U.S. Nuclear Office of Nuclear NUREGIBR-0117

Regulatory Material Safety No. 95-2

Commission and Safeguards June '95 IJuly '95

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APPOINTMENT OF COMMISSIONER

JACKSON

On April 6, 1995, the United States Senate confirmed the appointment of Dr. Shirley Ann

Jackson as a member of the Commission.

Dr. Jackson succeeds Dr. Forrest J. Remick,

whose term as Commissioner expired on June 30,

1994. In addition, Dr. Jackson will become the

next Nuclear Regulatory Commission Chairman

effective July 1.

Dr. Jackson brings to the Commission extensive

experience in research and management in the

areas of high-energy physics, nuclear physics, and

condensed-matter physics, as well as high-level

policy experience in business and higher education. Since 1991, she has been a Professor of

Physics at Rutgers University, New Brunswick,

New Jersey, and served as a consultant to AT&T

Bell Laboratories, where she had previously

worked from 1976-1991. In the mid-1970's, she

was a research associate at the Fermi National

Accelerator Laboratory in Batavia, Illinois, and a

Visiting Scientist at the European Organization

for Nuclear Research in Geneva, Switzerland.

Dr. Jackson earned her Bachelor's degree in

1968 and her Ph.D. degree in 1973 from the

Massachusetts institute of Technology (M. I. T),

where she became the first African-American

woman to receive a doctorate from M.I.T in any

field. Dr. Jackson is a native of Washington, D.C.

Dr. Jackson's appointment to the Commission

became effective on May 2, 1995. She and

members of her transition staff can be reached at

(301) 415-1820.

NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSING BUSINESS

PROCESS REENGINEERING

In October 1994, the NRC staff began to examine

the process used to issue materials licenses, to

identify ways to improve the process. The staff

was directed to develop a new licensing process

that would1. Maintain or raise the level of public safety;

2. Perform licensing reviews and associated tasks

an order of magnitude faster than the current

process;

3. Exploit modern information technology; and

4. Reduce the resources needed to carry out the

licensing program.

The method used for this examination is called

Business Process Reengineering (BPR). BPR is

the process of fundamentally changing the way

work is performed, to achieve significant

improvements in speed, cost, and quality. In the

first phase of this effort, a core team of people

who work in licensing, administration, and

information technology developed a generalized

design of a new materials licensing process. Soon

the core team and others will begin the detailed

design, building, and testing of the new process.

Implementation of NRC's new licensing process is

scheduled to begin in 1996.

The core team found that today, licensing is being

accomplished by a complex process that can

involve anywhere from 54 to 94 handoffs among

involved individuals and computer systems during

a routine license review. On average, NRC takes

84 days to complete a licensing action. Yet only 2

days are actually needed to complete the technical

safety review of a typical licensing request. During

the remaining 82 days, paper is either in transit or

(Contact: Kevin Ramsey, NMSS, 301-415-7887) a queue.
NMSS LICENSEE NEWSLETER -

JUNE-JULY 1995

Page

1. Appointment of Commissioner Jackson

(Contact: Kevin Ramsey, NMSS,

(301-415-7887) .......... 1

2. Nuclear Regulatory Commission

Materials Licensing Business

Process Reengineering (Contact:

Donald A. Cool, NMSS, 301-415-7197) .... 1

3. Status of the Enhanced Participatory

Rulemaking (Contact: Michael Weber,

NMSS, 301-415-7297) ........... .......... 3

4. Brachytherapy Issues Paper (Contact:

Patricia Holahan, NMSS, 301-415-7847) ... 4

5. Enforcement Policy Task Force Review

(Contact: E. William Brach, NMSS,

301-415-7196) ........................... 4

6. Certification of Radiography

Equipment (Contacts: Bruce Carrico,

NMSS, 301-415-7826; Michele

Burgess, NMSS, 301-415-5868) ............ 5

7. Transmission Source-Holding Devices Used

in SPECT Imaging (Contact: Janet Schlueter,

NMSS, 301-415-7894) ......... ........... 6

8. Semi-Annual Meeting of the Advisory

Committee on the Medical Uses of

Isotopes (Contact: Torre Taylor, NNSS,

301415-7900) ........................... 6

9. Review and Inspection of Implemented

Quality Management Programs (QMPs)

(Contact: Sally Merchant, NMSS,

301-415-7874) ........................... 7

10. NMSS Completes Regulatory Impact

Survey (Contact: Paul Goldberg, NMSS,

301-415-7842) ........................... 7

11. Availability of Videotapes (Contact:

Harriet Karagiannis, AEOD,

301-415-6377) ........................... 8

13. Generic Communications Issued

(General Contact: Kevin Ramsey, NMSS,

301-415-7887) ........................... 9

14. A Sampling of Significant Events

Reported to NRC by NRC Material

Licensees (First Quarter CY 1995)

(Contact: Walter Lescheck, AEOD,

301-415-6365) ........................... 9

15. A Sampling of Significant Enforcement

Actions against Materials Licensees

(Contact: R. Joseph Delmedico, OE,

301-415-2739) .......................... 10

16. Formation of Interagency Steering

Committee on Radiation Standards

(Contact: Phyllis A. Sobel, NMSS,

301-415-6714 .......................... 11

Comments, and suggestions you may have for

information that is not currently being included,

that might be helpful to licensees, should be sent to:

E. Kraus

NMSS Licensee Newsletter Editor

Office of Nuclear Material Safety

and Safeguards

Two White Flint North, Mail Stop 8-A-23

U.S. Nuclear Regulatory Commission

Washington, D.C. 20555-0001

I

On June 16, 1995, the Commission directed the

staff: (1) to proceed with the detailed design and

testing of the new licensing process; (2) to coordinate its efforts closely with the Agreement

States, licensees, and the public; (3) to separate

the payment of fees from the process of issuing a

license and continue streamlining fees; and (4) on

a one-time basis, to extend qualified licenses for

an additional 5 years.

12. Federal Register Notices (February 1,

1995-May 1, 1995) (General Contact:

Kevin Ramsey, NMSS, 301-415-7887) ...... 8

2
Proposed New Licensing Process and

Coordination Efforts:

The staff proposes to use a graded approach that

matches the safety hazards associated with a

license application. Applications for relatively

simple actions would go through an automated

review process. The automated review process

uses artificial intelligence-assisted review scripts

to help reviewers in rapidly determining if the

application conforms with established NRC

regulations and licensing policies. Any unanticipated circumstance or any improper or

incomplete response would automatically alert the

reviewer and require separate action for

resolution. This system would significantly alter

the current practice of using technical staff to

review well-established and relatively low-risk uses

of licensed materials.

Applications for more complex uses would be

reviewed by trained technical reviewers, working

either individually or in teams. The staff plans to

develop a new set of tools for reviewers to

facilitate consistent, high-quality reviews. These

tools include a single, comprehensive licensing

manual that consolidates all NRC regulations and

guidance in one easily accessible form. This

licensing manual will be made available to the

Agreement States, the public, and licensees in

both hard copy and electronic media (e.g., a

bulletin board), when it is completed later this

year.

The staff plans to hold various meetings and

workshops to get input from Agreement States,

licensees, and the public, and will issue

announcements when these plans are finalized.

Streamlining Fees:

The staff is working on a proposal that would

separate the collection of fees from the issuance

of a license and would also streamline fee

collection.

One-time Extension of Qualified Licenses:

To provide the resources needed to develop a

consistent Nuclear Material Safety and Safeguards policy on the duration of licenses and

certificates, carry out the detailed design and

testing of the new process, and develop the

licensing manual, the staff is proposing, on a

one-time basis, to extend all qualified byproduct,

source and some special nuclear material licenses

by 5 years. Each extended license would include

the same authorizations and limits that it does

now. Licenses would be considered qualified for

the extension if the authorized activities pose a

low safety risk and the results of the most recent

inspection are good. Licenses that fall into one or

* more of the following categories would not be

considered for license extension: (1) Any license

that requires an emergency plan; (2) Any license

lacking acceptable decommissioning financial

assurance; (3) Any license currently listed on the

Site Decommissioning Management Plan list;

(4) Any license for which an environmental

assessment is needed or has been prepared; or

(5) Any license subject to a significant enforcement action as a result of the most recent

inspection (i.e., an Order, a Severity Level I, II, or

III violation, a Confirmatory Action Letter, etc.).

NRC will publish the proposed license extension

criteria for comment soon.

(Contact: Donald A. Cool, NMSS, 301-415-7197)

STATUS OF THE ENHANCED

PARTICIPATORY RULEMAKING

The U.S. Nuclear Regulatory Commission has . been conducting an enhanced participatory

rulemaking to establish radiological criteria for

decommissioning. The proposed rule was

published in the Federal Register (59 FR 43200;

August 22, 1994) as proposed amendments to

10 CFR Part 20. The rulemaking was scheduled to

be completed in June 1995. However, because of

the substantial comments received on the proposed rule, the NRC staff now plans to submit the

rulemaking package for Commission review in

December 1995. Commenters raised a variety of

concerns, including the justification for selecting

0.15 millisievert (15 millirem) per year as the dose

limit for unrestricted use, and the large costs

associated with remediation of contaminated soil

and groundwater. The staff plans to conduct a

multi-day public workshop in the Washington,

DC, area in early September 1995, to discuss the

issues raised by the comments, describe current

staff evaluations based on real-world data, and

explore alternative approaches that could be used

to implement the final criteria. A Federal Register

notice about the workshop should be published by

July.

NRC staff is also cooperating with the U.S.

Environmental Protection Agency (EPA) in that

agency's development of residual radioactivity

standards. EPA circulated a preproposal draft

version of its standards in May 1994. Many of the

same issues raised in the public comments on

NRC's proposed rule were also raised about

EPAs draft standards. The objective of the agency

discussions is to allow EPA to find that NRC's

requirements provide sufficient protection of the

3
public and the environment. Based on such a

finding, EPA would exclude NRC and Agreement

State licensees from the scope of its standards.

