DATED: JUL 28, 1993


Lani Graham, M.D.


Director


Bureau of Health


State House, Station 10


Augusta, ME 04333


Dear Dr. Graham:


This letter is to confirm the discussion Mr. Lloyd Bolling and 


Mrs. Teresa Darden held with you and Mr. Warren Bartlett, Assistant Director,


Bureau of Health, on April 30, 1993, following our review of the State's


radiation control program, and follow-up discussions with me.


As a result of our review of the State's program and the routine exchange of


information between the Nuclear Regulatory Commission (NRC) and the State of


Maine, we are withholding findings of adequacy and compatibility for the


State's program for regulating agreement materials with the regulatory program


of the NRC. These findings represent a decline in your program that is very


disappointing. Only a year ago, the Maine radiation control program was found


adequate and compatible to regulate those materials subject to an Agreement. 


Stronger management involvement and control must be instituted along with


increased staffing in order to regain an adequate and compatible 274b program. 


We would appreciate meeting with you within about 30 days to discuss your


action plan for responding to the recommendations in the enclosure. 


The finding of program adequacy to protect the public health and safety and


compatibility will be withheld because of a significant finding in the


Category I Indicator, Status of Inspection Program. 


At the time of this review, the program had been in existence for one year and


only six inspections were completed. In our opinion, the backlog relates


directly to the failure of the State to maintain a staffing level that meets


our minimum staffing criteria. A plan should be developed to address the


current backlog of inspections and to monitor the pending inspection cases to


prevent future backlogs.

Lani Graham, M.D. 2


Response to Incidents and Alleged Incidents is a Category I Indicator. 


Although the State responded to reports of incidents in an acceptable manner,


the State has not developed a comprehensive set of written procedures


providing staff guidance on responding to reports of incidents and alleged


incidents. The reviewers recommended that the Maine staff work with their


legal staff to develop a comprehensive set of procedures in this area. 


Although Staffing Level is a Category II Indicator, staff shortages have a


direct relationship to the inability of the program to conduct inspections. 


The radiation control program is currently staffed at a level of approximately


0.9 person-year/100 licensees. This level of technical support is below our


guidelines for staffing level of 1-1.5 person-years per 100 licenses in


effect. The radiation control program (RCP) must not have less than two


professionals available with training and experience to operate the RCP in a


way which provides continuous coverage and continuity. The two professionals


available to operate the RCP should not be supervisory or management


personnel. We strongly recommend that one additional professional staff


person be added to the RCP staff.


Enclosure 1 contains an explanation of our policies and practices for


reviewing Agreement State programs.


Enclosure 2 is a summary of the review findings which were discussed with Mr.


W. Clough Toppan, Manager, Radiological Health Program, and Mr. Jay C. Hyland,


Radiological Specialist. We request specific responses from the State on the


comments in Enclosure 2.


In accordance with NRC practice, I am enclosing a copy of this letter for


placement in the State's Public Document Room or otherwise to be made


available for public review.


I appreciate the courtesy and cooperation extended to the NRC


staff during the review. I am looking forward to our meeting and your


comments regarding management involvement, inspection backlog, staffing,


training and your staff's responses to the Enclosure 2 recommendations. 

Lani Graham, M.D. 3


The present status of the Maine radiation control program is of serious


concern. The State should expect a follow-up review this fall to review the


State's progress toward developing an acceptable program. In addition, Mr.


James M. Taylor, Executive Director for Operations, NRC, will be communicating


our concerns to the Governor's office under separate cover.


Sincerely,


Carlton Kammerer, Director


 Office of State Programs


Enclosures:


As stated


cc w/encls:


W. Clough Toppan, Manager


 Maine Radiological Health Program


J. M. Taylor, Executive Director for


 Operations, NRC


Thomas T. Martin, Regional Administrator


 NRC Region I


State Public Document Room


NRC Public Document Room

Lani Graham, M.D. 3


The present status of the Maine radiation control program is of serious


concern. The State should expect a follow-up review this fall to review the


State's progress toward developing an acceptable program. In addition, Mr.


James M. Taylor, Executive Director for Operations, NRC, will be communicating


our concerns to the Governor's office under separate cover.


Sincerely,


Carlton Kammerer, Director


 Office of State Programs


Enclosures:


As stated


cc w/encls:


W. Clough Toppan, Manager


 Maine Radiological Health Program


J. M. Taylor, Executive Director for


 Operations, NRC


Thomas T. Martin, Regional Administrator


 NRC Region I


State Public Document Room


NRC Public Document Room


bcc w/encls:


The Chairman


Commissioner Rogers


Commissioner Remick


Commissioner dePlanque


Distribution:


SA RF


DIR RF


EDO RF


JMTaylor, EDO


HLThompson, DEDS


RBernero, NMSS


Ckammerer


Sschwartz


Jsurmeier


Cmaupin


Lbolling


SDroggitis


TDarden, RI Maine File DCD (SPO1)


