents~ make children sick.

Dr.

Marcus, at p. 216, refers to the Tripler incident, in which a Micronesian woman, given a diagnostic dose of I-131 as part of thyroid cancer followup, unwittingly gave an enormous dose of radiation to the thyroid of her newborn baby through her breast milk.

In Dr. Marcus's words:

"I remember being up until 11:30 at night with a reporter from a newspaper in Honolulu, to prevent her from writing an article in the Honolulu newspaper that basically suggested that Chernobyl had happened to Tripler because of an enforced press release by the NRC even before the dosimetry was done on the baby."

Since the Tripler incident, I have served in Micronesia as an administrative judge with the Nuclear Claims Tribunal of the Republic of the Marshall Islands; I have met many Marshallese thyroid patients who were treated at Tripler; and I am keenly aware of the extremely valuable service that Tripler, motivated by altruism alone, provides for the people of the former U.S. Trust Territories in the Pacific.

Nevertheless, in the instance referred to by Dr. Marcus, there did occur, through error, what might be called a Chernobyl for one.

It resulted in the destruction of a baby's thyroid gland.

The New York Times recently reported that a team from the World Health Organization, visiting the area near Minsk, Russia, had come up with wholly unexpected findings:

deaths from thyroid cancer (normally a disease slow in its onset and progress, with high cure rates) among children exposed to I-131 after Chernobyl.

This is not the time for the NRC to be approving regulatory changes that will have the effect of exposing American children to more 1-131.

Finally, I would draw the staff's attention to Dr. Flynn's troubling comment, at page 423-24 of the transcript, that "a lot 8

of things are being covered up and not talked about, that I hear about myself, and not making their way into reporting [as misadministr~tions]."

I believe that the NRC staff, instead of expending its resources on proposals to loosen current regulations for the protection of the public, should be applying its energies to making existing regulations more effective, and complied with more fully.

cc:

ACMUI members 9

rt1c es

• Understanding Behavior in Escalation Situations

• BARRY M. STAW AND JERRY Ross Everyday observation reveals that both individuals and organizations often become overly committed to losing courses of action; in a sense, throwing good money after bad. More than 10 years of research on this escalation problem shows that persistence is associated with at least four major classes of determinants: project, psychological, social, and organizational variables. The influence of these four sets of variables evolves over time, forming a dynam-ic model of behavior in escalation situations.

A T AN EARLY STAGE OF THE VIETNAM WAR, GEORGE BALL, then Undersecretary of State, wrote the following memo to Lyndon Johnson, warning him about the likely conse-quences of making further commitments of men and material:

The decision you face now is crucial. Once large numbas of U.S. troops arc committed to direct combat, they will begin to take heavy casualties in a war they arc ill-equipped to fight in a noncoopcrative if not downright hostile countryside. Once we suffer large casualties, we will have started a well-nigh irreversible process. Our involvement will be so gn:at that we cannot-without national humiliation-stop short of achieving our complete objec-tives. Of the two possibilities I think humiliation will be mort* likely than the achievement of our objectivcs---.:vcn after we have paid tcrrihk costs" [ l J ulv 1965 (I), p. 4S0).

George Ball's remarks were not only prophetic about the U.S.

experience in Vietnam. They also pointed to the more general problem of coping with what are now called "escalation situations."

These are situations in which losses have resulted from an original course of action, but where there is the possibility of turning the situation around by investing further time, money, or effort.

The: frequency of escalation situations can be: depicted by everyday examples. When an individual has a declining investment, a faltering career, or even a troubled marriage, there is often the difficult choice between putting greater effort into the present line of bd1avior versus seeking a new alternative. Ar the organizational level, similar dilemmas occur. Laboratories must make difficult decisions about whether to continue with or withdraw from disappointing research and development (R&D) projects; banks must decide how to

.manage their involvement in nonperforming loans; and industrial firms often need to determine whether to abandon a questionable vennirc versus investing further resources. In each of thc:se situations B. M. Sr;iw is at the Schcx>I of Bu~inc:ss Adrninisrrarion, Uni\\'asit,* nf C:.1lil(>rni.1 :ir llerkcky, CA 94720. J. Ross is at the Institute Europfrn d'Adminisrr'.1t1Cm de, :\\tt'.mcs, Fou11ta1m.. *hkau. FratKC.

• To whom correspondence should be addressed.

216 it is frequently observed that individuals as well as organizations can become locked in to the existing course of action, throwing good monev or effort after bad, This "decision pathology has been l'ariously labeled the escalation of commitment (2), the psychology of entrapment (J), the sunk cost effect ( 4), and the too-much-invcstcd-to-quir syndrome (5). We will review the state of research on this problem and then provide a summary theoretical model along with some guidelines for future research.

Classes of Escalation Determinants Much of the early work on the escalation problem focused on psvchological factors that lead decision-makers to engage in seem-ingly irrational acts-that is, behavior not explained by either objective circumstances or standard economic decision-making (5-7). In response, some researchers have stressed that escalation does involve rational decision-making, because individuals do attend to the economic realities of escalation situations once they are made salient or clear to the person (8). Alternatively, others have found (9) that escalation behavior can be depicted as a rational calculus, but this requires going beyond the narrow economics of the situation to include many psychological and social costs of withdrawal, such as the personal and public embarrassment of admitting failure.

Debates over the rationality of behavior in escalation or any other siruation are not likely to be settled soon. In fact, these arguments may detract attention away from the central phenomenon of interest, which is the tendency of individuals and organizations to persist in failing courses of action. To understand this tendency, one must account for a variety of forces, both behavioral and economic.

We will therefore summarize research on four classes of determi-nants: those associated with objective characteristics of the project as well as psychological, social, and organizational variables.

Project Determinants Project variables arc the most obvious determinants of persistence in a course of action. Research has shown, for example, that commitment is affected by whether a setback is judged to be due to a permanent or temporary problem (10); by whether further invest-ment is likely to be efficacious (11); by how large a goal or payoff mav result from continued investment (7); by furure expendirures,or costs necessary to achieve a project's payoff ( 12); and by the number of times previous commitments have failed to yield rerurns (13).

A tcw project variables are less obvious causes of persistence.

Endeavors such as R&D and construction projects often foster SCIENCE, VOL. 246

commitment because there is a long delay between cxpendin1rcs and economic benefits. In these cases, shortfalls in revenue or outcomes may not be monitored closely or cause alarm, since losses arc ( at least initially) expected to occur. In other cases, projects may continue, in part, because they have little salvage value and involve substantial closing costs if terminated in midstream (8). For example, the World's Fair Expo 86 reached the point late in its construction in which continuation was expected to produce large losses, but even larger losses would have been sustained if the project had been aborted before its formal opening (14). In a few cases, projects can become so large that they literally trap the sponsoring organization into continuing the course of action: The Long Island Lighting Company's construction of the Shoreham Nuclear Power Plant is an example of such a no-win situation, in which persistence was seen as costly, yet withdrawal was (until very recently) viewed as bringing even worse economic consequences to the organization ( 15).

Psychological Determinants In addition to the objective properties of a project, several psychological variables can also influence persistence in losing courses of action. Probably the simplest of these determinants are information processing errors on the part of decision-makers.

Although accounting and economics texts routinely state that investments should only be made when marginal (future) revenues exceed marginal costs (16), people may not actually behave this way.

Consider the responses of college students to the following two questions posed by Arkcs and Blumer (4):

Qutstio11 JA. & the president of an airline company, you have invested 10 million dollars of the company's money into a research project. The purpose was to build a plane that would not be detected by conventional radar, in other words, a radar-blank plane. When the project is 90% completed, another firm begins marketing a plane that cannot be detected by radar. Also, it is apparent that their plane: is much faster and far more economical than the plane your company is building. The question is: should you invest the last 10% of the research funds to finish your radar-blank plane:? Yes, 41; No, 7.

Qutstion 3B. & president of an airline company, you have received a suggestion from one of your employees. The suggestion is to use the last 1 million dollars of your research funds to develop a plane that would not be detected by conventional radar, in other words, a radar-blank plane.

However, another firm has just begun marketing a plane that cannot be detected by radar. Also, it is apparent that their plane is much faster and far more economical than the: plane your company could build. The question is:

should you invest the last million dollars of your research funds to build the radar-blank plane proposed by your employee? Yes, 10; No, 50.

These data clearly indicate that sunk costs (those previously expended but not supposed to affect investment decisions) arc not sunk psychologically. They continue to influence subsequent invest-ment decisions.

Not only do escalation situations involve sunk costs in terms of money, time, and effort; they also arc framed as losing situations in which new investments hold the promise of turning one's fonunes around. Unfortunately, this is exactly the context in which Kahnc-man and Tversky (17) and others (18) found individuals to be risk-seeking. People take more risks on investment decisions framed in a negative manner (for example, to recover losses or prevent injuries) than when the same decision is positively framed (to achieve gains).

The miscalculation of sunk costs and negative framing can be characterized as rather "cool" information processing errors, as heuristics (however faulty) called on by individuals to solve escala-tion problems. Escalation situations can also involve "warmer,"

more motivate_d cognitions, however. Self-justification biases (19) have been singled out as a major motivational cause of persistence.

In one of the earliest escalation experiments, Staw ( 6) hypothe-13 OCTOBER 1989 sized that people may commit more resources to a losing cause so as to justify or rationalize their previous behavior. He suggested that being personally responsible for losses is an important factor in becoming locked in to a course of action. This hypothesis was first tested in an experimental simulation with business school students.

All subjects played the role of a corporate financial officer in allocating R&D funds to the operating divisions of a hypothetical company. Half the subjects allocated R&D funds to one of the divisions, were given feedback on their decisions, and then were asked to make a second allocation of R.&D funds. The other half of the subjects did not make the initial investment decision themselves, but were told that it was made by another financial officer of the firm. Feedback was manipulated so that half the subjects received positive results on their initial decisions, while half received negative results.

Data from Staw's study showed that subjects allocated significant-ly more money to failing than to successful divisions. It was also found that more money was invested in the chosen division when the panicipants, rather than another financial officer, were responsi-ble for the earlier funding decision. These results suggest that individuals responsible for previous losses may try to justify (or save) their earlier decisions by committing additional resources to them. Also, because both high-and low-responsibility subjects faced a negative financial scenario (one with previous losses), it can be argued that justification motives may affect commitment above and beyond any sunk cost or framing effeets. Several experiments have replicated this self-justification finding with similar responsibility manipulations (20).

Closely related to the self-justification explanation of persistence are tl1e findings of other motivated biases. Cognitive studies show that people slant data in the direction of their preexisting beliefs and discredit information that conflicts with their opinions (21). Parallel effects in the escalation area have demonstrated that decision-makers responsible for a failing course of action tend to make greatest use of positive and exonerating information (22). Thus, it appears that justification motives may not only affect decisions to save a risky course of action, but may also affect the accuracy of data on which such decisions are made.

In addition to efforts to justify behavior, some passive self-inference processes may also affect individuals in escalation situa-tions. Salancik (23) and Kiesler (24) have posited that individuals are likely to become especially bound or committed to a prior behavior when (i) the individual's acts are explicit or unambiguous, (ii) the behavior is irrevocable or not easily undone, (iii) the behavior has been entered into freely or has involved a high degree of volition, (iv) the act has imponance for the individual, (v) the act is public or is visible to others, and (vi) the act has been performed a number of times. These six self-inference conditions assume that individuals draw inferences about their own behavior and the context in which it occurs. Though self-inference theories are less motivational than those that use self-justification concepts (no needs for rationaliza-tion arc implied), the two approaches overlap almost entirely in their empirical predictions (25).

Social Determinants Although most of the research on escalation has dealt with psychological or project variables, escalation situations are often more complicated social phenomena. For example, adrninistr.3tors may persist in a course of action, not just because they do not want to admit a mistake to themselves, but because they hesitate to expose their errors to others. Fox and Staw (26) tested this notion of external justification in a role-playing experiment. They found that ARTICLES 217

subjects holding administrative roles with low job security and lack of support by management allocated the greatest resources to a losing course of action. Conceptually similar results were reported by Brockner, Rubin, and Lang (12). They found persistence to be highest under a large audience, high social-anxiety condition and interpreted these results as a face-saving effect. Additional evidrnce of face-saving can also be found in the bargaining literature (27), in which it is common to find an escalation of hostilities as both parties refuse to back down from earlier positions. For example, using Shubik's (28) dollar auction game, Tegar (5) found that competitive bidding was influenced first by a simple desire to make money, then as a way to recoup prior losses, and finally, as a means to defeat the other party.

The external binding of people to behavior may also be important:

in escalation situations. Just as it is possible for individuals to form personal beliefs through a self-inference process (23, 24), observers tend to infer motivation and personal characteristics to actors after observing their behavior (29). Thus, people's social identity may become externally bound by their actions with respect to a project.

Though no research has specifically tested this idea, one would expect decision-makers to be most closely identified with a project when their advocacy of it has been public, explicit, perceived to be high in volition, and repeated. At the extreme, a project may start to carry the name of its sponsor (for example, "Reaganomics" or "Thatcherism"), increasing the binding of the person to the behav-ior, thus making withdrawal from the course of action much more difficult.

Although face-saving and external binding can both be viewed as social factors that increase decision-makers' costs of withdrawal, research has also isolated some social rewards for persistence. Staw and Ross (JO) had business students study the behavior of managers in a failing situation. Managers were described as either persisting in a losing course of action or switching to another alternative. The descriptions read by subjects also noted that managers' persistence or experimentation led either to further negative results or ultimate success. As predicted, managers were rated highest when they were persistent and successful. Most interestingly, the data also showed a significant interaction of persistence and outcome. This interaction can be interpreted as a "hero effect-special praise and adoration for managers who "stick to their guns" in the face of opposition and seemingly bleak odds (31).

Organizational Determinants Since many of the most costly escalation situations involve the persistence of an entire organization (rather than an isolated individ-ual) to a losing course of action, it is important to consider some organizational determinants of persistence. Unfortunately, few or-ganization-level studies have yet been conducted. Therefore, we arc forced to rely more on relevant theory than concrete data in outlining likely organizational determinants of escalation.

Probably the simplest organizational determinant is institutional inertia. Just as there is less than full consistency between individual attitudes and behavior (32), there is also a very loose coupling between organizational goals and action (33). Organizations have imperfect sensory systems, making them relatively impervious to changes in their environments. And, because of breakdowns in internal communication and difficulties in mobilizing tl1cir constitu-ents, organizations are slow to respond. Thus, even when the need for change is recognized, it may not occur. Moreover, if actions require altering long-standing policies, violating rules, or discarding accepted procedures, movement: is not likely to happen at all, even though (to an outsider) it may seem obviously useful.

218 Organizations attempting to withdraw from a losing course of action must also contend with political forces. Not only those who arc directly involved with a project will resist its dismantling, but so too will units interdependent or politically aligned with the venture.

This can become a special problem when projects are important or central enough to have political support on governing bodies and budget committees charged with their fate. As Pfeffer and Salancik (34) have shown in their research on organizational decision-making, organizational actions may turn as much on politics as any objective economic criteria.

Ar rimes, a project's support can go beyond politics. The project may be tied so integrally to the values and purposes of an organiza-tion that it becomes institutionalized (35), making withdrawal almost an "unthinkable" proposition. Two examples illustrate the problem. The first is Lockheed's LlOll Tri-Star Jet program.

Although most outside analysts found the plane unlikely to earn a profit, Lockheed persisted in the venture for more than a decade, accumulating enormous losses (36). The issue was not ending the project, per se, but in having to reinterpret the company's role in commercial aviation. For Lockheed to drop the LlOll meant having to change its identity from a pioneer in commercial aircraft co that of simply a defense contractor. Pan American Airlines recently faced a similar institutional issue. More than most airlines, Pan Arn sufl:ered major losses after deregulation of the industry.

However, as losses accumulated, it successively sold off most of its nonairlines assests. First, the Pan Am building was sold to meet debt obligations. Then, as losses continued to mount, the Intercontinen-tal Hotel chain was sold. Finally, Pan Am was forced to sell its valuable Pacific routes to United Airlines. Withdrawing from the real estate and hotel business was probably an easier decision for this organization tl1an ending the more institutionalized airline opera-tions, irrespective of me economics involved.

The Dynamics of Escalation This review of escalation research has been more illustrative than exhaustive. Yet, it is evident from even this brief summary that studies of escalation behavior have focus_ed primarily on psychologi-cal determinants, with social and organizational variables only recently receiving attention. Unfortunately, this difference in re-search emphasis has had less to do with the relevance of particular determinants of escalation than me difficulty of operationalizing concepts and conducting empirical studies at more macroscopic levels. Because many of the most disastrous escalation situations involve larger social entities such as governmental and business organizations, further macro-level studies of escalation are therefore needed.

As we have noted, escalation situations are also a forum for a

\\'ariery of forces, both behavioral and economic. Consequently, an important: question for future research is how these various forces combine to affect behavior in escalation contexts. Already some research suggests that escalation behavior may not only be multi-dctcrmined, but also temporally dependent. That is, escalation situations may change character over time, such that different:

determinants of persistence and withdrawal become dominant at separate stages in an escalation cycle. A preliminary model of how the influence of several key variables may unfold over time, based on two field studies of naturally occurring escalation situations (14, 15),

is shown in Fig. 1.

The first phase of escalation is dominated by the economics of a project, with the decision to begin a course of action made largely 011 the basis of me anticipation of economic benefits. However, when questionable or negative results are received (at Phase 2), the SCIENCE, VOL. 246

PHASE 1 PHASE 2 PHASE 3 Perceived project economics Perceived project economics Perceived project economics

+

Decision to beqln a course of acbon 0

Decision to persist Psychological and social forces for persistence Psychological and social forces for persistence Fig. 1. A three-stage model of the escalation process. The +, -, and O show positive, negative, and neutral influences, respectively.

Organiutional forces for persistence decision to persist is based not just on project economics, but also on psychological and social determinants. Assuming that psycholog-ical and social forces arc strong enough to outweigh (or bias) any negative economic forecasts, further investment or persistence in the project is likely. If this additional investment does not rum the situation around and further negative results are received ( at Stage 3), withdrawal tendencies may be heightened. Unforrunately, at this advanced stage in the escalation cycle any withdrawal tendencies (due to negative project economics) may be counterbalanced and biased by organizational forces for persistence. Thus, as economic outcomes worsen over time, it is possible for projects to be maintained by the accumulation of psychological, social, and organi-zational forces, each adding some weight to the decision to persist in a course of action.

At this time, the idea of distant stages of escalation remains more of a heuristic for understanding the process of persistence than an empirically tested theory. Y ct, two in-depth field srudies-an analy*

sis of British Columbia's decision to hold Expo 86 (14) and an examination of Long Island Lighting's commitment to the Shore*

ham nuclear power plant (15)-have provided support for a tempo*

rally based model. In each situation, economic variables were salient early on and psychological and social variables became important after negative consequences started to accumulate, whereas organi-zational determinants were manifested rather late in the escalation cycle. Of course, whether these time dependencies are always abrupt enough to constirute distinct stages, or whether in other contexts a more gradual shifting of influence occurs, is still an open ques-tion.

No doubt an important step in validating a temporal model of escalation will be the isolation of critical incidents setting off or preconditioning particular determinants of persistence. If these preconditions arc found to follow a predictable sequence (that is, arising early or late in the escalation cycle) across a variety of contexts, then a strong case can be made for a temporal model.

In searching for the preconditions of escalation, we would argue that escalation situations typically involve the following sequence of events. First, in launching a new product or project, individual "project champions" will not only work hard to promote the venture but in so doing will probably sow the seeds for subsequent commitment (for example, via self-inference effects). Once question-able or adverse results are received, a negative perceprual frame and sunk costs may then become associated with the project. At this time, those who have had an active hand in developing the project will likely suffer personal embarrassment ( or even loss of employ-ment) with the failing siruation, leading to self-justification and face-saving effects. And, once the losses associated with the project are 13 OCTOBER 1989 fully recognized throughout the organization, external binding of the proponents to the project (for example, "that's Jim's baby) is likely to make withdrawal even more costly to the individuals involved. Finally, assuming that the project docs survive several rounds of negative feedback, then more global, organizational processes may start to manifest themselves. Political support may arise as individual careers and whole departments become depen-dent on the project. And, if the project lasts long enough, withdraw-al can become extremely costly not only in terms of the economics involved, but also in terms of the identity of the firm itself.

As elaborated here, the sequence of critical incidents in escalation situations may tend to move from the individual, to the interperson-al environment, and then to the larger organization. We believe this is a narural evolution as project originators (or champions) try to defend a losing course of action, first by themselves (via risk-taking and information biasing) and then by the mobilization of resources involving the larger organization. Additional research on the devel-opment of escalation siruations is obviously needed to verify these temporal dynamics.

Escalation as a Multidetermined Event Since several sources of commitment can be triggered by losing courses of action, one might conclude that persistence is an over-determined variable, an almost inevitable consequence of escalation situations. A contrary view is that escalation is created by a series of small-impact variables, each insufficient by itself to cause one to remain in a losing siruation. For example, if economic losses are large and they occur early in a project's life cycle, withdrawal may well be the dominant response. However, if losses do not appear until later in the process (after several behavioral effects have been initiated), then persistence could be the typical response. Thus, the speed and severity of negative economic data could be a crucial clement in how relative forces unfold in escalation siruations.

Though not an explicit test of this hypothesis, an experiment by Golz (37) has shown how sensitive investment decisions are to the pattern of negative consequences. A slow and irregular decline may not only make a line of behavior difficult to extinguish (in the reinforcement theory sense), but may also allow the forces for persistence to grow over time. Adding support to this "unfolding argument" is a study by Brockner and Rubin (3), in whicl), they found that negative economic data prompted withdrawal when it was introduced early in an escalation situation, but had little influence when introduced after the decision to commit resources had already been made.

ARTICLES 219

Conclusion As shown by our temporal model, escalation situations contain a confluence of forces-some pulling toward withdrawal and others pushing toward persistence-with their relative strengths varying over time. This dynamic view of escalation is consistent with the contextualist perspective: (38) in which social reality is seen as dependent on the situation in which it occurs. Contextualist reason-ing supports the continued pursuit of case: studies on the dynamics of escalation situations and support.s efforts to add realism to experimental tests. Greater efforts are needed to capture: experimen-tally the life-span of escalation episodes so that the relative influence of contributing variables can be tracked over time. Only with such temporally based studies, from both the laboratory and the field, arc the dynamics of escalation situations likely to be fully understood.

REFERENCES AND NOTES I. The New York Times (based on the investigative reporting of Neil Sheehan), Thc Pr11ta.~011 Papm (Bantam Books, New York, 1971).

2. B. M. Staw, Acad. Ma11a,er. Rrv. 6,577 (1981).

3. J. Brockncr ffld J. Z. Rubin, E11trapmw1 i11 Escalati11,e Co11f/icts (Springer-Verlag, New York, 1985).

4. H. R. Arkes and C. Blunter, O~e*u. &hav. H11m. D,*cis. Prousscs 35, 124 (1985).

5. A. Tcgu, Too Muth /11vrsttd to Q11i1 (Pergamon Press, New York, 1980).

6. For example, B. M. Staw, O~e*11. &hav. H11m. Pr~{onNa11u 16, 27 (1976).

7. J. Z. Rubin and J. Brockncr, J. Pm. Sac. Psyc/ml. 31, 1054 (1975).

8. For example, G. B. Northcraft and G. Wolf, Acad. Ma11a,er. Rrv. 9, 225 (1984).

9. B. M. Staw and J. Ross, in Rrstarch i11 O~e*11izatio11al Brhavior, L. L. Cummings and B. M. Staw, Eds. (JAi Press, Greenwich, CT, 1987), vol. 9, pp. 39-78.

I 0. L. uatherwood and E. Conlon, write impact of prospectively relevant information and setbacks in persistence in a project following setback" (working paper 85-1, College of Business Administration, University of Iowa, 1985).

II. B. M. Staw and F. V. Fox, H11m. R,lat. 30,431 (1977); T. Bateman, "Resource allocation after success and failure: The roles of attributions of powerful others and probabilities offururc success" (Department of Management, Texas A&M. College Station, TX 91983).

12. J. Brockncr, J. Z. Rubin, E. Lang, J. Exp. Soc. Psych,,/. 17, 68 (1981).

13. B. E. McCain, J. Appl. Psycho/. 71, 280 (1986).

14. J. Ross and B. Staw, Adm. Sti. Q. 31,224 (1986).

220

15. ~

"Escalation and the Long Island Lighting Company: The case of the Shoreham Nuclear Power Plant" (Working paper, Institute Europccn d'Adminis-tration des Affaircs, Fontainebleau, France, 1989).

16. P. A. Samuelson, Eco11omics (McGraw-Hill, New York, 1988); C. T. Horngrcn, Cost Aao,mtin,e: A Ma11a.~rrial Emphasis (Prentice-Hall, Englewood Cliffs, NJ, 1982).

17. D. Kahncman and A. Tversky, &011omt1rica 47, 263 ( 1979); D. Kahneman and A.

Tversky, Scimct 211,453 (1981).

18. M.A. Davis and P. Bobko, Orga11. B,l,av. H11m. Drcis. Proctsm 37, 121 (1986).

19. E. Aronson, Th, Social A11imal (Freeman, San Francisco, 1984); L. Festinger, A T/11wy ~{Cog11itivr Disso11a11ct (Stanford Univ. Press, Stanford, CA, 1970).

20. M. H. Ba.zcrman, R. I. Beckum, F. D. Schoorman, J. Appl. Psycho/. 67, 873

( 1982); M. H. Ba.zcnnan ti al., Orga11. B,hav. H111n. PrrjonNa1rct 33, 141 (1984); D.

F. Ca/dweU and C. A. O'Reilly, /lead. Managt.J. 25, 121 (1982).

21. T. Gilovich, J. Prrs. Soc. Psycho/. 44, 1110 (1983); C. Lord, L. Ross, M. R.

Lepper. ibid. 37, 2098 (1979).

22. E. J. Conlon and J.M. Parks, J. Appl. Psycho/. 72, 344 (1987).

23. G. R. Sa.lancik, in Ntw Dirtctfous ;,, Orga11iza1iot1al Belraviorl B. M. Staw and G. R.

Salancik. Eds. (Krieger, Malabar, FL, 1977).

