ML20137Q697
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'p r'00 UNITED STATES 4(g. NUCLEAR REGULATORY COMMISSION
-$ ?> REGloN I E' f $31 PARK AVENUE KING OF PRUSSI A, PENNSYLVANI A 19406 JUN 2 4 W MEMORANDUM FOR: Richard E. Cunningham, Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards FROM: Thomas T. Martin, Director, Division of Engineering and Technical Programs
SUBJECT:
REGION I COMMENTS ON PROPOSED REVISION OF 10 CFR PATT 35 'i DATED MAY 5, 1982 This memorandum incorporates comments from the Region I Materials Program Sections, No. 1 and No. 2. My staff and I are pleased with the concepts set forth in the Proposed Revision of 10 CFR Part 35 and look forward to further participation in the review and implementation of Part 35, as necessary. Three general comments are discussed below. Additionally, specific comments are contained in the enclosure.
- 1. Although Part 35 is intended to cover all human use of byproduct material, neither the current nor the proposed version of Part 35 give definitive guidance on use of byproduct material for human medical research. Part 35 should provide that authorization for human medical research will be granted only if the applicant meets the requirements of 10 CFR 33.13 and has an FDA-approved Radioactive Drug Research Committee. In addition, " human medical research" should be defined. For example: "' Human Medical Research' means the internal or external administration of byproduct material, or radiation therefrom, to human beings for the evaluation of.new drugs and procedures, including studies of metabolism, safety, and effectiveness.
' Human Medical Research' as used in this part does not include the admini-stration of byproduct material or radiation therefrom to human beings for instructional purposes only."
- 2. There is a need for a requirement to maintain records of physician qualifi-cations. Otherwise the NRC could be required to prove a physician's qualifi-cations, if allegations are made.
- 3. With regard to procedures: a) licensees are required to have procedures, but no standards for required procedures are establishes, b) the proposed revision appears to abandon all the work which has gone into some excellent Appendices in Regulatory Guide 10.8 (i.e., G, K, & L); c) we suggest a requirement that the Radiation Safety Committee document their justification for deleting "model" Regulatory Guide procedures.
8509230220 850906 PDR PR 35 50FR30616 PDR
Memo for: Richard E. Cunningham 2 Please contact John Kinneman (488-1252) if additional information concerning our connents is required.
Thomas T. Martin, Director Division of Engineering and Technical Programs
Enclosures:
As Stated i
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4 JL212 41982 Enclosure 7
35.1 Based on our general comment regarding " Human Medical Research", the scope-should include: "The requirements and provisions of Parts 19, 20, 21, 30,33 and 170 of the chapter . . ."
35.15 Under definitions, add the following:
Human Medical Research: as defined in our general comment.
Vial Shield: define by performance (i.e., provides x half-valve layers)
Syringe Shield: define by performance (i.e., provides x half-valve layers)
Qualitative instrument: Any survey meter which is used primarily to detect the presence or absence of radiation or radioactive material.
Quantitative instrument: Any survey meter or measuring instrument calibrated against a certified standard source of radiation which reads out in mR/hr, R/hr or cpm with known efficiency.
1 Low level survey meter: define by performance (range) 35.,16 (a) Change to: "If the applicant is a Federal agency, if the applicant is an agency of the District of Columbia ..."
(b) Change to: "If the applicant is not a federal agency or an agency of the District of Columbia and is located in Connecticut, the District of Columbia, Delaware, Maine, Massachusetts, New Jersey, Pennsylvania, or Vermont, and ... Region I, Materials Program Section No. 2, 631 Park Avenue ...."
35.17(f) Does this refer to changes in the " procedures" of the licensed program which could result in a reduction of radiation safety or to something else?
35.30(c) How often is periodic? Should be more specific.
35.38 Supervision should also include protection of the patient. The authorized user should select patients, prescribe the dose, and interpret the results of procedures.
' 35.50(a)(2) Activity of standards is too low; six millicuries of activity per source is permitted. Radionuclides used for calibration should represent gamma energies of commonly-used nuclides.
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2 JUN Z 41982 35.50(b) Define " appropriate checks" (i.e., " Perform the required linearity, accuracy, and constancy checks and tests following adjustment or repair of dose calibrator.")
35.50(c) Shouldn't the instrument be adjusted / repaired?
35.51(a)(1) Change to: " Calibrate ' Quantitative' survey instruments," defini-tion provided in comments for 35.15.
35.51(a)(2) Change to: " Calibrate ' Qualitative' survey instruments," definition provided in comments for 35.15.
