ML20059B400
| ML20059B400 | |
| Person / Time | |
|---|---|
| Issue date: | 12/13/1993 |
| From: | Woodruff R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Mobley M TENNESSEE, STATE OF |
| References | |
| NUDOCS 9401040114 | |
| Download: ML20059B400 (39) | |
Text
r-QG December 13 -1993 h[d
~,
0
'Mr. Michael H. Mobley, Director Division of Radiological Health Department of Environment and Conservation L and C Annex, 3rd Floor 401 Church Street Nashville, TN 37243-1532
Dear Mr. Mobley:
This will confirm my recent discussion with Mr. Nanney of your staff concerning the review of the Tennessee Radiation Control Program scheduled for January 31 - February 4, 1994.
I am etclosing a list of questions entitled, " Appendix A, Evaluation of Agreement State Radiation Control Program: Part I, Program Guidelines and State Questionnaire Update, and Part II, Program Statistics." These questions and your response to the questions will become Appendix A to our final report.
The questionnaire was completely revised in 1992 to accommodate comment, from the Agreement States and to make the document consistent with the waste disposal criteria contained in the Commission Policy Statement published on May 28, 1992. A copy of this questionnaire was provided to your staff during our visit in June of 1993.
Part I of the questionnaire contains the guidelines and related questions.
The new portions of the revised guidelines have been " highlighted" for your convenience.
Part II contains program statistics essential for our exchange of information program. We would like to have the Part II data summarized for the calendar year 1992, and a separate Part 11 for the calendar year 1993.
The questionnaire is being furnished to you on a computer disk (wordperfect 5.1) as well as in printed form. As in the past, a copy of the completed questionnaire is requested prior to the review, by January 18, 1994.
Also, I would like to accompany inspectors from each of your Area Offices prior to the review. Tentatively, the last three weeks of January were discussed as possible time periods for the accompaniments, and the specific dates will be coordinated with your staff.
Sincerely, t
Richard L. Woodruff Regional State Agreements Officer
Enclosures:
(see next page) 030018 l[i 9401040114 931213
}
PDR STPRG ESGT
a 7-Michael H. Mobley 2
Enclosures:
1.
Appendix A, Evaluation of Agreement State Radiation Control Program 2.
Diskette bec w/ encl:
R. L. Woodruff Document Control Desk (SP01)
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RLWoodruff SDEbneter 12/02/93 12/J /93
1 i
4 APPENDIX A EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM i
PART I l
PROGRAM GUIDELINES AND STATE QUESTIONNAIRE UPDATE j
Name of State Program Tennessee i
Reporting Period from: December 13. 1991 to February 4. 1994-l r
I.
LEGISLATION AND REGULATIONS i
A.
Leoal Authority (Category I)
(
NRC Guidelines: Clear statutory authority should exist,
'i designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection and j
enforcement. States regulating uranium or thorium recovery and
+
associated wastes pursuant to the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA)_must have. statutes enacted to establish clear authority for the State to carry out the i
requirements of UMTRCA. StKiiiiFijalitisjpthEdliisbiilis'fBsi?
j 1FvelsTFidi siEtiVi_'{EiitiW perusribatidi sposalsfae11 l tissSnuiQh'sV3 -
i statht'esithat@rovildsjauth6ti tiffo6the d sshi6def6fiQNjgul at16nsl~^
forsi on1 hv61 Ewntei nanagementf and!di sposal?qThsistatutes?should alis$p6pidejbjulaistfipsog'raRauthorityliniUpfoyidolfo of! checks a toYdemonstrateithat? confl i ctMofsinterestibstw@een;thes; fugQon$fundtlon%hdithelgje]jstsljigypsytiosaf'~~~
Eedulit'6 s3hallinoboccurf l
Questions:
1.
What changes were made to the State's statutory authority to regulate agreement materials, low level waste disposal, or uranium mill operations in the reporting period?
2.
Are your regulations subject to a :" Sunset" or equivalent j
law? If so, explain and include the next expiration date 1
for your regulations, j
B.
Status and Compatibility of Reaulations (Category;I)
NRC Guidelines: The State must have regulations essentially 1'
identical to 10 CFR Part 19, Part 20 (radiation dose standards, effluent limits, waste manifest rule and certain other parts),
Part 61 (technical definitions and requirements, performance t
'The level of separation (e.g., separate agencies) should be determined-for each State individually.
.l l
~
t
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i 2
Appendix A objectives, financial assurances) and those required by UMTRCA, as implemented by Part 40. The State should adopt other regulations to maintain a high degree of uniformity with NRC regulations.
For those regulations deemed a matter of compatibility by NRC, State l
regulations should be amended as soon as practicable but no later than 3 years. The RCP should have establishet procedures for effecting appropriate amendments to State regulations in a timely manner, normally within 3 years of adoption by NRC. Opportunity j
should be provided for the public to comment on proposed regulation changes.
(Required by UMTRCA for uranium mill regulation.)
Pursuant to the terms of the Agreement, opportunity i
should be provided for the NRC to comment on draft changes in l
State regulations, j
Questions:
j I.
What is the effective date of the last compatibility-related amendment to the State's regulations?
J 2.
Referring to the latest NRC chronology of amendments,
)
identify those that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them.
'l 3.
Identify the person responsible for developing new or amended regulations affecting agreement materials.
II.
ORGANIZATION l
Under the Appendix B title sheet provided at the end of this document, please enclose copies of your organization charts as follows a) organization chart (s) showing the position of the radiation control program (RCP) within the State organization and its relationship to the Governor, other State and local RCPs (if any), and comparable health and safety programs.
]
b)
Internal organization charts for the Bureau of Radiological Health and the Bureau of Solid and Hazardous Waste.
If applicable, include regional offices and contract agencies.
All charts should be current, dated, and include names and titles for j
all positions.
j A.
Location of the Radiation Control Proaram Within the State l
Orcanization (Cateoorv II)
NRC Guidelines: The RCP should be located in a State organization parallel with comparable health and safety programs. The Program Director should have access to appropriate levels of State management. Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division 4
a
y 3
Appendix A of responsibilities and requirements for coordination.
Questions:
l 1.
During the reporting period, did the management, program name, or location of the RCP within the State organization change?
B.
Internal Organization of the RCP (Category II) t NRC Guidelines: The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. Where regional offices or other government agencies are utilized, the lines of communication and-i administrative control between these offices and the central office (Program Director) should be clearly drawn to provide.
uniformity in licensing and inspection policies, procedures and supervision.
Questions:
l 1.
What changes occurred in the organization of the RCP during the reporting period?
2.
If changes occurred, how have they affected the RCP and its effectiveness?
C.
Leoal Assistance (Category II)
NRC Guidelines:
Legal staff should be assigned to assist the RCP or procedures should exist to obtain legal assistance expeditiously. Legal staff should be knowledgeable regarding the RCP program, statutes, and regulations.
Questions:
1.
If legal assistance was utilized during the reporting period, briefly describe the circumstances.
2.
Was the legal assistance satisfactory during this period?
i If not, what were the problems?
D.
Technical Advisory Committees (Category II)
NRC Guidelines: Technical Committees, Federal Agencies, and other resource organizations should be used to extend staff capabilities for unique or technically complex problems. A State Medical Advisory Committee should be used to provide broad guidance on the uses of radioactive drugs in or on humans. The Committee should represent a wide spectrum of medical disciplines. The Committee i
l
1 i
4 Appendix A should advise the RCP on policy matters and regulations related to use of radioisotopes in or on humans.
Procedures should be developed to avoid conflict of interest, even though Comittees are advisory. This does not mean that representatives of the regulated comunity should not serve on advisory comittees or not be used as consultants.
l Questions:
1.