In the interim, until NRC promulgates radiological criteria for decommissioning in 10 CFR

Part 20, NRC will continue to use the criteria

identified in the 'Action Plan to Compel Cleanup

of Site Decommissioning Management Plan

Sites," which was published in the Federal Register

on April 16, 1992 (57 FR 13389).

(Contact: Michael Weber, NMSS, 301415-7297)

BRACHYTHERAPY ISSUES PAPER

The U.S. Nuclear Regulatory Commission is

currently in the process of reviewing the medical

use of byproduct material for brachytherapy, with

regards to the adequacy of existing regulations,

standards, and procedures. The need for

additional regulations and guidance for brachytherapy was discussed by the staff with NRC's

Advisory Committee on Medical Uses of Isotopes

(ACMUI). The ACMUI advised the staff to solicit

additional information from the regulated

community to sufficiently identify and evaluate

the problems and determine what additional regulations and guidance may be necessary

to further prevent errors. On November 3, 1994,

NRC published a Federal Register Notice (59 FR

55068) requesting comments from the medical

community on a list of issues and questions regarding those areas of medical use of byproduct

material, primarily brachytherapy, that are

currently being reviewed by NRC, to determine if

additional or modified regulations or guidance are

warranted. In addition, NRC conducted symposia

at the annual meetings of the Radiological Society

of North America and the American Brachytherapy Society.

The staff has developed an issues paper to

describe the background and issues that would be

associated with efforts to address brachytherapy,

either for future regulations and/or guidance. The

issues are categorized into three major topic

areas: all brachytherapy, remote afterloading

(RAL) brachytherapy, and manual brachytherapy.

Within these broad topic areas, the issues include

modification of the specific listing of brachytherapy sources and uses in 10 CFR 35.400;

specific licensing guidance and license conditions

for high-dose-rate (HDR) RAL that are not

explicitly addressed in the regulations; quality

assurance checks and calibrations for RAL

brachytherapy similar to teletherapy; computer

treatment planning; review of current brachytherapy definitions; training and experience;

pulsed-dose-rate brachytherapy; and mobile HDR

brachytherapy. This paper was discussed in detail

with the ACMUI in May 1995 and will be the

basis for future discussions with professional

societies and organizations.

(Contact: Patricia Holahan, NMSS, 301415-7847)

ENFORCEMENT POLICY TASK FORCE

REVIEW

On May 13, 1994, the Executive Director for

Operations established a task force to assess the

U.S. Nuclear Regulatory Commission enforcement

program. The charter asked the task force to

consider: (1) whether the defined purposes of the

program are appropriate; and (2) whether NRC's

enforcement practices and procedures are

consistent with those purposes. Over the last year, meetings were held with NRC regional and

Headquarters offices, and various Federal

agencies. Relevant documents were reviewed,

including applicable statutes and regulations,

NRC policies and procedures, previous

assessments, responses to requests for comment

in the Federal Register, and policies of other

Federal and State agencies.

On April 6, 1995, the Enforcement Policy Task

Force provided its report and recommendations

to the Commission for review and approval. The

task force concluded that the existing NRC

enforcement program, as implemented, is

appropriately directed toward supporting the

Agency's overall safety mission. The task force

also found, however, that the existing program, at

times, provides mixed regulatory messages to the

licensees, and room for improvement exists in

both the enforcement policy and its implementation. The task force recommended that

the overall program should be clarified to:

(1) emphasize the importance of identifying

problems before events occur, and of taking

prompt, comprehensive corrective action when

problems are identified; (2) direct Agency

attention to licensees with multiple enforcement

actions in a relatively short period; and (3) focus

on current performance of licensees. The report

recommends significant changes in the methods

and processes used to determine when civil

penalties should be considered and how the

amounts of civil penalties are calculated. The

following specific recommendations were made:

Severity Levels - NRC should continue to use a

graduated system of enforcement actions, in a

manner that reflects the varying safety

significance of different violations, and that can

be adjusted based on the circumstances of the

r

4
violation. Severity Level (SL) V violations should

be eliminated. Formal enforcement actions should

only be taken for violations categorized at SL I to

IV. Minor violations, if documented, should be

treated as Non-Cited Violations.

Enforcement Conferences - Enforcement conferences should be considered when the Agency

reasonably expects that an escalated enforcement

action will result, and additional information is

needed to make an enforcement decision.

Enforcement conferences should normally be

public meetings held in regional offices.

Civil Penalties - Applied with discretion and

judgment, civil penalties (CPs) can provide an

effective deterrent against future violations. With

limited exceptions, the task force recommended

maintaining the existing base CP amounts. Once a

violation has been determined to be SL III or

above, the CP assessment process should consist,

at most, of four basic decisional points: (1) consideration of previous escalated enforcement

action, (2) credit for identification, (3) credit for

corrective actions, and (4) exercise of discretion.

These four points are discussed below.

1. Consideration of Previous Escalated Action - When NRC determines that a non-willful SL

III violation has occurred, and the licensee

has not had a previous escalated action during

the past 2 years or two inspections, the only

consideration should be whether the licensee's

corrective actions for the present violation

may reasonably be considered prompt and

comprehensive (see discussion under 3,

below).

