ML20044A757
| ML20044A757 | |
| Person / Time | |
|---|---|
| Issue date: | 05/03/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Patterson E HOUSE OF REP. |
| References | |
| FRN-55FR1439, RULE-PR-35 CCS, NUDOCS 9007020193 | |
| Download: ML20044A757 (1) | |
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UNITED STATES 3-
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May 3,1990
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The Honorable Elitabeth J. Patterson United States House of Representatives
-Washington, DC 20515
Dear Congresswoman Patterson:
Thank you for your letter of April 10, 1990, regarding comments by Dr. Mark C.-
Bruels of Greenville, South Carolina on proposed amendments to 10 CTR Part 35..
The Nuclbar Regulatory Commission published a proposed rule on January 16, 1990,-
on " Medical Use of Byproduct Material" that would require medical use licensees-to implement a basic quality essurance program-and that would modify the-reporting and recordkeeping requirements.
The public.coment period closed April 12, 1990. To date, we have received 66:public comment. letters, including Dr. Bruels' letter which was enclosed with your letter.
The issues raised by the public comments will k' evaluated and used in developing a. final rule.
In addition, we are conducting a pilot program to try out the proposed performance based:regelatory requirements using about 65 volunteer medical use licensees from across the United Stetes.
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experience, evaluations, and suggestions-will also be used in developing a final rule.
I want to assure you that Dr. Bruels' coments will be-considered with the other public comments in developing a final. rule.
I trust that the above information is responsive to your request.
Sincerely, c
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Mr. Kenneth carr chairman Nuclear Regulatory Commission 11555 Rockville Pike-Rockville, Maryland 20852
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Dear Mr. Carr:
j I am writing on behalf of a constituent, Dr.. Mark C.
- Bruels, l
regarding the Commission's proposed rules on quality-assurance.
As you can see from the attached correspondence, Dr. Bruels raises a number of significant issues about the-proposed-rules.
His comments focus on the burdensome nature of the regulations-and the requirement of duplicative efforts-by rare medical physics personnel.
Dr. Buels is also concerr.ed-about the-penalty provisions of the new rule.
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I would appreciate your-givingtDr. Buels' views careful-l consideration as the Commission considers' issuing'a final: rule.
If I can provide additional information, please do not hesitate to contact me or Eric Spitler of my staff.
3 Cordially
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Mark C. Bruels, Ph.D.
500 Wenwood Road 1811 Greenville,.SC 29607 April 4, 1990 Secretary Nuc1 war Re5ulatory commission Washin5 ton, DC 20555 Attention:
Docketing and Service Branch
Dear Mr. Secretary:
I have had the opportunity to review proposed ruler to CFR part 35 RIN 3150 - Ac65.
I am extremely upset because less a an a year ago your pertonnel came to a professional American College of Medical Physics meeting and publicly stated that while there were proposed rules coming regarding Quality Assurance, these rules would simply state there should be a Quality Assurance Pro 5 ram.
The rules in their current proposed form can hardly be taken as that.
1_ find these rules to be unacceptable for. many reasons, far more than I can put into one letter.- First,,according to_your own information, there are only minimal numbers of risk events that you are attempting to control.
Further, you are definin5 #8. medically significant such insignificant doses as i KEM-to any organ of the. body from diagnosis or doses as low as 50 to 100 RAD-for cancer therapy patients.
These questions alone are far beyond your purview, and I feel that. to encode such nuitbers in Federai law is extremely poor regulations policy; You state that you have the support of professional organizations'in developing these rules.
Could you please list such support 7-There is no. professional support that I know of from the Physics community, rather_ total' opposition.
In your introductory explanation.to these', you claim you'reco5nise that all medien1 use should be planned with the realization that. individuals sake isistakes.
Yet in your enforewment you state clearly you view-the occurrence of a misadministration or other reportable events as-evidence of inadequate quality assurance in the medical use'of by product material and may subject the licensee to enforcement action;.This pair of statements is totally inconsistent.
This approach will cause a tendency to hide errors.
This is an undesirable effect.
Further, this will beg the le5a1 question as to whether or not there is. a matter of implied'11 ability inherent in the actions of an individual.
If an individual has1done everything that a prudent man woul'd do,.he may generally be judged in a court'of law to be found innocent of wrong doing.
However, commission of a simple error will be adequare for his civil prosecution with fiscal fines -
and other regulatory penalties according to your intentions.
To me this contradicts our basic Constitutional rights.
There are many questions of medical judgement that you enter into.. As 'I ass a physicist I will not comment on those, and-I am certain that many-physicians will comment on them.
I will reserve my comments regarding your g?
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April 2, 1990 Page 2
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ting of computer.
attempts to codify good practice regarding acceptance'tesfor a mandatory second opinion prograns'and your strange requirement Any Physicist, who is functioning regarding calibration of Cobalt Units.
grams *which.
in the accepted manner, does acceptance testing on computer proh t you.
are' uned in radiation therapy. treatment planning. ;The. program t aIt does-not outline is good in so far as it goes.to codify an adequate check'out procedure, course.
If you were to attempt What you hava done now is wrong in that onceand thus, you would fail totally.
someone has done this much they will stop,You should forget trying to make this a be checked;out by mediocrity into regulation again.
-Good practice requires that'such programsSince you feel you requirement.
individual users.-
inspections, then you might put in an item-that states: You have also-d.
progra=s have been checked out by a qualified expertdoubled th Thisfis not requiret a second independent calibration of a' Cobalt Unit.M To my independent evaluations of their prograas automatically follow.'
acceptable.
knowled c. only one event has occurred that could have been prevented S
Since that event, Physicists always regarding cobalt miscalibration.
double check their own work. if they are following good practicei h
procedures, and it You can not codify that due to its changin5-professional community.But this good practice standard is -that which is chec
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nature.
by Courts of Law, In summation, while I could go on for many pages, I find that this
'It is clear-truly have the patient' interest at heart.
i f items so-ragulation does notthat you are attemptin5 to develop an expanded laundry l st o j
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inspections,..
I that you can check them off when you come in to do your Youcare doing But your approach is wrong.
What that an increasing burden to already over burdened personnel.
something necessary.
l i imal.
translates to is that we will spend our time doing these m n f doing requirements, double checking the minimal requirements.;instead o l
our jobs as we define them.
What you should be doing is spending your areas of endeavor in a hospital.
bud et e.rying to' find ways of improving use of-nuclear energy a
S restricted field where developments are being choked off. by increasin medical environments.
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federal burdens and decreasing available income.
l Thank you for your time in reading this letter.
Sincerely, l
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Mark C. Bruels. Ph.D.
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