ML20247R582
| ML20247R582 | |
| Person / Time | |
|---|---|
| Issue date: | 07/27/1989 |
| From: | Woodruff R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Hill T GEORGIA, STATE OF |
| Shared Package | |
| ML20245D170 | List: |
| References | |
| NUDOCS 8908080059 | |
| Download: ML20247R582 (30) | |
Text
.p g
,/,/
~w
-n y
July 27, 1989 I
y Tom Hill, Acting Director Radiological Health Section Department of Human Resources Room 600, 878 Peachtree Street Atlanta, GA 30334
Dear' Mr. Hill:
This will confirm our recent discussion concerning the review of your Radiation Control Program scheduled for September 25-29, 1989.
I am enclosing a list of questions entitled, " Appendix A, Evaluation of Agreement State Radiation Control Program, State Review Guidelines and Questionnaire." These questions have been revised since our previous review and will become Appendix A to our report.
To facilitate the review process, please return a completed copy of the document including the guidelines, questions and your answers to me prior to September 15, 1989. Also, Appendix A questions are provided on an enclosed diskette.
Thank you for your cooperation and if 3 ou have questicos, please contact me.
Sincerely,
'ORIGNAC SIGNED BY RICHARD L WOODRUFF Richard L. Woodruff State Agreements Representative
Enclosure:
Evaluation of Agreement State Radiation Control Program State Review Guidelines, and Questionnaire cc w/ encl:
Vandy L. Miller, Assistant Director for State Agreements Program bcc w/ encl:
R. L. Woodruff Document Control Desk (SP01)
RII RLWoodruff: dim gf'OI 07/gj/89 89080B0059 890727
<(
PDR STPRC ESGCA I
PNU
' :4, $ '
! ;T :.Em.
i..
'n l-i l-APPENDIX A STATE REVIEW GUIDELINES AND
-5 TATE RESPONSES TO QUESTIONNAIRE i
i 1
i
.1 I
i i
b=
I
_ y
<3 y
i
{
j l
APPENDIX A' 1
EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM l
. 7 STATE-REVIEW GUIDELINES AND QUESTIONNAIRE
]
Name of State Program Georgia i
Date of NRC Review (Month, Year) September 1989 I.
LEGISLATION AND REGULATIONS A.
LegalAuthority(CategoryI) i NRC Guidelines: Clear statutory authority should exist, designating l
a State radiation cor. trol agency and providing for promulgation of i
regulations, licensing, inspection and enforcement. States l
regulating uranium or thorium recovery and associated westes 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 requirements of UMTRCA.
Questions:
1.
Please list all currently effective legislation that affects the radiation control program (RCP).
4 2.
What changes have been made to the state's statutory authority to regulate agreement materials. including LLW operations, since the last review? Please attach copies of the changes.
3.
Please cite legislation if the State has the authority to:
a.
apply civil penalties, b.
collect fees, c.
require performance bonds or sureties for decommissioning licensed facilities, d.
require performance bonds or sureties fcr clean-up of licensed facilities after a contamination accident, e.
require long term care funds for uranium mill or low-level waste facilities.
4.
If any responses to the above question are negative, explain any plans the State may have regarding those issues.
B.
Status and Compatibility of Regulations (Category I)
NRC Guidelines: The State must have regulations essentially l
identical to 10 CFR Part 19, Part 20 (radiation dose standards, I
effluent limits, waste manifest rule and certain other parts), Part
)
61 (technical definitions and requirements, performance 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 regulations should be amended as soon as practicable but no later than 3 years. The RCP I
2 a
(
u -:.
2 basestablished'proceduresforeffectingappropriateamendmentsto State regulations in a timely manner, normally within 3 years of adoption by NRC. ' Opportunity should'be provided for the public to-comment on preposed regulation changes.. (Required by UMTRCA for uranium mill regulation.) Pursuant to the terms of the Agreement, opportunity should be provided for the NRC to. comment on draft changes in State regulations.
Questions:
1.
What is the effective date of the last amendment of the state's regulations that was made~to maintain compatibility?-
2.
Referring to the NRC chronology of amendments attached to this questionnaire identify those thct have not.been adopted by'the
' State and explain the reason why they were not adopted and/or
. actions being taken to adopt them.
3.
Describe your State's procedure; for revising and adopting changes to regulations.
4.
How is the public involved in the process?
5.
.At what stage does the NRC have the opportunity to comment on draft changes to State regulations?
II. ORGANIZATION A.
Location of the Radiation-Control-Program Within the State-Organization (Category ll)
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 manage-
'{
ment'. Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division of responsibilities and requirements for coordination.
1.
Please attach a current dated organization chart (s) showing the position of the RCP within the State organization and its relationship to the Governor.
2.
Is the RCP on a comparable level within the State organization with other healt h and safety programs so as to compete effectively for funds and staff?
3.
