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l JUL 13 iS84 HEMORANDUM FOR: Those on Attached List FROM:
Richard E. Cunningham, Director Division of Fuel Cycle and Haterial Safety
SUBJECT:
REQUEST FOR CONCURRENCE ON PROPOSED REVISION OF 10 CFR PART 35 The attached Comission paper contains a proposed revision of 10 CFR Part 35 to be published in the Federal Register for coment. This proposed revision was prepared in response to a memorandum to Mr. Dircks from Mr. Chilk (see enclosure 2 of the Comission paper). An earlier draft was distributed for coaaent on February 13, 1984.
Coments were received from 26 NRC offices and Agreement States comprising
-105 pages. A sumary coment analysis appears as enclosure 8.
Due to the number of changes made, text changes have not been highlighted in the attachment. The following significant changes have been made.
1.
The draft memorandum from Mr. Davis to Mr. Dircks has been revised in its entirety.
2.
The comparison of the proposed regulatory regime to NRC's regulatory regime for reactors that appears in the staff paper has been expanded.
3.
In the regulation:
a.
The draft title has been changed from " Human Uses..."
to " Medical uses...."
b.
The term " area of use" was defined in 535.15.
c.
The duties of the Radiation Safety Officer (RS0) listed in 535.31(b)(1)wereexpanded.
d.
The Radiation Safety Comittee, in 535.32(b)(2), must review proposed authorized user credentials with regard to Subpart J standards.
e.
The visiting authorized user permission, it.. 335.34, is limited to 60 days each year.
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1ultiple Addressees jut 1319M f.
Ilobile nuclear medicine services, in 535.35(a), are restricted to unlicensed clients.
g.
A new 535.36, " Radiation safety program changes," has been added.
h.
In 835.60, syringe shields are required for mixing kits but not for drawing dosages.
- i. In 535.100 and 535.200, the permission to use materials authorized by a Radioactive Drug Research Committee has been withdrawn.
k.
135.205, " Control of aerosols and gases," has been expanded.
1.
In 535.315(g), the licensee must measure the thyroid burden of individuals who administer therapeutic iodine dosages.
m.
Tantalum wire has been removed from 535.400.
n.
535.404(a) has been clarified to require a radiation survey of implant patients innediately after the sources have been removed.
o.
535.406(c) has been added to require a survey immediately after making an implant to assure that no sources have been misplaced.
p.
535.606 no longer requires authorization before removing a teletherapy unit.
q.
Safety instructions in 635.610(a)(1) have been expanded.
r.
In 535.632(d), an alternative teletherapy calibration procedure is authorized.
s.
535.910(b) has been expanded for clarity.
t.
535.940(b) requires active practice of therapeutic radiolog~y and has been expanded for clarity.
u.
535.941 requires active practice in therapeutic radiology or ophthalmology.
v.
535.90 requires active practice in therapeutic radiology and has been expanded.for clarity.
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Multiple Addressees JUL is 1994 4.
The Regulatory Analysis, Enclosure 4, has ueen revised to indicate the number of licensees affected by the revision, the impact on llRC operations, and the irapact of alternatives 1 and 3.
S.
The comment analysis, Enclosure 8, is provided for your information. It will be removed from the final paper.
6.
The Appendices of the draft regulatory guide that support Sections 35.36 and 36.205 have been revised to reflect the content of those sections and are attached. Otherwise, only a few clarifying editorial changes were raade to the draft guide.
If you have any questions about the attached material, please contact Nonaan McElroy at (301) 427-4108.
Please provide your concurrence by cemorandum to me by iginal Signed by Ohchard E. Cunningham Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety
Enclosure:
As stated DISTRIBUTION:
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Addressees - Memorandum dated JUL 131984 Office Directors:
Your cognizant individual is:
Patricia G. Norry, ADM Michael Lesar Guy H. Cunningham, ELD Tom Dorian Robert B. Minogue, RES Judy Foulke Richard C. DeYoung IE Harriet Karagiannis G. Wayne Kerr, SP Lloyd Bolling Thomas E. Murley, RI John Glenn James'P. O'Reilly, RII Phillip Chambless James G. Keppler, RIII Bruce Mallett John T. Collins, RIV Jerry Everett John B. Martin, RV R. D. Thomas Advisory Committee on the Medical Uses of Isotopes Members:
Vincent P. Collins, M.D., Houston Institute of Cancer Frank H. Deland, M.D., Veterans Administration Hospital Jack K. Goodrich, M.D., Hamot Medical Center, Radiology Associates of Erie Melvin L. Griem, M.D., University of Chicago B. Leonard Holman, M.D., University of Chicago Edward W. Webster, Ph.D., Massachusetts General Hospital David H. Woodbury, M.D., Wayne County General Hospital Joseph B. Workman, M.D., Duke University Medical Center Consultant:
Peter R. Almond, Ph.D., M.D. Anderson Hospital i
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10.n.4. Spilled Gas Clearance Time Because normal roon ventilation is usually not sufficient to ensure timely clearance of spilled gas, the calculations described in section Q4 should be done to detennine for how long a room should be cleared in case of a gas spill. This clearance time should be posted in the roon.