Please list the names, affiliations, and terms of the technical comittee(s) members.
2.
If an advisory comittee or consultant was used during the reporting period, briefly describe each circumstance (i.e.,
the subject, the need, the result, and the manner obtained -
by meeting, phone call, or letter).
Ei jcontiiEt'6iT7AssistaWeQCjitejofjfl!J NRCJGsidsl iiii^sTEBididisT6ffthsTdiile^fsitWiiidW6sp]sili ff[5fil 6R level radioni:tive(waste (disposalflicensingiandiregulationRStates, regul ati ng 4heid t s po s aUJo fW l ow-l evel l radi oacti ve permanentW1sposalf facilitteinhohld have;procedu;wasteiin
~
restand~
i mechanismhinFpladc1forfachbisition?sf?t'echnicalland veridor i
servicss'nece'ssarijto. supportithesesfuictionsithat? aFeinoti.
i otherwise7available withinithes.RCP2The!RCPisho61diavoidsth_e selection 4ficontractors whishihaveleenTs~elsetedstoippovide~
i
' ervices[associatsdllwithitheLLLQacQitjfdevelopineintiof ~
I s
opeyations; 1.
Please describe the procedures that are in place for the acquisition of technical and vendor services or provide a copy for review.
2.
If the State has utilized outside contractors since the last review, please provide a listing of the contractors, the project under contract, and the status of the project.
i III. MANAGEMENT AND ADMINISTRATION A.
Quality of Emeroency Plannino (Category I)
NRC Guidelines: The State RCP should have a written plan for response to such incidents as spills, overexposures, transportation accidents, fire or explosion, theft, etc. The Plan should define the responsibilities and actions to be taken by State Agencies. The Plan should be specific as to persons responsible for initiating response actions, conducting operations and cleanup.
Emergency comunication procedures should be adequately established with appropriate local, county and State agencies.
Plans should be distributed to appropriate persons and
5 Appendix A agencies. NRC should be provided the opportunity to comment on the Plan while in draft form. The plan should be reviewed annually by Program staff for adequacy and to determine that content is current.
Periodic drills should be performed to test the plan.
Questions:
1.
Other than the communications list, when was the emergency plan last revised?
2.
If the plan was revised since the last review, what changes were made?
3.
If the plan was substantially revised during the reporting period, was the NRC provided the opportunity to comment on the revision while it was in draft form?
4.
When was the emergency communication list last reviewed or revised?
5.
When and how was the plan last tested?
B.
Budaet (Category II)
NRC Guidelines: Operating funds should be sufficient to support program needs such as staff travel necessary to conduct an effective compliance program, including routine inspections, follow-up or special inspections (including pre-licensing visits)_
and responses to incidents and other emergencies, instrumentation and other equipment to support the RCP, administrative costs in operating the program including rental charges, printing costs, laboratory services, computer and/or word processing support, office equ_ipment, hearing costs, radioactive wastsifidilitiestshouldsha[veiadequatel etc. as. appropriate. Stitesfr resouFce s? tot all 6w{ fo rfch;angesii hl fsnd i rigf hsedsiddri ngit he M(_
fa di l i tyJ11 fei cycl eMAf terj appropri ation sMt hefs ources.? ofs p rog. ram fun;dingpshouldLbeystablelandprotectedsfrom?competi} ion;fuhdsffromior f
invasion::byi:other$5 tat'e prog ~ramsa PFiEdipal operating sMUld~be"ffoni'shiirceT$hich hibilide continuity and reliability, i.e., general tax, license fees, etc. Supplemental funds may be obtained through contracts, cash grants, etc.
Questions:
1.
Show the amount for funds for the Division of Radiological Health (DRH) for the current fiscal year obtained from:
DRH Funds State general fund
l~
L
'1 i
[
6 Appendix A a.
Fees b.
Federal grants and contracts (identify) i c.
Other l
l d.
Total:
2.
Show the total amounts in the current DRH budget allocated for the following (if contract costs are incurred, please include):
DRH Budaet l-a.
Administration
?
l b.
Radioactive materials c.
X-ray d.
Environmentai surveillance e.
Emergency planning f.
Other (radon, non-ionizing, operator credentialing, etc.,
please identify).
i g.
Total:
'i l
l 3.
What percentage of your radioactive materials program is supported by fees?
l l
l 4.
Discuss any changes in program funding that occurred during l
the reporting period, the reasons for the changes (new i
programs, change in emphasis, statewide reduction, fee cost recovery percentage, etc.), and how the changes affected the program.
5.
Overall, is funding sufficient to support all of the program i
needs? If not, what are the problem areas?
j C.
Laboratory Support (Category, II)
NRC Guidelines: The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, etc.,shiiTatthgTih~s on a priority I
established by the RCP. IntiddittbhKStiteilV disiiosiHo f j osi3)9hEWdioictijeljaste]facil i t i esii njpsrma6@
l l
l l
A
P i
7 Appendix A j
' dis ~pos^aE fa~cilitin'~shsuld h'Ge~aiic~ sis ~ ts litidRt6rF sGppsK 'fof]
)
radiological and non-radiological analyses associated with the
' soils' testing',, testing ' of, environmental media',, testing,of" ^ jnj l
licensing' and regulation of low-level waste disposa1F includ i
' engineering propertieslof waste packages,and' waste foms, avid testing of other? engineering niaterials used'in the disposal,of i
low-level radioactive waste. Access to laboratory support sh'ould be available_on an "as needed"rbasis'for;nonradiologica1' analyses to confira Itcensees'and applicants' programs and conditions'for
-i
'nonradiological; testing, siiould belyrescribed in plans'or~~^" *~~~
procedures 3 j
Questions:
i i
1.
Describe changes in your laboratory support, such as rew l
instruments, cutbacks, etc., in this period.
i 2.
Have there been problems in obtaining timely and accurate i
lab results? If yes, discuss the circumstances and how the problem might be corrected.
D.
Administrative Procedures (Category II)
NRC Guidelines: The RCP should establish written internal procedures to assure that the staff performs its duties as.
required and to provide a high degree of uniformity and continuity in regulatory practices. These procedures should address internal q
processing of license applications, inspection policies, e
decommissioning and license termination, fee collection, contacts with communication media, conflict of interest policies for employees, exchange of information and other functions required of the program. Administrative procedures are in addition to the-technical procedures utilized in licensing, and inspection and enforcement.
i Questions:
i 1.
Briefly list the changes, such as new procedures, updates, policy memoranda, etc., made in your written l
administrative procedures during the reporting period.
3 Include internal processing of license applications,
.i inspection policies, decommissioning and license termination, fee collection, contacts with media,
)
conflict of interest policies for employees, and exchange of information procedures.
2.
Briefly list. any new procedures, policy, etc., that have
{
been implemented with respect to the implementation of the regulatory functions under the current organization.
L i
8 Appendix A E.
Management (Category II)
NRC Guidelines:
Program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions). RCP management should periodically assess workload trends, resources and changes in legislative and regulatory responsibilities to forecast needs for increased staff, equipment, services and fundings.
Program management should perform periodic reviews of selected license cases handled by each reviewer and document the
,results.Complexlicenses(majormanuf}cturers,16721sjlel.
+
radi.oactM. s1wa_ste d.isposa.lbt,adilMies; large scope-Type A Broad, g fg g 7g.ggg receive second party review (supervisory, committee, consultant).