Has the RCP program director experienced difficulty in obtaining access to appropriate levels of State management? If so, explain.
B.
Int rnal Organization of the RCP (Category II)
NRC Gt delines: The RCP should be organized with the view toward i
achieving e et ceptable degree of staff ef ficiency, place 3
s 4'
e 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 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:
1.
Please attach current, dated copies of the RCP organization charts.
Include titles for all positions and names for incumbents.
If applicable, include regional offices and contract agencies.
2.
If regional offices or contract agencies are used:
a.
To whom do regional or contract agencies personnel report admin'.stratively?
b.
To wham do regional or contract agencies personnel report technically?
3.
If the RCu shares the program with or contract 3 with other agencies to administer the program:
a.
Identify the agencies and indicate. their responsibilities, b.
How are their responsibilities set out (e'.g. statutes, MOU, contract)?
c.
To whom do their personnel report to administratively?
d.
To whom do their personnel report to technically?
C.
Legal 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.
Are legt.1 staff members assigned to assist the RCP or'do proceduaes exist to obtain legal assistance expeditiously?
2.
Is the legal staff knowledgeable regarding radioactive materials, the RCP, statutes, and regulations?
i 3.
If legal assistance was utilized since last review, provide a l
brief summary of the circumstances.
4
.4 t
-t 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 racio-active drugs in or on humans. The Committee should represent a wide spectrum of medical disciplines.
The Committee 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 Committees are advisory. This does not mean that representa-tives of the regulated community should not serve on advisory c.ommittees or not be used as consultants.
Questions:
1.
What technical advisory cc,mittees have ' cen established to assist o
the RCP?
2.
Are regular meetings scheduled?
If so, what is the frequency?
3.
Please provide a list of the names and affiliations of the technical committee (s) members.
4.
What procedures exist to avoid areas of conflict of interest by members of the committees?
I 5.
If any advisory committee was utilized during the review period, please provide a brief summary of the circumstances.
III. MANAGEMENT AND ADMINISTRATION A.
Quality of Emergency Planning (Category I)
NRC Guidelines:
The State RCP should have a written plan for response to such incidents as spilis, overexposure, 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 communication procedures should be aduquately established with appropriate local, county and State agencies.
Plans should be distributed to appropriate persons and 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 per-formed to test the plan.
Questions:
1.
What written plan does the RCP use for response to incidents involving radioactive materials (other than plans for fixed nuclear facilities)?
2.
According to the Plan, which State agency is responsible for:
5
.y i
a.
initiating response actions?
j b.
conducting operations?
c.
supervising cleanup?
3.
Describe your emergency communications procedures.
4.
Who is responsible for distributing the plan to the appropriate persons and agencies?
q 5.
When was the emergency communication list last reviewed and/or revised? (Please attaen a copy of the current list.)
6.
Other than the communication list, when was the plan last
. updated?
7.
At what stage is the NRC provided the opportunity to comment on the plan or the revision whiie it was in draft form?
8.
When was the plan last reviewed to assure its content is tp-to-date?
1 9.
When was a drill last performed to test the plan?
B.
Budget (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 (incluoing pre-licensing visits) and responset to
~1 incidents and other emergencies, instrumentation and other equipment l
to support the RCP, administrative costs in operating the program l
including rental charges, printing costs, laboratory services, computer and/or word processing support, preparation of correspon-dence, office equipment, hearing costs, etc. as appropriate.
Principal operating funds should be from sources which provide continuity and reliability, i.e., general tax, license fees, etc.
Supplemental funds may be obtained through contracts, cash grants,
)
etc.
1 Questions:
1.
Show the amount for funds for the RCP for the current fiscal I
year obtained from:
]
1 a.
State general fund b.
Fees c.
Federal grants and contracts (identify) d.
Other l
6 j
l l
L..
s 4
-'y.
e.
Total:
2.
Show the total amounts in the current RCP budget allocated for:
a.
Administration b.
Radioactive materials c.
X-ray d.
Environmental surveillance e.
Emergency planning f.
LLW regulation g.
Other (radon, non-ionizing, operator credentialing, etc.
Please identify).
h.
Total:
3.
What is the change in budget from the previous year and what is l
the reason for the change (new programs, change in emphasis, statewide reduction, etc.)?
j 4.
Describe your fee system, if you have one, and give the percentage of cost recovery for the radioactive materials program.
Please attach a copy of the fee schedule.
5.
Overall, is the funding sufficient to support all of the program needs? If not, specify the problem areas.
C.
Laboratory Support (Category, II) j NRC Guidelines: The RCP should hase the laboratory support capability inhouse, or readily available through established procedures, to conduct bicassays, analyze environmental samples, analyze samples collected by l
inspectors, etc., on a priority established by the RCP.
l Questions:
1.
Are laboratory services readily available in-house or through other departments within the State organization?
2.
