ML20138K367
| ML20138K367 | |
| Person / Time | |
|---|---|
| Issue date: | 01/21/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, MASSACHUSETTS, COMMONWEALTH OF, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF |
| Shared Package | |
| ML20136A699 | List: |
| References | |
| FOIA-97-54 SP-97-004, SP-97-4, NUDOCS 9702180199 | |
| Download: ML20138K367 (140) | |
Text
. .. .
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- M%q l p k UNITED STATES g j t
NUCLEAR REGULATORY COMMISSION j
WASHINGTON. D.C. 20006-0001 4
e% l o .,,g # January 21, 1997 ALL AGREEMENT STATES MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-97-004)
Your attention is invited to the attached correspondence which contains: i INCIDENT AND EVENT INFORMATION...........
PROGRAM MANAGEMENT INFORMATION.....XX REQUEST FOR COMMENTS ON DRAFT INSPECTION PROCEDURE AND INSPECTION GUIDANCE !
FOR 10 CFR PARTS 35.32 !
AND 35.33 TRAIN!NG COURSE INFORMATION......... .....
TECHNICAL INFO RMATIO N.................... ......
OTH ER I N FO R MATI O N........ ...... . ....... . ... .......
Sunclementarv information:
Two program management items are enclosed for your review and comment. Item 1 consists of the (ggfilnspection Procedure 87100, " Licensed Material Programs", additions to Field Notes to address the Constraint Rule and Patient Release Rule, and a ravision to Radiography Field Notes. We have also enclosed pertinent background information for the l
above, item 2 consists of routine and reactive inspection guidance for 10 CFR Parts j 35.32 and 35.33. '
To meet current schedules for issuance of these procedures, we would appreciate receiving any comments on the program management items by February 15,1997. Note i that the traditional radiation units are used in the documents. While this is not consistent with the current NRC policy on radiation units, the traditional units appear in the regulations and, consequently are most often used by the inspectors. Comments on this issue are also sought.
Please direct your comments to the respective NRC points of contact indicated below:
- 1. For comments on item 1, the point of contact is Cathy Haney, NMSS. She can be reached at 301-415-7844 or e-mailed at CXH@NRC. GOV. Written comments can be sent to her at the United States Nuclear Regulatory Commission, Mail Stop T-8-F5, Washington, D.C. 20555-0001.
c.,
N hs@
SP 004 2 WAN 211997 l 2. For comments on item 2, the point of contact is Sally Merchant, NMSS. She can
- be reached at 301-415-7874 or e-mailed at SLM2@NRC. GOV. Written comments can be sent to her at the United States Nuclear Regulatory Commission, Mail Stop T-8-F5, Washington, D.C. 20555-0001.
If you have any questions regarding this correspondence, please contact me or the
- individual named below.
POINT OF CONTACT: Thomas J. O'Brien TELEPHONE: (301) 415-2308 FAX: (301) 415-3502 INTERNET: TJO@N . GOV 1 i g
- lV .
6 Paul H. Lohaus, Deputy Director
- Office of State Programs J
Enclosures:
As stated 4
(
t l
1 I
SP-97 004 2 M E I 997.
i
, 2. For cornments on item 2, the point of contact is Sally Merchant, NMSS. She can j be reached at 301-415-7874 or e-mailed at SLM2@NRC. GOV. Written comments con be sont to her at the United States Nuclear Regulatory Commission, Mail Stop 1 T-8-F5, Washington, D.C. 20555-0001 j
, if you have any questions regarding this correspondence, please contact me or the individual named below.
POINT OF CONTACT: Thomas J. O'Brien TELEPHONE: (301) 415-2308 ,
' FAX: (301) 415-3502 l l lNTERNET: TJO@NRC. GOV
! OdginalSigned@ l PAUL H. LOHAU5 Paul H. Lohaus, Deputy Director j Office of State Programs
)
Enclosures:
- As stated l
I i
3 J
a Distnbution:
DIR RF (7S 2,6S323) DCD (SPX2)
RLBangart PDR (YES_ NO )
PLohaus SDroggitis RSAOs ) E-Mailed SMerchant. NMSS 1 TO'Brien RSLOs ) 1/21/97 CHaney, NMSS A/S File DOCU *
- v. MENT NAME:..G:\TJO\SP97004.TJ0Ndm
, .e em - mew wm c .)W See .nprevious nu.n w. gs - concu.rrence.
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OFFICE OSP l OS f':Wl OSP:D L l I l NAME T0'Brien:ndb PLohauh Y RBangart Hb
_DATE 01/14/97* 01/ M /97 Ol d. /97 OSP FILE CODE: SP-A-4
1 i
ITEM 1 Contents
- 1. Draft inspection Procedure 87100
- 2. Addition to Field Notes to Address Constraint Rule
- 3. Addition to Field Notes to Address Patient Release Rule j 4. Revision to Radiography Field Notes l 5. Attachment 1 i
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NRC INSPECTION MANUAL IMNS l
INSPECTION PROCEDURE 87100 LICENSED MATERIALS PROGRAMS PROGRAM APPLICABILITY: 2800 87100-01 INSPECTION OBJECTIVES 01.01 To determine if licensed programs are being conducted in accordance with NRC requirements.
01.02 To determine if licensed activities are being conducted in a manner that will ensure the health and safety of workers and the general public.
87100-02 INSPECTION REQUIREMENTS Review of the licensed activities should be commensurate with the scope of the licensee's program. To the extent possible, a determination regarding compliance with an NRC requirement should be based on direct observation of a work activity, interviews with workers. a demonstration by a worker of how he/she performs a task that is regulated by NRC. or an independent measurement of radiation conditions at the facility (rather than exclusive reliance on a review of records). Specific inspection requirements follow:
02.01 Proaram Administration. Review the following elements in sufficient depth to verify that organization and administrative systems have been established to ensure safe conduct of the licensed activity.
- a. Oraanization.
Reference:
Applicable lic.ase conditions.
The organizational structures will be found in license applications and may involve one or more individuals. Examine any changes in the organization with respect to changes that have occurred in personnel, functions. responsibilities and authorities since the previous inspection.
If individuals are named in the license application, an amendment must be i provided whenever changes in personnel are made (except for some broad and '
radiography licenses, where only responsibilities are defined). If there have been no changes in the organization since the ]revious inspection, there is no need to pursue that element in any dept 1 except to ask the licensee if there have been changes and to make inquiries of personnel to i confirm (to the inspector's satisfaction) that no changes have taken i place.
- b. 0A Proaram and Licensee Audit 1
References:
Medical 0A program to 1 j
mitigate therapeutic misadministrations (only if the program being 87100 lssue Date: 01/XX/97 i
i
l l inspected has OA requirements in the license). Applicable license ]
conditions. i I
The quality assurance program will be in the form of procedures specified in the license and covering a variety of activities and methodologies.
Generally. the procedures will specify limitations. "do's." and " don'ts."
! and how to perform one or more tasks. In any event, the licensee is bound I
to the procedures. The inspector should verify (preferably by direct i observation) the implementation of a selection of procedural activities !
to the extent that the inspector is satisfied that procedures are being l
l followed. l The inspector also should verify that internal audits are performed, as required. The results of audits of activities will be found in records of audits. Examine those records with particular attention to deficien-cies found by the auditors and note corrective actions taken as a result of deficiencies found. If no corrective actions were indicated whenever <
deficiencies were found, ask the licensee's representatives what actions l
l were taken and determine why they were not noted in the records. i Audits of field radiography sites are especially important. If at all practicable, accompany a licensee's auditor to a field site (this may ;
require special scheduling). Other kinds of internal audits for different i categories of licensees may involve such determinations as the use of syringe shields (hospitals), whether technetium generators are pro >erly i shielded (hospitals), and whether established ALARA programs are 3eing i implemented (all licensees). These are only a few examples: the inspector !
should examine the licensee's comitments in the license to determine the kinds and extent of audits required.
As one part of ass) ~ :nspections, the inspector should determine that the l licensee's inter a lepection program is actually being carried out in that facility, e example, the date of the last internal inspection j findings and the e :orrective actions taken should be oetermined. The above informatun x iuld be included in the inspection sumary report sent to the home region ej. if negative, so stated.
- c. Medical Licensees. Radiation safety quality assurance procedures for I radioactive drug and device research programs may be found in the US Food and Drug Administration (FDA) accepted investigational new drug (IND) or investigational device exemption (IDE) applications. These procedures should be audited by the RSO and/or the Radiation Safety Committee (RSC).
For nuclear medicine and teletherapy secondary checks of dose calculations ;
should be done to provide assurance that the final treatment plan will !
provide the dose prescribed on the patient's chart, if required in the !
license.
- d. Trainina.
References:
10 CFR 19.12. Instructions to workers.
10 CFR 34.31. 35.900-972. 39.61. Training.
Applicable license conditions.
i
! Certain kinds of training and instruction are found in the regulations:
how they are im)lemented will be found in the license. The inspector should verify t1at proper training and initial instructions are being -
l accomplished as specified in the license or regulations. Discuss with 87100 Issue Date: 01/XX/97 l l
l
11cer.see's representatives how and by whom the training is conducted and the content of the training (generally found in the license application).
Verify, pursuant to 10 CFR 19.12. that the initial instructions have been given to workers who enter restricted areas. Under the basic instruc-tions it is tranagement's responsibility to inform the workers of / l precautions to take when enteiing a restricted area, kinds and uses of radioactive materials in that area, exposure levels, and the types of 1 protective equipment to be used. The workers should also be informed of I the pertinent provisions of NRC regulations and the license and the rega1rement to notify management of conditions observed that may, if not corrected, result in a violation of NRC requirements. ;
Of the training program elements in the license application, training given to authorized users is of primary importance. One or more users of radioactive materials should be interviewed to determine that they have received the required training, both in the basic instructions and that specified in the license application. For medical licensees, this includes specific training needed to perform infrequent medical procedures and prepare and use radioactive material in medical research studies.
For the radiographers, the initial training should cover 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom instruction in those topics in Appendix A of 10 CFR Part 34.
The 40 hour4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> classroom training may vary by 20% as long as all topics in Appendix A are covered. To become a radiographer, a radiographer's assistant must have completed 520 hours0.00602 days <br />0.144 hours <br />8.597884e-4 weeks <br />1.9786e-4 months <br /> of on-the-job training as a j minimum. The training must include the topics in 10 CFR Part 34, Appendix l A, and the operating and emergency procedures.
Randomly examine records of training of personnel and attendant tests or examinations (if applicable) to the extent that the inspector is satisfied i that the training program is being implemented as required. Where !
examinations are required read a few of the examination questions to I ascertain that they are indicative of what the worker should knuw to carry !'
out his/her responsibilities.
For radiographers, a written test consisting of approximately 50 practical questions should be taken dealing with the topics in Appendix A of Part
- 34. A field examination also should be given to determine that the individual is competent to perform all assigned operations. The competence of an individual who has been a radiographer for another ;
licensee should be determined. As a minimum, that individual must be instructed in the operating and emergency procedures and the use of ;
equipment. The individual also must take the written and field i examinations. Whenever possible, observe a radiographic operation.
including the conduct of surveys, to determine the adequacy of a radiographer's training.
- e. Doeratina and Emeroency Procedures. Safety Component Defects.
Reference:
10 CFR 34.32. 10 CFR 39.63. Operating and emergency procedures.
10 CFR 21:21 Notification of failure to comply or existence of a defect andMtstevalBition.
ApplMbWlicense conditions.
Operating and emergency procedures will be found in license applications I and may vary from step-by-step procedures for radiography programs to more generalized procedures for lower inspection priority licenses. The Issue Date: 01/XX/97 87100
procedures will be approved by the NRC and reviewed and updated by the licensee. Any revision requires an amendment to the license except for broad -licenses, i Examine the emergency procedures to determine that the procedures are as l approved by NRC. Discuss with the licensee *s representatives, or observe (for the higher priority licensees), the conduct of periodic tests and drills, especially for scenarios involving fires and large releases of ,
i radioactive material. Also verify that operational procedures are being followed by observation of personnel performing tasks at selected work stations and comparison of their activities with operational procedure requirements.
For the larger licensees there may be agreements with other agencies to respond to emergencies. Such agreements may be in writing and include state regulatory commissions (or equivalent) and hospitals. Generally, there will be no agreements in writing with fire departments. Discuss with licensee's representatives what has been done to ensure that agencies (for which agreements are in effect) understand their roles in emergency responses. Also, inquire if fire departments are knowledgeable of fires involving large quantities of radioactive materials and high radiation levels and whether they are equipped to fight such fires.
i The inspector may. 'at his option, visit one or more agencies or l departments to determine their understandings of their roles in responding to emergencies.
Inspectors should verify that licensees have procedures Manufacturers for repo-ting defects. The complexity of the procedures will vary.
should have detailed procedures to evaluate the safety significance of identified defects. Other licensees need only to address identification l
and reporting requirements.
- f. Reoorts and Notifications.
References:
i 10 CFR 19.13 Notifications and reprts to individuals.
10 CFR 20.2201 Reports of theft or loss of licensed material.
10 CFR 20.2202 Notifications of incidents.
10CFR20.2203lR limits $ !
10;CFR120.2206~
10 CP 20.108 Rep Rep $er.; =0nfto per:OnnT %c.3MKdiaYji6iHQfss]
m ; On t0rin:t10n Of 0
=0nt Or work --
10 CFR 31.5 Certain measuring, gauging, or controlling devices.
10 CFR 32.12 Records and material transfer reports.
10 CFR 32.16 Certain items containing byproduct material reports of transfer: Records and reports of transfer 10 CFR 32.20 Records and material transfer reports. Quality 10 CFR 32.25 Conditions of licenses issued under 532.22:
control, labeling, and reports of transfer. Quality 10 CFR 32.29 Conditions of licenses issued under S32.26:
control. labeling, and reports of transfer.
10 CFR 32.52 Material transfer reports and records.
10 CFR 34.25 Leak testing, repair, tagging, opening. modification -
and ,
replacement of sealed sources.
Issue Date: 01/XX/97 I 87100
, o-
l o 10 CFR 35.21(a) and (b)(2)(x1) Internal audits or inspections and records !
Of the audits.
- 10 CFR 35.33(a) Reports of therapy misadmi..istrations.
- 10 CFR 35.33(c) Reports of diagnostic misadministrations.
10 CFR 150.20 Recognition of Agreement State licenses. i Applicable license conditions. i 1.
10 CFR 19.13 requires that licensees provide individuals with reports of external and internal exposures on an annual basis d' 4f the indh'idual rcqu=t the report-s.
The i=p= tor need net inutre Of 'i==c= that they 5:= prot'ided r0v. m :
report; uen : ucrkcr fll= ; ==phint that 50 .:= =t "ed under '
repcrt += h0 rcqueted it. For those employees who work contract temporarily and for permanent employees who have An left the j
company, the licensee must provide the report withl to the workers l
^
also involved.
provide reports (of excessive exposures)The regional of {
examine them for accuracy and completeness. :
4 Prompt follow-up of reports of excessive exposures .
20[2202(a) and (b) may require promptOther follow-up to determine essential items if l l
ade45 ate medical care is being provided.(including medic:
reported by telephone, telegraph etc.) may be obtained by telephone '
or by dispatch of an inspector to the site to determine the causes of overexposure and adequacy of corrective actions. ;
In the case of high exposures to personnel, if the exposure is l believed to be valid, an inspector must be dispatched to the site to i
- conduct an insEtion to support possible escalated enforcement dcr 10 CFP 20.105 l
4
- action. 'ht i = :pplix to report filed =ly =5 r=:. dep=di";
if cxpecur= Orc gr=ter ther 2 r=: but 1c= th=?:' '=p=tcr =cd =t be dl cr the ci rc=t==0.
pre ptly ". for c= ple, the report cut-itted =dcr 10 CFR 20.405 ;
i
- chcu: 2.01 rc=. -In these cases, an inspection should be as soon as practicable.
judgment of the region, depending on the circumstances set forth in r the reports and by telephone comunications.
1 During routine inspections, inspectors need only inquire if 10 CFR 20.2206 reports have been submitted without going into further depth.
unipsf the Office of Resource Management The == cpplir =d:r 10 CFRThose has r
, 20.108 for t=i=ted =p10y= . examined at random so that the reports are being generated.
10 CFR 20.2201 requires licensees to reports losses or theft of-
- 2. licensed ridibactive material when a substantial hazard may result l
to persons in unrestricted areas.
Sc=ur Of the legalitic =d dct:ih 4=0hed for ir.==ti= =d p0 =0. tu interpreti= puid= ucre dc=' 0;cd. The h== Or theft: 0" r:diac fol b a c;
!* vd= =cEE 50 u=d f0r folku up =kd "10 CFP 20.102: 'L=t or The guid= rc = tit ti = :teri:1 87100 Issue Date: 01/XX/97 i l
l
St010 'M4 sing) Radi= tive Materim at L100n=c's F=iliti='" and i "20.102: Transp0rtation. 100t Or Stolen Radic=tive S0urce:
Involved in Tr= 00rtation.'" "c= guid= =y be found 1" the "10 ,
~
CF9" :=ticn cf th: Insp= tion Mx=1
- 3. The remaining reports listed in 02.01f deal with leak tests above limits (10 CFR 31.5. 34.25.): materials transfer reports for manufacture or transfer of certain items (10 CFR 32.12, 32.16. 32.20.
32.25, 32.29. 32.52): reports of medical therapeutic and diagnostic misadministrations [10 CFR 35.33(a)) and (c)] and Form 241. reports ,
of activities conducted in Agreement States (10 CFR 150.20).
- 4. Inspections should be done for therapy misadministrations that result in serious illness or death, etc. Depending on the content of the reports, where significant cause appears to exist for follow-up, the follow-up shall be done promptly to gather additional details about the cause of the event and the circumstances under which the event occurred. Reports that indicate moderate health and safety problems may be followed up during the next inspection unless there appears to be sufficient cause for possible escalated enforcement actions.
The occurrence of a misadministration is not, in and of itself, the basis for enforcement action unless there is a failure to timely and properly report the misadministration as required in 10 CFR 35.33 or there is a violation of other applicable requirements.
- g. Records.
References:
10 CFR 20 SubpirtTWRs566ili 10 CFR 20.1101 #rrterfi3NTN66F3iisi 10 CFR 30.41 Radiatict}6'f'69pFo^dddt"isstsr'isl .
Trsh5fdr 10 CFR 30.51 Records.
10 CFR 34.24 Radiation survey instruments.
! 10 CFR 34.25 Leak testing, repair. tagging, opening, modification, and replacement of sealed sources.
10 CFR 34.26 Quarterly inventory.
10 CFR 34.27 Utilization logs.
10 CFR 34.28 Inspection and maintenance of radiographic exposure devices, storage containers and source chargers.
10 CFR 34.31 Training.
10 CFR 34.33 Personnel monitoring.
10 CFR 34.43 Radiation surveys.
10 CFR 35.33 NotifidthrQirep6rtsifyddirecords of misadministrations 10 CFR 35.59(e) Leiliti5 ting seilsd~ sources 10 CFR 35.75 Relea' sit 6f3ndGidsilRonth;ijihlsdfBMnssEeutKhT5366 3ermanentMaplants) i 10 CFR 35.632 rul W a'libFatioh~ measurements 10 CFR 35.634 Periodic soot checks l 10 CFR 35.630 Dosimetry Equipment 10 CFR 35.961 Teletherapy physicist l 10 CFR 40.61 Records.
Applicable license conditions.
During the course of an inspection most items examined will have attendant records to support each portion of the licensed activity. Some records should be only randomly examined: 1.e. , spot-checked to the satisfaction of the inspector that the records are being maintained and are complete. Other records that are more closely related to health and safety (such as personnel exposure records) should all be examined.
l 87100 Issue Date: 01/XX/97 l
- - - --- _.. - - - ~ - - -.- -. - . _ . .
However, examinations of records should not be construed as the primary part of the inspection program. Rather. observations of areas where personnel work, ecuipment, usage, etc.. will give the inspector a better idea of what is going on than records review and may also support what the records reveal. During examinations of records, look for trends such as trends in air sampling. Records such as surveys, waste disposal. effluent release, receipt and transfer of radioactive materials, training.
utilization logs, and air sampling may be examined randomly until the inspector is satisfied that the records are being maintained and are
- complete.
Records that should be examined in their entirety include personnel monitoring: leak testing of sealed sources: instrument calibrations:
4 inspection and radiography quarterly inventory of devices and sources: source changers used:
1 maintenance of radiographic exposure devices:
storage devices used: receipt and transfer records: final radiation surveys of radiographic exposure devices upon completion units.
of usage: full pocket and for teletherapy dosimeter results and calibrations:
calibration, spot-check measurements and records of calibration of dose calibrators and checks of dose calibrators. Other records to be exam may be found in license conditions such as ALARA records, records of
' safety committee minutes, etc. '
The extent to which records are to be examined, either randomly or in their entirety, will depend on the category of the licensee In aseach well ascase. the l history of noncompliance of the licensee inspected.
i judgment will need to'be exercised so that the inspector is satisfied that j
the licensed program is being operated safely to protect the health and
' safety of the workers and general public.
! As a general rule, records should be examined for the preceding Olderthree-year records period or back to the last inspection, whichever is less.
preceding the three-year period should be inspected if exposures. I 02.02 Authorized Materials. Uses. and Users. Determine from reviewing records. l observing the use of radioactive material, and discussing the activities withl licensee personnel that the type, quantity, :
licensee's facility are authorized by the license. Specific records and areas !
to be reviewed are as follows-
References:
- a. Receiots. Transfers. and Packaae-handlina Procedures.
10 CFR 20.19067PFo64dsfE%f6FFFsEEiVlixFssd;6pehindip~sEEigsH ~ ~ ~
10 CFR 30.41~"TransfeF6f^byriroduct~materiar~~'
Transfer of source or byproduct material.
10 CFR 40.51 Applicable license conditions.
Depending on the size of the licensed program, the proc many) care fully reviewed before an inspection is conducted. The reason for such a review is to determine completeness, repeated procedures that may be contradictory, and procedures that should be in the application but are missing.
The procedures for picking up. receiving, and open 87100 Issue Date: 01/XX/97
~ _,
wipe tests of packages upon receipt, and procedures for opening packages, n such as where in the facility packages are received. surveyed. and opened. "jd
- The procedures also should include what actions are to be taken if g packages are contaminated in excess of specified limits and radiation \f\
levels are higher than limits (the latter would depend on the package ~
index. i.e. . the dose rate at 3 feet for each category). If packages have arrived during the course of an inspection, observe the person performing the surveys as an indication of training.
The inspector should randomly examine records of surveys of packages received and also determine if inventories for each licensed nuclide is within the license limits. In this regard, records of inventories following receipt and transfer should always show that the materials on hand at any one time are within the license limit. The records examined should be compared with the physical . inventories of materials possessed.
By discussions with the licensee, inquire if the procedures have been changed or added to (requiring license amendment except for broad scope licenses and, in general, medical licensees that can change minor procedures by regulation). Randomly examine procedures used by the licensee to determine if they are in accordance with those in the license application (if the licensee's procedures are supplementary to those in the license application, or if the changes in certain procedures were minor.)
- b. Authorized Users. References- i i
10 CFR 33.17 Conditions of specific licenses of broad scope.
10 CFR 34.25 Leak testing, repair, tagging, opening, modification. and replacement of sealed sources.
Applicable license conditions.
Authorized users will normally be named in the license application, or. ;
if the license is a broad license, will be appointed as authorized users l by the radiation safety comittee or isotopes comittee. l The inspector should determine during an inspection that named authorized users are doing the work authorized rather than someone else not named in :
the license. This will depend on the wording in the license with phrases such as "used by or under the supervision of" except for radiography licensees in which supervision for users is defined in 10 CFR Part 34.
Guidance on the phrase "used by or under the supervision of" may be found in the "10 CFR" Section of the IE Hanual under 10 CFR Part 30 issued on 10/1/79 entitled " License Condition * ...used by or under the supervision of. '" For some specific or broad licenses (Types A. B. and C), the phrase for users is "under the direct supervision of" which implies the authorized user should be present at the facility for easy contact or to observe the individual (s) working lander the authorized user.
However, another phrase not often seen in licenses is "under the direct supervision and physical presence of" which means the authorized user must directly supervise and be present at the work station. Another phrase used for physicians doing patient therapy states "may or.ly be used by."
The inspector must use more than the usual amount of judgment during inspections to interpret the role of the authorized users, considering the many license condition phrases u*d above. First, a determination of qualifications should be made. Second, for the broad licenses, the 87100 Issue Date: 01/XX/97 '
radiation safety ccmmittee appoints the authorized users based on qualifications.
For a determination of required training, see " Training" under 502.01d of i this procedure. In general, authorized users must be specifically licensed by the Comission or otherwise listed in the license application .
and in a license condition for specific tasks that only the individual (s) !
named can perform. This includes leak testing of sealed sources. "
replacement of sealed sources, modification and opening for purposes of repairing or replacing sealed sources in teletherapy units and for radiogra ahy programs. changing sources from source changers or containers. t Such authorized users m;.y not be those of the licensee but of a separate : ~
4 firm specifically authorized by the Comission.
- c. Authorized Uses.
References:
10 CFR 33.13 Requirements for the issuance of a Type A specific license of broad scope.
10 CFR 33.14' Requirements for the issuance of a Type B specific license Tution studies. e 10 CFR 35.200 Use of radiopharmaceuticals. generator, and reagent kits-for imaging and localization studies. ;
1 10 CFR 35.300 Use of radiopharmaceuticals for therapy. .l 10 CFR 35.400 Use of sources for brachytherapy. l 10 CFR 35.500 Use of sealed sources for diagnosis. l 10 CFR 35.600 Use of a sealed source in a teletherapy unit. -j Applicable license conditions. '
Authorized uses of radioactive materials, excluding broad license applications will be found in the licenses and license applications.
Specific licenses will list the isotopes, physical or chemical forms, and l the maximum quantities. The inspector should physically examine the inventory of radioactive material on hand or examine records of receipt and transfer to determine that quantities and forms are as authorized.
For medical licenses of broad scope (Type A. B. C) the maximum quantities are listed (or narrated for Type A) in 10 CFR 33.100. For broad licenses.
any chemical or physical form is authorized.
The inspector must determine that nuclides are used as authorized, particularly for human use. that could otherwise become a misadministra-tion if not used as authorized. For medical facilities or institutions, examine patient log books to determine that radioactive materials are used ;
in proper chemical form on patients. l 7 _.
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Issue Date: 01/XX/97 87100 l
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- d. Material Control.
References:
10 CFR 20 $51j55Tt517Q31Fa56MHdEC6ht?B]Mfjlsc5&ssaMitEH5153 10 CFR 34.22~ T5cYnig drFidi6@?iphi^d~si$6sure deWess~3t~o~ rags ~e5htain- .
ers. and source changers. l 10 CFR 34.23 Storage precautions.
l Applicable license conditions.
The inspector should examine storage areas in unrestricted and restricted areas. Such storage areas should be locked and have limited and controlled access. In general, there will be procedures for access controls. Additional controls should 4aclude logging out radioactive This is material from storage areas and logging it in after use.
especially important for medical institutions because of the use of small 1 implant seeds for therapy. In the past. many seeds have been lost because The inspector also should determine that I of the failure of controls. l radioactive storage devices and source changers are locked when in storage l and that storage areas also are locked when not in use. l
- e. Area Radiation and Contamination Control.
References:
10 CFR 19.11, 10 CFR 21.6 Posting of notices to workers. I 10 CFR 20}S6tyhltjDfMRidiatbiD@%jiiit5]fgI6diVjMMembsisI6]
theiPeblics 10 CFR 20 SubpiftiEEM SiiFildyi~'and(H6 hit 6'FJHyC5htroKofsExp 10 CFR 20 SubpagGjiM' Restrict ~edBA"reas ~ ,
10 CFR 20.1901 Caution si'g657~ ~~ l 10; CFPd20?1902)PbstirifRuqnf~rsmedf51 10lCFRt20t1903?Escept16nct6?postin Ts "
10!CFR120:19041tsbs tirigicantsinsrs?g~"~^yUi FEmenfi?
~ ~ ~
10!CFR;20fl905iExemptionsstMlabelti%36htii6sFi?
~~~~~
Appli66bls'~Ti6siisFcahditT6Hs~~~
The inspector should ensure, during observation and by direct measurement.
that 10 CFR the radiation levels 20.1302(b). in unrestricted areas are w crFFc:trictive.
con:ccutiv6~ty . eithever The1: inspector may ask the licensee to spot-q occupancy is 0_ot. a factor. check radiation levels in selected area However. readings of radiation levels using the The inspector instrumentation.
licensee's instruments shall not be considered as valid.
must use his/her own instruments that have been calibrated, source checked prior to leaving the regional office and checked upon return to see if th calibration is valid.
By definition, surveys of radioactive materials or radiation areas are supposed to be done before the fact not after an individual gets expose If practicable, observe how licensees conduct surveys to determine the adequacy of surveys, particularly during the conduct of radiography Issue Date: 01/XX/97 87100
operations. Also, note the types of instruments used, and whether they are designed for the type of radiation being measured.
During the physical operations review (facility walkthrough) observe that proper caution signs are being used at access points to airborne radioactive materials. Randomly observe labeling on packages or other containers to determine that proper information is recorded such as
-exceptions to posting caution signs, primarQv f6r m Some types of licenses, such as those for teletherapy rooms radiography (fixed or permanent facilities), and irradiator operations also require signals or alarms, both visible and audible.
The~ inspector should examine these to determine operability. In addition, ,
during the walkthrough examine locations where notices to workers are '
posted. These should be located so that employees may examine them on J
their way to and from work locations.
- f. Packaaina and Transoortation.
References:
Packaging of Radioactive Material for Transport and 10 CFR Part 71 Transportation of Radioactive Materials Under Certain Conditions.
Use Inspection Procedure No. 86740. " Transportation" 49 CFR Parts 170-199 as applicable.
Waste Handlina. Use Inspection Procedure No. 84850. " Radioactive Waste g.
Management - Inspection of Waste Generator Requirements of 10 CFR Part 2 and 10 CFR Part 61."
- h. Performance Evaluation Factors. Use performance evaluation factors (PEFs) to assess the potential for degraded safety performance in priority 1. 2.
See Inspection Procedure 87101 for requirements and and 3 licensees.
guidance concerning PEFs.
02.03 Physical Plant Facilities and Eauioment General.
Most of the following line items are found in license applications and depending on the type of licensed activity, and may not be all will vary, These items should be inspected during the facility tour (operations inclusive.
review).
Other items may be identified in the regulations and also may be '
repeated in the license application for implementation of the requirements.
References:
10 CFR 20.1003 Unrestricted area (Definitions.)
Radiation area .
l 10 CFR 20 Subp~ art I Storage and Control of Licensed Material i
~
Limits on levels of radiation for radiographic exposure i 10 CFR 34.21 devices and storage containers.
Permanent radiographic installations.
10 CFR 34.29 10 CFR 34.41 Security.
-Teletherapy requirements 10 CFR 35.632-647 I
87100 Issue Date: 01/XX/97
i Review and verify that the equipment and the physical facility promote safe conduct of the licensed activity. The facility and equipment should conform to that described in the license application and the equipment should be operable.
Systems, subsystems, andaersonnel equipment important to the safe handling of materials and the public should be (1) examined for and protecticn of operating operability and (2) designec to carry out intcoded functions. ,
Examine records of the most recent five-year teletherapy maintenance program.
Some specific items which may need maintenange include the following, although these are not the only items to be serviced
- a. Field-light Cord Reel.
l
- b. Source drawer solenoids.
i i
- c. Low air pressure switch,
- d. Air hoses and fittings.
- e. Treatment timer.
