ML20141G883

Rev 4 to D.2 Scheduling,Conducting & Reporting Onsite Reviews of Agreement State Regulatory Programs

ML20141G883
Person / Time
Issue date:	12/27/1984
From:	Lubenau J, Nussbaumer D NRC, NRC OFFICE OF STATE PROGRAMS (OSP)
To:
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References
D.2, NUDOCS 8604240012
Download: ML20141G883 (89)

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l State Agreements Program Standard Approval  :

I The attached revision to D.2, " Scheduling, Conducting and Reporting  !

On-Site Reviews of Agreement State Regulatory Programs" is submitted for l final approval. 4 lE~El' N 1 Lu 51 mad, Senior Project Manager OLkL

/Dfnald A Msbaumer Jl2 sistant nest 1

Wirector for State Agr@6ements Program l

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9604240012 860417 PD9 GTPRGESGIQ eswem.-aw e-e %,.%,e, -- c-.___,.,%-- * - - --- - -

STATE AGREEMENTS PROGRAM

> DIVISION I t

INTERNAL PROCEDURE

! Post-Agreement D.2 Scheduling, Conducting Activities and Reporting On-Site Reviews of Agreement State Regulatory Programs I. Introduction l A. This section sets forth the general objectives and procedures j for scheduling, assigning personnel, reviewing, and reporting j the on-site regulatory program reviews of Agreement State

radiation control programs.

B. The Comission's Criteria for Agreements with States under Section 274 of the Atomic Energy Act of 1974, as amended, details the principal elements of an adequate and compatible -

program. The criteria were published in the Federal Register

on January 23, 1981, 46 FR 7540 and 46 FR 36969. An amendment to Criterion 9 (concerning waste disposal) was published July 21, 1984 at 48 FR 33376. To assure continuing adequacy and compatibility of Agreement State regulatory programs, on-site

reviews are held at appropriate intervals. Other elements of

, the NRC post-Agreement program also provide infonnation for l staff recomendations on adequacy and compatibility. These include, as examples, the exchange of information program, review of all Agreement State licenses, and review of proposed State regulations. Reviews of Agreement State programs are required by Section 274j of the Atomic Energy Act of 1954, as amended. These reviews are conducted in accordance with

! guidelines set forth in the NRC Guide for Evaluation of i Agreement State Programs. The Guidelines were published in the Federal Register at 46 FR 59341 on December 4,1981 and became effective that date. The Department of Labor will be

informed when the staff believes a State program is not adequate to protect public health and safety or compatible j with that of NRC.

C. The responsibility for scheduling reviews of Agreement State radiation control programs, recomending assignments of staff personnel to conduct program reviews, and review of reports of review meetings is assigned to the Senior Project Manager.

Ste.ff assignments and dates are subject to final approval by the A/D and Regional Administrators.

D. This procedure prescribes present SA practices for reviewing Agreement State programs. SA staff is always open to exploring new methods, particularly with respect to Revision 4 Orc t7/1984

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l documentation practices and welcomes suggestions and coments.

These should be directed to the SA A/D.

E. Major revisions to this procedure will be made in* consultation with the Regional State Agreements Representatives as appropriate and necessary.

II. Review Objectives A. The objective of the SA review of Agreement State radiatian .

control programs is to provide a substantial part of the nasts for detemining whether or not:

1. Agreement State regulatory programs continue to be adequate to protect the public health and safety from radiation hazards arising from possession and use of agreement materials, and

2. Agreement State regulatory programs continue to be compatible with the regulatory program conducted by the Comission. .

B. The reviews strengtheri Agreement State programs by:

1. Identifying actual or potential program deficiencies and recomending to State management appropriate actions to be taken by the Agreement State to correct the program deficiencies, and

2. Obtaining confirmation from the Agreement States that remedial action has been or will be taken to correct the program deficiencies.

C. The reviews also serve to obtain infomation needed by the.

Comission in the formulation of changes in the regulatory process and provide Comission staff with information on the Agreement State program.

III. Review Schedules Responsibility for preparing schedules for conducting reviews of Agreement State regulatory programs and field evaluations of Agreement State inspectors is assigned to the SA Senior Project Manager.

A. New Agreement State.

A special orientation meeting will be scheduled for each new Agreement State within 90 days following the effective date of a Section 274b agreement. A second meeting which includes a review of the Agreement State program, will be scheduled Revision 4 DEC 2 7/1984

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l approxi:nately 6 months later after the effective date of the l agreement.

B. Agreement States with established radiation contml programs. I

1. Agreement States with established radiatior, control ,

programs will be scheduled for regulatory program reviews j on a frequency of at least every 18 months except as i follows: 1

a. The interval between reviews of Agreement State regulatory programs in States with significant program deficiencies may be shortened to another

'; appropriate interval with the approval of the SA A/D. The recommendation of the reviewer shall be considered.

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b. The interval between reviews of a particular Agreement State regulatory program may be increased

, based upon a proposal by the Regional Administrator j

to SP setting forth the rationale for doing so.

2. Separate trips to the State to perform specific parts of the review are permitted and may be advantageous to the NRC and to the State. Examples are evaluations of State inspectors and visits to specific State licensed facilities. Such activities also serve to improve day-to-day contacts between the Region and the State.

Such activities, however, must normally be completed prior to the exit meetings with State RCP staff and the State Health Officer.

3. Agreement State special meetings,

a. A special meeting may be scheduled with an Agreement ,

j State when: '

i. The radiation control program is in serious difficulty because of the loss of key staff, loss of operating funds or other acute problems i having a major impact upon the program.

ii. The Agreement State implements a change to its regulations or operating procedures which introduces a serious conflict of compatibility, or purports to impose its regulatory authority on persons subject to Commission authority.

iii. The State indicates that a special meeting is necessary and provides appropriate t

justification for such a meeting.

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j U I iv. The previous routine review resulted in more than one significant Category I comment. In U

.; such cases, the special meeting shall be -

' considered a follow-up meeting and.should be conducted within 6 months of the p'revious review.

v. NRC staff learns of special ptchlems with a license or group of licenses or of an event a requiring special attention. i l

H IV. Assignment Of SA Personnel For Regulatory Program Reviews ,

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! SA Staff are assigned on the following basis. j I

A. Regional SA staff y

H* Normally, the Regional SA Representatives (RSAR) shall serve as the designated reviewer, or principal reviewer.or review manager for Agreement States in their regions. The RSAR will b consult with the A/D or Senior Project Manager to determine

'. the scope of SA or other NRC staff assistance that will be 4.

needed for reviews. SA Headquarters will serve as the primary l' source to backup and supplement RSAR review activities and will assist as appropriate in arranging for other NRC office participation as necessary.

Special problems in the State's program.

B.

Staff assignments may be made because of known or suspected

j. problems in some aspects of the State's program, e.g.,

b - licensing or inspection. In such cases, a staff member with h

specialized training or experience in the appropriate field 1 may be assigned to assist. Alternatively, technical d assistance from other NRC offices may be provided (See SA j!. ProcedureD.11).

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C. Special staff assignments and technical assistance from other NRC offices may also be necessary for reviews of States regulating uranium mills and low-level waste disposal sites.

p The need for such assignments should be explored by the j reviewer with the A/D or Senior Project Manager early in the

'i planning of the review.

\j D. Special orientation meeting with a new Agreement State.

1 A senior member is normally assigned for orientation meetings G with new Agreement States.

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• i 1 l V. Scheduling A Review Meeting With An Agreement State

. Dates for review meetings are arranged by the designated SA program reviewer in coordination with the Senior Project Manager or by the  !

A/D. When directed to schedule a regulatory program review the following will be done:

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A. The Senior Project Manager or the A/D will establish the scope ,

l of the program review and the extent, if any, of other NRC j participation in the review.

I B. The Senior Project Manager or the A/D will designate a desirable time slot (month) for the program review. )

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I l C. The reviewer will:

l 1. Contact the Agreement State at an a propriate management i level (usually the Program Director and set a definite j date for the program review within the designated time j slot. Staff members are encouraged to make early contact 3 with the State to " block out" the review dates with the ,

a understanding that details, such numbers of field i evaluations, site visits, etc. will be established later.

j Infom the Senior Project Manager when the dates are set.

i 2. The reviewer will pregare a letter to the State Health

! Officer or equivalent , Connissioner of Health, etc.,

f referencing the discussion with the Program Director and i setting forth the dates of the program review and requesting a meeting for the purpose of discussing the results of the review. Sample letters for State 3

officials familiar and unfamiliar with the Agreement i State program are shown in Attachment A. The letter is l signed by the Regional Administrator and copies are to be i sent to the State Program Director; to the NRC Regional l State Liaison Officer; Director, State Programs; A/D for i State Agreements.

l 3. The selection and scope of field evaluations of l inspectors is made by the reviewer assigned to the 4

progra;n review. The following guidelines apply:

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a. The region is responsible for tracking and maintaining records indicating the needs for field 4 esaluations of State inspectors.

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b. Unless tiine constraints dictate otherwise, review j meetings should include at least one field i

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1. Unless otherwise indicated, " reviewer" also means principal reviewer

or review manager.

2. See Attachment B for list.

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l c evaluation of an inspector, cr. as an extension of the review of licensing and compliance aspects, ~

accompaniment of an inspector during an inspection of a major licensee.  !

c. Agreement State inspectors ar'a to be selected for field evaluations using the following priorities:

1. All new Agreement State inspectors who the State have deemed to be qualified to i independently conduct inspections who have not i been previously evaluated.

{ ii. Agreement State inspectors who have been j recomended by previous reviewers for a new

field evaluation.

iii. Senior compliance personnel who have not been

evaluated for three or more reviews. This j includes persons who are directly responsible

for supervising inspectors of the compliance program.

! iv. Upon request of the State program director and j with the approval of the A/D.

d. When calling the State to arrange a review, the i reviewer should detemine from the program director j if there are new inspectors qualified to perform

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inspections. The reviewer should identify the

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Agreement State inspectors to be scheduled for field .

. evaluations and types and number of licenses to be

{ inspected.

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! e. Accommodations for the SA field evaluator should be  !

! made in advance with the assistance of the Agreement

! State Program Director or Compliance Supervisor when inspections are scheduled in locations requiring j overnight absence from the Agreement State offices.

i f. Field evaluations of new or junior State inspectors should include a representative cross-section of State licenses. Attempts should be made to schedule moderate sized academic, medical, and industrial

.' programs. Industrial radiography and teletherapy program should be included in the selection.

Licenses authorizing small programs such as private practice medical, civil defense, gauges, gas chromatographs, etc., should be avoided. When experienced, senior inspectors are accompanied, aim for broad licenses, major processors and distributors and other major, complex licenses.

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7 When scheduling accompaniments, check previous reports of field evaluations to avoid accompanying State inspectors to the same licensee.

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g. It may not be possible or advantageous to schedule field evaluations during the review meeting. In such cases, the reviewer may arrange evaluations at l

other times provided they are completed before the exit meetings that take place at the end of the review.

4. When other SA staff or other NRC staff are to participate in a review, the reviewer should consult with the Senior Project Manager to discuss the scope of their participation in the review. ,

VI. Preparing For Reviews Of Agreement State Radiation Control Programs Preparation for review of Agreement State programs and field evaluations of State insp::ctors include the following:

A. A detailed review of the Agreement State correspondence files should be conducted prior to departure for the review. This review should encompass file material back to the previous review meeting.

, 1. This review is made to determine subjects requiring ,

l attention at the review meeting and if there is any incomplete or pending business between the Agreement l'

State and the Comission. An effort should be made to resolve or complete all unfinished business prior to departure.

2. The current status of the Agreement State's regulations l for control of Agreement material should be determined.

i 3. Copies should be made of letters and file materials needed for the review.

j B. A detailed review should be made of the Agreement State meeting reports, coment letters, and State responses to

. coment letters. This review should include at least the i three routine previous reviews and intervening ssocial reviews or as many as possible if three routine reviews inve not been conducted. This review is made to assure that the SA representative is completely familiar with the State's program and is aware of any potential or actual coments that are repetitive. A copy of the last meeting report coment letters to the State, and the State's responses to the coment letters should be :aken to the meeting. The reviewer should also become specifically aware of repetitive coments and recomendt.tions. <

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. C. A review should be made of other information sources that may have data relating to activities in the State. These may include PN0's, AOR's, and the Conference State Profile l Reports.  ! l

/ D. Preparation of Questionnaire i 1. At least 2 mnths prior to the on-site review meeting, a ort questionnaire should be sent to copy the progran director (Attached E).

of the review rep This questionnaire provides tie basis for the report of the review. The

! State should be requested to return the completed (or i updated) questionnaire to the reviewer one month before *

! the on-site review.

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' For States not previously exposed to the questionnaire in 2.

this form it is highly recommended a pre-review visit be  ;

made by the reviewer to the State to acquaint the program director and his staff with its purposes and content.

For States having word processing capability, it is reconnended the questionnaire and the State's answers be handled using the word processor. l

3. For States now using the questionnaire the States should l be furnished a copy of the previous review's

questionnaire and the States responses with a request to i review and update the responses. If changes or additions have been made to the questionnaire, these should be highlighted by the reviewer.

4. It is to the State's end to the reviewer's advantage to have the questionnaire completed (or updated) and j returned to the reviewer 1 month prior to the on-site

/ review and the advantages should be stressed to the State to encourage timely returns of the questionnaire. These ,

advantages include:

i l a. Permits pre-identification of problems or potential

problems so that they can be fully discussed during

face-to-face meetings with RCP staff,

b. Conversely, by previewing the questionnaire responses, the reviewer can pre-identify program '

areas that meet applicable indicator guidelines and i thus narrow down program areas that require ,

! follow-up to resolve questions of adequacy or  :

compatibility, and 4

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c. By streamlining the review process, on-site time can be spent more efficiently and effectively by providing more time to focus on technical aspects of program such as license and inspection ! file reviews, field evaluations of inspectors (if appropriate),

potential problem araas, and discussions with RCP staff and managers.