If services are provide'd by other departments, discuss the~ arrange-ments, supervision, charges and interdepartmental communications.
3.
Have there been any changes in the status of the laboratory support since the last review?
If so, please explain.
4.
If laboratory services are provided by a non-State agency:
l l
a.
Discuss the contractual arrangements.
7 l
)
u
_____ ________ ____ ________ ___ _ ___ _ ___ _ _ _ _ __ _ _ _ _ ___ o
4-4 l
1 b.
Is the party providing the service a State licensee?
c.
If a State licensee provides the service or equipment, what are l
the costs?
5.
Describe the capability of the laboratory as follows:
Can it qualitatively and quantitatively analyze low-energy beta 6
a.
emitters?
i I
b.
Can it qualitatively and quantitatively analyze alpha emitters?
Can it selectively determine the presence and quantity of gamma c.
emitters?
d.
Can it handle samples in any physical form - wipes, liquids, solids, gaseous?
Does the lab participate in a periodic quality control program?
e.
If so, please identify the program.
6.
How much time does it take to obtain the results from sample analyses on both a routine basis and on an emergency basis?
7.
Please attach a list giving the types and numbers of laboratory l
instrumentation and services available.
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 l
provide a high degree of uniformity and centinuity in regulatory l
practices.
These procedures snould address internal processing of license applications, inspection policies, decommissioning and l
license termination, fee collection, contacts with communication l
media, conflict of interest policies for employees, exchange of l
l information and other functions required of the program. Administra-I tive procedures are in addition to the technical procedures utilized l
in licensing, and inspection and enforcement.
1 l
Questions:
1.
Have administrative procedures and polices been established, documented and made available to RCP staff regarding:
a.
Office administration, b.
Receipt, assignment and tracking of license applications, i
c.
Inspections (e.g., assignments, announcements of inspections),
j d.
Terminating licenses and decommissioning licensed facilities, 8
L_________--.---
ww
.,1
' 'l
[
y-e,
' Collecting fees, f.
Responding to press inquiries, g,
Conflict of interest for RCP employees, h.
~ Exchange-of-Information with NRC and Agreement States.
i.
Distribution (as appropriate) to staff and licensees of All Agreement. State Letters and-Information Notices.
'(Please have copies of these procedures available'for review).
2.
What other written administrative procedures have been
' developed?
3.
Have copies of these. procedures been distributed to regional offices and to other appropriate agencies?
4.
How are personnel and regional offices (if applicable) kept informed of changes in regulatory policies and practices?
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, regulatien revisions). RCP raanagement should periodically assess workload trends, resources and changes in legis-lative and regulatory responsibili' ties to forecast needs for increased staff, equipment, services and.fundings. -Program manage-ment should perform periodic reviews' of selected lense cases handled by each reviewer and document.the resultt amplex licenses
'(major manufacturers, large scope - Type A Broad, or potential for
-significant releases to environment) should receive second' party review (supervisory, committee, or consultant). Supervisory review of. inspections, reports and enforcement' actions should also be performed. When regional offices or other government agencies are utilized,. program management should conduct periodic audits of these 1
offices.
Questions:
1.
How does management track the status of the licensing and inspection programs -- workloads, backlogs, problem cases, etc.?
2.
How often are meetings held between program management and staff?
3.
How of ten is a statistical tabulation of licenses, licensees, licensing actions, inspections due, performed and overdue, etc.,
prepared?
4.
How does program management keep abreast of changes in legis-lative and regulatory responsibility?
9
j 7
L..
1 l
i l
)
l 5.
What license review practices are followed for unusual or
- omplex license applications?
6.
How many management reviews of license cases were performed since the last review?
7.
Wera all license reviewers included in the cases selected for management review?
8.
How many field accompaniments of inspector: were conducted by l
program management?
9.
Were all inspectors (including supervisors acting as inspectors or LLW inspectcrs, if r.pplicable) accompanied by management l
during the review period?
10.
Do all inspection reports receive supervisory review?
11.
Does all e,forcement correspondence receive supervisory review scior to dispatch?
12.
If applicable, how many management audits were made of regional offices or other government agencies involved in the regulation of agreement materials?
(Please have reports of audits performed on regional offices or contract agencies available for review.)
1 l'
F.
Office Equipment and Support Services (Category II)
NRC Guidelines:
The RCP should have adequate secretarial and l
I clerical support. Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses)
I programs.
Similar services should be available to regional offices, if utilized.
Professional staff should not be used for fee collection and other clerical duties.
la.
Describe the secretarial and clerical support for the radioactive materials. program, including if appropriate, any problem areas, b.
If your program has regional of fices, discuss the clerical support for those offices.
l In cases of unusual workloads or vacancies, can supplementary c.
secretarial / clerical support be obtained?
2.
Describe the computer equipment available to the RCP.
3.
What operating system do you use (i.e., MSDOS, UNIX, APPLE, etc.)?