24. C. A. Kieslcr, Tht Psyc/,olo,ey ~{Commitmrll/ (Academic Press, New York, 1971).

25. P. E. Tctlock and A. Levi, J. Exp. Soc. Psycho/. 18, 68 (1982).

26. F. V. Fox and B. M. Staw, Adm. Sci. Q. 24, 449 (1979).

27. H. Railfa, Tire Art a11d Sciwu 0JN,gotiatio11 (Harvard Univ. Press, Cambridge, MA, 1982).

28. M. Shubik, J. Co11.flict Rm/111. 15, 109 (1971).

29. E. E. Jones and K. E. Davis, in Adva11m i11 Exprrimwtal Social Psychology, L.

Berkowitz, Ed. (Academic Press, New York, 1965), vol. 2.

30. B. M. Staw and J. Ross, J. Appl. Psycho/. 65, 249 (1980).

31. M. G. Evans and J. W. Mcdcof, Ca11.J. Adm. Sci. l, 383 (1984).

32. M. P. Zanna and R. H. Fazio, in Comis1t11ty i11 Social &/,avior, M. P. Zanna, E.T.

Higgins, C. P. Herman, Eds. (Erlbaum, Hillsdale, NJ, 1982).

33. J. G. March and J.P. Olson, Ambig11ity a11d Choict i11 Orga11izatio11s (Universitctsfor-laget, Bergen, Norway, l 976).

34. J. Pieffer and G. R. Salancik, Adm. Sci. Q. 19, 135 (1974); G. R. Salancik and J.

Pfeifer, ibid., p. 453.

35. P. S. Goodman, M. Ba.zcnnan, E. Conlon, in Rtsrarclt i11 Orgarrizatio11al B,/ravior, B.

M. S1aw and L. L. Cummings, Eds. (JAi Press, Greenwich, CT, 1980), vol. 2, pp.

215-246; L. G. Zucker in R,s,arc/1 i11 1h, SociolOJly of Orga11iza1iom, S. Bacharach, Ed. (JAi Press, Greenwich, CT, 1983).

36. U. E. Reinhardt, J. Fi11a11ce 28,821 (1973).

37. S. M. Golz, "A learning-based analysis of escalation of commitment, sunk cost, and entrapment," paper presented at American Psychological Association meeting, Atlanta, GA, August 1988.

38. W. ). McGuire, in Adva11m i11 Exprrimrmal Social Psychology, L. Berkowitz, Ed.

( Academic Press, New York, 1984).

39. Supported by the Institute of Industrial Relations, University of California, Berkeley.

~

SCIENCE, VOL. 246

To:

DOCKET NUMBER PET!TICN RULE PAM 5.... / OA

{51 F fl J-,tJ~/3 October 31, 1992 Secretary of the Commission U.S. Nuclear Regulatory Commission Attention:

Docketing and Service Branch From:

Peter G. Crane

!.lCKEiEO USNHC

• 92 DV -2 Al~ :03

Subject:

DOCKET NOS. PRM-20 20, PRM-35-10, AND PRM-35-l0A (PATIENT RELEASE CRITERIA FOR PATIENTS TREATED WITH RADIOPHARMACEUTICALS)

The following are comments on the amended petition for rulemaking filed by the American College of Nuclear Medicine (ACNM), as noticed in the Federal Register with a request for comment. I realize that the Federal Register notice states that comments received after July 17, 1992, will be considered only if it is practical to do so.

I hope that the Commission will nevertheless elect to take my comments into account, because I believe my experience as a nuclear medicine patient, treated with a total of 760 millicuries of radioactive iodine as an inpatient and an outpatient, may be of some value in weighing the merits of the petition.

I apologize for the lateness of my comments.

I was living on an atoll in the Central Pacific at the time that the American College of Nuclear Medicine first proposed (on January 14, 1992) that the 30 millicurie limit be eliminated for outpatient treatments with radioiodine, and that "confinement of patients be redefined to include "remaining in a private

\\

qi. residence."

Although I rejoined the NRC in May, 1992, I was not

~,~

aware until October 30, 1992, when I first saw the transcript of

---

nie').meeting of the Advisory Committee on the Medical Uses of Isotopes, that such a proposal was under consideration.

I should emphasize that although I am now an employee of the Nuclear Regulatory Commission, I am submitting these comments in my capacity as a member of the public, 'rather than in my official role as Counsel for Special Projects in the Office of the General Counsel.

I am writing these comments at home, on my own time.

The ACNM proposes to allow patients to be treated with Iodine-131 in doses of up to 400 millicuries on an outpatient basis.

The argument is made that the increased dose to family members from the patient is compensated by the benefit to the family of having the patient at home.

It is further proposed that the definition of "confinement"

-- sine~ at present, persons receiving doses in excess of 30 m-il.l.icuries of I-131 must be confined until their activity level declines to prescribed levels -- be revised to include an instruction to remain at home.

The 30-millicurie limit would be abolished, and the dose to the maximally exposed member of the public would be increased from 1

7

< r-: *i.1 1' f~.,;~~o ~~.

_ _ _ -~::. _ y

• 7V * - ~tu ~.J~W,S

100 millirem to 500 millirem.

My experience with I-131, as an outpatient and as an inpatient, began in 1973, when I had a partial thyroidectomy for papillary thyroid carcinoma.

I received diagnostic doses of I-131 -- in what amount I no longer recall -- at that time and in subsequent checkups.

In 1983 and 1984, as an outpatient, I was given two doses of 29.9 millicuries each to ablate (burn out) the thyroid remnant.

For several years after that, I was tested with diagnostic scans of either 5 or 10 millicuries of I-131.

In 1988, after a scan showed evidence of new growth, I received 100 millicuries as an inpatient.

In 1989, after another positive scan, I received 150 millicuries as an inpatient.

In 1990, I received two more treatments as an inpatient, each of 150 millicuries, and in June 1991, I had a fifth inpatient treatment, again of 150 millicuries.

All seven treatments were given at the National Institutes of Health.

Earlier this month, after a 10-millicurie diagnostic scan, I was pronounced free of any sign of suspect tissue, Persons who have not had inpatient treatment with I-131 have no reason to be familiar with what it entails.

Because the patient becomes a radioactive source, emitting contamination through bodily fluids of all kinds, special precautions are taken.

The floor is covered with thick paper, fastened to the wall with duct tape, because the iodine exuded through the skin of the patient's feet will otherwise contaminate the floor.

All taps at the sink are covered with duct tape.

Male patients are instructed to urinate sitting down, in order to minimize the possibility of contamination, and patients are told to flush the toilet twice.

The patient is cautioned that any books he or she brings into the room will be have to be discarded or retained until their radioactivity has diminished to acceptable levels, At mealtimes, the patient is allowed to open the door momentarily to take the tray off the proffered cart; after the meal, one deposits one's tray and its contents in the trash, to be disposed of as low-level waste, Because the iodine in the patient is excreted through perspiration as well as through urine, the room tends to smell strongly of seaweed, Except for the people from Radiation Safety who test the patient for radioactivity, and the people who collect the trash, no one enters the room.

As I developed experience with radioiodine treatments, I learned how to make conditions more livable.

By wearing rubber gloves at all times, I could keep my books from being contaminated.

On one occasion, however, when Radiation Safety was checking me and my belongings for release, I was told that while my laptop computer, borrowed from NRC, was clean, its case was not.

I expressed amazement; I had not touched the case since entering the room two days earlier, whereas I had been handling the computer, albeit with rubber gloves, extensively.

It was explained to me that the case was on the side of the room close 2

to the bathroom, and that radiation from stray drops of urine had probably penetrated the thick concrete walls of the bathroom and reached the case.

A month later, the case had cooled down to the point that I could collect it from Radiation Safety.

Under the regulations now in force, one cannot be released from inpatient confinement until the level of residual radioactivity in one's body is equivalent to that of someone who has received a 30-millicurie dose.

Extensive advice is given as to precautions to be taken on returning home:

always flush twice, urinate sitting down, bathe frequently, minimize contact with and proximity to children, sleep apart from your spouse for a week, do not handle food that others will eat, etc.

I followed those instructions rigorously.

It was not that difficult to do so; I could understand the instructions and their rationale, my wife could serve the food, set the table, and make the children's lunches, and we had a bathroom in the basement that no one in the family but me ever used.

Even so, it is not easy to avoid physical contact with children who are used to hugs and kisses, especially when one of your first objectives is to preserve a sense of normality in the household.

On one occasion, I had just returned from a one-or two-night stay in NIH thinking rather smugly that with various distractions, my wife and I had succeeded in keeping the children blissfully unaware that anything seriously out of the ordinary had occurred.

It took my daughter, then about 6 years old, only about 20 minutes to figure out that I was keeping my distance from her.

She burst into tears and asked me, "Daddy, will you still love me after you die?"

This from a child who has never heard the word "carcinoma" or its equivalents spoken in front of her in reference to her father.

My family is fortunate:

we are a two-parent household, we have a spare bathroom and a spare bed, and we are educated enough to appreciate the significance of radiation protection guidance.

But imagine the single parent who does not have anyone else to do the shopping, prepare the meals, set the table, make the sandwiches for the children's lunches, bathe the children, and so on.

Imagine also the mother, frightened at the diagnosis she has received, who wants only to hug her children to herself.

Imagine the family that lives in a small apartment, with one bathroom shared by all and no spare bed.

In short, there are cases where it may be better by far for children to be farmed out to a relative or a family friend for several days than to remain at home with a parent who is a radiological hazard.

Speaking from experience, it is not always easy to remember at all times to follow the radiation protection guidance one has been given.

Especially in the home, one tends to follow habit, and when a child reaches up to you for a goodnight kiss, one may kiss her without thinking about it.

But all my experience 3

involves being at home with an activity level in my body of 30 millicuries or less.

Can you imagine how much worse the problems would be, and how much more serious the unintended exposures, if a patient is at home with 300 millicuries of I-131 working its way through his or her system?

The transcript of the ACMUI meeting shows Ms. Brown, the patient's representative on ACMUI, asking -- with a common sense practicality that reflects credit both on her and on the Commission that decided to add such a representative to the Committee -- for "some basic information to follow the issue here.

Is the person that before this change would have been hospitalized and now is likely to be able to go home -- is that patient going to feel bad?

Is it someone who is likely to go home to bed, or is it someone who would have just been feeling fine in the hospital and feeling fine at home -- is it just that you don't want them to expose other people?"

(Transcript, pp.

471-72).

To this, Dr. Cool of the NRC staff replies, "I am not sure I am really in a position to address how they may feel."

It may strike some as anomalous that the staff, in the issues paper prepared for the ACMUI meeting, should justify its proposed elimination of the 30-millicurie limit in part by pointing to "the emotional benefit provided the patient when in the direct care of family members," while at the same time confessing ignorance as to whether patients physically "feel fine" or "feel bad."

Can an agency which exists to protect people from the harmful effects of radiation be unaware of patients' physical condition and yet offer opinions on their psychological state?

I, however, am "in a position to address how they may feel."

Any patient being treated for carcinoma with a therapeutic dose of I-131, whether it is 30 millicuries or 400, is already severely hypothyroid, having been removed from all thyroid medication several weeks in advance of the scan.

As a result, the person is physically in a state of extreme exhaustion.

(When President Bush was recovering from his I-131 treatment for Graves disease, and was hypothyroid from having his thyroid ablated, there was comment in the press as to his surprising breach of protocol in sitting down in the presence of the Queen of England.

Any veteran of I-131 treatments could have come up with the explanation:

he was too weak to stand up a moment longer.)

The patient's reflexes are slowed, making driving more hazardous.

Mental processes are also slowed down, and there is a loss of short-term memory.

All these factors make it less likely that a patient will remember and follow radiation protection guidance if treated as an outpatient, especially at the extremely high doses envisioned by the petition.

(To my knowledge, 400 millicuries is a massive dose, used only with advanced metastatic disease.

On one occasion, when I was in NIH, I was told of a patient who was hospitalized for eight days after a 300-millicurie dose.)

4

In addition, one of the most common effects of I-131 treatment is nausea.

(As one reads the transcript of the October 1992 ACMUI meeting, one finds frequent references to patients vomiting.)

As an inpatient, one is instructed to call the nurses' station at the first sign of nausea, so that appropriate medication may be given.

Vomiting presents problems for hospital Radiation Safety departments, because they must enter the radiologically contaminated room in order to clean up.

Consider, however, how much worse it would be if the patient is at home, vomiting, and unprotected family members, rather than Radiation Safety personnel with rubber gloves and other protective gear, are having to clean up, probably without thinking for a moment, under the stress of the situation, of the radiological implications.

There are other reasons to keep a patient hospitalized:

for example, to remind the patient to suck hard candies, in order to purge the salivary glands of radioiodine.

Is the patient at home likely to remember that he or she is supposed to be sucking sourballs at frequent intervals?

I doubt it.

The question is asked by Ms. Brown, the patients' representative on ACMUI, at p. 472 of the transcript, "if this is a guy who might just, not having taken an altruism test, would go down to the 7-11 and stand behind me and my kind and get a pack of cigarettes."

I can speak to that.

Even though one is weak, it takes little effort to drive to a store, and one may do so either from necessity -- some patients must shop and prepare food for themselves -- or without thinking about the radiological consequences to others.

On one occasion, I was released from NIH after a treatment and decided to stop into a nearby toy store to pick up a homecoming present for my children.

Slap bracelets were the fad that winter, and I had handled the store's whole assortment before it suddenly hit me that I had contaminated them all.

Rather than have a child's contamination on my conscience, I bought 22 slap bracelets and kept them in a drawer for a month or two to cool down before giving them away.

But suppose it had never occurred to me, or suppose the product had been one costing not a dollar apiece but $50 apiece.

What then?

Suppose that the patient, full of 400 millicuries of I-131, stops by the grocery store, and, forgetting the fact that he or she is just out of the hospital, picks and chooses among the peaches and tomatoes as he or she has always done, leaving behind contaminated fruit and vegetables for the next shopper.

What about the patient, traveling home by public transportation, who cannot find a seat, and therefore spends half an hour or an hour exuding radioiodine onto the strap or pole of a subway or bus?

Has the staff thought about this at all when it speaks in the issues paper about the "infrequent nature of the exposure to members of the public"?

5

At p. 518 of the transcript, Dr. Siegel asks for a "worst case scenario."

Dr. Marcus replies, on the following page, by describing the Arizona misadministration in which a woman received 100 millicuries of I-131 by mistake :

"what we had as worst-case situation where someone behaves normally -- kisses the children, kisses husband -- all this stuff."

I believe that this understates the problem.

We have to consider contamination of food, contamination of the bathroom, the child who sits in a parent's lap (thereby receiving a dose from the patient's bladder), the child who crawls into bed with the patient at night and lies near the patient's thyroid, and a range of other possibilities.

I realize that the NRC staff's issue paper states that licensees would have to evaluate individual circumstances (including the presence of children in the home) before allowing the patient to be treated as an outpatient, but I question whether, in reality, a detailed and thoughtful evaluation of actual exposure pathways would take place, if hospital personnel are under pressure to cut costs by minimizing in-patient I-131 treatments.

Of all the reasons offered by the staff in support of removing the 30 millicurie limit, the first one is the most revealing:

"the benefit afforded the patient in reduced hospital costs."

I am no expert on the financing of medical care in America, but it is my strong impression that very few patients pay their own bills in hospitals.

Rather, the bills are paid by insurance companies or by Federal or state bodies.

Hospitals are no longer reimbursed for their actual costs, but at the levels that various governmental authorities see fit to pay.

Thus to the extent that the hospital's cost exceeds the reimbursement, the hospital is out of pocket; and to the extent that the hospital can cut costs by turning inpatients into outpatients, the hospital stands to profit.

In short, I am prepared to agree with the NRC staff that cost is the primary justification for this proposed change, but I cannot see that cost to the patient plays much of a role.

In sum, I see no good reason for changing existing requirements.

The 30-millicurie level or equivalent is a known benchmark.

Providing latitude to hospitals to cut costs by turning highly radioactive patients loose on their families and the community at large may provide health care providers with short-term economic benefits, but it carries serious risks to public health and safety.

Confinement to one's own residence is not equivalent to confinement in radiological isolation; it is self-delusion to imagine otherwise.

Ironically, this proposal may well be contrary to the longer-term economic interests of the regulated community.

When there is a perception of a public health need and a regulatory vacuum, other agencies, Federal or state, step in, with 6

unpredictable results.

Moreover, giving discretion to hospitals as to whether to release patients with large amounts of radiopharmaceuticals in them is an invitation to lawsuits charging that they have exercised their discretion unwisely.

The following scenario for a lawsuit is not so very improbable:

"Hospital X, you elected to treat my ex-boyfriend with 400 millicuries of I-131 as an outpatient.

He then came and spent the night with me, without telling me about his treatment.

You should have known that he was dangerous and that his judgment was impaired.

I now have received a dose to my thyroid, I'm seeing a psychiatrist because of my fear of developing cancer, and I am suing you for x millions of dollars for the physical and psychological harm I have suffered."

Stranger lawsuits than that are filed every day.

It is worth noting that Dr. Marcus, praising the NRC staff's proposed resolution of the outstanding medical issues, speaks of the "40-month gestation," and says that the staff's proposal "is far better than the petition Mr. McElroy help [sic] me write."

Transcript, p. 363.

Given that Mr. McElroy was until recently a member of the NRC staff, could the staff clarify whether in this proposal it is passing judgment on a petition that the staff itself helped to write, or did Dr. Marcus misspeak?

It is a blessing, however, that we have a responsible ACMUI majority to speak up in opposition to the position espoused by Dr. Marcus and the NRC staff.

As one reads the transcript, the contrast is startling:

at the same time that Dr. Marcus is urging that patients with 400 millicuries be treated as outpatients, Dr. Siegel is worrying that there is a regulatory gap, in that patients with 5 millicuries are not being given guidance about protection for family members.

Transcript, p.

512.

I can vouch from recent experience for the validity of Dr.

Siegel's concern.

On October 6, 1992, I received a 10-millicurie diagnostic dose of I-131 at a well-known teaching hospital in the Washington area.

I asked the technologist specifically whether there were any precautions I should take with regard to my family.

The answer was "None -- though you might not want to get close to babies."

My own memory was hazy on radiation protection matters, and I was used to dealing with larger doses, so I was prepared to believe this; nevertheless, from what I thought was an excess of caution, I used the basement bathroom most of the time, washed my hands frequently, let my wife pour the children's milk at the dinner table, and so on.

Fortunately, my scan was negative, which means (I believe) that most of the iodine was excreted fairly rapidly through my urine.

But I am sure that if I had been cautioned along the lines suggested by Dr. Siegel in the discussion beginning at p. 512, I would have been more circumspect than I was in physical contact with my children in the days following the administration of the dose.

Dr. Marcus and the NRC staff make the point (Transcript, p.

7 l

505) that raising exposure limits to family members fivefold --

to 500 millirem per year to a member of the family -- can be justified because, in Dr. Marcus's words, they "have some benefit to go with the risk."

Ever since Jimmy Carter quoted his daughter in a pre-election debate, people who quote their children on issues of public policy invite ridicule, but it's a risk I'm willing to take.

From years of experience, my children now know a lot about radioiodine and the precautions that go with it -- perhaps on some points more than the NRC staff -- so I described the issues at the dinner table last night, and the proposal to relax restrictions on exposure to family members.

The first question was, "Why?"

I said that people thought, among other things, that it was good for children to have their parents around.

My six-year-old son exclaimed, "Crazy!"

My eight-year-old daughter then clarified the point:

"It isn't crazy that it's good for children to have their parents around, but it is crazy for children to have their parents around if it's going to make them sick."

Doses of I-131 to parents can make children sick.

Dr.

Marcus, at p. 216, refers to the Tripler incident, in which a Micronesian woman, given a diagnostic dose of I-131 as part of thyroid cancer followup, unwittingly gave an enormous dose of radiation to the thyroid of her newborn baby through her breast milk.

In Dr. Marcus's words:

"I remember being up until 11:30 at night with a reporter from a newspaper in Honolulu, to prevent her from writing an article in the Honolulu newspaper that basically suggested that Chernobyl had happened to Tripler because of an enforced press release by the NRC even before the dosimetry was done on the baby."

Since the Tripler incident, I have served in Micronesia as an administrative judge with the Nuclear Claims Tribunal of the Republic of the Marshall Islands; I have met many Marshallese thyroid patients who were treated at Tripler; and I am keenly aware of the extremely valuable service that Tripler, motivated by altruism alone, provides for the people of the former U.S. Trust Territories in the Pacific.

Nevertheless, in the instance referred to by Dr. Marcus, there did occur, through error, what might be called a Chernobyl for one.

It resulted in the destruction of a baby's thyroid gland.

The New York Times recently reported that a team from the World Health Organization, visiting the area near Minsk, Russia, had come up with wholly unexpected findings:

deaths from thyroid cancer (normally a disease slow in its onset and progress, with high cure rates) among children exposed to I-131 after Chernobyl.

This is not the time for the NRC to be approving regulatory changes that will have the effect of exposing American children to more I-131.

Finally, I would draw the staff's attention to Dr. Flynn's troubling comment, at page 423-24 of the transcript, that "a lot 8

of things are being covered up and not talked about, that I hear about myself, and not making their way into reporting [as misadministrations],"

I believe that the NRC staff, instead of expending its resources on proposals to loosen current regulations for the protection of the public, should be applying its energies to making existing regulations more effective, and complied with more fully.

cc:

ACMUI members 9

r JOSEPH I. LIEBERMAN CONNECTICUT COMMITTEES:

ENVIRONMENT ANO PUBLIC WORKS GOVERNMENTAL AFFAIRS SMALL BUSINESS Hon. Ivan Selin Chairman OOCKET NUMBER PETITION RULE PRM 3 5-lOA Cs 7 ~ R 2 Io '-13) tinittd ~tatts ~matt WASHINGTON, DC 20510-0703

• Ot l O U' RC

• 92 S September 4, 1992

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F SfC 01)CKL i 1NG *,...t

~ft NC Nuclear Regulatory commission Washington, D.C. 20555 ATTENTION:

Docking and Service Branch

Dear C~air.nan Selin:

SENATE OFFICE BUILDING WASHINGTON. DC 20510 (202) 224-4041 STAT£ OFFICE:

0Nt COMMERCIAL PLAZA 21ST FLOOR HARTFORD, CT 06103 203--24~3566 TOLL FREE: 1-800-225-5605 I 'm enclosing a copy of a letter which I recently received from one of my constituents, Dr. Bruce Bower, in support of the Amended Peition for Rulemaking submitted by the American College of Nuclear Medicine, which would permit outpatient treatment of patients with thyroid cancer with Radioactive Iodide I-131.

I would greatly appreciate it if you would take Dr. Bower's concerns under serious consideration.

Thank you for your kind attention to this matter.

JIL:vh Enclosure PRINTED ON RECYCLED PAPER

ADULT AND PEDIATRIC ENDOCRINOLOGY METABOLISM DIABETES NEUROENDOCRINOLOGY PSYCHOENDOCRINOLOGY REPRODUCTIVE ENDOCRINOLOGY NUCLEAR MEDICINE senator Joseph Lieberman One Corporate Plaza Hartford, CT 06103

Dear Senatol. t.ie:

i..a.;;1.m~r.,

ENDOCRINE ASSOCIATES CONSULTING ENDOCRINOLOGISTS ENDOCRINE ASSOCIATES LABORATORY August 6, 1992 re: Docket No. PRM-35-l0A BRUCE F. BOWER, M.O., F.A.C.P., PG TEL. (203) 547-1278 L. EVERETT SEYLER. JR., M.D., F.A.GP.

TEL. (203) 547-1277 100 RETREAT AVENUE SUITE 605 HARTFORD. CT. 06106 Access to Affordable Quality Care:Outpatient Treatment Using Large Doses Radioactive I-131 I have enclosed a copy of a letter to the Nuclear Regulatory Commission supporting the use of radioactive iodide by home confinement rather than hospitalization for the treatment of patients with thyroid cancer.

The economic benefits are substantial and the available evidence indicates that thare is no radiation hazard to either family members or the general pU:llic.

The Ame~ican Association of Clinical ~ndocrinologists (AACE) representing Clinica: Endocrinologists in Connecticut would appreciate your support of this proposal.

Bruce F. Bower, M.D.

BFB/jcf

ADULT AND PEDIATRIC ENDOCRINOLOGY METABOLISM DIABETES NEUROENDOCRINOLOGY PSYCHOENDOCRINOLOGY REPRODUCTIVE ENDOCRINOLOGY NUCLEAR MEDICINE ENDOCRINE ASSOCIATES CONSULTING ENDOCRINOLOGISTS

• ENDOCRINE ASSOCIATES LABORATORY August 6, 1992 Secretary of the Commission Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docking and Service Branch BRUCE F. BOWER. M.D.* F.A.C.P.. P.C.

TEL. (203) 547-1278 L. EVERETT SEYLER, JR.* M.D.. f'.A.C.P.

TEL. (203) 547-1277 100 RETREAT AVENUE SUITE 605 HARTFORD. CT.

06106 re:.. Docket No. PRM-35-l0A Acce:c::s to Af_forda.ble guali ty Care: outpatient Treatment Using Large Doses Radioactive I-131 To whom it may concern:

On behalf of the American Association of Clinical Endocrinologists (AACE),

the national physician organization representing practicing Endocrinologists, we write to support the Amended Petition for Rulemaking submitted by the American College of Nuclear Medicine which would permit outpatient treatment of patients with thyroid cancer with Radioactive Iodide I-131.

The use of home confinement, as opposed to presently mandated hospitalization when doses in excess of 30 millicuries of NaI I-131 are required, would greatly simplify treatment of patients with thyroid disorders including thyroid cancer.

The estimated cost savings alone would be of the order of $75,000,000 annually.

Published data (Allen, Jr., H.C.: Non-Hospitalized Thyroid Cancer Patients Treated With Single Doses 50 -

400 mci, The Journal of Nuclear Medicine, Proceedings of the 37th Annual Meeting) in which 430 patients were surveyed during home confinement indicates no health hazard or potential radiation hazard to either family members or to the general public.

The American Association of Clinical Endocrinologists strongly supports this position and petitions the Commission to act favorably on this proposal.

cc: American College of Nuclear Medicine BFB/jcf Yours very truly,

~

Bruce F. Bower, M.D.

Steering Commlllee:

Dorla G. Bartuska, M.D.

Philadelphia, Pennsylvania H. Jack Baskin, M.D.

Orlando, Florida Donald A. Bergman, M.D.

New York, New York George A. Bray, M.D.

Baton Rouge, Louisiana C. Wayne Calla111ay, M.D.

Washington, D.C.

Rhoda H. Cobln, M.D.

Midland Park, New Jersey Yank D. Coble, Jr., M.D.

Jacksonville, Florida George E. Dalley, M.D.

San Diego, California David E. Dalrymple, M.D.

Atlanta, Georgia A.,llbert H. Daniela, M.D.