Supervisory review of inspections, reports and enforcement actions should also be performed. f 6r2thsYf5plsabhtiti65?6fNIFf~eds Tilcensthglicti3nsEsEEhlas11nitialdlicsnseirevieWX11censs~ ~jilsR
~~~
renewal s r and Ricen si ngiacti ons ?a s soc i ated31 thia 71 owl evel radi osct i ve Wa s teid i s po s als f acil i tMthe rsJh'ould (b4 %n foWrill 5 Proj ectf Han'ag'er.:tre spon si bl e} fo rit heTcoord i n ati on7 a ndfcompil a ti o o fethe Ldi verse 5 techni cal ? revi ewsy necess arysforithe? compl eti on!of theil.icensing {sctionl.[The;Pr;ojshtiManage.rfsho61d? hives train.ing y expe ri ence pin tonel o r? morelo fi thei mai nid i s c ipl ines7rel ated t t o s the' t echni e al Ws vi ews i whi chithe1Proj ect1 Man age ri wil l) be#co6rdi n a ti ng environmental; sciencei'Whe6~Feiibn$esrthtscienceier^' ~~~^~~al~6ffic suchiasihsslthi physicst engineering agenefes~sfe~^6tilizedi program management should conduct periodic audits of these offices.
Questions:
1.
How many management reviews of license cases were performed in this period?
2.
Were all license reviewers included in the cases selected for management review?
If not, explain.
3.
What audits were made of regional and contract offices?
F.
Office Eauipment and Support Services (Category II)
NRC Guidelines: The RCP should have adequate secretarial and clerical support. Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses) programs.
Similar services should be available to regional offices, if utilized. Stifss?shh61dihis/sTlihinss doc usentTmin ayEmenti sy stsisithitli sic a psbl~e L o f.Lorg an i zi ngi ths volume 3nd; diversity; oft materials (associated {sith? licensing T6d inspection off radioactive (materialsi ~Pf6fs5siorisl'Itaff~3h601d not be"ssid for fee collestl6n'and"6ther clerical duties.
Questions:
L r
9 Appendix A 1.
Has the secretarial and clerical support been adequate L
during this period? If not, explain.
2.
What word processing, data base, and spread sheet programs are you using?
G.
Public Information (Category II)
NRC Guidelines:
Inspection and licensing files should be available to the public consistent with State administrative procedures.
It is desirable, however, that there be provisions for protecting from public disclosure proprietary information and information of a clearly personal nature. Opportunity for public i
hearings should be provided in accordance with UMTRCA and ofJmajoMic. tate _admi.nistrative, procedure laws ddFihEtheijiF6Ehsj applicable S en si ng i acflonsi as sociitid sii t h(UMTRCA s andX1 ow-l evel Fadioac,tive;wistle g permahsnt @isposah fac Qities f - ~ ~~ ~
Questions:
1.
Have changes occurred in the manner in which you handle public information?
IV.
PERSONNEL A.
Qualifications of Technica, Staff (Category II) i NRC Guidelines:
Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences. Additional training and experience in radiation protection for senior personnel including the director of the radiation protection program should be commensurate _with_the type the State. FoEStiffs of licenses issued and inspected by^iiTingi$sfiffitvainingissd FssuluTs#7sFshiniRuillisind!E1111t sxpe rience!(s houl d ?al s6M ncl udeihid rol ohy g gio16gyh[sndi struct uf alj 2
engineeringi Mof[wastetinipermanentsfacilitlesMstaffitrainingprogra leveljradioactive and s expe rience ishould sincluderci vils chfmechsnicaMengineeringl geol ogy n hyd pol ogyW and Tothe6? e arthis ci ence N ahdienv i ronment al i
expe ri ence(Iniboth s tipe sj@fimite rial sMst'af 6 traih i nglandli[,_
science?):'
~
g u i del i nest applj)ttoia'vai l abl e s co ntracto rsy and e resource s in Sthte:agenciesiothe~rathanithelRCPFWFittin~ job ~ dis &Iptioiss~~ ~
'sh"60ld~be pFEphrsd~ia~'t}iit~piafessidnal qualifications needed to fill vacancies can be readily identified.
Questions:
2 Additional guidance is provided in the Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement (46 FR 7540, 36969 and 48 FR 33376).
s.,
i
-10 Appendix A-l 1.
Please list all new technical personnel in the Radioactive ~
j Materials Program and the Division of Radioactive Waste-l Management,'ind$cate the degree.they received, if l
applicable, and. additional training and years of experience.
in health physics, engineering, geology, hydrology, etc..
1 i
B.
Staffino level (Category II) 1 NRC Guidelines:
Professional staffing level should b=
l approximately 1-1.5 person-year per 100 licenses in effect. RCP i
must not have less than two professionals available.with training and experience to operate RCP in a way which provides continuous-coverage and continuity. ThsitW65Fofiiif66ilifiiffil~ablsits 6HfstN3cMMIM&uTp*tiisstEs@ti'il i ng ssavaissi@Miis12 l
For Stites reguliting uranium mills and mill current.
indications are that 2-2.75 professional person-years' of effort, l
including consultants, are needed to process a new mill license i
(including in situ mills) or major renewal, to meet requirements j
of Uranium Mill Tailings Radiation Control Act of 1978. Stitsi inhich rig ~ulats'theidi~spoial~of Tos; level"ridisictTvi"waite in~~
permanent disposal facilities should allow a baseline RCP staff q
effort of 3 '4 professional technical person-years;(in: addition td i
the two professionals:for the basic RCP' indicated. in the first"~
bullet of,this indicator) : However,' in" some cases,'the: level of particularly,1f contractor support :is en call;-In any av(est? site activity staff resources 'should be~ adequate te conduct inspectises,en a routine basis during'aperations of,the 11W facility, including j
inspection of incoming shipments and licenses site activities irid j
to respond to emergencies, associated with the site. Do' ring"^^ ~
periods of' peak activity additional staff orispecialty_consultasti should_be, available on a timely basis. 2 t
Questions:
-i i
1.
Complete a table listing the' professional (technical) j person-years of effort applied to the agreement or
}
radioactive material program by individual.
Include the name, position, and fraction of time' spent in the following j!
areas: administration, materials licensing & compliance, i
emergency response, LLW, U-mills.
If these regulatory responsibilities are divided between offices, the table'.
should be consolidated to include all personnel contributing to the radioactive materials program and the radioactive waste management program.
If consultants were used to carry out the program's RAM responsibilities, include their-1 efforts. The table heading should b.e:
NAME POSITION AREA 0F EFFORT FTE%
2.
Is the staffing level adequate to meet normal and special needs and backup? If not, explain.
j i
i
c 11 Appendix A 3.
Do you currently have vacancies?
If so, when do you expect to fill them?
C.
Staff Supervision (Category II)
NRC Guidelines:
Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel.
Senior personnel should review applications and inspect licenses independently, monitor work of junior personnel, and participate in the establishment of policy. Junior personnel should be initially limited to reviewing license applications and inspecting small programs under close supervision.
Questions:
1.
Identify your senior personnel assigned to monitor the work of junior personnel.
D.
Trainina (Category II)
NRC Guidelines: Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices. The RCP should have a program to utilize specific short courses and workshops to maintain appropriate level of staff technical competence in areas i
pf changing technology.
The!RCPytiff@hiulfbelaff6fdid
^
oppo rtuni_ti e s sf6KMai n ing;thatEl sicon s i stlentji thithejpedds_;_o f thelprogram; Questions:
1.