4.
What data base or spreadsheet programs do you use?
10 l
L_____..
4 5.
What word processing program (s) do you use?
6.
Does your word processing program have the capability to process documents that may be transferred to and from and from the IBM l
5520 system? (With the exception of Wordstar, most popular programs have this capability. This information can be found in your user manual index under "DCA" or " revisable format" files.)
7.
What licensing functions are on your computer system?
8.
What compliance functions are on your system?
9.
Do you have a modem?
If so, please describe how a connection can be made.
- 10. Are computers or terminals available to the professional staff, and if so, what use is made of them?
11.
Do you have access to a facsimile transmission unit?
If so, please identify it by name and type and provide the receive and verification '(information) telephone numbers.
- 12. Describe the fee collection system and identify the staff resources assigned to it.
G.
fublicInformation(CategorfII)
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 clear i
personal nature. Opportunity for public hearings should be provided in accordance with UMTRCA and applicable State administrative
-procedure laws.
Questions:
1.
Are licensing and inspection files available for inspection by the public?
2.
If so, what information may be withheld?
3.
What written procedures and laws govern this?
Please provide reference citations.
IV.
PERSONNEL A.
Qualifications of Technical Staff (Category II)
NRC Guidelines:
Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences. Addi-tional training r.nd experience in radiation protection for senior personnel including the director of the radiation protection program should be commensurate with the type of licenses issued and inspected 11
.4 by the State. Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.
Questions:
1.
Do all professional personnel hold a bachelor's degree or have equivalent training in the physical or life sciences?
2.
What additional training and experience does the RCP director have in radiation protection?
3.
What additional training and experience are required of the senior personnel?
4.
Do written position descriptions describe the c'uties, responsibilities and functions of each professional position in the RCP and the qualifications needed by applicants for them? Please attach copie.
B.
Staffing Level (Category II)
NRC Guidelines:
Professional staffing level should be approximately 1-1.5 person-year per 100 licenses in effect. RCP must not have less than two professionals available with training and experience to operate RCP in a way which provides continuous coverage and continuity.
For States regulating uranium mills and mill tailings current indications are that 2-2.75 professional person years' of effort, including consultants, are needed to process a new mill license (including in situ mills) or major renewal, to meet require-ments of Uranium Mill Tailings Radiation Control Act of 1978. This effort must incluce expertise in radiological matters, hydrology, geology, and structural engineering.
Questions:
1.
Complete a table as below, listing the professional / technical person years of effort applied to the agreement or radioactive material program by individual, include the name, position, fraction of time spent and include the following areas:
administrative / supervisor, inspection,,
laboratory, regulation development, other).
j Name Position Area of Effort FIE O
e e
a Total 1
12 e_______
1
2.
Compute the professional / technical person year effort of person years per 100 licenses (excluding mills and burial site licenses).
Show calculation.
3, Is the staffing level adequate to meet normal and special needs and backup?
]f not, explain.
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 indepen-dently, monitor work of junior personnel, and participate in the establishment of policy. Junior personnel should be initially limited to reviewing license applications and inspecting sma'l programs under close supervision.
i Questions:
1.
Identify the junior personnel and senior personnel.
2a. What duties are assigned to junior personnel?
b.
How is their work monitored?
3.
Is there adequate supervisory or senior guidance and direction for junior personnel?
4.
How do senior personnel participate in the develo.pment of program policy?
D.
Training (Category II) l NRC Guidelines:
Senior personnel should have attended NRC core l
courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices. (For mill States, mili training should also be included.) The RCP should have a program to utilize specific short courses and workshops to maintain appropriate level of staff technical esmpetence in areas of changing technology.
Questions:
J 1.
List materials personnel and all of the training coursos, workshops, seminars, symposia, etc. that your personnel have attended since the last review, and the source of the funding for the training (e.g., travel, per diem, tuition as applicable).
Source of Student Course Course Sponsor Dates Funding 1
9 4
13
2.
Explain how new employees are trained.
3.
If any of your RCP staff currenti, need NRC training, please identify the employees 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 area.
The RCP organization structure should be such that staff turnover is minimized and program continuity maintained through opportunities for promotion.
Promotion opportunities should exist from junior level to senior level or supervisory positions.
There aise -hould be opportunity for periodic salary increases compatible with experience and responsibility.
Questions:
1.
Identify the RCP employees who have left the Agreement materials program since the last review and give the reasons for the turnovers. Also state whether the positions are presently vacant, filled (name replacement), abolished or other status.
2.
I.ist the RCP salary schedule:
Position TitL_e Annual Salary Range 3.
Compare your salary schedule with similar employment alterna-tives in the same geographical area, such as industrial, medical, academic employers or other State agencies.
4.
Explain whether your salary schedule is adequate to recruit and retain staff.
5.