W'erook "le, Massachusetts Eugene T. Davidson, M.D.

Lakeland, Florida Jaime A. Davidson, M.D.

Dallas, Texas Richard A. Dickey, M.D.

Hickory. North Carolina Stanley Feld, M.D.

Dallas, Texas Wllllam W. Fore, M.D.

Baltimore Maryland Michael Garcia, M.D.

West Bloomfield, Michigan Stephen F. Hodgson, M.D.

Rochester, Minnesota John J. Janick, M.D.

Port Charlotte. Florida Paul S. Jelllnger, M.D.

Hollywood, Florida

. Conrad Johnston, Jr., M.D.

nd1anapol1s. Indiana Ann M. La111rence, M.D., Ph.D.

Maywood, Illinois Ho111ard R. Nankln, M.D.

Columbta. South Carolina Alan R. Nelson, M.D.

Sall Lake City, Utah Ed111ard Paloyan, M.D.

Maywood, Illinois WIiiiam F. Price, M.D.

Spartanburg, South Carolina Helena W. Rodbard, M.D.

Rockville Maryland John A. Seibel, M.D.

Albuquerque, New Mexico Victor E. SIiverman, M.D.

Atlanta. Georgia Staff:

Robert J. Harvey Executive Director Linda C. Flo111era Group Representative August 13, 1992 Secretary of the Commission Nuclear Regu]atory Commission Washington, D.C. 20555 Attention: Docking and Service Branch re: Docket No. PRM-35-lOA Access to Affordable Quality Care: Outpatient Treatment Using Large Doses Radioactive 1-131 To whom it may concern:

On behalf of the American Association of Clinical Endocrinologists (AACE), the national physician organization representing practicing Endocrinologi ts, we write to support the Amended Petition for Rulemaking submitted by the American College of Nuclear Medicine which would permit outpatient treatment of patients with thyroid cancer with Radioactive Iodide 1-131.

The use of home confinement, as opposed to presently mandated hospitalization when doses in excess of 30 millicuries of Nal 1-131 are required, would greatly simplify treatment of patients with thyroid disorders including thyroid cancer. The estimated cost savings alone would be of the order of $75,000,000 annually.

Published data (Allen, Jr., H.C.: on-Hospitalized Thyroid Cancer Patients Treated With Single Doses 50-400 mCi, The Journal of Nuclear Medicine, Proceedings of the 37th Annual Meeting) in which 430 patients were surveyed during home confinement indicates no health hazard or potential radiation hazard to either family members or to the general public.

The American Association of Clinical Endocrinologists strongly supports this position and petitions the Commission to act favorably on this proposal.

Yours very truly,

~~

Bruce F. Bower, M.D.

cc: American College of Nuclear Medicine H. Jack Baskin, M.D.

BFB/akj Ackn wfed SEP 1 8 1992 0

ged by card *HMltHHHU IHHtH~

2589 Park Street / Jacksonville FL 32204-4554 / (904) 384-9490 /

FAX (904) 384-8124

ADULT AND PEDIATRIC ENDOCRINOLOGY METABOLISM DIABETES NEUROENDOCRINOLOGY PSYCHOENDOCRINOLOGY REPRODUCTIVE ENDOCRINOLOGY NllCLEAR MEDICINE ooc:TT 'uM~ER ENDOCRINE ASSOCIATES PET111 I' i.E PRM CONSULTING ENDOCRINOLOGISTS

. -~ *. _ (5"7 FD 2-10'-l.l)

ENDOCRINE ASSOCIATES LABORATOI\\YJ'., l'\\L t l ['

f"'

.J~NHC BRUCE F. BOWER. M 0., F.A.C.P.* P C.

August 6, p 3 TEL. (203) 547-1278 1992 92 AUG 13

Ql L. EVERETT SEYLER. JR., M.D, F.A C.P.

TEL. (203) 547-1277

,_,Ff-/[:~. Jf St '11t-fA tlV DOCK[T ING S[i,,V lr:f l00 RETREAT AVENUE 0 AN CH SUITE 605 HARTFORD, CT. 06106 Secretary of the Commission Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docking and Service Branch re: Docket No. PRM-35-l0A Access to Affordable Quality Care: Outpatient Trea~ment Usi~g Large Doses Radioactive I-131 whom it may concern:

On behalf of the American Association of Clinical Endocrinologists (AACE),

the national physician organization representing practicing Endocrinologists, we write to support the Amended Petition for Rulemaking submitted by the American College of Nuclear Medicine which would permit outpatient treatment of patients with thyroid cancer with Radioactive Iochde I-131.

The use of home confinement, as opposed to presently mandated hospitalization when doses in excess of 30 millicuries of NaI I-131 are required, would greatly simplify treatment of patients with thyroid disorders including thyroid cancer.

The estimated cost savings alone would be of the order of $75,000,000 annually.

Published data (Allen, Jr., H.C.: Non-Hospitalized Thyroid Cancer Patients Treated With Single Doses 50 -

400 mci, The Journal of Nuclear Medicine, Proceedings of the 37th Annual Meeting) in which 430 patients were surveyed during home confinement indicates no health hazard or potential radiation hazard to either f~~ily mc~bcrs ~r tc th~ general public.

The American Association of Clinical Endocrinologists strongly supports this position and petitions the Commission to act favorably on this proposal.

cc: American College of Nuclear Medicine BFB/jcf Yours very truly,

~

Bruce F. Bower, M.D.

8EP1s Acknowfectged t-u

-~

"'1 card.........

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Huntington Hospital

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( S-7 Frt 2-I0~13J s1 Huntington Memorial Liospital 100 W. California Boulev.ird P 0. Box""013 Pasadena, California 91109-7013 Radiation TI1erapy (818) 397-5140 JU I y 2 1 1

1 9 9 2

-"92 Jl. 27 P6 :2r ---

ROSE & KADIN RADIATIO TilERAPY Medical Group J. Holt Rose M.D.

Michael R. Kadin, M.D.

Samuel J. Chi lk Secretary of the Commission US Nuclear Regulatory Commission Washington DC 20555 ATTENTI ON:

DOCKETI NG AND SERVICE BRANCH RE:

DOCKET #PRM t OA

Dear Mr. Chi lk:

As Radiation Safety Officer I am in favor of raising the amount of radiopharmaceutical to greater than 30 mC i that can be given as an out patient.

At the present time we are admitting "wel I" patients to the hospital for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for radiation precautions when greater than 30 mCi is given.

This means that nurses and other personnel in the child bearing age are irradiated while patients are hospitalized.

This causes increased anxiety among nursing personnel.

These patients who are receiving Iodine 131 and other radiopharmaceuticals would be better off confined to the home where they could receive appropriate radiation precautions.

The r e f o r e, I s u p po r t t he p r o po s a I s po n s o r e d by t he Ame r i c an College of Nuclear Medicine.

Sincerely,

~

- R~ri"'<>

J. Holt Rose, M.D.

Radiation Safety Officer JHR/ef SEP 18 1992---

Acknowladged by card... --"***'"*.............

\\

')'.:" :,Ei NUMBER

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Health Science Center

~

Syracuse Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch

Dear Sir:

Re: Docket No. PRi.\\1-35-lOA

'92 Jll 27 A10 :46 July 17, 1992 College of Medicine Department of Radiology Division of Nuclear Medicine (315) 464-7031 Fax (315) 464-7068 I support the requests from the American College of Nuclear Medicine to revise 10CFR Part 35 which would allow for the therapeutic use of radiopharmaceuticals in amounts greater than 30 mCi for outpatient therapy. In my own p:"actice, we are regularly required to hospitalize patients undergoing therapy with I-131 for thyroid cancer, and such patients are hospitalized merely for observation for three days. They require, while being inpatients, special nursing services and monitoring simply because of the radioactive material involved. Many of these patients come from homes in which no family members are under the age of 30, and thus would pose very little risk in terms of radiation exposure. Since wh:ile in the hospital all of the radioactive iodine excess which is excreted in the urine is directly flushed into the sewer system, there seems to be little need to utilize expensive inpatient facilities because of the arbitrary requirements of 1 0CJ:-R Part 35 to hold patients until they have reached a level of 30 mCi.

In consultation with our Radiation Safety Office and the members of our Radiologic Physics sedion, I have found that they are equally convinced of the desirability of such a change in policy.

FDT:cw College of Medicine Sincerely, d 9~

-[L,._

F. Deaver Thomas, M.D.

Professor an.1 Director Division of Nuclear Medicine SEP 18 1992 Acknowledged by card....... N.NHHHll,.HfflNUIII Committed to Excellence in Professional Education, Patient Care and Research.

College of Graduate Studies College of Health Related Professions 750 East Adams SU\\:et, Syracuse, N.Y. 13210 College of Nursing University Hospital

U.S_ NUCLE,'.:1 *,.:GULATORY COMMISSIO~

DOCKE:TH!G & SERVICE SECTION OF* ICF.: OF 1HE SECRETARY OF THi: COMMISSION DoctJm-:int SIJ!::,lics Poc;t, a,!- '.J 0 to Coois~ 1 *0.c~,* " j -

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......_. Al,ARA1'.1A /\\T BIRMINGHAM Secretary of the Cornmiss ion Via Mark Rotmr1n July 1/, 1992 U.S Nuclear Regulatory Commission Washington, DC 20555 ATTN : Docketing and Service Aranch Dear Secretary.

4-0OCKETED P02 Please considor this letter an initia l response address ing the receipt of petition ror ru le-making by the Arne ric,rn Co llege of Nucle,H Medicine to deletP-the requirement in 1 O C F R 35. 7?(a)(2) rega rding re lHase ot patients containing 30 millicu ri es (or less) from hospital confinement.

Hore at the University of Alabama (LJAB),

we have had considerable experience in handling radioiod ine monoclonal pa tients as we ll as thyroid carcinoma pa tients.

While we already allow patients to be released above the 30 mil licu ries amount (as long as the maximum exposure rate at on e meter from the patient is 5

milliroentgens or less), we fee l that certain restrictions arc necessary be fore such allowances are made prevalent.

While we may not be completely against the petition, we feel thal (1) there should be sufficient evaluation of each patient regarding their ability to care for themse lves and others in the event they a re released,

(2) there should be res trictions and

µrecr1utIonary measures tak en and instructions gi ve n to prevent unnece ssary ex posure to members of the public, friends and relatives of these patients, (3) individual that might have occasion to be in the vicin ity of these patients have a righ t to know the rad iation hazard involved. ('1-} the re should be suffici -,nt notice and 1n1ormation avciilnble regard ing the radioactive co ntent of the patient in ca se of an accident or a medical emerg ency, (5) fami ly physicians and nearby clinical laboratories should be informed regarding any possible! blood or urine culture work or urinalysis that might become necessary.

I h,, l lniH1,11,,,/ l\\l,1h1m.1..1t [\\1m1111gh.1m 44 1 t:,1mmu111l~ H""lrh --;,,r,1,,*, l-lud,ling-l '>cb

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P03 When proper notice, instruction and precaution is not given for all of the people involved, some of them will believe that insufficient precautionary measures are being taken and that they are being exposed to unnecessary levels of radiation.

More information regarding this matter is forthcoming.

Sincerely,

.~

Radiation Safety Officer

~ 8£p_TO __

• -*"'lliWliVed by Card -

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< TRANSACT ION REPORT>

07-17-1992(FRI> 14:31

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DATE TIME DESTINATION STATION PG.

DURATION MODE RESULT 4458 7-17 14:29 205 975 5035 3

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The University oi Alabama at Birmingharn D0p.1rtrnenr of 0,ClJp;:itional Health and s.~tf>ty FAX TRANSMITTAL TO:

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FAX # (3o~ () 0~ - J_ J_ (p 0 FROM:

DATE:

J NUMBER OF PAGES INCLU1)[NG COVER LETTER: --5 Phone: (205) 934*2487 Fax: (205 ) 975.4930 or (205 ) 975-5035 liA8 ',1,,1, r,,, I Brrn1ir1Rh:1m, Al;,1,,H*n,i 35294 1 n AtfirrnattVP 1\\1 \\1P n I LquJI Upportu111ty I rnplc1y,*r POI OOlK(i£.0 U5NRC

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TH*: l 1\\JIVER5ITY OF TFXAS efocw* ***o M[) AN)ERSON

, usN1~ct CANCEI~ C:ENTER

-gi Jll 20 Pl2 :46 MEMORANOUM TO:

Samuel J. Ch ilk FROM:

Secretary, Office of the Commission USNRC Mail Stop 16G 15 Washington, DC ?0555 Daniel J. Macey Ph.D.

Associate Professor/Physi 1;,.

Departmeul of Radiation Physics, Box 94 q_,,-- 7./7 James L. Murray M

/

Associate Professor I ~.90i6gisl Department of Clini

-n6Iogy and Biological Thcra ox 41

SUBJECT:

Petition by the American College of NucJear Medicine (ACNM) to tht' Nudt'ar Reguh-ltory Commission (NRC) on confinement of rndionuclidt* therupy patients.

DATE:

Ju I y l 7, 1992 This i. a letter of support for the above petition which appeared on the l'cderal Rcgi t.er on March 9. 1992. Fur the past 4 years we ha c been involved at our institution in treating canc;~r patients with therapy doses of rndiolabeled antibodies and other radiopharmaccuticals. We feel our experience if radionuclide therapy with J J 31 and various radionuclides and working with tl1e present 30 mCi nldionuclide limit for the confinement of patiems may be of value to the NRC in its consideration of die above petition.

Al our institution. patients are only released if they have less than 30 mCi of the administered radionudide as estimated from dose rates measured at I meter for photon emitters or pharmacoki.nctic tlala for beta emitters. This procedure llas bee11 used in radionuclide therapy trials with the following radionuclides, I-13 J, Y-90, Sm-153. We are offering tl1c following comments related to rndionuclidc Uicrapy trials at our institution.

11-XAS MFl>lC>\\I CEh!T[ll

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF T/--JE SECRETARY OF n,E -:nMMl3-;!Q I fx,,r11cr St

• sites Postmark Date ~

Copies Received ~ T

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Special DistribuHon e<</.3, /J/JR =

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M _9dirnl CVl.li,'._~n1_0; A r<Hlio11uclidc therapy prescript ion for the cancer pa1ic11t can repri:'.Sent n "scntenci:." of :solitary cu11fine111ent i11 a hospital room imposed primarily a.'> a l uu:-,np1cJ1cc of the present 30 mCi limit.

This confi11c111cut can be a distn::-;si11g e.xperie11ce for nrnny cancer patients. From tlle medical oncologist's viewpoint, home care for the radionuclide tl1c.rapy patient is an imp011ant benefit from the p:--ychologict1l point of view. Ca11cer patieuts often suffer t11111ccessary distress in hcing separated from their families and friends for mort'. than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> nud usually clo not require Lhe medical suppon provided by hospital 1..:are whcu they rn:eivc rndiouuclide therapy. The ability to administer therapy doses greater than 30 111Ci ou a11 outpatient setting is important in rcsturing the ptttiellt's peace (Jr mind,rnd strengthening the patient-doctor reL1tio11ship. rurthcrmon:, outpaliem treatment cau help tu reduce die cost of radionuclide therapy aud eliminate the cost of hospitalization for a patient can save as 111ucl1 as $6.000 for a 4 day period. Releasing radionuclide thern.py patients uw tl1ereforc reduce tlic rosl to 1l1e patient and be an important benefit to society, since it will make the procedure more widely available.

2.

R.i!illfil_!..Qn_ __ Sµ.{e_ty__:

RadiHtion safety considerations dictate special pro,:edures be folluwcd io the case of radionucli<lcs as well as the continued use of established rndionuclide thcr,1py patients in a hospital environment Tl.le increased patient use of antibodies labekd with thnapy doses of various radionuclides as well as the continued use: of (-:stahlished radionucfok thernpy proccdun;s for cann~r trea1me111 at 1l1is i11stinnion results in incrcase<.1 concerns for the radiation doses reviewed by Iturscs, pliysicia11s. allied health personnel and other pati~nts.

lt is becoming inucasingly ClHnplicatcd aml difficult to keep doses to tl1esc pasons at the "rcasunably achievable" d1>se levels of even a fi;w years ago.

Tile cun-cut 30 mCi patient release limit from hospitals is quite arhitr.Hy cve11 fur I-n 1 and nf lillk value for nwst other rndionuclides (unsealed sources) in therapy use or being considered such tts Y-90, Sm-1)3, Ho-166, etc.

A better guide would bl' the use of the philosophy expressed in NCRP Report No.57. pages 17--21. where factors of external dose rates and effective half-livl:s arc ust*d to deten11i.J1L: hospi1al relettse criteria and limit.s for patients with various radionuclide:-;.

The benefit.<.; of confining radionuclide therapy patients at home rather than in n hospital 1u-L: llte reduction in exposure for hospital personnel/patients and the reduced i111pacl or problems associated with possible contamination. We view t11e well hcing of the ractionuclid(* therapy palicut as the primary justification for cha11gi11g lhc preseut limits t11at require confinement of t11ese patients in hospital.

Proper safeguards would he required for educatiou and i11strnction on the increased responsihilities of the radionuclide therapy patient and feel the majority of patients and hospital personnel would welcome: this change i11 the present rcgu lat ions.

< TRANSACTION REPORT>

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DOCKET NUMBER

,8 5', I() II PETITION RULE PRM

(__q/ ~;f_ c2,/()¥3)

July 15, 1992 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention:

Docketing and Service Branch

Dear Secretary:

f JC hi.. 1 LD USNHC

'92 JUL 20 P 4 :43 On behalf of the over 28,000 members that comprise the American College of Radiology, I respectfully submit the following comments in response to the amended petition for rulemaking by the American College of Nuclear Medicine as published in the Federal Register on May 18.

The American College of Radiology firmly believes, given the current economic environment in health care today, that the NRC must carefully weigh the need for protection of the general public against the costs associated with additional days of confinement within the hospital.

While this analysis typically results in difficult tradeoffs, it is an analysis that must take place if a rational balance is to be struck between public safety and cost sensitivity.

The petition under review is a significant departure from the current Section 35.75.

Due to the sensitive nature of the petition and the lack of agreement as to the possible effect the change could have on public safety, the ACR feels strongly that a balanced analysis should be made prior to a decision being rendered on this petition.

The ACR urges that this petition be brought before the Advisory Committee for the Medical Uses of Isotopes (ACMUI) to assist in getting a balanced, professional judgement on the impact of the petitioner's request for change.

One related area that needs readdressing in terms of radiation effects to the public deals with a problem associated with the final rule on Part 20.

That rule changes the threshold for radiation absorbed dose permitted to the general public from 500 mrem/y ede to 100 mrem/y ede.

While there is little if any evidence available that maintaining the 500 mrem/y ede maximum would pose any significant health or safety hazard to the public, the decision to drop the absorbed dose to 100 mrem/y ede was made.

The effect of this change will be to require hospitalization of a significant number of patients at a tremendous cost to society in order to avoid the chance of family members receiving more than 100 mrem per year.

Accordingly, the ACR recommends in concurrence with the petition filed with the NRC on December 26, 1990 (Docket No. PRM 20) that the 500 mrem limit be retained for situations relating to diagnostic and therapeutic uses of radionuclides and that the guidance provided in NCRP Report No. 37 serve as the basis for determining compliance with this limit.

SEP 18 igg Acknowledged by card...................... 111,!,~m AMERICAN COLLEGE 0

