ML20149K745

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Responds to 940926 Memo Requesting OGC Input on Question of Whether Requirements of 35.415(a)(2) for Posting of Patients Rooms Would Prevail Over Any Posting Requirements in 10CFR20.Room Must Be Posted in Accordance w/10CFR20 & 35
ML20149K745
Person / Time
Issue date: 10/14/1994
From: Treby S
NRC OFFICE OF THE GENERAL COUNSEL (OGC)
To: Paperiello C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20149C780 List:
References
FRN-61FR52388, RULE-PR-20, RULE-PR-32, RULE-PR-35, RULE-PR-36, RULE-PR-39 AF46-1-013, AF46-1-13, NUDOCS 9707300125
Download: ML20149K745 (3)


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OFFICE OF THE October 14, 1994 w y'b E tel GENERAL COUNSEL j,

MEMORANDUM TO: Carl J. Paperiello, Director Division of Industrial and Medical Nuclear Safety /

Office of Nuclear Materials Safety

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FROM: Stuart A. Treby Assistant General Counsel for  !

Rulemaking and Fuel Cycle

SUBJECT:

PATIENT POSTING REQUIREMENTS 10 CFR PARTS 20 AND 35 This is in response to your memorandum of September 26, 1994 which requested 0GC input on the question ~ of whether the requirements of 35.415(a)(2). for posting of patients rooms would prevail over any posting requirements in 10 CFR Part 20.. Bas-ed on'our review it appears the correct interpretation of I

the regulations is that the patient'~s room must be posted in'accordance with  ;

the requirements of both 10 CFR Part 20 and Part 35. This does not l necessarily require that the licensee post two signs, but the sign that is /f posted should contain the information required'by both. provisions of the regulations, unless the requirements of-10 CFR 1903(b) grants an exception in /

the particular circumstances presented.

Our conclusion is based on several factors that are evident in re/iewing the provisions of Part 20 and the supporting material relating to the adoption of Part 20's provisions. First, Part 20 specifically addresses application of the posting provisions to patients hospital rooms. 10 CFR 1903(b). To the extent that the scenario presented in your questinn to us does not meet the exception provisions in Part 20 that specifically address hospital rooms, it would be strongly implied that the Part 20 posting provisions apply to such hospital rooms. While it is possible that Part 35 could provide an exemption to the posting requirements in Part 20, it does not do so. This further supports a conclusion that the posting requirements of Part 20 will apply. In fact, as you point out in the attachment to your memorandum, the August 1992 revisions to 10 CFR 1903(b) specifically reference the applicable section of Part 35 which defines a situation where an exception may be appropriate. The referenced provision does not include the situation contain d in the scenario i of your question.

This interpretation is reaffirmed in the questions and answers relating to Part 20 that were prepared to assist in the implementation of the revisions to Part 20. Question 219 provides as follows:

Ouestion 219: 10 CFR 20.1601 requires control of access to high radiation areas. It provides an exception for access to hospital areas with patients containing radioactive material, "provided that there are personnel in attendance..." who 9707300125 970711 "7 PDR PR 20 61FR52388 PDR y79] 3.(Jul) $ j

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will take certain specified precautions. (a) Does a ,

nursing station within the line-of-sight of a patient's room l satisfy the requirement? (b) Does a nursing _ station controlling access to a ward, but not in the line-of-sight, satisfy the requirements? -

Answer:

(a) Yes, provided there are personnel in attendance at all times who will )

take the necessary precautions to prevent the exposure of individuals to l radiation or radioactive material in excess of the limits established in i Part 20, and operate within the ALARA provisions of the licensee's radiation protection program.

i (b) Yes, provided the room 'is properly posted. (

Reference:

10 CFR 20.1601, l Appendix X to Regulatory Guide 10.8) i The language quoted in the question from 10 CFR 20.1601- is essentially identical to the first criteria in 10 CFR 20.1903 for granting an exception t~o the posting requirements of Part 20. Thus, in the huspital situations where there is no one "in attendance" as described in response to the above question, it appears that Part 20 posting restrictions would apply.

In spite of the staff's belief that the. intent of the regulations was to relax 1 the posting standards, the Statement of Considerations says exactly the opposite of that intent. The statement in the Fed. Reg. notice of May 21, 1991 could not be clearer. It' states: "The intent was to generally. require

. posting of therapy patients rooms." This statement was made in the context of' Part 20's posting requirements and it would be stretching beyond ,

reasonableness to argue that this provision meant posting under Part:35, but not Part 20. There is nothing in the August 31, 1992 amendments to Part 20 ,

and accompanying Sta+ement 'of Considerations that negates the statement from the earlier rulemaking. Even if the staff had a completely different intent, the Statement of Considerations-is the official statement of the agency's position on this' issue.

The same analysis would be applicable to teletherapy units. If they do not meet the exception requirements they must meet the requirements of Part 20 for posting, even if the specific license contains a posting requirement, unless the license specifically arants an exemotion from the Dottina reauirements in Part 20.

If.the. current regulations are not meeting the actual intent of the staff there are two possible solutions. First, it is always permissible in -

individual licenses to grant an exemption from the regulations, which may be particularly appropriate where the staff is already imposing site specific posting requirements in the license. This may be the most appropriate solution for the teletherapy unit issue reference in your September 24, 1994 memorandum. Simply indicate in the section of the license discussing site specific posting requirements that the licensee is exempt from the posting requirements of Part 20 to the extent that the posting requirements specified in the license already require posting of a specific area. Second, the

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3 l regulations can be amended to reflect the staff's intent. This is probably more appropriate for addressing the patients hospital room issue. One possible amendment would be to add the following lin'e to provisions such as 10 CFR 35.415(2): 1 4 '

l N, "This posting. requirement is in lieu of any posting that would '\

otherwise be required under 10 CFR Part 20.1902." g Since your memorandum already indicates that there is a reasonable basis for wanting a specific type of sign for hospital use (to avoid any unwarranted

'. unsettling effect on patients) the justification for such an' amendment should be relatively straightforward. If you decide to pursue the amendment option, i please let us know of any assistance we can provide in developing the  ;

rulemaking package. l l

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