What opportunities are there for promotion within the RCP organizational structure without a staff vacancy occurring?
Y.
LICENSING A.
Technical Quality of Licensing Actions (Category I)
NRC Guidelines: The RCP should assure that essential elements of applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persans wno will use material, facilities and equipment, and operating and 14 A
.o emergency procedures sufficient to establish the basis for licensing actions.
Relicensing visits should be made for complex and major -
licensing actions.
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:
la. How many specific licenses are currently in effect?
b.
Picase attach numerical totals of the licenses in each category.
2a.
How many new licenses (not amendments in entirety) have been issued since the last review, b.
How many were major licenses? (See questinn 31 for criteria.)
3.
List ts.e specific licenses (name and itcense number) that were terminat:
since the last review.
4.
How many amendments were issued curing the review period?
5.
Identify unusual or complex licenses issued since the last review, including name and license number.
6.
Note any variances in licensing policies and procedures or
~
exemptions from the regulations granted since the last review.
7e. Do you require licensees to submit contingency plans?
(
Reference:
All Agreement and Non-Agreement State letter dated May 21, 1987, or NUREG 0767).
b.
List the licensees (name end license number) who are subject to contingency plans requirements and the status of their plans (approved, under review, etc.).
Ba. What criterion does the State use to determine the need for a relicensing visit?
b.
How many relicensing visits were made during this review period? If so, explain.
9.
How do you ensure up-to-date information has been submitted prior to a license renewal?
- 10. Has the State taken any special licensing action with respect to licensees operating undar multiple jurisdiction?
11.
prepare a table as below showing the State's major licensees with name, number and type.
INCLUDE:
15
o Broad (Type A) Licenses o
LLW Disposal Licenses o
LLW Processi'ng and Brokers o
Major Manufacturers and Distributors o
Uranium Mills o
Large Irradiators (Pool Type or Other) o Radiopharmacies o
Other Licenses With a Potential Significance for Environmental Impact o
Other Licensees You Consider to be " Major" Licensees Name License Number Type B.
Adequacy 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 identifi-cations, and permissive or restrictive conditions.
Questions:
1.
List new and revised SS&D registrations of sealed sources and devices issued during the review period?
SS&D Name Type Registry of of Number Manufacturer, Device Distributor-or or User Source (Custom Evaluation)
?
~'
2.
How many SS&D evaluations have been made for which registry documents have not yet been issued?
3.
What guides and procedures are used to evaluate registry applications?
16
[
ii };
la..p,q:
a
- 4. -.Please describe the ' procedures for supervisory review of. SS&D:.
registrations.-
Sa. Do you have any pressing concerns about any sources / devices /
products currently authorized for distribution including lto p
persons _either generally licenseo or exempt from licensing?
l l
b.
If so,- identify the items by manufacturer's name and model number and describe ' our concerns, y
a C.
Licensing Procedures (Category II)-
~
NRC Guidelines: lhe RCP should have. internal. licensing guides, checklists, and policy memoranda consistent'with current NRC practice License applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions.. The present compliance status of licenstes should be considered ia-licensing actions. Under the NRC Exciange-of-Information program, evaluation sheets, service lic inses, 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.
Are current NRC Regulatory Guides furnished to reviewers?
2.
Do your reviewers use the standard review plans, model licenses, etc., that are furnished in the NRC Fuel Cycle Policy and Guidance Directives FC xx-xx?
3.
Are checklists used by the reviewers maintained in the files?
4.
Unat internal licensing' guides and procedures has the Statt developed?
5.
What licensing guides and regulatory positions are furnished to new and renewal license applicants?
6.
How do reviewers determine the present compliance status of-licensees when considerin~g licensing actions?
1 7.
For-what length of t' are licenses issued?
8.
Explain how soon-to-expire i censes are tracked to assure either timely applications are rece ved or procedures initiated to terminate the license.
9.
What mechanism exists to assure that SS&D registrations and service licenses issued by the State are distributed to the NRC?
17
nyg-...;
.j. p.
W
- 10. Have you developed your own-standard license conditions, and if so, when were they reviewed and updated?. Please provide copies for review.
- 11. How do you verify that'your standard conditions are comparable to the current NRC conditions?
12 How'is your SS&D registry; kept current?
L
- 13. Describe the system used to advise. licensees of. pertinent changes in regulations and regulatory procedures.
- 14. Describe'your procedures for maintaining the license files'.(How-are files and folders arranged?.Are telephone contacts and visits documented? Who is responsible for filing materials in folders?).
- 15. Are there opportunities for license reviewers to accompany inspectors?
VI.- COMPLIANCE A.
Status of Inspection Program (Category I)
NRC Guidelines: The State RCP should maintain an inspection program adequate 'to assess licensee' compliance with. State regulations and license conditions. The RCP should mair.tain statistics which are adequate to. permit Program Managemer.t to' 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 vs.
i
. 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:
1.