E. The reviewer should contact the SA staff person responsibic for reviewing Agreement State licenses and request the list of

" Priority Licenses to be Reviewed" and copies of licenses i selected for review or discussion with the State to be sent to

the reviewer.

i F. The reviewer should have necessary guides, reports, memoranda, equipment and supplies necessary to conduct the meeting. The reviewer should also have available additional copies of the NRC Guide for Evaluation of Agreement State Radiation Control Programs. Attachmer.t C is a list of suggested guides, j, memoranda, equipment and supplies for conducting a review meeting and field evaluations.

! G. RSAR's shall follow Regional procedures on preparing i itineraries.

VI. Conducting The Regulatory Program Review And Field Evaluation of

• State Inspectors The conduct of the regulatory program review can vary depending on the size and complexity of the State regulatory program. The scope i of the field evaluations of State inspectors may also vary 4 depending on the nunber of field inspectors to be evaluated, the

availability of licenses due for inspection, and the time needed for the remainder of the program review.

. The following procedures, unless otherwise approved by the Senior l Project Manager are to be followed:

f A. Fielu evaluation of Agreement State inspectors.

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1. Field evaluations are to be conducted before the end of l the on-site review segment of the meeting.

. 2. The protocol for conducting field evaluations is contained in Attachment D.

B. Program review procedures.

Routine program reviews should be conducted in sufficient-

depth and scope to fully evaluate all aspects of the agreement l materials program identified in the Guidelines and to obtain Revision 4 i 2 I 1984

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i e limited information on ancillary activities such as environmental surveillance, surveillance over radiation producing machines, etc., and any other areas as directed by the A/D. When special reviews are conducted (e.g., follow-up reviews of reviews limited to selected segments of a State program) the scope of the review shall be approved by the A/D.

1. Unfinished business.

a. The reviewer should bring to the attention of the appropriate Agreement State representatives:

, 1. Requests by NRC for infonnation which have not been furnished to SA or to the Region.

ii. Requests for documents and publications which have n.ot been furnished to SA or to the Region prior to the review meeting.

b .- The reviewer should also be prepared to discuss items of current interest to Agreement States. New information such as changes in NRC licensing and inspection procedures, proposed changes to NRC organization, administration and regulations affecting the Agreement State programs, new training programs, etc. may also merit discussion. A review of recent All Agreement States correspondence by the reviewer may be helpful in identifying such items.

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2. Use of the NRC Guide for Evaluation of Agreement State Radiation Control Programs,

s. The reviewer should ensure that as much infonnation is acquired as !s necessary to document the State's performance relative to each applicable program indicator specified in the Guide. For the larger programs, information on legislation and regulations, management and administration, and personnel is nonna11y obtained from the Program Director. Information on Licensing and Compliance is normally obtained from the respective i supervisors. For smaller programs, the Program Director may provide all the necessary infonnation.

Specific questions relating to all areas of the Agreement State radiation control program that are to be used during the review are shown in Attachment l I

E.

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6 b. The procedures for review of license and inspection files are contained in Internal Procedures D.3 and D.4. respectively.

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, c. Procedures for review of Agreement State uranium mill tailings and low-level radioactive waste i

disposal regulatory programs are contained in Internal Procedures D.2-1 and D.2-2 respectively.

l 3 3. Additional and/or special infomation.

[ Upon direction of the A/D. the reviewer may need to l

obtain additional infomation and/or more detailed j 1 informatiori. The request from the A/D regarding i additional or more detailed information may be by memo or i oral request. Reque,ts may be specific to a State or may

] be generic. Special generic requests are listed in 1 Section VII.C. of Attachment E.

l 1 4. Status of program' deficiencies noted during previous j reviews.

n The reviewer shall review the program deficiencies, if

)) any, noted in the previous coment letter to the State, q the response of the State regarding the coments, and

detemine the status of the program deficiency as noted during the current review.

5. Findings of deficiencies.

l The reviewer is encouraged to identify and discuss the State personnel deficiencies as they are identified.

l In these discussions the reviewer should seek to ,

identifythecauses(e.g.inadequatetraining,lackof I

procedures), which can serve as the basis for developing recomendations for corrective actions. The reviewer i '

should determine the indicator areas under which the deficiency falls under and, for Category I problems,

detemine if the deficiency is a significant problem or a i minor one.

1 i Guidance on evaluating inspection backlogs is provided in Attachr.ent J.

When reviewing individual licensing and compliance files, l' the reviewer is encouraged to discuss deficiencies with the appropriate license reviewer (s) or inspector (s) as they are. uncovered.

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1 c.

1 When the reviewer is ready to move into sumary meetings with the staff and management, there should be no surprises.

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6. Sumarizing the findings of the field evaluations and program review,

a. The principal reviewer or review manager shoulo conduct the discussions regarding the results of the field evaluation and program reviews at multiple levels of the radiation control program organization. Coments are intended to be constructive and to promote improvements,

b. The reviewer is responsible for assuring that ample ~

time is provided in the discussions for State representatives to express their reactions to the coments. If there is disagreement with the coments, they should be acknowledged by the reviewer. If, in a review, time is running short, priority shall be given to assuring adequate time is left for full discussion of the coments with staff and management. In such cases, the transmittal memo for the meeting report should identify and highlight those areas that were omitted from the review.

1. The first level of discussions should be at the working staff level and should be in sufficient detail so that the inspector or license.

reviewer and imediate supervisors are made aware of each specific deficiency, the reason why it was considered a deficiency, and the corrective action needed. Additionally, actions by the working staff which are considered to be meritorious should also be '

discussed. If the Program L rector wishes, it may be advantageous to hold a sumary discussion with the entire materials staff.

Coments made during these meetings, particularly on deficiencies, should be made in programatic terms and not reflect on individual perfomance, to the extent possible.

ii. The next level of discussion should be with the Program Director and supervisors. These ,

discussion should also be detailed as to deficiencies, and corrective actions needed.

As previously noted, anything considered meritorious also should be pointed out.

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At this time, the reviewer should infonn the Program Director of the indicators and their categories that the comments and recomendations fall under and whether or not each problem is significant. If one or more significant problem exists in Category I, inform the Director that improvement in these areas are critical and that a staff recomendation on adequacy and compatibility will only be made after receipt and evaluation of the State's written responses to our comments. The director should be infonned that when more than one significant problem exists in Category I, a follow-up review in 6 months is possible.

At the discussions with the Program Director, the reviews should identify the coments and recomendations to be made to the State Health Officer, or equivalent, at the scheduled sumary meeting. .

iii. The sumary discussion with the State Health

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Officer (SHO) should nonnally be confined to those items expected to be included in the letter to the SH0. It will be sufficient to note for the SHO that other coments relating to the technical aspects of the program were discussed with the Program Director and will be contained in a separate enclosure to the

, letter, to which the Program Director may respond directly. If the SHO requests, however, the reviewer should be prepared to include these in his discussion. See Appendix 1 to Attachment I for guidance of separating consnents out for the SHO and Attachment G for sumary discussion guidance. In all cases, be sure that the SHO is familiarized with the December 4, 1981 NRC* policy statement for handling coments in Categories I and II.

iv. If one or more significant problems in Category I Indicators are found, a sumary meeting must be held with the SHO. In those cases where the SHO could not be available, arrangements are to be made for such a meeting as soon as possible after conclusion of the review. The absence of a SHO does not preclude a sumary meeting with his designee at the end of a review; rather ,

because of the importance of the problems, the findings need to be discussed directly with him as well as with his staff. In such cases, the Revision 4 0 $ # / 1084

.- s reviewer is to keep the SA A/D advised of the arrangements for such meetings. If an

, exception is warranted, it is to be discussed with and agreed with by the Regional Administrator and the SA A/D.

v. The meritorious aspects as well as the deficiencies of the program should be noted.

The State Health Officer should be informed that fomal coments and recomendations will

, be provided by letter.

vi. If there are no significant problems in Category I Indicators the reviewer should state his or her opinion that the program is adequate and compatible. If a significant problem exist

in one or more Indicators in Category I, inform the SHO that the need for improvements in these areas is critical and that no staff recomendations on adequacy and compatibility will be offered until the NRC has received and has had an opportunity to review the State's

' responses to our coments. The SHO and Director should be urged to be specific in t

their written replies. In such cases, infom the SH0 and Director that NRC policy calls for I

consideration of a follow-up review in 6 months. ~

I VIII. Actions to be tj sen upon completion of the review and field evaluations A. Coment Letter

1. The reviewer is responsible for preparing the coment i letter following a review meeting, a

i 2. The language of the letter and the coments and i

recomendations are discussed with the A/D and Regional

l. Administrator, as appropriate, upon return from the i meeting. The specific coments and recomendations to be dispatched with the letter are also decided upon during these discussions.

3. The draft coment letter should be ready for review by

, OSP within 15 working days following the sumary meeting with Agreement State Officials. The final letter shall be prepared for concurrence by OSP and EDO. The letter should be ready for signature within 30 days following the sumary meeting unless otherwise authorized by the i Revision 4 b 2 ? 1984

-1 5-SA A/D. The standard format is shown in Appendix 1.

Since the letters will require OSP and EDO concurrence, deviations from the standard format should be discussed -

in advance with the SA A/D.  !

4. When the letter is dispatched prepare a statement for the Daily Staff Notes (which is sent to the Commission by the EDO) briefly reporting the findings of the review. A copy should be provided to the Director OSP. Daily j Staff Notes, when ready, should be faxed to the EDO

! Assistant for Operations (T. Rehm).

l S. The reviewer is responsible for establishing a tracking system for replies (and acknowledgements) to all review letters. It is necessary to "close the loop" in all

! cases. In cases where there were significant Category I l coments, and no reply is received within 30 days, the RCP Director shall be called by the reviewer and a target date established for a reply. The Regional Administrator shall be informed. In other cases the reviewer shall call the RCP Director if, after 8 weeks after the date of the letter no reply is received. At that time, a target date shall be sought and agreed upon, the Regional Administrator shall be informed and shall approve it. If no reply is received after 16 weeks (or the target date whichever is later), a reminder letter shall be sent to the SHO, as appropriate. If a finding on adequacy and compatibility is pending on the responses a reminder of this should be brought to the SH0's attention in any follow-up correspondence or letters.

6. In cases where a finding on adequacy and compatibility is pending responses from the State, the responses shall be reviewed by the reviewer in consultation with the A/D*.

A decision will be made within 2 weeks of receipt of the necessary responses to (a) offer staff recommendations on

, adequacyandcompatibility,(b)seekadditional consultation with the State (which may be in the form of telephone calls, or correspondence), or (c) to withhold staff recommendations on adequacy and compatibility until '

after a follow-up review meeting or other appropriate action. The reviewer shall prepare the draft correspondence as directed for review by OSP. The letter should be prepared for coordination with OSP and EDO prior to signature by the Regional Administrator. Upon dispatch, prepare and submit a statement for the Daily Staff notes reporting the decision.

In cases where the reviewer is unavailable fleave, meetings, etc.),

the Project Manager is responsible for consuiting with the A/D and taking subsequent action until the reviewer returns.

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7. Reviewers are responsible for designating copies of the letters and responses and acknowledgements to be included in the meeting report and distributed to the PDR. The SA

" RIDS" system may be used for this purpose. t B. Preparing the report of the meeting.

1. A typed draft of the report and appendixes should be submitted to the Senior Project Manager for review within 30 days following completion of the review. See Attachment H for guidance on format and contents.

2. The complete report in final is to be submitted to the SA A/D within 60 days following the date of the suwary meeting.

3. Within 5 working days of acceptance of the report, a copy is to be transmitted to the Program Director. See -

Attachment H for sample transmittal letter.

C. Action on comitments made to State representatives during the meeting and field evaluations.

1. As soon as possible upon return the reviewer should review his notes and attempt to fulfill any requests made by Agreement State personnel during the meeting.

2. If it is not possible to fulfill such requests within 3 weeks, the reviewer should contact the appropriate State representative and explain any reason for the delay.

D." Other activities.

1. Recomendations for special training for Agreement State staff members shall be discusse'i with the SA A/D and acted upon as necessary, including notifying appropriate SA course coordinators.

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List of Attachments to D.2

. A. Sample letters for scheduling regulatory program review meetings.

t State Health Officers or Equivalents B.

C. List of resource material for conduct of regulatory program reviews

' and field evaluations of Agreenent State inspectors.

. D. Protocol for field evaluations of Agreement State inspectors.

1 E. Questionnaire to obtain detailed information on the Agreement State's regulatory program and report format.

l I F. Cancelled.

SHO summary discussion guidance.

G.

H. Review meeting report - guidance - format and content.

1. Sample letters to SHO and RCP Director on results of review.

J. Guidance for handling cannents on inspection backlogs.

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Attachnent A-1 Letter to State Official Familiar With the State Agreement Program

Dear  :

During a recent discussion with (name the radiation control program .

director or other contact), the week of (month, day, year) was agreed to for the 198_ review of the (name the State or State agency) radiation control program for agreement materials. M . (name and reviewers will beourrepresentative(s). M . (name the reviewers) (for RSAR's, add as title, " Region StateAgreementsRepresentative") .

would like to dTscuss the results with you on the mornTng (afternoon) of (month, day, year).

Sincerely, Regional Administrator cc: Radiation Control Program Director)

State Coordinatt g Agency Representative, if appitcable)

G'. Wayne Kerr, Director. Office of State Programs)

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A-2 Attachment A-2  !

Letter to State Official Unfamiliar With the State Agreement Program

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Dear  :

l During a recent discussion with (name the program director or other i contact), the week of (month, day, year) was agreed to for the 198 review of the (name the State or State agency) radiation control p'rogram for radioactive materials. Under an agreement signed between (name the ,

1 State) and the Federal government, (name the State) assumed authority j over ceridin radioactive materials covered by the Atomic Energy Act of a 1954. Background on this agreement is provided in the enclosure.

