ML20034D476
| ML20034D476 | |
| Person / Time | |
|---|---|
| Issue date: | 09/08/1992 |
| From: | Bernero R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20034D477 | List: |
| References | |
| NUDOCS 9209300129 | |
| Download: ML20034D476 (4) | |
Text
e:
~
,]
,.. r' ^ I
^
- .n asr\\
/
UMTED STATES 4-I NUCLEAR REGULATORY COMMISSION p
- \\, e...
- h]
{
wAsmworow o.c.zonas g
SEP 0 81982 i
MEMORANDUM FOR:
James M. Taylor Executive Director for Operations i
FROM:
Robert M. Bernero, Director Office of Nuclear Material Safety j
and Safeguards l
SUBJECT:
MANAGEMENT PLAN FOR THE REGULAU ON OF THE MEDICAL USE OF BYPRODUCT MATERIAL
%2c4y E i
At the Office of Nuclear Material Safety and Safeguards Management Conference held on August 3 and 4, 1992, it was decided to prepare a management plan for reassessment, guidance and new initiatives in the medical use program. This memorandum briefly describes how the plan will be developed its anticipated i
content and a schedule for submission to the Comission.
BACKGROUND The issues associated with the regulation of medical use of byproduct material are complex, dynamic and controversial. During the last two years, the Advisory Comittee on the Medical Uses of Isotopes (ACMUI), the Medical l
Comunity and Agreement States have taken strong exception to a number of aspects of our current regulatory program. As a result, the staff has comenced a reassessment of the medical use program and initiated a number of actions to address the more pressing problems.
In SECY-92-175 the staff cited the medical comunity's increasing concern about the extent of the Nuclear Regulatory Commission's regulation and its potential for interfering with the practices of medicine and radiopharmacy,'and described current activities including rulemaking to address some of the concerns.
A key component of the management plan is continuation of the staff initiatives previously identified to senior management and the Comeission, as well as which Rave emerged as the result of continuing interaction with the r iconeenity. The staff believes that these efforts will satisf faddress many of the issues raised by the medical comunity l
while i the-overall effectiveness of the medical' use' regulatory program. lla: addition to these initiatives, the staff has identified other program areas which should be reviewed to determine if substantial changes would improve the medic;al use program and further address concerns expressed by the medical community. Finally, there are likely to be other programmatic issues and alternative approaches to regulation not yet identified by the staff which should be evaluated and possibly changed.
l h
L fW
I f,
2 All of these issues need to be explored in detail with iffected parties.
Consequently, the development of this management plan is tied to certain key meetings with the ACMUI, the Agreement Status, NRC Regional Management and, ultimately, professional societies and representatives of the medical comunity.
In th final analysis, current initiativas and those already identified by the staff as requiring imediate attention, may be all that is required to address the concerns of the medical community. However, this plan will allow a thorough review of all aspects of the medical use regulatory program and result in a long-term, comprehensive approach.
PLAN DEVELOPMENT A.
An issues paper will be developed and distributed to the ACMUI.ad the Agreement States to serve as a starting point for discussion. The issues paper will display the issues without drawing conclusions.
It will provide staff identified issues and solicit identification of additional issues. The paper will also include a disctJsion of work currently underway and how the outcome might affect the issues.
B.
The issues paper will be discussed with the ACMUI and Agreement States during meeting. scheduled for late Octobtv. An objective will be to obtain, to the extent possible, collegial views on the issues and how they should be resolved. Following these meetings Headquarters and Regional management will meet to begin formulation of the management plan. The plan is scheduled to be forwarder! to the Comission in January 1993.
C.
The proposed medical use plan based on these initial efforts will be provided for Comission consideration and direction.
It will include the following:
A formulation of long term objectives and an umbrella policy under which those objectives are to be achieved. This will include a proposed redirection or amplification, if appropriate, of the current Medical Policy Statement.
A strategy for achieving the objectives which consists of:
Completion or redirection of ongoing activities intended to address regulatory changes petitioned by the medical cotmunity as well as those recently identified by the staff (refer to enclosure for lie,t).
Assessments based on periodic meetings with ACMUI, Agreement Statss, RRC Regional Management and the medical comunity to consider status, direction and improverient of the program as well as staff assessment of perfonnance under recently adopted programatic changes.
Identifying, ovaluating and, if appropriate, undertaking new initiatives resulting from periodic s',sessments.
l
..j l
1 l
3 Provision for an annual update and modification of the plan, a i
report to the Comission, and adjustment based on Comission i
direction.
KEY MILESTONES FOR THE PLAN:
Issues paper, September 1992.
Meeting with Agreement States. October 1992.
Meeting with ACMUI, October 1992.
t Heating with NRC Regional Management, November 1992.
Complete Plan for Comission Consideration, January 1993.
Continuation of activities listed in enclosure (ongoing).
- w Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
1 Related Staff Activities l
Currently in Progress i
I t
i
-i tejws. #
t O h,'
Q~
+
~.p I
~
1{
ENCLOSURE RELATED STAFF ACTIVITIES CURRENTLY IN PROGRESS 1.
Radiopharmacy Rulemaking in response to ACNP/SNM Petition 2.
Preparation of Inspection and Enforcement Guidance for the QM Rule 3.
Contract to review submitted QM Programs 4.
Completion of Broad Scope Guidance including Standard Review Plan 5.
Public meeting with ACNP/SNM to explain QM Rule and ACNP Audit Program 6.
Truncation of recordkeeping requirements for Interim Rule 7.
Review and modification of Abnormal Occurrence Reporting Criteria for medical events 8.
Rulemaking to cover administration of byproduct material to pregnant and breast-feeding women 9.
Release Criteria for Radioactive Patients In addition to these efforts, three research projects are underway with the National Laboratories designed to examine the safety aspects of the use of medical devices. These are all basically safety analyses of high dose devices and procedures. This work will continue but recognizing the possible need for redirection. These projects include:
1.
Quality Assurance P?an for the Gamma Knife 2.
Quality Assurance Plan for Remote Afterloaders, and 3.
Misadministration Events Analysis Similarly, Human Factors studies are to be conducted by the Office of Research in the areas of teletherapy and brachytherapy. Techniques of risk analysis are also being examined to determine their utility in the regulation of the medical use of byproduct materials. These also are subject to redirection in the plan.
One initiative currently underway by the staff and our Visiting Medical fellow, Dr. Pollycove, is that of reassessing the training and experience criteria for physician authorized users. This project will continue through information gathering and additional meetings with the ACMUI.
O h.'s t
9
. _ _ _ _