How is statistical information maintained about the inspection program to permit periodic assessment of its status by RCP management?
2.
Prepare a table as below, indicating the Inspection Priority, the total number of licenses in each priority, the scheduled reinspection frequency, and the number of inspections made in each priority for the review period.
i
,I 18
= _ _ - - _ -
!+
' Inspection Number Scheduled Number of Priority-Licenses Frequency Inspections-3.
Prepare a table (or tables) as below which identify the State Inspection Priority 1, 2, and 3 licenses with overdue inspections. Include the inspection priority, the due date, and the number of months the inspection is overdue.
(If list is extensive, a comparable computer printout is acceptable.) The list should include' initial inspections that are overdue.
Due Months Licensee Priority Date Overdue 4.
Prepare a table as below indicating the total number of overdue license inspections.for all lower priorities.
Inspection Priority Number Overdue 6
e 5.
If there are overdue inspections, describe or attach a copy of your plan for eliminating it.
Identify priorities, target dates and procedures for measuring progress. Include, as appropriate, copies of memoranda to the RCP staff regarding the plan.
- 6.
Project the number of inspections needed to be done annually to meet your inspection priorities and to eliminate your overdues, if any.
7.
How are inspection schedules planned and how are the dates and personnel assignments made?
8.
How are initial inspections identified when they become overdue?
9a. Describe your inspection priorities for inspecting terminated licenses.
4 b.
Hew many of these inspections are pendiag at this time?
c.
How many were inspected since the last review?
i 1
19
10a. How many reciprocity notices were received in the review period?
- b. How many reciprocity inspections were conducted in the review period?
11.
How many field inspections of radiographer were performed in the review period?
i 1
B.
Inspection Frequency (Category I)
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, i
broad licensees, and industrial radiographer 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:
I 1.
please attach a copy of the State's priority system.
I 2.
How are inspection priorities assigned to licenses?
j 3.
Is the priority noted in the license file?
4.
Discuss any variances in the State's priorities from the NRC priority system and the reasons for the variances.
l 5.
Describe the State's policy for unannounced inspections and exceptions to the policy.
6 Describe the State's policy for conducting follow-up inspections.
7.
Identify any individual licensees or groups of licenses for which the State is inspecting more frequently due to compliance problems.
Please discuss the nature of those problems.
l C.
Inspector's Performance and Capability (Category I)
NRC Guidelines:
Inspectors should be co:npetent to evaluate health and safety problems and to determine compliance with State regulations.
Inspectors must demonstrate to supervision an under-standing of regulations, inspection guides, and policies prior to independently conducting inspections.
The compliance supervisor (may be RCP manager) should conduct annual field evaluations of each inspector to assess performance and assure application of appropriate and consistent policies and guides.
Questions:
l 20
g v
7
.m y
.. ;-/
1 1.
How do new inspectors become qualified to conduct
-independent inspections since'the last review?'
2.
Prepare a table showing the. number and types of supervisory accompaniments made'during the review period. Include:
Supervisor Inspector License Category Date 3.
Did all inspectors receive at least one accompaniment by the compliance supervisor during the~ review period?
If not, explain.
D.
Respo.nses to Incidents and Alleged Incidents (Category I)
.NRC Guidelines:
Inquiries should be promptly made to. evaluate the need for onsite, investigations. Onsite 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, investiga-tions should be made during the next scheduled inspection.. Onsite 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).
Investi-gation _(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 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.
Special Note: The criteria for reporting radioactive raterials events are set out in All Agreement States letter from D. Nussbaumer dated July 22, 1986:
o Abnormal Occurrences: These are the most significant events.
In addition to an early telephone notification to the regional office, a written report from the State is needed for inclusion in the Quarterly Report submitted by NRC to Congress (AOR).
Criteria for reporting and guidance on content of reports can be found in any AOR.
21
w
..s o
Telephone Reports: These are events for which NRC would like to receive early telephone notification. Typically, these include incidents requiring prompt or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notification by licensees to States or events that receive significant media attention.
o Other Reportable Incidents:
These are events for which reports are required of the licensees to the State.
Questions:
1.
What criteria is used to determine the need for and timeliness of onsite inspections of reported incidents?
2.
How many reports of incidents and alleged incidents were received during the review period?
3.
How many onsite inspections of incidents were conducted during the period?
4.
How many inspections of incidents revealed an incident occurred which required NRC notification, either by telephone or by written report?
(Refer to July 22, 1986 All Agreement State Letter for definition.)
5.
Please have summaries available of the events identified in questions 2 and 4 above. Use the incident summary forms attached for this purpme.
6.
If not included in the response to question 5 above please attach a summary of reports of leaking sealed sources.
Please identify the source by manufacturer, model number, age of source (if available), date of leak test and leak test result.
7.
Did any incidents involve equipment or source failure or operating procedures that were deficient but were approved?
