ML20140B789
| ML20140B789 | |
| Person / Time | |
|---|---|
| Issue date: | 05/16/1997 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Ratliff R TEXAS, STATE OF |
| References | |
| NUDOCS 9706060323 | |
| Download: ML20140B789 (7) | |
Text
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UNITED STATES g
j NUCLEAR REGULATORY COMMISslON WASHINGTON, D.C. 3056M001 l
May 16, 1997 i
Mr. Richard A. Ratliff, P.E., Chief Bureau of Radiation Control Texas Department of Health 1100 West 49th Street Austin, TX 78756-3189
Dear Mr. Ratliff:
We have reviewed your letter regarding enforcement of the requirement in NRC's 10 CFR 20.1101 for licensees to implement a " radiation protection program" (RPP). It is our understanding that, based on your discussions with various persons within and outside the
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NRC, that the expectations and extensiveness of enforcement requirements for a RPP are not well defined or understood. You also questioned the usefulness of a RPP for non-i power-reactor licensees. Finally, you requested guidance on the type of enforcement, or at least the minimal expectations for enf*>rcement, for several levels of license complexity, such as industrial radiography, well-logging, eye-applicator, and small medical licensees.
We would first like to note that the NRC has established a severity levelIV for violations of 10 CFR 20.1101 as referenced in NUREG 1600, " General Statement of Policy and Procedures for NRC Enforcement Actions," Supplement IV.D.4. In cases where the violation occurs with a potential for personnel exposure, the release of radioactivity, or 3
other adverse impact, a severity level lll would be considered.
l Additionally, NRC is currently revising its inspection Procedures and Field Notes (IP 87100 and appendices) for materials license inspections. The revisions will describe the elements that an inspector should review in order to determine whether that type of licensee has an adequate RPP in accordance with the provisions in 520.1101 and $20.2102. Copies of these inspection Procedures have been distributed to the Agreement States for comment i
and will be distributed as part of the normal distribution for the Ins; mtion Manual Chapter when they are issued in final form.
1 With respect to your concern on the usefulness of a non power reactor licensee RPP, the requirement for establishing a RPP applies to alllicensees, and not solely to reactor licensees. According to 10 CFR 20.1101, "Each licensee shell develop, document, and j
implement a RPP commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of this part." The key point to note in this requirement is that the required program be commensurate with the radiation hazards involved in the licensed operation. The Statements of Consideration (SOC) elaborate on this point by noting that, "It is expressi( intended that the level of this program and effo to document it are commensurate with the size of the licensed facility and the potential hazards from radiation exposure and the intake of radioactive material."
' P4% 97 970606032e 970516 PDR STPRG ESGTX i
MAY 161997~
Mr. Richard A. Ratliff, P.G.
-2 Two points are cicar from the above: the type and extent of the program is dependent on the radiation hazM involved; and, there are no specific and well-defined parameters for the size and ext.u of the RPP required by 10 CFR 20.1101. This is expected considering the wide variety of activities and facility sizes and complexity for which NRC issues licenses. The judgement as to whether a particular licensee has met the requirement w establish a RPP absent specific or well-defined parameters is therefore made on a case-by-case basis after a review of the lic nsee's program.
The requirement to establish a RPP implies that the licensee develop a formal program that is designed to be incorporated into the licensee's routine and emergency operations. The RPP should ensure the safe use of the licensed material under all anticipated conditions.
The form that such a formal arrangement will take is r.ot specified in the regulations, but is left up to the licensee, so long as the intent is met. Nevertheless, the arrangements must be formal, to ensure that all persons involved in the operation are aware of the requirements and limitations in the use of licensed materid The form that such a formal arrangement takes is left up to the licensee, and may range from a general company statement of policy to a set of detailed procedures each addressing a specific, narrow, aspect of the operation.
We would like to note further that the requirement to establish a r1PP is not new. As noted in the SOC, "it was discussed in the proposed rule (under ALARA)~and is consistent with the requirements in Part 33 (ll 33.13,33.14, and 33.15), Part 34, Part 35 (il 35.20-35.31) and Part 40 (5 40.32) of the NRC regulations, and with the conditions in most licenses issued by the Commission. The scope of the RPP required for a specific licensee will be, to a large extent, defined by the license conditions incorporated into the license.
Compliance with these conditions will, in most cases, also result in meeting the requirement to establish a RPP.