Prepare a table listing all of the training courses, workshops, seminars, symposia, etc. that your materials-personnel and your radioactive waste management personnel have attended since the last review. The table heading should be:
Student Course Sponsor Dates 2.
If any of your materials radioactive waste management staff currently need NRC training, please identify the employees i
and the courses needed.
E.
Staff Continuity (Category II)
NRC Guidelines: Staff turnover should be minimized by combinations of opportunities for training, promotions, and competitive salaries. Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications. Salaries should be comparable to similar employment in the geographical i
area. The RCP organization structure should be such that staff turnover is minimized and program continuity maintained through
t 1'
i 12 Appendix A j
opportunities for promotion.
Promotion opportunities should exist-from junior level to senior level or supervisory positions. There also should be opportunity for periodic salary increases compatible with experience and responsibility.
Questions:
c 1.
Identify the technical staff who left the Agreement program during this period and, if possible, give the reasons for the turnovers.
V.
LICENSING A.
Technical Quality of Licensino Actions (Category I) i NRC Guidelines: The RCP should assure that essential elements of i
applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use 1
material, facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Add i ti onal l F,~i n~ St a tiiT4f ch"ridul' ate ~th^e dlsposal of l'oit-leN1 stadioactive, waste in permanent disposal" facilities, the RCP should assure that'essentialjelements of sisti disposal applications' meet State licensing:requt/ements' for waste ^
product
- and volume, qualifications of personnel,' facilities'and^
equipment, operating and emergency procedures, financial"'~~~
qualifications and assurances, closure and decomissionin'g i
procedures and institutional arrangements in a manner suffitTent to establish a basis, for licensing action. ~ Licensing activities should be adequately documented. including safety eva' uation'"~' ~
reports /<' product certifications or similar documentation' of th^~e license review and app'd'ina35r"licin^ sing actions.roval proces s ; ' ~Pr' l
n b'e'mide^forco5plix an Licenses should be clear, complete, and accurate as to isotopes, forms, quantities, authorized uses, and permissive or restrictive conditions. The RCP should have procedures for reviewing licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program.
Questions:
1.
Update the list of the State'* major licensees.
In addition to the name, license number and type, please indicate if the license is new or was terminated (action).
Include:
i o
Broad Licenses i
o LLW Disposal o
LLW Brokers (All Types) t o
Manufacturers and Distributors o
Uranium Mills o
Irradiators (Other than Self-Contained) t
q 13 Appendix A o
Nuclear Pharmacies o
Other Licenses With a Potential Significance for Environmental Impact The table heading should be:
Licensee Name License Number License Type Action 2.
Identify any major, unusual, or complex licenses issued or renewed in this period.
r 3.
Have any new or amended licenses affected the list of licensees requiring contingency plans?
4.
Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the period.
B.
Adeouacy of Product Evaluations (Category I)
NRC Guidelines:
RCP evaluations of manufacturer's or distributor's data on sealed sources and devices outlined in NRC, State, or appropriate ANSI Guides, should be sufficient to assure integrity and safety for users. The RCP should review manufacturer's information on labels and brochures relating to radiation health and safety, assay, and calibration procedures for adequacy. Approval documents for sealed source or device designs should be clear, complete and accurate as to isotopes, forms, quantities, uses, drawing identifications,ilf6ffididiEtTVi?Iiiifs and permissive or restrictive conditions. App 6Falfd66sriisnt iia #KiisWsol id i f i citiin fan _dj s tab _il i zati onisedi aRo r?6the rWen@
nmpl ete q and taccurate rash tof the suse n ca.es foridispos al yshoul products;useditoltreatpadioactiVejwast andJ si te] sgci ficj re;stfj etLidljs[assoQatp@j tgeachy6dsctf Questions:
1.
Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the reporting period. The table heading should be:
SS&D Manufacturer, Type of Indicate Indicate if Registry Distributor or Device if Agreement Number Custom User or Source NARM Material 2.
List the applications for SS&D registrations for which registry documents have not yet been issued.
3.
Please provide a listing of approval documents for any radioactive waste packages, solidification and stabilization media, or other vendor products used to treat radioactive
14 Appendix A waste, that the State has approved since the last review.
C.
Licensina Procedures (Category II)
NRC Guide!ines: The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice. 16TStat'eilwhf shiF6pslitsithPdlipbillibEl oEEl sVil rsdi oiEtiisisiste ninipefesnsntidi spdialifscilitiiss theiRCPhhh0Td h ave f propam)speci fi c(l i cen s i nfg uideWpl assland y p rocidure'ssfo r ~ ~
l i cense Wev l esfa nd ipol i cy9nemorandaTWhi chirel ateYto r s peci fi c as peits o ffwas te sd _i sp6s al MThelprog ramis hdul d (16si nde?ths" pr.epirat i ontofis afe tyfeval u a tionireport sigp roductRe rti fi dtl,ohg crisimil aridocument. ationtofil icense s revi ew s and tapprovah process t ggg gg 66Mdifii"sppTi EiHfs^ ^f6F ^ Fin euil s )~ih6hld~ b"5 furnished copies of applicable guides and regulatory positions.
The present compliance status of licensees should be considered in licensing actions. Under the NRC Exchange-of-Information program, evaluation sheets, service licenses, and licenses authorizing distribution to general licensees and persons exempt from licensing should be submitted to NRC on a timely basis.
Standard license conditions comparable with current NRC standard license conditions should be used to expedite and provide uniformity in the licensing process.
Files should be maintained in an orderly fashion to allow fast, accurate retrieval of information and documentation of discussions and visits.
Questions:
1.
What changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period for materials licenses and for the radioactive waste licenses?
VI.
COMPLIANCE A.
Status of Inspection Proaram (Category I)
NRC Guidelines: The State RCP should maintain an inspection programadequatetoassesslicenseecomp@liarcewithStateThs hspe regulations and licens itions Statesishou.ld pr,ovidel.e cond.ssinsp.., tiontofflicenseef stwaste for:th ec gene ra ti onVac t iVi ti es ninds6t helState f sij urisdic tionlJln istifEs wh i ch Wegul at e! ths idi spo sal fofal ow 4l evel s radioacti ve Na s tM i n ~^ ^
pe rmanentid t s pos a$acil i ti ss$s@theIRCP3houldlincl ude?p roV forTpre!operationalMopeestich i n spe cti oninThsi n specti on silhoul d 0covehi1 Fprogram f sl esent s uh ichlarei rel ev a nt8 atith#1 time 76 f[theji nspect'i on t andi bef perfofsid.
i nde pendently To fianyf re sident g in s pec tors prog ram uinl[ add i ti on i i n specti on si: shoul d i befconducted sonia! rou ti net b'asi s t du ring ithe '
ope rs t ionTo f2 the.) LLW i fa cil i typ incl udisg"li n specthh fo f41neomi 6j
'shipmentQind(iEh are adequafe to permit Program Management toli st^st.istics wh
u.
15 Appendix A assess the status of the inspection program on a periodic basis.
Information showing the number of inspections conducted, the number overdue, the length of time overdue and the priority categories should be readily available. There should be at least semiannual inspection planning for the number of inspections to be performed, assignments to senior versus, junior staff, assignments to regions, identification of special needs and periodic status reports. When backlogs occur the program should develop' and implement a plan to reduce the backlog.
The plan should identify priorities for inspections and establish target dates and milestones for assessing progress.
Questions:
l 1.
Prepare a table identifying the Priority 1, 2, and 3 licenses with inspections that are overdue by more than 50%
of their scheduled frequency.