35.51(d) What if survey instrument fails test?
35.58 Add "... and are obtained from a manufacturer licensed in accordance with 32.74."
35.59(a) "A licensee .... shall not use the source contrary to the instructions" -
rather than present wording "shall use the source not contrary".
35.59 Second (b), should it be (c)? If so, all other lower case letters following need to be revised.
35.60 Syringe shields should be defined by performance in 35.15. When is the use of a syringe shield contraindicated? Who decides?
Most of the hand dose in nuclear medicine is received during kit preparation and dose preparation (J. E. Burr + R. Berg, JNMT 5, 158 (1977)). Syringe shields should be required during all manipulations of radioactive materials in syringes. In difficult injections, syringe shield may still be used, if puncture is made with a " butterfly",
through there is some controversy over whether this reduces dose. No mention is made of the use of waterproof gloves or tongs to reduce hand contamination and exposure. Surveys of hand and clothing, prohi-bition of food with radioactive material, prohibition of mouth pipetting, and other Appendix G (Regulatory Guide 10.8) requirements are not addressed.
35.61 Vial shield thould be defined by performance in 35.15.
35.70 " Low range suriey meter" should be defined in terms of performance in 35.15.
35.75 This should be changed to " Confinement and Release of patients".
Change 35.75(a) to read: "The licensee shall confine patients undergoing treatment with byproduct materials listed in 35.300 and 35.400 in a single (private) raom within a hospital or similar facility until the requirements of 35.75(b) or 35.404 are met." 35.75(b) as currently proposed for 35.75.
3 Jtk12 41902 35.90 The regulation as written may prevent releases to restricted areas.
How about the environment?
35.92(a)(2) Low level survey meter should be defined in terms of performance in 35.15.
35.92(a)(2) Does " unshielded" refer to the trash ar the probe of the survey meter?
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35.92(a)(4) Define " generator."
35.100(a) Should " human medical research" definition be placed here?
Should chis be restricted to 33.13 licensees? What about IND's and NDA's?
35.200(a) Same comment as 35.100(a).
35.204 Shouldn't Mo-99 content be checked prior to administration? What happened to five microcurie total limit?
35.304(a)(1),(2),(3),(4) What are the standards for these procedures? What can we do if they adopt inadequate procedures?
35.404 What is " confinement for medical care?" See 35.75 comments.
35.405(a)(1)(2) What are the standards for these procedures?
35.621 (1) Battery backup is unnecessary if power for monitor is independent of power for teletherapy. Reason for separate power is fact that
" Emergency Bar" usually disconnects all power to unit. Teletherapy source normally returns to safe position on power failure. The probability that a mechanical source jam will occur at the same time as hospital-wide power failure is small.
(2) An audible alarm is important. There have already been instances of a technologist ignoring the flashing light. Wording in 10 CFR 34.29(b) requiring audible alarm only if entry is attempted while source is on is appropriate. (Alarm will not normally sound during treatment). Monitors now in use (generally Nuclear Associ-ates Primalert 10 or Eberline SPI-2) can be easily retrofitted with a door-cancellable audible alarm.
35.630 Meaning of "have available" is unclear. Must instrument be present in hospital or is a consultant on call with instrument sufficient?
35.632(c) AAPM has new protocol in preparation under Task Group-21 (TG-21) chaired by R. J. Schulz, Ph.D. Preliminary document presented at AAPM meeting, August, 1981, Boston, probably out this year.
4 JUN 2 41982 35.633(b)(5) Spot check measurement should be compared with value used for treatment. A comparison with an ad hoc calculation of dose rate by decay from primary calibration value does not provide a check on value used for treatment.
35.633(f) ANSI N449-1974 recommends these functions be checked daily.
Regulation should require that these be checked each day unit is used. Since all checks require only cursory observation or a few :(
seconds, and consequences of failure could be serious, requirement S would not be an unreasonable burden.
35.900 What about certification by American Board of Radiology in Radiation Therapy, if license includes all groups?
35.920(b)(2)(vi) Alumina contamination assay not required by any other sections?
35.921(b) Top of Page 79. Correct to 35.920 instead of 35.921.
35.942(?) This section is refered to in 35.941. What is proper reference or is 35.942 missing?