2. Credit for Identification - This decision requires considering who identified the problem,

whether the problem resulted in an event, the

ease of discovery, the degree of licensee

initiative shown, whether prior opportunities

existed to identify the problem, and other

similar factors.

3. Credit for CorrectiveActions - This factor

encourages licensees to (1) take the immediate

actions necessary, on discovery of a violation,

that will restore safety and compliance with

the requirement; and (2) develop and implement (in a timely manner) the lasting actions

that will not only prevent recurrence of the

violation at issue, but also prevent occurrence

of violations with similar root causes. In

assessing this factor, consideration will be

given to the timeliness of the corrective action,

the adequacy of the licensee's root-cause

analysis, and, given the significance and

complexity of the issue, the comprehensiveness of the corrective action (i.e., whether the

action is focused narrowly to the specific

violation or broadly to the general area of

concern).

4. Exercise of Discretion - The ability to exercise

discretion (in tailoring sanctions to the circumstances of each case) must be preserved.

The recommended approach provides for the

use of discretion to deviate from the normal

approach where necessary to ensure that the

sanction reflects the significance of the

circumstances and conveys the appropriate

regulatory message.

As of May 23, 1995, the Commission had not

taken action on these recommendations. Copies of

the task force report, 'Assessment of the NRC

Enforcement Program," can be obtained free, on

written request, from the Office of Administration, Distribution and Mail Services Section, U.S.

Nuclear Regulatory Commission, Washington, DC

20555-0001.

(Contact: E. William Brach, NMSS, 301-415-7196)

CERTIFICATION OF RADIOGRAPHY

EQUIPMENT

Paragraphs (a) and (d) of 10 CFR 34.20 provide

that all newly manufactured radiographic

exposure devices and associated equipment

(manufactured after January 10, 1992) acquired by

U.S. Nuclear Regulatory Commission licensees

must meet the requirements specified in American National Standards Institute N432-1980

(ANSI-N432). Paragraph (e) of 10 CFR 34.20

provides that all equipment in use after

January 10, 1996, meet ANSI-N432 requirements.

One of the test criteria specified in ANSI-N432,

Section 8.9, is a prototype endurance test of the

entire radiography system and is intended to

ensure the integrity of the radiography system

(particularly the source assembly), and to ensure

that the system will remain operational after

20,000 operating cycles.

However, it has recently come to our attention

that this test criterion, as specified in ANSI-N432,

may not be reasonably attainable. Specifically, the

torque requirement specified in the ANSI test is

not attainable for two reasons. First, it exceeds by

a considerable amount the torque that an individual can likely exert on the radiography system.

Second, it would require that the typically used

drive cable (ype 187 teleflex cable) be operated

beyond the working load recommended by the

supplier of that component.

5
Four manufacturers of radiography exposure

devices and/or sealed source assemblies have

models ("newly-manufactured") approved and

registered as complying with the requirement.

However, even though the device/source assembly

manufacturers indicated that the devices/source

assemblies had been tested in accordance with the

ANSI provisions, the manufacturers used a more

attainable criterion. The staff is not aware of any

device problems occurring as a result of the use of

the alternative criterion. Nevertheless, because the

device/source assembly models were not tested as

specified in ANSI-N43Z these newly manufactured devices/source assemblies (and the licensees

who use them) are not in full compliance with the

regulation.

NRC is publishing in the Federal Register a final

rule revising 10 CFR Part 34 which becomes

effective 30 days after publication. The amendment includes language that relieves (exempts)

licensees from the requirement to comply with

Section 8.9.2 of ANSI N432-1980 when an

alternate and acceptable test criterion has been

applied. The amendment also includes a provision

that allows manufacturers to use engineering

analysis to demonstrate that a modest change in

an already approved design is acceptable without

the need to perform additional prototype tests.

The amendment is necessary to relieve licensees

from compliance with an impractical and

unnecessary test criterion that was required by

reference to ANSI-N432. Until the effective date

of the final rule, NRC staff has added a license

condition, as needed, that exempts the licensee

from the equipment torque test requirement.

Because the license condition is superseded by the

rulemaking action, the condition only remains in

force until the final rulemaking effective date.

Licensees who are authorized to use "newlymanufactured" equipment, identified as meeting

10 CFR 34.20 requirements, can continue to use

the equipment without requesting the exemption

license condition.

Any questions regarding the exemption condition

or the rulemaking should be directed to Bruce

Carrico, Office of Nuclear Material Safety and

Safeguards (NMSS). For questions concerning the

applicability of 10 CFR 34.20 to a particular

device, contact Michele Burgess, NMSS.