F RADIOLOGY 1891 Preston White Drive, Reston, Virginia 22091 (703) 648-8900

u.s. NUCLEA~ RcGULi\\TORY coMM\\S \\Ot-4 ooCKE TiNG s. SEl~V\\CE SECTION OFf ICE Or ThE SECRET ARY OF THE COMMISSION

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The ACR appreciates the opportunity to comment on these matters.

~~~

Gary W. Price Senior Director Government Relations Department GWP/bws

~

DOCKET NUMBER PETITION RULE PAM 3 5°-/ 0 A-

[ 57 Pie-£ /If J/3)

HERBERT C ALLEN. JR., M. D. FACNM 100 HERMANN PROFESSI ONAL BUILDING TEXAS MEDICAL CENTER HOUSTON, TEXAS 77030 CONSULTATION BY APPOINTMENT 1713 ) 790-0540 July 14, 1992 Samuel J. Ch ilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Attn: Documents and Services Branch NUCLEAR MEDICINE

• JFF!CE: OF SECH[TA v li1(JCf1 --

• 1L ! !NG,\\ Si-iiV/U i:lHANCli Re:

Docket No. PRM 35-10 and PRM 35-lOA

Dear Secretary Chilk:

As a member of the American College of Nuclear Medicine (ACNM), I would like to comment on the outpatient practice of nuclear medicine as it relates to radiopharmaceutical therapy involving medical dosages greater than 30 mCi I-131, with the patients not hospitalized but confined to a designated "restricted area" in their home.

For approximately 30 years, a few licensed nuclear medicine physicians in PRIVATE PRACTICE in Texas, participated in the treatment of more than 430 patients on an outpatient basis, with dosages of I-131 ranging from 100 to 400 mCi.

The I-131 therapy dosage was administered to the patient in the private office (non-hospital) of the Nuclear Medicine licensee and followed by immediate confinement to the patient's home until the body burden had decreased to less than 30 mCi.

The outpatient treatment protocol for home-confinement simulated our hospital protocol, developed over a 15 year period, regarding visitors, private bedroom and bath, no infants or children, release of patients from confinement, etc.

These studies, for 2.5 decades were authorized by the Texas Department of Health (TDH) from 1960-1988, the Texas Radiation Advisory Board (TRAB), and the Texas Bureau of Radiation Control

( TBRC)

• Approval by the Medical Committee of the TRAB and TDH followed a group of thyroid cancer patients studied on a case-by-case basis, beginning in 1960 and repeated again in 1969.

More recently 39 ambulatory new thyroid cancer patients were followed on a case-by-case basis for a third time (1982-1988). These were treated on an outpatient basis with radiopharmaceutical dosages, averaging 169 mCi I-131 (range 100-300 mCi) between 1982 and 1988.

SEP 18 '992 Acknowledged by card................................ "

,U.S.-NUCLEAR REGULATORY COMMISS:Or..

DOCKETING SERVICE SECTIO OFflCE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date 7,/; :5 /9 d-'

Copies Received. _ __..__-=---- --

Add'I Copies Reproduced.... ~""--- ---

Special Di:;tnnutiOn /qi)-;; f?OJC!

m. A~§ar

Scientific data of these three investigations had been routinely submitted to the TDH and the Bureau of Radiation Control (BRC) which showed that:

1.

The average external radiation dose to 44 members of the family attending the patient did not exceed the appropriate NRC or TRCA regulations.

2.

The internal radiation dose (thyroid burden) to family members of the household did not exceed State or Federal guidelines.

3.

There were no significant areas of contamination in violation of State (Appendix 21-C, TRCR) or Federal regulations (NRC).

4.

There was no undue external radiation in excess of Federal and State regulations or guidelines to members of the public (Federal 100 mr/yr and State 500 mr/yr).

It is for these reasons that we feel that the petitioner's (ACNM) requests for rulemaking change as published in PRM 35-10 and 35-l0A (regarding 10 CFR 35.310, 35.315 and 35.75) should be adopted in order to clarify current regulations and provide for an outpatient treatment option with greater than 30 mCi of I-131 followed by controlled home-confinement. We believe PRM 35-l0A should be adopted as newly reformed NRC Regulatory Policy.

This would enhance quality therapeutic and diagnostic medical care at a more affordable cost to the patient than mandatory/more costly hospitalization.

Respectively submitted,

~{~~l'<V Herbert C. Allen, Jr., M.D.

HCA/cd 2

LOWER COLUMBIA PATHOLOGISTS, P.S.

DOCKET NUMBEA PETITION RULE PRM 3 5'-_/0/I

~LffNO,t£1, ;::(6~51~~!22 C. E. BUCK, M. D.

W. J. ELTON, M. D.

11. C. NAU, M. D.

M. 8. f~0(iksi_ ; l[}

USNHC CUNICAL MICROIIOLOGIST:

LR. STAUFFER, SM(AAM)

8. 11. FERGUSON, M. D.

11. E. SANDSTl!OM, M. D.

"92..U. 20 P 4 :46 Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 ATTENTION:

Docketing and Service Branch

Dear Mr. Chilk:

H. H. KIM, M. D.

July 13, 1992 I am writing in regards to an amended petition for NRC rule making, docket

1. PRN-35-lOA regarding radiopharmaceutical therapy for patients receiving greater than 30 mCi of I-131.

I urge you to consider allowing the use of amounts greater than 30 mCi for outpatient therapy and redefine the terms of compliance.

Cur-rently, I-131 is used as therapy for various thyroid conditions including malig-nancy.

In patients receiving greater than 30 mCi, these patients have to be hospitalized incurring a significant hospital medical cost.

Radiation dosimetry in scientific studies have shown that there is no increased risk of external radiation exposure to the public and is in fact conservatively below the accept-able levels as published in the US Nuclear Regulatory Commission Regulations Title 10, Code Federal Regulation, Section 20 (10CFR20).

This will be accom-plished with confinement of these treated patients to their home immediately post therapy.

I would urge you to consider in favor of this petition. Enclosed is a copy of resolution 22 to American Medical Association House of Delegates by the Ameri-can College of Nuclear Medicine regarding Access to Affordable Quality Care:

Outpatient Treatment Using Large Doses Radioactive I-131.

Thank you for your attention and consideration.

Sincerely yours, fl~

Helen H. Kim, M.D.

Pathologist SEP 18,99?

HHK/cg Enclosure AcknowledgEMJ by card................... "...... ~.....

P.O. Box 3012 1606 E. Kessler Blvd., Suite 100 Longview, WA 98632 (206) 425-5620 Billing: (206) 425-9038 Fax: (206) 425-7219 1800 Cooks Hill Road Centralia, WA 98531 (206) 736-7626 Fax: (206) 736-7627

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERs/lCE SECTIO OFflCE OF THE SECRETARY Of THE COMMISSION Document StatlstiCS Postmark Date '1/(~ / 9 :;>-

Copies Received_

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AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Introduced by:

American College of Nuclear Medicine

Subject:

Access to Affordable Quality Care: Outpatient Treatment Using Large Doses Radioactive 1-131 Referred to:

Reference Committee E (John E. Albers, M. D., Chairman)

Resolution: 22

{A-91) 1 Whereas, Radioactive inorganic sodium lodide-131 has been used for the treatment of 2

certain thyroid disorders since 1946; and 3

4 Whereas, Other radioactive biologicals (i.e., monoclonal antibodies) have been labelled with 5

radioactive lodine-131 and used in the treatment of other malignant disorders; and 6

7 Whereas, Adequate radiation cancer therapy involves administering large doses greater than 8 30 millicuries (mCi) per patient (100-200 mCi); and 9

10 Whereas, There is no scientific evidence that external radiation exposure to the public in 11 this application will exceed the limitations published in 10 CFR 20.105 when treated on an 12 outpatient basis; and 13 14 Whereas, To the contrary, scientific research and professional published data has shown 15 that external radiation exposure to the public in this application is considerably below the 16 acceptable levels as published in the U. S. Nuclear Regulatory Commission Regulations Title 17 10, Code of Federal Regulation, Section 20 (10 CFR 20}; and 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38

, 39 40 41 Whereas, The health and safety of the public is not compromised by outpatient treatment with large doses greater than 30 mCi 1-131 followed by patient confinement in his/her home; and Whereas, There is a large body of experienced and licensed nuclear physicians and scientists qualified to ensure protection of the health and safety of tt,e public that did not exist in 1946 when current regulations were promulgated more than 30 years ago (1957); therefore be it RESOLVED, That the American Medical Association petition the Nuclear Regulatory Com-mission (NCR) to:

1. Recognize that the outpatient treatment of certain thyroid disorders and other malignancies can be treated with large doses of 1-131 exceeding 30 mCi is an acceptable legitimate policy not i.n violation of NRC regulations;

2. Recognize that no regulation requires hospitalization when large amounts greater than 30 mCi 1-131 arc to be administered to a patient provided there is no hazard to the health and safety of the public or occupational worker; and

3. Recognize that there is no legal limit of an amount of 1-131 or other radiopharma-ceuticals that can be administered to a patient by a licensed nuclear medical physician and the treatment of patients on an outpatient basis (not hospitalized) is not in violation of NRC regulations.

Fiscal Note: No significant fiscal impact

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Introduced by:

American College of Nuclear Medicine,

Subject:

Unnecessary Restrictive Nuclear Regulatory Regulations Adversely Affecting Access to Affordable Quality Care Referred to:

Reference Committee E (John E. Albers, M. D., Chairman)

Resolution: 23 (A-91) 1 Whereas, Radiopharma.ceuticals ha.ve been

• used in diagnosis a.nd therapy of patients 2

since 1946; and 3

4 Whereas, The Atomic Energy Commission (AEC) and Nuclear Regulatory. Commission 5

(NRC) have protected the public from unnecessary radiation over this period of time; and 6

7 Whereas, A recent revision of NRC regulations is beginning to affect the quality of care 8

of the patient because of over restrictive review protecting the public; and 9

10 Whereas, The recent regulations promulgated are lowering the radiation dose to the 11 public from 500 mR (5 mSv) to 100 mR (1 mSv} per year is such an example; and 12 13 Whereas, This unnecessary restrictive regulatory philosophy will materially incre:ise the 14 cost of quality care to the patient of the order of $75,000,000 annually ( for Na 1-131); and 15 16 Whereas, There is no clear human evidence of radiation induced genetic damage at low 17 dose levels and low dose rates of radiation of 500 mR (5 mSv) per year; therefore be it 18 19 RESOLVED, That the American Medical Association oppose the Nuclear Regulato;y 20 Commission's (NRC) implementation of 10 CFR 20.301 (a) (1) by petitioning the NCR for 21 regulatory relief of the new 10 CFR 20.301 in order to restore the previous external radiation 22 limit of the public to 500 mR (5 mSv) per year.

Fiscal Note: No significant fiscal impact

OOgt<ET NUMBER

-~- ~- -~

i,,eflTION RULE PRM JS-- 1 o A-

,. \\

?I{ 57,::"te_.:i_t di/~

Conference of Radiation Control Pf I

ram Directors, Inc.

July 10, 1992

• 92 JUL l 7 A11 :19 Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Mr. Chilk,

On June 16, 1992, we submitted a letter addressing Docket Numbers PRM-35-10 and 35-l0A. We discovered an omission on line 7 of the June 16 letter, and have enclosed a corrected copy.

You are requested to replace the original June 16, 1992 letter with the attached corrected version.

CMH/sah Enclosures cc:

SR-6 Members Board of Directors Federal Liaisons Sincerely,

'Charles M. Hardin Executive Director j

Conference of Radiation Control Program Directors, Inc.

Office of Executive Director 205 Capital Avenue Frankfort, Kentucky 40601 (502) 227*4543 Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 June 16, 1992 Re: Docket Nwnbers PRM-35-10 and 35-l0A

Dear Mr. Chilk,

With respect to these proposed rulemaking petitions referenced above, as submitted by the American College of Nuclear Medicine, the Board of Directors of the Conference of Radiation Control Program Directors, Inc. (CRCPD), based upon recommendations of the CRCPD Committee on Suggested State Regulations for Control of Radiation - Use of Radionuclides in the Healing Arts, offers the following comments:

The petitioner requests the term "confinement" as used in 10 CFR Part 35,

§35.75, be clarified to allow for confinement at home. As written, this regulation does not specify that the patient must be hospitalized. It is our opinion that NRC and Agreement States with the same terminology in equivalent regulations currently have the prerogative to authorize confinement by means other than hospitalization. Therefore, no definition of the term "confinement" is warranted. "Confinement" is taken to mean hospitalization or other limitations of patient activities to keep radiation exposures to other individuals within allowable limits which are acceptable to the Agency.

2.

The petitioner requests the requirement for confinement of patients containing more than 30 millicuries of activity be deleted. It is the recommendation of this Committee that the current release criteria be re-examined and modified to conform to t:he recommendations in Report.Nwnber 37 of the National Council on Radiation Protection and Measurements (NCRJ>) (Precautions in tht:

Management of Patients Who Have Received Therapeutic Amounts of Radionuclides, 1970). These recommendations provide for release of patients containing radionuclides when the activity in the patient is such that the effective dose equivalent to a hypothetical person one (l) meter from the patient during complete decay of the radionuclide will not exceed the maximwn pennissible dose to members of the public as specified in 0 CFR Part 20. We believe that this is a more reason d approach based on available scientific guidance and takes into consideration the administered radionuclide.

Samuel J. Chilk, Secretary June 16, 1992 Page Two

3.

We wish to reserve further comment on the safety of outpatient radiophannaceutical therapy in doses up to 400 millicuries of iodine-131 as sodium iodide until these data have been published in peer-reviewed scientific journals, especially in light of the recommendations in NCRP Report, Number

37. No references to such publicaticns were inrluded int.lie petitioner's request.

Thank you for the opportunity to comment on this petition for rulemaking. If you need further information or clarification, please do not hesitate to contact me.

AVG/CMH/sah cc:

Board of Directors Federal liaisons SR-6 Members Sincerely,

~

v; ~

Aubrey V. J{dwin / ~

CRCPD Chairperson

U.S. NUCLEAR REGUlAi OP.V COMM\\ S\\ON ooci<E1'"!G & SER\\/ICE SECTION Off ICE Or THE SECRETARY OF 1HE coMMISSIO~

Document Statistics

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,._,,.~,._.~ PITTS RfDIOlOGICAl ASSOCIATES, P.A.

Thomas A. Pitts, M.D., F.A.C.R., Emeritus U. Hoyt Bodle, M.D., F.A.C.R., Emeritus Arthur K. Walter, M.D.

Wiillam D. Meredith, M.D., President Gerald M. Chambers, M.D.

Geo. Badgar Humphries, Jr., M.D.

James R. Gettys, M.D.

Robert E. Fitzpatrick, M.D.

John W. Lauver, M.D.

John L. Thomas, M.D.

Charles R. Hubbard, M.D.

Francis H. NauHer, M.D.

John Edsel Garrick, M.D.

Mark A. Lovern, M.D.

Douglas M. Bull, M.D.

Samuet E. Friedman, M.D.

Lawrence R. Lough, M.D.

Secretary July 14, 1992 US Nuclear Regulatory Commission Washington, DC 20555 At tent ion:

Docketing and s*ervice Branch

Dear Mr. Secretary:

'92 M 17 All :19 tfFICf :)F 5i:.t.Rt. TA v no l TING

!;l.il 'ICf ANCI-,

Baptist Medical Center Taylor at Marlon Street Columbia, S.C. 29220 (803) 771-5060 Providence Hospftal 2435 Forest Drive Columbia, S.C. 29204 (803) 256-5350 Central carollna Radiological Svc.

CT Scanning Facility @ Prov. Hosp.

2433 Forest Drive Columbia, S.C. 29204 (803) 799-5852 MRI, Inc. of The Carolinas

@ Baptist Medical Center Taylor At Marlon Street Columbia, S.C. 29220 (803) 771-5101 I am writing in support of the proposed amended petition to 10 CFR, Part 35.

I am a Nuclear Radiologist in private practice in Columbia, South Carolina.

We see several patients per month who require large dose Iodine therapy.

These patients are confined in the hospital in radiation isolation at considerable costs (generally more than

$3,000.).

The majority of these patients could easily maintain adequate radiation isolation while confined in their homes.

Various studies in the literature have demonstrated no danger to family members if very rudimentary precautions are maintained.

In my experience with treating patients, I have yet to encounter any medical complications which would require the patient to remain hospitalized for any medical reason other than radiation isolation.

In summary, I believe the petitioners are correct in their assertion that granting of the amended petition would result in a considerable savings, while still maintaining high quality care.

While there would still be a small number of patients requiring hospitalization to maintian radiation isolation, I believe the vast majority of patients can be safely and effectively treated on an outpatient basis.

Thank you for your consideration of this matter.

SEF/dh SEP 18 1992 ~~m:n, M,D.

Medical Director, Nuclear Medicine Baptist Medical Center Acknowledged"' cmd... -

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _ _ -.-..c.._..____..._ __

Coples Recoivdd _________ _

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DOCKET NUMBER

..., ff PETITION RULE PRM.35; / O L s1 F'I<.. c:21 ot./3)

"92 J.ll 17 P4 :06 Dr. George L. Colvin D. O.,F.A.O. C. R.

224 N. Wellwood Ave.

JULY 8, 1992 Sammuel A. Chilk Lindenhurst N.Y. 11757 (516) 226-0011 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Re: Federal Register vol.57, #96 May 18, 1992 10 CFR part 35 Docket No. PRM-35-lOA

Dear Sir:

As a Physician and Radiologist I believe in keeping the dose of radiation of all people to a minimum.

However, th e new regulations are unsatisfactory and will not allow satisfactory evaluation of patients needing nuclear procedures.

I, therefore, request that you restore the previous external radiation limit of the public to 500 MR (5 mSv) per year.

Thank you for your time and consideration.

George L. Colvin, D.O.,F.A.O.C.R.

SEP.1*..,.,,.

Acknowledged b'f card..... ~Hi"!.!..~*~--

• J

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u.~. N'H,l.fJ,H rii:UUU\\TORY crn/PAbS!dr-.

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The Medical C,enter Bt>awr: Pa, Inc.

July 14, 1992 Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 DOCKET NUMBER

,4 PETITION RULE PRM 3--5, -/tJ

( S 7 F/l 2JO~j_)

LJl t\\t..; LD USNHC

• 92 JUL16 p4 :14

• FF!C!

  : OF SECK[TA~'r' GOCK[1 iNfi.~ SF ilV!U BRANCH ATTENTION:

Docketing and Service Branch

Dear Mr. Chilk:

I wish to add my support to the proposition that 10 CFR Part 35 be amended to allow doses greater than 30 mCi to be used in diagnostic studies and radioisotope therapy.

Medical research has made it clear that affordable quality care can be provided on an out patient basis at a significant savings.

Furthermore it is also clear that doses greater than 30 mCi do not create a safety hazard to the public or to radiation workers.

I am hopeful that the Commission will act favorably on the recommendation as outlined in Resolution 22 and Resolution 23 submitted to the A.M.A. House of Delegates.

Sincerely, Thomas W. McCreary III, M.D.

Medical Director Nuclear Medicine Department TWMcC/dc 1()00 llut<'h Ridge Road Rea\\'('l", PA 1 SOO!J 11 ~,~S-7000

U.S. Nv:*.. -:* < _::,_.,' :c.--rt COMIV11SSIO~

ooci-:t:*:*,.,. c. ~:/P.v:cE SECTION OF !Cr:. 0F *rHE SECRETARY Of THE COMMISSION Postmark D::.ta _....,__>-L-.~~ ~ ---

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( 51 F (l 2-10 'IV TEU:,.HONE (717) 771

• 23215 July 14, 1992 Mr. Samuel J. Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Attention:

Docketing and Service Branch

Dear Mr. Chilk:

• 92 JUL 16 P4 :16 I am writing in support of the amended petition for rule making (Docket *PRM-35-l0A) regardiug the diagnostic and therapeutic use of radiopharmaceuticals in ameunts greater than 30 mCi.

I have been in the practice o( Nuclear Medicine since 1969 and have used radioactive iodine extensively for treatment of thyroid carcinoma and hyperthyroidism.

I would agree with the conclusions of the study published by Herbert c. Allen, Jr.,

M.D., regarding treatment of thyroid cancer patients outside the hospital setting with doses of radibactive iodine above 30 mCi.

I also support the American Medical Association House of Delegates resolutions #22 and #23 regarding this issue.

In my experience, patients and their families can quite easily be trained in the responsible handling of radioactive iodine in the outpatient setting which would significantly reduce the cost incurred for this therapy.

In addition, diagnostic studies are now being developed that potentially could result in transient retained doses of greate r than 30 mCi, in particular the technetium labeled myocardial scanning agents.

These patients and patients undergoing monoclonal antibody scanning or treatment would make up a larger group of patients than are currently seen for treatment of thyroid carcinoma.

In summary, I would support this petition in the interest of promoting affordable medical diagnostic and therapeutic care for these patients.

-~_0 David M. Shearer, M.D.

aes A kn SEP 1 8 1992 c owledged by card..................................

l U.S. NUCL:..-;-:.. *cuULATOiiY COMMISSIOI'.

DOCKEiiNG & SERVICE SECTION OF.ICE OF THE SECRETARY OF THE COMMISSION

\\)OCUfliCrlt Stali::~cs Postmark Date

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L q1a--c 7

George H. Brenner, M.D Wm. Clyde Glover, M.D.

John W. Joyce, M.D.

Robert L. Fincher, M.D.

Doyne Dodd, M.D.

H. W. McAdoo, Jr., M.D.

CONSULTA l')...l.TC u HenryALile,M.D.

I '1tl Jjl 16 p 4j~r: ~~~;~~.\\v1MDD July 13, 1992 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Lindy Book, M.D.

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..* - - ~, -* --,. Mifihael T. King, M.D.

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DOCKET NUMBER PETITION RULE PRM 3 5 -/ 0 A

{_ 5 7 Ffl :2-I 0'-/3)

Subject:

Amended Petition for Rule Making (Resolutions 22 and 23 A9I),

From the American College of Nuclear Medicine, Refer to Reference Committee E (John E. Albers, M.D., Chairman)

Gentlemen:

Charles M. Boyd, M.D.

Steven R. Nokes, M.D.

Joseph S. Murphy, M.D.

Ronald C. Walker, M.D.

C. J. Fuller, M.D.

Kenneth V. Robbins, M.D.

W. Bradley Pierce, M.D.

Scott B. Harter, M.D.

Emeritus James R. Bearden, M.D.

John W. Lane, M.D.

This letter is to lend my support to the above-mentioned petitions.

Petition 22 (access to affordable quality care: outpatient treatment using large doses of radioactive 1-131) will allow a great cost savings for the patient and to third party payers, including Medicare, allowing appropriate patients to be treated with confinement in home following therapeutic doses of 1-131. This has been established to be a safe procedure in the vast majority so treated, reference Abstract Number 322 from the Thirty-seventh Meeting of the Society of Nuclear Medicine, concerning 439 hospitalized thyroid cancer patients treated with single doses of 1-131 varying from 50 to 400 mCi.

Resolution 23, concerning the unnecessary restriction of nuclear regulatory regulations adversely affecting access to affordable quality care, recommends that the new, lower radiation dose limits to the public (line 11) are an unnecessary and extremely expensive change with no proven benefit. The additional expenditure, borne by patients and third party payers, including Medicare, of $75,000,000 annually (reference line 14), is an unnecessary expense in a time of spiraling health costs.

Therefore, I recommend that the two resolutions, 22 and 23, submitted by the American College of Nuclear Medicine, be adopted as presented to the Nuclear Regulatory Commission.

Sincerely yours, R~.,~~

Trustee, S.W. Chapter, Society of Nuclear Medicine Member, Arkansas Radioisotope Committee RCW:mh SEP 1 ij 1992 Acknowf edged by card................... ::,::::;..-

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316HOLTON AVENUE YAKIMA, WASHINGTON 98902 (609)61~ i";FAX: (609) 676-7671 July 1, 1992 Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington D.C. 20555 Attn: Docketing and Se/Vice Branch Re: 10 CFR part 35

Dear Secretary Chilk:

"92 Jll 16 P4 :14

,:n I

'f ulJC l,

VICI I am writing to support the amended petition for rule-making for 10 CFR part 35 that appeared in Federal Register vol. 57 #96, Monday, May 18, 1992.

I have been a specialist in Nuclear Medicine for 25 years, and have long appreciated that ambulatory patients could receive oral or intravenous radial pharmaceuticals in amounts greater than 30 mCi without risk to the general public or family members should they have been allowed to leave the hospital: Unfortunately, unduly restrictive regulations have not allowed their management as outpatients, which would have been far more cost-effective.

Now that appropriate research has documented the safety of outpatient management for ambulatory patients receiving radiopharmaceuticals (Allen Jr., H.C. 1 Zielinski, J.D., 430 Non-Hospitalized Thyroid Cancer Patients Treated With Single Doses 50 - 400 mCi, (1990 31; 784.)

It is appropriate to relax the unnecessar,1 restrictions that have impost:d in the pt:J.st JTD:lal SEP 18 199z Aclalowledgecl by card....... "....... ".. '"'""'

LARRY K. BECK, M.D.

llerna,ology JAMES T. DODGE, M.D.

Endocrinology RICK L. JOHNSON, M.D.

DANIEL R. PETERSON, M.D.

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Medical Oncology Medical Oncology THOMAS E. BOYD, M.D.

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Dennatology GAYLE F. BREWER, M.D.

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Nuclear Medicine Hematology Thyroid Disease Internal Medicine Asthma Diagnosis KARSTE C. LEWIS, M.D.

GARY L. TREECE, M.D., FACP lntemaJ Medicine Diabetes Diagnosis Endocrinology/Metabolism lntemal Medicine D. ROBERT WEBB, M.D.

Allergy - Immunology Asthma JUDY HAGARTY Business Manager

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University of Cincinnati Medical Center 0,.:,,<t l Nu,.B,

PETITION RULE PAM 3S-/ 0,ll (51 F-rl 2-J CJ L/,V University of Cincinnati Hospital 234 Goodman Street Cincinnati, Ohio 45267-0577 di~~~~ - Saenger Radioisotope Laboratory

,cUS~iRC Mail Location #577 1

TELEPHONE (513) 558-4282

'92 JUL 15 P5 :14 July 14, 1992 Secretary of the Commission US Nuclear Regulatory Commission Washington, D.C. 20555 attn: Docketing and Service Branch 9

Dear Secretary,

These comments are submitted in regard to the American College of Nuclear Medicine; Receipt of an Amended Petition for Rulemaking to 1 0CRF Part 35 as published in the Federal Register Vol. 57, No. 96 for Monday, May 18, 1992 page 21043.

The petition requests revIsIon of 1 0CFR Part 35 in regard to confinement of patients at activity greater than 30 mCi and to permit a greater allowance for patients undergoing therapy with doses of that order of magnitude and greater.

In order to present a clear picture of the effect of granting the petition for relief from unnecessary hospitalization following administration of very high amounts of 1-131, the possible consequences of these dose levels on the patients' families as well as on other members of society who might have contact with such a patient are presented.

What is the radiation risk to the families and the community from patients who receive 100-200 mCi doses of 1-131 for thyroid ablation?

This form of therapy is essentially given only to patients being treated for thyroid cancer.

Usually there are one or two treatments given at intervals of 3-12 months.

Rarely will a patient receive more than three treatments in a year.

E.L. Saenger, M.D.

SEP 1 s \\99?.

Acknowtedged by card..................................

Patient Care

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2 There are roughly about 12,000 new cases of thyroid cancer in the US yearly.

Not all thyroid cancer patients will necessarily receive 1-131; about 20-30% will be treated by surgery alone or by surgery plus external radiation or anti-cancer drugs.

For this analysis we assume that all of the patients follow the regime described above.

Of the possible adverse late effects of ionizing radiation, leukemia is the most likely ("Health Effects of Exposure to Low Levels of Ionizing Radiation: BEIR V", National Academy Press, Washington D.C., 1990). It has become possible to evaluate a large number of patients who have received 1-131 for the subsequent development of leukemia.

This study included 802 cancer patients [46,988 patients: 80% female, 20% male]

(Hall P et al: Leukaemia incidence after iodine-131 exposure. Lancet 1992;340:1-4)..

As shown in Table IV of the paper the relative risk of radiogenic leukemia for the patients in the two highest dose groups was less than 1. Mean bone marrow doses in this group of patients ranged from 26-2226 mGy (2.6-222.6 rad).

Total body doses were calculated to be about 48-142 rad (Loevinger R et al: MIRD Primer for Absorbed Dose Calculations. Society of Nuclear Medicine, New York, NY, 1988). Thus at these very high treatment doses there was no increase in leukemia as compared to matched individuals in the Swedish population as a whole after 2-37 years of follow-up.

This observation is important in setting bounds for late radiation effects that might be expected in society where patients with "large" body burdens of 1-131 are moving freely.

Since essentially no late adverse leukemia is seen in any of the 46,988 patients in the Swedish study after long term follow-up, it would seem quite unlikely to find such an effect in the persons near such patients at the most for two or three ti mes a year.

The above comments present an order of magnitude of risks for those persons receiving high doses of radiation. What can be expected then from the families of the patients undergoing this form of treatment?

To obtain information on this topic we reviewed the measurements made on 39 patients in the University of Cincinnati Medical Center who have E.L. Saenger, M.D.

3 undergone this type of therapy.

Each patient was measured at 1 meter distance from the mid-surface of the body at the time of administration and at intervals of about 24, 48 and 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> depending on the levels found. The distance of 1 meter was chosen as being equivalent to an arm's length of an adult.

For the purposes of this estimate a 4 hour4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> period is deemed sufficient if other aspects of the patient's circumstance permits the patient to be cared for in the home environment.

It is not reasonable to postulate unreal scenarios, as for example that a baby will spend the first 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> held at the bosom of a treated patient or that a patient will be in intimate physical contact with another person for any time period of more than at most a few hours except for nursing care and other activities of daily living.

In NRG approved nuclear medicine programs, patients receiving therapeutic 1-131 are properly instructed to avoid intimate contact with family members including infants and children as well as friends and acquaintances.

In addition adequate advice is provided for the safe disposition of radioactive body excreta.

Measurements of 39 patients showed an average single administered activity of 168.5 mCi.

The average whole body effective half time for 1-131 excretion was 13.4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />.

At the time of administration the average external dose rate measurement was 30 mR/hr at a distance of 1 meter.

At about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> the dose rate fell to 10 mR/hr and at 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> the average dose rate was about 5 mR/hr.

Based on association with such a representative patient for the 4 hour4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> period the exposures to other individuals at a distance of 1 meter will be approximately:

Day 1 Day 2 Day 3 E.L. Saenger, M.D.

120 mR 40 mR 20 mR 180 mR

4 If there are two treatment episodes in a year the exposure to persons near the patient would be about 360 mR.

This level is well within the annual limits for a non-radiation worker as set forth in 1 0CFR Part 20.

A current paper by Culver and Dworkin (J Nuc Med 1992;33:1402-1405) presents similar data based on patient measurements.

They recommend a level of 2 mR/hr as an acceptable criterion for resuming contact, although the precise meaning of contact is not specified.

Based on the measurements and restrictions described above, the current NRG guideline specifying hospitalization until the estimate of the administered activity reaches a level of less than 30 mCi seems unduly restrictive.

If one would use so formidable a criterion as that of a lifetime excess risk for cancer of 0.8%/Sv (BEIR V, p6), the risk to a person receiving a dose of about 500 mR per year for two years (a reasonable exposure for someone caring for a thyroid cancer patient with active disease) the total additional dose under these circumstances could only increase the lifetime cancer risk by 0.008% at the most.

If this excess cancer risk is compared to the lifetime probability of 30% of developing cancer exclusive of radiation exposure there would be an increase of 2.6 chances in 10,000. This risk should also be compared to the risk of leukemia in the Swedish patients cited above who undergo treatment for thyroid cancer at levels similar to our patients and in whom the risk of leukemia is not increased.

For the low dose rate radiation of 1-131, the value of 2.6 chances can be reduced by a factor of 2 (BEIR V) so that the best estimate of the total excess lifetime cancer risk is about 1 in 10,000.

The elimination of the existing rules in 1 0CFR Part 35 will permit greater freedom and comfort for patients who do not need hospitalization for other purposes.

There will be no increase in risks from radiation to persons in the region of the patient.

There will be a considerable financial saving from unnecessary hospitalization and other supervisory measures.. These funds which at present are in increasingly short supply E.L. Saenger, M.D.

can then be applied to other uses in the care of cancer patients. The net benefit of removing these restrictions will be valuable to both patients and to the public since all of these groups will benefit by the requested changes.

ELS/sck E.L. Saenger, M.D.

Eugene L. Saenger, M.D.

Professor Emeritus of Radiology Director Emeritus, E.L. Saenger Radioisotope Laboratory 5

020524 dp Fl Nuclear Medicine DOCKET NUMBER OA PETITION RULE PRM 3 5; /

CS'J Fr2 ~,o'f3)

I U,}-!lN~cLtJ John V. Calce, M.D.P.C.

1100 Grampian Boulevard Williamsport, PA 17701

'92 J.l 15 P4 :sa Phone (717) 326-8175 June 30, 1992 Samuel J. Chilk, Secretary Commision United States Nuclear Regulatory Comm1ss1on Washington, DC 20555 ATTENTION:

Docketing and Service Branch

Dear Mr. Chilk:

As a Board Certified Nuclear Medicine physician with an active practice in Nuclear Medicine, I support the proposed rule published in the Federal Register Volume 57 Number 96 on May 18, 1992 regarding the use of radiopharmaceutical therapy in amounts greater than 30 mCi.

The outpatient treatment of certain thyroid disorders and other malignancies can be treated with large doses of I 131 exceeding 30 mCi and should not be considered a violation of NRC regulations.

When large amounts greater than 30 mCi I 131 are administered to patients and they are confined to their home there is no hazard to the health and safety of the public or to occupational workers.

JVC/lo SEP 18 \\992.

Acknowledged by card..................................

U-~- NUCLEAR REGULATOR'i' CO MISS\\01'.

ooci<ETING & SF..RVICE SECTION Off ICE OF THE SECRETAfW OF iH~ COMMISSION oo~ument St:.tsucs

UOCKETNUMBEA PETITION RULE PRU

. :._;/ fJA DONALD F. DEvRrns. M.o. Cs 7 F 1Z 1-ioi./J)

Internal Medicine and Nuclear Medicine LUL'/'\\i f[ii USNf-;C ~

622 FOURTEENTH AVENUE, S.E.

PUYALLUP, WASHINGTON 98372 Telephone 841-2471

• 92 JUL 13 p 3 :52 July 8, 19S2 Samuel J. Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Attn: Docketing and Service 6ranch

Dear r'lr. Ch ilk,

This letter is in support for the American College of Nuclear Medicine proposal for changes to 10 CFR Part 35 and the proposed rule changes as registered in the Federal Register Volume 57, Number 96, Monday May 18, 1992.

In our practice in Nuclear Medicine in a small hospital in this community we have occasion to treat patients with radioiodine and occasionally, also, higher doses of technetium for imaging purposes, Many of these patients would be more than willing to remain confined to their room at home, some of whom even live alone in apartments, but due to the NRC regulations that require to be hospitalized at considerable expense.

It would simplify many of these patients lives if they could be allowed to remain confined to their house or apartment in addition to a considerable cost savings to both their insurers and to their own personal expenses.

I strongly support the request by the American College of Nuclear ~edicine to amend the 10 CFR Part 35 as noted above.

Thank you for your attention in regards to this petition.

Sincerely~

D~ DeVrie:::.

DE'D:lg JUL 16 1992 Acknowledged by card."--*-""'""'.,

11.S. NUCt EAi) fl:: ;ULA TOr.y C'J,' 1n/.;,S!or~

DOCKE::: T !J $Er*\\/1,~': SECTION CJP-.=:cE CF TH.: SECR'.::TARY OF THE COMMiSSiON

"'9 MANTECA l~j !J MEDICAL GROUP, INC.

DOCKET NUMBER

• 1 P:TITION RULE PRU

.;_;/ 0 A l51 Ffl -2.I DL/V COC:K[iEO USNRC Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555

Dear Mr. Chilk:

• 92 Jll 13 P 3 :59 July 6, 1992 I am writing to ask the NRC to reconsider the 30 mCi dose limit for outpatient procedures in nucl ear medicine.

Given the current knowledge and availability of isotopes the 30 mCi dose is artifically low.