- nclude the licensee name, l
inspection priority, the due date, and the number of months the inspection'is overdue. The list should include initial inspections that are overdue. The table heading should be:
Insp. Freq.
Licensee Name (Years)
Due Date Months 0/D 2.
Describe your action plan for completing your overdue inspections.
If there is a backlog of (1) inspections with an inspection frequency of 3 years or less that are overdue by more than 50%
of thier scheduled frequency, or (2) inspections with lower inspection frequencies that are overdue by more than 100% of thier scheduled frequency, please include with the questionnaire a written action plan for eliminating the backlog. The written action plan should contain inspection priorities, numerical and time frame goals for reducing the backlog, provide a method to measure the program's progress, and provide for management review of the program's success in meeting the goals.
3.
How many on-site close-out inspections prior to license termination were made during.the reporting period?
4.
How many on-site close-out inspections are pendir iis m
time?
5.
How many reciprocity notices were received in the repoiiing period?
6.
How many reciprocity inspections were conducted?
4 3
16 Appendix A j
7.
Other than reciprocity licensees, how many field' inspections of radiographers were performed?
1 8.
What percentage is this of your total number of, radiographer licensees?
B.
Inspection Freouency (Category I)-
q NRC Guidelines: The RCP should establish an inspection priority system. The specific frequency of inspections should be based-upon the potential hazards of licensed operations,- e.g., major processors, broad licensees, and industrial radiographers should be inspected approximately annually -- smaller or less hazardous operations may be inspected less frequently. The minimum inspection frequency including for initial inspections should be no less than the NRC system.
Questions:
1.
Identify individual licensees or groups of licensees the State is inspecting more frequently than called 'for in the~
State's inspection priority system and discuss the reason for the change.
C.
Inspector's Performance and Capability (Category I)
NRC Guidelines:
Inspectors should be competent to evaluate health '
[
and safety problems and to determine compliance with State regulations.
Inspectors must demonstrate to supervision'an y
understanding of regulations, inspection guides, and )olicies offdbii51sK[1]c uEhissJsfishiit$1o$)4eyelsiUsipsEffin endently conductin F6 priortoindep'ehssdsicQyffiasss.ginspections.ra
~~"~
w T1e c6isiilfi6Es~sep&ns6E^(say"Td"RCP m]iliige)
'ip~roachlirdisitabTe!tolassurera5congetelcon
?
a sh60Td d5'6'dGet-~
annual field evaluations of each inspector to assess performance and assure application of appropriate and consistent policies and guides.
{
Questions:
I 1.
Prepare a table showing the number and types of supe'rvisory accompaniments made during the reporting period. Include:
Supervisor Inspector License Cateoory Date i
2.
Were all inspectors accompanied at least annually by the compliance supervisor during the reporting period? If not, evplain.
A i
r
s 17 Appendix A D.
Resoonses to Incidents and Alleaed Incidents (Category I)
NRC Guidelines:
Inquiries should be promptly made to evaluate the need for on-site investigations. On-site investigations should be promptly made of incidents requiring reporting to the Agency in less than 30 days (10 CFR 20.403 types).
For those incidents not requiring reporting to the Agency in less than 30 days, investigations should be made during the next scheduled inspection. On-site investigations should be promptly made of non-reportable incidents which may be of significant public interest and concern, e.g. transportation accidents.
Investigations should include in-depth reviews of circumstances and should be completed on a high priority basis. When appropriate, investigations should include reenactments and time-study measurements (normally within a few days).
Investigation (or inspection) results should be documented and enforcement action taken when appropriate. State licensees and the NRC should be notified of pertinent information about any incident which l
could be relevant to other licensed operations (e.g., equipment failure, improper operating procedures). Information on incidents involving failure of equipment should be provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency. The RCP should have access to medical consultants when needed to diagnose or treat radiation injuries. The RCP should use other technical consultants for special problems when needed.
Questions:
1.
In this reporting pariod, did any incidents occur that' involved equipment or source failure or approved operating procedures that were deficient? If so, a.
How and when were other State licensees who might be affected notified?
b.
Was the NRC notified?
2.
For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
3.
If the RCP utilized medical or technical consultants for an emergency during the reporting period, please describe the circumstances for each case.
4.
In the reporting period, were there any cases involving possible criminal wrongdoing that were looked into or are presently undergoing review? If so, please describe the circumstances for each case.
)
1 18 Appendix A l
')
1 5.
Please provide a copy of your written procedures for l
reporting events data and misadministrations to NRC.
6.
Please describe how you inform your licensees about the importance of reporting accurate and timely events information, including misadministration reporting.
1 L
7.
Please have copies of all misadministrations and events l
available for dicsussion and review.
E.
Enforcement Procedures (Category I)
NRC Guidelines:
Enforcement Procedures should be sufficient to provide a substantial deterrent to. licensee noncompliance with regulatory requirements.
Provisions for the levying of monetary t
penalties are recommended.
Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly specifying all items of noncompliance and health and safety matters identified during the inspection and referencing the appropriate regulation or license condition being violated.
Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions taken to prevent recurrence (normally 20-30 days).
l The inspector and compliance supervisor should review licensee l
responses.
Licensee responses to enforcement letters should be promptly acknowledged as to adequacy and resolution of previously unresolved items. Written procedures should exist for handling escalated enforcement cases of varying degrees.
Impounding of material should be in accordance with State administrative procedures. Opportunity for hearings should be provided to assure impartial administration of the radiation control program.
j Questions-l 1.
If during the reporting period the State issued orders, applied civil penalties, sought criminal penalties, impounded sources, or held formal enforcement hearings, identify these cases and give a brief summary of the l
circumstances and results for each case.
l 2.
Discuss changes made in the enforcement procedures during the reporting period.
3.
Briefly describe the enforcement program used to regulate permittees that transfer radioactive waste to the LLW site.
l 1
l l
I 19 Appendix A F.
Inspection Procedures (Category II)
HRC Guidelines:
Inspection guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in i
the inspection of licensed programs. NRC Guides may be used if i
properly supplemented by policy memoranda, agency interpretations, etc. Written inspection policies should be issued to establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previous violations, interviewing workers and observing operations, assuring exit interviews with management, and issuing appropriate notification of violations of health and safety problems.
t Procedures should be established for maintaining licensees 1
compliance histories. Oral briefing of supervision or the senior
[
inspector should be performed upon return from nonroutine inspections.
For States with separate licensing and inspection staffs, procedures should be established for feedback of information to license reviewers.
Questions:
1.
What changes were made to your written inspection procedures during the reporting period?
G.
Inspection Reports (Category II)
NRC Guidelines:
Findings of inspections should be documented in a report describing the scope of inspections, substantiating all items of noncompliance and health and safety matters, describing the scope of licensees' programs, and indicating the substance of discussions with licensee management and licensee's response.
Reports should uniformly and adequately document the results of inspections and identify areas of the licensee's program which should receive special attention at the next inspection.
Reports should show the status of previous noncompliance and the independent physical measurements made by the inspector.
Questions:
1.
What changes were made in the formats of your reports or inspection forms during this period?
H.