02.04 Radiation Protection. !
as l
- a. General. Use Inspection Procedure 83822 " Radiation Protection" j applicable.
N"$$ESE5$@EMIO3?l$EIMMENMMM RE M tifE@HidisTifff:sssisiF2 Referencest igtC@gil$g@si5fysdiViddi]5f1@@LWi@lydi6biftfli@i[Mj@@
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' its: &jtheltiesst td -~ ~~
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Regulatory references and 02.05 Radioactive Effluents and Waste Discosal.
license applications:
10!CFR120j'l101FYRidfitibdiPibts&ti5h!PiogfabiETRakhstlaglDgtelt 10~CFR 20 pubpaMDgg(dPub1f6 N
10?CFR1_2,,0N.3g,,.EFtRKNMWas_ts30f5M, 7g g7 g7g ,g isil, g Trcctment of dispc:S by incincration 10 CFP 20.305 1 May not be applicable to all types of units.
Issue Date: 01/XX/97 87100
in cro on one n.,4
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Review and verify that waste-handling equipment, monitoring equipment, and/or administrative controls are adequate to maintain radioactive effluents within the limits established the license and other r ulator irements and are ALARA. VdF3 ,,tj 86rshtahrssavetriotr ~
R4censeej C JEICMsfreguirisd;bygoi <
=
air! effluents 0havel ~
1 M g linessigffthe3 1L _ _
Examine the waste release records generated since the last inspection, all annual or semiannual reports, all. pertinent non-routine event reports, and a random ,
selection of liquid and airborne waste release records. Randomly select procedures for both liquid and airborne systems and verify that the procedural steps are being followed. The verification should be made by whatever means are available: i.e.. perform an observation of an operation, a review of selected i records, etc. !
Compare / verify on a sampling basis survey I 02.06 Confirmatory Measurements. !
results or data that are used by the licensee to show compliance with the regulations or license conditions. Examples of confirmatory measurements are: :
- a. physical surveys. using the region's own instrumentation.
i
- b. split samples. etc. l 02.07 Reauired Scoce of Selected Materials Insoections. The attachments contain standard formats for recording tne results of inspections of radiography, well logging. nuclear medicine and teletherapy licensees. Individual topics define the required scope of inspection for NRC inspections of these types of licensees. l 87100 03 INSPECTION GUIDANCE General. All inspections should include a mix of records and procedures review, observations. confirmatory measurements, and discussions with personnel involved l' in the " hands on" work.
03.01 Proaram Administration
- a. The regulatory requirements related to the organization and administration of the licensed program will be contained in license conditions. The i organization should be examined to verify that the responsibilities and authorizations of designated individuals comply with license conditions.
- b. The inspection is a verification of implementation of the required program. In the review to verify implementation, the inspector should pay attention to the scope of the programs; frequency of licensee audits: the use of qualified auditors: procedure for recording and reporting 87100 Issue Date: 01/XX/97
I deficiencies to management; methods and completion of follow-up actions by management: and the policy regarding announced and unannounced audits.
- c. No guidance.
- d. In verifying the implementation of the approved or required training program, pay attention to completion of requirements related to: initial training. . periodic retraining, on-the-job training, and tests and examinations of trainees (if applicable).
Inspectors should verify that procedures have been developed to implement the program, and that the staff has been trained in using these procedures. It is not the intent that inspectors routinely review and cite against internal procedures and protocols for the administration of byproduct material for medical use. Only in instances where there has been an event, misadministration, or evidence of a loss of management control is an in-depth review of internal procedures and protocol indicated. In such cases, the review should determine that necessary procedures are in place, and that adequate training or instruction has taken place prior to the administration of byproduct material. Failure to provide adequate procedures, and/or training could be a violation of 10 CFR 35.25(a).
In those instances where a performance error has resulted in the administration of byproduct material not in accordance with the physician's directions and also involves the failure to follow the instructions of the authorized user, or su3ervising authorized user, the procedures of the Radiation Safety Off'cer, or to comply with the regulations or licensing conditions, there could be a violation of 10 CFR 35.25(b) for lack of adequate supervision. If however, the event or misadministration was more clearly an isolated human error, e.g.,
distraction due to heavy workload, picking up the wrong container of radiopharmaceutical, etc. then 10 CFR 35.25 should not be cited.
10 CFR 35.25 should only be cited in instances where no other regulation is applicable to the violation. In other words this regulation should not be used as a catch-all for poor programatic management which is not smcific to supervision and training. It is imoerative to determine w1 ether adequate supervision has been provided, the supervised individual has followed instructions, or whether human error has occurred. If indicated, the appropriate section of 10 CFR 35.25 should then be cited.
- e. Regulatory requirements related to procedures will be contained in license conditions. It is necessary to verify that operating and emergency procedures have been developed, are adequate and functional and have been reviewed and approved by management.
- f. No guidance.
- g. No guidance.
03.02 Authorized Materials. Uses. and Users General. Authorized materials, uses, and users are generally described and authorized by the license, or as otherwise authorized in 10 CFR 33.
~
- a. Receipt and transfer of materials should generally be detailed in procedures sufficient to provide assurance of compliance with regulatory 87100 Issue Date: 01/XX/97 i
I
- - - - - _ . -. .- --.- - _ _ - - - . - =
requirements.
906. It - )
is necessary toSpecific reguirements assure that are setpersons only authorized forth in are 10 CFR involve 20.)nh the transfer and receipt of materials.
l The frequency of inventories is dictated by need or as specifically set l forth in certain parts of 10 CFR or in license conditions. License -
inventories can be used for two purposes: (1) to track the use of l material, and (2) to verify that the licensee is only receiving materials ;
authorized in the amounts listed in the license.
- b. No guidance,
~^"
- c. 10!CFR*34T26HWidiis .
J ~~~ S !
htgoingM rn.- .
INSIM featikesi assodfated!
1010FR$34f I assoc 14tsdi ~
requimentsy _
assthersourcet _ ,
exposure lheadsk ,'
i applicabilitjsf.
staff 2is9 current)
PendingihisTFett _. I that associated?
except when'anMnct the: use:TofcaRa publiciheslthiandhi non-compatiblelsysteiKord ..
an associated;eguipmegtjhri6ficos@lj
- d. Various strategies for control of materials should be in place. These are generally defined by procedures and should ensure that use is limited to authorized users and that secure storage is provided.
$ e. No guidance.
- f. Specific guidance is set forth in Inspection Procedure 86740.
- g. Specific guidance is set forth in Inspection Procedure 84850.
- h. Follow the guidance on PEFs in Inspection Procedure 87101.
03.03 Phvsical Plant Facilities and Ecuioment. Descriptions of the abysical plant are generally found in the applications for a license and su) sequent amendments that are usually tied down to a license condition. The actual or as-built facility should be configured to provide safe working areas separated from unrestricted areas and sufficient access controls to preclude unauthorized entry.
The facility should include utilities and other services sufficient to cope with emergencies, such as loss of power. loss of contamination control, etc.
Plant equipment is generally described in documents as noted above. Plant equipment should be appropriate to the scope of the licensed program. Processing equipment, associated process control equipment and ventilation and exhaust systems should be sufficient to provide safe use handling, and storage of the materials in use.
Issue Date: 01/XX/97 87100
- . - . . - ~ . . . - . _ - - - . . - - - . . _ .-_ .-
For the five-year maintenance of teletherapy units, critical repairs and maintenance may be recommended by service representatives, but might not be completed by the licensee. Talk to licensee representatives about any needed 1
repairs, and get commitments to complete repairs immediately.
03.04 Radiation Prptection.
~
Specific guidance is set forth in NRC Inspection Procedure 83822. l
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-- ~
d 16 - Issue Date: 01/XX/97 87100 I
- m. e a . - . , , .- -- - -.
"S 5!$NE8$MMIEE@d@_}i$!
03.05 Radioactive Effluents and Waste Discosal. Review the reports and records for obvious mistakes, anomalous measurements, trends, missing data (compare the recorded data with the requirements), and verify the accuracy of the data in the report or record with the licensee if any of these aspects are identified or suspected.
- _ ~ ,
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gscpedingithe[?o!(traintf]& elf 03.06 Confirmatory Measurements. Confirmatory measurements should be in sufficient scope to verify survey results or data as found in the licensee's
- records. Examples
- radiation levels in an unrestricted area; airflow to process or fume hoods: and air samples in process areas.
4 i
87100-04 ADDITIONAL REFERENCES 1 Proaram Administration (Section C3.01)
I RG 7.1 Administrative Guide for Packaging and Transpcrt.ng Radioactive Material.
RG 7.7 Administrative Guide for verifying Compliance With Packaging Requirements for Shipments of Radioactive Materials.
RG 8.2 Administrative Practices in Radiation Monitoring.
! RG 8.10 Operating Philosophy for Maintaining Occupational Radiation Exposures 1
As low As Is Reasonably Achievable.
RG 8.13 Instruction Concerning Prenatal Radiation Exposure.
RG 8.15 Acceptable Programs for Respiratory Protection.
RG 8.18 Information Relative to Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be As Low As Reasonably Achievable.
RG 10.1 Compilation of Reporting Requirements for Persons Subject to NRC
- Regulations.
RG 10.2 Guidance to Academic Institutions Applying for Specific Byproduct -
Materials Licenses of Limited Scope.
. Issue Date: 01/XX/97 87100
RG 10.3 Guide for the Preparation of Applications for a Special Nuclear Material License of Less Than Critical Mass Quantities.
RG 10.5 Applications for Type A Licenses of Broad Scope.
RG 10.6 Guide for the Preparation of Applications for Use of Sealed Sources and Devices for the Performance of Industrial Radiography.
RG 10.7 Guide for the Preparation of Applications for Licenses for Laboratory use of Small Quantities of Byproduct Material.
RG 10.8 Guide for the Preparation of Applications for Medical Programs.
RG 10.9 Guide for the Preparation of Applications for Licenses for the Use of Gamma Irradiators.
DRAFT RG Guide for the Preparation of Applications for Licenses in Medical Teletherapy Programs.
Authorized Materials. Uses. and Users (Section 03.02)
RG 6.1 Leak Testing Radioactive Brachytherapy Sources.
RG 7.2 Packaging and Transporting of Radioactively Contaminated Biological Materials.
RG 7.3 Procedures for Picking up and Receiving Packages of Radioactive Material.
RG 7.4 Leakage Tests on Packages for Shipment of Radioactive Materials.
RG 8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants.
Physical Plant Facilities and Eauioment (Section 03.'03) 1 RG 3.2 Efficiency Testing of Air-Cleaning Systems Containing Devices for Removal of Particles. l RG 8.1 Radiation Symbol.
RG 8.5 Immediate Evacuation Signal.
Radiation Protection (Section 03.04)
RG 8.3 Film Badge Performance Criteria.
RG 8.4 Direct-Reading and Indirect-Reading Pocket Dosimeters.
RG 8.6 Standard Test Procedures for Geiger-Mueller Counters.
RG 8.7 Occupational Radiation Exposure Records System.
RG 8.9 Acceptable Concepts. Models. Eauations. Assumptions for a Bioassay Program.
RG 8.14 Personnel Neutron Dosimeters.
RG 8.15 Acceptable Programs for Respiratory Protection.
RG 8.20 Applications of Bioassay for I-125 and 1-131.
RG 8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants.
RG 8.23 Health Dhysics Surveys at Medical Institutions.
RG 8.25 Calibration and Error Limits of Air Sampling Instruments for Total Volume of Air Sampled.
RG 8.28 Audible Alarm Dosimeters.
$tBf395 ' Release of/Patiehts]Admijii5teFedjRadj6aEtys[Mitsga))
Radioactive Effluents and Waste Discosal (Section 03.05)
RG 4.15 Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment.
RGJ47207 jCohjtriihtW661RhlE6EesMf?Aifo6FhEIRidf6HEtiys%Mayfigg61tijd Envi ronmentsfo61Licenseesi0theriThan? Powet Reactorsa RG 7.1 ' dmihi'stFatiVE^Guids~for"Pstkigihfi6d"TFahsp6Fting A Radioactive Material.
87100 Issue Date: 01/XX/97
RG 7.4 Leakage Tests on Packages for Shipment of Radioactive Materials. i Requirements for Shipments of Radioactive Materials.
RG 7.5 Administrative Guide for Obtaining Exemptions From Certain NRC Requirements Over Radioactive Material Shipments.
RG 7.7 Administrative Guide for Verifying Compliance with Packaging. >
Appendices:
A. Medical Teletherapy Inspection Field Notes.
B. Nuclear Medicine Inspection Field Notes C. Well Lmging Inspection Field Notes D. Indust'al Radiography Inspection Field Notes E. Industrial / Academic Inspection Field Notes '
F. Commercial Irradiator Inspection Field Notes END l
l i
l Issue Date: 01/XX/97 87100
1 4
4 ADDITION TO FIELD NOTES TO ADDRESS CONSTRAINT RULE
, The following sections will be revised in the IP 87100 Field Notes for Nuclear Medicine. Industrial / Academic. Medical Broad-Scope. and Radiopharmacy arograms and IP 87110 Field Notes for Industrial / Academic /Research programs, iote, subsections under the radioactive waste section where no changes are not shown but will remain unchanged.
i XX, RADIOACTIVE WASTE B. Effluents
- 4. Control of air effluents [20RIDI.
- ^~" ~ 1201.1301.
1501, 2001. L/C]
, {SeealsoIP87102.RG8.37} ffgf I?fECTft!
b?"Ilf 1 EIZZ [ ~" ' .jpn -
^ ^
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XX. NOTIFICATION AND REPORTS A, Licensee in compliance with [19.13] (reports to individuals, public and occupational, monitored to show compliance with Part 20) ( ) None ( ) Y ( ) N B. Licensee in compliance with [20.2201]
(theft or loss) ( ) None ( ) Y ( ) N C. Licensee in compliance with [20.2202]
(incidents) ( ) None ( ) Y ( ) N D. Licensee in compliance with [20.2203]
(overexposures and high radiation levels) ( ) None ( ) Y ( ) N E. Licensee aware of NRC Ops Center phone number ()Y()N F.
Licensee (constraint inlcompliiFicEwith?[2012203]
.ogaiflemijsjons;jy] [j}Q[QjdN@e[{@]{EQHN
]
~- - . . - - - - - . - . - - . . _ . - . - . . - . - - - . _ . - . _ . . . . - -
i I ADDITION TO FIELDNOTE TO ADDRESS PATIENT RELEASE RULE i i , The following section will be added to the Nuclear Medicine and Broad Scope Medical Fieldnotes. FOLLOWING GUIDANCE .T0 BE USED AFTER 1997 REVISION TO 10 CFR 35.75 BECGc.i EFFECTIVE - If using this section. do not answer items 8.C. and 9.C. in the field notes.
- - X. Patient Release ( ) N/A A. Individuals released when TEDE less than ( )Y ( ) N 0.5 rem [35.75(a)]
B. Instructions on ALARA provided to ( )Y ( ) N to individuals when TEDE exceeds 0.1 rem [35.75(b)] C. Instructions to breast-feeding women ( )Y (-) N include appropriate information [35.75(b)] ; D. Release records maintained if 35.75(c) ( )Y ( ) N criteria is met [35.75(c)] E. Records of instructions given to breast- ( )Y-( ) N feeding women maintained. . if appropriate [35.75(d)] ( )Y ( )N ( )N/A l l I \ 1 l l i l
- I k
L
REVISION TO RADIOGRAPHY FIELD NOTES The following section will be revised in the IP 87100 Radiography Field Notes.
- 7. E0VIPMENT m-->
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the requirements #MM}'.Wrgto,fcceply. vgMN.w;.w. > - -- l C. n : Licensee is ' aware th+etassectated< ust equipment <a. %.m;'<
~' comply with [34 20 NN v 0::<.ca
- , ~ J M. m . -V/O .o Nic'W< :%F_PYT_m'F_N D .. fSource> changers' 'storagt<: containers?meeti
.Equipment radiation'esaaptedifrom ,le. vel, limits.p{er134 84:20Myespe 21L'T,ditc. 4tcense+2^' A ? C l7 E. .
~^~ " condition u.s,.ed _in accordance_Vith
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. . - - - . _ _ __- . _ . . . _ . _ _ _ _ . _ . - _ . - ~ . . _ . . . .
F
^
I ATTACHMENT 1 ' Contents i 1. Federal Reaister Nohce 65120, December 10,1996, Resolution of Dual > Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act i
- 2. Regulatory Guide 4.20, " Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors" -
- 3. SECY-96-100, " Final Amendments to 10 CFR Parts 20 and 35 on Criteria for i i the Release of individuals Administered Radioactive Material l
! l l Only Attachment i to the SECY Paper is being forwarded for your information.
- The Regulatory Guide has undergone extensive changes since it was
)
j $ forwarded to the Commission with the rule package. A copy of Regulatory l i Guide 8.39," Release of Patients Administered Radioactive Materials," will be -I
- . forwarded under separate cover when it is finalized.
f-l l
\
l l
( 45120 Federal Register / Vol. 61, No. 238 / Tuesd:y, December. 10, 1996 / Ruhs and Regulations have been disposed of m accordance ini+"' de* mination that the NRC program NUCLEAR REGULATO."lY under the Atomic Energy Act provides an with 40 CFR Part 192. Radon-222 ColueSSION emissions from tailings were covered by safety Q pu 40 CFR Part 61. Subparts T (addressmg 10 CFR Part 20 However. EPA continued to express non, operational uranium mill tailings NN SWm piles) and W (addressing operating mill concern regarding the adequacy of the measures to assure that future emissions Resciution of Dual Regubtlon of tailings piles). EPA rescinded Subpart T from NRC heensees willnot exmed forNRClicensees after Appendix A to Airbome Effluents of Radioactive to CFR Part 40 was amended by the levels that will provide an ample marpn . Mativ.lats; Clean Air Act Commission to conform to changes EPA of safety. The stay on Subpart I expired issued to 40 CFR Part 192. Subpart W on November 15.1992. and Subpart I AGENCY: Nuclear Regulatory became effective on November 16,1992. Commusion. still applies to NRC licensees. Because Radon-222 is adequately addressed in Subsequently, in July of 1993, the EPA . Acn0N: Final rule. AdmNWator determined that there ' to CFR Part 40 Appendix A.and other was insufficient basis at that time to sutsuARY:The Nuclear Regulatory provisions of10 CFR Part 20,it is not CommMon is amending its regulations covered in this final rulemaHng, resemd Subpart L Consequently. NRC to estabhsh a constramt of to mrem (0.1 In 1990. Congress enacted and Agresment State licensed facilities mSv) per year total effective dose were subject to dual ragulation of amendments to the CAA. Section equivalent (TEDE) for dose to members airborne effluents of radionuclides 112(d)(9) of these amendments to the of the public from air emissions of CAA (the Simpson amendment) states: under both the AEA and the CAA. radzonuclides from NRClicensed including regulatory oversight by EPA facilities other than power reactors. This No standard for sdionuclide emissions (or authorized State) and NRC (or from caagwy a subcategmy of faculties action is necessary to: Provide assurance A ent State). licensees subject to EPA's to the Environme 2tal Protectioa Agency c mma. an alis Subpart I are also subject to NRC dose (EPA) that future emissions from NRC required to be pmmulgated undw this limits for members of the public limnsees will not exceed dose levels sectionif the Admini=trator determines,by that EPA has determined will provide rule, and after consultation with the Nuclear contained in to CFR Part 20. Subpart D, an ample margin of' safety; and to Regulatory f>=mia* ion, that the regulatory enntled " Radiation Dose Limits for provide EPA a basis upon which to program establishad bv the Nuclear Individual Members of the Pubhc" Regulatmy Comnussion pursuant to the (Subpart D). Under Subpart D, licensees rescind its Clean Air Act (CAA) Atomic Energy Act for such category or regulations as defined in 40 CFR Part 61 shall ensure that doses to members of
**85 pr am margin of the public are lem than 100 mrem (1.0 for NRC licensed facilities (other than g, Dower reactors) and Agreement State mSv) per year frcAn all pathways beensees, thereby relieving these Upon issuance, the effectiveness of (including airborne effluents) and all licensees from imn~~*ry dual Subpart I for all NRClicensees was sourms associated with the hcensee's immediately stayed by EPA pending operation. In addition, under Subpart B.
regulations. further evaluation. During the stay entitled " Radiation Protection EFFECTIVE DATE: his rule will become Pmgrams,%annees must ensure that effective January 9.1997. Period. EPA conducted two studies of the air emissions from NRC and doses to members of the public be kept FOR FURTHER DFORs4AT10N CONTACT: Agreement Sta*e materials license s. as low as is reasonably achievable Alan K. Roecklein. Office of Nuclear ne Erst was a suxwy of 367 randomly (ALARA). Based on the studies Regulat)ry Research.U.S. Nuclear selected nuclear materials hcemes- condudedby EPA andlicensee Regulatory CommMon. Washington, EPA determined that the highest reportmg of doses to members of the DC 20555-0001, telephone (301) 415- . . ima ed d se to a member of the public from airborne effluents to EPA it 6223* public from air emissions from these is evident that less than to mrem ( 0.1 SUPPLEMENTARY INFORIAATION: facilities was 8 mrem (0.08 mSv) per mSv) per year to the mawmally exposed year. based on very conscivative member of the public from airborne Background modeling. In addition,98 percent of the radioedive e!!!uents to the environment The EPA promulgated National facilities surveyed were found to have is reasonably achievable Emiecion Standards for Hazardous Air doses to members of the public resultin8 NRC power reactor licensees subject Pollutants (NESHAPs) for radionuclides from air emissions less than 1 mrem to 10 CFR 50.34a must keep doses to on October 31,1989.Under 40 CFR Part (0.01 mSv) per year.We second study members of the public from airborne 61, Subpart I emissions of evaluated doses from air emissions at 45 effluents consistent with the numerical radionuclides must be limited so that no additional facilities that were selected guidelinesin Appendix!to to CFR Part member of the public would receive ar. because of their. potential for air 50.nese licensees have reported effective dose equivalent greater than to emissions resulting in significant public estimated doses to members of the mrem (0.1 mSv) per year,' Subpart I of exposures. EPA found that 75 percent of public from air eminions well below 40 CFR Part 61 was promulgated to these licensees had air emissioD5 the subpart I value for many years. implement the CAA and limit doses to resulting in an estimated maxf mum Based on the combination of a roembers of the public from air public dose less than 1 mre:r. (0.01 mSv) continuing regulatory basis for redumd emissions of radionuclides (other than per year. For the licensees e. valuated, air emissions and documented proof of Radon-222) from all NRC heensees other none exueded to mrem (0.1 mSv) per the effectiveness of the NRC program for than liansees possessing only sealed year. these licensees. EPA rescinded Subpart souras. high-level waste repositories. In its initial proposalto rescind I for power reactors licensed by NRC (60 and uranium mill talhgs piles that Subpart I for NRC licensees other than FR 37196; September 5,1995). power reactors.FPA stated that: i t subpart l expremes dou in et!.ctiu dou Amendments Based on the results of the survey equivalent (EDEL NRC upresses dou in total The amendments proposed on undertaken by EPA and the commitments ensuin dou equivalent (TEDEL These terms are December 13,1995 (60 FR 63984) and essentially equivalent. made by NRC in the MOU. EPA has made an
Federal Register / Vol. 61. No. 238 / Tuesday December. 10, 1996 / Rules and Regulations 65121 finabr%.ms rule estabhsh a to take to ensure that the constraint is that the constraint was preferable to
- constraint of to mrem (0.1 mSv) per not again exceeded, a timetable for dual regulation or Subpart I alone.
yearTEDE to members of the public implementing the corrective steps, and Those commenting that existing NRC from airborne radioac:1ve emuents to the expected results. Records of the programs are adequate to protect the the environment from NRC-licensed results of measurements and public cited the two EPA studies on facilities, other than power reactors, as calculations needed to evaluate the doses from air emissions. Two-thirds of a part of its program to maintain doses release of radiowive effluents to the these commenters were opposed to ALARA. These amendments codify environment will stillbe required acidh forward with the constraint numerical values for NRC's application pursuant to 10 CFR 20.2103(b)(4). Eecause they believed it was not needed of ALARA guidelines for radioactive air Exceedmg this constramt will not and that licensee and regulator costs emissions from its licensees, other than result in a Notice of Violation (NOV) as could not be justined given the power reactors. For power reactors, would be the case if a limit needed for expectation that risk to public health l ALARA guidelines have already been adequate protection of public health and and safety would not be reduced. These established within 10 CFR Part 50 and safety were exceeded. In the case of the mmmenters encouraged NRC to existing facility licensing conditions. constraint rule, an NOV will be issued continue working with EPA to provide nose final amendments ensure that air only if and when (1) a licensee falls to sufficient basis for rescission of S emissiocs are r nintained at very low report an actual or estimated dose from I without the imposition of an y levels and, taa% w consideration the airborne effluent releases imm a facility naaa~==>y regulation. A few eliminatica of dur. regulation, at some that has -W1 the constrawt value: commenters stated that the risk was reduced cost to li~a- This action or (2)if a licensee fails to institute considerably less than estimated brings consistency between th EPA's agreed upon~ corrective measures because excessively conservative
; dose standard and the NRC's ALARA intended to prevent further airborne calculational methods were used by application, and is expected to be the effluents in excess of those which EPA. A few mmmanters compared the l
4 i final step in providing EPA with the would resultin doses exceedmg the to mrem (0.1 mSv) per year constraint i basis to resemd Subpart I as it applies constraint level to variability in backgmund or doses i to NRC licensed facilities other than The rule applies to airbome effluents imm mmmercial air traffic as evidence power seactors. NRC has been working of radioscuve materials to the that the dose and the risk is trivial cooperatively with EPA to achieve environment, other than Radon-222 and Seven commenters cited burden rescission of EPA's standards in 40 CFR daughters, fmm all NRC liansees reduction and sinM oversight as Part 61. Subpart I.under Section except power reactors. Power reactors the reasons for agreeing that the 112(d)(9) of the CAA. EPA published a are exempt imm this rule because they unstraint was preferable to dual proposed rescission of 40 CM Part 61, are already required, under 10 CFR regulatiozi or EPA's Subpart I alone. Subpart L on December 1.1992 (57 FR 50.34a. to identify design objectives and ammenters opposed to the 56877). On September 28,1995. EPA the means to be employed for keeping constraint as a less protective standard. a published a notice in the Federal doses to members of the public from air stated that the constraint was based Register reopening the comment period efDuents ALARA in their license upon a voluntary per gram (ALARA) on rescission of Subpart I (60 FR 50161). application. Appandiv I to 10 CFR Part and, as such, was not adequate to The objective of this effort is to 50 contains the numerical guidelines to protect the public. One cxunmenter eliminate duplicative regulations that meet this requirement. stated that NRC does not perform
~""='ory E==-ts and provide no incremental beneSt in terms Response to h=amts therefore. NRC junsdiction was not of public and environmental protection.
ne regulatory framework that NRC is Fifty-seven individuals and adequate. providing as a basis for rescission of organizations provided writteu Response:NRC and EPA have .nen EPA's Subpert I consists of the comments on the proposed rule and working to develop a basis upon which requirement in to CFR Part 20 to limit Draft Regulatory Guide DG-8016. dual regulation could be eliminated. doses to members of the public to 100 Among the 57 commenters 24 were EPA has stated that there are two mrom (1.0 mSv) per yev. and the licensees, seven were professional necessary components to any finding requirement to constrain doses to organizations, five were States.16 were that NRC's is sufficient to members of the public from airborne members of the public, and five were protect the th and safety of the
, effluents of radioactive matenals to the environmental organiv=tions. Because public. The first is evidanca that doses environment from a single beensed many letters commenting on the Draft from air emissions are below to mrem operation to to mrem (0.1 mSv) per Regulatory Guide DG-8016 also (0.1 mSv) per year to a member of the year. included comments on the rule, these Public.This has been demonstrated Cunently, under 5 20.1501 licensees comments were also considered in thmugh the two studies by EPA and by are required tc make or cause to be developing the final rule. Licensee reporting of actual air
. made surveys that may be necessary to emissions.ne second component is a 1ssue 2-ProposedRule Approach program to ensure that doses remain at comply with the regulations in to CR
< Part 20.This data would be made Comments: A total of thirty-one this levet in the absena of rulemaking available to inspectors upon request. If individuals and organizations requiring limnsees to maintain doses to the licensee estimates or measures a commented on the basis for the rule. levels of no more than to mrem (0.1 dose to the nearest resident from air Five mmmenters agreed with the m5v) per year, EPA would not rescind emissions greater than to mrem (0.1 approach and need for the constraint. Subpart I and dualregulation would mSv) per year, the liansee would be Four commented that the rule should continue.
required tu report the dose to NRCin not be finaWad and that EPA's Subpart The Federal Radiation Council (FRC) writing within 30 days, which would I should remain in effect. Twenty-two was formed in 1959. to provide include the circumstances that led to commenters stated that existing NRC recommendations to the President for the greater than to mrem (0.1 mSv) per programs provided an ample margin of Federal policy regarding radiation year dose, a desaiption of the corrective safet . and that 'he constraint was not matters that affect health. In May 1960, steps the licensee had taken or proposed needed. However,of these seven agreed FRC set forth basic principles for o
?