M . (name the reviewers) will be our representative (s) for the review.

H. would like to discuss the results of the review with j y'ou during the (morning, afternoon) of (month, day, year).

j Sincerely, 4

Regional Administrator

Enclosure:

. As stated cc: Program Director)

StateCoordinatingAgencyRepresentative,ifapplicable)

G. Wayne Kerr, Director, Office of State Programs) l l

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A A-3 ENCLOSURE TO ATTACHMENT A-2 Section 274 of the Atomic Energy Act was enacted by the Congress in 1959

- to recognize the States' interest in atomic energy activities, to clarify the respective responsibilities of the States and the AEC under the Act, and to provide a mechanism by which the AEC could relingilish, and the States assume, a part of the Atomic Energy Comission's regulatory authority. Under Section 274, the Atomic Energy Comission was permitted to relinquish to the States on a State-by-State basis, certain of its authority to regulate the use of reactor-produced

- isotopes, the source materials uranium and thorium, small quantities of special nuclear materials, uranium mill tailings, and low-level radioactive waste disposal. These materials collectively are referred to as agreement materials. The Act reserved certain areas to the Atori;ic i

Energy Comission, such as regulation of the construction and operation of nuclear reactors and fuel fabrication and reprocessing plants, the

export and import of agreement materials, certain disposal of radioactive wastes, and distribution of items to persons exempt from licensing.

TheEnergyReorganizationActof1974(P.L.93-438)transferredthe l regulatory functions of the Atomic Energy Comission to the newly fomed Nuclear Regulatory Comission (NRC). The NRC's Regional Offices carry l out the major portion of the Agreement State program under policy and j guidance provided by the NRC Office of State Programs.

I

Before the Comission is pemitted to relinquish regulatory authority to a State under the Act,the Governor must certify that the State has a regulatory program that is adequate to protect the public health and safety. The Comission must find that the State's program is adequate j from the health and safety standpoint and compatible with the

, Comissior's program. The Comission works closely with each State to 1 assure that the State's program for regulation of agreement materials

! meets these requirements and that the State is equipped with a

' sufficient number of technically qualified personnel to administer the l regulatory program, i

(State) became an Agreement State when a Section 274 agreement between the Comission and the State of became effective on

! . At present there are twenty-seven Agreement States.

1 (For mill States with UMTRCA amendments only): On ,1982, an amendment to the agreement became effective which provides for continued State regulations of uranium mill tailings under provisions of Section 274(o) of the Act.

Since the beginning of the Comission's Agreement State program, a system of post-agreement relationships with the States has been developed to promote continuing compatibility and adequacy by Revision 4

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l A-4 periodically reviewing and evaluating the capabilities of the State to -

protect the public health and safety. The periodic reviews of State i regulatory programs for control of agreement materials cover the principal administrative and technical aspects of radiation control program. An in-depth examination is made of the program's legislation and regulations, organization, management and administration, personnel, licensing, and compliance and enforcement activities.

• Our review will use as a reference, the NRC " Guidelines for the NRC 4

Review of Agreement State Radiation Control Programs," published in the Federal Register on December 4,1981 as an NRC Policy Statement. The Guides provides 30 Indicators for evaluating Agreement State program e

areas. Guidance as to their relative importance to an Agreement State program is provided by categorizing the Indicators into 2 categories.

Category I Indicators address program functions that directly re, lated to the State's ability to protect public health and safety. Category II Indicators address functions which provide essential technical and administrative support.

If a significant problem exists in a Category I Indicator, the deficiency may seriously affect the State's ability to protect the public health and safety and needs to be addressed on a priority basis.

If significant problems exist in more than one Category I Indicator, then improvements are critically needed. In such cases, we will need a timely response from the State and staff recomendations for adequacy and compatibility will not be offered until after the responses are received and evaluated. A follow-up review within 6 months may also be scheduled.

A I

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B-1 Attachment B l t

i Agreement State State Health Officers or Equivalents

. 1. Alabana - State Health Officer State Department of Public Health

2. Arizona - Executive Director Arizona Radiation Regulatory Agency

3. Arkansas - Director Department of Health

4. California - Director Department of Health Services

5. Colorado - Executive Director Department of Health 1

6. Florida - Secretary Department of Health and Rehabilitative Services

. 7. Georgia - Commissioner' Department of Human Resources

8. Idaho -

Director Idaho Departrent of Health and Welfare

9. Kansas - Secretsry Department of Health and Environment

- 10. Kentucky - Secretary Department of Human Resources

11. Louisiana - Secretary Department of Environmental Quality

12. Maryland - Secretary Department of Health and Hental Hygiene

13. Mississippi - State Health Officer State Board of Health i

14. Nebraska - Director

] Department- of Health 1

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15. Nevada - Director -

Department of Human Resources  ;

16. New Hampshire - Director Division of Public Health Services

17. New Mexico - Secretary Department of Health and Environment .

18. New York Health - Comissioner Department State Department of Health .

19. New York - Industrial Comissioner

, Department of Labor New York State Department of Labor

20. New York City - Comissioner New York City Department of Health

21. New York - Comissioner Department of New York Department of Environmental Environmental Conservation Conservation

22. North Carolina - Secretary ,

Department of Human Resources

23. North Dakota - State Health Dfficer North Dakota Department of Health

24. Oregon - Administrator Health Division Department of Human Resources

25. Rhode Island - Director of Health Department of Health

26. South Carolina - Commissioner South Carolina Department of Health and Environmental Control

27. Tennessee - Comissioner Department of Public Health

28. Texas - Comissioner Texas Department of Health

29. Utah - Executive Director State Department of Health

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30. Washington - Director Division of Health Department of Social and Health Services Revision 4 08 I7198(

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C-1 Attachment C Suggestions for Guides, Memoranda, Equipment and Supplies for Meetings

1. Current NRC regulations (Parts 19, 20, 21, 30-35, 40, 51, 61, 70, 71, 150 and 170).

2. Current chronological list of changes to NRC regulations.

3. Applicable, current NRC licensing guides and checklists for materials.

4 Copies of all Agreement State letters regarding licensing and

! compliance matters since the last review meeting necessary for the review.

5. Copies of current, applicable inspection procedures.

6. Recorder and tape cassettes, if desired.

7. Calculator, if desired.

8. Tablets, pencils, and pens.

i 9. NRC organization charts, etc.

10. Copies of the Guide for Evaluation of State Radiation Control j Prbgrams.

l 11. Film badge and pocket dosimeter for field evaluations.

12. Procedures D.3 and 0.4, and as applicable. D.2-1 D.C-2. D.14 and

D.15.

13. Copies of State licenses selected for review and list of priority licenses for review.

Revision 4 Ad[71984.

. . . l D-1 Attachment D .

t Protocol for Field Evaluations of Agreement State Inspectors A. Prior to the Start of the field evaluations, ground rules should be clearly established and discussed by the reviewer regarding:

, 1. The extent of the participation by the reviewer in the inspection. ,

2. The procedure for introducing the reviewer and explaining his presence during the inspection.

3. The procedures for critiquing the inspector's perfomance.

B. The evaluation should cover the following points:

1. The professionalism of the inspector.

2. Was the inspector's preparation for the inspection adequate?

3. Were all unusual conditions covered?

4. Were all pending items from last' inspection checked?

5. ~

Did the inspector have all material necessary for the inspection trip?

6. Was the inspector on time?

7. Did he listen to the licensee or registrant?

8. Did he ask questions that required an explanation, or did he ask leading questions?

9. Did he observe actual operations?

10. Did he interview workers to verify their training in radiation safety procedures?

11. Were his surveys adequate and performed appropriately?

12. Management Sumation Did the inspector:

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a. -

Sumarize strong and weak points fairly?  ;

b. Clearly distinguish noncompliance from recomendations?

c. Explain what follow-up actions would occur (compliance

letter,etc.)?

13. Was the inspector adequate concerning:

i 2

a. Evaluating radiation safety?

b. Detemining compliance with regulations and license and/or registration?

c. Infonning the licensee and/or registrant of requirements?

14. Did the inspector explain the terms properly?

15. V items were overlooked?

C. During the accompaniment, the reviewer should also obtain information which reflects the inspector's awareness of and instructioninStateinspectionpoliciesandprocedures(e.g.does the inspector have copies of inspection guides). Information on supervisory accompaniments, planning of inspections, staff meetings, availability and calibration of field equipment and access to secretarial and laboratory services should be sought. In States having field offices, special attention by the reviewer should be focused as how well the field offices' activities are cobrdinated with the central offices as seen by the field personnel (including availability of license a correspondenceandStateprocedures)pplications,enforcementThe inform such interviews can supplement and serve to confirm information on these matters provided by the RCP directors and supervisors.

D. An oral critique should be furnished to the State inspector after return to the Office. A summary of the critique regarding the professional conduct of the inspector and technical quality of the conduct of the inspection should also be furnished to the appropriate supervisor. Comments should be constructive. If attendance at NRC sponsored training would be useful, the specific training courses should be identified.

E. The meeting report should state the identity of the State -

l inspectors that were accompanied and identify (name, license  :

number, and type of license) of the licensees that were inspected. "

If a re-evaluation of the inspector should be perfonned, indicate this in the report and highlight it in the transmittal memo for the report. l l

Revision 4 Old 2'T 1984.

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Attachment E

?

Dear

! Enclosed is the new document " Evaluation of Agreement State Radiation l Control Program; State Review Guidelines, Questions and Assessments,"

I which repisces the old list of questions sent to the Agreement States

! prior to their review.

The view format follows the outline of indicators in " Guidelines for NRC

! Review of Agreement State Radiation Control Programs" and includes the

! NRC guidelines, followed by questions pertaining to each indicator and I

the reviewer's assessment of the State program in that specific area.

The entire document with your answers and the reviewer's coments will become the final report.

We suggest you keep this document in its entirety in your word processing system so that in the future you need only be concerned with

! changes occurring within the current review period.

Tables have been added to replace appendices where possible in an effort l

. to enhance the readability of the report. Copies of such items as job j descriptions, staff resumes, licensing guides and others as specified in i

the document should be available for the reviewer, but should not be attached unless necessary for clarity. These documents will be selectively reviewed at your office by the Regional State Agreement Representative and the evaluation will be included in the reviewer

, assessment of that indicator.

Please ' return a completed copy of the document including the guidelines, questions and your answers to me by (30 days before on-site office review).

If you have any questions, please contact me.

Sincerely, i

i State Agreement Representative f

l

Enclosure:

As statto i

t A

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• l E-2 EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM .

STATE REVIEW GUIDELINES, QUESTIONS AND ASSESSMEllTS Name of State Program Date of HRC Review (Month, Year)

I. LEGISLATION AND REGULATIONS A. Legal Authority (Category I)

HRC Guidelines: Clear statutory authority should exist, designating a state radiation control agency and providing for promulgation of regulations, licensing, inspection and 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 requirements of UMTRCA. Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division of responsibilities and requirements for coordination.

Questions:

1. Please list all currently effective legislation that affects the radiation control program.

2. What changes have been made to the statutory authority of the State to license, inspect, and otherwise regulate agreement materials since the last review?

. 3. If your State regulates uranium or thorium recovery operations and associated wastes pursuant to an amended agreement and UMTRCA, explain any changes to the statutory authority fur these functions.

4. Are copies of the current enabling act and other statutes (e.g., Administrative Procedures Act Sunshine Act.,

etc.) which govern the conduct of the agreement materials program on file in the Radiation Control Program (RCP) office and with the NRC? If revisions have occurred since the last review, the changes should be included.

5. If the State's regulatory authorities are divided between agencies, what procedures and memoranda are in effect to provide clear understanding of the divisions of responsibilities and requirements for coordination?

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6. Does the State have the authority to: -

a. apply civil penalties? If so, cite legislation.

b. collect fees? If so,' cite legislation.

c. require surety or long-term care funds?. If so, cite

legislation.

, d. require performance bonds or sureties for

~

decomissioning licensed facilities? If so, cite legislation.

e. require perfomance bonds or sureties for clean-up

, of licensed facilities after a contamination accident? If so, cite legislation.

f. require long tem care funds for urantua mill or low-level waste facilities. If so, cite legislation,

g. enter into low-level waste compacts? If so, cite 1egislation.

i h. establish, license and/or operate a low-level waste site? If so, cite legislation.

. 6. If any responses to the above question are negative, explain any plans the State may have regarding those

, issues.

1 I.A Reviewer Assessment:

B. Status of Regulations (Category I)

NRC Guidelines: The State should have regulations essentially i identical to 10 CFR Part 19. Part 20 (radiation dose standards j and effluent limits), and those required by UMTRCA, as i

implemented by Part 40. The State should adopt other l regulations to maintain a high degree of unifomity with NRC regulations. l 1

Questions: l

! 1. When did the State last amend its regulations in order to l maintain compatibility and when did the revisions become

! effective?

i j 2. Referring to the enclosed NRC chronology of amendments (Appendix A) note the effective date of the NRC changes last adopted by the State.

! 3.a. Were there any compatibility items that were not adopted by the State?

b. If so, please identify and explain why they were not adopted.

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l 1.B. Reviewer Assessment 4

C. Updating of Regulations (Category II) -

t NRC Guidelines: The RCP should establish procedures for effecting appropriate amendments to State regulations in a

timely manner, normally within 3 years of adoption by NRC.

For those regulations deemed a matter of compatibility by NRC, i State regulations should be amended as soon as practicable but

! no later than 3 years. Opportunity should be provided for the 1 public to coment on proposed 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.

{ 1. Does your State have a schedule or program for revising 1 and adopting changes to regulations within three years of j adoption by the NRC?

d 2. Has your State adopted all regulations deemed a matter of 4 compatibility by NRC within three years? (RefertoNRC j chronology).

3 j 3. What are your State's procedures for adopting new

regulations? tiriefly describe each step in the procedure.