If so, now and when were State licensees and the NRC notified of per'.,inent information relevant to other licensed operations?
8.
Was information on incidents involving failure of equipment or sources provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency?
Please provide details.
9.
If the RCP utilized medical or technical consultants for an emergency during the review period, please describe the circumstances.
10.
Describe the procedures for looking into allegations or other f
reports of possible wrong doing by licensees, for example, a.
Protecting the identity of allegers or persons requesting that their identities not be made available for public disclosure.
1 22 i
b.
Obtaining documentation (e.g., signed statements, copies of records).
c.
Obtaining the services of persons with specialized training and experience such as conducting and documenting formal interviews.
- i. Obtaining necessary legal counsel for inquires into wrong doing.
e.
Guidance for staff when allegations or inspections disclose the possibility of willful violations of regulatory requirements or other evidence of criminal wrong doing.
Picase attach copies of these procedures.
11.
In the review period, are there any cases involving possible criminal wrong doing that were looked into or are presently.
undercoing 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 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).
The inspector and compliance supervisor should review licensee responses.
Licensee responses to enforcement letters should be promptly acknowledged as to adequacy and resolution of previously unresolved j
items. Written procedures should exist for handling escalated i
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.
Questions:
~
1.
What enforcement measures are available to the State to provide a deterrent to licensee noncompliance with regulations or license provisions?
2.
Are there written procedures establishing severity levels for violators? Please attach a copy.
3.
Are there written procedures for escalated enforcement? Please attach a copy.
23
~%
4.
If the RCP can apply civil-penalties, have procedures been established to determine when they apply and the amounts?
Please attach a copy.
5.
Describe the State's provisions for criminal penalties.
6.
Are enforcement letters issued within 30 days following inspections?
7.
Do you have a standard format for enforcement letters?
8.
How are recommendations differentiated from items of non-compliance in the letters?
9.
Do the letters reference the appropriate regulation or license condition being violated?
- 10. What. time period is specified in the enforcement letters for the licensee to respond with corrective actions taken?
11.
Do inspectors write enforcement letters?
If so, do the letters undergo supervisory review before they are sent to the licensee?
j
- 12. Who reviews licensee responses?
- 13. What is the time limit for the State's acknowledgement of licensee responses and what tracking system exists'for assuring resolution of the items of non-compliance and unresolved items?
14.
Does the State have the authority to impound radioactive material?
15.
Can the State issue Orders, including Emergency Orders?
16.
Do State administrative procedures permit the opportunity for hearings in major enforcement cases?
17.
Describe the State's policy for conducting follow-up inspections.
18.
If during the review period the State has issued orders, applied civil penalties, sought criminal penalties, impounded sources, or held foriaal enforcement hearings, identify these cases and attach a summary of the circumstatices and results.
19.
Have any compliance problems occurred involving licensees operating under multiple jurisdiction or under reciprocity?
If so, please identify the licenses and explain if other Agreement States and NRC were advised.
F.
Inspection Procedures (Category II) 24 j
NRC 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 the inspection of licensed programs.
NRC Guides may be used if properly supple-mer.ted 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.
Procedures should be established for maintaining licensees 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.
Do you use inspection guides that are specific to categories of licensees?
2.
Has the RCP developed its own inspection guides or does it use NRC guides?
3.
Discuss the use of inspection policy memoranda, interpretations, etc., to supplement inspection guides.
4.
Are there written policies and procedures for:
a.
unannounced inspections?
b.
obtaining corrective action?
c.
following-up and closing out previous citations of violations?
d.
interviewing workers?
e.
observing operations?
f.
exit interviews with management?
g.
issuing notices of violations and findings of health and safety problems?
~ ' '
Please have copies of these procedures available for the reviewer.
I 5.
Describe the procedures for maintaining licensee's compliance l
histories.
1 l
l 25
y
.7
/:a p.
r-E
,6.
Explain your policy for~ supervisors debriefing inspectors upon return from inspections.
1 i,,
7..
What procedures are there for providing feedback of compliance l
~information to licensing?-
G.
Inspection Reports,(Category II) l NRC Guidelines:
Findings of inspections should be documented in a l
rep' ort 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.
Describe the format (s) used by the RCP for documenting
. inspections.
.2.
Do the reports doccment:
a.
the entrance and exit discussions held with' license management?
b.
follow-up of previous citations of violations?
c results of interviews of workers?
d.
results of observations of operations?
e.
confirmatory measurements conducted by the inspector?
l t
f.
areas of the licensee's program needing snecial attention at the next inspection?
g.
the items of non-compliance found in the inspection?
i H.
Confirmatory Measurements (Category II) 1 1
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.
RCP instrumentation should be adequate for surveying license operations (e.g., survey meters, air samplers,' lab counting equipment for smears, identification of isotopes,etc.).