65122 Federal Register / Vol. 61. No. 238 / Tyesday. December, 10, 1996 / Rules and Regulations from individual pathways of exposure continue to protect public health in the i protecta,.4 m voth workers and the public. The council was abolished in and individual radionuclides to ensure future. EPA undertook studies to . , 1970 wh_, 's functions were that the total dose does not exceed determine tne level of protection transferred to the EPA Administrator. In recommended levels. Both programs provided by the existing regulatory 1981, EPA published proposed achieve similar levels of protection. program and found that doses were NRC agrees that adoption of the sufficiently low to protect the health recommendations for new Federal guidance for occupational exposure. In constraint in $ 20.1101(d) is preferable and safety of the public with an ample 1987. President Reagan approved to dual regulation due to the reduction margin of safety. The implementation of recommendations by the EPA in burden on licensees as well as State this rule will ensure that doses to and Federal agencies. Under the members of the public from air effluents Administrate for new " Radiation Protection Guidance to rederal agencies provisions of 40 CFR Part 61,heensees will continue to remain below to mrem for Occupational Exposure." EPA has w2th doses to members of the public (0.1 mSv) per year and provide evidence not yet issued recommendations on to EPA that the current level of greater thanto1mrem but less than miem(0.1(0.1mSvmSv)per p)er year protection will continue. limits for the public. A working group year must submit reports. However. The purpose of this rulemaking is not comprised of representatives from to reduce doses, because it has already affected Federal agencies and experts on under to CFR 20.1101(d), these radiological health matters has been licensees will not have to Ele reports for been demonstrated that doses are developing these recommendations for doses below the constraint level because sufHeiently low.The purpose is to several years and expects to provide doses can be evaluated durmg routine ensure that doses are maintained at the inspections. Under the final rule, the low levelcurrently achieved by NRC them during the next year. licensees, eliminate unnecessary dual In 1977, the International Council on burden of calculating doses should be Radiological Protection (ICRP) issued its reduced for most licensees because the regulation, and reduce costs associated l with the current level of protection, by i Report No. 26 " Recommendations of the proposed guidance for demonstrating International Council on Radiological compliance with to CFR 20.1101(d) providing a basis upon which EPA can Protection"in 1977. These allows significantly more flexibility and find that doses will not increase as a simpler methods for calcu'ating doses resd!t of rescission of Subpart L recommendations concluded that the average doses to members of the public than the model currently used to demonstrate compliance with 40 CFR I#" # #" # N ' #"# "#
## "*I 8 should not exceed 100 mrem (1.0 mSv)
Part 61. Theac new methods for cs m per year with a linut of 500 mrem (5.0 Commentsr There were a number of mSv) per year to any individual. calculating doses should result in fewer ; commenters who objected to the The National Council on Radiation reporting and conective actions, as ALARA basis for the proposed Protection and Measurements (NCRP) is under EPA's Subpart 1. Licensees are required under constraint rule. Some commenters required by Congress to recommend limits for exposure to ionizing radiation. $ 20.2103 to maintain records of surveys objected on the ground that ALARA is required to demonstrate compliance a matter of operating philosophy, good < in June 1987. NCRP issued its Report with the public dose limit. Review of radiation protection practice and No. 91. " Recommendations on Limits licensee Judgment, and cannot be for Exposure to lonizing Radiation." licensee records used to demonstrate This report contains recommendations comphana with the public dose limit is translated into en enforceable dose number. Other commenters objected on on exposure limits for both part of the NRC inspection program. the basis that ALARA is inherently site occupationally exposed individuals and Confirmatory measurements would generally not be useful since most spedfic and cannot be defined individual members of thes lic. The generically or that the proposed dose report recommended 7 ases to Licensees in this category do not have individual members of the publir be routine ongoing efDuent releases. constraint cannot be ALARA but must limited to 100 mrem (1.0 mSv) per year Finally, concerning those commenters be a limit because the constraint averaged over a lifetime, not to exceed that believe NRC's requirements are less contemplates some enforument actions 500 mrem (5.0 mSv) in 1 year. safe than Subpart I, Congress enacted for exceedance even if the licensee has legislation comprehensively amending followed all good radiation protection In 1991. NRC revised to CFR Part 20
" Standards for Protection Against the Clean Air Act (CAA), which practims. Some commenters argued that Radiation." This revision included new included a section addressing the issue the rule cannot be ALARA because it of regulatory duplication between EPA adds costs with no safety benefit. Other limits for individual members of the public.Though both the ICRP and the and NRC in 1990.The 1990 CAA commenters stated that the constraint is NCRP recommended limits of 500 mrem amendments permit the EPA inconsistent with a prior NRC decision (5.0 mSv)in any one year, the NRC Administrator to rescind the CAA in to CFR Part 20 (56 FR 23360) on the standards as they apply to use of " reference levels."
established a limit of 100 mrem (1.0 Responser The Commission has mSv) per year because it was radionuclides, at sites licensed by NRC, and the Agreement States. if he or she retained an ALARA basis for the rule impractical to control dose in terms of but recognizes that its use of the term in lifetime average without keeping track finds that the NRC regulatory program this rule may have led to some , of individual exposures. In addition.10 provides an ample margin of safety to protect public health. confusion. The Commission CFR Part 20 requires that licensees use acknowledges that the ALARA concept pro &dures and engineering controls to EPA's analysis of the NRC regulatory maintain doses ALARA. program focused on two general issues: in to CFR 20.1003 is an operating Both the NRC and EPA regulatory (1) whether the implementation of the philosophy which requires good NRC regulatory program results in radiation protection practice and the programs are designed to achieve exercise of expert licensee judgement. protection of the public with an ample sufSciently low doses to protect the health and safety of the public with an The ALARA concept is site specific in margin of safety.The approaches of the two agencies differ. NRC limits TEDE, ample margin of safety; and (2) whether that some of the fact ors to be considered the NRC program is sufficiently 'may vary from case to case, as the court requires that doses are maintained comprehensive and thorough, and so found in York Committeefora Safe ALARA.and maintains an active Environment v. ivRC,527 F. 2d 812 inspection program. EPA limits dose administered in a manner that will
I Federal Register / Vol. 61, No. 238 / Tuet. day. December, 10. 1996 / Rults and Regulations 65123 (D.C Cir.1975). The Cnmminion has sense that exceedance will lead to contmh Fowever the rule can be said I presumed, without deciding, that the corrective action, but it is not a limit in to ofte a small, but positive, net health l ALARA concept in 6 20.1003 can be the sense that exceedance per se wou and saisty beneSt in that it will prevent enforced in a particular case so as to constitute a violation of any regulatory a decreace in the level of protection require a specific radiation protection requirement. A violation occurs only afforded tic publicif Subpart Iwere ; practice, but it is clear that the existing when a licensee fails to report an rescinded in the absence of a rule like regulation does not translate readily into exceedance or fails to take appropriate the constraint. Under the ALARA a generic dose number, which. If corrective actions. A limit would be concept.It is appropriate to base a exceeded, will lead to enforcement appropriate 11 compliance were needed requirement on a small positive health action. to ensure adequate protection of public and safety benefit when cost savings are j The NRC intended the constraint rule health and safety. In this case, the alsolikel . to be a somewhat broader concept found constraint is needed only to ensure that The NdC does not expect that any in the governing statute. the Atomic currently afforded levels of protection licensee st:Sject to the rule will be Energy Act of 1954, as amended (Act). are not reduced. This will provide the unable to demonstrate that doses to The Act,as construed by both the basis for rescission of 40 CFR Part 61, members of the public from rdeases of Commission (e.g., to CFR 50.109) and Subpart I by EPA. airborne radioactive materials to the the courts (Union of Concerned Thus, to say that the constraint rule environment are less than 10 miem (0.1 Scientists v. NRC,824 F.2d 108 (D.C cannot be based on ALARA because it mSv) per year. In the unlikely case that Cir.1987)). contemplates two distinct is in effect a " limit." interchanges a this dose is exceeded or is projected to approaches to radiological regulation. narrow conapt of"ALARA" with a be exceeded due to some temporary First, a level of " adequate protection" broad concept of" limit."If a broad circumstan= or lapse in controls, the must be defined and enforced without definition is used, the constramt rule NRC expects the licensee to take regard to economic cost. Secad, risk withstands scrutiny as both ALARA and whatever corrective actions are may be reduced to a level below that a limit. In the statutory context of the necessary (if any) to protect public assrs.ated with " adequate protection" Atomic Energy Act and general health and safety, to report the dose, to to
- minimize danger to life or property" principles of administrative law, the recommend further corrective actirns if with economic cost and other factors as constraint rule is a limit based on necessary, and take those correctit e permissible balancing considerations. generic ALARA considerations. The actions agreed upon with NRC. NRO See " Revision of Backfitting Proass for constraint rule is not a limit needed for staff will review and approve corrective Power Reactors."(53 FR 20603: June 6. adequate protection and the constramt actions to ensure that they are 1988). It is important to note that rule is something more than a narrow appropriate to reduce airborae Section 161b of the Act authortzes the translation of the particular ALARA emissions sufEciently to comply with Comminion to adopt and enforce concept contained in 10 CFR 20.1003. the constraint in the future. In the generic requirements using either The term " constraint" was used for the unhkaly case that a licensee is unable to approach. Many recent NRC regulat2ons rule to avoid confusion with the narrow take adequate corrective actions.
(e.g., to CTR 50.63) have been directed concepts of ALARA and the limit because oflimits'in technology or cost at incemental risk reduct2on under the employed in radiation protection constramts, these issues can be secor'd approach based on a generic discussion. addressed in the future on a case-by-regulatory or backfit analysis wtuch Three matters must be addressed, case basis. considered and halan&d economic and (1) The enmment that the rule ca-not ne application of the ALARA other cost and safety backfits. nese be based on ALARA because it will principle used in this rule is not the
" minimize danger" regulations provide result in increased cost with no safety same as the concept of reference level " limits" because they estabbsh generic benefit; which was rejected by the Commmion requirements directly enforteable ") The problem of the licensee who when 10 CFR Part 20 was recently against licensees. However, in a broad cannot meet the dose constraint despite revised. Co-nmanters on the 1991 sense they are also ALARA regulat2ons using all good radiation protection revision to 10 CFR Part 20 objected to because cnst, feasibihty. and other practices; and the use of reference levels because they relevant factors identined in to CFR (3) The allegedly inconsistent were implemented exactly the same as 20.2003 are evaluated. Coounission discussion of referena adequate protection limits. For that Viewed in its larger statutory context. levels in a recent revision to 10 CFR Part reason, the Commission did not adopt the use of ALARA in 10 CFR 20.1003 is 20- referena levels in the 1991 revision.
one means to implement the secord The Comminion disagrees with the knplementation of the constraint is approach to radiological reguistion. premise of the first comment.There was different than such a limit because However, other similar requirements no disagreement with the Comminion's exceedmg the constraint is not a can also be part of this second approach. conclusion that all of the licensees violation, and only requires the licensee While the ALARA concept in to CFR affected by the rule are achieving a level to report the dose and take corrective 20.1003 may not be consistent with a of control such that doses are below the actions to reduce future doses. generic enforceable dose requirement, to mrem (0.1 mSv) per year level and I so there is no factual dispute over issue 3-Whether the Constrmnt Is other conapts of ALARA premised on Actually o Ilmet generic considerations are appropriate. whether this level of radiation This concept of ALARA as a broadly protection is readily achievable. The Comments:Nine enmments were applicable dose requirement based on a final rule and EPA's rescission of its received on whether the constraint is or generic weighing and balancing of Clean Air Act emission limittrand should be a limit.Two commenters health and safety, feasibility, and other related requirements will result in a believed that the constraint was no factors is the basis for the longstanding significant net cost savings to licensees. different than a limit. One commenter limits on nuclear power reactor The NRC acknowledges that the positive agreed with the term constramt. Three emissions in to CFR Part 50. Appendix direct health effects are likely to be commenters expressed concern that the 1 and is the basis for the constraint rule. small and possibly nonexistent in the constraint was an inappropriate The ALARA rule imposes a limit in the near future, given the current level of relaxation of requirements.
65124 Federal Register / Vol. 61, No. 238 / Tuesday, December, 10, 1996 / Rules and Regulations i Those commenting that the constraint requirements. Three commenters a :eed reports section requires 20.2203(b)l2) to contain to the constraint was a de facto limit interpreted the that this rule should not be codifieo as a Division 2 requirement, but rather as demographic information on the requirements to indicate that a second a Division 1 matter of compatibility. exposed individual. These commenters exceedance of the constraint would Under Division 1, the States would be expressed concern that a member of the resultin enforcement action and public would be under no obligation to therefore the constraint is a limit. Three required to adopt regulations that were essentially identical. These commenters provide demographic information to commenters indicated that the rule licensees and that licensees would not should be a strict limit. They expressed believed that if stricter standards were permitted, reactor and non-reactor always be able to comply with the concern that the constraint was less requirement. protective than EPA requirements. Licensees would be under different Response:If a licensee exceeds a limit requirements and certain practices, such Response:NRC agrees that members thatis needed to protect health and as nuclear medicine, could be of the public may choose to withhold safety,the NRC may take immediate jeopardized. One commenter noted that the demographic information from because this is really a limit,it should licensees. Such information is only enforcementaction.If alicensee exceeds a constraint, the licensee will be under to CFR 20.1301 and would be needed for occupationally exmsed be required to notify NRC, take any a Division 1 matter of compatibility, individuals to ensure that listime actions that may be necessary to protect Another commenter stated that NRC exposure records are accurate. Section public health and safety, and implement should have prodded a greater 20.2203 has been changed to only any further corrective actions that NRC opportunity for State involvement in require such inforantion on staff agrees are adequate to prevent this rulemaking. and that as a division occupationally exposed individuals. further doses in eness of the constraint. 2 rule. Agreement States would have to However,if the limnsee failed to report spend scarce resources to develop a Issw 7--MecWe Date a measured or calculated dose in excess compatible rule. Comment:One commenter requested Response: Section 116 of the Clean of the constramt to NRC or failed to Air Act speciaes that noihing precludes that an effective date be added to the implement appropriate corrective States fro u im ' g air emission final rule to reincide with EPA's actions as agned upon, enfan:ement 1. Response: The action would be expected. His is requirements t are more stringent rescission of Sub than those developed by EPA. Section NRC and EPA to the extent because, unlika an adequate protection limit, the constraint is not needed to 116(dl(9), which contains the provisions possible, publish tbth final rules so that related to EPA's margin of safety they h u ff d e - 4 provide adequate protection of public determination for NRC or Agreement health and safety. State licenses, specifies that: "Nothing issue 8-Enforcement The NRC does not agree that the in this subsection shall preclude or constraint is lesa protective than current deny the right of any State or political Comments:Five commenters stated EPA requirements. Both EPA's Subpart subdivision thereof to adopt or enforce that NRC should establish a limit rather I and the NRC constramt require than a constramt. They believed that if any standard or limitation respecting the limit has been exceeded, a notice of licensees to take actions to ensure that emi" ions of radionuclides which is doses to members of the public do not violation and civil penalties should exceed to mrem (0.1 mSv) per year from more stringent than the standard or always result.One commenter ambient air emissions. NRC routineJy limitation in effect under Section 7411 of this title or this section." The expressed concern that "self-reporting inspects licensed facilities to ensure that Commission believes that this provision and confession"is not adequate. air effluents do not result in doses to clarifies that EPA's determination Another stated that because ALARA is members of the public that exceed the only guidance, it is not enforce-ble. regarding NRC and Agreement State mJets in to CFR Part 20. The licensees has no effect on the existing Response: ALARA is not guidance. As inspection and enforcement program authority of States to impose air stated previously, the 1991 revision to will be amended as a sesult of this final emission stanrlards that are more to CFR Part 20 codified ALARA as a rule to review licensee records used to o nquired part of the licensee's radiation dem te compliance with the ggntthan i Protectionprogram. Alimitoften concerning involvement of the implies that doses must be controlled l Issue 4-Citizen Suits Agreement States in the development of below that levelin order to rovide ; Comments:Three commenters this rule. NRC has routinely reported its adequate protection of heal and safety opposed finahration of the constraint on progress on providing an adequate basis of the pubhc and workers.To mee the basis that it forfeits citizen rights to upon which EPA could rescind Subpart ALARA requinrnents licensees are sue a licensee who exceeds the I to both the Organitation of Agreement currently controlling efDuents to levels constramt. States (OAS) and the Conference of below that which would be required Radiation Control Program Directors under the constraint. If aliansee Response:The Commission's regulations in to CFR 2.206 provide the (CRCPD) at each of their annual exceeds the constraint,the rule requires public with the right to petition the NRC meetings. 'Ibe Agreement States were that this be reported and that corrective to take enforcement action against a consulted extensively on this issue ove, actions be promptly taken. If a liansee , the last several years. There were does not comply with the obligation to l limusee for a violation of the extensive discussions of the concept Commiaion's regulations.This would report and take corrective actions, j include the final constramt rule. with the individual States and with the enforcement action will result. In NRC's Executive Board of the OAS. judgment, as a matter of enforcement ! issue 5-Agreement State Compatibility issue 6-Demogrophic information policy,it is not necessary to issue a Comments: Four commenters Contained in Requr, ed Report' notice of violation or civil penalties addressed the proposal that the upon exmedence of the constraint level; Comments!Seven commenters it is sufficient that this be reported and constraint be a Division 2 matter of addressed the application of the compatibility. Under Division 2. States that prompt corrective action is taken. could adopt similar or more stringent requirement contained in 10 CFR I i
4 i Federal Regist3r / Vol. 61. No. 238 / Tuesday, Dec: doer. 10, 1996 / Rules and Regulations 65125 Issue 9 5%mptions patients do not need to be speci5cally Response:Drah Regulatory Guide i addressed in the calculation of : lose DG-6010 provides sewral me+ hods for Co Five commenters stated i used to demonstrate comphance with demonstrating compliance with the that the rule should only apply to the constraint. constraint, and only one of the methods members of the public offsite.They Comtrwnts:Four commenters stated described would require direct cited the EPA's Subpart I requimment to . ! calculate dose to the nearest resident or that in addition to Rn-222, all daughters measurement at the receptor location. lf Produced after release should also De this method is not practical due to the offsite individual likely to receive the hisbem dosehlw Subpast I,lianse excluded. Re8Ponse: EPA's Subpart I exempts
==ia= ion characteristics of the radionuclide releases, bm are other j wodd ad calculam dme fran Mr
,- both Rn-222 and any daughters G 4 - emissions to visitors in hospitals options cited DG-oo16 that doinnot Draft Regulatobuide
~
- wakers that are um mdiation wa' kers kroduced use these types aAer release of aleases are of Rn-222 te measurement to dem j ..within the facility, or other members of normcIly not attributable to licensed compliance with b constraint.
the pubhc within the facility. acuvides.N nroposed rule was am j Response:The language in the rule intended tobe more stringent than Issue 22--Scope of the Rule
" 8 Subpart L The rule language has been I
g, a c,,,,,,,,. Onm=======ie== maad
'# tlus n. that if there must be a constraint,it airborne o' fBuents to the environment. 'E. 7,, m,,
i h DreA Regulatory Guide DC-8016 should apply to all hann==== incl ~ Iia-
>=== dad that in addition to Ra-will be revised to indicate that the dose 222.Ra-220 and its daughters should Power seactor Ita==w== .t limit is to be calculated or measured at also be exesupud. One =====ter Response Ahhoughthisiuleonly
- the nearest resident or individual offsite stated that it was an EPA oversight tha'. applies to hcensees other thanyower .
4 likely to receive the higbeet dose.& ld to &is erroneous a-lenisia from tk. reactor lianna===, the t' 's Anal regulatory guide will be available And Subpart I. ""8a'in* res"latiana in to CFR Part 50, when the rule h=rr==== effective. . r- - Rn-220 is normally - Appendix L already ==*ahlf ah a simildr Cosaments:Two ra====ters stated attribirtable to he====rl activities. EPA segulatory fremswerk for power ,
- l. that air emissions from adieaant nearby does not exempt Rn-220 orits . reactors. AppendixIlachinie esperate l exempt uranium mills should not be daughte s from consideradonin ee n-' "- - - to develop design
- included in the calculation of dose. One dose alculations in support of obiedivesand , "' levels
. --ter stated that materials from .nm,4=nt to d==aam ste connpliance nal-==d portions of the facility such demonstmung t g m,, w am.,phance wie ."ubpart with EPA's Subpert 1. In adelitism i l as are stockpiles should not be ~ -:aa t'a at an oversight led to the armnsous on.inston reactor ha== must annually report I . considered in the calculataon of dose. ,,i,,n fran Iis quanddes of rashoacdve materials i
- Response Subpatt I does not apply to og gg,.,,,,,,d incorred, an Rn-220 nm be misesed into the enviran===' as mil
- disposal at facilities segulated under 40 excludd he b calculadons eat am as the resuldng doses.
Part or y ,,,,,,,, ,,,,p gg ,,, ,gg uranium p ,, lasue,22-4mation ofConstromt fr: NRC l been disposed of under 40 CFR Part 192. Commerses:Six aa===aturs .--- --- ' - - l . N constraint applies to airborne that in eddition to sealed sources', sealed h t'a==na=ian - ^ " specific effluents of caly licenisd materials to the environmnt. DraA RegulatoO containers should also be excluded freen ,wi=====* an to ep de= of whe&ar b ) { the rule. 10 mrosa (0.1 mSv) per year constreist l Guide DG-8016 will be changed to Response. Paragraph 2(a) of Appendix should be ==enhliaharl in to GR Part 20 1
- clanfy that windblown particulates from. D to 40 CFR Part 61 states
- Radioactive as propoemd or whetherit should be l other hcensed facilities or unlicensed matenals in sealed packages that :==ain .=*=hh=had separately in each -
L materials do not need to be considered unopened, and ha ie not leaked during appropriate part of Title to instead.
- in the calculation of doses used to the- rt period should not be i demonstrate compliance with the Canments
- Tm commats mm included in the calculations." Subpart I received in rayonse to his imus. %
- constraint. exempts sealed packages, har== any Comments
- Four commenters stated =====w stated est se mammint
! package that has remained sealed abould be in to TR Part 2E1he o&er j that air emissions from patients should cannot centnbute to airborne affluents. be exempted from this rule. When a totalinventory oflicensed ====aw mated est &e, constraint [ Response:The regulatory impact metanals --- - - i during the year is shouldbeineach m dthatitshould-- perde analysis (NUREG-1492) for a recent other --*=s state used to model potential doses,it is ! NRC raladna analyzed potential unnecessary to include materials that in 52amt wie se dme umas. f doses from exposure to patients who could not have contributed to airbonne Re8Ponse:While the mostraint could !- were pleased aAer administration of effluents. The Regulatory Guide trill just as easily be included under other
- radiopharmaceuticals.This analysis provide further guidance on this issue. Parts of the regulations, including it in
- concluded that internaldoses from . to CFR Part 20 provides uniformity. ,
!. Inha1=,ian of radaoective meterials in Issw Ic 5"ubility of 20 mrum (0.2 Because 10 CFR Part 20 is the I inSv) Per Year designated area lor radiatian protection the exhaled air of a released patient are i trivial For lir==- using an inventory Comments:Three commenters stated -- -- - ^= it is , l- approach to demonstrating cmsnpliance that to mroen (0.1 mSv) per year was not the =*==Ameds and related =}or' the appropriate location 1 a with the mie, such as the COMPLY measurable. One r<====nter stated that constraint.h rule will be each A=d i + computer code, there is no need to - although to nuem (0.1 mSv) per year under 6 20.1101 to make it clear that
=ra==='specifically for the matenals . might be easily achievable,it is not althoubh the constraint is not the same that might be re1=== art to the air thmugh culy measurable. Another stated that as a limit. Hr=na=== are expected to
- respiration or transpiration by patients. the exposure rate corresponds to 1 develop redaation programs to ensum ;
y b Regulatory Guide will make it clear microR (0.01 micro-Sv) per hour and that doses froen air ==ia= lana are beloe l j that dose frosa air ==iasions from cannot be measured accurately. 10 mesa (0.1 mSv) per year. i i d i~ }
l l 115126 Federal Register / Vol. 61 No. 238 / Tuesday, December, 10, 1996 / Rules tnd Regulttions l average 80 bours per response, with *be proposed ru.e. The final Agreement State Compatibility l regulatory guide will be available by the including the time for reviewing structions, searching existing data The Commist%n believes that the effective date of this ruiv. Division 2 compatibility designation for sources, gathering and maintaining the i the rule is consistent with state Conforming Amendments To NRC's data needed, and completmg and authority in this area as described in the Enforcement Policy reviewing the collection ofinformation. Clean Air Act. The Division 2 BY Separate notice in the Federal . Send comments on any aspert of this designation means that Agreement Register, the Cornmission is modifytag collection of information, fr.&rsfing States must address these rules in their its " General Statement of Pohey and suggestions for further reduca.g this regulations but may adopt requirements Prc.cedures for NRC Enforcement burden, to the Infonnation and Records I more restrictive than those of NRC. Actions * (Enforcement Policy), to Management Branch (T 6 F33), U.S. Accordingly, the authr -ity of the address the new regulation, and t Nuclear Regulatory Con. nission, ' Agreement States to impose air P.mvide an example Severity levelIV Washington, DC 20555-0001, or by emissions standards under their Atomic violation of the constraint.This change g g Energy Act authority after the effective will also be reflected when the and to the Desk Officer, Of5ce of , date of this rule wi i be consistent with Enforcement Policy is reprinted in its Information and Regulatory Affairs, i their existing authority. Under Section entirety in the next revision of NUREG- NEOB-10202, (3150-0014), O!! ice of 274 of the Atomic EnEIAct the 1600- Management and Budget, Washington, Commission uviews Agreement State piegrams to ensure that adequacy and Small Business Regulatory Enforcement DC 20503' compatibility of the State Program is Fairness Act Public Protection Notification maintained.The Commission has als bmh@hM The NRC may not conduct or sponsor, j approved procedures t.) suspend or Business Regulatory Enforcement I terminate nrograms that are not Fairness Act of1996, the NRC has and a person is not required to respond ' adequate or compatible. determined that this action is not a to, a collection ofinformation unless it ! displays a currently valid OMB control Sumunary of Changes in the Final Rule " major rule" and has verified this determination with the Office of number. I Based on the responses to comments, Information and Regulatory Affairs, a few changes were made in the final Regulatory Analysis Office of Management and Budget. rule. Otherwise, the provisions of the The NRC has prepared a regulatory final rule are the same as those Finding of No Significant analysis for this final mle. The analysis presented in the proposed amend.t .nts. Environisentallmpact examines the costs and benents of the f [ [on, . " " The Commission has determined under the National Environmental ahernatives considered by the NRC in the response to comments, the NRC (1) Section 20.2203(b'):21 has beenPolicy Act of 1969, as amended, and the concluded that only some minor changed to require the name, social NRC's regulations in Subpart A of to security number, and date of birth only CFR Part 51, that this rule,if adopted, changes to the draft regulatory analysis for occupationauy overexposed were necessary, corresponding to some would iot be a major Federal action individuals and not for merobers of the significantly affecting the quality of the minor procedural changes in the Snal rule. The regulatory analysis is avallable public who have received doses in human enviror'nent and therefore, an , excess of the public limits, including environmental impact statement is not for inspection in the NRC Public the constraip* Ca.ument Room,2120 L Street, NW. required. 'Diis action is not expected to (lower level), Washington, DC 20555-(2)The lai,;aage of the rule has been changed tc adicate that Rn-222 andimpact all have any signiScant environmental 0001, Sing!r copies of ae analysis may . because the programs will be obtained from Alan K. Roecklein, daughters produced after the release of the radon cre categorically excluded provide equivalent protection. Also, Office of Nuclear Regulatory Research. airborne effluents of radioactive U.S. Nuclear Regulatory mmmmion, from this rc. materials to the environment are not (3)The langew of the rule has been expected to increase. The changes to the Washington, DC 20555-0001, telephone changed to indic.te that the constraint final rule are to the procedural methods (301)415-6223, applies only to tw nase of airbome for demonstrating compliance as well as F yalatory Flexibility Certification radioactive einues is to the environment licensing and inspection procedures. and, thus, dose to . Se nearest resident, accordance with the Regulatory I offsite business or.chool,is to be The environmental asr essment and finding of no signifier.nt impact on Me ty Act of 1,980,(5 E constrained. which this determinntion is based are 605(b)), the Commission certifies that In addition, the foDowing cbuges wulbe made to Draft Regulatory Guide available for inspection and this rule will not have a significant , photocopying for a fee at the NRC economic impact on a, suostantial DG-8016: Public Docament Room,2120 L Street (1) An inventory of radioac.tive number of small entities.This Anal rule materials used to model a potential dc ae NW. (Lower 14ve'). Washington, DC. only impacts NRC licensees with to a member of the public need not emissions of significant quantities of Paperwork Rediction Act Statement include radioactive materials i s seejed radioactive material who would be nis finalrule amends information required to report the exceedance to the t containers that have remained sealeo coUaction reqvaements that are subject I throughout the compliance period, NRC. It will relieve licensees from the (2) Airbome emissions of radioactive to the Paperwurk Reduction Act of 1995 unnecessary burden of dual regulation. l' materials from patients does not need to (44 U.S.C. 3501 et seq.). These ne level of air emissions from NRC-requirements were approved by the licensed facilities has historically been be considered if the materials have Office of Management and Budget, already been included in the site wellbelow the NRC dose limit and
. opproval number 3150-0014. except for a few unusual cases, readily inventory. The public reportingburden for this ne Regulatory Guide was issued in draft for public comment concurrent collection of information is estimated to met the EPA standard.
Federal Register / Vol. 61 No. 238 / Tuesday. Dec;mber, 10, 1996 / Rules and Reguhtions 65127 Backfit Anatysis 206. 88 stat.1242. as amended.1244,1246 $ 20.2201 Deports of exposures, radiation l (42 U.S.C. 5841,5842,5846). levels, and concentrations of rad 6oacuve l The NRC has determined that the material eaceeding the constraints or umits. backfit rule,10 CFR 50.109, dms not 2. In 5 20.1003, the definition of apply to % final rule because it does Constmint is added to read as follows: (a) * *
- not apply to power reactor licensees. $ 2M003 Dennl6ona. (2) * *
- and therefore, a backfit analysis.is not , , , , e tvi)The ALARA constraints for air required for this final rule because these emissior.s established under Constraint (dose constraint / means a amendments do not involve any value above which specified licensee 5 20.1101(d): or provisions which would impose backfits actkns are W (b) * *
- as defined in to CFR 50.109(a)(1). , , , , , ,,,
List of Subjects In to CFR Part 20 3. In $ 20.1101, paragraph (d) is added (iv) Corrective steps taken or planned Byproduct material, Crimbal to read as follows: to ensure ainst a recurrence,includmg I penalties, Licensed material, Nuclear $ 2M101 Radiadon Protection Programa, the sched e for achieving conformance materials, Nuclea:t power plants and , , , , , with applicable limits. ALARA reactors. Occupational safety and (d)To implement the ALARA c nstraints, generally applicable health, Packaging and containers, requirements of $ 20.1101 (b), and environmental standards, and Radiation protection, Reporting and notw o h*hdia thquirements 6 associated license conditions. rewriikeeping mquirements, Source $ 20.1301 of this part, a constramt on air (2) Each report filed pursuant to ! material Special nuclear material, emissions of radioactive material to the paragraph (a) of this section must Waste treatment and disposal environment, == lAia Radon-222 and inchide for each ocx upationally For the reasons set out in the its daughters, shall be estabhshed by averexposed' individual: the name, preamble and under the authority of the licensees other than those subject to Social Security account number, and Atomic Energy Act of 1954, as amended. $ 50.34a such that the individual dats of birth. The report must be the Energy Reorganization Act of 1974. rnember of the public likely to receive prepand so that this information is as amended, and 5 U.S.C. 553, the NRC the highes' dose will not be expected to stated in a separate and detachable part is adopting the following amendments receive a total effective dose equivalent of the report. to 10 CFR Part 20. In excess of to mrem (0.1 mSv) per year * * * *
- PART 20-STANDARDS FOR m ese e ns. a icensee Dated at Wh. %M this 3rd day subject to this requirement exceeds this of December,1996.