4. How is the public involved in the process?

i i 5. a. Does the NRC have the opportunity to coment on draft changes to State regulations?

{

b. If so, does your State respond to the coments?

l 1.C. Reviewer Assessment f II. ORGANIZATION i

! A. Location of the Radiation Control Program Within the State

} Organization (category II) l NRC Guidelines: The RCP should be located. in a State j organization parallel with comparable health and safety j programs. The Program Director should have access to

appropriate levels of State management.

l 1. Attach a dated organization chart (s) showing the RCP and

its location within the department and State

. organization.

2. Is the RCP on a comparable level within the State organization with other health and safety programs so as to compete effectively for funds and staff?

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3. Does the RCP program director have access to appropriate

levels of State management? -

t I II.A Reviewer Assessment:  !

i B. Internal Organization of the RCP (Category II)

! NRC Guidelines: The RCP should be organized with the view

! toward achieving an acceptable degree of staff efficiency, i place appropriate emphasis on major program functions, and

! provide specific lines of supervision from program management l for the execution of program policy. Where regional offices

! are utilized, the lines of communication and administrative 3 control between the regions and the central office (Program Director) should be clearly drawn to provide uniformity in i inspection policy, procedures and supervision.

i i

Questions:

1. Attach dated copies of your internal RCP organization 5 charts.

2. How is the RCP organized so as to provide specific lines i of supervision from program management for executing

! program policy?

1

' 3. If regional offices are used: .

l a. To whom do regional personnel report

administrative 1y?

l

b. To whom do regional personnel report technically?

4 If the RCP contracts with other agencies to administer i the program:

a. Identify the contracting agencies and indicate their 3

responsibilities, f b. To whom do contract personnel report administrative 1y?

~

i i c. To whom do contract personnel report technically?

II.B Reviewer Assessment

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.

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1. Are legal staff members assigned to assist the RCP or do procedures exist to obtain legal assistance !

expeditiously?

2. is the legal staff knowledgeable regarding the RCP, statutes, regulations and needs?

3. If legal assistance was utilized since last review, provide a sumary of the circumstances.

II.C Reviewer Assessment: ,

D. Technical Advisory Comittees (Category II)

NRC Guidelines: Technical Committees. Federal Agencies, and other resource organizations should be used to extend staff capa'oilities for unique or technically complex problems. A State Medical Advisory Comittee should be used to provide bread guidance on the uses of radioactive drugs in or on hu'.nans . The Committee should represent a wide spectrum of mr dical disciplines. The Comittee should advise the RCP on r,olicy 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 community should not serve on advisory comittees or not be used as consultants.

Questions:

1. Discuss practices followed for obtaining tecM1ical assistance when needed (e.g., consultants, tCchnical and

. medi:al advisory comittees, licensees, the NRC and other State and Federal Agencies).

2. What steps are den to avoid conflicts of interest?

3. Are any comittees involved in setting policies? If so, explain.

4. Attach a list showing the mentership, specialties and affiliations of the Medical and/or Technical Advisory Comittees.

5. Indicate whether the advisory comittees are established by statute, by appointment of the Governor, by

appointment of the State Board of Health, by appointment

( of the Agency, or by other means.

t i

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6. What is the formal meeting frequency of each comittee, and are minutes of comittee meetings prepared? ,

i

. 7. What was the date of the last formal meeting'of each comittee?

8. Are individual comittee members contacted for consultation?

9. Discuss how each comittee is used, the average workload 7

placed on the comittee, and the remuneration, if any. I l II.D Reviewer Assessment:

III. MANAGEMENT AND ADMINISTRATION A. Quality of Emergency Planning (Category I)

{ NRC Guidelines: The State RCP should have a written plan for i response to such incidents as spills, overexposures, transportation accidents, fire or explosion, theft, etc.

The Plan should define the responsibilities and actions to be 1 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 i local, county and State agencies. Plans should be distributed I to appropriate persons and agencies. NRC should be provided the opportunity to coment on the Plan while in draft fom.  ;

The plan should be reviewed annually by Program staff for i adequacy and to detemine that content is current. Periodic J drills should be perfomed to test the plan.

2 i

Questions:

1. Is the RCP t-esponsible for its own emergency plan or are accidents involving radioactive materials incorporated j into a comprehensive State plan developed and administered by another State agency? Please provide j copies of all applicable plans for review.

2. What written procedures or plans does the RCP use for responding to incidents involving radioactive materials?

Y 3. If the plan covers major accidents at nuclear facilities, how does it cover non-catastrophic incidents such as those involving transportation of materials?

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.. s j E-8 i 4. How does the plan define responsibilities and actions to be taken by all State Agencies (initiating response actions, operations, cleanup,etc.)? -

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4

5. How does the plan provide for notification of and comunications with appropriate government agencies?

~

6. How is the response program organized so that qualified individuals are readily available through identifiable channels of comunication?

7. Has the plan been distributed to all participating i . agencies?

I

) 8. Has the NRC had opportunity to coment on the plan in draft form?

9. Is the plan reviewed annually by the RCP for adequacy and i to assure the content is current?

I

10. Are drills performed periodically to test the plan for radioactive materials emergencies? Explain, for example, how non-routine office hours comunications are checked.

III.A Reviewer Assessment:

l B. Budget (Category II) t

! NRC Guidelines: Operating funds should be sufficient to i

support program needs such as: staff travel necessary to conduct an effective compliance program, including routine inspections, followup or special inspections (including j pre-licensing visits) and responses to incidents and other

emergencies; instrumentation and other equipment to support j the RCP; administrative costs in operating the program j including rental charges, printing costs, laboratory services, ,

! - computer and/or word processing support, preparation of l j correspondence, office equipment, hearing costs, etc. as I

appropriate. Principal operating funds should be from sources ,

t which provide continuity and reliability, i.e., general tax, i license fees, etc. Supplemental funds may be obtained through contracts, cash grants, etc.

Questions:

1. What fiscal year is used by your State?

2. Indicate the amount for funds obtained from aach revenue t source (fees, State General fnnds, HHS, NRC environmental monitoring or transportation surveillance contracts, EPA,

, FDAandothers).

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3. Show the total amounts assigned to:

a. the total radiation control program

b. the radioactive materials program.

4. What is the change in budget from the previous year and what is the reason for the change (new programs, change in emphasis, statewide reduction, etc.)?

5. Describe your fee system, if you have one, and give the percentage of cost recovery. Enclose a copy of the fee schedule.

6. Does the RCP administer the fee system?

7. What recourse does the RCP have in the event of non-payment?

8. Overall, is the funding sufficient to support all of the program needs? If not, specify the problem areas.

III.B Reviewer Assessment:

C. LaboratorySupport(CategoryII)

NRC Guidelines: The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bionssays, analyze environmental samples, analyze samples collected by inspectors, etc., on a priority established by the RCP.

Questions:

, 1. Are laboratory services readily e.vailable in-house or j through other departments within the State organization? .

4

2. If services are provided by other departments, discuss the arrangements, supervision, charges and interdepartmental comunications.

3. If laboratory services must be provided by a non-State agency:

a. Discuss the contractual arrangements.

b. Is the party providing the service a State licensee?

c. If a State licensee prov* des the service or equipment, what are the costs?

4. Describe the capability of the laboratory as follows:

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a. Can it qualitatively and quantitatively analyze low-energy beta emitters?

~

! b. Can it qualitatively and quantitative 1y' analyze l' alpha emitters?

c. Can it selectively detemine the presence and j quantity of gama emitters?

d. Can it handle samples in any physical fom - wipes, liquids, solids, gaseous?

q e. Does the lab participate in a periodic quality a control program?

5. How much time does it take to obtain the results from i sample analyses on both a routine basis and on an l

.j emergency basis? l 9 ,

1 6. List the number and types of laboratory instrumentation  !

3 and services available.  ;

III.C Reviewer Assessment:

.l.

D. AdministrativeProcedures(CategoryII)

NRC Guidelines: The RCP should establish written internal j procedures to assure that the staff perfoms its duties as

] required and to provide a high degree of unifomity and '

continuity in regulatory practices. These procedures should i

address internal processing of license applications.

inspection policies and procedures, decomissioning, and other functions required of the program.

]

Questions:

]4 l 1. What procedures are established to assure adequate and i unifom regulatory practices (e.g., administrative procedures, policy memos, licensing and inspection guides, escalated enforcement procedures, decomissioning

procedures,etc.)?

2. To what extent are the procedures documented? I

3. If your State has separate licensing and inspection j; staffs, what are the procedures used to assure adequate comunication between the two staffs? -

I

4. How are personnel kept informed of current regulatory policies and practices?

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5. If your State collects fees, are fee collection duties

assigned to non-technical staff?

6. How are contacts with comunication media hahdled?

7. What procedures exist to ensure timely release of factual infonration on matters of interest to the public, the NRC

and Agreement States?

8. If your RCP has regional offices:

i a. what procedures are in effect to assure the regions have complete copies of the procedures and files?

i b. how often are periodic staff meetings held with headquarters staff?

c. how often are periodic visits / audits made by i headquarters staff to regional offices?

d. how is unifonnity assured? ,

e. how is supervision handled?

j III.D Reviewer Assessment: l E. Management (Category II)

] ^

l NRC Guidelines: Program management should receive periodic i

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, 1 equipment, services and fundings. ,

t 1

] Program management should perfonn periodic reviews of selected l

license cases handled by each reviewer and document the l j results. Complex licenses (major manufacturers, large scope -  !

Type A Broad, or potential for significant releases to 2 environment) should receive second party review (supervisory,

comittee, or consultant). Supervisory review of inspections,

reports and enforcement actions should also be perfonned.

I

Questions

1. How does the staff keep program management abreast of the status of regulatory actions (such as backlog, problem cases, inquiries, and revision of regulations)?

4 2a. Is a periodic statistical tabulation of licenses.

3 licensees, inspections and backlogs prepared by category?

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b. If so, specify how frequently the tabulation is prepared.

3. How does RCP management assess workload trends and resources in order to determine future needs or the need for program changes?

4. How does the RCP management keep abreast of changes in legislative end regulatory responsibility?

5. Discuss the procedures followed by licensing supervision or RCP management to monitor licensing quality.

6. Discess the procedures used for supervisory review of inspection reports.

7. What license review practices are followed for unusual or complex license applications?

8. If applicable, discuss the procedures used for supervisory review of work performed by contract agencies or regional offices.

III.E Reviewer Assessment:

F. Office Equipment 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.

la. In terms of the person-year /100 licenses figure, what level of secretarial / clerical support is provided?

b. If you program has regional offices, provide the figures for the support for those offices.

2. Describe the ADP and word processing capabilities available to the RCP.

III.F Reviewer Assessment:

G. Public Information (Category II)

NRC Guidelines: Inspection and licensing files should be

-available to the public consistent with State administrative procedures. Opportunity for public hearings should be provided in accordance with UMTRCA and applicable State administrative procedure laws. -

Revision 4

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QFS 211984

- -- . . . - . _ - . - . . _ . - . . . ~ . . - -

E-13 Questions:

1. Are licensing and inspection files available for

. inspection by the public?  !

2. Can medical and proprietary data withheld?

3. What other parts, if any, are not available?

4. What written procedures and laws govern this? Please provide reference citations.

5. For mill States, are opportunities provided for public j hearings in accordance with UMTRCA and applicable State administrative procedures and statutes?

, III.G Reviewer Assessment:

IV. PERSONNEL l

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. Additional training and experience in radiation protection for senior personnel should be comensurate with the type of licenses issued and inspected by the State.

I 1 Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.

Quettions:

j

1. Do all professional personnel hold a bachelor's degree.or j have equivalent training in the physical or life 1

sciences?

.i j 2. What additional training and exp;rience do the senior j personnel need to have in radiation protection?

j 3. Wh'at written position descriptions describe the duties, 2 responsibilities and functions of each professional

' position?

IV.A Reviewer Assessment:

B. Staffing Level (Category II)

NRC Guidelines: Staffing level should be approximately 1-1.5 persen-year per 100 licenses in effect. RCP must not have L less than two professionals available with training and t experience to operate RCP in a way which provides continuous coverage and continuity.

h Revision 4 A 271984 1 __ _

.. +

E-14 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 insitu mills) or major renewal, to ~

meet requirements of Uranium Mill Tailings Radiation Control Act of 1978. This effort must include expertise in radiological matters, hydrology, geology, and structural

, engineering.

Questions:

1. Complete a table as below, listing the person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position,

, fraction of time spent and the duty (licensinC, inspection, administration, etc.).

Name Position FTE% Area of Effort I

Total Person-Years

2. Compute the person-year effort of person-years per 100 licenses (excluding mills and burial sites). Show calculation.

I

3. Is the staffing level adequate to meet normal and special needs and backup?

IV.B Reviewer Assessment

s C. Staff Supervision (Category II)

~

i NRC Guidelines: Supervisory personnel should a 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 i 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 the junior and senior personnel.

, Pa. What duties are assigned to junior personnel?

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E-15

b. Do they review applications and perform inspections independently?

3a. What dutfes are assigned to senior personnele

b. Do they independently review and monitor the work of junior personnel?

4. Is there adequate supervisory or senior guidance and direction for junior personnel?

5. Discuss procedures established to ensure supervisory review of the licensing, inspection and enforcement functions.

6a. Are RCP staff members allowed to consult or work part time for State licensees?

b. If so, how are conflicts of interest avoided?

IV.C Reviewer Assessment:

D. Training (Category II)

NRC Guidelines: Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices. (For mill States, mill training should also be included.) The RCP should have a program to utilize specific short courses and workshops to maintain oppropriate level of staff technical competence in areas of changing technology.

Questions:

1. List materials personnel and their attendance at training courses in that they have attended.

Name of Student Course Agency Sponsor Dates

2. How does the RCP utilize short courses and workshops to maintain staff proficiency?

IV.D Reviewer Assessment:

E. Staff Continuity (Category II)

NRC Guidelines:

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__ m _ _ _ . _ _ .