RCP instrumentation should include the following types:
26
~
GM Survey Meter:
0-50 mr/hr Ion Chamber Survey 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 uc/ 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.
Questions:
1.
Discuss the State's policy for conducting confirmatory measure-ments as a part of each inspection (e.g., air samples, wipe samples, air flows, dose rates).
2.
List the equipment that is readily available to the RCp for 1
surveying licensed operations and conducting appropriate confirmatory measurements.
3.
Describe the method used for calibrating survey instruments and the frequency of calibration.
VII. OTHER ASPECTS OF THE STATE'S RADIATION CONTROL PROGRAM i
i 1
A.
Non-Agreement Sources of Radiation
)
Questions:
1.
Are the licensing and inspection procedures for NARM the ;ame as
)
for agreement materials?
B.
Environmental Monitoring Program Questions:
1.
To indicate the scope of the env'ironmental monitoring programs 1
undertaken specifically to evaluate the environmental radio-j logical impacts of State licensed facilities describe:
)
a.
the licensee (name, license number and type of operation) b.
types of media sampled c.
the number and locations of stations sampled d.
the frequency of sample collection e.
the analyses run on each type of sample 27 l
p,,,,. 4 g..
JJ 15 I
2.
How is such data used in your licensing anc' inspection programs x
for.these'~ State licenses?
Please attach copies of any summaries or periodic reports relating to this_ aspect of your environmental surveillance program.
C.
Other Areas This?section of the review is for the use of either the reviewer or the RCP to address issues pertaining only to the. individual State, to-new areas of concern, or to generic or State-specific issues raised by NRC staff.
p Questions:
i 1.
Have there been any' applications or' approvals for incineration, compacting or for methods of LLW disposal not provided for in the regulations (i.e.,
10 CFR 20.302 requests)?
If 50, please list the appli_ cant and nature of application and status.
2.
Is the State making-any effort during inspections of nuclear pharmacies'to' observe-the licensee conducting the required.
molybdenum breakthrough tests, i.e., what is the State doing in addition to record reviews to establish compliance or noncompliance with the requirement?
3a.
Is the State mounting any special effort to look at the i
possibility of reconcentration of radionuclides-in sanitary
^
sewers and sewerage treatment plants as part of the regular' inspection program? If so, please describe.
b.
If' reconcentration of radionuclides in sanitary sewers or sewerage treatment plants has been found, please identify the site and licensee.
4.
How does the RCP handle inspection fir; dings concerning industrial safety hazards? (Reference A/S letter dated January 18,1989.)
Sa.
3M has reported not all of their customers returned static eliminators.that were subject to recall. Are you aware of this?
b.
If such customers were located in~your State, please provide a summary of any actions.taken by the RCP to locate the users-,
im etc. (Note: We recognize that by this date the Po-210 has significantly decayed and reduced _the potential hazard.
The information is requested because of its relevance to the question of maintaining a system to adequately account for GL devices.)
l 28
- W.
.:3
_....z
- j INCIDENT REPORTING CHECK LIST
.1.
' Type of Incident orl Alleged Incident:
2.
.Was an investigation conducted by your staff?
.Date Initiated:
3.'
Did the investigation reveal: (check all appropriate blocks).
[
] Loss of packagefeffectiveness or contamination?
.['
] Thef t or loss of licensed material?
-[
] Overexposure of. individual to radiation.or radioactive material?
[
.] Excessive levels.of radiation or concentrations of RAM?
'[
'] Safety. failure of GL.ievices?
[~
] Equipment ~ failure t',at could occur on similar licensed devices? -
[-
] Leaking' source?
[
- ] Misadministration?.
.[
.] Transportation incident?
[
.] Uranium mill occurrence?
[
]:Possible criminal violations?
If any boxes ar checked or if the event is newsworthy, review the criteria for
- telephone rept,ing Agreement State Materials Events to the NRC Regional Office (see All-Agr; snent State letter. dated July 22, 1986 and December 23,'1988). A description of the. incident should he summarized as follows for'the next NRC review.'(Use extra sheets if necessary.)
SUMMARY
OF EVENT Licensee:
__ License No.:
Location of event:
Description of event:
1-
-Isotope:
Amount:
Date:
Date of Report to RCP:
Identify
. any-other licensees involved:
Licensee:
License No. :
Jurisdiction:
Reciprocity Licensee: Y/N Describe clean-up actions taken the RCP?
What radiation measurements were taken by the RCP?
' What' other ' action' was required of the RCP?
What. action was taken to notify the NRC, other Agreement States or licensecs?
Is the case closed?
Is record of incident in RAM files?
What enforcement action was taken?
h NAME OF PERSON PREPARING THIS
SUMMARY
DATE 29 I;
t
_ - _ _ _ _ _ _ _ _ - _ - _ _ _ _ _ _ - _ - _ _ - - _ _ - _ _ _