PROTECTION AGAINST RADIATION dose mnstraint, the licensee shall mport For the Nuclear Regulatory ammi== ion. 1.the authority citation for Part 20 the ewd== as provided in 5 20.2203 pha C byte, continues to read as follows: and promptly take appropriate % ofthen ;.m Authority: Secs.53,63.65.81.103,104. co ve adon to ensum against [FR Doc. 96.-31221 Filed 12-9-.96: 8:45 am) 161,182.186. 68 stat. 930,933. 935,936, mcurmnce. asAaseooot m 4 937,948,953. 955, as amended sec.1701. 4. In $ 20.2203 the section heading is 106 Stat. 2951,2952. 2953142 U.S.C 2073, mvised, a new parapph (a)(2)(vi)is ,m 2093.2095,2111,2133,2134,22ol.2232, added, and paragraphs (b)(1)(iv) and se the w h emWw (120.120sL the identi5ers should be those of the 2236. 2297f): sect 201, as amended. 202. (b)(2) are revised to read as follows: da.lared pregnant womaa 4 9 l l 7
J U.S. NUCLEAR REGULATORY COMMISSION December 1996 l g'rnog%,) REGULATORY GUIDE
***** OFFICE OF NUCLEAR REGULATORY RESEARCH REGULATORY GUIDE 4.20 (Draft issued as DG-8016)
CONSTRAINT ON RELEASES OF AIRBORNE RADIOACTIVE MATERIALS TO THE ENVIRONMENT FOR LICENSEES OTHER THAN POWER REACTORS A. INTRODUCTION than those subject to 10 CFR 50.34a, such that the in 10 CFR Part 20, " Standards for Protection individual member of the public likely to receive the highest dose will not be expected to receive a total Against Radiation," i 20.1302(b) requires that: effective dose equivalent in excess of 10 mrem (0.1 A licensee shall show compliance with the annual mSv) per year from these emissions. If a licensee dose limit in 6 20.1301 by (1) Demonstrating by subject to this requirement exceeds this dose con-measurement or calculation that the total effective straint, the licensee shall report the exceedance as dose equivalent to the individual likely to receive provided in 10 CFR 20.2203 and promptly take ap-the highest dose from the licensed operation does propriate correcuve action to ensure against not exceed thc annual dose limit; or (2) Demonstrat- recurrenee. ing that (i) The annual average concentrations of ra-dioactive material released in gaseous and liquid This regulatory guide provides guidance on meth-effluents at the boundary of the unrestricted area do ods acceptable to the NRC staff for mmpliance with the not exceed the values specified in Table 2 of Appen- mnstraint on air emissions to the environment. If addi-dix B to Part 20; and (ii) lf an individual were contin- tional significant comments are received in the first year uously present in an unrestricted area, the dose following its issuance, the staff will revise the guide as ap-from external sources would not exceed 0.002 rem propriate. Guidana on ALARA programs can be found (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a in other regulatory guides. Although these guides deal year, primarily with occupational exposure and may be specif-IC 1 no tYPc of licensee, they mntain programmatic in-In addition,10 CFR 20.1101(d) requires that. formation that may be useful to all licensees. These To implement the ALARA [as low as is reasonably guides are: achievable] requirements of f 20.1101(b), and not-withstanding the requirements in 6 20.1301 of this e Regulatory Guide 8.10, " Operating Philosophy for part, a constraint on air emissions of radioactive ma- Maintaining Occupational Radiation Exposures As terial to the environment, excluding radon-222 and Low As Is Reasonably Achievable." This guide de-its daughters, shall be established by licensees other lineates the components of an ALARA program. ! usunc azcuwoav cutoes ,. pa a e = ==,.me =n wo.a a- on. . Regaanary Guces a to enacree .e mee es.estne to m putze e esame j ton as mamaan .xassane e v. wc e s i. .onem no sosoec par at a com. t ,,,, n,,ma,, g p,ooucis I neease py N NIC elas em esme .W ard.ss g tenanh "llTO':"::" ".*.a"T"o..",l".";.' *J." O*::::"rl: O'.".7",".*,4":<'.".".* ,',l"c".", "a""~ " " - " "
; 5;;;;;;=,",=,52.,,, a W-
$ ,","5E""".j *",",,,",",=',, $".E' NMNENEI"
~~ ~ ~, ,. 7 . - e ~ - - - on ADeA U S Nummer Asym.ory Comme.un. Wear.igtort DC 20fi65-0001
'"""T ~ /::T~.0:::'O.", ".'lr"ll1".%"."n".TJ'" l=
e,
,8 Pyel Road. Sonngnesa. VA 22161 L
i o Regulitory Guide 8.18, "Inf:rmation Relevant to The NRC staff cxamines licensee progr:ms to deter-Ensuring that Occupational Radiation Exposures at mine whether they are in compliance with the require-Medicalinstitutions Will Be As low As Reasonably ments of 10 CFR Part 20. This guide addresses only a
- Achievable." part of a licensee's overall radiation protection program. s SPecifically, i, cddresses methods for demonstrating
- Regulatory Guide 831, "Information Relevant to Ensuring that Occupational Radiation Exposures at MmPhance with the constraint on releases of airborne radi active materials to the environment. In addiuon to j Uranium Mills Will Be As low As Is Reasonably e ntrolling doses from the releases of airborne radioac- j Achievable - uve matenals to the environment, licensees mustimple- l
- Regulatory Guide 837, "ALARA Levels for Efflu- ment a radiation protection program that controls liquid ents from Materials Facilities." effluents and dose rates in unrestricted areas.
- Regulatory Guide 10.8, " Guide for the Preparation Many NRC licensees possess source, byproduct, or of Applications for Medical Use Programs." Sec- special nuclear material in a form that would not cause i tion l'3 and Appendix G deal specifically with doses to members of the public from releases'of airborne ALARA programs for medical facilities. radioactive material to the environment. These limns-In addition, further information can be found in Re. ces include radiographers, well loggers, and other users
' vision 1 to NUREG-0267," Principles and Practices for of sealed sources. These licensees need not take any ac-Keeping Occupational Radiation Exposures As low As tions to demonstrate compliance with the constraint on j Reasonably Achievable" (October 1982).1 releases of airborne radioactive materials to the l The information co!!cetions contained in this regu-latory guide are covered by the requirements of 10 CFR CONSTRAINTS Part 20, which were approved by the Office of Manage-ment and Budget, approval number 3150-0014. The A dose limit derived from a basic radiation protec-NRC may not conduct or sponsor, and a person is not ;c- tion standard is the upper acceptable bound of radiation quired to respond to, a collection ofinformation unless it dose and is needed to protect the health and safety ofin-displays a currently valid OMB control number. dividuals; a limit is a value not to be -@d Such lim-its should be set with the assumption that effluent re-B. DISCUSSION leases associated with licensed activities would result m
- The dose limits in 10 CFR Part 20 are based on limit- doses to the public that are substantially below that val-ing dose to an acceptably low level of risk to the exposed ue. Such limits are approached only under unusual cir-individual. However, any radiation exposure may carry cumstances, and only for a small fraction of the exposed l
- some risk. Thus, the NRC requires licensees to take ac- population. A constraint is a dose value above which li-tions, to the extent practicable, utilizing procedures and ansees are required to report to NRC and to take mr-i engineering controls to further redum risk below the lev- rective actions to lower the dose below the mnstraint val-i els implicit in the dose limits in keeping with the princi- ue. Enforcement action would only occur if a limnsee Pl c that exposures should be as low as is reasonably fails to report an exceedan :e of the o.,nstraint or fails to achievable. This is the goal and purpose for radiation take appropriate and timely corrective actions. protection programs. In order to achieve this goal, li-censees must control the way radioactive material is han. C. REGULATORY POSI110N died from remipt through disposal.
- 1. CONSTRAINT ON ENVIRONMENTAL AIR AIARA EMISSIONS j The following methods are acceptable to the NRC j Components of an effective radiatio P staff for determining the dose to members of the public program, as required by 10 CFR melude 20.1101, rads- p protecti from exposure to airborne radioactive material that has ation exposure control, written procedures and pohcies, been released to the environment by NRC licensees oth-control of radioactive materials, radioactive contamina-er than power reactors. Licensees should choose a moni- ,
j . tion control. radioactive waste management, training, j
, toring period (e.g., a year, month, or quarter) to demon-program reviews, and audits. strate compliance with the airborne emissions constraint in accordance with 10 CFR 20.1101(d). For most licens-ICopics are availaLle for purchase from the U.S. Government Prmung ees, the monitoring period will be one year.
Offsm. P.O. Box 37082. Washington, DC 20013-7082, telephone (202) 512-2249; or from the Nauonal Technical Information Sernce 1.1 Licensees who (1) operate a nuclear power reac-by writmg NTIS at 5285 Port Royal Road. Springfield.VA 22161. Co. pies arc available for mspecuon orcopying for s fee from the NRCPub. tor su 'eet to 10 CFR 5034a or (2) Possess and use radio-i he Document Roorn at 2120 L$trect N W., Washington. DC; the PDM nuclides only in the form of scaled sources need not take , 4 maihngaddressisMailStopu -6. washington,DC20555. telephone any actions to demonstrate compliance with the (202)634-3273;Iax (202)634-3343. constraint. ! l 4.20- 2 l l l
1.2 Radioactive materials in sealed containers that C " fg p-remain unopened and have not leaked during the assess- ' ment p+9eed not be included in the calculations. Ea-s amples of scaled containers would include radiopharma- Where-ceuticab in unopened manufacturers packages and C = Average air concentration at the receptor materials in undamaged shipping containers. Indepen-(Ci/m3 orpCi/tal) dent spent fuel storage canisters that do not have vents to the atmosphere may also be mnsidered sealed f = Fraction of the time the wind blows toward containers. the receptor of interest (dimensionless) l (For a single " puff" release, the appropri- l 1.3 Effluents from patients need not be included if ate value is 1.) compliance with the constraint is demonstrated by using an inventory approach. If mmpliance with the constraint Q = Effluent release rate (Ci/s) is demonstrated by using measured or calculated mn- V = Volumetric flow rate at the point of release centrations of radioactive materials in the environment, 3 (m /s) the contribution from patients is considered insignifi- The " sum of the fractions" technique should be used cant and need not be considered. to assess compliance for effluents containing multiple ra-1.4 Ifit can be determined that some detected mate- dionuclides. With this technique, if radionuclides "a," rials did not result from licensed activities of the licens- "b," and "c" are present in conantrations Ca, Cb, and Cc, ee, only radioactive materials from the licensed activity and if the applicable effluent concentrations in Column 1 need be considered. Materials that are windblown from of Table 2 in Appendix B to 10 CFR Part 20 are ECa, other facilities need not be considered. EC b, and ECe respectively, satisfying the following in- l equality is sufficient to demonstrate mmpliana with the j 1.5 in determining the member of the publiclikely mnstraint. to receive the highest dose from airborne radioactive ' material released from licensed operations to the envi-ronment, limnsees need not consider nonresidents with- ,C,., , ,C.,. , 1 < 0.2 in the facility boundary. EC. EC. EC,
- 2. CALCUIATION OF DOSETO THE MEMBER 2.3 Additional methods acceptable to the NRC staff OF THE PUBLIC UKELY TO RECEIVE THE for demonstrating compliance with 10 CFR 20.1101(d)
HIGHEST DOSE MtOM AIR EFFLUENU can be found in the worksheets contamed in either in demonstrating comphance with 10 CFR NCRP Commentary No. 3, "Sacening Techniques for 20.1101(d), licensees should determine whether there Determmmg Compliance with Environmental Stan-dards,"2 or EPA 520/1-89-002,"A Guide for Deter-have been any facility or design modifications, increases in radionuclide inventories, or operational changes; li- mining Compliance with the Clean Air Act Standards for censees should determine wt *her any of these factors Radionuclide Emissions from NRC-Licensed and Non-resulted in vanations to airborne emissions since the last DOE Federal Facilities" (Revision 2).3 monitoring period. If hcensee operations have not 2.4 Another method that is acceptable to the NRC changed, the review of hcensed operations and demon- staff for demonstrating compliance with 10 CFR stration of compliance with the constraint will be rela- 20.1101(d)is the use of the computer code COMPLY. tively straightforward. COMPLY was developed by the EPA to assess doses by using site-specific information in the determination of Any of the followmg methods are acaptable for dose. COMPLY has four screeninglevels. In Level 1, the demonstratmg comphance with 10 CFR 20.1101(d). simplest level, only the quantity of radioactive material 2.1 The simplest screening technique is to assume possessed during the monitoring period is entered. The that the air concentration at the receptor is equal to the calculations are based on generic parameters. Level 4 air concentration measured at the point of release. This produces a more representative dose estimate by provid-is analogous to using Appendix B to 10 CFR Part 20 to ing for more complete treatment of air dispersion by re-demonstrate compliance with the dose limits in Part 20. quiring site-specific information. It is expected that all 2.2 To demonstrate compliance with the constraint 2 NTRP Commentary No. 3 was pubhshed in January 1989 and the ad. on air emist. ions, the licensee should demonstrate, by dendum was pubhshed in October 1989. Copies may be purchased from the Na*aonal Council on Radiation Protecuon and Measure-measurement or calculation, that the annual average ** " * ^~ *' '
- concentration of airborne radioactive material released 2 ist '"
to the environment does not exceed 20er: of the values in 3 Copies may be obtained trom the US. Environmental Protection Column 1 of Table 2 in Appendix B to 10 CFR Part 20. Agency,omce of Radiation and tndoor Air 40t M Strect SW. Wash-1 inston, DC 20460. The following formula demonstrates this technique. 4.20 -3
NRC licensees will be able to demonstrite compliance at learning of the dose in excess of the constr int, and 10 one of the fourlevels.The basis for the compliance mea- CFR 20.2203(b)(1) requires licensees to describe the ex-sures in COMPLY are contained in " Background Infor- tent of exposur- The report should include the follow-mation Document: Procedures Approved for Demon- ing information. strating Compliance with 40 CFR Part 61, Subpart 1"
- An estimate of the dose (EPA 520/1-89-001, October 1989).'
- The concentrations of the radioactive material If a computer code other than those listed above is released used to demonstrate compliance with the constraint, the licensee thould be prepared to demonstrate that the
- The cause of the elevated concentrations in code has undergone verification and validation (V & V). effluents For more information on software quality assurance in-
- The corrective steps taken or planned to ensure cluding V & V, licensees may refer to NUREG/ against a recurrence BR-0167," Software Quality Assurance Program and Guidelines." This document can be purchased from the
- A schedule for completing the corrective steps. The U.S. Government Printing Office, P.O. Box 37082, Wash- report should contain enough information to allow the NRC staff to verify the calculations.
ington, DC 20402 -9328. The report should be sent to the U.S. Nuclear Regu-
- 3. REPORTS TO NRC IF CONSTRAINT HAS latory Commission, Document Control Desk, Washing-BEEN EXCEEDED t n. DC 20555-0001, with a copy to the appropriate If the constraint of 10 mrem (0.1 mSv) per year to ,
NRC Regional Office h,sted in Appendix D to 10 CFR the member of the public likely to receive the highest p
- dose has been exceeded as determined by measurement or calculation,10 CFR 20.2203(a)(2)(vi) requires licens- D. IMPLEMENTATION ees to send a report to the NRC within 30 days after The purpose of this section is to provide informa-
'Copiesof the EPA Background !nformauon'Docume'nt and the COM. i staff's plans for using this gu.de. PLY computer code with us Users Guade may be obtained bywriting to the Center for Federal Guidance and Air Standards (6602J).Offx* of Radianon and Indoor Air, Environmental Protecuon Agency, Wash. Except m those cases in which an applicant proposes ington, DC 20460. It can also be downloaded from the Technology an aCreptable alternative method for complying with Transfer Network (TTN) Electrone Bulleun Board under the Office sPCcified Portions of the NRC's regulations, the meth-of Radsauon and Indoor Air technical .aformauon area. De number odS described in this guide will be used in the evaluation for the TTN is (919)S41-5742. In ad.Wn, EPA has pages on the World Wide Web as another mechanism tc provide computer codes to of applications for new licenses, license renewals, or li-es The addresses are tinttp.rtpac. epa.gow and cense amendments and for evaluating compliance with 10 CFR Part 20. 4.20 -4
. .m.__. -. . .. _ ___.. _ . . _ . - _ _ . . - _ _ . _ . . . . . _ . _ _ -_ _ _ _ . . . _ . . . _ _ . . _ . . _ _ _ . _ _ . _ , _ . . _ .
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l l l 1 REGULATORY ANALYSIS i .
.. A separate regulatory analysis was not prepared for this regulatory guide. The regulatory analysis prepared for the amendments to 10 CFR Part 20," Standards for .'rotection Against i . Radiation," provides the regulatory basis for this guide. A copy of this regulatory analysis is l available, as an enclosure to SECY-95-133, for inspection or copying for a fee at the NRC Public Document Room,2120 L Street NW., Washington, DC.
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RULEMAKING ISSUE (Affirmation) l May 8, 1996 SECY-96-100 LQB: The Commissioners fB21: James M. Taylor Executive Director for Operations ElWf.C.I: FINAL AMENDMENTS TO 10 CFR PARTS 20 AND 35 ON CRITERIA FOR THE M.ICASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIAL PURPOSE: To obtain Commission approval to publisn a notice of final rulemakicg in the Federal Reaister. BACKGROUND': On May 21,1991 (56 FR 23360), the NRC published a final rule that amended 10 CFR Part 20, " Standards for Protection Against Radiation." The rule ! contained a dose limit of 1 mil 11 sievert (0.1 rem) total effective dose equivalent for members of the public in 10 CFR 20.1301(a). When 10 CFR Part 20 was issued, there was no discussion in the supplemental 4 information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.
' The subject paper was submitted to the Commission on November 30, 1995 (SECY-95-286). Subsequently, the staff requested withdrawal of the paper to revise the regulatory analysis (RA) to conform with the new RA guidelines. In a Staff Requirements Memorandum dated December 21, 1995, the Commission granted the request. The staff revised the RA (a summary of major changes is attached to the RA) and made conforming changes to the Federal Register Notice (FRN) and the Environmental Assessment (EA). These revisions did not affect the content of this staff paper except in Items 1 and 5 of the DISCUSSION in which the staff mentioned the expanded dise.ussions of breast-feeding women in the RA.
CONTACTS: NOTE: TO BE MADE PUBLIOLY AVAILABLE WEN Stewart Schneider, RES THE FINAL SRM IS MADE AVAILABLE 415-6225 Stephen A. McGuire, RES 415-6204 1
- e
The Commissioners 2 ; NRC's current patient release criteria are contained in 10 CFR 35.75, " Release of patients or human research subjects containing radiopharmaceuticals or permanent implants." That section states: "(a) A licensee may not authorize release from confinement for medical care any patient or human research subject administered a radiopharmaceutical until either: (1) The measured dose rate from the patient or human research subject is less than 5 millfrees , per hour at a distance of I meter; or (2) The activity in the patient or human ! research subject is less than 30 millicurfes; (b) A licensee may not authorize release from confinement for medical care of any patient or human research subject administered a permanent implant until the measured dose rate from the patient or the human resea,ch subject is less than 5 milliress per hour at a - distance of 1 meter." Some licensees were uncertain about the effect that the revised 10 CFR l king Part 20 would have on patient relea i werereceivedontheissue.gecriteria,andthreepetitionsforruema To resolve this uncertainty, two steps were taken. The short-term resolution was to inform licensees of the NRC's position that i 10 CFR 35.75 governed patient release. The Commission was informed in
- SECY-94-01 of the staff's recommendation that 10 CFR 35.75 governs patient i release. Information Notice No. 94-09 was issued on February 3, 1994, to
! inform licensees of this position in accordance with a Staff Requirements Memorandum (SRM) dated January 28, 1994. A The longer ters resolution was to address this issue through rulemaking.
- proposed rule was transmitted to the Commission in SECY-94-054 and responses
> to questions raised by the Office of the Inspector General are contained in SECY-94-05(A. In an SRM dated May 11, 1994, the Commission directed the staff to proceed with the proposed rule. As a result, a draft rule was published for comment :n June 15,1994 (59 FR '0724), and this paper transmits the tinal j - rule for Commission approval. , ' DISCUSSION: The final rule (Attachment 1) takes into consideration the recommendations of the Agreement States, as well as the comment letters received on the proposed rule and the petitions. In all, 232 comment letters were received on the 4 three petitions, and 63 comment letters were received on the proposed rule. The rule was also discussed with the Advisory Committee on Medical Uses of Isotopes (ACMUI) at several public meetings, the last on October 18 and 19, i 1995. 2 One commenter raised an issue about contacts allegedly relating to this The rulemaking between one of the petitioners and the Office of the Chairman. staff notes that the final rule is based on the public record associated with the rulemaking and that the NRC decision maker with whom contact was made is no 4 longer with the Commission. The staff has not included any further comment with respect to this issue in the final rulemaking package. 4 6 i i
i The Commiissioners 3 4 4 The following summarizes the main features of the amendments: P 1. The major changes to the final rulemaking are: (1) significant. expansion of the discussion on breast-feeding in the Statement of 1 Considerations and the regulatory analysis and (2) explicit use of the l l term " breast-feeding" in the final rule text to make it clear that l - breast-feeding women are a class of patients requiring additional j records and instructions to limit the dose to the breast-feeding child. l The subject of breast-feeding was mentioned in the Statement of j Considerations to the proposed rule but not in the proposed rule text.
.2. The amendments make it clear that patient release is governed by 10 CFR 35.75 rather than by 10 CFR 20.1301(a). There was very broad f agreement with this position in the comment letters, with ACMLil, and
- 1 with the Agreement States.
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- 3. The amendments revise the criteria for release of patients administered radioactive material for medical use under 10 CFR 35.75 to permit a maximum likely total effective dose equivalent of 5 millisieverts (0.5 res), excluding background or any occupational exposure, to an
} individual. exposed to the patient. 3 E 5 Specifying the release criterion in terns of radiation dose requires , ' that the NRC provide an acceptable method that relates the quantity of ; radioactivity administered to that dose. That relationship will be l included in a regulatory guide. A working draft of that guide is l attached (Attachment 2); the staff is still reviewing the guide, but will publish it in final form before the final rule becomes effective. ) The guide presents two methods to relate dose to quantity of radioactivity administered. The first method is the use of a default l l j table of release quantities and release dose rates based on conservative '
- assumptions. For the radioactive material of greatest significance, iodine-131, the default table is essentially equivalent to the release criteria in the current regulations. The staff anticipates that nearly all patients will be released based on the default table of activities.
The seconc method is to perform a case-specific dose calculation using l the method described in the guide. The case-specific method can be less ! conservative than the default table because it permits a more realistic estimate of how quickly the radioactive material leaves the patient's ?- body. Thus, use of this method would, in some cases, pemit the release
- j. of patients containing several times more radioactive material than the current regulations pemit or allowed with use of the default table.
1; The authorization to release a patient is based on the licensee's determination that the total effective dose equivalent to an individual from the released patient is not likely to exceed 5 millisieverts l (0.5 ren). The dose to the breast-feeding child from breast-reeding is j not necessarily a criterion for release since it can be controlled by , i i i
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J 4
f 4
- The Commissioners b giving the woman guidance on the interruption of breast-feeding, as j
required by the amendments (see No. 5). j overall, a substantial majority of all comments supported 'an explicit l' dose limit of 5 millisieverts (0.5 ren) for individuals exposed to i patients released with radioactive material in their bodies. In i addition, ACftl! and the Agreement States supported the criterion based [ on a dose limit. A few commenters who thouaht that the present criteria !. were working well and were adequate opposed allowing the release of j patients with quantities of radioactive material greater than that - pemitted under the current regulations. j i 4. The proposed rule would have required licensees to maintain, for j 3 years, a record of the basis for the patient's release and the total effective dose equivalent if any individual is likely to receive a dose in excess of 1 mil 11 sievert (0.1 rem) in a year from a single ) administration. This requirement was proposed so that records would be available to calculate the dose if a patient received multiple administrations in a year. This proposed recordkeeping requirement met a great deal of opposition. l Commenters were especially concerned about having to retrieve records of i previous administrations, sometimes from another medical facility. Upon reconsideration, it was decided to delete this requirement because a review of nuclear medicine procedures indicated that there was no significant likelihood of exceeding a 5-m1111 sievert (0.5-ren) annual dose because of multiple administrations. In place of the deleted recordkeeping requireent, the final rule , cont: bs requirements to maintain: (1) a record for the basis of the release for a limited number of certain radiophamaceutical administrations (e.g., therapeutic administrations of iodine-131) and (2) a record that instructions were provided to a breast-feeding woman if the administered activity could result in a totai effective dose equivalent to the breast-feeding child exceeding 5 millisteverts (0.5 ren) if the woman did not interrupt breast-feeding. The requirements (in 10 CFR 35.75 M 'and (d)) would affect about 20,000 of the 8 to g million administrat.ons done annually.
- 5. The amendments require that the patient be given instructions, including written instructions, on how to maintain doses to others as low as is reasonably achievable if the dose to an individual is likely to exceed 1 mil 11 sievert (0.1 res). In general. most commenters agreed with this requirement, although a few did not think that instructions should necessarily have to be written.
The proposed rule had a requirement to provide instructions which would include guidance on breast-feeding children, but some commenters wanted information on when instructions would have to be given and what the instructions should say about interruption or cessation of breast-feeding. The final rule requires that guidance regarding interruption l
. - . - - - . - - - . - . . - - - . - - - ~ . - - - - . - .. .
The Commissioners 5 i < j of breast-feeding and consequences be provided if the released
- individual may ba breast-feeding an infant or child and the total effective dose equivalent is likely to exceed I mil 11 sievert (0.1 res).
l The regulatory guide will contain interruption periods that keep the
- dose from breast-feeding to less than 1 mil 11 sievert (0.1 res). The ,
purpose of describing the consequences is so that women will understand l that breast-feeding after an administration of certain radionuclides l
- could cause_ ham (e.g., iodine-131 could harm the child's thyroid). In
! other cases, the guidance could simply address avoidance of any unnecessary radiation exposure to the child from breast-feeding. The regulatory analysis indicates the basis for selecting the option of l enhancing communications and instructions to breasting-feeding women. , i ! 6. The amendments make it clear that the limit on dose in unrestricted j areas presented in 10 CFR 20.1301(a)(2) does not include dose contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that licensees are not responsible for doses outside of thei-i restricted areas from radiation sources not under their control. The i connents supported this position. j The final amendments represent a partial granting of the regulatory relief requested by the petitioners. The request to delete 10 CFR 20.1301(d) was ' denied because the reference to the Environmental Protection Agency's i regulations in 10 CFR 20.1301(d) has nothing to do with the patient release issue. Also, the request to permit licensees to authorize release from hospitalization any patient administered a radiophamaceutical regardless of i the activity in the patient by defining " confinement" to include not only l confinement in a hospital, but also confinement in a private residence, was
- denied. The staff considers it inadvisable to use .a patient's home for the i
purpose of confinement when the activity *.n the patient is expected to reault
- j. in a dose exceeding 5 millisieverts (0.5 rem) to another individual.
At its last meeting, held on October 18 and 19,1995, the ACMUI passed several , motions suggesting changes to three aspects of the rule. t
- First, the ACMUI suggested using the term " rationale" instead of
" consequences" in the requirement, under 10 CFR 35.75(b), to provide " guidance l
on the interruption of breast feeding, and infomation on the consequences of l a failure to follow the guidance" for cases where failure to follow the ' instructions could result in a dose to the infant exceeding 1 mil 11 sievert (0.1 res). Since most of the administrations that would be affected by this i requirement are technetium-99m administrations, the ACMUI suggested the change i because there was concern that the consequences of low doses of radiation ! cannot always be explained to the patient without causing unjustified alarm. - Also, there was concern that physicians cannot explain with certainty the 3 effects of low doses of radiation, such as would be caused by diagnostic administrations of technetium-99m. The staff did not change the rule in j response to the ACMUI comment because the requirement to provide inionnation j on the consequences is included primarily to protect the breast-feeding infant 4 from therapeutic admiristrations of radiciodine, which could cause serious ) s ^
1 6 The Consiissioners thyroid damage. Regulatory Guide 8.39 will contain guidance on the types of infonsation, including expected consequences, to be provided to patients to meet this requirement. ' Second, the ACWI suggested using the phrase "the retained activity rather than the activity administered" instead of "an activity otner than the activity iniministered" in the requirement under 10 CFR 35.75(c), to maintain a " record of the basis for authorizing the release of an individual, if the total effective dose equivalent is calculated. The ACMUI was concerned that the meaning was not clear, and in addition, the requirement was already implicit The in the remainder of the recordkeeping requirements in 10 CFR 35.75(c). 4 ' staff changed the rule in response to the ACMUI comment. This infomation would be needed for cases where a patient would be held for some time period prior to release. Such cases would not be covered in the default release l table that appears in the regulatory guide. In this case, a record is needed
- to confirm that the licensee has released the individual in accordance with the limit in Part 35. Regulatory Guide 8.39 will provide guidance on cases where such records will be needed for release.
Third, the ACMUI suggested that the term " discontinuation" should be used in conjunction with " interruption" in the requirement to provide " guidance on the ; interruption of breast-feeding" if failure to follow the instructionsThe couldACMUI result in a dose to the infant exceeding 1 mil 11 sievert (0.1 res). suggested the change beca ase they said that there is a distinct differ between the two terms. comment. As stated in the Federal Register notice, "the instructions must Table 2 in include guidance on the interruption period for breast-feeding." the guide gives interruption periods for various radiopharmaceuticals which dan be temporary (48 hours or less) in some cases, or discontinuation (no resumption) when necessary. Finally, the ACMUI recommended that the Commission proceed with the rule as promptly as possible. RESOVRCES: Resources needed to conduct and implement this rulemaking are included in the FY 1995-1999 Five-Year Plan. (QQBDINATION: the Office of the General Counsel has no legal objection to this paper. RECOfMENDATION: That the Commission: 1. Anorove the notice of final rulemaking for publication (Attachment 1).
1 1 The Commissioners 7 l I
- 2. Certify that this rule will not have a significant , economic impact on a substantial number of small entities; such certification will satisfy requiremerets of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
3. figtn:
- a. The final rule will become effective 120 days after pubifcation in the Federal Reafster.
- b. A final regulatory guide will be published, for use, before the final rule becomes effective (Attachment 2).
1 c. A final regulatory analysis will be available in the Public ! Document Room (Attachment 3).
- d. A final environmental assessment and a finding of no significant impact have been prepared (Attachment 4).
4
- e. The Chief Counsel for Advocacy of the Small Business i Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as i
" required by the Regulatory Flexibility Act.
- f. The appropriate Congressional Committees will be infomed l (Attachment 5);
- g. A public announcement will be issued (Attachment 6). ;
- h. The rule contains information collection requirements that are i subject to review by the Office of Management and Budget. Upon l Commission approval, the OMB supporting statement (Attachment 7) i l
will be submitted to OMB for approval.
- i. Copies of the Federal Reaister notice of final rulemaking and the associated regulatory guide will be distributed to all NRC medical licensees and each Agreement State. The notice will be sent to other interested parties upon request.
A ~ Tf s M. Ta or 4 ecutive rector for Operations Attachments: As Stated (7)
8 Cosmaissioners' c<.nnnents or consent should be provided directly to > the Office of the Secretary by COB Thursday, May 23, 1996. l Commission Staff Office comunents, if any, should be submitted to the j Ccemaissioners NLT May 16, 1996, with an information copy to the Ofice of the Secretary. If the paper is of such a nature that it requires additional review and cosmient, the Conunissioners and the Secretariat should be apprised of when comuments may be expected. 1 This paper is tensatively scheduled for affirmation at an Open Meeting during the Week of May 27, 1996. Please refer to the appropriate Weekly l - Commaission Schedule, when published, for a specific date and time. . > DISTRIBUTION: Comunissioners l OGC OCAA OIG OPA OM EDO SECY I i I e
9 ATTAuffENT I FEDERAL REGISTER NOTICE l l
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1 l l 1 l l 1 [7590-01-P] NUCLEAR REGULATORY COpMISSION 10 CFR Parts 20 and 35 RIN 3150-AE41 i Criteria for the Release of Individuals Administered Radioactive Material I AGENCY: Nuclear Regulatory Commission. l ACTION: Final rule.
SUMMARY
- The Nuclear' Regulatory Commission (NRC) is amending its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release are based on the potential dose to other individuals exposed to the patient. The new criteria are consistent with the recommendations of the National Council on Radiation Protection :7d Measurements (NCRP) and the International Commission on Radiological Protection (ICRP). This final rule requires the licensee to provide written instructions to patients on how to maintain the doses to others as low as is reasonably achievable if the total effective dose equivalent to any other individual exposed to the released patient is likely to exceed 1 millisievert (0.1 rem). This final rule responds to three petitions ivr rulemaking regarding the criteria for release of patients administered radioactive material.
EFFECTIVE DATE: (120 days following publication in the Federal Register).
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ADDRESSES: Co;r.4s icf Regdiatory rMde 3.39,, " Release of P&ients Administered Radioactive Materiilr"; the final regulatory : analysis,, :NURLB-2492, " Regulatory Analysis on Criteria for the Release of Patients Adminiistered Radioactive Material' (1996); Revision 2 of. NUREG/BR-0058, "Regulater,y Analysis Guidelines of the U.S. Nuclear Regulatory Commission" (1996); and the public comments received on the proposed rule may be examined and copied for a fee in the Commission's Public Document Room at 2320 L Street NW. (Lower Level), Washington, DC. Single copies of Regulatory Guide 8.39 may be obtained free of charge by writing the Office of Administration, Attn: Distribution and Services Section, USNRC, Washington, DC 20555, or by fax at (301) 415-2260. i Single copies of NUREG-1492 and NUREG/8R-0058 may be purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washtngton, DC 20402-9328 (telephone (202) 512-1800); or from the National Technical Information Service at 5285 Port Royal Road, Springfield, VA 22161. FOR FURTHER INFORMATION CONTACT: Stewart Schneider or Stephen A. McGuire, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6225.