(Contacts: Bruce Carrico, NMSS, 301-415-7826

Michele Burgess, NMSS, 301-415-5868)

TRANSMISSION SOURCE-HOLDING

DEVICES USED IN SPECT IMAGING

Recently, Ohio Imaging submitted a request to

the U.S. Nuclear Regulatory Commission for a

sealed source and device review of a device used

with SPECT imaging systems, referred to as a

"STEP" device. The STEP device received 501(K)

approval by the Food and Drug Administration

(FDA), and NRC recently approved the STEP

device for use as described below. The sourceholding device is a shutter shield affixed to the

rotating gantry of a tripleheaded scintillationcamera patient-imaging system and contains

either a Technetium-99m, Cobalt-57, or

Gadolinium-153 source, of various activities. The

purpose of the device is to provide, during image

acquisition, a photon beam of differing energy

from that administered to the patient, to improve

resolution loss caused by non-uniform absorption

in the patient. In other words, it acts as a thickness compensator to improve image resolution. A

similar device, manufactured by ADAC and

referred to as "VANTAGE," is currently undergoing a 501(K) review by the FDA. The State of

California is performing the sealed source and

device review of the VANTAGE device. The

STEP and VANTAGE devices function essentially

the same; however, the VANTAGE devices use a

higher-activity source.

Licensees are reminded that these devices do not

meet the definition of either a calibration or

reference source (authorized by 10 CFR 35.57) or

a sealed source for diagnosis (authorized by

10 CFR 35.500). Therefore, if you are using the

STEP or VANTAGE device, or a similar device,

you must submit a request to amend your license

to authorize the possession and use of such

devices. If the device for which authorization is

sought has not undergone a sealed source and

device review by either NRC or an Agreement

State, either the requesting licensee or

manufacturer of the device must submit the

required information, for a sealed source and

device review to occur. Once the sealed source

and device review is completed and the device is'

registered, either by NRC or an Agreement State,

the license will be amended to authorize its

possession and use.

(Contact: Janet Schlueter, NMSS, 301-415-7894)

SEMI-ANNUAL MEETING OF THE

ADVISORY COMMITTEE ON MEDICAL

USES OF ISOTOPES

The U.S. Nuclear Regulatory Commission's

Advisory Committee on Medical Uses of Isotopes

. .

6
(ACMUI) held its regularly scheduled

semi-annual meeting on May 11 and 12, 1995, at

the NRC Headquarters office in Rockville,

Maryland. Agenda items included a discussion of:

brachytherapy issues; guidance documents for the

final Radiopharmacy Rule, and a petition to

review the final Radiopharmacy Rule; prostate

implant procedures; training and experience of

authorized users to allow exemptions to Subpart

J; dose ranges in written directives; information

on Sr-90 calibration errors for eye applicators;

and revisions to Regulatory Guide 10.8. The staff

discussed the status of the implementation of the

Quality Management Rule; provided an update of

the study of the medical use program by the

National Academy of Sciences; and presented a

summary of "Business Process Reengineering." In

addition, NRC staff provided an update on

several rulemakings: "Medical Administration of

Radiation and Radioactive Materials"; "Release of

Patients Containing Radiopharmaceuticals or

Permanent Implants"; and 'Administration of

Byproduct Material or Radiation from Byproduct

Material to Patients WVho May be Pregnant or

Nursing."

Copies of the transcripts and summary minutes

for the meeting are available through the Public

Document Room, at 202-634-3273. The next

meeting of the ACMUI will be held in October

1995, and will be noticed in the Federal Register:

(Contact: Torre Taylor, NMSS, 301-415-7900)

REVIEW AND INSPECTION OF

IMPLEMENTED QUALITY MANAGEMENT

PROGRAMS (QMPs)

Since August 1, 1994, U.S. Nuclear Regulatory

Commission inspectors have been reviewing both

the written and implemented QMPs as part of the

inspection of applicable medical use programs.

Based on NRC inspectors' findings, it is apparent

that the majority of licensees have implemented

programs that meet (or nearly meet) the requirements described in the Quality Management

Program and Misadministration Rule (10 CFR

35.32). However, the inspection findings indicate

that a few licensees do not have procedures in

place to ensure that final plans of treatments and

related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are

in accordance with the respective written directive

(objective 3 of the rule), and that each administration is in accordance with the written directive

(objective 4). Most licensees inspected are reviewing their QMP within each 12-month period.

However, the inspectors have identified a number

of recordable events that had not been previously

identified by the licensees during their reviews.

All the inspection findings have been entered into

a database to be used to evaluate the implementation of the Quality Management rule.

(Contact: Sally Merchant, NMSS, 301-415-7874)

NMSS COMPLETES REGULATORY IMPACT

SURVEY

The Office of Nuclear Material Safety and Safeguards (NMSS) has completed a mail survey of

licensees to determine the impact of NRC

regulation on safety and operations. In the first

phase of the Regulatory Impact Survey of

Materials Licensees, the staff interviewed representatives of nine large licensees and reported to

the Commission the results of the interviews and

possible changes in the regulations based on those

results. The objective of the second phase of the

Regulatory Impact Survey is to obtain the views of

a broader range of licensees on the impact of

NRC regulation on licensee operations. The staff

will report to the Commission shortly on the

results of this second phase.

With the assistance of a contractor, the staff

developed a self-administered, mail-out survey

questionnaire based on the interview protocol

used in the first phase of the survey. The

questionnaire covers five aspects of regulation:

(1) Regulations, Policies, and Guidance;

(2) Licensing; (3) Inspection; (4) Reporting; and

(5) Enforcement. Staff chose a stratified, random

sample design for the survey to sample a wide

range of licensee categories while giving greater

weight to certain categories (i.e., sampling a larger

number within the category) based on relative

hazard, heterogeneity within categories, and

regulatory issues in the various categories.