I fully support the American College of Nuclear Physicians' position in this issue in asking for a larger dose to be approved on an outpatient basis.

In this era of cost containment and significant hospital charges, the NRC should reconsider its rules and regulations.

AKS/svz JUL 16 1992 Acknowledged by card.................................

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Proposed Rules Federal Register Vol. 57. No. oo 1'lo:u.!z1*. ).(;cy 18; 1992 21043 Petitioner's Request The petitioner,eGuc~ts the NRC :o re\\*ise 10 CFR part 35 to-(1) Delete the requirement in _lO CFR

---

35.75 (a) (2J that licensees rr.av no:

authorize release from confinem~nt for This section ol the FEDERAL REGISTER cor.:ains notices lo the pub!1c ol the proposed issuance ol rules and reguiations. The l)llrpose ol these nc;ices is to give interested persons an cpportunily 10 participate in the :ule making p<iOf to

• the ad(Y,ltion ol the fi~al rules.

NUCLEAR REGULA TORY C MMISSION (Docket No. PAM-3S-10AJ A

American College of N:.iclear Uediclne; W Receipt ot an Amended Petition i<K Rulemaklng AGENCY: Nuclear Regulatory Commission Office of Administration. U.S. Nuclear Regulatory Commission. Washington.

DC 20555. Telephone: 301-192-7758 or Toll Free: 800-368-5642.

The petition and copies of comments received may be inspected and copied for a fe.? at the NRC Public Document Room, 2120 L Street NW. (Lower Le\\*el).

Washinglon, DC.

FOR FURTHER INF,ORMATION CONTACT:

Michael T. Lesar. Chief. Rules Review Section. Rules and Directives RP.view Bran::h, Division of Freedom of lnfor,11ation and Publications Services.

Office of Administration. U.S. Nuclear Regulatory Commission, Washington, DC 20555, Teiephone: 301-49Z-7755 or Toll Free: 800-368-5642.

SUPPU:MEt.°TARY INFORMATION:

Background

On January 14, 1992, the Nuclear Regulatory Commission (NRC) docketed

SUMMARY

The Commission is publishing a petition for rulemaking submitted by for public comment a notice of receipt of the American College of Nuclear an amended petition for rulemakir.g Medicine (PR.\\{-35-10). The notice of ACTION: Amended petition for rulemaking: Notice of receipt.

which was filled with the Co:nm:ss:on receipt of this petition was published on by the American College of Nuclear

?-.farch 9, 19!l2 (57 FR 8282), and a Medicine. The amended petition was document correcting a typographical docketed by the Commission on April error in a reference to codified text from

21. 1992, and has been assigned Docket

§ 35.72(a)(2) to§ 35.75(a)(2) was No. PRM-3~10A. The petitioner. in both published on March 24, 1992 (57 FR the original petition and in this 10143). On April 21, 1992. the NRC a:nendment to that petition. requests docketed an am-?ndment to this petition.

that the Commission amend its The amended petition was also A

regulations regarding confinement, submitted by the American College of W' safety instructions, and precautions Nuclear_Medicine. The amended petjtion used for patients receiving was assigned docket number PRM l radiopharmaceutical therapy in amcunts lOA. ~-e amen~~d pelilion supplements greater than 30 millicurh:s. The the ongmal pelttion by requestmg that petitioner requests that the orjginal i the NRC consider the need to allow the petition be expanded to consider t.~e

'use of amounts greater than 30 n~~~ to _allow amounts greater than 30 milJicuries i_n_ diagnositic studies and m11hcunes to be used in diaimostic add 6 definition of the term

{ studies and to add a definition of conf:nement.

( confinement.

~

The petitioner requests amendments DATES: Submit comments by uly 17 to 10 CFR part 35 that would clarify the 1992. Comments received aft is date requirement for confinement for will be considered if it is practical to do ambulatory patients receiving oral or so but the Commission is able to assure intravenous radiophannaceuticals in consideration only for ccmrnents r ater than 30 millicuries and received on or before this dale.

allow patients the option to be treale on an outpatient basis if they qualify i

ADDRESSES: Submit written comments medically.

to the Secretary of the Commission. U.S.

The petitioner stales that the N'udear Regulaiory Commission.

requested amendment is in the best Washington, DC 20555, Attention:

interest of patients who require access Docketing and Service Branch.

lo affordable quality care and that For a copy of the petition. write: Rules scientific published data support the Re\\*iew Section. Rules and Directives changes requested by the petition as Review Branch, Division of Freedom of consistent with protection of the public Information and Publications Services, as stated in 10 CFR part 35.

medical care any patient administered a radiopharmaceutic3I cntil the activity in the patient is less than 30 millicuries; (2) Amer:d § 35.75 (a) (2) to allow for an outpalacr.l option mslea~ ol mandating confinement for patients receiving oral or intravenous radiophannaceuticals in amounts greater titan 30 rnillic~ries.

(J) Allow doses greater than 30 m1lhcunes lo be used m d1agnost~~

studies. in addition to radioisotope theraoy. The petitioner believes that these doses are desirable in that ma:iy of the new Technetium 99m labeled radiophannaceuticals available today

ar. Le performed without risk tc> the hea!ih and safety of the public or*

occupational workers.

(4) Define "confinement" to mean remammg m a hospital or a pnvaie

• residence.

Reasons for Petition Section 35.75 prohibits an NRC medical use licensee from releasing from confinement for medical care any patient administered a radiopharm:iceutical until certain criteria are met. One of the criteria* is that the activity in the patient is less than 30 millicuries. The petitioner believes that the regulation should be clarified to allow for temporary home confinement. The petitioner claims thal with the advent of monoclonal radiolabelled antibodies and other new radiophannaceuticals for diagnosis and treatment, outpatient diagnosis and therapy would provide efficient care and allow costs to be minimized without increased risk to the public. The petitioner also states thaJ published scientific papers attest to the safety of cl.!tpa!ient ra<liopharmaceutical theraov in doses of up to 400 millicuries of 1-tJi Nal.

Conclusion The petitioner slates that if this amended petiton is granted. it would bene{il patients.by giving them affordable quality care wh,ik ii.ll.Q~ing them to be diagnosed and treated on Rn ot:tpalient basis instead of being_

confined to a hospital. The petitioner claims that scientific studies support the finding that diagnosi~g and tr_eati~~

oalients on an outpahent basis wit radio harmaceuticals in doses realer than 30 mi icuries wou not create a

~afe:\\' hazard to the public.

Octted al Rockville. Muryt:,nd. this t~th da)*

o! :,.t,1,* 1992.

for 0

th~ Nuclear Regulatory Commis~ion.

Samuel J. Chilk.

s~ut~n* of the Commissio11 (FR Oo::.. 92-11589 filed ~15-92: 8:.is iun(

Scientific Papers neglected.

In the present \\o/Ork M:mte Carlo codes were used to investigate the effect of topology of the CB and FM interface on the backscatter dose to the RM.

Planar, cylindrical and si:herical ~tries were included. For the planar gec:rretry, a maxim:m dose increase of 9 :t 1 (S.E.)\\ was obtained in the region within 12 rrg/arf fran the interface due to a semi-infinite soorce of electrons with energy greater than 0.5 !-2V.

Averaged over the region of FM irroedding electron soorces between t1olO planar CB/FM interfaces 1000 microns apart, no dose enhanc:erent was predicted for electron energies fran 0.1 to 1. 75 "2V.

For the cylindrical interface with 500 micron radius of curvature, the maximJm dose increase averaged over the whole cylinder due to an intiedded source of monoenergetic electrons was 12 +/- 1 (S. E.) \\.

'lhis occurred at O. 75 !-2V.

For the spherical interface with 500 micron radius of curvature, the maxim.ml do:je increase in the region within 20 microns (2.1 rrg/arf) fran the interface due to an int:e::lded source of m:inoenergetic electrons was as high as 21 +/- 1 (S.E.)\\.

'!his occurred at about 0.5 1-2v.

The dose increase, averaged over the whole sphere, was 12 +/- 0.6 (S.E.)\\.

'lhi.s provides an estimate of the maxinun dose

~ihancenent: to t:he l<M due to electron backscatter.

No. 320

'lltREE--DlMFR,IOW.. ImE <XMIUrATICN FCR HEPATIC MICRlS~ 'lliERAPI{.

P,L-Roberson. R.K. Ten Haken. D-L-Mc:Shan, P.E. Mc:Keever, K.H. Pillai, W.O. Ensmirqer.

University of Michigan Medical Center, Ann Arbor, HI.

'lhree-dimensional dose distributions have been developed for liver for the VX2 rabbit model treated with hepatic arterial administration of Y-90 glass microspheres (Y90 MS).

Colored, plastic, nonradioactive

~

were administered by hepatic arterial injection in order to mimic the treatment deposition of Y90 MS.

Sa!Tple blocks of treated liver were serially sectioned (200 urn thickness), fixed an::! inotOJraphed showirq the position of the micro5Fheres.

The slide i:;ootographs were projected on a vertically mounted digitizer to enter the sphere positions into the University of Michigan '.l-D treatlnent planninJ system.

A ?Jblished point dose kernel for Y-90 (*) was used to perform dose calculations for each sµ1ere.

Doses were si..um,ed to produce '.l-D dose distrilirt:ion.s. Because the di.Jrensions of the sairpled sections were less then the range of the Y-90 beta particles, the dose to the sairpled volume due to the surroondinJ tissue was estimated by placirq sphere distributions representative of the sairple in the surrcundirq tissue.

Dose volU!!e histograms were derived fran the dose distribution.

'Ille mininum calculated dose to a representati,re volU!Te is approximately one-half of the MIRO calculated (or average) dose.

Significantly higt.er dc.ses ;;ere calc..1.lated tor small vo::.u.,ies due to clusterinJ of the microspheres.

Dose distributions and dose-volume histograms will be shown am cnipared to the MIRD--type dose calculations.

• Prestwich, WV, Nunes, J, K'wok, CS J Nucl Med 30:10'.36, 1989 ard J Nuc:l Med :io:17'.39, 1989.

No. 321 QUANTIT A TION IN RADIO IODINE TIIERAPY OF MET AST A TIC TIIYROID CANCER: COMP A RISON OF PROJECTED AND ACl1JAL TIJMOR ABSORBED DOSES. PB Zanzonico, JR Hurley, and DV Becker, New York Hospital-Cornell Medical Center, New Yort. NY.

In order to more rationally plan and monitor radioiodine (1131-iodidc) therapy or metastatic differentiated thyroid cancer, we now perform serial measurements or tumor activity (as well as blood activity concentration and total body activity) following both tr.leer

(-S mCi) and therapy(> 100 rnCi) administrations and calculate the resulting tumor (as well as blood and total body) absorbed doses.

Tumor activity is measured (+/-20%) using planar ("conjugate view")

and SPECT imaging methods and tumor mass is calculated using the tumor dimensions on planar gamma camera images. Cumulated DCtivity is calculated by numerical integration and absorbed dose is calculated as the sum or the mean beta-ray absorbed dose (assuming 784 Thursday Proceedings of the 37th Annual Meeti~g complete local absorption) and the mean total body photon absorbed dose ("g factor" method). For 8 metastases in 4 patients receiving 120 to 359 mCi 1131-iodidc (corresponding to a maximum "safe" absorbed dose or200 rad to blood), the projected (from tracer) and the actual therapy individual tumor absorbed doses ranged from 2,400 to 85,000 rad and from 1,900 to 29,000 rad, respectively. In 7 of 8 tumors, the actual tumor absorbed dose was 38 10 73%

(average: 53%) less than the projected tumor absorbed dose; in 1 site (in the neck and therefore possibly residual thyroid), it was 45%

greater. Although the absolute absorbed doses arc somewhat uncenain, due primarily to inaccuracies in tumor mass estimates, the projected and actual tumor absorbed doses should be similar.

However, since acute radiation damage and resulting accelerated radioiodine turnover in tumor often follow large therapy administrations, an_oventimation (ba.~ on the tracer) of the actual tumor absorbed dose is not unexpected, but should be systematically considered in rational radioiodine therapy of thyroid cancer.

No. 322 430 NOH-HOSPITALIZED THYROID CANCER PATIENTS TREATED WITII SINGLE DOSES 50-400 mCi, H,C. Allen 1 Jr., J.D.

Zielinski. Nuclear Medicine Labs of Texas; Texas Medical Center; Houston, Tx.

A preliminary report on a prospective study beginning 35 years ago during vhieh more than 600 thyroid cancer patients have been evaluated for: (1) Rads delivered to the thyroid gland and (2) determining the advisability of private office treatment followed by confinement in their home without exposing the family and general public to haniful radiation levels.

For 30 years, vith official approval of the Texas State Department of Health (TRCA), 430 ambulatory pa-tients vere confined in their homes until the total body burden declined to < 30 mCi.

46 treated patients were studied with specific empha-sis on determining the potential radiation hazard to household members and general public.

Leak/vipes of pertinent household areas were assayed for radiation con-tamination. The entire house was surveyed during confine-ment and prior to release.

No violation of regulations was found.

Radiation exposure to family members met NRC/TRCA regs.

Thyroid burden studies of family mem-bers attending ablated patients was determined.

Data indicated:

(1) there was no health hazard to family members or general public when ambulatory non-hospitalized patients were treated v1th > 30 mCi and confined to their home; (2) outpatient treatment with home confinement has proven cost effective; ('.l) pre-vailing regulations are unnecessarily too restrictive and over-regulatory as currently being applied; and (4) this method of treatment should be recognized by the reg-ulatory authority as a legitimate, safe and sound form of therapy for the patient's benefit.

Cardiovascular Basic Ill: Myocardial Perfusion and Metabolism 10:30-12:00 Session 55 Moderator: George A. Beller. MD Comoderator: Randolph E. Patterson, MD No.323 Room 31 QUANTITATIVE ISONITkILE IHAGING FOR RISK AREA DETER-HINATION FOLLOVING TRANSTF.NT CORONARY UCCLUSIQN.

J.D. Bergin, A.J. Slnusas, V.H. Smith, N.C. Edwards, b.D. Uatson, H. Ruiz, and C.A. Beller.

University of Virginia, Charlottesville, VA.

Ve have previously shown that Tc-99m labeled 11ethoxy-isobutyl isonitrile (HIBi) delineates anatomic risk area (RA) In a model of myocardial Infarction.

However, re-distribution (RD) of HIBi has been noted by so11e follow-Ing transient coronary occlusion (OCC).

To evalu~te the The Journal of Nuclear Medicine

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Resolution: 22 (A-91) 1 2

3 4

5 6

7 8

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Introduced by:

Amer ion.College of N uclcar Medicine

Subject:

Access to Affordable Quality Care: Outpatient Treatment Using Large Doses Radioactive 1-131 Referred to:

Reference Committee E (John E. Albers, M. D., Chairman)

Whereas, Radioactive inorgaflic sodium lodide-131 has been used for the treatment of certain thyroid disorders since 1946; and Whereas, Other radioactive biologicals (i.e., monoclonal antibodies} have been labelled with radioactive lodine-131 and used in the treatment of otht:r malignant db.orders; c1.nd Whereas, Adequate radiation cancer therapy involves administering large doses greater than 30 millicuries (mCi} per patient (100-200 mCi); and Whereas, There is no scientific evidence that external radiation exposure to the public in this application will exceed the limitations published in 10 CFR 20.105 when treated on an outpatient basis; and Whereas, To the contrary, scientific research and professional published data has shown that external

• radiation exposure to the public in this application is considerably below the acceptable levels as published in the U. S. Nuclear Regulatory Commission Regulations Title 10, Code of Federal Regulation, Section 20 (10 CFR 20); and Whereas, The health and safety of the public is not compromised by outpatient treatment with large doses greater than 30 mCi 1-131 followed by patient confinement in his/her home; and

~hereas, There is a large body of experienced and licensed nuclear physicians and scientists qualified to ensure protection of the health and safety of t!ie public that did not exist in 1946 when current regulations were promulgated more than 30 years ago (1957); therefore be it RESOLVED, That the American Medical Association petition the Nuclear Regulatory Com-mission (NCR) to:

1. Recognize that the outpatient treatment of certain thyroid disorders and other malignancies can be treated with large doses of 1-131 exceeding 30 mCi is an acceptable legitimate policy not in violation of NRC regulations;

2. Recognize that no regulation requires hospitalization when large amounts greater than 30 mCi 1-131 are to be administered to a patient provided there is no hazard to the health and safety of the public or occupational worker; and

3. Recognize that there is no legal limit of an amount of 1-131 or other radiopharma-ceuticals that can be administered to a patient by a licensed nuclear medical physician and the treatment of patients on an outpatient basis (not hospitalized) is not in violation of NRC regulations.

Fiscal Note: No significant fiscal impact

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Introduced by:

American College of Nuclear Medicine

Subject:

Unnecessary Restrictive Nuclear Regulatory Regulations Adversely Affecting Access to Affordable Quality Care Referred to:

Reference Committee E (John,, E. Albers, M. 0., Chairman)

Resolution: 23 (A-91) 1 Whereas, Radiopharmaceuticals have been used in diagnosis and* therapy of patients 2

since 1946; and 3

4 5

6 7

8 9

Whereas, The Atomic Energy Commission (AEC) and Nuclear Regulatory Commission (NRC) have protected the public from unnecessary radiation over this period oftime; and Whereas, A recent revision of NRC regulations is beginning to affect the quality of care of the patient because of over restrictive review protecting the public; and Whereas, The recent regulations promulgated are lowering the radiation dose to the public from 500 mR (5 mSv) to 100 mR (1 mSv) per y"ear is such an example; and 10 11 12 13 Whereas, This unnecessary restrictive regulatory philosophy will materially increase the 14 cost of quality care to the patient of the order of$ 75,000,000 annually (for Nal-131 ); and 15 16 17 18 19 20 21 22 Whereas, There is no clear human evidence of radiation induced genetic damage at low dose levels and low dose rates of radiation of 500 mR (5 mSv) per year; therefore be it RESOLVED, That the American Medical Association oppose the Nuclear Regulatory Commission's (NRC) implementation of 10 CFR 20.301 (a) Cl) by petitioning the NCR for regulatory relief ohhe new 10 CFR 20.301 in order to restore the previous external radiation limit of the public to 500 mR (5 mSv) per year.

Fiscal Note: No significant fiscal impact

lOCi<ET i*~U:VBER

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• PETiTiON RULE PRM J S - ) 0 A (5 1 rR 210LJV Loma Linda University July 6, 1992 Samuel J. Chilk Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D. C.

20555 Attention:

Docketing and Service Branch

Dear Mr. Sir:

Department of Radiation Sciences Diagnostic Radiology Therapeutic Radiology Nuclear Radiology Ultrasound Cardiovascular Radiology Radiation Physics Radiation Biology Radiation Engineering School of Medicine Loma Linda, California 92350 714 / 824-43 77 I am writing in support of the petition by American College of Nuclear Medicine (Docket No. PRM-35-l0A) to allow use of radiopharmaceuticals in dose activities greater than 30 millicurie on outpatient basis for both diagnostic and therapy.

This would allow confinement of patients in their home instead of in special hospital rooms.

This step would significantly contribute to cost-containment of medical expenses in a nation-wide manner.

Hoping the Nuclear Regulatory Commission will be receptive to this petition, I remain.

J. G.

Professor Sciences JUL 16 1992 Acknowledged by card............................. "\\"

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• USNRC The Children's Hospital of Philadelphia92 JUL 13 All :l 7 34th Street and Civic Center Boulevard Philadelphia, Pennsylvania 19104 PHONE (215) 590-2594 FAX (215) 590-4318 The Secretary of the Commission U.S_ Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch

Dear Sir:

• JF~ !C~. uF St Cf t TAn Y GOCKri!NG.,. SFflVfCf

JHJ\\NCH July 8, 1992 DEPARTMENT OF RADIOLOGY Kenneth E. Fellows, M.D.

Radiologist-In-Chief Richard D. Bellah, M.D.

Larissa T. Bilaniuk, M.D.

M. Patricia Harty, M.D.

Sydney Heyman, M.D.

Anne M. Hubbard, M.D.

Sandra S. Kramer, M.D.

Soroosh Mahboubi, M.D.

Richard I. Markowitz, M.D.

James S. Meyer, M.D.

Robert A. Zimmerman, M.D.

David J. Thomas, Administrator I am wntmg to comment on Docket No. PRM-35-lOA, regarding the receipt of radiopharmaceuticals as outpatients in amounts greater than 30 mCi. This is highly desirable for both diagnostic studies, such as when Technetium 99m is used to label monoclonal antibodies or other substrates, and for therapy. With regard to therapy, 1-131 is primarily considered_ This will make this form of therapy considerably more economical and thus increase its availability. As has been pointed out in the petition the radiation hazard to the public, and to the individuals attending the patient, is not compromised by outpatient treatment. I feel that this option should be available to patients who qualify; this will depend both on the medical circumstances and the ability to keep the patient isolated at home until the radiation burden falls below 30 mCi.

SH:jlb Radiologist-in-Chief (215) 590-2564 Yours fncerely_*r /,

t111l~~~(

Sydney 4eyma:n, M 1

.D_

JUL 16 1992 Acknowledged by card.. -.. -......,........ _

Radiology Slaff (215) 590-2575 Radiology Administrator (215) 590-2562

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EL CAMINO HOSPITAL DISTRICT 2500 GRANT RoAD, P.O. Box 7025 MOUNTAIN VIEW, CA 94039-7025 415-940-7000 A PUBLIC ENTITY July 3, 1992 Secretary of the Commission

• iJOCKET r UMBER fEilTION RULE PAM

-/ tJA (51 Ffl 2./()~J)

U.S. Nuclear Regulatory Commission Washington D.C.

20555 AITN:

Docketing and Service Brance Commission Members:

RE:

IOCFR Part 35 I support changing regulations to permit outpatients to recieve diagnostic or theraputic radio-isotopes in doses greater than 30 millicuries.

(See attached resolution from American College of Nuclear Medicine).

In my over twenty years in nuclear medicine, the confinement of the patients receiving doses greater than 30 millicuries at times is a hardship and appears unwarranted by current standards.

Sincerely, M. P rbaugh, M.D.

Radiation Safety Officer El Camino Hospital Mt. View, CA 94040 JU\\. 16 ~~

Acknowledged by card-""'...,

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• ,.A 1 ORY COMMISSIOt

' *. ' ~ SERVICE Sl::CTION

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1 2

3 4

5 6

7 8

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Introduced by:

American College of Nuclear Medicine

Subject:

Access to Affordable Quality Care: Outpatient Treatment Using Large Doses Radioactive 1-131 Referred to:

Reference Committee E (John E. Albers, M. D., Chairman)

Resolution: 22 (A-91)

Whereas, Radioactive inorganic sodium lodide-13 l has been used for the treatment of certain thyroid disorders since 1946; and Whereas, Other radioactive biologicals (i.e., monoclonal antibodies) have been labelled with radioactive lodine-131 and used in the treatment of other malignant disorders; and Whereas, Adequate radiation cancer therapy involves administering large doses greater than 30 millicuries (mCi) per patient (100-200 mCi); and Whereas, There is no scientific evidence that external radiation exposure to the public in this application will exceed the limitations published in 10 CFR 20.105 when treated on an outpatient basis; and Whereas, To the contrary, scientific researcb and professional published data has shown that external

• radiation exposure to the public in this application is considerably below the acceptable levels as published in the U. S. Nuclear Regulatory Commission Regulations Title 10, Code of Federal Regulation, Section 20 (10 CFR 20); and Whereas, The health and safety of the public is not compromised by outpatient treatment with large doses greater than 30 mCi 1-131 followed by patient confinement in his/her home; and

\\Yhercas, There is a large body of experienced and licensed nuclear physicians and scientists qualified to ensure protection of the health and safety of ttie public that did not exist in 1946 when current regulations were promulgated more than 30 years ago (1957); therefore be it RESOLVED, That the American Medical Association petition the Nuclear Regulatory Com-mission (NCR) to:

1. Recognize that the outpatient treatment of certain thyroid disorders and other malignancies can be treated with large doses of 1-131 exceeding 30 mCi is an acceptable legitimate policy not in violation of NRC regulations;

2. Recognize that no regulation requires hospitalization when large amounts greater than 30 mCi 1-131 arc to be administered to ;i patient provided there is no hazard to the health and safety of the public or occupational worker; and

3. Recognize that there is no legal limit of an amount of 1-131 or other radiopharma-ceuticals that can be administered to a patient by a licensed nuclear medical physician and the treatment of patients on an outpatient basis (not hospitalized) is not in violation of NRC regulations.

Fiscal Note: No significant fiscal impact

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Introduced by:

American College of Nuclear Medicine

Subject:

Unnecessary Restrictive Nuclear Regulatory Regulations Adversely Affecting Access to Affordable Quality Care Referred to:

Reference Committee E (John E. Albers, M. D., Chairman)

Resolution: 23 (A-91) 1 Whereas, Radiopharmaceuticals have been used in diagnosis and* therapy of patients 2

since 1946; and 3

4 Whereas, The Atomic Energy Commission (AEC) and Nuclear Regulatory Commission 5

(NRC) have protected the public from unnecessary radiation over this period oftime; and 6

7 Whereas, A recent revision of NRC regulations is beginning to affect the quality of care 8

of the patient because of over restrictive reviev.:, protecting the public; and 9

10 Whereas, The recent regulations promulgated are lowering the radiation dose to the 11 public from 500 mR (5 mSv) to 100 mR (1 mSv) per year is such an example; and 12 13 Whereas, This unnecessary restrictive regulatory philosophy will materially increJse the 14 cost of quality care to the patient of the order of $75,000,000 annually (for Nal-131); and 15 16 Whereas, There is no clear human evidence of radiation induced genetic damage at low 17 dose levels and low dose rates of radiation of 500 mR (5 mSv) per year; therefore be it 18 19 RESOLVED, That the American Medical Association opposP. the Nuclear Regulatory 20 Commission's (NRC) implementation of 10 CFR 20.301 (a) (1) by petitioning the NCR for 21 regulatory relief of the new 10 CFR 20.301 in order to restore the previous external radiation 22 limit of the public to 500 mR (5 mSv) per year.

Fiscal Note: No significant fiscal impact

t'l'i- *'"l ET NUMBER ST. LUKE'S\\ROOSEVELT ( s-; ~!t ~~~ ~;" )t[JA Hospital Center ul t\\i..ii.. J Amsterdam Avenue at 114th Street, New York, NY 10025 U::iNHC

• 92 JUL 13 A11 :36 Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATT: Docketing and service branch RE: Regulations for hospitalization of therapy patients

Dear Sir,

In keeping with the quest for lower health care costs, I wish to bring to your attention the abstract presented at the Society of Nuclear Medicine Meeting in June 1990, regarding the safety of outpatient 131 I cancer therapy treatment.

Because some physicians are unwilling to have their patients incur the cost of hospitalization, particularly for post-surgical thyroid ablation, they often attempt low dose (below 30 mci 131 I) therapy.

Almost all of these patients require multiple treatments, thus delaying definitive therapy as well as adding to the overal cost of the treatment.

Home confinement is apparently a safe alternative to hospitalization.

Newer isotopically labeled antibody therapy for many other cancers are on the Horizon, soon to become a clinical reality.

We need a more pragmatic, less costly approach to radiotherapy of cancer patients.

AM/dh Anita Moallem, M.D.

Site Director, st. Luke's site st. Luke's-Roosevelt Hospital Center Amsterdam Avenue at 114th Street New York, N.Y. 10025 JUL 16 l99l A University Hospital of Acknowledged by card"'""'.. -""".. "'""--;.

Columbia University College of Physicians & Surgeons

U.S. NUCLEAR R':GUiJ-:ORY C'":Mf,1iSSIO:-.

OOC!<'P:t..:i r, '.: 1.:ri'.'iCE S('C:i":vN OV i,.(* tJ,.: : *,: :-LC'P.f:-:-/,;-\\ {

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'jQCKET NUMBER Veterans Administration PETITION RULE PRM ~ -/ tJA

{_ 5" 7 (- Yl ).JO'fJ)

July 7, 1992 Samual J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington D.C. 20555 ATTN: Docketing and Service Branch

• 92 Iron Mountain Ml 49801 i Jll'li:. i LO USNRC JUL 10 P3 :S3 As a nuclear medicine physician and radiobiologist over the last forty years, I have become aware of the dangers of both short and long term effects of radiation injury having engaged in extensive animal experiments in the field and having served on the Internal Emitter Subcommittee of the Nuclear Regulatory Commission. The recently proposed regulation (10CF Part 35) limiting the dose of the administered radionucleotides on patients on an outpatient basis to less than 30 me appears to be unnecessary and an expensive mistake to our population. This of course is a well meaning regulation following the precept that if alot of radiation is harmful then a little bit is also harmful.

The problem is that the irradiation affects on other people in the environment of a patient containing say 35 me of technetium 99M would be negligable.

In fact, even with an isotope such as iodine 131, the irradiation dose received by a person in contact with a patient containing this amount of radiation within their body would have to be extremely close such as in the same bed for many hours before an appreciable radiation dose could be delivered to the second party. The key to limiting secondary dosage in Il31 therapy is the short biologic half time. It makes sense to prevent this sort of second party radiation dosage in the case of growing children or a pregnant women in the family.

Certainly in any case short lived radioisotopes such as technetium 99M with relatively low gamma ray energies would pose no problem in the range of 30-40 me.

In the present day environment of concern about medical costs,an attempt is being made to transfer all medical procedures to an outpatient basis even to the point of one day major surgery. It occurs to me that the restriction of the use of therapeutic doses of radionuclides to less than 30 me on an outpatient basis is not warranted.

Not only is this restriction not warranted on the basis of potential irradiation hazard but is also not warranted on the basis of medical economic cost considerations. In this country at this time it appears much more important that we make medical services more affortable and available to a larger number of people than concerning ourselves with further lowering the already vanishing small and preventable risk to a small JUL 16 1994 Acknowledged by card "*N""_".......... -~

"America is #I-Thanks to our Veterans"

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segment of the population. The possible damage to infants and pregnant women could be eliminated by careful physician and patient explaination of the hazards. If secondary radiation could not be avoided to children and pregnant women, then treatment would have to occur on an inpatient basis. Certainly by increasing the cost for such treatment to all people who would receive it on an outpatient basis is superimposing the cost of hospitalization on top of the cost of the therapy. This would in effect make the cost of therapy too expensive to be performed on many people, therefore depriving them of medical services.

The question is, is this bad (the millions of dollars of increased cost and depriving thousands of patients therapy of any kind) compensated by the good to be achieved by sparing an unknown miniscule population of infants and fetuses from receiving at worst low and probably inoccuous secondary irradiation dose. I think not. It would appear that we are so terrified by irradiation scare which was certainly warranted in the past from exposure to irradition from large sourses,therapeutic x-ray and reactor accidents that we are now over reacting.

We just have to face it, there are many risks in life and we can't be protected from them all.

Millions of people die in automobile accidents for every irradiation exposure problem, yet we don't outlaw automobiles, motorcycles, horse back riding or football.

We still use penicillin to treat pneumonia inspite of the real danger of antiphylactic shock. Eliminating outpatient internal emitter nuclear medicine therapy and high dose kinetic studies is going to have a very negative impact and at best is treating an emotional fear buggy bear that probably doesn't exist.

Thank you for your consideration and I hope withdrawal of this proposed rule.

Sincerely,

~~Jdc?~

,James s. Arnold, M.D.

{/'

DOCKET NUMBER PETITION RULE PAM ~

It)

{__~ 7 f- /2 :LI o~/ 3) r.L i i__ L;

, Ni<C Health Care Division July 3, 1993 Samuel J. Chilket Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Attn:

Docketing and Service Branch:

Dear Mr. Chilket:

'92 JUL 10 P 3 :53 FF!CE TAHY 00 Kt v'IC f.

As a nuclear medicine physician, I understand that there is a petition pending before the Nuclear Regulatory Commission which would permit nuclear medicine physicians to give greater than 3 mCi of I-131 on an out-patient basis.

I have long held that this is important for patient care.

There are many patients with thyroid cancer that safely can be managed with up to 75 mCi of I-131 on an out-patient basis.

Having to hospitalize them for greater than 30mCi of I-131 is extraordinarily costly.

I urge you to consider allowing this petition to go through.

It is extremely important for the welfare and care of patients with thyroid cancer.

If we can manage patients on an ambulatory basis with greater than 30 mCi of I-131, we will have achieved a giant step.

Sincerely, liv~<Ul40 Lawrence V. Basso, M.D.

Division of Endocrinology Nuclear Medicine Palo Alto Medical Foundation Palo Alto i\\ledical Clinic

.:100 Homer Ave.

JUL k~~tff&

Acknowledged by cardH.-llfuRDl(§fj,rij1"'}enwt1

Board of Governors David Druker, M.D.

Chairman Kevin R. Wheaton, M.D.

Vice Chairman Robert L.M. Hetland, M.D.

Secretary Calvin D. Brenneman, M.D.

Joel P. Friedman, M.D.

Morton R. Maser, M.D.

William E. Straw, M.D.

R. Hewlett Lee, M.D.

E><ecutive Director Emeritus Allergy William D. McKee, M.D.

Margaret Delano, M.D.

Anesthesiology Lynn W. Winchester, M.D.

John C. Damron, M.D.

Kevin R. Wheaton, M.D.

Christopher W Dueker, M.D.

John H. Redpath, M.D.

John R. Cooper, M.D.

Janet Wyner, M.D.

Steven C. Merlone, M.D.

John Urbanowicz, M.D.

Dermatology David Druker, M.D.

David G. Deneau, M.D.

Christine Miller, M.D.

Renata Henzl Mullen, M.D.

Family Practice Myron Gananian, M.D.

William E. Straw, M.D.

James Stringer, M.D.

William E. Page, M.D.

Susan D. Smith, M.D.

Mary P Hufty, M.D.

Arthur CK. Liu, M.D.

Eileen Byrne, M.D.

Ann Younker, M.D.

Thomas Wisler, M.D.

Cynthia Cornelius, M.D.

Internal Medicine Cardiology Palo Alto Medical Clinic Health Care Division Palo Alto Medical Foundation Neurology George Perlstein, M D Joseph R. Lacy, M.D.

Barbara D. Barnes, M.D.

Nuclear Medicine John F. Scholer, M.D.

Lawrence V. Basso, M.D.

Obstetrics-Gynecology James E. Stickler, M.D.

Shirley Tom, M.D.

Bryan D. Thom, M.D.

Peter A. Nelson, M.D.

Occupational and Environmental Medicine Albert F. Mazzie, M.D.

Gary R. Fujimoto, M.D.

Ophthalmology and Optometry Norman Ballin, M.D.

Robert L.M. Hetland, M.D.

Susan H. Ryu, M.D.

Alan Z. Booth, M.D.

James C. Ahn, M.D.

Michael Gaynon, M.D.

Philip G. Sloan, 0.0.

Dessie Athens, 0.0.

Marc Swanson, 0.0.

Otolaryngology/Head & Neck Surgery Louis Pang, M.D.

Michael R. Mccaffrey, M.D.

Pathology John T. Differding, M.D.

Pediatrics Margaret S Kosek, M.D.

Harry E. Hartzell, Jr., M.D Frederick A. Lloyd, M.D.

Jane A. Morton, M.D.

Bettina C McAdoo, M.D.

Ross E. DeHovitz, M.D.

Matthew A Eisenberg, M.D.

Harry L.E. Dennis, M.D.

Pediatncs and Pediatric Cardiology Richard A. Greene, M.D.

Podiatry Elston D. Rothermel, D.P.M.

Arthur F. Widtfeldt, D.P.M.

Robert Dibble, D.P.M.

Gary A. Fry, M.D.

Psychiatry and Clinical Psychology Joel P Friedman, M.D.

Nan A. Link, M.D Marc D. Gradman, M.D.

Jonathan Segal, M.D.

Aria DiBiase, M.D.

Gale Hylton, M.D.

Endocrine and Metabolic Diseases Karen L. Nelson, Ph.D.

John F. Scholer, M.D.

Psychiatry and Pediatric Psychiatry Lawrence Basso, M.D.

Bruce Bienenstock, M.D.

Randolph B. Linde, M.D.

Radiology-Diagnostic Carol Clewans, M.D.

G. Melvin Stevens, M.D.

Gastroenterology George P. Janetos, M.D.

Richard R. Babb, M.D.

Solon I. Finkelstein, M.D.

Brian Paaso, M.D.

Roger J.,Jackman, M.D.

Paul Craig, M.D.

Jos!i:p_ll_F. Walter, M.D.

General 1}:Ji,nb;~J.iedicl'ne** **;:_l!~ ilTJ~'( C0rJ~olrlt1A-Kramer, M.D.

Walter M. BorttjJ_, M.D...

. "1~rWICE SECTl"l'lhael J. Shepard, M.D.

Calvin D. Brennemag, M,D_. ;: T*iE SECRETAR'fladlology-Therapeutic Wayne J. Pietz, M'. D.,,..,*;_*,:.,*~- c'oMMISSION t.ordon R. Ray, M.D.

Deirdre A. Stegman, M:0. 1,,t.:

t Gregory O Colburn, M.D.

James Audet, M.D.

Robert M. Meier, M.D.

Katherine M. Williams, M.iR:ument Statistics James D. Maxwell, M.D.

Patti A. Yanklow1tz, M. cY.

Surgery Margaret L. Forsyth, M.D.

/

}b Cardiac and Vascular Surgery Suzanne fillo~

ail!<- fl'\\~

7 7 _

7 2-David B James, M.D.

Karen Bu(ter'tlela: 'M'.tl'.'v Hemato1dg9piafJ ~

General Surgery.

~~lfi~: ~.~~i~~*mproduced J

