ML20128J192

Ack Ltr for Maine W/Ri Concurrence

ML20128J192
Person / Time
Issue date:	08/19/1996
From:	Craig Gordon NRC
To:	Kerr K, Maupin C NRC
Shared Package
ML20128J188	List: ML20128J186 ML20128J192
References
NUDOCS 9610100207
Download: ML20128J192 (1)

Text

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A From: Craig Gordon To: CHM, KJK C /N .

Date: 8/19/96 7:58am

Subject:

HAINES LETTER -Forwarded Cardelia/Kathaleen Attached is the acknowledgement letter for Maine w/ RI concurrence.

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nw 1 UNITED STATES E S NUCLEAR REGULATORY COMMISSION E

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%..... October 1, 1996 I DoraAnne Mills, M.D.

Director, Bureau of Health Maine Department of Human Services 11 State House Station 151 Capitol Street Augusta, Maine 04333-0011

Dear Dr. Mills:

This is in response to the letter dated July 23,1996 from Philip Haines, Acting Director, Bureau of Health which responded to the comments and recommendations from our March 21,1996 review of the Maine radiation control program. The responses provided detailed information on how the Maine radiation control program has addressed, or is addressing, our recommendations. We appreciate the positive actions that the Maine radiation control program has taken with regard to our comments and recommendations.

However, we believe additional action is needed by the Maine radiation control program to resolve one comment and recommendation. This comment concerns the application of the emergency planning rule requirements to a Maine licensee, Binax. In your response, you '

indicated that this licensee currently physically possesses material below that requiring submittal of an emergency plan; however, the Binax license authorizes the company to possess amounts of material which require an emergency plan. The amount of radioactive material authorized by the license, not the amount in actual possession by the licensee, should determine whether an emergency plan is required. In light of this, the Maine radiation control program should either request the submittal of an emergency plan by Binax, condition the Binax license to reduce its authorized possession limit, or if justified, formally exempt the licensee from this requirement.

We request a response addressing this issue regarding the emergency planning rule. In addition, we will review the status of other comments and recommendations as a part of our next program review.

Thank you for your support of the Maine program.

Sincerely, EC (RA C &$

Ric ard L. Bangart, Directo Office of State Programs cc: R. Schell, RCP W. Clough Toppan, State Liaison Officer G)&Mo O %) Nf

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EXECUTIVE TASK MANAGEMENT SYSTEM

<<< PRINT SCREEN UPDATE FORM >>> l TASK # - 6S193

_____. DATE- 08/06/96 MAIL CTRL. - 1996 r

i TASK STARTED - 08/02/96

__.__...____ TASK DUE - 08/16/96 TASK COMPLETED - / /

TASK DESCRIPTION - 7/23/96 LTR - RESP TO NRC FINDINGS & RECOMMENDATIONS

.._______.~~~~~~

OF MAINE RAD CONTROL PROGRAM (ACKNOWLEDGEMENT LTR)