Confirmatory Measurements (Category II)
NRC Guidelines: Confirmatory measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensees measurements. InI5fi 6s?QfiE U sy& lits t h'eid l5)iihllj fp opQeVel[ Fad ioidtWE!ws tsii n7 pernianenp di spos,al:
facilities;(acce.ssstoftestingishouldibe svailfableNntanjas needed h bss i s t foricon fi rmi ng@sl i censee ograms forfmeasurementijslatsdjto ohradi ol og'icals a s pe ctsfo f((acigtf
20 Appendix A 6Fsfalt'i6ssifss?hisilss1Mf5dystifii1RiisiliiiiihdI6hViF6hiiishis1'
' ampiing sandianalysis?toifdemonstrate?compijance? withe 10(CFR(PArt s
614oricoml atible?AgpehmsstiStatej regslati.onsllindiensdreifacility i
perfoFmancebjconditionsyfodnonradiologicaljteitingyhouldibe ~ ~
pre s cri bsd fin 1pl ans e or? procedure s : RCP instrumentation should iiicliidi^ths~f61T6siis[tyiies:' ' ~~
GM Survey Meter: 0-50 mr/hr Ion Chamber Survej Meter: up to several R/hr Neutron Survey Meter:
Fast & Thermal Alpha Survey Meter:
0-100,000 c/m Air Samplers: Hi and Low Volume Lab Counters: Detect 0.001 c/ wipe Velometers Smoke Tubes Lapel Air Samplers Instrument calibration services or facilities should be readily available and appropriate for instrumentation used.
Licensee equipment and facilities should not be used unless under a service contract.
Exceptions for other State Agencies, e.g.,
a State University, may be made. Agency instruments should be calibrated at intervals not greater than that required to licensees being inspected.
(Note: Addition types of instrumentation that are highly desirable are thin window plastic or Nal detectors for low energy gammas and
" micro-R" meters with audio signal for searching for lost gamma emitter sources.)
Questions:
1.
Describe any changes in your instrumentation or methods of calibration in this reporting period.
VII. SPECIAL TOPICS OF CURRENT INTEREST A.
If you like, describe your program's successes, problems or difficulties that occurred during this reporting period.
21 Appendix A PART II PROGRAM STATISTICS t
For calendar year ending December 31. 1992
- 1.
How many specific licenses are currently in effect?
2.
During the last calendar year, a.
how many new licenses were issued?
b.
how many licenses were terminated?
t c.
how many licenses were renewed?
j d.
how many amendments were issued?
e.
how many SS&D evaluations were completed?
3.
How many prelicensing visits were made during this past calendar year?
4.
How many new licenses (or major amendments) were hand delivered to the licensee?
i 5.
How many materials incidents, other than unfounded allegations, occurred
[
during the last calendar year?
6.
How many on-site investigations of incidents were conducted during the last calendar year?
- 7.
How many incidents required NRC notification, either by telephone or by written report?
- 8.
How many of the incidents required Abnormal Occurrence Reports?
- 9.
How many of the incidents involved leaking from sealed sources?
- 10.
How many misadministrations occurred during the last calendar year?
11.
How many civil penalties were imposed during the last calendar year?
l 12.
How many orders were issued during the last calendar year?
9 i
5
1 22 Appendix A
- 13.
How many technical FTE's (not including administrative, clerical or unfilled vacancies) are currently assigned to the:
Radioactive materials program?
Low-Level waste program?
Uranium mills program?
- 14.
Compute the professional / technical person-year effort of person-years per 100 licenses (excluding management above the direct RAM supervisor, vacancies and personnel assigned to mills and burial site licenses).
Count only time dedicated to radioactive materials.
- 15.
List the RCP salary schedule as follows:
Position Title Annual Salary Ranae
- 16.
Please complete the following table using the license categories as shown, and including the total number of specific licenses in each category, the priority or inspection frequency, the number of inspections made during the review period, and the number of overdue inspections in each category.
(In Priorities 1-3, include those overdue i
by more than 50% of their scheduled inspection frequency; in lower priorities, include those overdue by more than 100% of their scheduled frequency.)
Insp.
No.
No.*
No. of Freq.
Insps.
Overdue License Cateaory Licenses (years)
Made Insos.
Academic Type A Broad Academic Type B Broad Academic Type C Broad Academic Other Medical Institution Broad Medical Institution Limited Medical Institution Custom Medical Private Practice Medical Private, Custom Eye Applicators Strontium-90 Mobile Nuclear Medicine Service HDR Remote Afterloader Mobile HDR Remote Afterloader Teletherapy Veterinary Non-Human In-Vitro Testing Laboratories 1
6 v
23 Appendix A Insp.
No.
No.*
No. of Freq.
Insps.
Overdue License Cateaorv Licenses (years)
Made Insos.
i
-Nuclear Pharmacies Medical Product Distribution (Prepared Radiopharmaceuticals)
Medical Product Distribution (Generators and Kits)
Medical Product Distribution (Sources and Devices)
Well Logging, All Sources Well Logging, Sealed Sources Only Well Logging, Unsealed Sources Measuring Systems Fixed Gauges Measuring Systems Portable Gauges Measuring Systems Analytical Measuring Systems Gas Chromatographs Measuring Systems Other Mfg. and Dist., Type A Broad Mfg. and Dist., Type B Broad Mfg. and Dist., Type C Broad Mfg. and Dist., Other Nuclear Laundry Decontamination Services Leak Test Service Only Calibration Service Only (Less Than 100 Curies)
Calibration Service Only (Greater Than 100 Curies)
Leak Test & Instr. Cal. Service (Less Than 100 Curles)
Leak Test & Instr. Cal. Service (Greater Than 100 Curies)
Other Services Waste Disposal (Burial)
Waste Disposal Service, Prepackaged Waste Disposal Service Incineration Waste Disposal Service Processing General License Distribution Ind. Radiography Fixed / Temp. Site Ind. Radiography Temp. Site only Irradiators Self Shielded I
(Less Than 10000 Curies)
Irradiators Other i
(Less Than 10000 Curies) i
24 Appendix A Insp.
No.
No.*
No. of Freq.
Insp.
Overdue License Category.
Licenses (years)
Made Insos.
Irradiators Self Shielded (Greater Than 10000 Curies)
Irradiators Other (Greater Than 10000 Curies)
R and D, Type A Broad R and D, Type B Broad R and D, Type C Broad i
R and D, Other Civil Defense Byproduct Material Possession Only Decommissioning of Facilities low Level Waste Storage - Other U-Mills Source Material Other (Less Than 150 Kilograms)
Source Material Shielding Source Material GL Distribution Source Material Other (Greater Than 150 Kilograms)
Heap Leach, Ore Buying Stations, Byproduct Recovery Rare Earth Extraction and Processing Source Material Possession Only Hot Cell Operations SNM - Unsealed, Less Than 200 Grams a
SNM - Sealed Sources in Devices Pacemaker - Medical Institution Pacemaker - Individual Pacemaker - Mfg. and' Dist.
f f
=.
PART II PROGRAM STATISTICS For calendar year endina December 31. 1993 I
- l.
How many specific licenses are currently in effect?
2.
During the last calendar year, a.
how many new licenses were issued?
b.
how many licenses were terminated?
c.
how many licenses were renewed?
I d.
how many amendments were issued?
e.
how many SS&D evaluations were completed?
3.
How many prelicensing visits were made during this past calendar year?
4.
How many new licenses (or major amendments) were hand delivered to the licensee?
5.
How many materials incidents, other than unfounded allegations, occurred during the last calendar year?
i 6.
How many on-site investigations of incidents were conducted during the last calendar year?
- 7.
How many incidents required NRC notification, either by telephone or by written report?
- 8.
How many of the incidents required Abnormal Occurrence Reports?
l
- 9.
How many of the incidents involved leaking from sealed sources?
- 10.
How many misadministrations occurred during the last calendar year?