In response to your comment that you questio 7 the utility of a RPP for non-reactor licen' sees, we would agree with your assessmelt if that requ'rement is viewed as establishing a uniform, rigorous, and well-defined requirement for all licensees. However, as discussed, this is not the case. Establishing a RPP in the ecse of most materials licensee serves the purpose of specifying, in a written docurm at. the methods and precautions all persons authorized to handle the licensed mt u, rial will follow to ensure their safety and to minimize their exposures. We believe this to be a worthwhile goal, and should not be burdensome if the extent of this effort is commensurate with the hazard.
Finally, you requested guidance on the type of program to expect for certain types of non-reactor licensees. We do nnt believe that this would be useful because the adequacy of the program depends to a great extent on the type of licensed operation. Even within a certain type of license, such as industrial radiography, there are wide variations regarding the number of sources used, the number of people authorized to use these sources, the types of locations in which the sources are authorized to be used, the proximity of trained radiation safety personnel to the radiographic operations, and so on, all of which will have a substantial effect on the type of RPP necessary to ensure the safe use of the radiography sources.
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MAY10 EI Mr. Richard A. Ratliff, P.E.
3-For the above reasons, assessment of the appropriate enforcement action depends on the circumstances of the specific licensee, if, after inspecting the licensee's operation, it is determined that the licensee has not established a program that is adequate to ensure the safe use of the licensed material,'then the licensee has not met the requirements of 10 CFR 20.1101 and the enforcement actions noted above would be appropriate.
We hope the above discussion has clarified the issues raised in your letter. We realize that we have not provided you with specific guidance to aid in enforcing the rule. However, in i
this case, the exercise of good judgement based on the inspector's experience in the field is vital.- As noted, however, the conditions included ir' the license, as well as the specific requirements in the applicable regulations, such as Parts 33,34, or 35, should help define the broad outlines of the type of program that would be considered adequate for the licensee.
l If you have additional questions, please call me, at (301) 415-3340, or Tom O'Brien, at (301) 415-2308..
Sincerely, lC )[t (
Anf1 Richard L. Bangart, Direct [r Office of State Programs v 1
i Mr. Rich:rd A. Ratliff, P.E. MAY I 61997 For the above reasons, assessment of the appropriate enforcement action depends on the circumstances of the specific licensee, if, after inspecting the licensee's operation, it is determined that the licensee has not established a program that is adequate to ensure the safe use of the licensed material, then the licensee has not met the requirements of 10 CFR 20.1101 and the enforcement actions noted above would be appropriate.
We hope the above discussion has clarified the issues raised in your letter. We realize that we have not provided you with specific guidance to aid in enforcing the rule. However, in 1
this case, the exercise of good judgement based on the inspector's experience in the field is vital. As noted, however, the conditions included in the license, as well as the specific requirements in the applicable regulations, such as Parts 33,34, or 35, should help define the broad outlines of the type of program that would be considered adequate for the licensee.
If you have additional questions, please call me, at (301) 415-3340, or Tom O'Brien, at (301) 415-2308.
Sincerely, OdginalSigned By RICHARD L BANGART i
Richard L. Bangart, Director j
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Office of State Programs i
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Distribution:
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NAME TO'Brien:nb qd7 PHLo $f DCool JLieberman RLBangart~
DATE 05/ h /97 05/ 6 /97 05/15/97*
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8P/h ROUTING AND TRANSMITTAL SUP l
DATE: May 7,1 7 PARRALLEL CONCURRENCE / SIGNATURE 1.
D. COOL, NMSS - CONCURRENCE
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J. UEBERMAN, OE - CONCURRENCE l
LETTER TO:
MR. RICHARD A. RATUFF, P.E., CHIEF BUREAU OF RADIATION CONTROL AUSTIN, TX l
f FROM:
RICHARD L. BANGART, DIRECTOR OFFICE OF STATE PROGRAMS I
SUBJECT:
ENFORCEMENT OF THE REQUIREMENT IN NRC'S 10 CFR 20.1101 FOR UCENSEES TO IMPLEMEIJT A RADIATION PROTECTION PROGRAM
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- PLEASE' NOTE THIS IS A REVISED VERSION PREVIOUSLY ROUTED FOR CONCURRENCE TO REFLECT CHANGES REOUESTED BY OE.
l YOUR CONCURRENCE IS REOUESTED BY WEDNESDAY. MAY 14.1997 4
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OSP CONTACT: TOM O'BRIEN, 415-2308 i
PLEASE CALL NANCY BELMORE. OSP. 415-2326. FOR PICK-UP.