E-16 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 qualifMcations.

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 also should be opportunity for periodic salary increases compatible with experience and

, respansibility.

s Questions:

f

~i

1. Identify the RCP employees who have left the 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. List the RCP salary schedule:

Position Title Annual Salary Range

3. Compare your salary schedule with similar employment alternatives in the same geographical area, such as industrial, medical, academic or other departments within your State.

4. What opportunities are there for promotion within the RCP organizational structure without a staff vacancy occurring?

IV.E Reviewer Assessment V. LICENSING A. Technical Ouality of Licensing Actions (Category I)

NRC Guidelines: The RCP should assure that essential elements of app'tications 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 material, facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Prelicensing visits should be made for Revision 4

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e o E-17 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 vtviewing licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program.

Questions:

1. How many specific licenses are currently in effect? .

I 2a. How many new licenses (not airendwers & suirety) have been issued since the int resisd.i

b. How many were major licenses?

3. How many specific lic:rdes were terminated since last q review?

4. How many a=MarM W6te issued during the review period?

4

5. Identify unusual or complex licenses issued since the last review, including name and license number.

6. Note any variance in licensing policies and procedures '

granted since the last review.

7. Do you require license poplicants.to submit details on their radwaste packaging and shipping procedures?

Ba. When do you require licensees to submit contingency plans?

b. List the licensees who have been required to submit contingency plans.

9. How many prelicensing visits were made during this review period?

10. What criterion does the State use to determine the need for a prelicensing visit?

11. How do you ensure up-to-date information has been submitted prior to a license renewal?

12. Do license files contain all necessary data required to evaluate an application prior to issuing a license? 6

13. Has the State taken any unusual 1Icensing action with respect to licensees operating under multiple jurisdiction?

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EG.2 719th r --

E-18

14. Prepare a table as below showing the State's major licensees with name, number and type.

~

INCLUDE:  !

Broad (Type A) Licenses LLW Disposal Licenses LLW Brokers Major Manufacturers and Distributors Uranium Mills i Large Irradiators (Pool Type or Other) '

1 Other Licenses With a Potential Significant Environmental Impact Other Licensees You Consider to be " Major" Licensees Name Llect.e4 huder M V.A. Reviewer Assessment:

B. AdequacyofProduct_Evalqn11gg(Cate:Hy 1)

+

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 in 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, and permissive or restrictive conditions.

Questions:

1. How many new and revised evaluations were made of sealed sources and devices during the review period?

2. How many SS&D evaluations have been made for which approval documents have not yet been prepared?

3. How does the RCP evaluate manufacturer's data on SS&D's to ensure integrity and safety for users?

4. Do you determine whether the manufacturer's information on labels and brochures relating to health, safety, assey, and calibration procedures is adequate on all products?

Revision 4

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QEC. 2 71984

\

E-19 j V.B. Reviewer Assessment:

C. Licensing Procedures (Category II) -

NRC Guidelines: The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice. License applicants (including

applicants for renewals) should be furnishe

: 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 6

I program, evaluation sheets, service licenses, and licenses authorizing distributico to general licensees and persons exempt from licensing should be submitted to NRC on a timely basis. Standard license ronditions comparable with current NRC i

stilndard ifreg a4KMas should be used to expedite and

' pc.'iG unifomity in the licensing process. Files should be saintained in an orderly fashion to allow fest, accur3te retrieval of infonnation and huw.Maa af uiku:,aicn$ ard visits.

Questions: 1 i

1. Has the RCP developed its own licensing procedures or j does it use NRC guides? Please provide copies for

review.

2. What licensing guides, checklists and policy memoranda l are made available to the staff?

3. What guides and/or regulatory position statements are

, furnished to license and renewal applicants?

4. Describe the syster, for advising classes of licensees of f

t new licensing procedures and regulations.

j Sa. How are licensing actions coordinated with the compliance 4

e staff?

l b. Are licensing actions taken while enforcement action is I

pending?

6. For what length' of time are various categories of licenses issued?

7a. Does the RCP use standard licensing conditions?

b. If so, how does the RCP assure they are comparable with those used by NRC7

8. Are the licensing conditions on file in the RCP office and with NRC?

Revision 4

.2 7 1984 L __- ._ _ _ _ -

s E-20

9. . What SS&D sheets, service, distribution and "E" licenses are available for RCP staff use?

10. Describe your practices for distributing SS&D sheets, as well as GL distribution and service licenses, to the NRC.

11. Describe your proced,ures 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?).

12. Are there opportunities for license reviewers to accompany inspectors?

4 V.C. Reviewer Assessment:

VI. COMPLIANCE A. Statiis of Inspection Program (Category I)

NRC Guidelines: The State RCP should maintain an inspection

. pmgrea ahqcros to Wti., licensee compliance with State regulations and license conditions.

4 The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the

! inspection program on a periodic basis. Infomation showing

, the number of inspections conducted, the number overdue, the i 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 perfomed, assignments to senior vs. junior staff, assignments to regions, l

identification of special needs and periodic status reports.

Questions:

! 1. How '.s statistical infomation maintained about the

inspection prc, gram to pemit periodic assessment of its status by RCP management?

l

i. 2. Prepare a table as below, indicating the number of l inspections made in the review period, by category and 1

'. priority.

I License Scheduled Inspection Number of Category Frequency Priority Inspections i

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E-21 l

l

3. Prepare a table (or tables) as below which identify the Priority 1, 2, and 3 licensees with overdue inspections.

Include the license category, the due date, and the -

number of months the inspection is overdue. e (If list is i extensive, a comparable computer printout is acceptable.)

! Due Months

Licensee Category Priority Date Overdue l . . . . .

l . . . . .

1

'i 4. Prepare a table as below indicating the nunt>er of overdue license inspections for Priorities 4 through 7.

I j License Category Priority Nunter Overdue

~

5. How are inspection schedules planned and how sre the dates and personnel assignments made? -

VI.A Reviewer Assessment:

B. Inspection Frequency (Category I)

~

KRC Guidelines: The RCP should establish an inspection l priority system. The specific frequency of inspections should I be based upon the potential hazards of licensed operations,

[ e.g., major processors, broad licensees, and industrial 1 radiographers should be inspected approximately

! annually -- smaller or less hazardous operations may be inspected less frequently. The minimum inspection frequency should be consistent with the NRC system.

! Questions:

l 1. Enclose a copy of the State's priority system.

1

2. Who assigns licenses to the priority categories?

3. Discuss any significant variances in the State's

' priorities from the NRC priority system.

l Revision 4

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RiiG271984.

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. o E-22 1

4. Is the inspection priority system designed to assure that ,

the more hazardous and/or complex operations are I inspected at an appropriate frequency?

?

5. Describe the State's policy for unannounced inspections and exceptions to the policy.

6. Describe the State's policy for conducting follow-up i inspections. I 7.a. Does the RCP inspect out-of-state fims working in the State under reciprocity or under State licensure?

b. How many reciprocity notices here received? .

c. How many were inspected since the last review?

VI.B Reviewer Assessment:

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 understanding 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:

la. Does the senior inspector or supervisor periodically accompany the inspectors?

b. Are these accompaniments documented?

2. List the nutter of supervisory accompaniments of inspectors since the last review meeting and identify the persons accompanied and the supervisors.

VI.C Reviewer Assessment:

D. Responses 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 Revision 4 l

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LEC 2 71984

u E-23 than 30 days, investigations 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 indepth reviews of circumstances and should be. completed on a high priority basis. When appropriate, investigations should include reenactments and time-study measurements (nonna11y 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 infonnation about any incident which could be relevant to other licensed operations (e.g.,equipmentfailure,improperoperating procedures). Infonnation 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 creat radiation injuries. The RCP should use other technical consultants for special problems when needed.

Questions:

1

1. How does the RCP respond to incidents and alleged '

incidents? j 4 2. Are major incidents (10 CFR 20.403 types requiring reporting in less than 30 days) investigated on a priority basis?

3. Are other incidents followed up in the next scheduled inspection?

4. Ate non-reportable incidents that may be of significant public interest and concern promptly investigated?

5. How many incident investigations were conducted during the review period?

6. Attach as an appendix a summary of each incident i investigated. Include documentation of investigation i

results, enforcement action when appropriate, any reenactment and time motion studies, as well as

notification of the NRC and state licensees of incident

' infonnation that may have been relevant to other licensed operations.

, 7. Were any incidents attributed to generic-type equipment l failure?

8. What action was or would be taken by the RCP pertaining to incidents attributable to generic equipment failures .

r Revision 4

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D E C 2 7 19.8 1

.- e E-24 in regard to notification of the NRC, other licensees and the regulatory agency which approvad the device?

9. If a failure should occur in equipment manufactured by a State licensee, what action would be taken to:

a. stop the manufacture or force changes in design?

i

b. assure retrofit of existing devices?

^

10. When are other State licensees and the NRC notified of

pertinent information about an incident?

l 11a. Are medical consultants available and used who necessary?

b. Is th

Lcate aware of the availability of medical

const.itants from NRC?

I i 12. Explain any use of other technical consultants for

} special problems encountered in incident investigations.

13. Were there any incidents since the last review meeting that met Abnonnal Occurrence Report (AOR) criteria?

l i VI.D Reviewer Assessment:

E. Enforcement procedures (Category 1)

NRC Guidelines: Enforcenent Procedures should be sufficient t to provide a substantial deterrent to licensee noncompliance

+

with regulatory requirements. Provisions for the levying of I monetary penalties are reconnended. Enfo. cement 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.

-j Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions i taken to prevent recurrence (nonna11y 20-30 days). The inspector and compliance supervisor should review licensee i responses. Licensee responses to enforcement letters should be promptly acknowledged as to adeqt;acy 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.

Questions:

l Revision 4

// 4 QFS 2 71984,  !

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E-25

1. Describe the State's enforcement procedures.

2. If the RCP can apply civil penalties, explain the procedures for keying monetary penalties to triolations.

3. Describe the State's provisions for criminal penalties.

4. Describe the policies in effect for issuing field forms equivalent to NRC fom 591 or letters for enforcement action.

5. Are there written procedures for handling escalated enforcement cases? Please provide copies for review.

6. Can thi State issue Orders; including Emergency Orders?

7. Can the PCP impound radioective material?

8. Do State administrative procedures permit the opportunity for hearings in major enforcement cases? l l

9. If during the review period the State has issued orders. l applied civil penalties, sought criminal penalties, impounded sources, or held fonnal enforcement hearings,

identify these cases and enclose copies of the pertinent State enforcement correspondence or orders

Name of License Type of Date of License Number Enforcement Action Action a I

10. Are enforcement letters issued within 30 days of the  ;

inspection? l 1

11. Are enforcement letters written in regulatory language  !

and reference regulations and license conditions?

l

12. Do the enforcement letters clearly differentiate between noncompliance items and health and safety recomendations? '

13. If applicable, do the letters separate actions subject to the State radiation control ect and State OSHA regulations?

14a. Are enforcement letters issued by inspectors or supervisors?

b. If issued by inspectors, do they undergo supervisory Revision 4

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DE.C 2 71984

< v E-26 reviewpriortodispatchh

15. Do enforcement letters recuire the licensee to respond within a stated time period? Note the period.

i 16a. Are licensee's responses to enforcement letters reviewed by the inspector and the super.'isor?

b. Are they acknowledged?

i

17. Has the State taken escalated enforcement action against licensees who operate in multiple jurisdictions.

VI.E Reviewer Assessment:

4 F. Inspection Procedures (Category II) l NRC Guidelines: Inspection guides, consistent with current

< NRC guidance, should be used by inspectors to assure unifonn i and complete inspection practices and provide technical 1 guidance in the inspection of licensed programs. The NRC

, Agreement States Guides may be used if properly supplemented

by policy memoranda, agency interpretations, etc. Written inspection policies should be issued to establish a policy for

! conducting unannounced inspections, obtaining corrective j action, following up and closing out previous violations, i 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 irMpector should be performed upon return from i

nonroutine inspections. For States with separate licensing and inspection staffs, procedures should be established for

! feedback of informatiori to license reviewers. -

1

{ Questions:

1. Has the RCP developed its own inspection guides or does it use NRC guides?

2. Art current copies of the internal inspection foms and i guides on file in the RCP office and with NRC? Attach l revisions or new guides developed since the last review. 1

3. Are inspectors furnished copies of inspection guides?

4. Discuss the use or non-use of inspection policy

memoranda, interpretations, etc., to supplement i inspection guides.  !

i I

Revision 4 i //

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.a_,--..- -

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E-27 I

i

5. Are there written procedures establishing policy for:

J a. unannounced inspections?

b. ~ obtaining corrective action?  !

c. following-up and closing out previous citations of l violations? '

1

d. exit interviews with management?

' e. issuing notices of violations and findings of health and safety problems?

l f. categorizing the seriousness of violations?

Please provide copies of these procedures for review, i

6. What procedures have been established for maintaining l licensee's compliance histories?

7. Does the senior inspector or supervisor orally debrief the inspector upon return from inspections?

8. What procedures are there for providing feedback from j! inspectors to licensing?

VI.F Reviewer Assessment:

} )

! G. Inspection Reports (Category II)  !

NRC Guidelines: Findings of inspections should be documented j in a report describing the scope of inspections, I

1 substantiating all items of noncompliance and health and l safety matters, describing the scope of licensees' programs,  !

and indicating the substance of discussions with licensee manegement and licensee's response. Reports should uniformly and adequately document the results cf inspections and i identify areas of the licensee's program which should receive i special attention at the next inspection. Reports should show the status of previous noncompliance and the independent j physical measurements made by the inspector.

Questions:

1. How do inspection reports document the inspection that was condacted and the inspection findings? Explain how the reports substantiate noncompliance and health and safety matters and describe the scope of the licensee's program.

2. Do the reports j '

a. relate the discussions held with license management  !

and interviews with workers?

b. include independent measu oments conducted by the

inspector?