11.
How many civil penalties were imposed during the last calendar year?
12.
How many orders were issued during the last calendar year?
- 13.
How many technical FTE's (not including administrative, clerical or unfilled vacancies) are currently assigned to the:
a.
Radioactive materials program?
b.
Low-Level waste program?
c.
Uranium mills program?
i
t l
26
- 14.
Compute the professional / technical person-year effort of person-years per 100 licenses (excluding management above the direct RAM supervisor, vacancies and personnel assigned to mills and burial site licenses).
Count only time dedicated to radioactive materials.
.l
- 15.
List the RCP salary schedule as follows:
Position Title Annual Salary Range
- 16.
Please complete the following table using the license categories as shown, and including the total number of specific licenses in each category, the priority or inspection frequency, the number of inspections made during the review period, and the number of overdue inspections in each category.
(In Priorities 1-3, include those overdue by more than 50% of their scheduled inspection frequency; in lower priorities, include those overdue by more than 100% of their scheduled frequency.)
Insp.
No.
No.*
No. of Freq.
Insps.
Overdue License Categor_v Licenses (years)
Made Insos.
1 Academic Type A Broad Academic Type B Broad Academic Type C Broad j
Academic Other Medical Institution Broad Medical Institution Limited i
Medical Institution Custom Medical Private Practice Medical Private, Custom l
Eye Applicators Strontium-90 Mobile Nuclear Medicine Service HDR Remote Afterloader Mobile HDR Remote Afterloader Teletherapy.
Veterinary Non-Human In-Vitro Testing Laboratories 1
?
i t
I
Q-w j
l 27 Insp.
No.
No.*
No. of Freq.
Insps.-
Overdue i
License CateoorY Licenses (Years)
Made InsDS.
Nuclear Pharmacies Medical Product Distribution (Prepared Radiopharmaceuticals) t Medical Product Distribution (Generators and Kits)
Medical Product Distribution (Sources and Devices)
Well Logging, All Sources Well Logging, Sealed Sources Only Well Logging, Unsealed Sources Measuring Systems Fixed Gauges Measuring Systems Portable Gauges Measuring Systems Analytical Measuring Systems Gas Chromatographs i
Measuring Systems Other Mfg. and Dist., Type A Broad Mfg. and Dist., Type B Broad l
Mfg. and Dist., Type C Broad Mfg. and Dist., Other Nuclear Laundry Decontamination Services Leak Test Service Only Calibration Service Only (Less Than 100 Curies)
Calibration Service Only (Greater Than 100 Curies)
Leak Test & Instr. Cal. Service (Less Than 100 Curies)
Leak Test & Instr. Cal. Service (Greater Than 100 Curies)
Other Services Waste Disposal (Burial)
Waste Disposal Service, Prepackaged Waste Disposal Service Incineration Waste Disposal Service Processing General License Distribution Ind. Radiography fixed / Temp. Site Ind. Radiography Temp. Site only Irradiators Self Shielded (Less Than 10000 Curies)
Irradiators Other (Less Than 10000 Curies)
28 Insp.
No.
No.*
No. of Freq.
Insp.
Overdue License Cateaory Licenses (years)
Made Insos.
Irradiators Self Shielded (Greater Than 10000 Curies)
Irradiators Other (Greater Than 10000 Curies)
R and D, Type A Broad R and D, Type B Broad R and D, Type C Broad R and D, Other Civil Defense Byproduct Material Possession Only Decommissioning of Facilities Low Level Waste Storage - Other U-Mills Source Material Other (less Than 150 Kilograms)
Source Material Shielding Source Material GL Distribution Source Material Other (Greater Than 150 Kilograms)
Heap Leach, Ore Buying Stations, Byproduct Recovery i
Rare Earth Extraction and Processing Source Material Possession Only Hot Cell Operations SNM - Unsealed, Less Than 200 Grams SNM - Sealed Sources in Devices Pacemaker - Medical Institution Pacemaker - Individual 1
Pacemaker - Mfg. and Dist.
i l
'i i
i
E m
ap.
h A
- xAa, a
4
-,).n
-a m
m A
{
l I
l l
29 i
t h
I APPENDIX B ORGANIZATION CHARTS j
i A
)
i i
b 7
h L
v
-i i
r e
t a
b I
I i
i I
l CHRONOLOGY Amendments to be Considered by Agreement States (from September 1971)
Effective Date 10 CFR Part Regulations' Summary Sept. 24, 1971 20 Part C, Sch. B
- Addition of an exempt 30 Part D, App. B quantity for Ba-133.
March 26, 1971 20 A.3
- Addition and modification 30 C.40 of transport and packaging 40 C.100 procedures.
70 D.207 71 Nov. 2, 1972 20 Part D, App. A
- Changes in values of radionuclides of all concentrations in air and water.
Sept. 17, 1973 19 Part J
- Requirements for notices, instructions and reports by licensees to workers, and options available to workers with regard to inspections.
Oct. 24, 1973 20 A.2(i)
- Change to abbreviations 30 Part C, Sch. A for " curie" and " micro-32 Part D, App. A curie," and addition of and App. B definition for " milli-curie."
Jan. 10, 1974 31 C.22(i)
Authorization to use 32 C.28(h)
C-14~in in vitro clinical or laboratory tests.
March 11, 1974 30 C.40
- Requirement that suppliers 31 must verify;that customers 40 are authorized to receive 70 the material shipped.
150 July 29, 1974 20 A.2(i)
- Special curie definitions Part D, App. A and concentration values for U and Th.
)
- Compatibility Item.
' Refers to the Suggested State Regulations for Control of Radiation prepared by the Conference of Radiation Control Prngram Directors, Inc.
2 Chronology
_ Effective Date 10 CFR Part Reaulations' Summary Aug. 16, 1974 31 C.22(h)
Addition of H-3 and Fe-59
{
32 C.26(c) to in vitro tests and 35 C.28(h) extension of Medical Group l
C.28(j) licensing.
Jan. 15, 1975 31 C.22(d)
- Modification of require-32 C.28(d) ments for distribution of 31.5 GL devices.
Jan. 19, 1975 A.3(c)
- Clarification of AEC I
contractors exemption pursuant to Energy Reorganization Act.
June 25, 1975 20 D.206
- Requirements'for control of licensed material-in i
unrestricted areas and not in. storage.
June 25, 1975 35 Part C, Sch. C Addition of I-125 seeds for interstitial treatment of cancer to Group VI.
i Jan. 19, 1976 20 D.1(a)
- Incorporation of "As Low As Is Reasonably Achievable j
(ALARA)" wording.
Jan 29, 1976 20 Part D, App. A
- Modification of occupa-tional exposure limit for Rn-222.
i Feb. 23, 1976 35 Part C, Sch. C Addition of Sn-ll3/In-113m generators to Group III.
l April 19, 1976 35 Part C, Sch. C Addition of Yb-169 DTPA for I
cisternography to Group II.
-l June 2, 1976 20 Parts C, D Requirements for preser-31 and E vations of certain records 32 required by the regulations 35 40 70 i
150
- Compatibility Item.
3 Chronology Effective Date 10 CFR Park Reaulations' Summary Aug. 4, 1976 34 E.203 Personnel monitoring requirements for industrial radiographers.
Aug. 16, 1976 35 Part C, Sch. C Addition of I-125 fibrinogen for detection of deep vein thrombosis to Group II.
Dec. 29, 1976 20 D.103
- Authorizes use of respirators. Bases internal exposure limits on intake into the body.