1. Background
Each year in the United States, radioactive pharmaceuticals or compounds or radioactive implants are administered to approximately 8 to 9 million individuals for the diagnosis or treatment of disease or for human research. These individuals to whom radioactive materials have been administered are 2
i 4 . l 1 4 , hereinafter referred to as " patients." These patients can expose others - around them to radiation until the radioactive material has been excreted I their bodies or the radioactivity has decayed away. ' i NRC's current patient release criteria in 10 CFR 35.75, " Release of , patients or human riesearch subjects containing radiopharmaceuticals or
- permanent implants," are as follows
"(a) A licensee may not authorize release from confinement for medical 3
care any patient or human research subject administered a radiopharmaceutical (1) The measured dose rate from the patient or human research j j until either: l i subject is less than 5 millirems per hour at a distance of I meter; or (2) The i activity in the patient or human rese1rch subject is less than 30 millicuries; l j
' j ' (b) A licensee may not authorize release from confinement for medical care of any patient or human research subject administered a permanent implant until
- the measured dose rate from the patient or human research subject is less than 5 millirems per Four at a distance of 1 meter."
On May 21,1991 (56 FR 23360), the NRC published a final rule that The 3 amended 10 CFR part 20, " Standards for Protection Against Radiation." 1 rule contained limits on the radiation dose for members of the public in 10 CFR 20.1301. However, when 10 CFR part 20 was issued, there was no 1 ? discussion in the supplem;ntary information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients. i i' Some licensees were uncertain about what effect the revised l 10 CFR part 20 would have on patient release criteria, and two petitions for l rulemaking were received on the issue. On June 12, 1991 (56 FR 2694M , the _ NRC published in the Federal Register a notice of receipt of, and request for 3 Attachment 1 1
j consent or., a petitinn 'for rm3emaking (PRM-20-20) from Dr. Carol S. Marcus. ! l In addition, Dr.. Marc:n .sube.it.ted a letter dated June 12, 1992, further characterizing'her position. March 9,1992 (57 FR 8282), the NP.C published a notice of receipt. and l
'On t request for comment in the. Federal Register on another petition for rulemaking l i
l (PRM-35-10) on patient release criteria from the American College of Nuclear ! Medicine (ACNM). On May 18,1992 (57 FR 21043), the NRC published in the l Federal Register notice of an amendment submitted by the ACl#1 to its original petition (PRM-35-10A). In addition, a third petition (PRM-35-ll) dealing, in part, with these j That ; same issues was submitted by. the American Medical Association (AMA). . l petition was noticed in the Federal Register on July 26, 1994 (59 FR 37950). ! The main point raised in the petition was that the radiation dose limits in l 10 CFR part 20 should not apply to individuals exposed to the patient and that I The AMA l the dose limit to the individuals should be 500 millirens per year. l i believed that 10 Cr. 20.1301 would have an adverse impact on the availability : j and the cost of treatment of thyroid disease, which would outweigh the i advantages of reduced radiation exposure to the public. The AMA stated that. treatment of up to 10,000 cancer patients annually for thyroid carcinoma would require the hospitalization of the patients under the revised regulation (10 CFR 20.1301), reducing both early release of patients and the treatment of I patients at home. II. Publication of the Proposed Rule 4 Attachment 1 i S
Dn June 15, 1994 (59 FR 30724), in response to the first two petitions, the NRC published a proposed rule on criteria for the release of patients administered radioactive material. The proposed rule discussed the pub Three additional comment comment letters received on the first two petitions. These letters each letters were received on the third petition (PRM-25-II). supported the petition but did not contain any additional information no covered by the letters on the first two peti +, ions. The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically state that the dose to individual members of the public from a licensed operati does not include doses received by individuals exposed to patients who wer This released by the licensed operation under the provisions of 10 CFR 35.75. was to clarify that the Commission's policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301. The NRC proposed to amend 10 CFR 20.1301(a)(2) to specifically s that the limit on dose in unrestricted areas does not include d contributions from patients administered radioactive material and re The purpose was to clarify that licensees would accordance with 10 CFR 35.75. not be required to control areas (such as waiting rooms) simply If a patient has l presence of a patient released purst nt to 10 CFR 35.75. l been released from licensee control pursuant to 10 CFR 35.75, f the not be required to limit the radiation dose from a patient to members o
)
public (e.g., visitors in a waiting room) to 0.02 mi111 sievert (2 \ l Patient waiting rooms or hospital rooms would need only be in any I hour. controlled for those patients not meeting the release criteria in 10 CFR part 35. 5 Attachment 1
The NRC proposed to adopt a'new 10 CFR 35.75(a) to change the patient l release criteria from 1,110 megabecquerels (30 millicuries) of activity in a patient or a dose rate of 0.05 millisievert (5 milliress) per hour at I meter from a patient to a total effective dose equivalent not to exceed , 5 millisieverts (0.5 rem) in any 1 year to an individual from exposure to a j i released patient. A dose-based limit provides a single limit that could be used to provide an equivalent level of risks from all radionuclides. Also, j i the proposed changes were supported by the recommendations of the ICRP and the i i NCRP that an individual could be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situation when exposure to radiation , is not expected to result in annual doses above 1 millisievert (0.1 rem) for ; e long periods of time. The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that the f licensee provide released patients with written instructions on how to i maintain doses.to other individuals as low as is reasonably achievable if the j total effective dose equivalent tc any individual other than the released ; f patient is likely to exceed 1 millisievert (0.1 rem) in any 1 year. A requirement to give instructions to certain patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the proposed requirement would also j require instructions for an additional 50,000 individuals who are administered iodine-131 for the treatment of hyperthyroidism and another 27,000 individuals 1 who are breast-fecuing and administered various diagnostic and therapeutic i l radioactive materials. The purpose of the instructions is to maintain doses to individuals exposed to patients as low as is reasonably achievable. The NRC proposed to adopt a new 10 CFR 35.75(b)(2) to require that licensees maintain, for 3 years, a record of the released patient and the 6 Attachment 1
\
?
calculated total effective dose equivalent to the ' individual likely to receive ! 4 ! the highest dose if the total effective dose equivalent to any individual ! other than the released patient is likely to exceed 1 af111 sievert (0.1 rem) i ! in a year from a single administration. The major purpose was to provide a I record to allow licensees to assess the need to limit the dose to individuals l exposed to a patient who say. receive more than one administration in a year. e i Finally, the NRC proposed to amend its requirements on instructions in l 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already required l instructions (not necessarily written) in certain cases, but the phrase "if i i required by 5 35.75(uj" was added to each. The purpose of this change was to li 1 make Part 35 consistent as to when instructions must be given. ! q < In addition, the NRC concurrently issued an associated draft regulatory guide and supporting draft regulatory analysis for public comment. The draft i i regulatory guide, DG-8015, " Release of Patients Administered Radioactive Materials," proposed guidance on detemining the potential doses to an individual likely tc receive the highest dose from exposure to a patient and ] established appropriate activities and dose rates for release of a patient. l The draft guide also proposed guidelines on instructions for patients on how to maintain doses to other individuals as low as is reasonably achievable and it described recordkeeping requirements. The draft regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (May 1994), examined the benefits and impacts of the proposed rule considered by the NRC. 7 Attachment 1 )
\
~_ - _ _ ~ _ . .. _ - - . -
III. Public Comments on the Proposed Rule t A total of 63 comment letters were received on the proposed rule, the draft regulatory guide, and the draft regulatory analysis. A majority of the comment letters were from medical practitioners and medical organizations, but there were also comment letters from private individuals, public-interest groups, and regulatory agencies in Agreement States. Overall, the majority of comment letters supported a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material. However, about one-fourth of the comment letters opposed the proposed recordkeeping requirement. The significant comments are discussed below, arranged by subject. 1 EXCLUSION OF PATIENT RELEASE FROM i 20.1301(a) 1 All the commenters except one supported governing patient release by the regulations in 10 CFR 35.75 and excluding the dose to individuals exposed to a released patient from 10 CFR 20.1301(a). f Cassent. One comenter, representing a public-interest group, objected
, to any exposure of a member of the general public who has not consented freely to the dosage. They said that such exposure would lead to widespread morbidity and mortality.
Response. In its revision of 10 CFR part 20 (56 FR 23360; May 21,1991), the NRC determined that, while doses should be maintained as 1 8 Attachment 1 1
low as 'is reasonably achievable, a dose limit of 1 mil 11 sievert (0.1 res), or , a dose limit of 5 millisieverts (0.5 ren) in certain special circumstances, l provides adequate protection. The revised Part 20 is based, in part, upon the recommendations of the International Commission on Radio 1@ical Protection (ICRP) and the recommendations of the National Council on Radiation Protection and Measurements (NCRP). The NCRP recommends public dose limits of I mil 11 sievert (0.1 rea) for continuous or frequent exposure and 5 millisieverts (0.5 rea) for infrequent exposure. The ICRP recommends that the limit for public exposure should be expressed as an effective dose of 1 millisievert (0.1 rem) in & year, except I that, in special circumstances, the dose could be higher in a single year ! provided the average over 5 years does not exceed 1 mil 11 sievert (0.1 rem) per f year. In ICRP Publication 60, in defining medical exposure, ICRP stated that medical exposure includes " exposures (other. than occupational) incurred 1 knowingly and willingly by individuals helping in the support and comfort of - patients LN ergoing diagnos;s or treatment." Furthermore, in explaining dose 1 limits in medical exposure, the ICRP stated in the raw publication that "the ' Commission theref:re recommends that dose limits should not be applied to medical exposures." Thus, in ICRP's opinion, family members who are helping in .the support and comfort of patients would not be restricted under the dose limit stated above. The iavision of Part 20 incorporated the long-term objective as the dose limit and included a provision (i 20.1301(c)) to allow for alternative limits on an occasional basis. Section 20.1301(c) provides that an annual dose of up to 5 millisieverts (0.5 rem) is acceptable if there is a need for it and if g Attachment 1
steps . ira taken to reduce the dose to as low as is reasonably achievable. The NRC reaffirms that previous determination in this rulemaking. In the case of released patients, it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 1 mil 11 sievert (0.1 rem) because large therapeutic doses (greater than 3,700 megabecquerels (100 millicuries)) are rarely administered more than once to the same patient in a given year. Comment. One commenter said that the NRC should change the 0.1 rem dose limit for the public in 10 CFR 20.1301(a)(1) to 0.5 rem for all licenead activities because a dose limit of 0.5 rem offers adequate protection and is a dose that has no proven effects. Response. This issue of the general public dose limit is outside the scope of this rulemaking. The issue was dealt with when 10 CFR part 20 was recently revised (56 FR 23360; May 21,1991). That rulemaking explained the NRC's rationale for ao pting the 1-millisievert (0.1-rem) dose limit in 10 CFR 20.1301(a)(1). ACTIVITY-BASED VS. DOSE-BASED RELEASE LIMIT The issue .., whether to retain the current patient release limit in 10 CFR 35.75, which is expressed as an activity limit together with an alternative but approximately equivalent limit on dose rate at 1 meter, or to express the release limit as a dose to an individual exposed to the patient. 10 Attachment I
j The majority of connenters supported the dose-based limit. However, some commenters opposed the dose-based approacn. Comment. A number of commenters safd that 10 CFx 35.75 should not be changed and that the 30 millicurie or 5 millirem per hour release criteria should be retained because they are working well. Some commenters said that a dose-based release 11mit as proposed would cause confusion and potential problems. One commenter said that the Part 20 revision was not intended to alter the status quo for patient release. Commenters objected to the i dose-based release limit because they thought the dose estimates to the public would be very inaccurate as these estimates are based on the unreliable method of predicting the anticipated time and proximity to others. Commenters also said that dose estimation and the subsequent recordkeeping would be time consuming and would add to the cost of treatment without a probable significant decrease in radiation exposure. Response. The NRC is adopting a dose-based limit rather than an activity-based limit because the dose-based limit better expresses the NRC's primary concern for the public's health and safety. A single activity requirement was not retained because different radionuclides with the same activity can give very different doses under identical exposure conditions. Likewise, a single dose rate requirement for all radionuclides was not retained because different radionuclides with the same dose rate, at the time , of release, can give very different doses depending upon the half-life of the radionuclide. The total dose depends on the effective half-life of the 11 Attachment 1 , v i
radioactive material in the body of the patient and other factors that vary for different materials. For these reasons, the NRC is establishing a dose l l limit rather than an activity or dose rate limit. l
'.he NRC is establishing a dose limit of 5 millisieverts (0.5 rem) total i effective dose equivalent to an individual from exposure to the released patient for each patient release. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35.75 (50 FR 30627; July 26, 1985), the recoimeendations of the NCRP and the ICRP, and the provisions in 10 CFR 20.1301(c) pertaining to temporary situations in which there is justification for a dose limit higher thaa 1 millisievert (0.1 rem).
The NRC believes 6nat the dose-based release limit can and will work well because the associated Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," can be used to relate the dose to the quantity of activity in the patient. The guide provides conservative estimates of activities for conunonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dose limits in the final rule. The approach used in the regulatory guide is based on NCRP Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."* In the case of iodine-131, the most significant radionuclide, the release quantity based on the standard conservative assumptions is 1,221 megabecquerels (33 millicuries), which is essentially the same as the current release quantity. )
' National Council on Radiation Protection and Measureinents (NCRP), " Precautions in the Management of Patients Who Have Received Therapeutic l Amounts of Radionuclides," NCRP Report No. 37 (October 1,1970). (Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
12 Attachment 1 l l
. __ . _ _ _ . . .. ~ _ . _ _.. _ __m. __ _ m. _ _ _
i NUREG-1492 contains a detailed examination of the benefits and impacts of the final rule that includes dose estimation, recordkeeping, and radiation exposure. Single copies of the final regulatory analysis and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," are f. I available as indicated in the ADDRESSES heading. Comment. A ct,.monter said that the calculational approach in the rule would require the physician to ask many personal questions of the patient. Response. The commenter is incorrect in believing that the dose-based I approach will generally require persoul information from the patient. The NRC anticipates that nea.ly all patients will be released based on default assumptions which do not require any personal information from the patient. l A table of release quantities, based on standard conservative assumptions, is j provided in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." However, the rule does allow the physician to calculate patient-specific dose estimates to allow early release of a patient not otherw"e subject to re; ease under the default values in Regulatory Guide 8.39. Personal information may be necessary for such patient-specific cases. f Comment. One commenter said that it should continue to be acceptable to release patients based on the dose rate at I meter. Aesponse. The rule authorizes release of patients based on the dose in i a year. However, release quantities based on dose rate and conservative l assumptions can be calculated. The table of release quantities in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," l 13 Attachment 1 I
I j i ! specifies the derse rate at 'l meter of tonmonly used ntionuc'lides that allow l licensees to authorize patient re'lene. RELEASE QUA#TIi1ES . 4 Using a dose-based system based on a dose to the most highly exposed. l individual of 5 millisieverts (0.5 res) would, in some circumstances, allow i release of a patient with more than 1,110 megabecquerels (30 mil 11 curies) of activity. Some connenters were opposed to allowing releases with higher activities than are now permitted. ; Comment. . Several commenters said that the release of patients with more ., than 30 millicuries of iodine-131 should not be permitted because of concerns about the risk of internal exposure. One commenter said that doses to family - l members from the patient vomiting were not adequately considered. The same lJl ; consenter also said that a study indicated that in-home contamination by l l l patient's dosed with I-131 could double family members' risk of developing ! i[ thyroid cancer. Iit l Response. The concern over contamination is not justified by the radiation doses that are likely to be caused by the removal of radionuclides j! from the patient's body by the pathways of exhaled air, feces, saliva, sweat, urine, and vomit. Measurements from several studies, as discussed in the *i l supporting regulatory analysis, have shown that a relatively small proportion ! of the radioactive material administered will appear as contamination. Doses to family members exposed to contamination from living in close contact with I 14 Attachment 1 ! j I i l i
1 released patients have been measured in several studies and in every case were less than 10 percent of the 5-mil 11 sievert (0.5-rem) total effective dose equivalent limit and were most often less than 1 percent of the 5-mi111 sievert In addition, the internal doses resulting from contamination j (0.5-rem) limit. i were always less and generally far less than the external dose, meaning that These ; contamination was the less important source of radiation exposure. measurements show that even if the family members repeatedly touched household items touched by the patient, contamination does not cause unacceptably high
)
dosas. These findings were true even in the case of a British study where j eleven patients volunteered to disregard special precautions against ' contamination and minimizing spousal and family exposure. These measurements are discussed in NUREG-1492. Also, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP J Commentary No.11, " Dose Limits for Individuals Who Receive Exposure from i Radionuclide Therapy Patients," and concluded that, "... a contamination incident that could lead to a significant intake of radioactive material is i very unlikely."' In general, the physical reactions (e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare. Vomiting is seldom an important elimination route for radiopharmaceuticals after the patient has left the medical facility since orally administered radiopharmaceutic=k such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system. l
' National Council on Radiation Protection and Measurements, ' Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Commentary No. 11 (February 28, 1995). (Available for sale from the NCRP, 7910 1oodmont Avenue, Suite 800, Bethesd*, MD 20814-3095.)
15 Attachment 1
Regarding the commer:t mi the <doodrmg tof :r.isk of developing thyroid cancer, there is no sc'ientWir antsensus by the Wited htions Scientific Committae on the Effects uf Atomic R.adiation, ICRP, ;or NCRP to support the suggested increased risk of thyroid cancer following ingestion of iodine-1 l Based on the information currently. available, the Commission continues to l conclude that the benefits outweigh the potential of small increased risks associated with this rule. Y One commenter noted that hospitals now make great efforts to Comment. control contamination from patients who are now hospitalized because they This commenter stated that it contain more than 30 cillicuries of iodine-131. ' would not be possible to~ maintain the same level of contamination control at ! these patients' homes if these patients were released with more than 30 millicuries of iodine-131. t l Response. The NRC agrees that, even though released patients are given instructions on how to limit the hazard from contamination, contamination control in a hospital can be more effective than contamination control out of In the i the hospital. However, the two situations are not really comparable. ! case of the released patient at home, therapeutic administrations almost never occur more than once in a year and only rarely occur more than once in a j lifetime; but in the case of a hospital, large therapeutic administrations ace Therefore, areas in hospitals have the f done repeatedly on many patients. j potential for contamination from many patients, and people who frequ l hospital (e.g., clergy or a hospital orderly) have the potential to be ex l In addition, the 5-millisievert to contamination from many patients. ! l 16 Attachment 1 l i
~-
(0.5-ren) limit that is applied to household members exposed to a patient is a special limit that is appropriate for only occasional use and for use where there 'is a definite need. This special limit fits the case of doses received by the household members of a released patient, but does not fit the case of people who frequent a hospital on a routine basis. Lastly, in limiting doses,. the NRC considers what is reasonably .chievable. . The mere fact that a home l i cannot control contamination as well as a hospital does not mean that the contamination control achieved in homes is not adequate. Actual measurements of doses to household members from contamination, as discussed in NUREG-1492, show that the' doses from contaliination are low, demonstrating that the degree of contamination control that was achieved is adequate. Comment. One commenter said that the proposed rule did not adequately
. address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries. l Response. In consenting on the petitions, a number of States expressed !
\
concerns about releasing patients administered 14.8 gigabecquerels ! (400 millicuries) of iodine-131, which one of the petitioners had reovested. However, the States that commented were generally favorable to the proposed rule limiting the. dose to the most exposed individual to 5 millisieverts .I; (0.5 res), and none of the States indicated that their concerns were misrepresented. In fact, one Agreement State commented that it was pleased 'l that the NRC had considered the comments made by the Agreement' States at l various meetings with the NRC. The dose-based limit would generally permit releases if the dose to another individual would not be likely to exceed 17 Attachment 1 4 i
For example, if a licensee uses the default table 5 millisieverts (0.5 rem). basis for of release quantities provided in the regulatory guide as the i ) or less release, a patient administered 1,221 megabecquerels (33 millicur e , f release is of iodina-131 could be immediately released and no record o required. However, if the licensee wishes to release a patient with an h licensee activity that is greater than the value in the default table, t e t te must do a dose calculation using case-specific factors to demons ra Furthermore, if the table is used as compliance with the release criteria. l in the the basis for release but the administered activity exceeds the va ue h the retained table, the licensee must hold the patient until the time at whic dose rate at activity is no greater than the quantity in the table or the When the administered I meter is no greater than the value in the table. d of the basis activity is greater than the value in the default table, a recor for the release must be maintained for NRC review durirg h dose inspectio Regardless of the method used by the licensee to Byauthorize licit of 5 millisieverts (0.5 rem) in the revised 10 CFR 35.75 in appli identifying more than one method for calculating for the release o accordance with 10 CFR 35.75, the NRC provides greater flexibility iding : licensees to achieve compliance with the new requirement whil adequate protection of public health nd safety. One commenter said that in some cases it should be Comment. 4# the dose to a family member to authorize the release of a patient even l and acceptable to might exceed 0.5 rem because the release might be beneficia family members. Another commenter said that a dose of 0.5 rem to a Attachment 1 18
. - . . - - - - . . ~ =. . - . . __ - - . . . .-
s ( l l individual exposed to a patient has 50 little hazard that the NRC should not l be concerned with it.
# espouse. The NRC does not believe that individuals exposed to a patient should, in general, receive doses in excess of 5 millisieverts '
l (0.5 res). ' This is consistent with the recommendations of the ICRP in Publication 60,' "1990 Recossendations of the International Cossaission on . Radiological Protection"; and the recommendations of the NCRP in NCRP Report No.116,' " Limitation of Exposure to Ionizing Radiation." Each of these recommendations provides a basis for allowing individuals to receive annual , Both the doses up to 5 millisieverts (0.5 rem) under certain circumstances.
- ICRP and the NCRP recommend that an individual can receive a dose up to 5 millisieverts (0.5 rem) in a given year in situations when exposure to radiation is not expected to result in doses above 1 millisievert (0.1 rem) per year for a long period of time, as would be the case for doses from released patients. In NCRP Commentary No. II, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients,"' the NCRP recommended a dose limit of 5 millisieverts (0.5 ren) annually for members of the patient's family. However, on the recommendation of the treating physician, the NCRP considered it acceptable that members of the patient's family be permitted to receive doses as high as 50 millisieverts (5 rems).
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.
' National Council on Radiation Protection and Measurements, " Limitation of Exposure to Ionizing Radiation," NCRP Report No.116 MD 20814-3095.
19 Attachment 1
I' The NRC does not agree that the latter NCRP recommendation should apply in general. The NRC believes that if the dose to another individual is likely to exceed 5 millisieverts (0.5 rem), the patient should remain under the control ! of the licensee. Licensee control is necessary to provide adequate protection to the individuals exposed to the patient. RECORDKEEPING The strongest opposition to the proposed rule was to the proposed requirement to maintain a record of the released patient and the calculated total effective dose equivalent to the individual likely to receive the i highest dose if the dose to that person is likely to exceed I millisievert (0.1 rem). Under the proposed rule, if a patient had or might have had one or more administrations within the same year, the licensee would use the records to determine the dose from the previous administrations so that the total dose to an individual exposed to a patient frcm all administrations would not exceed 5 millisiev rts (0.5 rem). Comment. Many commenters indicated that this requirement would cause excessive costs in time, effort, and money to track down records of previous { administrations, to perform calculations, and to keep records of all the work i and asked that the requirements to make calculations and keep records be removed. The commenters believed that the work would not produce an increased level of safety, that the NRC greatly underestimated the cost, and that the recordkeeping would be unnecessary, inappropriate, and impractical. Some comenters said that multiple administrations that would result in a total 20 Attachment I l 1
a 4 1 effective dose equivalent greater than 1 millisievert (0.1 res) are not done-to the same patient routinely. Other commenters said that there have been decades of experience unencumbered by any papemork burden at all with no j f evidence that a lack of paperwork has resulted in any additional problems. l
- One commenter said that if 0.5 res is acceptably safe, why have the
. documentation required at the 0.1 rem level. j Another commenter said that it cannot be a licensee's responsibility to l l 'know the details of a radionuclide therapy performed by another licensee in i- tems of which members of the public received the most radiation dose from ' { that other licensee's the,apy procedure. . i i One commenter said that the excessive recordkeeping cost would be a nonreimbarsable cost, and the burden will cause many physicians to stop l l L l offerint iodine therapy, which would force patients to travel to large medical j i facilitits in cities and cause problems with patient access in sparsely
- populated areas.
4 Aesponse. Upon reconsideration,- the NRC has decided to delete the ; f requirement to keep records when the dose to the most highly exposed ; individual is likely to exceed 1 mil 11 sievert (0.1 ren). The requirement was f proposed so that it would be possibL to account for the dose from multiple administrations in the same year to ensure that the total dose to an individuai exposed to the patient did not exceed 5 millisievrets (0.5 res). The NRC has an advisory committee, the Advisory Commiittee on the Medical Uses of Isotopes, or "ACMUI," which advises the NRC on rulemakings and other , initiatives related to the medical use of byproduct materials. 't e NRC also has a visiting medical fellows program that recruits selected physicians or 21 Attachment 1 ,
Both the ACMUI pharmacists to work for the NRC for a period of 1 to 2 years. and the current Visiting Medical Fellow, Myron Pollycove, M.D., provided In addition, advice to the NRC during the development of this rule. ; Barry A. 'Siegel, M.D., Chairman of the ACMUI, reviewed the oatient records at his medical facility for the 1-year period from July 1,1993, to June 30, 1994 i (Mallinckrodt Institute of Radiclogy, St. Louis, Missouri). Drs. Siegel and Pollycove concluded that no routine nuclear medicine practice, be it diagnostic, therapeutic, or a combination of the two, results in multiple , large administrations that would be likely to cause the 5-mi111 sievert [ (0.5-rem) dose limit to be exceeded because of multiple administrations in a v year. While the proposed requirement to maintain a record of the dose to ! another individual if the dose is likely to exceed 1 millisievert (0.1 rem) has been deleted, a recordkeeping requirement with a reduced impact has been retained as discussed'under the heading, " Discussion of Text of Final Rule." i Comment. Several comenters said that those who pay for health care ! t will put great pressure on physicians to optimize calculations to reduce ; in-patient days and to justify out-patient treatments. , Response. There is no objection to optimizing calculations to reduce , in-patient days as long as the calculations are realistic and the 5-millisievert (0.5-res) limit in 10 CFR 35.75 is met. Regulatory Guide 8.39, l
" Release of Patients Administered Radioactive Materials,"' describes examples of calculations that are acceptable to the NRC. ,
t 22 Attachment 1
' ' ~ ' ' ' --- . , . . ,. , , ,,
4 i I i WRITTEN INSTRUCTIONS TO PATIENTS l l 1 In general, there was little objection to providing instructions to. ; s d patients on how to minimize the dose to others, but there was significant
- opposition to the proposed requirement that the instructions would have to be i written.
i - ( l
- Commet. One commenter said that the Statement of Considerations for ,
1 l the proposed rule was in error in stating that the existing regulations
- already required the the instructions to patients be written.
4 ? Response. The commenter is correct. The Statement of Considerations l was-in error on that point. The existing regulations do not specify that instructions have to be in written form. i l. l Comment. A number of commenters said that instructions should.not need l to be written and that oral instructions should be permissible. Some of these commenters said that oral instructions are more effective and that. how the b instructions should be given is within the province of the doctor-patient relationship and that the NRC and its regulations should not interfere with f that relationship. One commenter said that the physical condition of the patient could lessen the patient's ability to follow the instructions. Another consenter said that the standard written instructions require too much time explaining how each patient varied from the standard instruction sheet, However, one Agreement' State and a major health maintenance organization f i strongly supported the requirement that the instructions be written. 4 I 23 Attachment 1 I
l Response.. The NRC be'.13 eves titat pr.uvidng wr..nto instructions has a significant value because often pafients vf71:noi rememour all of the instructions given orally. In addition., wr!tien 'irtstr.uttions can be read by other family members or care givers. The requirasent to provide the instructions in written form was also supported by the ACNUI. This regulation allows the licensee to determine the fom of the written instructions. The NRC believes that for the majority of releases requiring written instructions, the written instructions can be prepared in a generic fom. For example, the Society of Nuclear Medicine has prepared a brief pamphlet, " Guidelines for Patients Receiving Radiciodine Treatment," which can However, be given to patients at nominal cost (less than $1 per patient). oral instructions may also be provided in all cases. Consent. Several commenters said that dictating to a physician how and what he or she must tell a patient is not the purview, mandate, or competence of the NRC and interferes with an essential part of medical practice, which is communication between physician and patient. Response. In a policy statement published on February 9,1979 (44 FR 8242), entitled " Regulation of the Medical Uses of Radioisotopes; The Statement of General Policy," the NRC made three specific statements. third statement of the policy is "The NRL will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to f q be a part of the practice of medicine." The final rule is consistent with this statement because it does not dictate the choice of medical treatment or i l diagnosis, does not specify the details of what the physician must say or must 24 Attar.hment 1 1 1
1
' include in the contents of the written instructions, and is directed at minimizing the risk to the patient's family who have no doctor-patient relations to the prescribing or administering personnel. However, Regulatory Guide 8.?s, " Release of Patients Administered Radioactive Naierials,"
recommenct contents of the written instructions. Furt:,1er discussion of the 1979 Medical Policy Statement is presented
~
under the heading, "VIII. Consistency with 1979 Medical Policy Statement." Comment. Several comenters asked whether written instructions were appropriate if the patient was blind, illiterate, or did not read English. Another commenter said that the instructions should be both written and oral and should be in the primary language of the patient. Aesponse. The NRC believes that writicn instructions are useful and should be required. If the patient is blind, illiterate, or does not read English, i'c is likely that someone else will be able to read the instru,: *ons for the patient. NRC considers it too much of a burden to require that the instructions be given in the primary language of the patient, although the regulations do not preclude foreign language written instructions if the 1 I licensee chooses to provide them. In most situations, it will be possible to The requirement find someone who can translate for the patient if necessary. that written instructions be given to the patient does not preclude additional I oral instructions. Comment. Several commenters asked how the NRC would enforce Another commenter implementation of the instructions given to the patient. 25 Attachment 1 1
= .- - . .