Licensees with recent interactions with NRC (half

for inspections and half for licensing actions) were

selected at random for the sample.

Almost 600 questionnaires were sent to licensees.

A total of 371 licensees returned completed

questionnaires for a response rate of 63 percent,

distributed across the licensee categories.

Licensees were grouped into the following nine.

categories on the basis of the type of operation:

Academic

Medical Institution

Medical Other

Well Logging

Gauges

Manufacturing/Distribution

Services

7
Industrial Radiography

Research and Development

The surveys were confidential; neither NRC nor

the survey analysts were able to associate

licensees with the responses. The responses were

analyzed statistically, using computer software,

and responses to open-ended (write-in) questions

were also analyzed. The contractor's report

summarizes the results of these analyses, using

text and supporting graphs, tables, and charts,

and suggests a number of areas in which NRC

may consider changes. The results were analyzed

both in overall terms and by licensee categories.

The survey yielded a number of findings significant for the materials regulatory program,

involving usefulness of regulations and guidance,

timeliness of licensing actions, performance of

license reviewers and inspectors, and open

communication with licensees. These findings

point to areas for assessment of the program and

for future monitoring. Staff expects to address

licensee concerns identified in the Regulatory

Impact Survey through existing initiatives. The

staff is considering the best means, given available

resources, for eliciting licensee views of NRC

regulation on a regular basis.

The contractor's report of the project is available

as NUREG/CR-6330. The staff's report to the

Commission is available as SECY-93-130.

(Contact: Paul F. Goldberg, NMSS, 301-415-7842)

AVAILABILITY OF VIDEOTAPES

Nuclear Regulatory Commission and Agreement

State licensees may obtain free videotapes that

have been sponsored by NRC. The purpose of the

videotapes is to illustrate the importance of good

practices and the safe use of radioactive material.

All requests must be made in writing and

addressed to:

Chief, Distribution and Mail Services Section

Mailstop O-P1-37

U.S. Nuclear Regulatory Commission

Washington, D.C. 20555-0001

or Faxed to 301-415-2260.

The videotapes are as follows:

1. "Good Practices in Preparing and

Administering Radiopharmaceuticals"

2. "Good Practices in Co-60 Teletherapy"

3. "Taking Control: Safety Procedures for

Industrial Radiography"

Contact:

Harriett Karagiannis, AEOD, 301-415-6377

FEDERAL REGISTER NOTICES

February 1, 1995 - May 1, 1995

FINAL REGULATORY GUIDES (NOTICE OF

AVAILABILITY)

Regulatory Guide 6.9, "Establishing Quality

Assurance Programs for the Manufacture and

Distribution of Sealed Sources and Devices

Containing Byproduct Material," 60 FR 12789,

March 8, 1995.

DRAFT POLICY STATEMENTS

"Freedom of Employees in the Nuclear

Industry to Raise Safety Concerns without

Fear of Retaliation," 60 FR 7592, February 8,

1995.

Contact:

James Lieberman, OE, 301-415-2741

PETITIONS FOR RULEMAKING (All Parts are

from 10 CFR.)

Part 20, "Steve Gannis, Denial of Petition"

(for 0.01 millisievert (1 millirem)/year public

dose limit), 60 FR 13385, March 13, 1995.

Contact:

Charleen T Raddatz, RES, 301-415-6215

Parts 170 and 171, 'American Mining

Congress; Denial of Petition" (for reduction of

fees), 60 FR 20918, April 28, 1995.

Contact:

Glenda C. Jackson, OC, 301415-6057

PROPOSED RULES (All Parts are from 10

CFR.)

Parts 170 and 171, "Revision of Fee Schedules;

100% Fee Recovery, FY 1995," 60 FR 14670,

March 20, 1995.

Correction, 60 FR 16589, March 31, 1995.

Correction, 60 FR 18882, April 13, 1995.

Contact:

James Holloway, OC, 301415-6213

Part 2, "Petition for Rulemaking; Procedure

for Submission," 60 FR 15878, March 28,

1995.

8
-.

Contacts:

T Y. Chang, RES, 301-4154450, or

Chris Rourk, RES, 301 415-5865

Parts 50 and 70, "Physical Security Plan

Format Changes," 60 FR 19170, April 17,

1995.

Contact:

Carrie Brown, NMSS, 301-415-8092

FINAL RULES (All Parts are from 10 CFR.)

Part 20, "Frequency of Medical Examinations

for Use of Respiratory Protection

Equipment," 60 FR 7900, February 10, 1995.

Contact:

Alan K Roecklein, RES, 301-415-6223

Parts 50, 55, and 73, "Reduction in Reporting

Requirements Imposed on NRC Licensees,"

60 FR 13615, March 14, 1995.

Contact:

Naiem S. Tanious, RES, 301-415-6103

Parts 20 and 61, "Low-Level Waste Shipment

Manifest Information and Reporting," 60 FR

15649, March 27, 1995.

Contacts:

William R. Lahs, NMSS, 301-415-6756, or

Mark Haisfield, RES, 301-415-6196

Part 2, "NRC Size Standards; Revision" (used

to qualify a licensee as a "small entity"), 60

FR 18344, April 11, 1995.