If you will calculate spilled gas clearence times according to the following procedure, you may respond to item 10.n.4. by saying, "We will calculate spilled gas clearance times according to the procedure that was published in Regulatory Guide 10.8, Revision 2, Appendix 04, (*** insert R.G. publ date***)"
You nay develop your own procedure for review.
If you do so, you should consider all the above infornation and carefully review the requirements of 535.205. Say on your application, "We have developed a procedure for calculating spilled gas clearance times that is appended as ATT 10.n.4." and append your procedure.
Q4: Model Procedure for calculating spilled gas clearance time.
1 1.
Collect the following data:
a.
Highest activity of gas in a single container; b.
Measured airflow supply fron each vent in the room (if different during heating and cooling seasons, use the lesser value);
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c.
Measured airflow exhaust to each vent in the room (the exhaust should be venteo and not recirculated within the facility); this may be either the normal air exhaust or a specially installed gas exhaust system; d.
Maximum permissible air concentrations in restricted and unrestricted areas. For Xe-133, the naximun permissible values are 1 x 10-5 uCi/nl in restricted areas and 3 x 10-7 uCi/ml in unrestricted areas.
For other gases see Appendix B to 10 CFR Part 20.
2.
For each room make the following calculation:
a.
Decide whether you will control the room as a restricted or unrestricted area.
b.
Divide the largest single container activity by the total exhaust rate.
c.
Divide the quotient from step b. by the maxinun pernissible concentration.
This is the clearance time that should be posted.
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4.
For protection equipment:
a.
What level of protecticn does it provide?
b.
What is the required level of protection?1 c.
In case it fails, is back-up equipment available, and can it be repaired in a timely fashion?
Procedure changes:
1.
Why is the change needed?
2.
What doses or dose rates apply to the individuals af fected by the change?
3.
For each step in the procedure, what things are likely to go wrong either by equipment failure or human error.
4.
What are the likely consequences of problems noted in question 37 5.
What steps can be taken to nitigate the consequences noted in question 47
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APPENDIX W i
Considerations in Making Progam Changes (See 135.36)
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iThe regalations allow the licenseg to nake changes in radiation safety procedures, equipnent that~is used to meet regulatory
.requirener.ts, and roons where byproduct
- r>aterial is received, stored, or?used.
In an institution the1 changes must be approved 1
by4the Radiation Safety Officer, the Radiation Safety Connittee, and the management representative (see 535.32). In non-institution licensees, changes nust be approved by the Radiation Safety Officer and management (see 635.31).
.Wherk naking changes it is the licensee's responsibil'ity to ensure I
that the result will be in accord with the regulations and license conditions. Any change nust be reviewed for radiation safety -
considerations before it'is approved. Licensees should consider the following questions before making changes.
Not all the i
cuestions apply to all changes.$ There may be other questions the !i,censee should consider before naking changes.
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BC sure proposed changes are fully explained and do not include i
abbreviations or undefined words.
Spell out neasurement units such as_ millicurie and nicrocurie; only use the abbreviations in calculations or 1,og sheets. Identify, by name or office', who is _ responsible for doing each task. Do not simply assume the; task will be done.
l Roon changes:
1.
Why is the change needed?
~2.
Can the roon be secured-in case of spills?
3.
Can the roon surfaces be cleaned?
4'.
Is the room adequately ventilated?
5.
Does the roon provide radiation shielding?
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j 6.
What are the anticipated doses each week in the roon and in surrounding areas?
7.
What are surrounding areas used for? What night they be
' used for in the future.
.Equipbentchanges:
1.
Why xis the chunge needed?-
g 2.
Was the equipment designed for the intended purpose?
i 3.' For detection 13nd neasuring equipment:
.a.
What is tne' lowest' level of detection for the equipment?-
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- b. What is' the level of detection ' required?
c.
Will the ' instrument be interfered with by ambient radiations, light, tenperature, humidity, or chemicals in the area?
d.
In case it fails, is back-up equipment available, and can it be repaired in a timely fashion?
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