I asked how the licensee could verify that the instructions are followed. Another commenter said that a sizable fraction of patients may not follow i radiation safety instructions to protect spouses and may be even less careful j about protecting total strangers. This commenter also asked whether it is reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others. Response. The NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's responsibility. However, it is the . responsibility of licensees to provide instructions to the patients. Following the instructions is normally the responsibility of the patient. However, American medical practice routinely depends on patients following instructions, such as instructions on when and how to take medications. With regard to compliance with the instructions, surveys of patients and their spouses, as discussed in the supporting regulatory analysis, indicate that most will attempt to follow tne instructions faithfully, especially with regard to protecting 'leir children, although some patients and their spouses indicated that they might not keep physically distant from their spouse for prolonged periods of time. Comment. One comenter said that instructions shoulc' be given for all administrations of radioactive material, regardless of the quantity administered. Response. The NRC does not agree. In some cases, particular13u the large number of diagnostic administrations, the potential doses are so small 26 Attachment 1 4
4 . l that the burden of requiring instructions cannot be justified. Under the i final' rule, if the 6osa to any individual Exposed to the patient is not likely to exceed 1 millisievert (0.1 res), instructions are not required but the l physician could give any instructions that he ?)r she cc.:iders desirable. i I CONFINEMENT OF PATIENTS Cassent. Two commenters said that patients cannot be confined against their wishes and that the rule provides no penalty for the patient who leaves confinement in the hospital "against medical advice." Another commenter said i that the rule seems to . require that the licensee have control of the patient's activities after release. Response. The NRC recognizes that patients cannot be held against their will. The rule deals with the conditions under which the licensee may authorize release. The NRC would not penalize a licensee for the activities of the patient af ter release or if the patient were to leave "against medical advice." Comment. One commenter asked whether a patient who was releasable but was still hospitalized for other reasons would still be considered under the licensee's control. Response. Once the licensee has authorized the release of the' patient, there is no need . keep the patient under licensee control for radiation protection purposes if the patient remains hospitalized for other reasons. 27 Attachment I
._. . . . _ . - . . . . . _ _ . _ . _ _ . . . _ . _ . _ . - _ - - _ _ . _ . . . _ . _ . . . _ _ . . _ . _ _._ -- m . _ . _ _ _ _ _ _
- s. :
i ! 8 Lwever, good health physics practice would be to continue to make efforts to maintain doses to people' at the facility as low as is reasonably achievable. : i Comment. Commenters also asked how a patient can.be confined to his or t
~
l her house. Aesponse. These commerters misunderstood the concept of confinement. As explained in the Statement of Considerations for the proposed rule j (59 FR 30724), the term " confinement" no longer applies to the revision to Instead, the text of.the rule uses the phrase " licensee ; 10 CFR 35.75. control" to more clearly reflect the NRC's intent. ; The NRC believes ~that'there'is a distinct difference between a patient : being under licensee control in a hospital or other licensee facility (e.g., a In a hospital or other area or f hospice or nursing home) and being at home. address of use listed on the NRC license, the licensee has control over access- ; to the patient as well as having trained personnel and instrumentation : available for making radiation measurements not typically available at the j patient's home, in addition, while under licensee control, a licensee has control over the dase by limiting the amount of time that individuals are in-close proximity to the patient. A patient who goes home is released from f i licensee cor.i.rol. I t Comment. One comunenter thought that the rule should define the term
" release." .l i
l l
\
l 28 Attachment 1 4
1 k (
#esponse. The term " release from licensee control," when read in context, refers to radiation protection considerations and is sufficiently clear that there is no need to define the ters.
MISCELLANEOUS COMENTS ON THE RULE l Cassest. Sevee al commenters said that the rule should not be a matter of Agreement State compatibility at any level. Response. The NRC does not agree. The NRC conducts an assessment of each proposed requirement or rule to determine what level of compattility f d will' be assigned to the rule. These case-by-case assessments are based, for the most part, on protecting public health and safety. NRC has evaluated the final rule and assigned compatibility designations ranging from level 1 (full compatibility required) to level 3 (uniformity not required) as detailed later f in this Federal Register notice. Comment. Seve al consenters said that a breast-feeding infant should J not be considered as an individual exposed to the patiant for the purposes of determining whether patient release may be authorized. These commenters said that consideration of the breast-feeding infant should be under the jurisdiction of the physician, that the issue is a medical issue rather a regulatory issue, and that the NRC should not interfere in medical issues. The NRC does not agree. The NRC has a responsibility to . Response. protect the public health and safety, and that responsibility extends to all individuals exposed to a patient administered licensed radioactive materials, including breast-feeding children. When the release is authorized, it is 29 Mtachment 1 1
r based on the licensee's determination that the total effective dose eq to an individual from the released patient is not likely to exceed The dose to the breast-feeding child from 5 millisieverts (0.5 rem). breast-feeding is a criterion for release but it can be controlled by giving : the woman guidance on the interruption or discontinuation of breast-fee However, the release could be based on as required by the new 10 CFR 35.75. the default table of relea:e activities in the regulatory guide or a The issue patient-specific calculation, as required by the new 10 CFR 35.75. of the dose to the breast-feeding child is discussed in NUREG-1492 and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." Consent. One commenter said that the proposed rule did not accurately represent the position of the Advisory Committee on Medical Use of Isoto A review of the transcript for the ACMUI meeting in May 1992 Response. h shows that the Federal Register Notice provided an accurate descripti ACMUI position. The final rule was discussed with the ACMUI on October 18, (For ACMUI's comments 1995, and the ACMUI, in general, supported the rule. and NRC's responses, see V. Coordination with the ACMUI.) One commenter said that its facility treated many foreign Consent.
.ls. These patients frequently may l patients with therapeutic pharmaceut' Thus, there leave the hospital and innediately board a plane to return home.
l is a limit to the amount of control that a licensee has over tha patient. Attachment 1 30
#esponse. The NRC recognizes that the licensee has no control over the ;
patierit after the patient has been released. The quantities for release l listed in Table 1 of Regulatory Guide 8.39, " Release of Patients Administered f j Radioactive Materials," were calculated using conservative assumptions (for example, by using the physical half-life of the radioactive material rather than the more realistic effective half-life). Thus, the NRC considers it unlikely that the dose to an individual in real circumstances would approach 5 millisieverts (0.5 res). In special situations, such as when a released patient would inanediately board an airplane and would therefore be in close contact with one or more individuals, it may be necessr.ry to base the release on a more realistic case-specific calculation. Once the patient is released, the responsibility for following the instructions is entirely the, patient's, not the licensee's. COP 9 TENTS ON THE DRAFT REGULATORY GUIDE Comments were also requested on Draft Regulatory Guide, DG-8015, ,
" Release of Patients Administered Radioactive Materials,' associated with this rulemaking. Because the guide is associated with the rule, the comments received on the draft guide are discussed here. Most of the comments l concerned the method and the assumptions used to calculate the dose to the
)
individual likely +o receive the highest dose. ! Several comunenters said that' the calculational methodology in -l Comment. the draft guide is too complex and that the assumptions are too conprvative. f As an example, several commenters said that the assumed 24-hour nonvoiding 31 Attachment 1 n
As evidence that assumptier uset im dicdiating dasa; 're t.no anwoh the calculations an too conservat.in. several rnwres said that the doses measured using dosimeters were much lower than dases dlculated using the models in the draft guide. Response. The NRC has revised the gu16e to use a phased approach for While the calculations ca,. deterinining when release can be authorized. sometimes be complex, the results of calculations that use conservative assumptions are given in a table of release quantities in Regulatory Of the Guide 8.39, " Release of Patients Administered Radioactive Materials." 8 to 9 million administrations performed ar.1ually, in all except about 10,000 cases (radioiodine therapy for thyroid cancer), release can be authorized based on conservative assumptions and using Table I with no calculational effort on the part of the licensee and no additional recordkeeping beyond what is already required. For permanent implants, the guide provides dose rates at 1 meter from the patient at which release may be authorized. Thus, for implants, there would be no calculational effort needed. In addition, the guide provides information on iodine therapy for thyroid cancer that can be used for determining release based on retent4a and elimination. This additional information in the guide will allow the licensee to perform the calculation with relatively little effort. With regard to the coments that the methodology is too conservative and that measured values are lower than calculated by the methodology, the methodology in the table giving default release quantities is intended to be conservative. The NRC believes it is appropriate and prudent to be conservative when providing generally applicable release quantities that may 32 Attachment 1
be used with little consideration of the specific details of a particular patient's release. A review of published information, as described in the regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (1996), finds that measured doses are generally well below these predicted by the methodology used to calculate the table of default release Quantities. Thus, the default ; 1 release quantities are conservative as the NRC intended. However, the licensee is given the option of using case-specific calculations that may be f I less conservative. l Nevertheless, the NRC ag ees that the assumption used in the draft ouide of 24-hour nonvoiding in the thyroid cancer example was overly conservative. l The revised example uses an excretion half-life of 8 hours as recommended by the ICRP in ICRP Publication 53, " Radiation Dose to Patients from Radiopharmaceuticals. "' Cassent. One comenter said that the occupancy factor (generally assumed to be 0.25 at 1 meter) should not be left to the discretion of ti.a licensee because low occupancy factors could easily be justified by providing strict safety instructions without any verification that the instructions will be ollowed. Another comenter liked the flexibility provided by being able to adjust the occupancy factor, but wanted to know if other considerations are
'llowed ar' if it is acceptable to use values lower than 0.125.
i
' International Commission on Radiological Protection (ICRP), " Radiation l Dose to Patients from Radiopharmaceuticals," ICRP Publication No. 53 (March i 1987). Anilable for sale from Pergamon Press, Inc., Elmsford, NY 10523.
33 Attachment 1
I Response. Draft Regulatory Guide 8.39 discussed situations in which it might be permissible to lower the occupancy factor from 0.25 to 0.125, but did , not recommend occupancy factors less than 0.125. Occupancy factors less than 0.125 may be difficult to justify because it is generally not realistic to assume that the patient can avoid all contact with others. However, lower values for the occupancy factor are not prohibited by the regulation, but they must be justified in the record of the calculation, as the record will be l subject to inspection. Cassent. Several commenters said that the iodine-131 retention fraction of 0.3 used in the draft guide for treatment of thyroid cancer is too large and that the correct value should be 0.05 or less. Another commenter said that the biological half-life of extrathyroidal iodine should be 0.5 day for ; both the euthyroid and hyperthyroid condition. One commenter said that the biological half-lives from ICRP Publication No. 53 should be used for thyroid cancer. Response. The NRC agrees that the commenters raised valid points. In Regulatory Guide 8.39, the iodine retention fraction for thyroid cancer was changed to 0.05. The biological half 'ife for the extrathyroidal fraction was 1 In addition, the biological half-lives from ICRP l changed to 0.33 day. Publication No. 53 were used for the thyroid cancer case. Comment. One commenter said the table of release quantities in the draft guide should be expanded to include beta emitters such ac strontium-89 34 Attachment 1
3 l and phosphorous-32. Another commenter said that the table should be expanded f to include chromium-51, selenium-75, ytterbium-90, tin-117s, and iridium-192. : Aesponse. Values for the beta emitters strontium-89 and phosphorous-32 ! 1 have been added to the table of release quantities in Regulatory Guide 8.39. l The table of release quantities was also expanded to add values for chromium-BI, selenium-75, . ytterbium-90, tin-ll7m, and iridium-192. l' i, , 4 ' 2 Comment. The table of release quantities in the draft regulatory ' guide
~
's i should be expanded to include accelerator-produced radioactive materials as an aid to Agreement States.
#esponse. Several accelerator-produced materials were added to The
~ Regulatory Guide 8.39 as an aid to the States and to medical facilities.
! NRC has no regulatory authority over the release of patients administered ; a ) accelerator-produced materials and would not inspect the release of patients administered accelerator-produced materials. l l l Cassent. One commenter said that the regulatory guide should have a l table of release quantities based on biological half-life rather than only the i physical half-life. Response. Regulatory Guide 8.39 now provides more information on release quantities for iodine-131 based on biological half-lives. j l 35_ Attachment 1 I 1 4 e ,. ., - 1-, -
, , , _ .-# ~
1 l Comment. One commenter said that the factor of 10 used in the draft I 1 guide to estimate internal dose is not well supported for nonoccupational i exposures. Another commenter said that the calculation of dose.to individuals ( exposed to the patient ignores the potential of radiation dose from the
~
j excretion of radioactive material from the patient, and this could present a significant radiological hazard to family members. j f Aesponse. It is true that there is not a great deal of information on. the use of the factor in nonoccupational settings, but measurements (described { in NUREG-1492) have been made in which iodine uptake was measured in people ; exposed to a patient. These data suggest that the fractional uptake of the l administered activity will be on the order of 10-'. Since iodine is among the ! most soluble and volatile radiopharmaceuticals, it can be expected that the transfer to others of less soluble and less volatile radiophamaceuticals j would be less than that of iodine. j In addition, the NCRP recently concluded that, for individuals exposed to' radionuclide therany patients, the risks of external irradiation and q potential contamination are minor from a public health viewpoint; therefore a I significant intake from a contamination incident is very unlikely." Comment. A medical organization commented that the draft guide is not t complete and does not provide sufficient comprehensive examples to assist licensees in complying with the rule. ' Aesponse. The NRC has expanded the guide to include infomation and { further examples on the biological elimination of iodine-131 and on when
)
1 36 Attachment 1 i
guidance on the interruption or discontinuation of breast-feeding should be given. Expanded examples are now given in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." The example on thyroid cancer was revised to include more realistic assumptions, and an additional example on hyperthyroidism was added. The NRC believes that the examples provided illustrate the techniques sufficient to perform the whole range of potential calculations. Comment. One connenter said that the draft regulatory guide did not provide enough information on when and for how long breast-feeding of infants should be interrupted. Response. Regulatcry Guide 8.3G has been greatly expanded with respect to information on the breast-feeding child, including a table on recommendations for the interruption or discontinuation of breast-feeding for specific raciopharmaceuticals. Cassent. One commenter said that the sample instructions in the draft guide concerning implants should include a picture of an implant seed. Response. The sample instructions were not expanded to include this because of graphics limitations, but licensees may add photos if desired. Comment. Several consenters asked whether multiple individual calculations have to be done or if a generally applicable calculation could be done once and used for many patients. 37 Attachment 1
i Segpense. The NRC believes that there may be some situations for which a case-specific calculation could be done for a class of patients. The record for a particular patient's release could then reference the calculation done for the class of patients. However, depending on a patient's individual , status (e.g., lower occupancy factor), there may be cases when the calculation will be done for a specific individual. Comment. One comenter said that the discussion on radiolabeled antibodies in the draft guide was wrong because antibodies labeled with iodine-131 will be deiodinated in the body and the iodine will beh4ve like other iodine. None of the radiolabeled antibodies now being developed or planned for the future should have an internal dose hazard for the general public. Response. The NRC agrees with this comment. Statements in Regulatory Guide 8.39 are now modified. COMMENTS ON THE DRAFT. REGULATORY ANALYSIS (DRAFT NUREG-1492) i Comment. One commenter said that the value of a person-rem should be
$40 rather than $1,000 as used in the draft regulatory analysis for the purpose of evaluating the costs and benefits of the rule. The commenter cited a 1993 Health Physics Society position paper as a reason that the value should be $40 per person-rem. ~
l 38 Attachment 1 i 1 4 I
i The Commission rece.ntly adopted a value of $2,000 per Response. person-rem as explained in Revision 2 of NUREG/BR-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission (November 1995)," i Section 4.3.3, " Evaluation of Values and Impacts." (Single copies of 1 l l NUREG/BR-0058 are available as indicated in the ADDRESSES heading.) The draft l l regulatory analysis, which was prepared utilizing $1,000 per person-rem, employed a simple computational model using the physical half-life only of radiopharmaceuticals. The regulatory analysis has been revised to include use .I of 52,000 per person-rem, as well as a more realistic dose model based on biological retention :nd elimination of the radiophansaceuticals. The more 1 1 ' realistic model with a .value. of $2,000 continues to demonstrate the
- l 2 cost-effectiveness of the dose-based limit. Specifically, the. savings in
' hospital costs under the earlier release time allowed are estimated at 4 514 million, whereas the collective dose of 2,740 person-rem (at a value of
- 52,000 per person-rem) corresponds to a cost of about S5 million.
J NUREG-1492 contains a detailed discussion of the model and the benefits j and impacts of the dose-based limit. Single copies of the final regulatory ) analysis are available as indicated in the ADDRESSES heading. l
- Consent. One commenter said that the benefits of the rule were s
overestimated because the length of time that a thyroid patient would have to remain in the hospital was overestimated and the cost of a hospital room was { j ' overestimated, being $450 per day rather than $1,000 per day as assumed in the draft regulatory analysis. .j i I Response. The consenter is correct that the benefits of the rule were overestimated. The estimates in the draft regulatory analysis of days of j hospitalization requirad did not include biological elimination of the 39 Attachment 1 i
i i As a 4 radioactive material; only radioactive decay was cuosidered. l consequence, '
.he draft regulatory analysis, in some cases, overestimated the l
time that. patients would need to be retained under license'e control, and l The final regulatory j therefore the costs of patient retention were too high. analysis corrects the estimates.
-The NRC believes that the current cost of $1,000 per day for a hospital
- i room is not an overestimate. Under 10 CFR 35.315(a)(3), licensees are j
required to provide a private room with a private sanitary facility for each' l
! patient receiving radiophamaceutical therapy and hospitalized for compliance Considering this NRC requirement and the recent reference with 10 CFR 35.75.
' cited in the final regulatory analysis or. the cost of hospitalization, $1,000 per day for a hospital som is a reasonable estimate. i' . j- One commenter said that the description of the measured. doses Comment. received by family members was not consistent with the reference cited. i 1 i . ( i
. Response. The commenter is correct. An incorrect reference was given.
!~ The final regulatory analysis provir'es the correct reference. ! I e~ IV. Coordination with NRC Agreement States t The NRC staff discussed the status of this rulemaking effort at two - + l public meetings: ' the Agreement State Managers Workshop held.on July 12-14, , ~ l 24-25, 1994. ' 1994, and at the. All Agreement States Meeting held on October E The. Agreement States expressed no objections to the approach in this rule. ' r i V. Coordination with the Advisory Cosmiittee on Medical Uses of Isotopes i. The Advisory Cosmiittee on' Medical Uses of Isotopes (ACMUI) is an ' [ advisory body established to advise the NRC staff on matters that involve the 'l 40 Attachment 1 .] t i , t l
, t d
1 administration of radioactive material and radiation from radioactive 1 material. The NRC staff presented a summary of the comments on the proposed rule to the ACMUI during a public meeting held in Rockville, Maryland, on November 17 and 18,1994. Drafts of the final rule and regulatory guide were discussed with ACMUI in Rockville, Maryland, on October 18 and 19,1996. The ACMUI supported the approach in this rule but suggested some clarifying changes. The NRC staff made all but one of the suggested changes. The ACMUI suggested using the term i
"rhtionale" instead of " consequences' tn the requirement under the revised 35.75(b), to provide " guidance on the interruption or discontinuation of breast-feeding, and information on the consequences of failure to follow the guidance" for cases where failure to follow the instructions could result in a dose to the infant exceeding 1 millisievert (0.1 rem). Since most of the administrations that would be affected by this requirement are technetium-99m J
administrations, the ACMUI suggested the change because there was concern that the consequences of low doses of radiation canr.ot always be explained to the patient without causing unjustified alarm. Also, there was concern that physicians cannot explain with certainty the effects of low doses of radiation, such as would be caused by diagnostic administrations of technetium-99m. The staff did not change the rule in response to the ACMUI comment. The requirement to provide information on the consequences is included primarily to protect the breast-feeding infant from therapeutic administrations of radiciodine, which could cause serious thyroid damage. Regulatory Guide 8.39 will contain guidance on the types of information, including evpected consequences, to be provided to patients to meet this requirement. Transcripts of the meetings have been placed in and are available for examination at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washingt a, DC. 41 Attachment 1
. e
_ ._ ,_ ~. __ . . _ _ _ _ __ VI. Discussion of Text of Final Rule This section summarizes the final rule. The NRC is amending 10 CfR 20.1301(a)(1) to state specifically that the dose to individual members l of the public from a licensed operation does not include doses received by l individuals exposed to patients who were released by the licensed operation l under the provisions of 10 CFR 35.75. This is not a substantive change. It l 1s a clarifying change to make clear that the Commission's policy is that l patient release is governed by 10 CFR 35.75, not 1,0 CFR 20.1301. ; For the sake of consistency and clarity, the same words are used in ) 5 20.1002, " Scope"; in 5 20.1003, " Definitions" (in the definitions of both ! public dose and occupational dose); and in 5 20.1301, " Dose limits f,. , individual members of the public." Also for consistency and clarity, the exclusion of dose from background radiation and from voluntary participation in medical res: arch programs that are now included in !! 20.1002 and 20.1003 are added te i 20.1301(a). In addition, the definition of " member of the i public," as published in 60 FR 36038 on July 13, 1995, is revised by removing the footnote which read, "Except as d'elineated in other parts of 10 CFR Chapter 1." With the publication of this rule that footnote is no longer l 1 needed. l The NRC is amending 10 CFR 20.1301(a)(2) to state specifically that the limit on dose in unrestricted areas does not include dose contributions from individuals administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that after a patient has been releasad under 10 CFR 35.75, licensees are no longer required to control radiation from the patient. The regulation uses the terin " individual" to refer to the individual to whom the radioactive material has been administered rather than " patient" to clarify that the regulation refers to anyone receiving a medical administration. 42 Attachment 1 l
The NRC is amending 10 CFR 20.1903(b) to use the term " licensee control" rather than " confinement" because the latter term no longer applies to 10 CFR 35.75. The conforming change is necessary since the term " licensee control" more clearly reflects the NRC's intent in 10 CFR 35.75. The NRC is adopting a new 10 CFR 35.75(a) to change the patient release criteria from 30 mil 11 curies of activity in a patient or a dose rate of 5 milliress per hour at I meter from a patient to a dose limit of 5 millisieverts (0.5 ree) total effective dose equivalent to an individual from exposure to a released patient. (The dose from the radionuclide involved is taken to be the dose to total decay.) A dose-based limit provides a single limit that can be used to provide an equivalent level of protection from risks from all radionuclides. Also, the changes are supported by the recommendations of the ICRP and NCRP tnat an individual can receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where exposure to j radiation is not expected to result in annual doses above I millisievert (0.1 rem) for many years. Usually, the only individuals likely to exceed a dose of 1 millisievert (0.1 rem) will be those who are aware of the patient's condition such as the primary care-giver, a family member, or any other individual who spends significant time close to the patient. l This dose-based rule would, in some instances, permit the release of patients with activities greater than currently allowed. This is especially true when case-specific factors are evaluated to more accurately assess the l dose to other individuals. The individuals exposed to the patient could receive higher doses than if the patient had been hospitalized longer. These higher doses are balanced by shorter hospital stays and thus lower health care costs. In addition, shorter hospital stays may provide emotional benefits to patients and their families. Allowing earlier reunion of families can improve the patient's state of mind, which in itself may improve the outcome of the treatment and lead to the delivery of more effective health care. 43 Attachsent 1
The release criteria in 10 CFR 35.75(a) could prevent a woman from being released because of the potential transmission of radioactive materials in breast milk. The dose to the breast-feeding child is controlled by giving the woman guidance, as required by 10 CFR 35.75(b), on the interruption.or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance. The expectation is that the woman would . . . . . . follow the instructions and would interrupt or discontinue breast-feeding. Finally,10 CFR 35.75(a) includes a footnote to inform licensees that the NRC has made available guidance on rule implementation. The footnote states that Regulatory Guide 8.39, " Release of Patients Administered Radioactive Material," contains tables of activities not likely to cause doses
. . . . . exceeding 5 millisieve +s (0.5 rem) and describes methods for calculating
,e . ms doses to other individuals. The NRC is adopting a new 10 CFR 35.75(b) to require that the licensee provide released patients with instructions, including wriiten instructions, ...,.,n, on how to maintain doses to other individuals as low as is reasonably
,;. achievable if the total effective dose equivalent to any individual other than
- -- the released patient is likely to exceed 1 millisievert (0.1 rem). This also requires giving instructions to breast-feeding women if the dose to the child could exceed 1 millisievert (0.1 rem) assuming there were no interruption af breast-feeding. The instructior.s must include guidance on discontinuation or the interruption period for breast-feeding and the consequences of failing to follow the recommendation. Regulatory Guide 8.39 contains tables that show temporary interruption periods for various radiopharmaceuticals or discontinuation. The temporary interruption periods were calculated based n the determination that the dose to a child from breast-feeding is unlikely to exceed 1 millisievert (0.1 rem). However, the physician may use discretion in the recommendation, increasing or decreasing the duration of interruption somewhat deoending on the woman's concerns about radioactivity or interruption of breast-feeding.
44 Attachment 1
~
l . 1 The purpose of describing the consequences is so that women will j understand that breast-feeding after an administration of certain ! t radionuclides could cause harm (e.g., iodine-131 could harm the child's thyroid). In other cases, the guidance could simply address avoidance of any unnecessary radiation exposure to the child from breast-feeding. l A requirement for instructions for certain patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the modified l l requirement for written instructions adds approximately (a) 50,000 patients per year who are administered iodine-131 for the treatment of hyperthyroidism l and (b) 27,000 patients per year, among about 8 million administered radiopharmaceuticals, who may be breast-feeding to whom additional written j instructions be given. The purpose of the written instructions is to maintain doses to individuals exposed to patients as low as is reasonably achievable. The instructions may be either written only or written plus oral. The NRC believes that written in:,tructions are necessary so that the patient and the patient's family and friends will have a document to refer to rather than having to rely solely on the patient's memory and understanding of the instructions. The requirement of 10_ CFR 35.75(b), requiring a licensee to provide guidance on discontinuation or the interruption pcried for breast-feeding and the consequences of failing to follow the recannendation, presumes that the licensee will make appropriate inquiry regarding the breast-feeding status of l the patient. For breast-feeding women where the dose to the child is likely to exceed 1 mil 11 sievert (0.1 rem), the NRC requires that the patient be orovideri "+h specific instructions, as described in 10 CFR 35.75(b). There is no specific rc;:irement to maintain a record indicating that breast-feeding y status was determined prior to the release of the patient. f The NRC is adopting a new 10 CFR 35.75(c) to require that the licensee maintain a record of the basis for authorizing the release for 3 years if the calculation of the total effective dose equivalent to other individuals uses 45 Attachment 1
i i 1 l l the retained activity rather than the activity administervd, an occupancy [ factor less than 0.25 at 1 meter, the biologici) or effective half-life of the l l- radionuclide, or shielding of radiation by the pat'* ant'.s tissue. Thus, , . records of release are required when the default assumptions are not used as ! discussed in Regulatory Guide 8.39. Measurements made in several studies indicate that the default assumptions should generally overpredict the dose j even when instructions are not given or are not strictly followed. If a i licensee administers an activity no greater than the value in the default table of release quantities provided in the regulatory guide as the basis for ; p release, no record of release is required. l 4 Licensees are already required by 10 CFR 35.53 to retain records of the ! l
" measurement of the activity of each dosage of radioactive material ,
!, ' administered to a patient; these records are typically maintained in a patient j dose log. In addition,10 CFR 35.32 requires licensees to retain a written , r : ' directive and a record of each administered radiation dose or ; radiopharmaceutical dosage for therapeutic administrations and diagnostic ! administrations of iodine-125 or iodine-131 sodium iodide greater than 30 ; i ; j: microcuries. These records can be used in conjunction with Regulatory ; l Guide 8.39 to demonstrate that patient releases meet the requirements of 10 CFR 35.75(a) when no record is required by 10 CFR 35.75(c). When the l licensee determines that the patient must be held to allow the reduction of l radioactivity and then released, the licensee will need a record of release ' time to demonstrate that the release criteria have been met. A licensee may j use any existing record to establish the release time. If biological elimination of radiciodine is a baeis for release and the licensee uses the information in Regulatory Guide 8.39, a record of the thyroid uptake may be i necessary as part of the basis for rei .se t4cause it is one of the nonstandard conservative assumptions listed in 10 CFR 35.75(c). If other case-specific factors are used as the basis for patient releasa that are in addition to, or modify, the standard conservative assumptions, a record of the 46 Attachment 1
j i I l basis for the release, including the. assumptions used for the calculations, j i must also be maintained. 1 This recordkeeping requirement is a modification of the proposed rule. ] The ,*oposed rule would have required that a record be maintained of the basis for the patient's release, including all calculations performed, if the total i effective dose equivalent to any individual other than the released patient is
- likely to exceed I millisievert (0.1 res) in a year from a single e
administration. Under the proposed rule, the major purpose of the record was to provide the basis for limiting the dose to 5 millisieverts (0.5 rea) to individuals exposed to a patient who may receive more than one administration in a year. Upon reconsideration, based on public comments and consultation with the ACMUI, an NRC medical consultant, and the NRC Visiting Medical Fellow, the NRC has decided to delete this requirement. A review of medical treatment practices revealed no routine practice that would result in doses j exceeding the 5 mi111 sievert (0.5 rem) limit because of multiple administrations in the same year to the same patient. Without the need to f account for the dose from multiple administrations, maintaining records for l 1 the many tens of thousands of patients released when their dose to an individual is likely to exceed 1 millisievert (0.1 millisievert) becomes an unnecessary burden. The requirement to retain these records has therefore been deleted. Each patient release is to be treated as a separate event, and licensee knowledge of previous administrations is unnecessary. The NRC is also adopting a new 10 CFR 35.75(d) to require that the licensee maintain a record that instructions were provided to a breast-feeding woman if the administered activity could result in a total effective dose equivalent to the breast-feeding child exceeding 5 millisieverts (0.5 rea) if the mother did not interrupt or discontinue breast-feeding. Thus, the NRC is requiring records for certain radiophansaceutical administrations (e.g., therapeutic administrations of iodine-131). The activities of i 47 Attachment I
i i radio,.harmaceuticals that require this record are described -in Regulatory , Guide 8.39. f
~ Finally, the NRC is deleting its requirements on written instructions in :
i
.10 CFR 35.315(a)(6) and 35.415(a)(5) because those paragraphs are redundant 4
In addition, now that.10 CFR 35.75 has requirements for instructions. ID LrR 35.415(a) and a(1) are reworded to clarify the original intent of the l The paragraphs, which was to limit the dose rate at I meter from the patient. , ambiguity was. introduced when Part 20 was revised and a conforming char.ge was made in 10 CFR 35.415. The conforming change that was made was not fully f j consistent with the original intended meaning of 10 CFR 35.415(a) and (a)(1). i i VII. Di position of the Petitions for Rulemaking , i The three petitions for rulemaking submitted by Dr. Marcus (PRM-20-20), the ACNM (PRM-35-10 and PRM-35-10A), and the AMA (PRM-35-11) requested that the NRC amend the revised 10 CFR part 20 and 10 CFR pa.t 35. These requests and their disposition by this rulemaking are discussed below. The requests made by Dr. Marcus and their disposition may be summarized as follows: (1) Raise the annual radiation dose limit in 10 CFR 20.1301(a) for . individuals exposed to radiation from patients receiving radiopharmaceuticals . for diagnosis or therapy from 1 mil 11 sievert (0.1 rem) to 5 millisieverts i (0.5 res). The final rule grants this reouest. (2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel , (30-millicurie) limit for iodine-131, but provide an activity limit for other I radionuclides consistent with the calculational methodology employed in the National Council on Radiation Protection and Measurements (NCRP) Report No.' 37, " Precautions in the Management of Patients Who Have Received f Therapeutic Amounts of Radionuclides."' The final rule does not contain ) activity limits, but Regulatory Guide 8.39 uses a calculational methodology 48 Attachment 1 l l i
- 1 i
i based on NCRP Report No. 37 to relate the dose to the quantity of activity in the patient. Therefore, the wish of the petitiener to have an easy method to determine when the patient may be released is granted in Regulatory l l Guide 8.39. (3) Delete 10 CFR 20.1301(d), which requires licensees to comply with provisions of the Environmental Protection Agency's environmental regulations i in 40 CFR part 190 in addition to complying with the requirements of 10 CFR part 20. The EPA regulations referenced in 10 CFR 20.1301(d) are
- contained in 40 CFR part 190, which deals only with doses and airborne emissions from uranium fuel cycle facilities. Part 190 of Title 40 of the ;
' Code of Federal Regulations does not apply to hospitals or to the release of patients. Furthermore,10 CFR 20.1301(d) does not incorporate the EPA's clean Air Act standards in 40 CFR part 61 that applies to hospitals. The NRC is l separately pursuing actions with the EPA to minimize the impact of dual regulation under the Clean Air Act and to take agreed upon actions that will lead to EPA recision of 40 CFR part 61 for NRC and Agreement State licensees. ' Because the reference to EPA regulations in 10 CFR 20.1301(d) has nothing to l J do with the patient release issue, ar.d therefore is outside the scope of this rulemaking, the final rule denies this request. 4 The requests made by the ACNM and their disposition may be sumarized as follows: (1) Adopt a dose limit of 5 millisieverts'(0.5 rem) for individuals The exposed to patients who have been administered radiopharmaceuticals. final ru! grants this request. ~ (2) Permit licensees to authorize release from hospitalization any patient administered a radiopharmaceutical regardless of the activity in the patient by defining " confinement" to include not only confinement in a hospital, but also confinement in a privete residence. The final rule denies this request for the reas,ns described in the discussion on this issue. 49 Attachment 1
<1
l - Finally, the requests made hy the AMA did not all pertain to the issue l, of patient release. The final rule grants the request pertaining to patient release, i.e., that the radiation dose limits in 10 CFR 20.1301 should not apply to individuals exposed to the patient and that the dose limit to the individuals should be 500 millf rems. - The request to change the term
" hospitalized" in 10 CFR 35.310(a) and 35.315(a) to the term " confined" was denied for the reasons discussed above. The request not related to the subject of patient release. (that it should be clear in Part 20 that Part 20 does not limit the intentional exposure of patients to radiation for the- ,
purpose of medical diagnosis or therapy) was addressed in another rulemaking,
" Medical Administration of Radiation and Radioactive Materials," which was ,
published as a final rule on September 20,1995 (60 FR 48623), and became effective on October 20, 1995. s VIII. Consistency with 1979 Medical Policy Statement On February 9,1979 (44 FR 8242), the NRC published a Statement of
' General Policy on the Regulation of the Medical Uses of Radioisotopes. The ,
first statement of the policy reads "The NRC will continue to regulate the medical uses of radi isotopes as necessary to provide for the radiation safety ; of workers and the general public." The rule is consistent with this statement because its purpose is to provide for the safety of individual members of the public exposed to patients administered radioactive materials. The second statement of the policy is "The NRC will regulate the radiation safety e' patients where justified by the risk to patients and where ( voluntary standards, or compliance with these standards, are inadequate." This statement is not relevant to the rule because the rule does not affect the safety of patients themselves. The rule instead affects the safety of . individuals exposed to patients. , L 50 Attachment 1 i
.. . .-. .= _- - -. - - . . . - . - . . - - . - . - - . - . . . .. - ~
i i~ I 2 The third statement of the policy reads "The NRC will minimize intrusion i into medical judgments affecting patients and into other areas traditionally [ considered to be a part of the practice of medicine." The rule is consistent ) with this statement because it places no requirements on the administration of radioactive materials to patients and because the release of patients administered radioactive materials has long been considered a matter of regulatory concern to protect members of the public rather than solely a matter of medical judgment. i Thus, the final rule is considered to be consistent with the 1979 5 Medical Policy Statement. 4 i i' IX. Issue of Compatibility for Agreement States T The NRC considers the definitions contained in i 20.1003 and the text.in l i 20.1301(a) that are modified by this rulemaking are Division I levels of compatibility. The definitions and text in these sections must be the same-for all NRC and Agreement State licensees so that national consistency can be b ~ j maintained. I Section 20.1002, '5 cope," is a Division 3 level of compatibility because this section by nature is not a.reguintory requirement and many States are prohibited by their administrative procedures act from including such sections , l l in their rules. The scope section is a general statement of scope of the rule and does not cor.tain specific requiremets that are not presented in other j i sections of Part 20. Rules at the Division 3 level would be appropriate for !- Agreement States to adopt, but they do not require any degree of uniformity l j 1 between NRC and State rules.- Additionally, il 35.75(a) and (b) are a Division 2 level of compatibility because the patient release criteria required by the rule are l 1 the minimum requirements necessary to ensure adequate protection of +.he public 1 healt,h'and safety. The Agreement States will be allowed to establish 51 Attachment 1 } (
requirements that :are more str.in. gent than -ths NRf.'.s reou~trerpents, but not less i stringent. The recordkeeping r.eguirements 'in li 35.l75(c) and (d) are a Division 3 level of compatibility because urrVormit:y 'in recordkeeping is not considered essential for this rtile, X. Finding of No Significant Environmental Impact: Availability The NRC has determined under the National Environmental Policy Act of l 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR part 51, that the amendments are nct a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact .utement is not required. The final amendments clarify the pertinent regulatory language to reflect explicitly the relationship between 10 CFR part 20 and part 35 with respect to release of patients, and the amendments revise the release criteria for patients receiving radioactive material for medical use from an activity-based standard to a dose basis. It is expected that there will be relatively little change in radiation dose to the public or to the environment as a result of the revised regulation. The final environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment and the finding of ne significant impact are available as indicated in the FOR FURTHER INFORMATION CONTACT heading. - 52 Attachment 1 4'
l 1 i' XI. Paperwork Reduction Act Statement t
' This final rule amends information collection requirements that are i subject to.the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seg i ;
i These requirements were approved by the Office of Management and Budget, 3 < approval number 3150-0010. l The public reporting burden for this collection of'infomation is 4 estimated to ' average 13 hours per licensee per year, including the time for l reviewing instructions, searching existing data sources, gathering and j
; maintaining the data needed, and completing and reviewing the collection of 4
information. . Send comments on any aspect of this collection of information, [ 3 including suggestions foi reducing the burden, to the Information and Records Nanagement Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, l DC 20555-0001,- or by Internet electronic mail at BJS19NRC. GOV; and to the Desk I Officer, Office of Information and Regulatory Affairs, NE08-10202, (3150-0010), Office of Nanagement and Budget, Washington, DC 20503. X'I. Regulatory Analysis l 1 i The NRC has prepared a final regulatory an41pis (NUREG-1492) on this regulation. The analysis examines the benefits and impacts considered by the NRC. The NRC has received public comments regarding the draft regulatory i i analysis and has addressed the couac ts (see Comments on the Draft Regulatory 1 j Analysis in III. Public Comments on the Proposed Rule). The final regulatory ' :nalysis ; available for inspection at the NRC Public Document Room 4 at 2120 L Street NW. (Lower Level), Washington, DC. Single copies are 1 l available as indicated in the ADDRESSES heading. 1: 4 4
) 53 Attachment 1 .