~~~::tt,~~r;zoni, Jr, M.D.

James B. liHf:ll~~ ~tribution 1rr-J/IG f'Dfthn B. Runnels, M.D.

Paula D. ~l;'ti

,'1Jr.D.

rt..:f.t.. ~ '6::tll Cliang, M.D.

Infectious Dis MVwwaola~t QQ~c/Colon/Rectal and General Jack S. Remington, M.D.

Surgery Pulmonary Diseases Micl,ael L Trollope, M.D.

Norman W. Rizk, M.D.

Qrthopedir: Surgery David J. Carlson, M.D.

George D. Griffin, M.D.

Rheumatology C. David Petersen, M.D.

Ronald L. Kaye, M.D.

Oakley Hewitt, M.D.

Melvin C. Britton, M.D.

William J. F. Maloney, Ill, M.D.

Arthur M. Bobrove, M.D.

Medical Instrumentation 11/91 Noel P Thompson, M.D.

Orthopedic Surgery and Athletic Medicine Frederick L. Behling, M.D.

Kenneth G. Campbell, M.D.

Donald R. Bunce, M.D.

William E. Nichols, M.D.

Sally Harris, M.D.

Warren King, M.D.

Arthur Ting, M.D.

Plastic and Reconstructive Surgery Morton R. Maser, M.D.

David N. White, M.D.

Leo A. Keoshian, M.D.

Thoracic and General Surgery Walter B. Cannon, M.D.

Urologic Surgery Eric Strauss, M.D.

James B. Bassett, Jr., M.D.

Fremont Center Internal Medicine David E. Hooper, M.D.

Albert Wang, M.D.

Richard Lee, M.D.

Anita Bhandia, M.D.

Family Practice Sue K. Milhalko, M.D.

Paul F. DeChant, M.D.

Thuan P. Duong, M.D.

Donald F. Lofland, M.D.

Pamela Levine Brown, M.D.

R. Scott Kehl, M.D.

Kelly Miller, M.D.

Obstetrics-Gynecology Michael J. Slesinski, M.D.

Jan T. Rydfors, M.D.

Pediatrics Falin Scobel, M.D.

Barbara Kennedy, M.D.

Psychiatry Debra Bunger, M.D.

Urgent Care Center Richard Deslauriers, M.D.

Director Felice R. Sussman, M.D.

Medical Staff David Druker, M.D.

Executive Director George Perlstein, M.D.

Medical Director Health Plans Sydney P. Hecker, M.D., M.S. (Med)

Medical Director Health Care Division Administration Robert L. Boyle, Jr.

Administrator William C. Brown Assistant Administrator/Controller Lily L. Hurlimann Assistant Administrator Health Plan Administration/Satellites Wanda Kownacki Assistant Administrator Medical Services/Marketing Charles D. Wirth Assistant Administrator Lab/Technical Services J. Bert Rose Assistant Administrator Support Services/Facilities Donna Mollenhauer Assistant Controller Palo Alto Medical Foundation Robert W. Jamplis, M.D.

President and Chief Executive Officer Nancy W. Collins Assistant to the President David Druker, M.D.

Vice President, Health Care Division Allen D. Cooper, M.D.

Vice President for Research William C. Brown Chief Financial Officer Darrel Dummett Personnel Director Jay Thorwaldson Director of Community Relations The Health Care Division of the Palo Alto Medical Foundation is staffed by the physicians of the Palo Alto Medical Clinic.

D r 11 -l UMBER KENNEDY PE I ITI N RULE PR::..:.=M~

~ / tJ A (s 1 P fl.. :LI o'-13)

Kennedy Memorial Hospitals University Medical Center PROFESSIONAL RADIOLOGY ASSOCIATES, P.A.

DEPARTMENT OF RADIOLOGY & MEDICAL IMAGING MILTON METZMAN, D.O.

PAUL J. CHASE, D.O.

MARVIN A. KUPERSMIT, D.O.

STEVEN ALLEN, D.O.

KALPANA DESHMUKH, M.D.

July 8, 1992 Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555

• 92 Jll 10 P J :53 CHERRY HILL

• STRATFORD

• WASHINGTON TOWNSHIP uFFICt OF St CKt f At, v

-oct<rTtNG. 5fttVIU ANl,;~

STRATFORD DIVISION 18 E. Laurel Road Stratford, NJ 08084 609-435-2415 ATTN:

Docketing and Service Branch RE:

Resolution:22 Access to Affordable Quality Care:

Outpatient Treatment Using Large Doses Radioactive I - 131 Resolution 23 Unnecessary Restrictive Nuclear Regulatory Regulations Adversely Affecting Access to Affordable Quality Care

Dear Mr. Chilk:

e This letter ~s written to urge you to support the petitions that are now before the NRC that will allow physicians treating patients with radiopharmaceuticals in amounts greater than 30 mCi to provide their patient's health care on an outpatient basis.

This petition, i f passed, will be a step towards affordable healthcare in the home.

Please give this petition your attention and support.

PJC:ps c:

L. Haene 1, D. 0.

Pau

. Ca

, D.O., FAOCR Vice Chai man, Department of Radiology and Medical Imaging Section Head, Nuclear Medicine JUL 16 1992 Acknowledged by card... ___ '"""'"

The Major Teaching Affiliate of the University of Medicine and Dentistry of New Jersey New Jersey School of Osteopathic Medicine

I U.S. NUCLEAt, nCGuLAtORV COMMISSIO"-

DOCKETING & SER ICE SECTION OFflCE OF THE SECRETARY OF THE COMMISSION oocument Statistics Postmark Date _

g_:;,,:i<-,.;......:.-----

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PROVIDENCE HOSPITAL 2446 Kipling Avenue Cincinnati, Ohio 45239 L c'eJ?l ~rtsooo U'.:>NRC

• 92 JUL -8 A10 :35 July 3, 1992 Samuel J. Chil k Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATTN: Docketing and Service Branch

Dear Sir:

e Having been very active in Nuclear Medicine since 1951 and having set up the first Nuclear Medicine Department at Providence Hospital in Cincinnati, Ohio and being Board Certified by the American Board of Nuclear Medicine since 1974, I would like to request the NRC to revise 10 CFR part 35 to:

1.

Delete the requirement in 10 CFR 35.75 (a) (2) that licensees authorize re 1 ease from confinement for med i ca 1 ca re any administered a radiopharmaceutical until the activity in the is less than 30 millicuries.

may not patient patient

2.

Amend 35.75 (a) (2) to allow for an outpatient option instead of mandating confinement for patients receiving oral or intravenous radiopharmaceuticals in amounts greater than 30 millicuries.

3.

Allow doses greater than 30 millicuries to be used in diagnostic studies in addition to radioisotope therapy.

The petitioner believes that these doses are desirable in that many of the new Technetium 99m labeled radiopharmaceuticals available today can be performed without risk to the health and safety of the public or occupational workers.

4.

Define 1:confinementl! to mean remain'ing

• in d

i,osp'ital or a private residence.

I and my staff would appreciate your acting upon our request.

Respectfully yours,

~,t,:;vi/V..{kt,;,,,tC.1?T 4,:t/ 1":

. _-£"'1 \\,

• /fr.-/:::/~

Vincent J/Seiwert, M.D.

Director Nuclear Medicine Providence Hospital VS/ba JUL 16,ssz Acknowledged by card" __,..................

FRANCISCAN HEALTH SYSTEM OF Cl\\/CI'.'J:-,..;ATI. INC Member-Frane1scan Sisters of the Poor edlth ~v5trnl....lru:..

.,.>1.ATORY COMMISSIOI'.

~ & SERVICE SECTION

• -,.*:;; OF THE SECRETARY i:..'-f THE COMMISSION Document Statistics Postmark Date _.,,_?..t...,.1,~~ ~---

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,r DOCKET NUMBER PETITION RULE PRU

-i OA (57Ffl 2ICL/3 L

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• ti.,_JL.I\\U u:,

ew1s own osp1 c:\\JSNf~C 400 Highland A venue Lewistown, PA 17,0.4.4-1 ]JJ~

(717) 248-5411

':JL JUL -8 AlO :35 uH*IC:~ i.tF -;:c, tiAHV OOCKfTJNG sr1,vrr.r iJRANCl-i 2 JULY 1992 muel J. Ch ilk Sec'y of the Commission U.S. Nuclear Regulatory Commission Washington, O.C. 20555 ATTN: DOCKETING AND SERVICE BRANCH SOMcN This is to support the recommendation of the American College of Nuclear Medicine docketed by the Commission on April 21, 1992, assigned Docket No. PRM-35-10A. It is my belief this amendment will insure quality care for both diagnostic procedures and radiopharmaceutical therapy in a more affordable manner without risk to health and safety of the public and their family members.

Yours truly, ~/

~

§D.~.r-Ui:~.~:f Nuclear Medicine Acknowledged by card.... ~~

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• * :,.;;1 COMMISSIO"

• .:AVICE SECTION

_, fHE SECRETARY

• 1 HE COMMISSION OQcvrnent Statistics Copies Received _ ___.i...-----

Add'I Copies Reproduced _J._ ___ _

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June 26, 1992 "92 Jtl. -7 All : l 2

'J~ ll:f. Qi-5t Cfh. T 11" GJC '[TING. S( I vier 3R Nlh Samuel J. Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 AIT:

RE:

Docketing and Service Branch Docket No. PRM-35-l0A

Dear Secretary Chilk:

I am writing this letter to voice my support of the petition requesting modification of NRC rules to permit use of radiopharmaceuticals in amounts greater than 30mCi for diagnosis or therapy.

I have been a practitioner of nuclear medicine for 20 years. In those years I have treated many patients with I-131for thyroid cancer. These patients were hospitalized/or one to two days to comply with NRC regulations. I have never seen a significant immediate adverse reaction to therapy. Generally, if these patients develop problems with neck tenderness, etc., the problems will arise several days after the patient has been discharged from the hospital. It seems to me that hospitalization adds unnecessary expense to the care of these patients. I believe outpatient therapy plus home confinement (which has had favorable evaluation in Texas) would be a reasonable cost-effective alternative.

For diagnostic purposes, the frequently used technetium-based agents could be advantageously used in doses greater than 30mCi with safety. As you know, this tracer decays with a half-life of only six hours and is a pure gamma emitter. It seems unrealistic to "confine" these patients following administration of a 50mCi diagnostic dose.

The proposed rule change would be a small, but safe, step in the direction of cost containment in medical care. I believe this petition dese,ves your support.

Sincerely,

~ /~

Gayle F. Brewer, M.D.

GFB:mrh LARRY K. BECK, M.D.

Hematology Medical Oncology THOMAS E. BOYD, M.D.

Hematology Medical Oncology GAYLE F. BREWER, M.D.

Nuclear Medicine Thyroid Disease JAMES T. DODGE, M.D.

Endocrinology Nuclear Medicine JOHN P. HACKEIT, M.D.

Dermatology A. SHERMAN HILL, JR., M.D.

Hematology Internal Medicine RICK L. JOHNSO, M.D.

DANIEL R. PETERSON, M.D.

Adult Allergy Internal Medicine Asthma Diagnosis KARSTEN C. LEWIS, M.D.

GARY L. TREECE, M.D., FACP lntemal Medicine Diabetes Diagnosis Endocrinology/Metabolism WILLIAM F. VON STUBBE, M.D.

Medical Oncology Internal Medicine D. ROBERT WEBB, M.D.

Allergy - Immunology Asthma JUL 'iiy

~

RTY Business Manager Acknowledged by card ""NN..

• cc"""""'***~

U.S. NUCLE_.A REGULATORY COMMlSSIOt.

DOCKETING & SERVICE SECTiON OFFICE 0F Tl-!E SC01E I A~Y c;.. iHc COMM1SSi0N Document Statistics Postmarir Da1E1 z I I I q,z_

Copies Received I

Jdd'I CoJ)itJs Reproduced - -,_ __

$peclaJ DiStril)ufion}l"!:: J:2~, /J(l/J t L--estNC

,. -'--L- ~R 3 S:.- V IA (57 F iZ J__J o~~J UNIVERSITY OF WASHINGTON MEDICAL CENTER DIVISION OF NUCLEAR MEDIOINE Wednesday, July 1, 1992 U!)NHC Samuel J. Chill(

Attention: Docketing and Service Branch Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Dear Mr. Chill(

"92 JUL -6 UW Medical Center RC-70 P

t!llttl,:i ~ashing ton 98195

..J *U ('106) 548-4240 I am responding to an article appearing in the Federal Register, Volume 57, Number 96, Monday, May 18, 1992, regarding the American College of Nuclear Medicine petition for changing 10 CFR Part 35.

I have been in the practice of nuclear medicine for thirty years and have treated hundreds of patients with radioactive iodine for hyperthyroidism and thyroid cancer. The State of Washington, an agreement state has from time to time given special permission so that patients who could not afford mandatory hospitalization were permitted to return to their homes after they had received more than 30mCi of 1-131. We have successfully used doses as high as 225mCi, on an outpatient basis.