Contact:

Michael T Lesar, ADM, 301-415-7163

Part 20, "Standards for Protection against

Radiation; Clarification," 60 FR 20183, April

25, 1995.

Contacts:

Mary L Thomas, RES, 301-415-6230, or

Jayne M. McCausland, RES, 301-415-6219

Parts 2 and 7Z "Interim Storage of Spent Fuel

in an Independent Spent Fuel Storage

Installation at a Reactor Site; Site-Specific

License to a Qualified Applicant," 60 FR

20879, April 28, 1995.

Contact:

C. William Reamer, OGC, 301-415-1640

GENERIC COMMUNICATIONS ISSUED

February 1, 1995 - May 1, 1995

Note that these are only summaries of U.S.

Nuclear Regulatory Commission generic communications. If one of these documents appears

relevant to your needs and you have not received

it, please call one of the technical contacts listed

below.

Administrative Letters (ALs)

None.

Information Notices (INs)

IN 94-64, Supplement 1, "Reactivity Insertion

Transient and Accident Limits for High

Burnup Fuel," April 6, 1995.

This supplement to IN 94-64 provides addressees

with additional information on high-burnup

fuel-performance data acquired since the original

notice, and discusses NRC and industry actions.

Contacts:

L.E. Phillips, NRR, 301-415-3232

S. Wu, NRR, 301-415-3284

Bulletins (BLs)

None.

Generic Letters (GLs)

None.

A SAMPLING OF SIGNIFICANT EVENTS

REPORTED TO NRC BY NRC MATERIAL

LICENSEES (FIRST QUARTER CY 1995)

Event: Medical Brachytherapy

Misadministration

Date Reported: November 22, 1994

Licensee: Welbom Memorial Baptist

Hospital, Inc.

Evansville, Indiana

On November 18, 1994, a 73-year-old female

patient was prescribed to receive a brachytherapy

treatment dose of 600 centigray (cGy) (600 rad) at

the vaginal cavity using a GammaMed IHi highdose-rate (HDR) afterloading unit. However,

because of a treatment programming error the

patient received a 1250-cGy (1250-rad) dose

instead of the prescribed dose. The GanimaMed

Ili unit contained a nominal 370-gigabecquerel

[10-curie] iridium-192 sealed source.

9
The licensee identified the misadministration

during a quality management review on

November 21, 1994. The licensee reported the

event to the U.S. Nuclear Regulatory Commission

on November 22, 1994, and followed up with a

written report on December 6, 1994. The referring

physician was notified. The patient was notified

on November 23, 1994, by the licensee's Radiation

Safety Officer and was provided with a written

report of the incident.

An NRC medical consultant was retained to

evaluate the medical consequences of the misadministration. The medical consultant expressed

concern that long-term effects such as fibrosis or

loss of blood supply may occur as a result of the

1250-cGy (1250-rad) treatment. The medical

consultant also suggested that this case be considered for the U.S. Department of Energy

(DOE), Office of Epidemiology and Health

Surveillance long-term medical study program.

Information regarding the DOE program and a

copy of the NRC medical consultant's report were

provided to the referring physician.

The licensee concluded that the causes of this

misadministration were as follows: (a) the

technologist failed to activate a button that

automatically corrects for the treatment time

based on source decay, manually reentered the

treatment time instead, and failed to notice the

error message generated; and (b) the treatment

software, installed to prevent treatment data entry

errors, failed to prevent initiation of the

treatment, despite entry of erroneous data.

To prevent recurrence of the incident, the licensee

revised its internal procedure for all HDRs" to

require both individuals operating the unit to

verify the displayed time factor and compare it to the factor supplied by the manufacturer.

Before this misadministration, the device operators were required to verify only operatorentered data. Also, the unit was evaluated and the

printed circuit board (card) with the

read-only-memory integrated circuits containing

the defective software program was replaced with

a card having the correct software program.

No violations of NRC requirements were identified. As a result of the defective software

program, NRC sent a letter to all GammaMed Ili

users to inform them of this potential problem

and tell them how to test their software for the

defect.

Contact:

(Walter C. Leschek, AEOD, 301-415-6365)

A SAMPLING OF SIGNIFICANT

ENFORCEMENT ACTIONS AGAINST

MATERIALS LICENSEES

1. Forrest L. Roudebush, IA 95-03

An Order Prohibiting Involvement in U.S.

Nuclear Regulatory Commission-Licensed

Activities and Requiring Certain Notification

to NRC was issued based on deliberate

violations of NRC requirements, including

providing inaccurate information to NRC

inspectors and investigators, and untruthful

testimony before the Atomic Safety and

Licensing Board. The Order prohibits the

individual from becoming involved in licensed

activities for a period of 5 years from the date

that the NRC staff issued an immediately

effective Order suspending the license of the

company (October 17, 1991). After the 5-year

prohibition, the individual shall provide notice

to NRC of acceptance of any employment in

an NRC-licensed activity for an additional

5-year period.