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UNITED STATES
- pa"%g% NUCLEAR REGULATORY COMMISSION
) P( REGloN I 3 D... ~f 631 PAR K AVENUE Nf KING OF PRUSSI A, PENNSYLV ANI A 19406 MEMORANDUM FOR: Richard E. Cunningham, Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards FROM: Ronald C. Haynes, Regional Administrator, Region I
SUBJECT:
REGION I COMMENTS ON PROPOSED REVISION OF 10 CFR PART SS DATED MAY 5, 1982 This memorandum incorporates comments from the Region I Materials Program Sections No. 1 and No. 2. My staff and I are pleased with the concepts set forth in the Proposed Revision of 10 CFR Part 35 and look forward to further participation in the review and implementation of Part 35, as necessary. Three general comments are discussed below. Additionally, specific comments are contained in the enclosure.
- 1. Although Part 35 is intended to cover all human use of byproduct material neither the current nor the proposed version of Part 35 give definitive hM guidance on use of byproduct material for human medical research. Part 35 'hQ should provide that authorization for human medical research will be granted ,d d only if the applicant meets the requirements of 10 CFR 33.13 and has an FDA-approved Radioactive Drug Research Committee. In addition, " human medical research" should be defined. For example: "' Human Medical Research means the internal or external administration of byproduct material, or radiation therefrom, to human beings for the evaluation of new drugs and procedures, including studies of metabolism, safety, and effectiveness.
' Human Medical Research' as used in this part does not include the admini-stration of byproduct material or radiation therefrom to human beings for i instructional purposes only." ->
- 2. There is a need for a requirement to maintain records of physician qualifi-cations. Otherwise qualifications, the NRC if allegations could are made. be /60 requtred mn ' to proye a p,hysici n's#47 rJ
- 3. With regard to procedures: a) licensees are required to have procedures,P h/
but no standards for required procedures are established; b) the proposed g revision appears to abandon all the work which has gone into some excellent'7-Appendicies in Regulatory Guide 10.8 (i.e., G, K, & L); c) we suggest a requirement that the Radiation Safety Committee document their jus.tification for deleting "model" Regulatory Guide procedures. '8 M '
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Please contact John Kinnerman (488-1252) if additional information concerning our comments is required.
Ronald C. Haynes Regional Administrator
Enclosures:
As stated
Enclosure 35.1 Based on our general comment regarding " Human Medical Research", the scope.should include: "The requirements and provisions of Parts 19, 20, 21, 30,33 and 170 of the chapter ..." w idtV 35.15 Under definitions, add the following:
Human Medical Research: as defined in our general comuent. M 4 Vial Shield: define by performance (i.e., provides x half-valve layers)+isdig' weg s as&O , m d surnXk, ccku&td. <n e , v J
Syringe Shield: define by performance (i.e., provides x half-valve layers)
Qualitative instrument: Any survey meter which is used primarily to dgtect the presence or absence of radiati,on or radioactive material.
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Quantitative instrument: Any survey meter or measuring instrument -
calibrated against a certified standard source of radiation which reads out in mR/hr, R/hr and cpm with known efficiency.
Low level survey meter: define by performance (range) m86 35.16 (a) Change to: "If the applicant is a Federal agency, if the applicant is an agency of the District of Columbia ...." Ac h (b) Change to: "If the applicant is not a federal agency or an agency of the District of Columbia and is located in Connecticut, District of dau:
Columbia, Delaware, Maine, Massachusetts, New Jersey, Pennsylvania, or Vermont, and ... Region I, Materials Program Section No. 2, 631 Park '
Avenue ...."
35.17( f) Does this refer to changes in the " procedures" of the licensed program whichcouldresultingSAWreduction of radiation safety or to something else? n,y /b } ~ W 35.30(c) How often is periodic? Should be more specific.
35.38 Supervision should also include protection of the patient. The authorized user should select patients, prescyibe dose, and interpret the results of procedures, spetAJ a //wevA t
.i/. a d e '3 "
.35.50(a)(2) Activity of standards is too low; six millicuries of activity per source is permitted. Radionuclides used for calibration should represent gamma energies of commonly-used nuclides.
! 35.50(b) Define " appropriate checks" (i.e., " perform the required l linearity, accuracy, and constancy checks and tests following
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adjustment or repair of dose calibrator.")
2 35.50(c) Shouldn't the instrument be adjusted / repaired? 920 $l u M US 35.51(a)(1) Change to: " Calibrate ' Quantitative' survey instruments," defini-tion provided in comments for 35.15.8 7 35.51(a)(2) Change to: " Calibrate ' Qualitative' s/urvey instruments," definition provided in comments for 35.15. 6 35.51(d) What if survey instrument fails test? /d v e."a9 % /. ku d </"
- n. w mk f.m an. m y92 35.58 Add "... and are obtained from a manufact'urer licensed in accordance * "
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with 32.74."