REQUESTING OFF. - MAINE REQUESTER

- P. HAINES WITS - 0 FYP - N PROG.- CG/ CHM FERSON - STAFF LEAD - CH/ CHM PROG. AREA PROJECT

~~~~~~~~~~~~~~

STATUS - DRAFT DUE TO MANAGEMENT: 8/16/96 8/2/96 FAXED TO CRAIG GORDON; PLANNED ACC. -N LEVEL CODE - 1 1

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CC LD Knin W. Conannon l STATE OF M AINE DEPARTMENT OF HUMAN SERVICES Al'GllSTA. M AINE 04333 BUREAU OF HEALTH 11 State House Station,151 Capitol Street Augusta, ME 04333-0011 Phone 207-287-3201 FAX 207-287-4631 July 23,1996 Mr. Richard Bangan Office of State Programs U.S. Nuclear Regulatory Commission Washington, DC 20555

Subject:

Nuclear Regulatory Commission Evaluation of the Maine Agreement Program, June 2.

1995, Response to Findings and Recommendations

Dear Mr. Bangart:

Thank you for your letter of March 21,1996, and the attachments, which reponed the results of the Nuclear Regulatory Commission (NRC) review of the Maine Agreement State Program for radioactive material licensing and inspection. The review was conducted by Mr.

Craig Gordon and concluded on June 21995. You specifically requested responses to your findings and recommendations and Mr. Robert Schell, Program Manager, has responded to these items (attached). Clough Toppan and I have reviewed these responses and I believe you will find this complete and responsive to your report.

I appreciate the efforts of the Nuclear Regulatory Commission in reviewing our program.

We have found the reviews to be instructive in the past and appreciate the tone.

As an added note, The position of Acting Director, that I currently now hold, will be filled on a permanent basis on 3 September by DoraAnne Mills, M.D. Upon the appointment of Dr. Mills, I will resume my position as Director of the Division of Health and Environmental Laboratories, within the Bureau of Health, although I will retain some administrative duties in the Bureau of Health.

In the meantime, ifI can be of assistance in any way please contact me.

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Sincerely, i l

p . ai es, Dr.P. .

i Acting Director, Bureau of Health l l

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i Radiation Control Program July 23,1996 Maine Bureau of Health Nuclear Regulatory Commission evaluation of the Maine Agreement Program, June 2,1995 l

. Response to Findings and Recommendations

1. Status and Compatibility of Regulations The NRC review indicated several rule changes which are matters of compatibility and will l require a rule making in the upcoming year to ensure compliance. The Program is planning a rule i making for early 1997. That rule making will address our fee schedule, and will also include the .l rule changes identified in your report. j In particular, the reviewers identified the emergency planning rule and that it had not been /

adopted within a timely manner as required under provisions of our agreement. This rule,10 CFR 30.32 (i), requires that certain licensees must have a response plan for the accidental release of radioactive materials. Your report does state that the Maine RCP indicated that no Maine Licensees would fall under this requirement and that we could defer adoption. Your report also asks that we substantiate our asseation that no Maine licensee meets the requirements of this rule.

The majority of our licensees would not be required to develop emergency plans based on l physical form, or licensed quantities. Six licensees were identified for further review based on likelihood of exceeding the 30.72, Schedule C. limits. 'Ihese 6 licensees are listed below. Of these, only Binax has a possession limit which meets or exceeds that listed in 30.72, that being 10 i curies of Iodine-125. However, our inspection records for Binax indicate that the actual amount l onsite is closer to 2 curies, and in fact, Binax is slowly phasing out their radioimmunassay product line and willlikely reduce this inventory as time goes by.

Accordingly, I feel confident in saying that we don't have a licensee with materials in -

excess of the NRC Emergency Planning Rule limits and as such have no licensees that would be j required to submit an Emergency Plan to this agency based on the referenced NRC regulations.

We willincorporate the EP rule provisions in a future rule making. As an interim measure l we will incorporate the provisions of the rule through license condition whenever appropriate. l l

Response to Findings and Recommendations NRC Evaluation of June 2,1995 July 23,1996 Page 2 4

GS Building (Am-241 foil) Diamed(I-125)

Binax (I-125) Pharm-Corp (I-131. Tc-99, Mo-99)

UMO (broad scope) MMC (medicalisotopes, H-3, C-14) 4

2. Technical Advisory Committee.

The review noted that, though authorized in legislation (1994), a technical advisory

" committee had not been appointed at that time. Since then, the committee members have been

' solicited and appointed, with six of the seven openings on the Maine Advisory Committee on Radiation successfully filled. The cunent membership includes representatives from the industrial, research, academic and medical licensee communities.

3. Training The NRC is aware that at the time of the program review, the NRC had announced that it

- would discontinue funding of Agreement State training, travel and technical assistance (SP  !

153). The NRC is also aware of the wide disagreement with this decision by the Agreement States. While, much of the opposition had to do with costs incurred, there was also concern that NRC had not explicitly d fined an acceptable level of training, j j

SP-96-028, March 4,1996, responded to a number of related questions from the State of Illinois. In particular, liiinois asked what the core courses are. The NRC, in turn, identified 8  ;

core courses. These courses, as well as other specialty training courses, will remain open to  !

Agreement States, though the States must now pay the cost of travel and training. The States also have the option of creating their own core traimng program.

At this time, the Maine Radiation Control Program is working to resolve the issues arising from the NRC decision. The easiest plan to implement would be to commit to attendance at NRC developed courses. This may also prove the most costly. Alternatively, Maine, along with the other New England Agreement States may implement a regional training plan. The New England Radiological Heahh Committee has discussed the feasibility of regional training. However, a formal proposal has not been developed and costs have not been projected.