! Revision 4 D C 2 71984.

~. _ _.

e o E-28

c. document follow-up of previous citations of i violations made by the inspector?

l d. identify areas of the licensee's prograin needing i special attention at the next inspection?

i

3. Are inspectors routinely inspecting radwaste package preparation and shipping practices and do the reports document the results?

VI.G Reviewer Assessment:

H. Independent Measurements (Category II) i NRC Guidelines:

Independent measurements should be sufficient in nuder and type to ensure the licensee's control of materials and to validate the licensee's 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.).

GM Survey Meter: d-20mr/hr Ion Chader Survey Meter: several r/hr Neutron Survey Meter: Fast & Thennal 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 instrumen*,s should be calibrated at intervals not greater than thatrergiredtolicenseesbeinginspected. ,

Questions:

1. Discuss the State's policy for conducting independent meascrements as a part of each inspection (e.g., air samnles, wipe samples, air flows, dose rates). Are these measurements documented in the inspection report?

2. List the instrumentation that is readily available to the RCP for surveying licensed operations and conducting appropriate independent measurements.

Revision 4 i /

QFS 2 7 ISSA

6 9 E-29 1

3. Describe the method used for calibrating survey instruments and the frequency of calibration.

~

VI.H Reviewer Assessment:  !

VII. OTHER ASPECTS OF THE STATE'S RADIATION CONTROL PROGRAM A. Non-Agreement Sources of Radiation Questions:

1. Are the licensing and inspection procedures for NARM the same as for agreement materials?

2. Give the number of X-ray machine (or tube) and accelerator registrants by category, e.g., dental, medical, industrial, etc.

3. How many machine and accelerator inspections were made in the last year (or other appropriate interval)?

4. Does the State license X-ray or nuclear medicine technologists? ,

VII.A Reviewer Coment:

B. Environmental Monitoring Program ,

Questions:

1. To indicate the scope of the environmental monitoring program, describe:

a. types of media sampled

b. the number and locations of stations sampled

c. the frequency of sample collection

d. the analyses run on each type of sample

2. Is a copy of the latest environmental surveillance report ,

available fur review?

J VII.B Reviewer Comment:

l C. Other Areas j 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 co'tcern, or to generic or State-specific issues raised by NRC staff.

Revision 4 l l

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MD 2 71981 1

i

s i E-30

1. Other Generic Issues Questions:

?

a. For radiography inspections, to what extent do you make inspections at temporary job sites?

b. Are you finding Ir-192 contamination on radiographic equipment?

c. What are the State's plans to adopt the low-level waste (LLW)manifestrule(ifnotalreadyadopted)?

d. For States with LLW disposal sites, what are the State's plans to implement 10 CFR 61?

e. Will your State have access to a LLW disposal site after January,1986. If not, what contingency plans are there for after January,19867

f. Have copies of 10 CFR 61 and NRC technical positions on waste form and classification been distributed to State licensees? If there has been feedback please provide documentation.

g. Have there been any applications or approvals for incineration, compacting or disposal?

h. What use is being made of IE infonnation nutices?

1. Identify any group of materials licensees for which the State has increased the frequency of inspection due to problems with that general category. Please discuss the nature of those problems.

j. With respect to medical licensees, is the State making any effort during inspections of nuclear phannacies to detennine whether the licensee is actually conducting the required molybdenum -

breakthrough tests i.e., what is the State doing in addition to record reviews to establish compliance j

or noncompliance with the requirement?

, k. Is the State mounting any special effort to look at the possibility of reconcentration of radionuclides in sanitary sewers and sewage treatment plants as part of the regular inspection program? If so, please describe.

VII.C. Reviewer Coment:

Revision 4

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QU 2 1 1984

a. ,

E-31 t

CHRONOLOGY Amendments to be Considered by Agreement States  !

(fromSeptember1971) r Effective Date 10 CFR Part Regulations Sumary

. 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 j 71 i

Nov. 2, 1972 20 Part D. App. A

• Char.ges in values of radionuclides of all

! concentrations in air and

water.

I 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(1)

• Change to abbreviations 30 Part B Sch. A for " curie" and " micro-32 Part D. App. A curie," and addition of and App. 8 definition for " milli-curie."

Jan. 10, 1974 31 C.22(1) Authorization to use l 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

• l 70 the raterial shipped.

150 i

July 29, 1974 30 A.2(i) . *Special curie definitions Part D. App. A and concentration values

for U and Th.

Aug. 16, 1974 31 C.22 Addition of H-3 and Fe-59 32 C.26 to in vitro tests and 35 C.28 exteiision of Medical Group C.28 licensing.

• Compatibility item.

Revision 4

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' E-32

! Jan. 15, 1975 31 C.22(d)

• Modification of require-

' < 32 C.28(d) ments for distribution of 31.5 GL devices.

i Jan. 19, 1975 --

A.3(c) *Clerification of AEC contractors exemption pursuant to Energy Reorganization Act.

June 25, 1975 20 D.206

• Requirements for control of licensed material in unrestricted areas and not in storage.

June 25, 1975 35 Part C, Sch. C Addition of I-125 seeds for interstitial treatment J

of cancer to Group VI.

L Jan. 19, 1976 20 D.1(a)

• Incorporation of "As Low l As Is Reasonably Achievable l

(ALARA)" wording.

Jan 29, 1976 20 Part D, App. A

• Modification of occupa-

' , tional exposure limit for 1

Rn-222.

b Feb. 23, 1976 35 Part C, Sch. C Addition of Sn-113/In-113m generators to Group III.

I April 19, 1976 35 Part C, Sch. C Addition of Yb-169 DTPA for cisternography to Group II.

June 2, 1976 20 Parts C D Requirements for preser-i 31 and E vatiens of certain records 32 required by the regulations

! 35 40 70 150 i Aug. 4, 1976 34 E.203 Personnel monitoring

! requirements for industrial

' radiographers.

l Aug. 16, 1976 35 Part C, Sch. C Add' tion 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.

• Compatibility Item.

Revision 4

/ / QEC 2 71984.

a

• E-33 March 7, 197'a 40 C.3(c)

• Exemption for personnel neutron dosimeters containing thorium.

t May 31, 1977 31 C.22 i Addition of Se-75 to in -

32 C.28 h vitro GL.

June 27, 1977 31 C.22 i Addition of Mock Iodine-32 C.28 h 125 calibration sources tojnvitroGL. .

Aug. 15, 1977 35 C.26(b) Modification of requirements for individual physician use of radioactive material for human use.

Jan. 6, 1978 40 C.21(a) Extends small quantity source material GL to Federal State and local governments for operational 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.

Feb. 16, 1978 30 C.4(c)

• Exemption for spark gap irradiators containing Co-60.

March 14, 1978 20 D.203(c)

• Additional requirements for controlling areas in which radiation levels

, in excess of 500 rems /hr exist.

June 16, 1978 35 Part C. Sch. C Addition of Tc-99m j gluceptate sodium for brain and renal perfusion imaging to Group III.

l 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

• Compatibility Item.

Revision 4

//

. DEC 2 719M i

J o'

E-34 for venography to Grcup III.

~

Dec. 28, 1978 35 G.2(c) , Requirement to perfonn

. survey of patients t)

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(c) Notice of discontinued

,; 40 licensed operations.

70 July 9, 1979 35 ( , Teletherapy calibrations 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.

March 3, 1980 34 Part E Amendments to industrial

, C.26(e) radiography requirements.

4 March 28, 1980 71 A.3(b)

• Correction to reference

. C.101 to Postal Service regulations.

i ' Sept. 2, 1980 35 C.26(c) Testing of radioisotope

generators.

Sept. 19, 1980 40 C.21(a) Deletion of GL for source material medicinals.

Nov. 10, 1980 35 D.409 Medical misadministration reporting.

Nov. 17, 1980 40 A.2

• Requirements to implement C.25(e),(f) the Uranium Mill Tailings (g),(h) Act. l C.29 Part C, Sch. E .

Dec. 1, 1980 20 D.106(g)

• Reference to 40 CFR 190 for uranium fuel cycle

, operations.

4

• Compatibility Item.

Revision 4

//

Off 2 71984

E-35 Jan. 28, 1981 20 D.304

• Deletion of waste burial authorization.

March 6,1981 35 Part C, Sch. C Addition of 1!t:-99m oxidronate sodium to Group III.

March 13, 1981 34 E.203(b) Disposal of dosimeter records.

March 31, 1981 20 D.306 Biomedical waste rule.

May 13, 1981 30 C.4(c)

• Exemption for survey instrument calibration sources.

Sept. 23, 1981 30 C.4(c)

• Addition of Am-241 to exemption for survey instrument calibration sources.

Nov. 30, 1981 20 D.201

• Radiation protection -

survey requirement.

Dec. 24, 1981 40 C.3(c)(6)

• Clarification of 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 Reg. Guide 8.15 in regulations.

June 29, 1982 35 Part C, Sch. C Addition of Tc-99m labeled succimer to Group III.

July 6, 1982 71 C.104

• Advance notification of transport of waste.

Sept. 13, 1982 35 C.26(a) Change medical isotope conw ttee to radiation safety connittee.

Jan. 26, 1983 61 Part M

• Licensing requirements D.307 for land disposal of

~ radioactive waste, and waste classification.

• Compatibility Item.

Revision 4

//

EG 2 719B

.. . E-36 Dec. 27, 1983** 20 D.311

• Transfer for disposal and manifests.

March 4, 1983 35 G.4(h),(1) Teletherapy twom monitors

- and servicing of source exposure mechanisms.

March 7, 1983 35 C.26(c) Exemption from requirements for ure of approved l radiopharmaceuticals for unapproved procedures.

June 28,1983 35 Part C, Sch. C Addition of I-125 scaled source in portable device

- to Group VI.

Aug. 15, 1983 30 C.32 Expiration and termination j 40 of licenses. .

70 j

I Sept. 6, 1983 71 Part T Transportation regs compatibility with IAEA.

' (proposed)

Sept. 28, 1983 30 W.501 Irretrievable well logging

70 source.

150 Sept. 11, 1984 40 C.3(c)'

• Elimination of ext gtion for glass enamel and glass j enamel frit.

~

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• Compatibility Item.

• • Published in conjunction with Part 61.

Revision 4

//

, QE0 2 71984

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Attachment F Cancelled l

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Revision 4

.. ! . J : 19.8A.

.. o G-1 l Attachment G  ! <

STATE HEALTH OFFICEk SUtHARY DISCUSSION  ;

1. Express appreciation for cooperation of staff. Staff has been diligent in providing infonnation and materials requested.

2. Reviews are part of continuing program of reviewing A/S programs and technical assi. stance to A/S. Other activities include reviews of all licenses, consultation on licensing and compliance matters, 1 training, exchange of information, etc. )

l Note publication of the Guide as a Comission Policy Statement, 3.

guides and indicators, and provide copies. Coments developed as a result of review are intended to be positive, i.e., promote improvements in the program.

4. Review included accompaniments of on by . Elements of review included Legislation and Regulations, Organization, Management and Administration, Personnel, Licensing and Compliance including reviews of selected license and inspection files. Technical coments which were develcped have been discussed with the staff and sumarized with .

. State whether or not staff agreed with the coments.

5. Our coments are divided into 2 parts: (1)Thoseaddressingareas wiere l Department management attention or action is needed and; (2)

+

areas, usually technical in nature, in which the RCP Director can

implement improvements. The former will be contained in a letter i from the Regional Administrator to forthcoming j within 4 weeks. The second group of coments will be included in

an attachment to the letter which the RCP Director may respond to, i We will request a response to our letter (unless there are no l coments).

I i 6. We place copies of our letters to the State and the States' replies l in our Public Document Room and will furnish extra copies of our t letters to the State to be made available to the public in State

PDR's or equivalent.

! 7a. In the Staff's opinion, the program is i adequate to protect the public health and safety and is comp.tible

with the NRC and other Agreement State programs for those 4

materials. We feel, however, that improvements can be made in the program. Technical improvements in tie areas of have been discussed with . We wish to bring the following coments and recomendations to your attention.

Revision 4 Oh 7 ISS,(,

G-2

-or-7b. In the staff's judoement, siDnificant problems exist in (one area)

(several areas) whl:h, under our published guidelines, are of sufficient important that a recommendation on adequacy and compatibility should be postponad until we have received and evaluated the State's response;onse. We wish to bring these to your attention as follows. (The reviewer should state is significant problems exist in one or more Category I Indicators, state that the need for improvements ir, critical and whether or not ,

a follow-up review within 6 months is likely. The reviewer should  !

urge the States to be as specific as possible in their responses.) l

8. In summary, 1

9. I would like to solicit any comments you might have in response to I

our review, or any other comments or questions you may wish to discuss.

10. Thank you.

1 l

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l Revision 4 i GEb t'71984

u H-1 Attachment H t

SAMPLE REPORT FORMAT AND GUIDE FOR CONTENTS l

A. The reviewer is responsible for assuring that the draft report contains the following:

1. Transmittal memo to A/D (original)

2. Transatittal letter to State RCP Director (copy)

3. Coment letter to SHO (copy)

4. Replies from SHO and RCP Director, if available, (copies).

Note - Principal reviewers are responsible for ensuring these letters are added to the final report or incorporated into a supplementary report, as appropriate.

5. Draft report (original).

B. Samples of acceptable transmittal memos and letters are in Appendices 1 and 2. Guidance on the report femat and content is given in Appendix 3.

C. The draft report should be submitted to the SA Senior Project Manager within 30 days after the completion of the review. The final report must be ready for sign-off by the SA A/D within 60 days after the review.

D. Copies of the final report are to be distributed to OSP SA (Original plus 1 copy) and the appropriate Region (copy).

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KC 2 7198g l

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H-2

Appendix 1 to Attachment H  ! .

SAMPLE REPORT FORM AND CONTENTS TRANSMITTAL MEMO TO A/D G.