i-
- l i
- i
_. -~ _ . __ . . - XIII. Regulatory Flexibility Certificat;or. As required by the Regulatory Flexibility Act of 1980, 5 tl.S.C. 605(b), the NRC certifies that this rule will not have a significant economic impact . l on a substantial number of small entities. This rule affec+: medical use of byproduct material licensees. The impact of the final rule will not be significant because the final rule basically represents a continuation of current practice. XIV. Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this rule, and therefore, that a backfit analysis is not required for this :ule, because these amendments do not invalve any provisions that impose backfits as defined in 10 CFR 50.109(a)(1). Lists of Subjects in 10 CFR part 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal. Lists of Subjects in 10 CFR part 35 Byproduct t'erial, Criminal penalty, Drugs, Health facilities, Health orofessions, Incorporation by reference, Medical devices, Nuclear materials, Occupatior.a1 safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements. 54 Attachment 1 i
_ _. _ _ . _ . _ . . _ . . _ -. ~ . _ . _ _ _ _ . _ . _ m _ _ _ ___ - . . _.._. _ i , i i i I ~ For the reasons set out in the preamble and under the authority of the j Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. '552 and 553; the NRC is adopting the following ! amendments to 10 CFR parts 20 and 35. ; I PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION 4
- 1. The authority citation for part 20 continues to read as follows
d Authority: Secs. 53, 63, 65, 81,103,104,161,182,186, 68 Stat. 930, l I 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951,. 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, j-j 2297f), secs. 201, as amended, 202, 206, 68 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846). l i
- 2. Section 20.1002 is revised to read as follows:
4 5 20.1002 Scope. f i l ! f 1 The regulations in this part apply to persons licensed by the Comission ' to receive, possess, use, transfer, or dispose of byproduct, source, or j special nuclear material or to operate a production or utilization facility The l under parts 30 through 35, 39, 40, 50, 60, 61, 70, or 72 of this chapter. I ] limits in this put do not apply to doses due to background radiation, to i I exposure of patients to radiation for the purpose of medical diagnosis or j therapy, to exposure from individuals administered radioactive miterial and :
.l released in accordance with i 35.75, or to exposure from voluntary 2
participation in medical research programs. j 1 1. 55 Attachment 1 , i 4 ] 4
- 3. In i 20.1003, the footnote to the definition of aember of the pubife is removed and the definitions of occupational dose and public dose are revised to read as follows:
i 20.1003 Definitions. Occupational dose means the dose received by an individual in the coursa of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does ;t include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 5 35.75, from voluntary participation in medical research programs, or as a member of the public. Public dose means the dose received by a member of the public from exposure to radiation or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with i 35.75, or from voluntary participation in medical research programs. 1
- 4. In 5 20.1301, paragraph (a) is revised to read as follows: ,
l i 20.1301 Dose limits for individual members of the public. l 56 Attachment 1
(a) Each licensee shat 1 conduct operations so that-- (1) The total effective dose eq2ivalent to individua~1 members of the public from the licensed operation does not exceed 0.1 rem (1 millisievert) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 5 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 5 20.2003, and (2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with ! 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.
- 5. In 5 20.1903, paragraph (b) is revised to read as follows:
i 20.1903 Exceptions to pos+1ng requirements. i (b) Rooms or other areas in hospitals that are occupied by patients are 20.1902 provided l not required to be posted with caution sians pursuant to i that the patient could be released from licensee control pursuant to 5 35.75 : of tnis chapter. l PART 35--MEDICAL '?E OF BYPRODUCT MATERIAL
- 6. The authority citation for part 35 continues to read as follows:
57 Attachment 1 ; l
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841).
- 7. In Section 35.8, paragraph (b) is revised to read as follows:
1 35.8 Information collection requirements: OMB approval. (b) The approved information collection requirements contained in this part appear in il 35.12, 35.13, 35.14, 35.21, 35.22, 35.23, 35.27, 35.29, 55.13, 35.50, 35.51, 35.53, 35.59, 35.60, 35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.se6, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, and 35.647.
- 8. Section 35.75 is revised to read as follows:
5 35.75 Release of individuals containing radiopharmaceuticals or permanent implants. (a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to eraad 5 millisiever's (0.5 rem).* (b) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to 2 Regulatory Guide 8.39, " Release of Patients Administered D=dioactive Materials," describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem). 58 Attachment 1
maintain doses to other individuals as low as is reasonably achievable if the total effective dose cquivalent to any other individual is likely to exceed I millisievert (0.1 rem). Ii the dose to a breast-feeding infant or child could exceed I millisteverc (0.1 rem) assuming there were no interruption of ' r. breast-feeding, the instructions shall also include (1) guidance on the interruption or discontinuation of breast-feeding and (2) information on the consequences of failure tn follow the guidance. (c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated (1) using the retained activity rather than the activity administered, (2) using an occupancy factor less than 0.25 at 1 meter, (3) using the biological or effective half-life, or (4) considering the shielding by tissuc. (d) The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem). 5 35.315 (Amended] I
- 9. In 5 3S.315, paragraph (a)(6) is removed and reserved.
1 35.315 Safety precautions.
* *
- I (a) .
(6) (Reserved]
* *
- l l
1 59 Attachment 1 l l k
- 10. In i 35.415, the introductory text to paragraph (a) and
- paragraph (a)(1) are revised and paragraph (a)(5) is removed.
635.4'5 Safety precautions. (a) For each patient receiving implant therapy and not released from licensee control pursuant to i 35.75 of this part, a licensee shall: (1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy. 7 *
- day of , 1996.
Dated at Rockville, Maryland, this For the Nuclear Regulatory Commission. i John C. Hoyle, Secretary of the Commission. i i 60 Attachment 1
+T
i a ITEM 2 1 Contents: Memorandum (w/ three attachments) to OSP dated December 3,1996,
Subject:
l Routine and Reactive Inspection Guidance for 10 CFR 35.32 and 35.33, " Quality ' Management Programs" and " Notifications, Reports, and Records of Misadministrations" l I
7
- , , ilEMORAIEnst T0: Those on Attached List
, FRON: Donald A. Cool, Director g g gtgn.aty i Division of Industrial and j,g A +
~
! Medical Nuclear Safety, letSS 1
SUBJECT:
ROUTINE Alm REACTIVE INSPECTION GUIDANCE FOR 10 CFR 35.32 Ale 35.33, " QUALITY MANAGEMENT PROGRAMS" AND i NOTIFICATIONS, REPORTS, AND RECORDS OF MISADMINISTRATIONS" l i On August 1, 1996, Temporary Instruction (TI) 2800/025, " Quality Management Program and Misadministration Rule, Revision 1," expired. As a result, the 1 Division of Industrial and Medical Nuclear Safety (INNS) provided the regions
- interim guidance in a memorandum dated August 1, 1996, (Attachment 1). Since
- then, IfBtS has developed two sets of guidance
- (1) "QM Inspection Procedures:
New and Regularly Scheduled Inspections," (Attachment 2), and (2) " Reactive
- Inspections of Quality Management Programs," (Attachment 3).
Begin using these draft inspection procedures immediately for inspection of l both regularly scheduled and reactive inspections. Comments received from the j regions within 60-days from the date of this memorandum will be considered for , j incorporation into the final guidance, . t I The procedure for inspection of new and regularly scheduled inspections will j ultimately be provided to the working group revising Inspection Procedures , - (IP) 87100 for inclusion, and the procedure for reactive inspections will become a part of IP 87103. Manual Chapter 2800 was reviewed, and no changes , i were needed to acconeodate these new procedures. \ Attachments: 1. Interim Guidance dated 8/1/96
- 2. "QM Inspection Procedures:
! New and Regularly Scheduled Inspections" 1 3. " Reactive Inspections of x
- Quality Management Programs" i
j CONTACT: Sally L. Merchant, 19455 i 1 (301) 415-7874 i 1 i TR n 1 bO :a
.2 O 4 -
4 1 6
'O
MEMORANDUM T0: THOSE ON ATTACHED LIST DATE: December 23, 1996
SUBJECT:
ROUTINE AND REACTIVE INSPECTION GUIDANCE FOR 10 CFR 35.32 AND 35.33, " QUALITY MANAGEMENT PROGRAMS" AND NOTIFICATIONS, REPORTS, AND RECORDS OF MISADMINISTRATIONS" Attached List: Charles W. Hehl, Director Division of Nuclear Materials Safety, RI Bruce S. Mallet, Director Division of Nuclear Materials Safety, RII Cynthia D. Pederson, Director . Division of Nuclear Materials Safety, RIII Ross A. Scarano, Director Division of Nuclear Materials Safety, RIV James Lieberman, Director Office of Enforcement [ i
)
l j l
t S t i I. 9
+
Attachment 1 l I 1 1 l 1 j
g e .
,r m j .
. p i UNITED STATES . g g NUCLEAR REGULATORY COMMISSION i f WASMSNGTON, D.C. Spee64eet j o, ] s*****/ August 1, 1996 I NDIDRANDlM TO: T.tose on Attached List 3 FRON: Donald A. Cool, Directo 6% 47 - i Division of Industrial and i Nedica) Nuclear Safety, fNSS l 1 i SU6 JECT: INPLENDITATION OF 10 CFR 35.32 and 33
" QUALITY M4NAGDIENT Afm MISADNINISTRATIONS" On August 1,1996, Temporary Instruction (TI) 2800/025, " Quality Management Program and Misadministration Rule, Revision 1," expires. The TI implemented the inspection procedures for the rule, and established the areas of inspection and procedures for determining compliance with the performance- :
based portions of the rule. This memorandum provides guidance for inspection of the requirements set forth in 10 CFR 35.32, " Quality Management program, and 35.33, " Notifications, reports, and records of misadministration," after the TI expires. After August 1,1996, inspectors will no longer complete the QM field notes (Attachment A of the TI) during routine inspections (for reactive inspections, see instructions in item 2 below). Inspectors are required to submit copies of the QN fleid notes, coupleted before August 1, by August 9,1996. This information is needed to complete the data collection so that the Headquarters-staff may begin the analysis of the TI findings. The staff is revisino Nanual Chapter 2800 and Inspection Procedure 87100 to include field notes .or both routine and reactive inspections of qua'!ty management programs. In the interim, inspectors should implement the i following procedures:
- 1. For aan and routiae insnactipqs. inspectors are instructed to implement a more performance based approach to the review of licensees' activities intended to comply with 10 CFR 35.32. In an unobtrusive manner, inspectors should verify that: a quality management program (QlF) commensurate with the licensee's activities is being implemented; all modalities of use under the license are included; the licensee is conducting a review of the QM program at least annually; and the records of the review are maintained in an auditable form for 3 years. If during the araal review the licensee identified recordable events, assure that an evaluatten was performed and that any appropriate corrective actions were taken. This evaluation should be completed as part of the normal inspection of a medical use program. The applicable sections of the existing QM field notes are to be used to verify the ,
four key elements previously discussed as part of the performance l CONTACT: Sh11y L. Merchant, letSS (301) 415-7874
&Q 0 $0 EQ (0$' 5
_ _ _ . _ _ _ _ _ _ . _ _ _ _ _ . - .. _ _ _ . . . _ ~ _ . _ _ _ _ _ _ . . _ . j - 1 i b l i
. 2 I oriented inspection until the new field notes are available. The extent i of documentation required should closely fo110w the performance oriented j 1 inspection.
- 2. For re:ctive insnections, inspectors should follow the guidance provided 4 in Management Directive 8.10, "NRC Medical Event Assessment Program,"
{ and, for the modality involved with W event, e.g., fodine therapy or j high dose rate afterloading brachytherapy, etc, (1) review the
- ifcensee's written QNP; (2) follow N existing guidance in TI 2800/025
] to ensure that W licensee's QNP has been implemented; and, (3) review
- the findings of the annual reviews for the last 3 years. Only the
.i modality involved should be evaluated as part of this inspection.
- 3. For mis
- inistrations, (1) follow the procedure for reactive l
inspections (above), and (2) ensure that the licensee has complied with j the reporting requirements described in 10 CFR 35.33, " Notifications, ! reports, and records of misadministrations."
- In addition to reviewing QNPs during event investigations, QMPs submittui with new license applications should continue to be reviewed following the guidance c provided in Policy and Guidance Directive PG 3-15. j 1
i' During the past two years, the inspectors have devoted considerable time and effort to completing the extensive field notes associated with the TI. This
- laformation will be analyzed to determine the manner and degree of success in j uhich licensees implemented the QM rule. This information will be of i substantial value in informing the Commission of the outcome of the rule and j in making recommendations for future consideration.
I j
Attachment:
PG 3-15 - t j k
- 4
) t 3 I i t i
1 N:se0RANDUM To: INOSE ON ATTACHED LIST DATE: July 12, 1996 SU8 JECT: INPLEMENTATION OF 10 CFR 35.32 ar.1 33 " QUALITY MANAGEMENT AND MISADNINISTRATIONS" Attached List: James Lieberman, Director Office of Enforcement Charles W. Hehl, Director Division of Nuclear Materials Safety, RI Bruce S. Mallet, Director Division of Nuclear Materials Safety, RII Cynthia D. Pederson, Director Division of Nuclear Materials Safety, RIII Ross A. Scarano, Director Division of Nuclear Materials Safety, RIV
n- a p 8 l l Attachment 2 M
t ! QM INSPECTION PROCEDURES j j New and Regularly Scheduled Inspections l l l Ogglity Mar:aamment Proaram (OMP)
- For routine inspections of applicable facilities, inspectors are instructed to i implement a performance based approach to the review of licensees' activities intended to comply with 10 CFR 35.32. Inspectors should observe and interview i individuals as they perform applicable duties to ensure that the QMP, as
- impiamented, provides high confidence that byproduct material, or radiation from j byproduct material, will be administered as directed by the authorized user.
General Guidance: i a. %is guidance applies to those medical Itcensees who are authorized to possess and use byproduct material for applications involving the j following modalities:
- 1. Quantities greater than 30 microcuries of either sodiw iodide I-125 4 or I-131; l 2. Therapeutic administrations' of a radiopharmaceutical, other than sodium iodide I-125 or I-131;
?.- Brachytherapy, including . High-Dose-Rate Remote Afterloading and Strontium-90 eye applicators;
- 4. Teletherapy; and
- 5. Gamma Stereotactic Radiosurgery.
- b. The intent of the inspection is to determine if the licensee effectively implements policies and procedures designed to meet the objectives and requirements in 10 CFR 35.32, and the notification, reporting, and record keeping requirements in 35.33.
The inspection should n::1ude consideration of the licensee's I implementation of.a esntinuous improvement process in the QMP. This review should includu (1) the monitoring process - has the licensee been looking for unintended deviations (e.g., errors, mistakes, or omissions) that could hae led to a nisadministration; (2) the identification process - has the licensee found unintended deviations (e.g., through reviews or representative sampling) that could have led to a misadministration; (3) the evaluation process - has the licensee made assessments of the unintended deviations (e.g., what, when, how, or why the events occurred, including an analysis of any trends and patterns) that could' have led to a misadministration; (4) the corrective action process - has the licensee implemented an action plan to fix 'the unintended deviations that, if not addressed, could have led to a , misadministration; and (5) the preventive measures process - has the l licensee instituted actions to prevent- recurrence of the unintended deviations (e.g., modifications to the policies or procedures) that could have precluded the likelihood of a misadministration? ! P.eview of all records associated with the licensees' QMP is not necessary i unless: (1) there is reason to suspect that the QMP has not been ! appropriately implemented; (2) all modalities requiring a QMP have not been addressed; (3) a recordable event occurred, and the licensee did not identify, evaluate and institute corrective actions; or, (4) an i unreported or previously unidentified misadministration was identified during the inspection. . 12/ /96 l
%. - . _ _ , . - - ~ . - - - _ - . - - , , , 4 v,, rm - - ,
- a. Scone of OMP Verify that a written QMP, commensurato with the licensee's activities, has been established and implemented. It is not necessary to perform an in-depth review of the written program unless this is a new license or modality (e.g., brachytherapy has been added requiring a QMP). However, the inspector should verify that the QMP includes procedures to address each of the applicable objectives set forth in 10 CFR 35.32. Ensure that all applicable modalities of use identified on the license are included. The QMP need not be maintained in totality in one location, but may be segmented in various areas of use (e.g., radiopharmaceutical therapy, brachytherapy, teletherapy, etc.).
_. Annual Review of OMP The frequency of the review may vary. However,10 CFR 35.32(b)(1) requires that a review of the QMP be perfonned at intervals of no greater than 12 months. Verify that a review of the QMP has been perfomed, at least, at this interval. Ensure that the review includes: (1) a representative sample of patient (and human research) administrations; (2) all recordable events; and, (3) all misadministrations. Ensure that the reviews were evaluated to determine the effectiveness of the QMP, and if required, modifications to the QMP were made and implemented.
- c. Records Verify that records of each annual review, including each written directive, a record of each administered dose or dosage, and the evaluations and findings, are maintained, in an auditable form, for three years'.
- d. For recordable events if the recordable event was self-identified (identified by the licensee), verify that an evaluation was performed within 30 days after discovery of the event, and note the corrective actions that were taken. If no or inadequate corrective actions were taken, decermine whether the lack of corrective action caused the license to be in non-compliance with regulatory requirements. If a recordable event is identified by the inspector, bring the event to the attention of the 14 m e. The licensee has 30 days in which to evaluate the event, take any necessary corre tive action.
- e. For misadministrations: if during an inspection, a previously unidentified misadministration is identified by the inspector: (1) follow the procedure for reactive inspections (Attachment 3), and (2) remind the licensee of the need to comply with the reporting requirements described in 10 CFR 35.33, " Notifications, reports, and records of misadministrations."
- f. For all reactive inspections, inspectors should follow the guidance provided in Management Directive 8.10, "NRC Medical Event Assessment Program," and follow the procedure for reactive inspections (Attachment 3).
Issue Date: 12/ /96
QM FIELD NOTES ! New and Regularly Scheduled Inspections Quality Manaaement
)
A. Scone of Ouality Manaaement Proaram (OMP) (1) Written QMP commensurate with the licensee's , activities established and implemented. ()Y()N l (2) All modalities of use under the license l included ()Y()N i (3) QMP includes procedures to address each of the applicable objectives: (a) OBJECTIVE 1 Written directives ! prepared for each patient l [35.32(a)(1)] ()Y()N ; (b) OBJECTIVE 2 Licensee uses more than one method to verify patient's i identity [35.32(a)(2)] ()Y()N j (c) OBJECTIVE 3 Procedures implemented to verify final plans of treatment and related calculations in accordance l with written directives [35.32(a)(3)] ()Y()N ' (not applicable to radiopharmaceutical therapy including sodium iodidos) (d) OBJECTIVE 4 Procedures implemented to i verify, prior to administration, specific j details in accordance with written ' directive [35.32(a)(4)] ()Y()N l (e) CJECTIVE 5 Procedures iriplemented to ensure unintended deviations identified, evaluated, and corrective action taken (35.32(a)(5)) ()Y()N B. Annual Review of OMP The frequency of the review may vary. However,10 CFR 35.32(b)(1) requires that:
- 1. QMP reviewed within 12 month intervals ()Y()N Review includes:
-(a) Representative sample of patient (and human research) administrations ()Y()N (b) All recordable events ()Y()N (c) All misadministrations ()Y()N 1
12/ /96 l l
, - ~ -. _. _ _ - - _
q 2
- 2. Effectiveness of the QMP was evaluated ()Y()N
- 3. If needed, modifications to the QMP were made and implemented ()Y()N C. Records:
Records of each annual review, including: written directive, record of each administered dose or dosage, and evaluations and findings, maintained, in auditable form, for three years. ()Y()N D. Recordable Events and Misadministration: (1) Recordable event (s) self-identified since the ! last inspection [35.32(c), 35.2] ()Y()N Dates of events: j I (2) Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N (3) If no, was there a potential violation of NRC regulations ()Y()N (4) Recordable events identified by inspector ()Y()N , (5) Licensee identified misadministration (s) since the last inspection ()Y()N (6) If response is yes to item D.S., licensee , met the requirements of 10 CFR 35.33 ()Y()N { (7) Inspector identified misadministration (s) since the last inspection (not previously - identified by the licensee ()Y()N 1 l l 4 1 Issue Date: 12/ /96
6
~
W 1 1 1 i l 1 l 1 1
)
l 1 1 Attachment 3 ! i 1
~ REACTIVE INSPECTION OF QUAI.ITY MANAGEMENT PROGRAMS INSPECTION REQUIREMENTS: The following requirements should be completed for reactive inspections of medical licensees who are required to implement a Quality Management Program (QMP). The inspector should determine licensee compliance with 10 CFR 35.32 and 35.33, as applicable. For any investigation that includes a medical event, the inspector must first follow NRC Management Directive 8.10, "NRC Medical Assessment Program" to ensure that medical events are reviewed in a manner that is timely, objective, systematic, and technically sound; that factual information pertaining to the i events .is documented; and that probable causes are documented. 4 Inspectors are reminded that an event evaluation is not complete without an evaluation of the root cause. In addition, if the licensee is not in compliance, j then the region should take appropriate enforcement action. l The regional inspector should complete the "QM Field Notes" given in Attachment A, as applicable. General Guidanqe:
- a. TI.is guidance applies to those medical licensees who are authorized to possess and use byproduct material for applications involving the following modalities: l i
4 l
- 1. Quantities greater than 30 microcuries of either sodium iodide I-125 or I-131;
- 2. Therapeutic administrations of a radiopharmaceutical, other than ,
' sodium iodide I-125 or I-131; Brachytherapy, including High-Dose-date Remote Af terloading and ' 3. Strontium-90 eye applicators;
- 4. Telethe apy; and
- 5. Gamma Stereotac.ic Radiosurgery.
- b. The intent of the inspection is to determine if the licensee effectively implements policies and procedures designed to meet the objectives and i 1
requirements in 10 CFR 35.32, and the notification, reporting, and record keeping requirements in 35.33. In addition, a determination should be made between the caliber and implementation of the licensee's QM program in l relation to the misadministration event. The emphasis during the reactive insgction will be on the analysis of the sequence of events and the The analysis i condWons that existed at the time these events occurred. ! should lead to the determination of contributing factors and root causes, and to the formulation of corrective actions to prevent recurrence.
- c. Review the licensee's policies and procedures for instruction of supervised individuals in the QMP. Verify that the staff training has occurred.
Inspectors should interview individuals present. If an apparent failure in the QMP is identified, determine whether the failure could be attributed to poor, inadequate, or no instruction in the area of the failure. Determine 12/ /96
[ REACTIVE INSPECTION OF QMP 2
- l. if the failure is isolated, broad or involves other individuals.
i Additionally, determine if the failure represents an implementation problem ,
! involving only specific areas of the department's QMP, or general aspects of l the institution's entire QNP. J i d. If the subject event is a misadministration,. ensure that the I.censee has
~ complied with appropriate notification, reports, and records as required in
'O CFR 35.33.
Descriotion: i
- The QN Field Notes for the QMP are provided in the form of a reactive inspection cover document and a series of modules, each containing a checklist for a specific modality of use.- As part of the preparation for inspection, the inspector should 1 read the licensee's submitted QMP and any modifications, and assemble available I
i' details of the misadministration or other event. The inspector should enter the available information on the cover document as part of the inspection preparation. The inspector should be familiar with the licensees QMP in order to compare the written program with the program as implemented. The inspector should not attempt
, to detemine that th program, as written, is acceptable, but rather should determine as a resalt of the in saction, that the licensee's program as implemented, meets the objectives of 10 CFR 35.32.
Since all informatiou needed to complete the field notes on notifications, reports,
- and records of misadministration may not be available at the time of the !
a inspection, the inspector should provide the information that is known, and 1
- complete the notes as information becomes available. j 3necific Guidance:
I 1. Although only tha modality for which there was an incident / misadmiriistration need be inspected, confirm that the licensee has a written i QMP(s) that specifically addresses each modality that is utilized by the i licensee. ,
- 2. For all medical misadministrations, the inspector must follow the guidance provided in NRC Management Directive 8.10. "NRC Medical Assessment Program." i' 1 -
4 3. Confirm that the QMP includes written policies and procedures that require - a written directive and program review.
- 4. Interview supervised individuals (e.g., technologists, dosimetrists,
- physicists, or physicians) to determine if these individuals are familiar with and have been instructed to use and follow their QMP (e.g., written l~ policies and procedures that address each objective, and procedures to l
conduct the required review). Confirm that the licensee has a system in place-whereby the licensee's staff clearly understands the assignment of j daily activities that relate to the effective implementation of the QMP. < d Instruction should be specific and appropriate to each individual's use of
- byproduct material as required by 10 CFR 35.25. Inspectors should document the names and positions of all individuals who have not received training in l l- the licensee's QMP.
f Issue Date: 12/ /96 4 e n- w -- .- , ,- , n , 4 - m&: q
. e 4
L
- REACTIVE INSPECTION OF QMP 3
! Additionally, document the reasons given for ee failure to instruct as ; 4 stated by the individual, the radiation safety officer, and the supervising i authorized user.
- 5. Confirm that the licensee has selected and reviewed a representative sample !
j of patient administrations within each 12 month period. The licensee may . use any representative sampling methodology to confirm that there are no , previously unidentified recordable events or misadministrations. Regulatory i Guide 8.33 provides an example using the acceptance sampling tables of ! 10 CFR 32.110 and' assuming an error rate of 25. If the tables in 10 CFR 1 . 32.110 are used, any table is acceptable. j i 1 l
- 6. Select a random sample of patient administrations to review in each modality :
- . using the following multi-step process
- l r i 4 a. Request licensees to previde the approximate total number of '
- administrations requiring a written directive since the last inspection. In order to eliminate any bias in the sample, the j administrations to be reviewed .should be selected randomly. Document the total number of administrations for the subject modality.