However, the majority of patients have had to comply with the overall NRC regulations that if they had received 30mCi or greater, then hospitalization was mandatory.

In the truest sense, this mandatory hospitalization for most patients is purely custodial.

Occasionally when patients are ill and require medical care and assistance for a complicating situation, then hospitalization is most appropriate, however this is rarely the situation.

I believe that if patients are medically capable of self-care, and that they are informed and cooperative, that outpatient treatment with radiopharmaceuticals in amounts greater than 30mCi is most sensible.

The most distressing portion of the requirement for hospitalization when more than 30mCi of radiopharmaceutical has been administered is the cost. For example, a dose of 1-131 in the range of 200mCi requires at least a 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> hospital stay. This costs the patient from $1500 to $3000, during which time he requires no skilled nursing care, and in our institution waste disposal (primarily urine) is through the local community sewer system, via a toilet in the patient's room!

I would urge that the NRC require their rules as per the petition from the American College of N

Medicine.

Wi B. Nelp,

.D.

Professor, Medicin Head, Division of Nuclear Medicine Past President, Society of Nuclear Medicine WBN:hhi JUL 16 IJ9Z Acknowledged by card... """""""'"'"*nfflffffl

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OOCKET NUMBER I

PiilTION RULE PRM 5 - IO A NORTH COUNTY MEDI-SCAN, LTD.

2095 W. Vista Way, Suite 212

• Vista, CA 92Pt,.(6~!9) 631-3045

• Fax (619) 631-3039 C 5 1 F f2-J-ICJ'fJ)

NUCLEAR MEDICINE July 1, 1992

• 92 Michael S. Kipper, MD.

JUL -6 P 3 :09 Secretary of the Commission, U.S.

Nuclear Regulatory Commission Washington D.C.

20555

,jFF !Ct OF :3[Crtr f,'\\RY OOCK[1 ING,*,,.,[1<VIU BRANCJ-i Attention:

Docketing and Service Branch This letter is in support of an amended petition, Docket No.

PRM-35-l0A.

It is my strong feeling that the requirement in 10 CFR 35.75 should be changed in favor of the amended petition.

As a practitioner in the fiela of nuclear medicine it is my belief that the amended petition will allow facilitated care for outpatients, utilizing radioactive iodine.

Data are available to confirm safety and efficacy as presented by the American College of Nuclear Medicine.

Thank you for your consideration in this matter and I look forward to a positive response.

Very truly yours,

'-rYl.5. IGf>p~

Michael S. Kipper, M.D.

Director of Nuclear Medicine, North County Medi-Scan, Ltd.

Assistant Clinical Professor of Radiology, University of California, San Diego MSK/ja Acknowledged by card JUl 16 ~

""11'*!0 i il:CHAIOIMS:W#,

DOCKET NUMBER PETITION RULE PRM 3S-/oA

[51F/22-IOL/3 )

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July 1, 1992 Samuel J. Chilk Secreta..ry of t.lie CoI11II1issiorr U.S. Nuclear Regulatory Commission Docketing and Service Branch Washington, D.C. 20555 Regarding:

Petition for Revision of 10 CFR Part 35

Dear Mr. Chilk:

"92 Jll -6 All :10 As a long-time practitioner of Nuclear Medicine who treats many patients with thyroid cancer, I ernestly endorse efforts to allow larger amounts of radioactive materials to be given to patients as outpatients.

The majority of my patients could be confined at home wit.11 suitable precautions and at greater comfort without endangering family or the public. The cost :,avings to individuals and insurance companies would be significant Thank you for any efforts to improve medical care.

Director, e,

Pacific M Associate Professor of Medicine and Radiology, University of Washington RJG/bh 1200 12th Avenue South, Seattle, Wa, 98144 JUL 16 1992 Acknowledged by card nlli:S:!ii:CC::UJIM55S5123-(206) 326-4000

fJ r,K T,: MBER l

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(_ <; 7 F /2 J_J o 4 3)

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USHRC Department of Diagnostic Radiology and Medical Imaging 2799 West Grand Boulevard Carol Maywood. MD. MSA "92 J\\l -6 p 3 :Q9erim Chairman Kastyt1s C. Karvel1s. MD, Director D1v1s1on of Nuclear Med1c1ne Detroit. Michigan 48202-2689 (313) 876-2862 June 30, 1992 Samuel J. CWlk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington D.C. 20555 Attention: Docketing and Service Branch RE:

Docket #PRM-35-lOA

Dear Mr. Chilk:

,)H !C~. r f S[CRJ,ll\\R r DOCKUtNG \\ 5tt, VICL 8RAHCl-i This letter is in reference to the American College of Nuclear Medicine amended petition for rulemaking, (Docket #PRM-35-l0A). I strongly urge you to enact the petition of the American College of Nuclear Medicine for the following reasons:

1.

There is no scientific evidence that external radiation exposure to the pubic in this application will exceed the limitation published in 10 CFR 20.105 when treated on an outpatient basis.

2.

Furthermore, the health and safety of the public is not compromised by outpatient treatment with doses greater than 30 millicuries of Iodine-131 followed by patient confinement in their home.

3.

Perhaps most importantly, the unnecessarily restrictive regulatory philosophy currently held is a significant financial burden to both patients and the United States medical system. The ability to treat these patients as outpatients would significantly impact on the cost of treating such patients.

4.

The current regulations cause significant hardship among the patients and the physicians involved in the treatment of patients with therapeutic and diagnostic doses greater than 30 millicuries.

Thank you for your attention in this matter.

K.. Karvelis, M

., Director Division of Nucl ar Medicine Department of Diagnostic Radiology Henry Ford Hospital prm-35-1 0a/kck.2 JUL 16 1992 Acknowledged by card..,"....

-'] /1/12-1

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e

r O )' *T NUMBER P I I rlON RULE PRM 3§ (J A PHILADELPHIA HEART INSTrrUTE Cs 1Ff?.-:Llt:J'-/3)

L ulr.i. i LD Presbyterian Medical Cen~~µ Rc 39th and Market Streets Jaekyeong Heo, M.D.

Associate Director Nuclear Cardiology Lab Philadelphia, P ~:2 9 Jti4_6 PJ~cnf62-9757 June 30, 1992 C,F.:!CE Or 3tCRFlAti -1 OOCKf: f1NG i ';f_t,VIU fif<ANCi-;

Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention:

Docketing and Service Branch Re:

Proposed rules in 10 CFR Part 35

Dear Sir:

I would like to limit my comments to the application of rule changes to Nuclear Cardiology practice since my subspecialty is Nuclear Cardiology.

Thallium-201 has been the work horse for myocardial perfusion imaging over 15 years, and its dose for clinical use is in the range of 2 to 4 mci.

Since technetium-99m has better dosimetry because of a short half life, and excellent energy range of gamma rays (140 Kev),

technetium-99m labeled myocardial perfusion imaging agents would be ideal.

Indeed, two such agents, i.e. sestamibi and teboroxime, have been approved by the Food and Drug Administration, and in clinical use since January 1991.

Due to its better characteristics, the patient's dosimetry with 30 mci of technetium agents is comparable to that with 3 mci of thallium-201.

There are a few different protocols using these technetium agents, i.e. two-day protocol, and one-day protocol (rest followed by stress, or stress followed by rest), and selections of these new protocols will be up to the clinical judgement of nuclear physicians. Clearly, there is a difference in dosimetry between 30 mci of one agent versus the other.

In nuclear cardiology application, these new restrictions may delay the diagnostic procedures for one more day, thereby increasing the cost and inconvenience to the patients, and may jeopardize patient care.

Therefore, there should be individual variations for these different radiopharmaceuticals (I-131, Tc-99m, etc).

Thank you for the opportunity to comment on this subject.

Sincerely,

~.to.

JH/sjk f'r,, c,IJytcr icrn Medici I Cl'nt,'r ic, a n.:1ffilic1tl' of Ull' llnivl'r'->ity of p,,rrn ~ylv,rni;i JUL J6 1392 Acknowledged by carJtx.*,r!,'-M-~~.,......,......

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Radiologic Specialists of Indiana, Inc.

PRFSIDENT Buame D. Van Hove, MD.

VICE PRDIDENT Lany L Heck, M.D.

SECREl'ARY Newell O. Pugh, Jr., M.D.

TREASURER Anulac::i.o C. Na, M.D.

ASSISTANTSECREl'ARY Kenneth B. Marnocha, MD.

ANGIOGRAPHY&: INTERVENT!ONAL Greg M. Gaylord, M.D.

Harry L Hodel, M.D.

~E.

Mamocha,M.D.

ul C. Pelcnon, M.D.

BONE Suaan J.P. Meyer, M.D.

David R. Fames, M.D.

Thomu N. Vahey, M.D.

GASTROINTESTINAL, CT ULTRASOUND,ANDINTERVENTIONAL Gonzalo T. Cltua, M.D.

mderick M. Kelvin, M.D.

Dun D.T. Maglinte, M.D.

Anulacio C. Na, M.D.

ThomuN. Vahey,M.D.

MAMMOGRAPHY Patrick A. Dolan, M.D.

JCeMllh E. Mamocha, M.D.

San McCracken, M.D.

David R. Penn*, M.D.

NEURORADIOLOGY Ric:hanl L Oilmor, M.D.

-- Bude Oniuman, M.D.

.-WR.Hudman,M.D.

Benjamin B. Kuzma, M.D.

JohnA.S-,M.D.

NUCLEAR MEDICINE n.ld ?.t. Apcd*ca. Ml>.

Larry L Heck, M.D.

Jerry L Xiahl, M.D.

Eua-D. Van Hove, M.D.

OUTREACH David L Brown, M.D.

Frederick T. McFall Jr., M.D.

Buban E. Tayler, M.D.

PEDIATRICS Kathy s. ClaJk, M.D.

Rober& E. Oerth, M.D.

0. Byinaton Pran m, M.D PUIMONARY Anthony v. Zancanuo, M.D.

RADIATION ONCOLOGY Thomu C. Dugan, M.D.

l'der 0. Ouren. M.D.

Robert W. Haerr, M.D.

Newell 0. l'llgh, M.D.

William R. Rate, M.D.

David B. Rou, M.D.

EXECUTIVE DIRECTOR Junea S. Caimey, PACHB ASSISTANT OfflCE MANAGERS E. Jm111 Aleunder Cynthia L Wud

°92 Jll -6 A11 :Q9 June 30, 1992 Samuel J. Chilk Secretary, U.S. Nuclear Regulatory Comm

• Washington, D.C.

20555 Attention:

Docketing and Service Branch

Dear Mr. Ch ilk:

I would like to support the petition to alter 10 CFR part 35 to utilize greater than 30 mCi of 131-I (radioiodine) for thyroid therapy.

In patients with thyroid cancer, there is little retention in the patient after 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

These patients can return home where they will not endanger anyone.

This will greatly improve patient comfort while reducing medical expenditures by a considerable amount.

This can be accomplished without any significant risk to the public.

Likewise, there should be no maximal limit in terms of millicuries for diagnostic administrations.

Dosimetry guidelines are available for all diagnostic agents and these will and should be the prevailing guide for physicians to prescribe these radionuclides.

ly yours,

~~

Larry L. Heck, M.D.

Nuclear Medicine Methodist Hospital of Indiana LLH:lwm Larry L. Heck, M.D.

Nuc. Med. Methodist Hosp.

1701 N. Senate Avenue Indianapolis, IN 46202 "JUL 1-6~

Acknowledged by card,. __ """"'""'......,..

U.S. HUCl~ HEGVt.ATOAV COMMISSIOh OOCKE Th O

• SERVICE SECTION Cf

• 1 ~c OF THE SECRETARY OF THE COMtA:SSION Dorument Statistics Pottmark Date

/ 'r2-Coples Re~ived _

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DEPARTMENT OF RADIOLOGY (803) 792-4262 Samuel J. Chilk U!:>

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'92 Jl -6 Al 1 :08 Secretary of the Commission U.S. Nuclear Regul atory Commission Washi ngton, DC 20555 Attention: Docketing & Service Branch

Dear Mr. Chilk:

MEDICAL UNIVERSITY OF SOUTH CAROLINA 171 Ashley Avenue Charleston. South Carolina 29425-0720 June 30, 1992 I am giving my support to AMA resolutions #22 & 23 in support of decreasing medical care costs improving patient care for cancer, especially cancer of the thyroid gland.

To my knowledge, doses greater than 200 mci 131! are extremely rare.

A scientific presentation (abstract 322 at 37th annual Society of Nuclear Medici ne, June 1990) addresses the safety issue for thyroid cancer patients confined to their homes after a 50-400 mci dose of radioiodine.

Radiation to family members met the then present NRC r egulations.

As a practiti oner o f Nuclear Me d i cine since board certificati on in 1972, I have found the previous r egul ation of hospital confinement until the activity in the patient i s less than 30 mci, an expensive and unnecess a r y r estriction.

I hope this requirement c an be deleted.

JBS/nl "An equal opportunity employer" JUL 16~

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fPETITJON RULE PAM 35-IOA NMC (S7 t-fl 2-101-!3)

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~~c~!~YA~~?o~~l~;P CONSULTANTS LCLHL i LB MALCOLM R. POWELL, MD, FACP (1,2,4)

~NDREA S. BLUM. MD (1.2.3 41 KATHLEEN A. MEIER. BA. MBA. ADMINISTRATOR June 30, 1992 Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 ATTN:

Docketing and Service Branch RE:

Docket No. PRM-35-lOA

Dear Mr. Chi 1k:

U~NHC 350 PARNASSUS AVENUE, SUITE 908 SAN FRANCISCO, CA 94117 (415) 664-7400

'92 Jll -6 A11 :09 We wri te in support of rev1s1on of 10 CFR Part 35 to allow outpatient treatment with more than 30 mCi of radiopharmaceuticals if the patient is confined to his private residence with appropriate radiation safety precautions.

We also petition to allow doses greater than 30 mCi to be used for diagnostic studies.

We have long experience in the use of radioiodide-131 for treatment of thyroid cancer and occasional ly for ablation of benign thyroid tissue for other reasons and believe that we are quite cognizant of all the requirements for a safe administration of this therapy.

We believe that this therapy can be administered using home confinement to a private residence with no public risk and in doi ng so, it would be a very large savings in the cost of med ical care.

Certainly, the present hospitalization that we impose upon our patients does not accomplish anything in terms of radiation safety that we could not easily accomplish in the patient 1 s own home.

Regarding the use of diagnostic doses greater than 30 mCi, this will become increasingly frequent with newer Technetium labeled agents and also with shorter half-life agents that may yet be introduced to general clinical use.

Such diagnostic studies can be performed without risk to the health and safety of the public or occupational workers and wou ld be in the patient 1 s best interest.

Newer instrumentation, such as the just announced ISIS scintillation camera, will be capable of counting much higher rates than current instrumentation and the use of larger diagnostic doses of certain radiopharmaceuticals will become more feasible than it is with many current instruments.