. Assistant Director for State Agreements Program

, Office of State Programs Thru: SA Project Manager i Office of State Programs i

REPORT AND STAFF EVALUATION -

j RADIATION CONTROL PROGRAM ,

1 Enclosed is the subject report and staff evaluation.

As noted in the report, the (State) radiation control program has --

' (this is for significant problems in Category I in the program or other comments which you want to emphasize for the A/D). Indicate whether or not a finding on adequacy and compatibility was postponed pending replies to our letters.

Also highlight here any omissions in the review and identify areas of

.the program that deserve special attention or follow-up by the next reviewer.

Based on the results of the meeting, the staff recommends that the next

! routine or follow-up meeting be conducted in months. (If

! applicable, indicate if the next review meeting is to be a follow-up j meeting.)

I t

i ~

i

Enclosure:

Subject Report Revision 4

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DEC 2 71984.

r .

H-3 Appendix 2 to Attachment H TRANSMITTAL LETTER (AddressedtoRCPDirector)

\

Dear  :

Enclosed is a copy of our report of the 198 review of the (State or State Agency) radiation control program for~ agreement materials. The report contains the findings of the NRC staff. The " Guidelines for NRC Review of Agreement State Radiation Control Programs" published in the Federal Register on. December 4,1981 as an NRC Policy Statement was used by the NRC staff as its criteria. The report is oriented to evalustion of the program and not of the individuals.

The results of the inspector accompaniments and of our review of the qualifications of the new staff were factored into our overall evaluation of the program.

If you have any questions concerning the report, please do not hesitate to contact me. -

Sincerely, Regional Administrator or RSAR

Enclosure:

As stated cc: G. Wayne Kerr Director Office of State Programs, (w/o encl.)

Revision 4

//

QED 2 71984

.. a H-4 Appendix 3 to Attachment H  !

'l FORMAT AND CONTENT FOR REPORT

)

I. The report consists of five parts:

A. Control and Cover Sheets B. Comment Letters -

C. Sumary section including conclusions, results of exit meetings, and status of previous coments and recomendations, D. Stateresponsestoquestionnaire(AttachmentE)andreviewer's assessmentt, and E. Appendices.

II. A. Formats for the Control and Cover Sheets and sumary sections are given at the end of this appendix.  !

B. For the questionnaire section, the reviewer should provide the completed questionnaire (questions State responses and the reviewer's assessment of each element of the State's program vis & vis each guideline.)

1. The States responses should be factual and complete.

Problems with the responses should be resolved during the review and, if necessary, agreement reached on resolution of problems of wording or content.

2.a. The reviewer must state whether or not the State's program meets the specified guideline. The assessment must specify the basis for the conclusion, e.g.. State responses, State responses and discussions with State staff, review of license files, etc. In such cases, assessments should normally~ be short and to the point.

b. If the guideline is not met, the assessment should so j stateandstatethebasis(e.g.,refertotheresponses, results of discussions or reference to results of file reviews). I

c. If the reviewer does not agree with responses to the questions and was unable to resolve differences with the State, the assessment should address this.

Revision 4

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QEC 2 71984 c_____ . . _ _ _ _ _ _ __ _ _ - _

H-5

d. The assessment section is also ava'ilable for the reviewer torecordissuesthatmaybeofconcern(eventhoughthe guideline is apparently met) as well as meritorious

, actions by the State. t

C. Appendices.

l

1. With respect to Appendices, they should be kept to a minimum. To the extent practicable, States should be encouraged to include requested information in the body of the questionnaire rather than supply separate documents as appendices. When the latter occurs, the reviewer should review them as nscessary and dispose of them in accordance with the following guidelines:

Appendix Item Mandatory Retention Optional Retain Copy Provide in Report as an Retention in Regional OSP copy Appendix in Report File for its file Statutes X X Protocol for Revising Regulations X X Rosters of Technical Advisory Comittees X l

Organization Charts X Emergency Plan Call List (ifseparate) X

! Budget (Basicdata X should be in report, .

details in regional file)

Fee Schedule X X License and Inspection Guides X i Forms X License File Review X SS&D File Review X Inspection File Review X Inspection Priority X Systems Revision 4 0 Q 2 I 1984

H-6 Appendix Item Mandatory Retention Optional Retain Copy Provide

in Report as an Retention in Regional OSP copy i Appendix in Report File for its file Incident Summary (See X X SA Procedure D.17)

Orders and Civil Penalties (copies or summaries) X X Internal RCP Procedures and memos X List of field and lab equipment X Details of attendance at

.trainingcourses(basic information should be in report) X Environmental Survey Program Reports X X Position Descriptions X Special Casework Reviews X Other State and Local j agency NOU's, cor. tracts, etc. X X Standa'rd License Conditions X Escalated Enforcement-Policy X Salaries (should be in report)

Other Consult with Senior Project Manager

2. In cases where appendices were provided by the State as part of their response to the questionnaire and which do need to be retained in the report, according to the above guidelines:

a. In the index of appendices, list all appendices supplied by the State,

b. Asterisk those which will not be retained in the report, and

. 1 I

Revision 4 )

Od 2 71984 i

. _ _ u

H-7 i

c. At the bottom of the index add the statement: j

" Appendix has been reviewed by the reviewer and a copy retained in the Regioral files."

3. This approach not only helps control the size of the i report but also avoids the need to renumber the ,

appendices and the references to the appendices. 1 l

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i Revision 4

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0 3 2 7 1984

-,w,,, . . , , , , ,

• .- -- . _ . _ - . _ m. __...m- _ ---- _

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H-8 (ControlSheet) *

1. Radiation Control Program

2. Type of Review i 3 Dates of Review

a. Field Evaluations

b. Regional or Contract Agency Office Visits

c. Visits to Licensed Facilities

d. Office Review

e. Exit Meeting

4. Period of Review TO

5. Regional NRC Representatives Staff-Days in State i SA Representatives -Staff-Days in Str.te I Other NRC Representatives 5Gff-Days in State Instructions _: l

1. Identify State RCP that was reviewed.

t

2. Enter type of review: Routine, Follow-up Orientation or Special.

3. Enter dates for each of the activities, e.g., "3/18-20/84." If none, enter "none."

4. For routine reviews, enter the last dates of the previous review l and the present review. For other reviews, leave blank.

5. Enter the total staff-days spent by each category of personnel o'n-site in the State participating in or attending the review.

The intent of this section is to capture the NRC staff effort expended in the State during reviews.

t t

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Revision 4 ,

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1 i

STAFF REPORT AND EVALUATION OF THE RADIATION CONTROL PROGRAM F0ii THE PERIOD TO l

I (No.)RegulatoryProgramReview Revision 4 Of&YIIQ

\

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[ H-10 i

l STAFF REPORT AND EVALUATION OF THE RADIATION CONTROL i PROGRAM FOR THE PERIOD To  ? . The j umpteenth regulatory program review meeting with representatives was held during the period

to , in . The state was l represented by , ,and .

A review of selected license and inspection files was conducted by

on . conducted

! accompaniments of Inspectors during the period to . A sumary meeting regarding the results

! of the regulatory program review and inspection accompaniments was held j with , ,and , on i .

Cenclusions 1

The program for control of agreement materials is adequate to protect the public health and safety and is compatible with j the regulatory programs of the NRC and the Agreement States.

I

-or ,

j Significant problems were found in more than one (or more) Category I Indicator (s). These and other coments and recomendations were as

follows-1 1

,' (Examples)  !

3 s

1. The inspection backlog has increased slightly and steps need to be  :

taken to more closely monitor the backlog. .'

This Inspection comentProgram," relatesbut to thea Category I Indicator,("

backlog was minor 10 out Status of 120of l licensees) and the coment was precautionary. It was not indicative of a significant problem in this indicator area. *

2. Information on two incidents involving teletherapy malfunctions j , was indicative of possible generic design failures. Such j information should be provided to tht Agencies responsible for evaluation of the devices (in this case NRC) for an assessment of

{ the problem.

! This coment relates to a Category I Indicator, " Response to 1 Actual and Alleged Incidents" and it is a significant one in view of the finding of two incidents. The State has promised to instruct its staff on the importance of recognizing possible j generic design problems and infoming the appropriate agency and

information on the referenced two cases was submitted to NRC and sent to NMSS.

1 Revision 4

/ / i afS 2 71984 l

L -._- - -- - - __- - - - - - - -

- a 1

H-11 I

3. The 2nd teletherapy incident appears to meet Abnormal Occurrence j Report (AOR) criteria. We request a report on it fortinclusion in the next quarterly AOR.

There is no indicator area covering this comment and it is a reminder to the State.

These conclusions area based on the review of the technical and l administrative aspects of the State's regulatory program for

.ontrolling agreement material.

Included in this review were examinations of selected license and 4 inspection files, the program indicators specified in the NRC " Guide j for Evaluation of Agreement State Radiation Control Programs," the accompanimentsofStateinspectors(whenappropriate),thereviewof l

, and our

all licenses issued by since

continting exchange of information program.-

! Sumary Discussion With State Representatives.

A sumary meeting to present the results of the regulatory program review meeting was held with and on i

Division of Radiation Control attended the meeting.

The following comments and recomendations were made tc and .  ;

In respense to the NRC representative's comments, Comissioner stated:

Program Changes Related to Previous NRC Coments and Recomendations

! 1. Coment ,

Recome1dation -

I State Response l

Present Status

2. etc. ,

t 1

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Revision 4 Ok0 2 71984

.,.,,m., - * - p ap_. e-* *

• Sep : _._.._5 .

ew h aouerh e a=ea,*e-p=a.wuss= w eo,

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i Completed Questionnaire and Reviewer Assessments i

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Revision 4

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AF.d271984. ,

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s- - __ .. . - - - - . .

a ..

H-13 i

List of Appendices e i

r A.

B.

C.

D.

E.

F. .

G.

o =l H.

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Revision 4 Y h I 1984

l 1-1 ATTACHMENT I e i

SAMPLE LETTERS TO STATE HEALTH OFFICERS

! Attached are guides and sample letters in acceptable fonnats to SH0's reporting the results of the reviews of State programs.

Appendix 1 provides general guidance on the contents of letters and 3

enclosure to letters to SH0's. ,

Appendix 2 is a sample letter to a State whose program has been found )

adequate and compatible. The letter also contains a paragraph favorably comenting on certain aspects of the program.

4

)

j Appendix 3 is a sample letter for a State where a finding of adequacy ,

, and compatibility cannot be made because of significant problems in j Category I Indicators.

There are slight variations in the "boilerplate" in the two letters as

~

well as in the handling of the copy for the State PDR (or equiv&1ent). ,

i Either version is acceptable however, deviations from these should be  !

discussed in advance with the A/D.

Appendix 4 is the standard " Enclosure 1" to the letters to SH0's. .

l Appendix 5 contains guidance for the form and content of " Enclosure 2" to the letters to SPO's.

Additional enclosures to the letter may be appropriate, e.g., coments on specific casework or problems or coments on uranium mill and low-level waste disposal regulatory programs.

When problems, coments and reconnendations are repeated from the j previous review, this is to be specifically mentioned in the letter.

l I

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Revision 4

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KC 2 / 1964

1-2 App (ndix 1 to Attachrent I

! i TYPES OF GENERIC COMMENTS 1 l

i I. Items to be included in the letter to State Health Officer or equivalent management official

1. All significant comments in Category I Indicators. These should be concisely stated in the letter (identifying )

Indicator and sunnarizing problem). Details can be provided i in an enclosure. -

l

2. Updcting regulations.

3. Location of radiation control program in Department.

4. Budget.

5.- Office equipment and support services. l

6. Numbers of staff and staff continuity.

7. Instrumentation (if the problem is funding or obtaining approval to purchase).

8. No comments and favorable items.

9.

Other connents as directed by A/D.

II. Items to be included in the "Enclosire 2" to the SH0 letter (i.e.,

matters for the attention of the program director)

1. Details of signif tcant connents in Category 1 Indicators.

2. All problems in Categories I and !! not identifieo in letter to SHO.

3. No comments and favorable items.

Revision 4 DEC271984 c .. _ __ _ ._. _ _ _. . _ _ _ .__ -. _ _ _ ._ _ _..._ _ ._ __ .__. . _ _ . _ _ _ _ _ _ _--

( / .

4 I-3 t,etag, y,s780 STATES - 1 l 41, Nus6e Am ReGULATCOY COMMisslON

,, e nacio= n

• 1 sei manitrrA rran s t. e, w  !

, g / atLANT A. ce oacia acaos '

j ....- OCT 2 91984 I

Appendix 2 to Attachment !

l l Jaries G. Ledbette , Ph.D. l Comissioner Georgia Department o' Hurar Rescurces State Office Building

, 47 Trinity Avenue l Atlanta, Georgia 30331 1

l

Dear Comissicate Ledbetter:

l This is to con'inr. the discussier Pr. Richarc L. Woodru", NR* State Agree ee.

jl Representative, held with Messrs. W. Scott Sprinkle and Bobby G. Rutledge following our review and evaluation of the State's radiatier control progra or i August 31, 1984 The review covered the principal adeinistrative and technical islettor aspects and regulaof tio the program and in:1udedad-fr.istration, an emarrination of .the prograr.'s le ts, o-ganization, managernent, perscr.nel, i and com:11ance, and the accorcaninent of a State inspe: tor.

Our review was perfortaed 1 accordance with the NRC Policy de'ined in the I " Guidelines for NRC Review of Agreement State Radiatier. Centrcl Prograr.s."

These GutJelines were oubliv.ed in the feceral Registe" cr. Dete .ber 4,1921, ar.c i

! de'ined the 30 Indicators 'ast are used for evaluating Agreement State Prograes.

A description of how the irdicators are used in reporting the results of the j  ; program reviews to State mar.agement is enclosed (Enclosure 11.