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l Mr. Rich:rd A. R tliff, P.E. <
l For the above reasons, assessment of the appropriate enforcement action depends on the circumstances of the specific licensee. If, after inspecting the licensee's operation, it is j
determined that the licensee has not established a program that is adequate to ensure the safe use of the licensed material, then the licensee has not met the requirements of 10 CFR 20.1101 and the enforcement actions noted above would be appropriate.
We hope the above discussion has clarified the issuds raised in your letter. We realize that we have not provided you with specific guidance to aid in enforcing the rule. However, in i
this cese, the exercise of good judgement based on' the inspector's experience in the field is vital. As noted, however, the conditions included in the license, as well as the specific requirements in the applicable regulations, such as Parts 33,34, or 35, should help define the broad outlines of the type of program that would be considered adequate for the licensee.
If you have additional questions, please call me, at (301) 415-3340, or Tom O'Brien, at (301) 415-2308.
I Sincerely,
\\
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Richard L. Bangart, Director l
Office of State Programs i
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Distribution.
DIR RF 6S174
/
DCD (SP03)
SDroggitis
/
PDR (YES V' NO
)
DSollenberger JPiccone Texas File
/
DOCUMENT NAME: G:\\TJO\\ RAT.LTR
- See Previous Concurrence.1 g T2,.c.6 e e con of this document. indeste in the box: *C' e. Qopf without suschrnenvenclosure
- E' = Copy wrth shachment/ enclosure
- N' = No copy OFFICE OSP l/
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OSP:D NAME TO'Brien:nb 'jdy /
PHLo$qf' DCool JLieberman RLBangart DATE 05/ b /97 ;
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TASK DESCRIPTION - 6/24/96 LTR RE RULE 10 CFR 20.1101 REQUIREMENT FOR LICENSEES TO IMPLEMENT A RADIATION PROTECTION PROGRAM REQUESTING OFF. - TXDOH REQUESTER - R. RATLIFF WITS -
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96 AM il: 05 Texas Department of Health David R. Smith, M.D.
I100 West 49th Street Carol S.Daniels Commissioner Austin, Texas 78756-3189 Deputy Commissioner for Programs (512)458-7111 Randy P. Washington Radiation Control Roy L. Hogan Deputy Commissioner for Health Care Financing (512)834 4688 Deputy Commissioner for Admmistration June 24,1996 Richard L. Bangart, Director Re: Radiation Protection Office of State Programs Programs U. S. Nuclear Regulatory Commission Washington, D.C. 20555
Dear Mr. Bangart:
In 1992, the Nuclear Regulatory Commission (NRC) established in rule (10CFR20.1101) a requirement for licensees to implement a " radiation protection program"(RPP). Consequently, Agreement States (AS) implemented the same, or similar, mies to maintain compatibility. Further, many AS have programs of registering x-ray producing devices, causing the impact ofimplementation of RPPs to be more extensive throughout the areas ofmedicine, education, and industry, on a national level.
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After Texas had adopted the RPP requirement in rule, a question ofhow it should be enforced arose. Up contacting NRC administrative, inspection, and Office of State Programs staff, we found diffedng expectations on the level and extensiveness of enforcement. This was found to be true with staff of other AS, as well. The spectmm of regulatoiy concepts observed ranged from one of simply adopting ALARA into the licensee's operating and safety procedures, with a brief annual review, to one of full preparatica of an extensive "new" document describing the entire program and requiring an annual review with every detail of the review fully documented. To further compound the question, NRC administrative staff reported that the primary purpose intended for RPPs was to improve the safety programs of nuclear power i
plant licensees. While the RPP may provide for a significant improvement in safety operations of nuclear j
power facilities, we question it's usefulness for improvmg safety for other types oflicens*s/ radiation users.
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I At this point, it appears that the NRC and the AS all have differing levels of enforcement of RPPs. We j
therefore request formal guidance from the NRC so that we, and other AS, may propedy enforce the RPP requirement It would be helpful if the guidance would review the purpose and intent of the RPP as it relates to nonnuclear power licensees, as well as describe the type of enforcement, or at least the mmimal
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expectations for enforcement, for several levels of license complexity. Descriptions of recommended j
inspection / compliance / enforcement procedures for a major processor ofloose materials license, an industrial radiography or well-loggmg license, and an eye applicator or small medical license may provide the hN l
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guidance and insight that the AS need to seek a uniform level ofenfdtcanent Inasmuch as this problem has a nationwide impact, we ask that the NRC respond to this reque' t as quickly as possible.
s Sincerely, 4_k Richard A.
P.E., Chief Bureau of diation Control i
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