- b. A target sample is calculated, using the table supplied in Attachment A for each modality of use. If recordable events are identified in the review of the target sample for the specific modality, the target sample should be -increased until the inspector believes he has assessed the extent of the problem.
- 7. Based on the review of the representative sample, confirm that the objectives for each modality have been met and that appropriate records were retained.
- 8. If the licensee failed to follow their QMP procedures, it may not necessarily be a violation. The inspector should determine if the objective was set. The inspector should make the licensee aware of any identified weaknesses.
- 9. Ask individuals to explain how the patient's identity is verified by more )
than one method, prior to the administration, as the individual named in the written directive. If possible, observe the individuals to confirm their understanding and effective implementation of. redundant identification procedures. 10.- Interview individuals (e.g., radiation oncologists or radiation therapists, j neurosurgeons, clinical medical physicists, dosimetrists, or radiation i therapy technologists) in eadi applicable modality who are involved in the final plans for radiation therapy treatment of patients. Ask individuals to explain how they verify that the final plans of treatment and related i i calculations are in accordance with the written directive. Confirm that the licensee performs checks of dose calculations. If the licensee uses ; treatment planning or dose calculating computer programs for dose calculations, ask if the licensee has implemented procedures for acceptance i testing before first use of the program for patient dose calculations. l 12/ /96
4 , REACTIVE INSPECTION OF QMP 4
- 11. Ask individuals to explain how the specific details of the administration
. are verified, before administering ggh radiation dose or. I radiophamaceutical dosage, in order to be in accordance with the written t directive. ! i 12. After administering a radiopharmaceutical dosage or radiation dose, the i
, licensee must make, date, ano sign or initial a written record that i i documents the administered dosage or dose, as a minimum, in the patient's i j chart or other appropriate record. This documentation should serve as an
' additional check, after the administration has been perfomed, for the licensee to compare the prescribed with the administered dosage or dose. !
- 13. Ask individuals whether any policy exists that requests workers to seek L guidance if they do not understand how to carry out the written directive.
Additionally, detemine if the department encourages workers to ask questions :: bout what to do or how it should be done rather than continuing 4 a procedure when there is any doubt. !
- 14. Review the licensee's implementation of procedures to identify, evaluate, l
- = and take appropriate corrective action when uncovering any unintended l dewiations from the written directive. This objective should be a key part of the licensee's continuous improvement process in their QMP and should include procedures for monitoring, identification, evaluation, corrective
- actions, and preventative measures. If the licensee identified unintended
- deviations from the written directive since the last inspection, track the licensee's processing of the unintended deviations from beginning to end.
Describe any unintended deviations from the written directive that were , identified by yourself. ) 1 1 3 15. Examine the licensee's reviews of their QMP, performed at intervals not to
- exceed 12 months, for each applicable modality. If the licensee identified
- any recordable events since the last inspection, the inspector should review 1
the documentation of the licenree's evaluation of the eveat, and any i corrective a. tion that was taken by the licensee within 30 days after ! discovery. ! I
- 16. Based on the administrations sampled and reviewed in the target sample, document any recordable events or misadministrations identified by yourself that the licensee failed to identify.
i 17. Any' identification by the licensee of misadministrations that were not subsequently reported to the NRC should be closely reviewed to determine the cause of the licensee's failure to report the misadministration.
- 18. For misadministrations that were reported, review documentation and/or copies of notifications, reports, and records.
- (
i l 1ssue Date: 12/ /96 i s
- - p-- v, s,~,-1 4
RtAu1VE INSPECTION OF QMP 5 STAlISTICAL DATA REPORTING: l All direct reactive inspection effort expended should be charged to Inspection Procedure 87103.
Attachment:
i A. Field Notes - Quality Management l Program (QNP) Modules: 1 A-1. Nai I-125 or I-131 > 30 pCi and Radiopharmaceutical Therapy A-2. HDR Remote Afterloading Brachytherapy A-3. Brachytherapy (Other than HDR) A-4. Strontium-90 Eye Applicators A-5. Teletherapy A-6. Gamma Stereotactic Radiosurgery I i
!I s
12/ /96
-. -. . ~. - . .- . ~. --. .
ATTACHMENT A QUALITY MANAGEMENT PROGRAM (OMP) OM FIELD NOTES FOR REACTIVE INSPECTIONS 1.- GENERAL A. Facility name(s): B. License number (s): C. Docket number (s): D. Last inspection date(s): - E. Current inspection date(s):
- 2. PREPARATION A. Se familiar with the submitted QMP and any modifications in preparation for inspection of the licensee's implemented QNP.
Fasiliarization should focus upon awareness of the submitted program in order to compare the written program with the program as , j implemeated,
- 3. MODALITY:
I A. Identify applicable modalities listed on the license: Module:
- 1. Nal I-125 or I-131 > 30 pCi and/or Therapeutic radiopharmaceutical other than NaI ()Y()N '
- 2. High-Dose-Rate Remote Afterloading Brachytherapy ( ) Y ( ) N )
- 3. All Other Brachytherapy ()Y()N
- 4. Strontium-90 eye applicator ()Y()N
- 5. Teletherapy ()Y()N
- 6. Gmuna Stereotactic Radiosurgery ()Y()N B. Verify, through interview or observation, that a QMP has been implemented for each modality listed on the license. (only the modality where the event occurred need be inspected)
C. Identify modality where the event (s) or misadministration (s) occurred, and attach appropriate inspection module (s):
- 4. Incident: !
A. Misadministration ()Y()N B. Other incident ()Y()N If yes, briefly state what type: C. Modality of event or misadministration: D. Therapeutic or diagnostic event: E. Date of event: F. Date of discovery: G. Identified by:
2 H. Licensee implemented :t QMP for this modali:y [10CFR35.32] ()Y()N
- 5. DESCRIPTIK0E EYQiT A. Event classified as misadministration [35.2] ()Y()N If yes, which paragraph (s) under 35.2 best describes the event:
- 8. Describe sequence of eye ats leading to misadministration. If not a misadministration, go to C:
C. Describe the event: If necessary, attach separate sheet. D. Number of patients or others exposed / overexposed: E. Time period: F. Occupational workers exposed ()Y()N If yes, describe: i G. Licensee evaluation and actions ,
- 1. Calculated prescribed and actual doses ()Y()N Prescribed: Actual:
- 2. Evaluated effect on patient ()Y()N Describe:
- 3. Corrective actions taken to prevent recurrer.ca ()Y()N l Describe: l l
l
- 4. If licensee did not evaluate or take action, reason provided: i
- 6. EVALUATION 0F THE EVENT A. Cause of event:
J
- 1. Human error ()Y()N
- 2. Patient intervention ()Y()N
- 3. Mechanical error ()Y()N
- a. Manufacturer / vendor:
- b. Serial number:
- c. Model number:
Issue Date: 12/ /96 q
. o 3
- 4. Computer software error ()Y()N
- a. Manufacturer / vendor:
- b. Version:
- c. Serial number:
d Model number: Remarks:
- 5. Failure to follow QNP ()Y()N
- a. Authorized user [35.32(a)J ()Y()N
- b. Supervised individual [35.32(a)(2)] ()Y()N Describe:
- 8. Root cause(s) and contributing factor (s) that led to this incident:
- 1. Identified by licensee:
- 2. Evalcated by inspector:
- 7. NOTIFICATIONS A. NRC's Operations Center within next calendar day -
after discovery [35.33(a)(1)] ()Y()N Report Number and date: 1 B. Referring physician notified ()Y()N , Patient notified within 24 hours after discovery [35.33(a)(3)] ()Y()N (Referring physician may inform the licensee either that he will inform the patient; or that, based on medical judgement, telling the patient would be harmful) C. If patient was notified, patient i so notified in writing within 15 days after discovery 1:35.33(a)(4)] ()Y()N If not within 15 days, date notified: What information was provided in the report: , D. If patient was not notified, the licensee notified the responsible relative or guardian ()Y()N If no, licensee documented justification for decision ( ) Y ( ) N Remarks:
- 8. Attach appropriate module (e.g. Module 2 'mR")
12/ /96
MODULc Al RAD 10 PHARMACEUTICAL .NERAPY "1CLUDING GREATER THAN 30 MICR0 CURIES NAl I-125 or I-131
- 1. SAMPLING (Inspector random sample of each radiopharmaceutical in use):
Total Written Directives Minimum Taraet Samole All I to 5 I 5 to 100 5 Target Number
> 100 5% Total j Written Sample Reviewed I D.ir t.
- 1. Nal I-125 or I-131 > 30 pCi _._,
- 2. Radiopharmaceutical:
(Name:) If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or l represents a substantial failure of the QMP.
- 2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
- 3. OBJECTIVES:
Nut.ber OBJECTIVE _1 Missed A. A written directive (order for a specific patient, dated & sianed by authorized user (a.u.) or physician under supervision of an a.u.) is prepared for each patient (35.32(a)(1)) ()Y()N B. Written directives for sodium iodide: required dosage information [35.2] ()Y()N C. Written directives radiopharmaceutical therapy: radiopharmaceutical, dosage, and route of administration [35.2] ()Y()N D Exceptions to written directives are documented (footnote to 35.32(a)(1)] ( ) N/A
- 1. Written revisions ()Y()N
- 2. Oral revisions ()Y()N
- 3. Oral directives ()Y()N
Module A-1 2 OBJECTIVE 1 A. Licensee uses more than one method to verify the l patient'sidentity[35.32(a)(2)) ()Y()N l OBJECTIVE 3 (Does not apply) ! OBJECTIVE 4 ! l A. Procedures implemented to verify, prior to l administration, that the specific details are in accordance with written directive [35.32(a)(4)) ( ) Y ( ) N B. Procedures may include: (not reautrements)
- 1. Dosage measuced prior to administration ()Y()N !
- 2. Parameters confirmed 1 just prior to administration ()Y()N ]
C. Record of administration maintained in auditable form [35.32(d)(2)) ()Y()N OBJECTIVE 5 j l A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action taken [35.32(a)(5)] ()Y()N
- 1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2) ()Y()N Dates of events:
1
- 2. Recordal,le events identified by inspector ,
[35.32(c),35.2) ()Y()N
- 3. Nisadministration resulted from the unintended deviation ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)) ()Y()N C. Procedures may include: (not recuirements)
- 1. Assemble relevant facts including cause ()Y()N
- 2. luentify correctin action to prevent recurrence ( ) Y ( ) N
- 3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since tha last inspection [35.33(a)) ()Y()N E. Licensee identified misadministrations that were not subsequently reported [35.33(a)) ()Y()N If ves. clarifv:
Issue Date: 12/ /96
J Module A-1 3
- 4. PERIODIC _ REVIEWS OF THEOMP A. Review conducted of the QMP at intervals no greater 1
than 12 months [35.32(b)(1)) ()Y()N Date of last review: B. Review includes a representative sample of all patient I administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)) ()Y()N C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the
- events were isolated ()Y()N i D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made modifications to meet Ob,iectives [35.32(b)(2)] ()Y()N F. Records of reviews including evaluation and findings maintained for at least 3 years {35.32(b)(3)] ()Y()N
- 5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.
a 12/ /96
l MODULE 4-2 HIGH-DOSE-RATE REMOTE AFTERLOADING BOACHYTHERAPY i' 1. SAMPLING (Inspector random sample of each modality) Total Written Directives Minimum Taraet Sample I to 5 All 5 to 100 5
> 100 5% Total Target Number i Written Sample Reviewed ;
Dir I
- 1. HDR remote afterloading brachytherapy l l
If two (2) or more written directives are incomplete or missing, the ' review raust be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP. ! 1 l
- 2. SUPERVISION ;
i A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained: 1
- 3. OBJECTIVES: 1 9W 1CTIVE I l l
A. A written directive (order for a specific , patient, dated & J ianed by authorized user (a.u.) I or physician under supervision of an a.u.) is ! prepared for each patient (35.32(a)(1)] ('Y()N B. Written directives contain required information: ! isotope, treatment site, & total dose [35.2] ()Y()N j C. Exceptions to written directives are documented (footnote to 35.32(a)(1)] ( ) N/A
- 1. Written revisions ()Y()N
- 2. Oral revisions ()Y()N '
- 3. Oral directives ()Y{}N OBJECTIVE 2 '
A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N i
- i i
Module A-2 2 1
- . OBJECTIVE 3 i .A. ' Procedures implemented to verify that final p'lans ;
of treatment and related calculations are in l accordance with written directives (35.32(a)(3))( ) Y ( ) N
- 8. Procedures may include: (not reevirements)
- 1. Check of dose calculations by an authorized ;
user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations ()Y()N
- 2. Performing acceptance testing (based on licensee's specific needs & applications) on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N
- 3. Other, describe:
1 OBJECTIVE 4 { l A. Procedures implemented to verify, prior to l administration, that the specific details are'in. l accordance with written directive [35.32(a)(4)] ( ) Y ( ) N ! l B. Procedures gay include: fnet requirementsl '
- l. Plan of treatment prepared in accordance with the written directive ()Y()N
- 2. Person administering therapy treatment confirms the prescribed radioisotope, site, & total dose ( ) Y ( ) N
- 3. Dwell times and positions verified prior to start of treatment ()Y()N
- 4. Verify source position using dumny sources or fixed geometry applicators prior to inserting sealed sources ()Y()N'
- 5. Prompt record by the authorized user, of the treatment parameters and signing or initialing patient's chart or appropriate record ()Y ()N ,
- 6. Other, describe: i C. Record of administration maintained in auditable ;
form [35.32(d)(2)) ()Y()N Issue Date: 12/ /96 l N i
i 7 Module A-2 3 l
- OBJECTIVE 5 i A. Procedures implemented to ensure that unintended i deviations are identified, evaluated, and corrective action taken [35.32(a)(5)] ()Y()N q
- 1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events:
1
- 2. Recordable events identified by inspector
[35.32(c),35.2] (--) Y ( ) N
- 3. - Misadministration resulted from the unintended deviation ()Y()N B. Procedures implemented to evalutte & respond within 30
! days to each recordable event discovered [35.32(c)] (-) Y ( ) N C. Procedures say include: (not recuirements) I 1. Assemble relevant facts including cause ()Y()N
- 2. Identify corrective action to prevent recurrence ( ) Y ( ) N
- 3. Retain a record of items 1 and 2 ()Y()N l D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N
' E. Licensee identified misadministrations that were nel subsequently reported (af yes, also complete module 7) [35.33(a)) ( ).Y ( ) N 4.
^
PER100!C REVIEWS 0F .HE QMP
.A. Review conducted of the QMP at' intervals no greater j j 'than 12 months [35.32(b)(1)] ()Y()N '
Date of last review:
- B. Review includes a representative sample of all patient
! administrations including all recordable events and misadministrations(35.32(b)(1)(1)(ii)(iii)] ()Y()N j The licensee should utilize a representative sampling process which L embodies a valid statistical sampling methodology. Regulatory Guide ; 2 33 provides an exampic using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. . If the tables in 4 4 10 CFR 32.110 are used, any table is acceptable. i i s' C. If review identified recordable events or misadministrations, not previously identified, the , review was expanded by the licensee to ensure the
~
events were isolated ()Y()N i 12/ /96 l
. .- a, ,,. -- . - - - -. - . . . --e--8 ., - - - - - - . m
4 Module A-2 4 D. Licensee evaluated each review to determine the effectiveness of the QMF [33.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y( )N F. Modifications seilt to NRC within 30 days [35.32(e)] ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)J ()Y()N
- 5. RESULTS 0F REVIEW Briefly describe the overall implementation of the QMP and sumarize the inspection findings. ,
r l l l l 1 Issue Date: 12/ /96
l MODULE A-3 BRACHYTHERAPY : (OTHER THAN B R REMOTE AFTERLOADING)
- 1. SAMPLING (Inspector random sample of each modality)
Total Written nirectives Minimum Taroet Sample 2 1 to 5 All - 5 to 100 5 4
> 100 5% Total Target Number Written Sample Reviewed k i
- 1. Brachytherapy l If two (2) or more written directives are incomplete or missing, the ;
review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.
- 2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
- 3. OBJECTIVES:
0GJECTIVE.1 A. A written directive (order for a specific patient, dated & signed by authorized user (a.u.) or phyrdcian under supervis'on of an a.u.) is prepared for each patient (35.32(a)(1)] ()Y()N B. Written directives contain required information (35.2]:
- 1. Prior to implantation: radioisotope, number of sources, and source strengths ()Y()N
- 2. After implantation & prior to com;:letion of procedure: radioisotope, site, total source strength & exposure time (or total dose) ()Y()N C. Exceptions to written directives are documented (footnote to 35.32(a)(1)] ( ) N/A
- 1. Written revisions ()Y()N
- 2. Oral revisions '()Y()N
- 3. Oral directives ()Y()N 9HfEIIVE_2 A. Licensee uses more than one method to verify the patient's identity (35.32(a)(2)] ()Y()N
i Module A-3 2 O N ECTIVE 3 ) A. Procedures implemented to verify that final plans of treatment and related calculations are in ; accordance with written directives [35.32(a)(3)]( ) Y ( ) N l l B. Procedures may include: (not reauirements) l
- 1. Check of dose calculations by an authorized ;
user or a qualified person under supervision l of an authorized user who whenever possible ! did not make the original calculations ()Y()N
- 2. Performing acceptance testing (based on licensee's ,
specific needs and applications) on each treatment i planning or dose calculating computer program that could be used for dose calculations ()Y()N l
- 3. Other, describe:
I OBJECTIVE 4 A. Procedures implemented to verify, prior to i administration, that the specific details are in l accordance with written directive (35.32(a)(4)) ( ) Y ( ) N i
- 8. Procedures may include: (not reauirements) ;
- 1. Plan of treatment prepared in accordance with I
the written directive ()Y()N
- 2. Person administering treatment confirms prescribed I radioisotope, number of sources, source strengths, l
. treatment site, loading sequence, & total dose ()Y()N l
- 3. Verify source position using dumy sources or i fixed geometry applicators prior to inserting ;
sealed sources ()Y()N 1
- 4. Prompt record by the authorized user, of the number of sources, the actual loading sequence i of sources implanted (location of each sealed 1 source in a tube, tanden, or cylinder) and i signing or initialing the patient's chart or
, appropriate record ()Y()N
- 5. Ensure that source.will not move or dislodge while implanted ()Y()N
- 6. Inspect implanted sources ()Y()N Frequency:
Inspecting individual trained ()Y()N
!ssue Date: 12/ /96 n
Module A-3 3
- 7. Other, describe:
C. Record of administration maintained in auditable form [35.32(d)(2)J ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N
- 1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events-l
- 2. Recordable events identified by insoect::r
[35.32(c),35.2] ()Y()N
- 3. Misadministration resulted from the unintended deviation (If yes, .Do complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures ma.1 include: (not recuirements)
- 1. Assemble relevant facts including cause ()Y()N
- 2. Identify corrective action to prevent recurrence ( ) Y ( ) N
- 3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) (35.33(a))( ) Y ( ) N E. Licensee identified misadministrations that were ngt subsequently reported (If yes, also complete module 7)
[35.33(a)) ()Y()N
- 4. PERI 001C REVIEWS OF THE ON PROGRAM T10 CFR 35.3Mb)1 A. Review conducted of the QMP at intervals no greater than 12 months (35.32(b)(1)) ()Y()N Date of last review:
- u. Review includes a repr::entative sample of all patient administrations including all recordable events and misadministrations (35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.
12/ /96
a Module A-3 4 i i C. If review identified recordable events or . misadministrations not previously identified, the ! l review was expanded by the licensee to ensure the ! events were isolated ()Y()N , i D. Licensee evaluated each review to determine the ' effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N
- j. F. Modifications sent to NRC within 30 days )
[35.32(e)) ( ) Y ( ) N ( ) N/A , i G. Records of reviews including evaluation and findings l maintained for at least 3 years [35.32(b)(3)] ()Y()N l ' \
- 5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the l inspection findings. l l
l l l l i l I l Issue Date: 12/ /96
MODULE A-4 STRONTIUM-90 EYE APPLICATORS
- 1. SAMPLING (Inspector random sample of each modality)
Total Written Directives Minimum Taraet Sample I to 5 All 5 to 100 5
> 100 5% Total Target Number Written Samole Reviewed h
- 1. Strontium-90 Eye Applicator: _
If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.
- 2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
- 3. OBJECTIVES:
@JECTIVE 1 A. A written directive (order for a specific patient, dated & 11gngd by authorized user (a.u.)
or physician under supervision of an a.u.) is prepared for each patient (35.32(a)(1)] ()Y()N B. Written directives contain required information: source strength, site, & exposure time or total dose (35.2) ()Y()N C. Exceptions to written directives are documented [ footnote to 35.32(a)(1)) ( ) N/A
- 1. Written revisions ()Y()N
- 2. Oral revisions ()Y()N
- 3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N
Module A-4 2 ONECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N
- 8. Procedures ga.y include: (not reauirementsi
- 1. Plan of treatment prepared in accordance with the written directive ()Y()N
- 2. Assess quantity of material remaining after decay (decay chart or other method) ()Y()N
- 3. Other, describe:
ONECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) W j B. Procedures ga.y include: (not reauirements)
- 1. Method used to time the administration ()Y()N
- 2. Person administering treatment confirms the prescribed site and the total dose, or source strength and exposure time ()Y()N ,
- 3. Other, describe:
C. Record of administration maintained in auditable . form [.5.32(d)'2)) ()Y()N l I 9tJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken (35.32(a)(5)] ()Y()N
- 1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events:
- 2. Recordable events identified by inspector
[35.32(c),35.2] ()Y()N
- 3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N issue Dato: 12/ /96 s
1 I , Module A-4 3 B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures ga.y include: (not recuirements)
- 1. Assemble relevant facts including cause ()Y()N Identify corrective action to prevent recurrence ( ) Y ( ) N 2.
- 3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported afsadministration(s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were att subsequently reported (If yes, also complete module 7) i
[35.33(a)) ()Y()N !
- 4. PERIODIC REVIEWS OF THE OMP J
A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review: i
- 8. Review includes a representative sample of all patient i administrations including all recordable events and l misadministrations (35.32(b)(1)(i)(ii)(iii)) ()Y()N '
The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide , 8.33 provides an example using the acceptance sampling tables of i 10 CFR 32.110 and assuming an error rate of 2%. If the tables in ; 10 CFR 32.110 are used, any table is acceptable. l C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to EC within 30 days [35.32(e)) ( ) Y ( ) N ( ) N/A - G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N 5 RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findirsgs. If necessary, use an attachment.
} 12/ /96
i 4 MODULE A-5 TELETHERAPY a 1. SAMPLING (Inspector random sample of each modality) : Total Written Directives Minimum Taraet Samalg j 1 to 5 All 5 to 100 5 ); > 100 5% Total Target Number Written Sample Reviewed ' h I. _ Strontium-90 Eye Applicator:
- If twa (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence
- or represents a substantial ~ failure of the QMP.
l J 2. SUPERVISION t !- A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained: ;
- 3. OBJECTIVES:
r OBJECTIVE I A. A written directive (order for a specific 4 patient, dated & sianed by authorized user (a.u.) or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)]. ('Y()N B. Written directives contain required information, total dose, dose per fraction, site, & overall treatment period [35.2] ()Y()N C. Exceptions to written directives documented
- [ footnote to 35.32(a)(1)] ( ) N/A l
- 1. Written revisions ()Y()N
- 2. Oral revisions ()Y()N
- 3. nral directives ()Y()N 1
i' OBJECTIVE 2 i A. Licensee uses more than one method to verify the , patient's ident'.;/ [35.32(a)(2)] ()Y()N i n , n - - - - , -~q - -
Modul: A-5 2 DBJECTIVE.3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with wr3ttnn directives [35.32(a)(3)]( ) Y ( ) N B. Procedures any include: (not reauirements)
- 1. Check of dose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations ()Y()N
- 2. Performing acceptance testing (based on licensee's specific needs and applications) on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N
- 3. Determining transmission factors for beam modifying devices before first use and after replacement of the source ()Y()N
- 4. Output measurements for treatment parameters not addressed in the most recent full calibration ()Y()N
- 5. Checking dose calculations administration in fracticns (procedure should include consideration of number of fractions and specified time within which the check should be performed) ()Y()N
- 6. Other, describe:
OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive (35.32(a)(4)] ( ) Y ( ) N E. Procedures Egy include: fnot reautrements)
- 1. Plan of treatment prepared in accordance with the written directive ()Y()N
- 2. Person administering treatment confirms the written dit active and plan of treatment. At a minintm, che verification of treatment site 3
and dose per fraction ()Y()N . 3. Other, describe: lssue Date: 12/ /96
. . ~ _. __ . ._ . _ . - _ - _ _ _ . _ _ . . . . _ . _ _ . _ . _
Module A-5 3 l B. Record of each administration or fraction j maintained in auditable fom ()Y()N eBJECTIVE 5 A. Procedures implemented to ensure that unintended l deviations are identified, evaluated, and corrective action'is taken [35.32(a)(5)] ()Y()N
- 1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N j- Dates of events:
I
- 2. Recordable events identified by inspector
[35.32(c),35.2] ()Y()N
- 3. Misadministration resulted from the unintended ,
deviation (If yes, also complete module 7) ()Y()N j B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures gar include: fnet reeuirements)
- 1. Assemble relevant facts including cause ()Y()N L 2. . Identify corrective action to prevent recurrence ( ) Y ( ) N
- 3. Retain a record of items 1 and 2 ()Y()N l
D. Licensee reported misadministration (s) since the last inspection'(If yes, also complete module 7) [35.33(a)]( ) Y ( ) N 1
- l E. Licensee identified misadministrations that were agl
- subseq.antly r. ported (If yes, also complete module 7)
L [35.33(a)] ()Y()N l L
- 4. PERIODIC REVIEWS 0F THE GNP l
- l. A. Review conducted of the QMP at intervals no greater !
than 12 months [35.32(b)(1)] ()Y()N l Date of last review: ' B. Review includes a representative sample of all patient
- administrations including all recordable events and misadministrations(35.32(b)(1)(1)(ii)(iii)] ()Y()N l The licensee should utilize a. representative sampling process which l
. embodies a valid statistica1' sampling methodology. Regulatory Guide l i: 8.33 provides an example using the acceptance sampling tables of j i 10 CFR 32.110 and assuming an error rate of 2%. If the tables in i 10 CFR 32.110 are used, any table is acceptable. 12/ /96 l l y - g - , - -,, p ,p.- - - --3--, .,y ,7---. - . , - - - -m---p. ,,w-- - m.-. .e,
=
l Module A-5 4 C. If review identified recordable events or i misadministrations not previously identified, the i review was expanded by the licensee to ensure the : l events were isolated ()Y()N l l D. Licensee evaluated each review to determine the i effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on the evaluation of reviews, the licensee made ; modifications to meet Objectives [35.32(b)(2)] ()Y()N j F. Modifications sent to NRC within 30 days [35.32(e)) ( ) Y ( ) N ( ) N/A G. Records of reviews including the evaluation and findings maintained for at least 3 years [35.32(b)(3)) ()Y()N Remarks:
- 5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the l inspection findings. If necessary, use an attachment.
i l l l l l l t l l t Issue Date: 12/ /96 l l l
i I MODULE A-6 i GAMA STERE 0 TACTIC RADIOSURGERY ! l l l l
- 1. SAMPLING (Inspector random sample of each modality) ,
Total Written Directives Minimum Taroet Samole l 1 to 5 All 5 to 100 5 l > 100 5% Total Target Number l Eritten Samole Reviewed D_lL.
- 1. Gemma Stereotactic Radiosurgery l If two (2) or more written directives are incomplete or missing, the
! review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.
- 2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable I to the modality of use (35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
l 3. OBJECTIVES: OBJECTIVE 1 l A. A written directive (order for a specific patient, dated & sianed by authorized user (a.u.) or physician under supervision of an a.u.) is prepared for each patient [25.32(a)(1)] (: Y()N B. Written directives contain required information, ! target coordinates, collimator size, plug pattern, and total dose [35.2] ()Y()N C. Exceptions to written directives are documented (footnote to 35.32(a)(1)] ( ) N/A
- 1. Written revisions ()Y()N
- 2. Oral revisions ()Y()N
- 3. Oral directives ()Y()N i
! OBJECTIVE 2 I l A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N 1 l
- i l
t l
-1 l- MODULE A-6 2 -
i UBJECTIVE 3 ! l \ l A. Procedures implemented to verify that final plans ' of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N i l B. Procedures may include: (not reevirements)
- 1. Check of dose calculations by an authorized l user or a qualified person under supervision i ,
of an authorized user who whenever possible i did not make the original calculations ()Y()N
- 2. Performing acceptance testing (based on !
licensee's specific needs and applications) on each treatment planning or dose i calculating computer program that could be used for dose calculations ()Y()N , 1 3. Plan of treatment prepared in accordance with ; the written directive ()Y()N j
- 4. Imaging and localization precision assured ()Y()N ]
i'
- a. Stereotactic frame aligned and affixed ()Y()N
- b. Imaging films correctly centered & labeled ( ) Y ( ) N i i
- 5. Verify correct helmet & plug pattern selected ()Y()N
- 6. Verify computer generated dose calculations were cc.rectly entered into unit and that the computer print out shows correct data for the patient were used in the calculations ()Y()N
- 7. Other, describe:
OBJECTIVE 4 , A. Procedures implemented to verify, prior to l administration, that the specific details are in l accordance with written directive [35.32(a)(4)] ( ) Y ( ) N I B. Procedures gay include: (not recuirements)
- 1. Check of treatment parameters by an authorized
- user or a qualified person under supervision i of an authorized user who whenever possible did not make the original calculations ()Y()N lssue Date
- 12/ /96
- . - . - - - - . .~. - . . . - . - . . - .-
. .^. ,
4 NGGbi.E A-6 3
- 2. Verify stereotactic frame coordinates on the 4 patient's skull match the p h n of treatment ()Y()N
- 3. Person administering treatment confirms' prescribed.
target coordinates, collimator size, plug pattern, i and total dose prior to administration. ()Y()N I 4, Prompt record of treatment parameters ano signing or initialing of the patient's chart or appropriate record ()Y()N
- 5. Other, describe:
J
- 8. Record of administration maintained in auditable l form [35.32(d)(2)) ()Y()N OBJECTIVE 5 j A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)) ()Y()N
- 1. Recordable event (s) self-identified since the lastinspection[35.32(c),35.2] ( ) Y (.) N Dates of events:
- 2. Recordable events identified by inspector ..
[35.32(c),35.2)- (~) Y ( )'N
- 3. Misadministration resulted from the unintended c' viatior (If yes, also complete module 7). ( ) Y-( ) N i B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)) ()Y()N C. Procedures an include: (not rair--- .ts)
- 1. Assemble relevant facts including cause ()Y()N ~l
- 2. Identify corrective. action to prevent recurrence ( ) Y ( ) N
- 3. Retain a record of items 1 and 2 .( ) Y ( ) N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that'were nel subsequently reported (If yes, tiso complete module 7)
[35.33(a)) ()Y()N l l 12/ /96 1 d l
MODULE A-6 4
- 4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)) ()Y()N Date of last review:
- 3. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(lii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.
C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on the evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ( ) Y ( ) N ( ) N/A F. Modifications sent to NRC within 30 days (35.32(e)) ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)]: ()Y()N
- 5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.
i Issue Date: 12/ /96}}