35.59(a) "A license .... shall not use the source contrary to the instructions" # 7# ' '
/
rather than present wording "shall use the source not contrary".
35.59 Second (b), should it be (c)? If so, all other lower case letters following need to be revised. // W 35.60 Syringe shields should be defined by performance in 35.15. When is the use of a syringe shield contraindicated? Who decides? 0 "W Most of the hand dose in nuclear medicine is received during kit $2E *-
preparation and dose preparation (J. E. Burr + R. Berg, JNMT 5,158 dmjuu (1977)). Syringe shields should be required during all manipulations <
of radioactive materials in syringes. In difficult injections, syringe ##g shield may still be used, if puncture is made with a " butterfly",
through there is some controversy over whether this reduces dose. No mention is made of the use of waterproof gloves or tongs to reduce hand contamination and exposure. Surveys of hand and clothing, prohi-bition of food with radioactive material, prohibition of mouth pipetting, and other Appendix G (Regulatory Guide 10.8) requirements are not addressed. m tw 35.61 Vial shield should be defined by performance in 35.15. fd 7 35.70 " Low range survey meter" should be defined in terms of performance d' in 35.15.
L 35.75 This should be changed to " Confinement and Release o patients". # , D#
Change 35.75(a) to read: "The licensee shall confine patients undergoing treatment with byproduct materials listed in 35.300 and 35.400 in a single (private) room within a hospital or similar facility until the requirements of 35.75(b) or 35.404 are met." 35.75(b) as currently proposed for 35.75.
, 35.90 The regulation as written may prevent releases to restricted areas. .4 < b l How about the environment?
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35.92(a)(2) Low level suryey,. meter should be defined in terms of performance in 35.15. fG/
35.92(a)(2) Does "unghielded" refer to the trash or the probe of the survey meter? p u t m:..f & ail W 35.92(a)(4) Define " generator." co,m m M A w ,
35.100(a) Should " human medical research" definiticn be placed here?
Should this be restricted to 33.13 licensees? What about IND's and NDA's? 7 35.200(a) Same comment as 35.100(a).
g f L A-35.204 Shouldn't Mo-99 content be checked prior to admirtistration? What happened to five microcurie total limit?//SM 35.304(a)(1),(2),(3),(4) What are the standards for these procedures? v. hat can we do if they adopt inadequate procedures?
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Whatfq[)
35.404 s " confinement 'for medical care?" See 35.75 comments.
35.405(a)(1)(2) What are the s'.andards for these procedures? /
35.621 (1) Battery backup i, unnecessary if power for monitor is independent of power for teletherapy. Reason for separate power is fact that
" Emergency Bar" usually disconnects all power to unit. Teletherapy source normally returns to safe position on power failure. The probability that a mechanical time as hospital-wide powersource failurejam will occu[r is small. f71 at the same (2) An audible alarm is important. There have already been instances of a technologist ignoring the flashing light. Wording in 10 CFR 34.29(b) requiring audible alarm only if entry is attempted while source is on is appropriate. (Alarm will not normally sound during treatment). Monitors now in use (generally Nuclear Associ-ates Primalert 10 or Eberline SPI-2) can be easily retrofitted with a door-cancellable audible alarm. / ace V #f;h t -
35.630 Meaning of "have available" is unclear. Must instrument be present in hospital or is a consultant on call with in.strument sufficient?
- % E 61 35.632(c) AAPM has new protocol in preparation under Task Group-21 (TG-21) chaired by R. J. Schulz, Ph.D. Preliminary document presented _at AAPM meeting, August, 1981, Boston, probably out this year. rui 35.633(b)(5) Spot check measurement should be compared with value used for treatment. A comparison with an ad hoc calculation of dose rate by decay from primary calibration value does not provide a check on value used for treatment. s a ;;/, f, d '(, e av a n i s; - Q " . q' .j, .
9,
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35.633(f) ANSI N449-1974 recommends these functions be checked daily. ",7,L, Regulation should require that these be checked each day unit is (4j#, /
used. Since all checks require only cursory observation or a few seconds, and consequences of failure could be serious, requirement would not be an unreasonable burden. #
35.900 What about certification by American Board of Radiology in Radiation Therapy, if license includes all groups? dr,u v 35.920(b)(2)(vi) Alumina contamination assay not required by any other sections? ) d ,,
35.921(b) Top of Page 79. Correct to 35.920 instead of 35.921. dub >ch,,v 35.942(?) This section is refered to in 35.941. Whatisproperreferencee/t<[
or is 35.942 missing?
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