2. Babcock and Wilcox Company, Lynchburg,

Virginia

Supplement VI, EA 94-169

A Notice of Violation and Proposed Imposition of Civil Penalty was issued based on two

violations involving: (1) two examples of the

failure to conduct activities involving licensed

material in accordance with established

nuclear criticality safety limits and controls;

and (2) two examples of the failure to adequately consider pertinent process conditions

and known modes of failure in establishing

these safety limits.

3. Material Testing Laboratories, Inc., Norfolk

Virginia

Supplement VI, EAs 94-244 and 95-003

An Order Modifying License (Effective Immediately) and Notice of Violation and Proposed

Imposition of Civil Penalty was issued based

on violations involving: (1) use of NRClicensed material by an unauthorized and

unqualified individual; (2) failure to perform

an adequate survey; (3) failure to maintain

direct surveillance of radiographic operations;

(4) failure to post the high-radiation area; and

(5) failure to post a radiography vehicle as a

radioactive material storage area. The Order

requires the licensee to: (1) retain and maintain the services of a Radiation Safety Officer;

(2) retain the services of an independent consultant; (3) have the consultant submit an

assessment report and quarterly audit;

10
(4) submit a response to each audit report;

(5) ensure that within 30 days of returning the

radiographer, who was involved in the

November 15, 1994, violations, to unsupervised work, an audit be conducted by the

consultant quarterly for a period of 1 year;

and (6) notify the regional office for a period

of 1 year-each week-of the location in

non-Agreement States where the radiographer

will be conducting radiography operations.

4. Veterans Affairs Medical Center, Memphis,

Tennessee, Supplement VI, EA 94-245

A Notice of Violation was issued based on a

violation involving a source found taped under

the center desk drawer of a physician's desk

in the nuclear medicine department. The root

cause of the violation was an apparent

deliberate failure to adhere to procedures for

the control of the source by a licensee employee. A civil penalty was not proposed

because the licensee identified the violation,

took prompt and extensive corrective actions,

and had good past performance.

FORMATION OF INTERAGENCY STEERING

COMMITTEE ON RADIATION STANDARDS

The U.S. Nuclear Regulatory Commission and the

Environmental Protection Agency (EPA) have

formed the Interagency Streering Committee on

Radiation Standards (ISCORS) to expedite the

resolution and coordination of regulatory issues

associated with radiation standards. This

committee was formed in response to October 27,

1994, letters from Senator John Glenn to NRC,

EPA, and the Office of Science and Technology

Policy (OSTP). ISCORS is an expanded version

of the Interagency Steering Committee on

Radiation Cleanup Standards. It is also one of

the committees recommended by OSTP to achieve

the goals of the former Committee on Interagency

Radiation Research and Policy Coordination

(CIRRPC). The objectives of the committee

include the following: (1) facilitate a consensus on

acceptable levels of radiation risk to the public

and workers, (2) promote consistent risk

assessment and risk-management approaches in

setting and implementing standards for

occupational and public protection from ionizing

radiation, (3) promote completeness and

coherence of Federal Standards for radiation

protection, and (4) identify interagency issues and

coordinate their resolution.

In addition to NRC and EPA, ISCORS

membership also includes senior managers from

the Department of Defense (DOD), the

Department of Energy (DOE), the Department of

Labor's Occupational Safety and Health

Administration (OSHA), and the Department of

Transportation (DOT). Representatives of the

Office of Management and Budget (OMB) and

OSTP are observers at meetings. The NRC

members are Dr. Carl Paperiello, Nuclear

Material Safety and Safeguards (NMSS) Office

Director and Dr. Malcolm Knapp, NMSS Deputy

Office Director.

Committee meetings involve pre-decisional

intragovernmental discussions and, as such, are

not open for observation by members of the

public or media. However summary meeting

notes and agendas will be made available to the

public and media after they have been cleared by

all agencies. The committee will not act as a

decision-making body. Instead,

recommendations on specific issues will be

provided to the heads of member agencies, OMB,

and OTSP. The committee will meet

approximately once each calendar quarter, with

additional meetings held if needed for addressing

specific issues. Subcomittees will meet at a

frequency and location determined necessary by

the subcommittees.

The first ISCORS meeting was held on April 5,

1995. Representatives from Senator Glen's office,

NRC, EPA, DOD, DOE, and OMB attended. The

committee discussed a draft charter, and future

actions, including the issues that could be

addressed by the committee. The committee

agreed to increase the membership to include

OSHA and DOT

Among the committee's first actions is finalization

of the NRCJEPA "Risk Harmonization White

Paper," which outlines the similarities and

differences in the agencies' approaches to

radiation risk assessment and risk management.

NRC and EPA are currently reviewing a draft of

this paper with the other Federal agencies who

are members of ISCORS. Based on the findings

in this white paper, ISCORS plans to develop a

specific set of actions that will be submitted to the

EPA Administrator and the Commission for their

approval by September 30, 1995. Other possible

key policy areas for ISCORS review are standards

for low-level radioactive waste disposal,

radioactive mixed waste, naturally-occurring and

accelerator produced adioactive materials

(NARM), and recycling criteria.

(Contact Phyllis A. Sobel, NMSS, 301-415-6714)

11
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