Sincerely,

~~~~

Associate Clinical Professor of Medicine University of California, San Francisco MRP :jm JUL. J6 ~

Acknowledged by C8fd **"""'""'*m"""~

1. DIPLOMATE. AMERICAN BOARD OF NUCLEAR MEDICINE

3. DIPLOMATE. AMERICAN BOARD OF ENDOCRINOLOGY & METABOLIC DISEASES

2. DIPLOMATE, AMERICAN BOARD OF INTERNAL MEDICINE

4. MEMBER, AMERICAN THYROID ASSOCIATION

U.S. NUCtt:.*r* H':G~*LATORY COM~.iiSSIOr-.

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DOCKET NUMBER PETITION RULE PRM,3 's-( 0 A

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FREEDMAN & ASSOCIATES-NUCLEAR MEDICINE, PC. t. ;(. E 1 LO 60 Temple Street USNRC New Haven, Connecticut 06510 203-789-2299

'92 '1l -6 A11 :09 June 30, 1992 Samuel J. Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Attention:

Docketing and Service Branch

Dear Mr. Secretary:

uff- !Ct Ot SE :i<t lt,<<Y DOCKftt G,4 SL1 VICT SRJ\\ NCH I am writing in support of Resolutions 22 & 23 by the American College of Nuclear Medicine and in response to the NRC amended Petition 51892 dealing with radiation dosage and public exposure.

As a board-certified radiologist and board-certified specialist in nuclear medicine, and having served on the faculty of the Vale University School of Medicine, Department of Nuclear Medicine, and having been a member of the Society of Nuclear Medicine and having served in an executive capacity several times over the last twenty years, and having had my own individual private practice of Nuclear Medicine in New Haven, CT for the past fifteen years, I wish to speak in favor of expanding the accessibility of radioactive material for administration in private offices.

both in the availability of radiopharmaceuticals and in their maximum dosage, increased availability in the private sector would be cost-effective, more comfortable for the patients, and at no measurable hazard to the public (1).

I appreciate your willingness to consider my views in this determination.

• , FAC R (1).

Allen, H.C. Jr., and J.D. Zielinski. Non-Hospitalized Thyroid Cancer Patients Treated with Single Doses 50-400 mCi.

Journal of Nuclear Medicine, Proceedings of the 37th Annual Meeting p784 JUl. 16 199' Acknowledged by card.. ea*******.. ***"'..,,..,.

U.S. NUCt EAR REGULATORY COMMISS~

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'92 '11. -6 All :11 Saint John's Hospital and Health Center 2420 Duxbury Place Los Angeles, CA 90034 June 29, 1992 Mr. Samuel J. Chilk Secretary, NRC Washington, D.C. 20555

Dear Mr. Chilk:

I am a physician engaged in the full time practice of nuclear medicine and have been a member of the Health Physics Society since 1973.

I believe most patients can be safely treated with doses greater than thirty millicuries as outpatients.

Not only would it save many millions of dollars every year, but these patients would feel so much more comfortable in their own homes.

A scientific paper given by H. c. Allen, et al, at the 37th Annual Meeting of the Society of Nuclear Medicine, June, 1990, supports my view.

I hope you will consider amending the current regulations.

Sincerely yours,

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Julian R. Karelitz, M.D.

Acknowledged by card...., uscsoetCQURUWMMQ4Wft\\

1328 Twenty-Second Street, Santa Monica, California 90404 * (213) 829-5511

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'92 Jll -6 All :11 June 29, 1992 Samuel Chilk Secretary of Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20552 ATTN:

Docating and Service Branch Mr. Chilk:

Please consider this a

petition on my part to recommendations of the AMA as set forth in resolution and to make the proposed rule changes to NRC 10 C FR recorded in the federal register Monday May 18, 1992.

accept the

1. 22 and #23 part 35 as I

agree wholeheartedly that an outpatient dose of greater than 30 milicuries would be very advantageous in many clinical i nstances.

This is particularly the case in therapy of thyroid carcinomas.

Thank you very much for significant improvement therapy for our patients and Medicare costs.

Thank you very much.

w. J Strader, M.D.

WJS/lg your consideration.

This will result in in the affordability of appropriate and result in significantly less hospital JUL 16 1992

t!.~ ~.,,.. ~.-:.., l~GULAT"OAY COMMtSSO.

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Harvard Medical School Beth Israel

,rpital Gerald M. Kolodny, M.D.

Associate Professor of Radiology Harvard Medical School Samuel J. Chilk, DOCKET NUMBER PETITION RULE PRU 3 S -1 (J) A

( S1 FR ?-JtJ 'i3)

Director of t:l-C:K[ i I:. 0 USNRC Nuclear Medicine "92 JJL -6 Al 1 :Q6 Department of Radiology Beth Israel Hospital June 2'Sfl !199.'2 :)tCKf lA11¥ DOCKET!NG '"< Str*VICf GRANcH Secretary of the Commission U.S. Nuclear Regulatory Commission Washi ngton, DC 20555 Att:

Docketing and Service Branch

Dear Mr. Chilk,

Beth Israel Hospital 330 Brookline Avenue Boston, MA 02215 (617) 735-2071 I strongly support the amended petition pending before the Nuclear Regul atory Commission (Docket No. PRM-35-l0A), to allow the use of radi opharmaceuticals in amounts greater than 30 mCi on an outpatient basis with post-therapy confinement to the home.

This would ensure quality care for both diagnosti c procedures and radiopharmaceuti cal therapy and would indeed be a giant step forward i n expanding the horizons of nuclear medicine for ambulatory patient s.

GMK/df f~~z4~

Gerald M. Kolodny Director of Nuclear Medicine Beth Israel Hospital JUL 16 1992 Acknowledged by cardwwuw m.c,-.wca4

U.S ~1L*r~t ~,.;: i-2GiJLATORY COMMISSIO~

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(~1 Ffl :)..I HARVARD MEDICAL SCHOOL DEPARTMENT OF RADIOL GY JOINT PROGRAM IN NUCLEAR MEDICINE BETH ISRAEL HOSPITAL

• BRIGHAM & WOMEN'S HOSPITAL

• DANA-FARBER CANCER INSTITUTE

• THE CHILDREN'S HOSPITAL

!1Ut; 'i:.ILQ USNRC "92 Jll. -6 All :Q6 June 29, 1992 Samuel J. Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Att:

Docketing and service Branch

Dear Mr. Chilk,

I strongly support the amended petition pending before the Nuclear Regulatory Commission (Docket No. PRM-35-l0A), to allow the use of radiopharmaceuti cals in amounts greater than 30 mCi on an outpatient basis with post-therapy confinement to the home.

This would ensure qual ity care for both di agnostic procedures and radiopharmaceutical therapy and would indeed be a giant step forward in expanding the horizons of nuclear medicine for ambulatory pati ent s.

JAP/df

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J. Anthony Parker, M.D., Ph.D

• Associate Professor of Radiology Beth Israel Hospital JUL 16 1992 Acknowledged by caro HE

• a UPII DIVISION OF NUCLEAR MEDICINE BETH ISRAEL HOSPITAL 330 BROOKLINE AVENUE BOSTON, MASSACHUSETTS 02215 (617) 735-2071

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Beth Israel Hospital Boston 330 Brookline Avenue Boston. MA 02215 (617) 735-2000 A maior teaching hospital of Harvard Medical Schoo DOCKET NUMBER PETITION RULE PRU J's.-/ tJ A (51 Ffl.. :U0~3J A constttuent agenc Combined Jewish Mitchell T Rabkin. MD President Philanthropi~

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NCH Samuel J. Chilk, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Att:

Docketing and Service Branch

Dear Mr. Chilk,

I strongly support the amended petition pending before the Nuclear Regulatory Commission (Docket No. PRM-35-lOA), to allow the use of radiopharmaceuticals in amounts greater than 30 mCi on an outpatient basis with post-therapy confinement to the home.

This would ensure quality care for both diagnostic procedures and radiopharmaceutical therapy and would indeed be a giant step forward in expanding the horizons of nuclear medicine for ambulatory patients.

Sincerely, Staff Physician Beth Israel Hospital KD/df JUL 16 1992 Acknowledged by card II 1,,

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U.S. NUCLEAR REGULATORY COMMIS

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LOWER COLUMBIA PATHOLOGISTS, P.S.

Samuel J. Chilk Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D.C. 20555 ATTN:

Docketing and Service Branch DOCKET NUMBER f'E.flTION RULE PRU 35-JtJA,

[5 7 F fl;;_, O£J.:LJ CONSULTING PATHOLOGISTS:

C. E. BUCK. M. D.

W.J. ELTON. M. D.

R. C. NAU. M. D.

II. II. FERGUSON, M. D.

R. E. SANDSTROM, M. D.

H. H. KIM, M. D.

June 29, 1992 IUSINBI MANI.GIi:

CLINICAL MICROIIOLOGIST:

M. B. THOM~ t:. l LQ L. II. STAUFFER, SM(AAM)

USN C "92 Jl -2 All :10 1'.!F.!Ct OF St:CRUA V u{JCKf TING.... Sf 11v1cr BRANCH I am a practicing Nuclear Medicine physician in Southwest Washington and strongly urge NRC approval of the amended petition for rulemaking, 10 CFG Part 35 (Docket No.

PRM-35-l0A).

This would be of great benefit to patients by allowing them economic quality care through access to outpatient diagnostic and therapeutic radioactive materials in excess of 30 mCi, without creation of safety hazard to the public (home confinement).

Adoption of this principle will very likely prove to be a significant cost-saving measure, especially with the recent advent of cancer treatment with I-131 labelled monoclonal antibodies.

Also, please consider support of petition 10 CFG 20.301 in order to restore the prior external radiation limit to the public to 500 mR (5 mSv) per year.

There is no scientific basis for the current and recently promulgated regula-tions for lowering the limit to 100 mR (1 mSv) per year, which will signifi-cantly increase the cost of patient care.

WJE:ss cc:

Dr. Herbert C. Allen American College of Nuclear Medicine William J. Elton, M.D.

JUL 16 1192 Acknowledged by card... -*--*-*-...

P.O. Box3012 1606E.KesslerBlvd.,Sulte100 Longview,WA98632 (206)425-5620 Billing:(206)425-9038 Fox:(206)425-7219 1800 Cooks Hill Road Centralia, WA 98531 (206) 736-7626 Fax: (206) 736-7627

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U:>Ni C KARL THO RD DOCKRAY. M. D.

• 92 Jll -2 A11 :16 DIPLOMATE, AMERICAN BOARD OF RADIOLOGY DIPLOMATE, AMERICAN BOARD OF NUCLEAR MEDICINE ufFlC:: OF SEC~F.T>;-r1't ROENTGENOLOGY. RADIUM THERAPY. AND NUCLEAR ~t&c I iJ..,/

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(.f 1808 19TH STREET LUBBOCK, TEXAS 79401 1-806-763-577-4 June 29, 1992 Samuel J. Chilk Secretary of the Commiss i on U. S. Nuclear Regulatory Commission Washington, D. C.

20555 Att ention: Docket i ng and Serv i ce Branch Sir:

Please list my name as not in favor of the l i mitations on outpatient or home therapy.

Thank you.

x~ 5 ~.b--. II).t; _

-...,*"'7, 9-c.J Kar l T. Dockray, M.D.

KTDJjw A PROFESSIONAL ASSOCIATION JUL 16 199l Acknowledged by card....,.£!,esnsMWu;~

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SlllJCJ American Medical Laboratories, Inc.

14225 Newbrook Drive P.O. Box 10841 L

t t: J USNRC Chantilly, Virginia 22021-0841 703-802-6900

• 92 JUL -1 P 4 :08 June 29, 1992

,)FF!CE: OF SECRfTAn v OOCKF f ING,\\ '.jt iiVICL BR.I\\N Cl-i Mr. Samuel J. Chilk Secretary of the commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention:

Docketing and Service Branch

Dear Mr. Chilk:

It is my understanding that there is a petition before the Nuclear Regulatory Commission in relationship to the use of radiopharmaceuticals in amounts greater than 30 mCi on an outpatient basis.

I am a nuclear medicine physician, and I support the petition.

It is my belief that it will make it possible to render better care to certain patients if this is allowed.

I hope that you will act favorably upon this petition.

Sincerely,

/4&_~

Ira D. Godwin, M.D.

IDG:lm Acknowledged by card "'.. ~UI.. 1 6 1992 sseaas.C1till;;iiihwtft

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Nuclear Regulatory Commission Michael T. Lesar,Chief, Rules Review Office of Administration i.,(.KL ;* fJ June 12, i'§~fSC

'92 JJN 23 P 3 :QB Mr Lesar, I would like to make a written comment concerning 10 CFR part 35.75.

I have just read in the Federal Register Vol.57 #96 dated May 18,1992 a petition for ammending the rule to allow certain patients the option of having their studies done on an out patient basis.

This proposed rule change does have,Ifeel, considerable merit, how ever I am very concerned about smme of the statistics given by the petetioner.

They state that in some instances doses of up to 400 millicuries of 1131 Nal could be given safely to the patient on an out patient basis.

I'n response to this statement I can only say that I certainly would NOT allow any of my family or myself to sit in close proximity to this patient.

Any radiopharmaceutical that has a half life of 3 days should be used with the utmost scrutiny and control.

I'n my opinion,any ammendment made should allow outpatient doses greater thAn 30 mtllicuries only if the radiopharmaceutical used has a half life of less than 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />.

This addendum would allow all the Tc99m and 1123 agents to be used.

I realize that excluding the long half-lived agents may cause some concern for some institutions,but using shorter half r vea f£ a 1,.,Ph +]jliilC~i ticals will still allow the majority of us to live and work SAFELY within the guidelines of the NRC.

Dexter Memorial Hospital 1200 N. One Mile Road Dexter, MO 63841

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David M. Garnet, CNMT, NMTCB IJ VS: Ont ZZ MT Z6.

JIil 16 1.492 Acknowledged by card ***---m IIHICNtNf '

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Office of Executive Director 205 Capital Avenue Frankfort, Kentucky 40601 (502) 227-4543 June 16, 1992 "92 JUN 19 A 9 :26 Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: Docket Numbers PRM-35-10 and 35-l0A 9

Dear Mr. Chilk:

With respect to these proposed rulemaking petitions referenced above, as submitted by the American College of Nuclear Medicine, the Board of Directors of the Conference of Radiation Control Program Directors, Inc. (CRCPD), based upon recommendations of the CRCPD Committee on Suggested State Regulations for Control of Radiation - Use of Radionuclides in the Healing Arts, offers the following comments:

1.

The petitione_r requests,the tenn "confinement" as used in 10 CFR Part 35,

§35.75, be clarified:to allow for confinement at home. As written, this regulation does not specify that the patient must be hospitalized. It is our opinion that.NRC and Agreement States with the same terminology in equivalent regulations currently have the prerogative to authorize confinement by means other than hospitalizaticn. Therefore, no definition of the term "confinement" is taken to mean hospitalization or other limitations of patient activities to keep radiation exposures to other individuals within allowable limits which are acceptable to the Agency.

2.

The petitioner requests the requirement for confinement of patients containing more thrui 30 mHJj~~es cf activit"J be c!e!eted. It is the recom.T..endation of this Committee that the current release criteria be re-examined and modified to conform to the recommendations in Report Nwnber 37 of the National Council on Radiation Protection and Measurements (NCRP) (Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides, 1970). These recommendations provide for release of patients containing radionuclides when the activity in the patient is such that the effective dose equivalent to a hypothetical person one (1) meter from the patient during complete decay of the radionuclide will not exceed the maximum permissible dose to members of the public as specified in 10 CFR Part 20. We believe tl1at this is a more reasoned approach based on available scientific guidance and takes into consideration the adntlnistered radionuclide.

JUL 16 199t Acknowledged by card "'".'""'111""""'""""

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Samuel J. Chilk, Secretary June 16, 1992 Page Two

3.

We wish to reserve further comment on the safety of outpatient radiophannaceutical therapy in doses up to 400 millicuries of iodine-131 as sodium iodide until these data have been published in peer-reviewed scientific journals, especially in light of the recommendations in NCRP Report Number

37. No references to such publications were included in the petitioner's request.

Thank you for the opportunity to comment on this petition for rulemaking. If you need further information or clarification, please do not hesitate to contact me.

AVG/CMI-Vsah cc:

Board of Directors Federal liaisons SR-6 Members Sincerely,

~/~

Aubrey V. Godwin CRCPD Chairperson

ET fJUMBER

. J RULE PRM 55--. J O A LUC/'ilfEe USNHC

( s, F rz. :;_, 0'-1.JJ Mobile Cardiac/Pulmonary Testing "92 JJN 17 P 1 :09 Secretary of the Commission US NRC June 12, 1992 Washin9ton, DC 20555 Attention:

Docketing and Service Branch

Dear Secretary of the Commission:

This letter is in reference to an amended petition, Docket No.

PRM-35-l0A.

I agree with the petitioner's request, item 3, for the following reasons:

Current use of the first pass radionuclide ventriculography (FP RNA) routinely requires two, 20 mci doses of Tc-99m DTPA to acquire the most clinically useful study.

In the end, an accurate noninvasive study can save a many fold higher radiation dose from more invasive studies in diagnostic radiology.

Not only is this consistent with lowering the radiation burden to the patient, but it also decreases the morbidity of testing -- two significant benefits.

The study described above allows for a majority of tracer clearance through the urine in less than 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />, and the radionuclide has a low ener9y and short half life.

The probable intent of the original document was meant for therapy applications, not diagnostic procedures.

This ap~lication (FP RNA) also is probably more physio-logic with a lesser total body dose than its closest alternative diagnostic study -- equilibrium blood pool or MUGA.

Therefore, for many practical and theoretic reasons, item 3 is valid.

I also agree with items 1, 2, and 4 for the following reasons:

Confinement of radioactive patients in an outpatient settin9 as in our practice is inconsistent with lowering radiation exposure to the general public.

The low energy of Tc-99m and rapid excretion pose little risk to the public.

Greater radiation exposure to our staff and patients would be a concern if confinement was considered.

To allot space for confinement would add significant financial burden.

1218 W Kilbourn Avenue Suite 220 Milwaukee, WI 53233 (414) 283-7060 JUL l 6 1992 Acknowledged by card----....... N......... "

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To instruct out~atients about private residence confine-ment would significantly increase apprehension needlessly in terms of this simple noninvasive procedure.

Maybe another arbitrary number could be selected.

In sununary, I certainly respect the concerns of radiation exposure to both workers and the general public. It is necessar¥ to look logically at the total picture and possible a~plication of various modalities, however.

An arbitrary figure may actuallr cause other untoward effects to workers, facilities and patents.

Sincerely, 9fhr Director

D:ldoaimcat\\Ldten\\NRC.A92 5335 N. Via Celeste Marshall Brucer MD FAAAS Tucson, Arirona 85718 I *I BER (602) 299-6288

• - PR 3..!.:/ 0 A

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(~7 FYl ~ 104'!:J)

Samuel J Chilk Secretary of the Commission Nuclear Regulatory Commission Docketing & Service Branch, Docket #PRM-35-lOA Washington DC 20555 Mr Secretary

• 92 JUN 12 A9 :04 June 3, 1992 I note that the Federal Register/vol 57, No. 96/ Monday May 18, 1992 lists a reasonable petition that physicians be relieved of mandatory, but unnecessary jailing of patients undergoing therapy for certain diseases. (You call it "hospital confinement", but with no medical benefit it is durance vile properly called "jailing".) I request that the NRC grant these requests with one minor correction.

In the third column, under 1 (3), I suggest that all reference to 99mTc be removed. Technetium is just an example, many other nuclides are equally safe in large dose. Regulatory lawyers have proved themselves incapable of differentiating such subtleties and, in the future, such specificity might cause the same troubles we now have with the 30 mCi stupidity.

Marshall Brucer JUL 16 1992 Acknowledged by card"----""""-"

U.S. NUCLEAR H:GUL/\\TORY COMM1S' !C, DO KE.TIN(;'

. ERV! "E SEC r1 N OFF1CE o-= THc "[~' ETf,R Postmark o~t _6 / J,-/ q 2-

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Cop*es Rer.eiv ~_/ _____ _

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University of Cincinnati Medical Center June 2, 1992 DOCKET NUMBER*

PE Fl jl RULE PRM 35 JOA (21 l 51 F (l ~ I 0'-1.J

~

University of Cincinnati Hospit~iLULS~E')iC!:.D Eugene L. Saenger Radioisotope Laboratory r,L Mail Location #577 234 Goodman Street TELEPHONE (513) 558-4282 Cincinnati, Ohio 45267-057?

92 JUN l Z p 3 :2S Secretary of the Commission US Nuclear Regulatory Commission Washington, D.C.

20555 Attention:

Docketing and Service Branch RE:

Docket #PRM-35-l0A--American College of Nuclear Medicine Petition for Rule Making as Reported in the Federal Register, Vol. 57, No. 96, Page 21043, Monday, May 18, 1992 I have been involved in the practice of medicine for the last 25 years.

I hold dual appointments in Medicine (endocrinology) and in Radiology (nuclear medicine) at the University of Cincinnati Medical Center.

I have a substantial clinical practice that is concerned exclusively with the care of patients with thyroid disease, and in particular thyroid cancer.

In addition, I head a multi-center cooperative study of the treatment of patients with thyroid cancer at 12 leading medical centers.

Approximately 12,000 new cases of thyroid cancer requiring clinical treatment are diagnosed in the United states each year.

About 95%

(11,400) of these cases are patients with papillary carcinoma and non-Hurthle cell follicular carcinomas.

These are cell types that generally are considered to be amenable to radioiodine-131 therapy.

Of the 11,400 new cases of papillary or follicular carcinoma each year, our data indicate that 76%

(8664) will be sent for radioiodine ablation of thyroid remnants following surgery.

Seventeen percent (1473) of these radioiodine-131 ablative therapies will use activities less than 30 mci as an outpatient, while 83% (7191) of these ablation therapies will be given with larger amounts that typically require hospitalization.

Approximately 50% of the low administered activity outpatient (737) therapies will fail as will approximately 20% (1438) of the higher activity inpatient therapies, with the failed patients {2175) requiring higher activity in-patient repeat therapies. Thus, given the current NRC rules, there will be about 9,366 hospitalizations per year required of newly diagnosed patients with thyroid cancer for purposes of radioiodine-131 ablation of thyroid remnants.

Given an average hospital stay of 3 days at an average cost per hospital day of $400.00, the resulting cost to the American health Acknowfedged by card

• .JUL l S 1Bi2.

" 1111*uunec:assuenH:wm1m, Patient Care

• Education

• Research

• Community Service An affirmative action/equal opportunity institution

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Secretary of the Commission/NRC June 2, 1992 Page 2 system for these hospitalizations is at least $11,239,000.00 per year.

Spread of the thyroid cancer beyond the thyroid gland can be expected in about 30-50% of these 11,400 new patients with thyroid cancer each year, usually to lymph nodes in the neck and more rarely to distant locations.

Treatment of metastatic disease almost always requires higher administered activities of 1311 as in-patients.

About half of the time this will be combined with the initial ablation of thyroid remnants.

our experience suggests that about 12% (1368) of the patients will require at least two subsequent in-patient radioiodine treatment sessions for metastatic disease.

If one assumes an average three days of hospitalization required per session at a cost of $400.00 per hospital day, there will be an additional cost for hospitalization of at least

$3,283,000.00 per year.

Based on current patterns of treatment and current incidence rates for well differentiated thyroid cancer within the United States, we thus estimate that at least $14,500,000.00 per year is spent by the American public for the hospitalization of patients treated with radioiodine-131 in order to comply with current NRC rules that require admission whenever whole body burdens are greater than 30 mci.

There have been a number of studies evaluating radiation exposures to personnel and to the families caring for such

patients, and these consistently have shown only very low exposures.

The health risk to family members and to the public can be minimized with very simple home radiation safety precautions that would permit the treatment of the vast majority of patients with thyroid cancer at home rather than in hospitals.

Substantial savings of at least $14,500,000.00 per year in health care costs would be possible if the current NRC rules were modified as proposed in the petition without any apparent danger to the American public.

Very sincerely yours, HRM:klb (C0002 I Pctitioo.NRC)

DOCKET NUMB ETITION RULE PAM j

- J (J A

( !;" 7 F fl :i-J 0 '1\\~t K[ TED (j)

THOMAS W. 0RTCIGER D IRECTOR STATE OF ILLIN0IS DEPARTMENT OF NUCLEAR SAFETY 1035 OUTER PARK DRIVE SPRINGFIELD, IL 62704 (217) 785-9900 June 3, 1992 Secretary of the Commission U.S. Nuclear Regulatory Commis-sion Washington, D.C.

20555 Attention: Docketing and Service Branch

.. u~NRC JIM EDGAR GOVERNOR Re:

American College of Nuclear Medicine:

Receipt of Petition for Rulemaking

[Docket No. PRM-35-10] and American College of Nuclear Medicine:

Receipt of an Amended Petition for Rulemaking

[Docket No.

PRM-35-I0A]

Gentlemen:

The Illinois Department of Nuclear Safety (Department) hereby submits its comments on the above-identified petitions for rulemaking.

The requests represent changes to NRC's medical rules (10 CFR 35) that would allow release of a patient from hospitalization, but not release from confinement for medical care, any patient containing more than 30 millicuries of activity or having a measured* dose rate greater than 5 mi 11 i rems per hour at one meter.

The Department believes the rules in 10 CFR 35.75(a) are clear enough to allow the release of a patient containing more than 30 millicuries of activity as long as the measured dose rate at one meter is less than 5 millirems per hour, and this is the way the Department interprets these regulations.

In instances where a patient is to be released having a measured dose rate greater than 5 millirems per hour, the Department would prefer to review this in the form of a request for an amendment to a license. This would ensure that adequate training is provided and safety precautions are in place for each patient "confined" rather than "hospitalized." The Department does not wish to restrict the practice of medicine, however, the Department is required to protect public health and safety, including family members of patients undergoing radiation therapy treatments on an outpatient basis.

'JUL 15 1992 Acknowledged by card",._,...~--*

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American College of Nuclear Medicine Petitions Page 2 In general, the Department has concerns about implementing "confinement" restrictions outside a hospital setting, especially in light of the request to release patients containing up to 400 mCi of 1-131.

The proposed definition of "confinement" does not address transport to the confined area, and does not prohibit a patient from taking a bus home, for example.

In addition, it is very difficult to control the actions of an ambulatory patient and difficult to assure the patient has remained in confinement.

If you have any questions regarding these comments, do not hesitate to call me or Kathy Allen at (217) 785-9947.

Si?e:ely, 0

~~

6 3 CJiJ!t~

Steven C. Collins, Chief Division of Radioactive Materials SCC:KAA cc:

B.J. Holt

I NUM* ER PETITION RULE PR.

3 S-I A (S7 F/2 J.. J0'/3]

10 CFR Part 35 "0(; [i[D US HC

[7590-01]

• 92 HAY 22 All :26 (Docket No. PRM-35-l0A)

American College of Nuclear Medicine; Receipt of an Amended Petition for Rulemaking AGENCY:

Nuclear Regulatory Commission.

ACTION:

Amended petition for rulemaking:

Notice of receipt.

SUMMARY

The Commission is publishing for public comment a notice of receipt of an amended petition for rulemaking which was filed with the Commission by the American College of Nuclear Medicine.

The amended petition was docketed by the Commission on April 21, 1992, and has been assigned Docket No. PRM-35-l0A.

The petitioner, in both the original petition and in this amendment to that petition, requests that the Commission amend its regulations regarding confinement, safety instructions, and precautions used for patients receiving radiopharmaceutical therapy in amounts greater than 30 millicuries.

The petitioner requests that the original petition be expanded to consider the need to allow amounts greater than 30 millicuries to be used in diagnostic studies and to add a definition of confinement.

2 7/11/11-DATE:

Submit comments by (60 days after publication in the Federal Register).

Comments received after this date will be considered if it is practical to do so but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES:

Submit written comments to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

For a copy of the petition, write: Rules Review Section, Rules and Directives Review Branch, Division of Freedom of Information and Publications services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Telephone: 301-492-7758 or Toll Free:

800-368-5642.

The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street NW.

(Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar, Chief, Rules Review Section, Rules and Directives Review Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: 301-492-7758 or Toll Free: 800-368-5642.

3 SUPPLEMENTARY INFORMATION:

Background

On January 14, 1992, the Nuclear Regulatory Commission (NRC) docketed a petition for rulemaking submitted by the American College of Nuclear Medicine (PRM-35-10).

The notice of receipt of this petition was published on March 9, 1992 (57 FR 8282), and a document correcting a typographical error in a reference to codified text from §35.72(a) (2) to §35.75(a) (2) was published on March 24, 1992 (57 FR 10143).

On April 21, 1992, the NRC docketed an amendment to this petition.

The amended petition was also submitted by the American College of Nuclear Medicine.

The amended petition was assigned docket number PRM-35-l0A. The amended petition supplements the original petition by requesting that the NRC consider the need to allow the use of amounts greater than 30 millicuries in diagnostic studies and add a definition of the term confinement.

The petitioner requests amendments to 10 CFR Part 35 that would clarify the requirement for confinement for ambulatory patients receiving oral or intravenous radiopharmaceuticals in amounts greater than 30 millicuries and allow patients the option to be treated on an outpatient basis if they qualify medically.

The petitioner states that the requested amendment is in the best interest of patients who require access to affordable quality care and that scientific published data support the changes requested by the petition as consistent with protection of the public as stated in 10 CFR Part 35.

4 Petitioner's Request The petitioner requests the NRC to revise 10 CFR Part 35 to-(1)

Delete the requirement in 10 CFR 35.75(a) (2) that licensees may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until the activity in the patient is less than 30 millicuries; (2)

Amend §35.75(a) (2) to allow for an outpatient option instead of mandating confinement for patients receiving oral or intravenous radiopharmaceuticals in amounts greater than 30 millicuries.

(3)

Allow doses greater than 30 millicuries to be used in diagnostic studies, in addition to radioisotope therapy.

The petitioner believes that these doses are desirable in that many of the new Technetium 99m labeled radiopharmaceuticals available today can be performed without risk to the health and safety of the public or occupational workers.

(4)

Define "confinement" to mean remaining in a hospital or a private residence.

Reasons for Petiti on Section 35.75 prohibits an NRC medical use licensee from releasing from confinement for medical care any patient administered a radiopharmaceutical until certain criteria are met.

One of the criteria is that the activity in the patient is less than 30 millicuries.

The petitioner believes that the regulation should be clarified to allow for temporary home

5 confinement.

The petitioner claims that with the advent of monoclonal radiolabelled antibodies and other new radiopharmaceuticals for diagnosis and treatment, outpatient diagnosis and therapy would provide efficient care and allow costs to be minimized without increased risk to the public.

The petitioner also states that published scientific papers attest to the safety of outpatient radiopharmaceutical therapy in doses of up to 400 millicuries of I-131 NaI.

Conclusion The petitioner states that if this amended petition is granted, it would benefit patients by giving them affordable quality care while allowing them to be diagnosed and treated on an outpatient basis instead of being confined to a hospital.

The petitioner claims that scientifi c studies support the finding that diagnosing and treating patients on an outpatient basis with radi opharmaceuticals in doses greater than 30 millicuries would not create a safety hazard to the publi c.

~

Dated at Rockville, Maryland, this/ -,,,,.- day of,~~r

, 1992.

clear Regulatory Commission.

~~

of the Commission.

DOCKET NUMBER A

PETITION RULE PRU 3 £ - J O AMERICAN COLLEGE OF NUCLEAR MEDICINE P.O. Box 175, Landisville, PA 17538 (71 7) 898-6006 April 14, 1992 Samuel J. Chilk Secretary of the Commission U.S. Regulatory Commission Washington, DC 20555 ATTN:

Docketing and Service Branch

Dear Mr. Chilk:

RE:

DOCKET #PRM-35-10 APR 2 1 1992 DOCKETING&

SERVICE BRANCH SECY-NRC

'i, I

acknowledge Mr. Grimsley's letter of March 3, 1992 and the enclosed copy of the Commission's notice of receipt of the American College of Nuclear Medicine Petition for Rule Making.

In discussion with Mr. Michael T. Lesar, Chief, Rules Review Section, I pointed out that the reference on page three (3) of the NRC notice (Section-Petitioner's Request) Item (1) refers to 10 CFR 35.72 (a) (2) which appears to be a typographical error.

Insofar as we can determine, the reference should have been as in (2) of the same section of the Commissioner's letter, which refers to Paragraph 3 5. 7 5 (a) ( 2).

Attention is also drawn to the need to allow greater than 30 mci in diagnostic studies, in addition to radioisotope therapy, since such doses are desirable tk.De..many of the new Technetium 99m labeled radiopharmaceuticals and Ac an be performed with no hazard to the health and safety of the public or occupational workers.

We have taken the liberty of making changes in the enclosed copy of the Commission's Notice of Receipt of the American College of Nuclear Medicine Petition for Rule Making, reflecting suggestions in this regard and in addition, suggest in the definitions of Section #35. 2 as follows:

"confinement" means remaining in a hospital or a private residence.

The American College of Nuclear Medicine supports these revisions to the Commission's notice, as attached, and requests that these additions and corrections be published in the Federal Register.

US. NUCLE R REGULATORY COMMISSIOtc DOCKETING & SERVICE SECTION Off ICE OF THE SECRET ARY OF THE C ~.llSS JN

Samuel J. Chilk Secretary of the Commission April 14, 1992 Page Two Thank you for your help in this regard and we certainly appreciate your continuing efforts on this change.

Sincerely, t&JMa/$ffe{

Richard A. Wetzel, M.D.

for the American College of Nuclear Medicine RAW:sls Enclosures cc:

Michael T. Lesar Chief Rules Review Section Regulatory Publications Branch Division of Freedom of Information &

Publication Services Office of Administration U.S. Regulatory Commission Washington, DC 20555 Donald Grimsley, Director Division of Freedom of Information &

Public Services Office of Administration United States Nuclear Regulatory Commission Washington, DC 20555

(7590-0 l )

NUCLEAR REGULATORY COMMISSION 10 CFR Part 35

[Docket No. PRM-35-10]

American College of Nuclear Medicine; Receipt of Petition for Rulemaking AGENCY:

Nuclear Regulatory commission.

ACTION:

Petition for *ru1emaking:

Notice of receipt.

SUMMARY

The Commission is publishing for public comment a notice of receipt of* a petition for rulemaking which was filed with the Commission by the American College of Nuclear Medicine.

The petition was docketed by the Commission on January 14, 1992, and has been assigned Docket No. PRM-35-10.

The petitioner requests that the commission amend its regulations regarding confinement, safety instructions, and precautions used for patients receiving radiopharmaceuticalstherapy-in amounts greater than 30 millicuries.

DATE:

Submit comments by (60 days after publication in the Federal Register).

Comments received after this date will be considered if it is practical to do so but the Commission is able

2 to assure consideration only for comments received on or before this date.

ADDRESSES:

Submit written comments to the Secretary of the commission, U.S. Nuclear Regulatory commission, Washington, DC 20555, Attention: Docketing and service Branch.

For a copy of the petition, write: Rules Review Section, Regulatory PUblications Branch, Division of Freedom of Information and Publications services,*Office of Administration, u.s. Nuclear Regulatory Commission, Washington, DC 20555.

Telephone: 301-492-7758 or Toll Free:

800-368-5642.

The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar, Chief, Rules Review Se~tion, Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, u.s. Nuclear Regulatory commission, Washington, DC 20555, Telephone: 301-492-7758 or Toll Free: 800-368-5642.

SUPPLEMENTARY INFORMATION:

Background

on January 14, *1992, the Nuclear Regulatory Commission (NRC)

/

3 docketed a petition for rulemaking submitted by the American College of Nuclear Medicine.

'l'he petitioner requested amendments clarifY.ing to 10 CFR Part 35 by -deleting the requirement for 1MH'tdtteed confinement hosp~l:1/4tsft1/4en for ambulatory patients receiving oral or IV radiopharmaceuticals in amounts greater than 30 millicuries and allowing patients the option to be treated on an outpatient basis if they qualify medically.

The petitioner states that the requested amendment is in the best interest of patients who require access to affordable quality care and that scientific published data support the changes requested b~ the petition as consistent with protection of the public as stated in 10 CFR Part 35.

Petitioner's Request -

The petitioner requests the NRC to revise 10 CFR Part 35 to-1 35.75 (1)

Delete the requirement.in 10 CFR 35.~(a) (2) that licensees may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until the activity in the patient i~ less than 30 millicuries; (2)

Amend §35.75 (a)(2) to allow for an outpatient option confinement instead of mandating hoep!~tt:i:lta~ for patients receiving oral or IV radiopharmaceuticals in amounts greater than 30 millicuries.

I

rJr

• 4 Reasons for Petition Section 35.75 prohibits an NRC medical use licensee from releasing from confinement for medical care any patient administered a radiopharmaceutical until certain criteria are met.

one of the criteria is that the activity in the patient is less than 30 millicuries.

'l'he petitioner believes that the clarified regulation should be_-ehetftgeti-to allow for temporary home confinement.ine~ead-of-metftCHtM-ng-hospi~at.3/4oft. The petitioner claims that with the advent of monoclonal radiolabelled and other new radiopharmaceuticals diagnosis and antibodiesAfor diagnosis and treatment, outpatient~therapy would provide efficient care and allow costs to be minimized without increased risk to the public.

'l'he petitioner also states that published scientific papers attest to the safety of outpatient radiopharmaceutical therapy in doses of up to 400 millicuries of I-131 NaI.

conclusion The petitioner states that, if this petition is granted, it would benefit patients by_ giving them affordable quality care diagnosed and while allowing them to bel\\treated on an outpatient basis instead of being confined to a hospital.

The petitioner claims that diagnosing and scientific studies support the finding thatl\\treating patients on an outpatient basis with radiopharmaceuticals in doses greater

5 than 30 millicruries ~ould not create a saf~ty hazard to the public.

Oated at Rookvill\\\\, Maryland, this ~

day of kAlU!..~, 1992.

For the Huolear*Regulatory connnisaion,

~.

J.~ C9t.~~

Secrata,:,Y ~the eommission,

.........