! I i

As a result of our review of the State's progea . and the routine exchange of information betwsen the Nuclese Regulatory Corrissier and tne State of Georgia, I the, staff dete'"-ined that overall the Georgia p*0 gram for regulatien of agete9 eat j materials is adeouate to prote:t the publi: healtn and sa'ety and is cot;atible i

with the Conrission's progra .

i We have observet cortinued ir: evement ir the orograe anc me believe that the J

i

} support giver b,. you and y:ue sta'f contributed significaetly te this irpec.enea.t.

In particular, we noted that the progra- *.as received le;4:*4tive authe-it, te assess chil pea.alties, a ra:iatier ad.ise b:sec eas tee estat'ishet, aa: t.-

!  ; vacar:ies ir. tre radica:tive P4:e 141s urit we e 'illed. 1 l Enclosure 2 certains a:ditice.a1 co reats regnading the te:6 ical aspects of cue

review o' your pro re . These co rierts were discussee wite Mr. Rutledge du*frg i our exit nettin; w in him. Mr. Rutledge was a6' sed at the ti me snet a res

:ast i

l tc these fincirgt would be ressested by tris o"i:e. '

I

.  ; In accordaace witt Mi practi:e, I ar crevidirg, as Entles. e 3, a co;y cf t*. i s

!  : letter fo plate .ea.t in the State's Public Do:ti 46: Reo o- etherwise te be rede I

available 'o cutlic re.iea. ,

uj'[.ff]?3 j

Revision 4 f:@

h2 719M

--,.,,%.%m-w--y, ww-,-.--- .r,-----,- w--rw m m-----.---m-,,,,,-----w--r- -e--w------ -'-r-~ -~e-ww-r ~+--w--e&+-'-'-- ------~~v'w--w+---- -'-w

t .

. I4 h

Corrissioner James G. Ledbetter 2 ' OCT 2 91984 1 aooreciate the ceurtesy anc coeperation e> tea.de: by your sta" th Pr. W:odru "

during the review.

l Sincerely, )

i Sw 'I h_ 6 k __

i mes D. C'Feilly l ,

R cionat Ac-inistrato

Enclosures:

1. Applicatfor o' " Guidelines fo De Review o' Agreenent State Radiation Control Programs" '

2. Coments and Racomendaticas on l

Technical Aspects of the Georgia

Radiation Centrol Progra-for Agreer. eat Materials -!

3. Letter to James G. Ledbette*, Ph.D.

from Janes P. O'Reilly, dated 10/29/Et I i ec w! enc 1:

Bobby G. Rutledge Director

! Radiological Health Section l

G. Wayne Kerr, Dire: tor j Office of State Programs, NR*

. NR* Public Doc 0 cent Room. .

N Revision 4

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0 E 2 7 1984 mm

- - =. - .- -

. 5 l

i I-5 Appendix 3 to Attachment I

~

. e s

Lillian Roberts Conmissioner of Labor

, New York State Department of Lacor Two World Trade Center 1 New York, NY 10047

Dear Connissioner Roberts:

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This is to confirm the discussion Mr. Paul Lohaus, Region I State Agreements Officer, and Mr. Joel Lubenau, Office of State Programs, i held with Deputy Comissioner Robert J. Maaer and Dr. Francis J. Bradley on July 17, 1984, following our review and evaluation of the Department's radiation cortrol program. The review

.i covered the principal administrative and technical aspects of this

( program and included an examination of the crogram's legislation and regulations, organization, management and administration, personnel, j licensing and compliance. '

j The review was performed in accordance with the NRC policy defined in a the " Guidance for NRC Review of Agreement State Radiation Control Programs." These Guidelines were published in the Federal Register on  ;

December 4,1981, and define the 30 indicators that are used for  ;

1 evaluating Agree:nent State programs. A description of how the ,

1 indica, tors are used in reporting the results of program review to State j managementisenclosed(Enclosure 1).

As a result of our review of the Department's program and the routine exchange of information between the NRC and the Department, we are l

, withho' ding, at this time, a determination of adequacy and j c spatibility for the program pending receipt and evaluation of 3 '

esponses to significant connents concerning inspection backlogs and the need to complete the upditing of the Department's radiation protection regulations. These relate to 2 Cate f Status of Inspection Program and Status of Regu$ cryAeditionally, ations. I Indicators, our review of the EAD incident disclosed a potential for significant problems existing in two other Category I Indicators, Response to

, Actual and Alleged Incidents and Enforcement Procedures. These and 1 other coments were discussed with Mr. Maher and Dr. Bradley and are detailed in Enclosures 2 and 3. We believe the matters identified J should receive prompt attention. Also, we believe existing -

i arrangements for coordination of regulatory actions between the New York agencies responsible for regulatory control should be examined in j the areas of your Department's responsibilities, particularly in the area of inspection of Department licensees routinely discharging radioactive material to the environment.

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! We believe that a major problem area in the program is staffing level.

Our guidelines suggest a professional staffing level of 140 to 1.5 staff-years per 100 licenses. The present staffing level is 1.1 )

and is essentially unchanged since the last review. We have previously 1 comented that while the staffing effort appears to be within '

guidelines, the significantly larger number of complex licenses administered by the Department creates larger demands on staff

! resources. Your staff has been operating very well under difficult I

circumstances, but without additional staff, the program will not be able to make necessary improvements. As an absolute minimum, the  !

i program needs one additional full-time professional staff member l imediately. Given the aforementioned large proportion of complex )

licenses administered by your Department and the additional need to be

• able to adequately respond to special situations such as Auburn Steel, Radium Chemical Company and EAD Metallurgical Inc., wi. believe you i should also seriously consider adding a second professional staff I position to the program. l l

I We understand that you have supported Department budget requests in '

l prior fiscal years for additional staff but that these requests were turned down as part of the State's overall fiscal process. We also understand the fiscal year 1986 budget includes requests for additional

staff. Given the critical need for additional staff resources now, we suggest that you consider assigning a vacant position to the program,

if that is possible, within the Department's overall personnel ceiling.

Assigning a position to the program now would enable Dr. Bradley to

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j imediately begin action to fill the position. This will reduce help J the time required to recruit, hire and train new staff.

I We would appreciate your review and response to our coments and

] recommendations. In accordance with NRC practice. I am enclosing a copy of this letter for placement in the State Public Document Room or otherwise to be made available for public review. As discussed recently with Dr. Bradley and representatives of the other radiation i . control programs in New York, we are also furnishing copies of these review letters to other New York Department heads involved in the

)! Agreement program, i I appreciate the courtesy and cooperation extended by you and your

staff to Hr. Lohaus and Mr. Lubenau during the review.

Sincerely, l

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Thomas E. Murley

! Regional Administrator

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Enclosures:

As stated

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cc: w/ enc 1. t D. Axelrod, M.D., Comissioner State Dept. of Health H. J. Williams, Comissioner State Dept. of Environmental ,

Conservation l D. J. Sensor, M.D. , Comissioner New York City Dept. of flealth J. Dunkleberger. Director Bureau of Nuclear Operation I

NRC Public Document Room j State Public Document Room G. Wayne Kerr. OSP 1 t

F. J. Bradley, Ph.D.

New York Dept. of Labor i

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, I-8 Appendix 4 to Attachment I e Enclosure 1 1 1

A) plication of " Guidelines for NRC Review of Agreement 5 tate Radiation Control Programs ,

I The " Guidelines for NRC Review of Agreement State Radiation Control Programs", were published in the Federal Register on December 4,1981 as an NRC Policy Statement. The Guide provides 30 Indicators for  ;

evaluating Agreement State program areas. Guidance as to their  !

relative importance to an Agreement State program is provided by l categorizing the Indicators into 2 categories.

Category I indicators address program functions which directly relate to the State's ability to protect the public health and safety. If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.

Category II indicators address program functions which provide essential technical and administrative support for the primary program functions. Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e., those that fall under Category I indicators. Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators. .

It is'the NRC's intention to use these categories in the following manner. In reporting findings to State management, the NRC will indicate the category of each coment made. If no significant Category I consents are provided, this will indicate that the program is adequate to protect the public health and safety. If at least one significant Category I coment is provided, the State will be notified that the program deficiency may seriously affect the State's ability to protect the public health and safety and should be addressed on a priority basis. When more than one significant Category I coment is provided. the State will be notified that the neeo cv improvement in the particular program areas is critical. The NRC would request an 1 mediate response, and may perfonn a follow-up review of the program within six ronths. If the State program has not improved or if  :

additional deficiencies have developed, the NRC may institute i proceedings to suspend or revoke all or part of the Agreement. Category

!! coments would concern functions and activities wh' ch support the State program and therefore would not be critical to the State's ability to protect the public. The State will be asked to respond to these coments and the State's actions Will be evaluated during the next regular program review.

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Appendix 5 to Attachment I f

Guidance for " Enclosure 2" I. Guidance on Fomat A. Coments and recomme'idations should be arranged according to the six main divisions of the Policy Statement:

1. Legislation and Regulations

2. Organization i

3. Management and Administration

4. Personnel ,

5. Licensing '

6. Compliance l B. The indicator should be identified and stated as a Category I .

or Category II Indicator. If a Category I Indicator, an ' '

additional statement is needed to specify whether the coment is of minor significance or major.

C. Coments and recommendations are to be kept separate.

D. The coment should consist of a brief statement of the -

guideline that is at issue and a statement of the problem.

E. The recomendation should be specific. Whenever possible, specify timeframes or other administrative targets.

F'. All problems discovered under one guidelines should be discussed under one coment and recommendation.

G. Occasionally problems may be' uncovered that may be covered under different guidelines or even different indicators or division (e.g. procedures are addressed under an indicator in Managerent and Administration, in Licensing and in Compliance. As another example, a deficiency discovered in the inspection reports ma be related to r. problem in documentation " Reports"; { Inspection Procedures"; or

" Inspectors Performance and Capability." somejudgementon the part of the reviewer will be needed to resolve these. In general:

1. Keep the number of comments and recomendatio.is to a minimum. If the problem can be covered under an indicator for which you already hwe a coment, consider including it there.

2. If the problem can be covered under a Category I Iridicator, even as a minor coment, it my to more dtsirable to cover it that way than as a Category II.

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I-10 II. Guidance on when to make coments on file review findings, t

A. Since the States are provided copies of the reports, including file review coments..coments on license and compliance actions that are contained either in the SHO letter or in enclosures should be confined to:

1. Problems for which there are indications that they are generic, or

2. Problemswhich,evenifnotgeneric(i.e.are case-specific) represent signif'icant potential or real threats to public health and safety and require prompt remedial action by the State. In sach a case, a significant Category I Indicator is involved.

B. For borderline II.A.1 cases, such as when a problem is found in more than one but only a "few" file reviews, try to determine through discussions with staff and RCP management, and reviews of procedures and previous reports if it is '

generic. For example, is more than one reviewer or inspector making the same error, the problem may be generic.

Inadequate procedures may contribute to creation of a generic problem. If the problem was identified in any of the 3 previous reviews, then there is strong incentive to include ,

the coments in the letter or enclosure. In such borderline cases, be sure to provide supporting documentation for making the coment in the appropriate appendix to the report.

C'. If the reviewer uncovers a specific file case where, in the I reviewer's opinion, the problem merits prompt remedial action (and specific mention in the SHO letter), the findings should be discussed with the A/D prior to the exit meeting with the SHO.

III. Example A. An example of an acceptable " Enclosure 2" is provided on the following page. .

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ENCLOSURE 2 COMMENTS AND RECOMMENDA' IONS ON TECHNICAL ASPECTS OF THE GEORGIA RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS f I. LICENSING Licensing Procedures is a Catego*y II Indicator. The following coment with our recorrendation is trade.

Concent i The radiation control program should have interna' licensing guides, checklist, and policy memoranda censistent with current NRC practice. With ,

regard to the measurement of radiopharmaceutical dosages, NRC requires i that the licensee assay the radioactivity of each radiopharmaceutical dosage before it is administered to a patient and keep a record of the

. assay results. This is required te ensure that the patient receives the:

intended dosage. We noted that some of your medical. ir.stitutional type licerisees are not required to assay the radiophamaceuticals prior to being ,

administered to the patlant. These-facilities receive unit doses prepared j by a nuclear pharmacy and transferred through a third party licenses that i may perform certain " mobile van" services.

Recomendation 1

, We recorrrrend that your procedures fer medical licenses require the licensees  ;

assay each radiopharmaceutical dosage prior to its administration to the l I patient and keep a record of the assay results, consistent with MC

! practice.

!  !!. COMPLIANCE -

Status of Inspection Program is a Category ! Indicator. The following coment of minor significance is trade with our recorreridation.

Com ent The State has mace considerable progress in reducir; their inspectier. l backlog fro 34*, to 20', since the previous review. However, we neted trat I the State has three priority !! licer.ses (Broad Acade*ic, typt A) that have not had a complete inspecticn within the last five years, and 35 priority

!!! licenses that are overdue fer inspection.

Recerrenda tion We recocrend that the State contin';e their ef#crts to reduce the inspection backlog in accordance with their inspection schedule and that speciel effert be devoted to inspecting the overc'.t licenses in prie ities !! and II:.

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Attachment J Guidance for handling coments on inspection backlogs.

Scone of Backlog Results of HRC Review l Coment on Backlog - Withhold Staff in letter Finding of Adequacy and/or Compatibility I Any license in Priority

1. 2. or 3 past due by 50% of its inspection frequency or in Priority

4. 5 or 6 past due by f 100% of its inspection frequency (State Priority .

System)

State has initiated action

• plan to ar' dress overdui. inspections Yes No State has had an action plan

• in place since the last review but the backlog has grown Yes Yes State does not have action plan and backlog is growing Yes Yes j

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'An action plan must (1) be written, (2) contain numerical aled timefrane goals for reducing the backlog, (3) contain benchmarks or l

milestones to measure progress and (4) cail for review of the programs

! progress in meeting benchmarks by progran management. Other, lesson

! efforts, such as simply placing an emphasis on inspecting Priority I

! licensees does not constitute an acceptable action plan.

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