We are considering our options, and will likely settle upon a mix of NRC and regional training for meeting core course requirements. In any case, existing senior staff have attended the identified core courses. 'In addition, we have identified continumg education requirements as attendance at I national meeting, such as the CRCPD or the Health Physics Society annual meetings or the AS technical meeting each year and attendance at regional meetings, such as the New England Radiological Heahh Committee meeting. This yearlicensing staff have attended the AS technical meeting, the CRCPD meeting and one staff member is attending the HPS meeting in July.

4. Inspection Frequency The NRC review recommends that the Program change the ins nuclear laundries. There are no nuclear laundries in the state at thisas however, time,pection this is a frequen category I item, the RCP will ensure that the inspection frequency is amended Inspection .

frequencies are pan of the State of Maine rules and will require a rule change to implement this change. As stated previously, a rule making is planned for early 1997.

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Response to Findings and Recommendations NRC Evaluation of June 2,1995 July 23,1996 l

Page 3 l 1

5. Inspector Performance and Capability l l

The review recommended that the compliance supervisor (program manager) periodically 1 accompany inspectors to evaluate the inspectors performance. The program manager, Roben Schell, and licensing staff were aware of this requirement, but had delayed field evaluations while new staff, Shawn Seeley, completed field trauung. Mr. Seeley has since completed his training i and is quahfied in all license categories. Supervisory reviews may now be completed without  ;

interfering in the training activity or presenting an unnecessary large group of inspectors to the i licensee point of operation. Mr. Schell has accompamed licensing staff at a facility undergoing  ;

decomnussioning and has set a goal of going out with the inspectors at least once each year to each major license category, i.e. medical, industrial, academic.... .

6. Enforcement Procedures The review raised a concern that ' regulatory language' was inconsistent in letters to the licensees reponing inspection results. The reviewers recommended that the prog clearly defined terminology to describe findings and problem areasspections. identified during m, ;

The perceived inconsistency was a result of a program philosophy to bring attention to areas for improvement over and above cited violations. Often, these were areas that technically met regulatory requirements, but the inspector felt couki be improved. Terms such as ' point of emphasis' or ' area of concern' were used to bring attention to tkse items, especially to licensee management.

The reviewers did correctly point out that our attempt to bring in this t lead to some inconsistencies between individualinspection letters. this did However,not seem to ype of comme create any confusion among the licensees and was viewed as beneficialin most cases.

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l Following the NRC review, the RCP did review inspection and reporting practices and opted to develop a safety inspection form. This form, HHE-891(attached) allows the inspectors to capture those items which previously were reported on inspection letters. Inspection letters now follow the NRC format. .;

unp96. doc

Mrine Form HHE 891 State of Maine

,'(6/95)! Radiation Control Program SMRRRP Part B SAFETYINSPECTION Page1cf

1. LICENSEE 2. OFFICE Division ofHealth Engineering Radiation Control Program 10 State House Station

'157 Capitol Street Augusta, ME 04333-0010

3. LICENSE NUMBER (S) 5. DATE OFINSPECTION l LICENSEE:

The inspection was an examination of the act!vities conducted under your license as tc.ey relate to radiation anfety and to compliance with the State of M:.ine rules and regulations and the conditions of license. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, a < J observations by the inspector (s). The fmdings as a result of this inspection are as follows:

l. Within the scope of this inspection, no violations were observed.

2. The inspector a!so verified the steps you have taken to correct the violations identified during the last inspection. We have no further questions on those actions at this time.

3. Dur'ng this inspection certam of your activities, as described below or attached, were in violation of State of Maine requirements. This

_ form is a NOTICE OF VIOLATION, which is required to be posted in accordance with Part JJ.

A. was not properly posted to indicate the presence of

_ . (D.27 - D.31 or E.16)

_ B. of scaled sources were not performed at the proper frequencies per or License Condition Number .

- C. Records of were noc properly maintained as per

- or License Condition Number .

D. Documents were not properly posted or otherwise made available. (Part J.2)

- E. Reports of notification of were not made in accordance with

- or License Condition Number .

- F.

1 hereby state that, withm 30 days, the acuons desenbed by me to the inspector wiu be taken to correct the violations identified in the items checked above. This statement of corrective actions is made in accordance with the requirements of Part B (SMRRRP). No further resporae will be submitted unless required by the State of Maine.

SIGNATURE LICENSEE DATE SIGNATURE STATEINSPECTOR DATE ORIGINAL TO LICENSEE

Mine Form HHE-891 Part 2 State ef Maine (6/95) Radiation ControlProgram SMRRRP Part B SAFETYINSPECTION Page 2 or

, 1. LICENSEE 2. OFFICE Division ofHeahh Engineering  !

Radiation Control Program  :

10 State House Station  !

157 Capitol Street Augusta, ME 04333-0010 '

3. LICENSE NUMBER (S) 5. DATE OF INSPECTION I

3. Continued

- G.

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_ 11.

.- I.

- 4.

The violations listed below are not being cited because they were self-identified, and corrective action was or is being taken as per

_ Part B (SMRRRP).

.- A.

_ B.

- C.

ORIGINAL TO LICENSEE

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