Jan. 5, 1977 40 C.21(d)
Establishes GL for depleted uranium products.
I March 7, 1977 40 C.3(c)
- Exemption for personnel neutron dosimeters containing thorium.
May 31, 1977 31 C.22(i)
Addition of Se-75 to in 32 C.28(h) vitro GL.
l 2
June 27, 1977 31 C.22(i)
Addition of Hock Iodine-32 C.28(h) 125 calibration sources j
to in vitro GL.
]
Aug. 15, 1977 35 C.26(b)
Modification of requirements for individual physician use of radioactive material for human use.
i Jan. 6, 1978 40 C.21(a)
Extends small quantity source material GL to Federal, State and local i
governments for operational i
purposes.
Jan 16, 1978 35 Part C, Sch. C Addition of Tc-99m human serum albumin for heart blood pool imaging to Group III.
Feb. 7, 1978 35 Part C, Sch. C Addition of Tc-99m medronate sodium for bone imaging to group III.
- Compatibility Item.
l 1
4 Chronology Effective Date 10 CFR Part Regulations' Summary Feb. 16, 1978 30 C.4(c)
- Exemption for spark gap irradiators containing l
i March 14, 1978 20 D.203(c)
- Additional requirements
[
for controlling areas in which radiation levels in excess of 500 rems /hr exist.
I June 16, 1978 35 Part C, Sch. C Addition of Tc-99m gluceptate. sodium for brain and renal perfusion j
imaging to Group III.
June 23, 1978 20 D.203(f)
- Removal or defacing of radioactive material labels on empty containers.
Sept. 7, 1978 35 Part C, Sch. C Addition of Tc-99m human
~
serum albumin microspheres for venography to Group III.
[
Dec. 28, 1978 35 G.3(c)
Requirement to perform survey of patients to confirm that implants have been removed.
March 22, 1979 35 Part C, Sch. C Deletion of diagnostic procedures from medical groups.
June 5, 1979 30 C.31(d)
Notice of discontinued l
40 licensed operations.
70
. July 9, 1979 35 G.3(d),(e),
Teletherapy calibrations (f),(g),(h) l Aug. 20, 1979 19 D.1,
- Control of radiation to 20 D.101, D.102 transient workers.
J.13 Sept. 27, 1979 71' C.100
- Modification of transportation requirements.
- Compatibility item.
i h
h
.im-e.
v.
L I
5 Chronology j
fffective Date 10 CFR Part Reaulations' Summarv i
March 3, 1980 34 Part E Amendments to industrial C.26(e) radiography requirements.
l l
March 28, 1980 71 A 3(b)
- Correction to reference C.101 to Postal Service i
regulations.
l Sept.
?.,
1980 35 C.26(c)
Testing of radioisotope I
generators.
Sept. 19, 1980 40 C.21(a)
Deletion of GL for source i
material medicinals.
Nov. 10, 1980 35 D.409 Medical misadministration l
reporting.
Nov. 17, 1980 40 A.2
- Requirements to implement C.25(e),(f) the Uranium Mill Tailings (g),(h)
Act.
C.29 Part C, Sch. E Dec. 1, 1980 20 D.106(g)
- Reference to 40 CFR 190 l
for uranium fuel cycle operations.
Jan. 28, 1981 20 D.304
- Deletion of waste burial authorization.
March 6, 1981 35 Part C, Sch. C Addition of Tc-99m oxidronate sodium to l
Group 111.
March 13, 1981 34 E.203(b)
Disposal of dosimeter l
records.
March 31, 1981 20 D.306 Biomedical waste rule.
May 13, 1981 30 C.4(c)
- Exemption'for survey instrument calibration j
sources.
' Sept. 23, 1981 30 C.4(c)
- Addition of Am-241 to l
exemption for survey.
instrument calibration sources.
- Compatibility item.
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Chronology Effective Date 10 CFR Part Reaulations' Summarv Nov. 30, 1981 20 D.201
- Radiation protection.
survey requirement.
Dec. 24, 1981 40 C.3(c)(6)
- Clarification of 1
exemption for uranium shielding in shipping containers.
March 26, 1982 35 Part C, Sch. C Addition of Tc-99m labeled disofenin to Group III.
April 15, 1982 20 D.103 Placement of provisions of i
Reg. Guide 8.15 in regulations.
June 29, 1982 35 Part C, Sch. C Addition of Tc-99m
[
labeled succimer to Group III.
j July 6, 1982 71 C.104
- Advance notification of j
transport of waste.
Sept. 13, 1982 35 C.26(a)
Change medical isotope i'
committee to radiation safety committee, i
i Jan. 26, 1983 61 Part M
- Licensing requirements D.307 for land disposal of D.308 radioactive waste, and i
D.309 waste classification.
j Dec. 27, 1983**
20 D.311
- Transfer for disposal and manifests.
March 4, 1983-35 G.4(h),(i)
Teletherapy room monitors and servicing of source exposure mechanisms.
March 7, 1983 35 C.26(c)
Exemption from requirements for use of approved radiopharmaceuticals for j
unapproved procedures.
i
- Compatibility item.
t
- Published in conjunction with Part 61.
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' Chronology Effective Date 10 CFR Part Regulations' Summarv June 28, 1983 35 Part C, Sch. C Addition of I-125 sealed source in portable device to Group VI.
Aug. 15, 1983 30 C.32 Expiration and termination 40 of licenses.
70 Sept. 6, 1983 71 Part T
- Transportation regs e
compatibility with IAEA.
Sept. 28, 1983 30 W.501 Irretrievable well logging 70 soi.t rce.
150 Sept. 11, 1984 40 C.3(c)
- Elimination of exemption for glass enamel and glass
_1 enamel frit.
Sept. 10, 1985 35 C.26(c)
Addition of T-99m labeled pharmaceuticals for gastro esophegeal imaging and other -
clinical procedures.
Nov. 15, 1985 40 Part U
- Uranium Mill Tailings Appendix A (proposed) EPA-Standards 150 July 16, 1986 34 Part E
- Industrial radiography l
storage surveys and quarterly audits Feb. 11, 1987 30 Part C,M,U
- Bankruptcy notification 40 61 70 l
March 24, 1987 35 Part G, Exemption for use of.
(proposed) aerosols.
- i Part C April 1, 1987 35 Part G, Revision for medical use.
(proposed)
- Medical misadministration i
Part C reporting July 14, 1987 39 Part W
- Requirements for well
.j
- Compatibility Item.
t t
j r
8 Chronology Effective Date 10 CFR Part Reaulations' Summary l
Feb. 12, 1988 20 Part 0
- NVLAP certification of dosimetry processors.
-July 27, 1988 30,40, Part C
- Decommissioning i
70 June 26, 1989 61 Part D Greater than Class C July 17, 1989 39 Part W Exemption-Authorized to use sealed sources in well-logging.
October 12, 1989 35 Part G Addition of Palladium-103 for Intersti',ial Treatment of cancer.
l April 7, 1990 30,40, Part C
70 August 23, 1990 35 Part G Use of Radiopharmaceuticals
+
August 23, 1993 for therapy 1
January 10, 1991 34 Part E
- Safety requirements for radiographic equipment l
April 18, 1991 34 Part E ASNT Certification of 1
Radiographers June 20, 1991 20 Part D
- Standards for Protection Against Radiation t
October 15, 1991 20,30,31 Part C, D
- Notification of Incidents i
34,39,40 70 J.;
January 27, 1992 i5 Part G
- Quality Management Program and i
'Misadministrations j
i
- Compatibliity Item.
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