*See previous concurrence G:\93LETTER.ME


OFC OSP:SA OSP:SA OSP:SA:AD OSP:DD 

NME LBolling CMaupin JSurmeier SSchwartz 

DTE 06/25 /93* 06/25 /93* 06/25 /93* 06/28/93* 

OFC NMSS:D OSP:D DEDS EDO 

NME RBernero CKammerer HLThompson JMTaylor 

DTE 07/15/93* 07/27/93* 07/27/93* 07/ /93 
SUMMARY OF ASSESSMENTS AND COMMENTS 


FOR THE MAINE RADIATION CONTROL PROGRAM


APRIL 1, 1992 TO APRIL 30, 1993


SCOPE OF REVIEW


This program review was conducted in accordance with the Commission's Policy


Statement for reviewing Agreement State Programs published in the Federal


Register on May 28, 1992, and the internal procedures established by the


Office of State Programs, State Agreements Program. The State's program was


reviewed against the 30 program indicators provided in the Guidelines. The


review included inspector accompaniments, discussions with program management


and staff, technical evaluation of selected license and compliance files and


the evaluation of the State's responses to an NRC questionnaire that was sent


to the State in preparation for the review.


The first annual regulatory program review meeting with Maine representatives


was held during the period April 27-30, 1993 in Augusta, Maine. The State was


represented by W. Clough Toppan, Manager, Radiological Health Program and Jay


C. Hyland, Radiological Specialist.


Selected license and compliance files were reviewed by Lloyd Bolling, State


Agreements Program, NRC Headquarters and Teresa Darden, Acting Regional State


Agreements Officer, Region I. One inspector was accompanied during two


inspections on April 27 and 28, 1993. A summary meeting regarding the results


of the review was held with Dr. Lani Graham, Director, Bureau of Health, and


Mr. Warren Bartlett, Assistant Director, Bureau of Health on April 30, 1993.


CONCLUSION


Findings of adequacy to protect the health and safety and compatibility are


being withheld, pending the resolution of a significant finding in the


Category I Indicator, status of inspection program. 


STATUS OF PROGRAM RELATED TO THE INITIAL REVIEW VISIT


The results of the orientation meeting were reported to the State in a letter


to W. Clough Toppan, dated September 15, 1992. At that time, the reviewer


noted that the program had gotten off to a slow start in both licensing


actions and compliance cases completed.


The current finding indicates the need for a more aggressive inspection


schedule and the need to keep up to date on licensing amendments, as well as


new applications.


CURRENT REVIEW COMMENTS AND RECOMMENDATIONS


All 30 program indicators were reviewed and the State fully satisfies 23 of


these indicators. Specific comments and recommendations for the remaining


indicators are as follows:


1. Status of Inspection Program is a Category I Indicator


Guideline Statement


The State should maintain an inspection program adequate to assess


licensee compliance with State regulations and license conditions. When


backlogs occur, management should develop and implement a plan to reduce


the backlog.

2


Comment


During the onsite review of vital program data, the NRC staff noted that


inspection statistical information is handled quite well by computer. 


Ten licensees were overdue for inspection by greater than 50% of the


scheduled inspection interval. In addition, there are another 23


priority 1, 2, and 3 licensees, including medical facilities, which are


currently in the 50% overdue area. Based on review findings, you are


not conducting inspections of reciprocity licensees. 


Recommendation


We strongly recommend that all licensees in inspection priorities 1, 2,


and 3 be placed on a schedule which will eliminate the backlog.


We further recommend that an effort be made to inspect reciprocity


licensees coming into Maine from other jurisdictions to conduct field


work. This effort should include inspections and/or observations of


reciprocity servicing of the State's only teletherapy unit and any self­


contained irradiators, as these are complex and potentially hazardous


operations.


2.	 Response to Incidents and Alleged Incidents is a Category I Indicator


GUIDELINE STATEMENT


! Inquiries should be promptly made to evaluate the need for onsite 

investigations. 

! Onsite investigations should be promptly made of incidents 

requiring reporting to the Agency in less than 30 days (10 CFR 

20.403 types).


! For those incidents not requiring reporting to the Agency in less 

than 30 days, investigations should be made during the next 

scheduled inspection. 

! Onsite investigations should be promptly made on non-reportable 

incidents which may be of significant public interest and concern, 

e.g., transportation accidents. 

! Investigations should include in-depth reviews of circumstances 

and should be completed on a high priority basis. When 

appropriate, investigations should include reenactments and timestudy measurements (normally within a few days). Investigation 

(or inspection) results should be documented and enforcement 

action taken when appropriate. 

! State licensees and the NRC should be notified of pertinent 

information about any incident which could be relevant to other 

licensed operations (e.g., equipment failure, improper operating 

procedures). 

! Information on incidents involving failure of equipment should be 

provided to the agency responsible for evaluation of the device 

for an assessment of possible generic design deficiency. 
3


! The radiation control program (RCP) should have access to medical 

consultants when needed to diagnose or treat radiation injuries. 

The RCP should use other technical consultants for special 

problems when needed. 

Comment


The State did not have a comprehensive set of procedures to provide


guidance to the staff for handling reports of incidents and alleged


incidents.


Recommendation


We recommend that basic procedures to guide staff on handling reports of


incidents be drafted with the assistance of the legal staff. We also


recommend that the State use its equivalent to Part 20 and the various


guidance letters sent to all Agreement States focussing on the QM Rule,


Abnormal Occurrences, or procedures already developed by other Agreement


States, like Illinois, etc., to develop its procedures for handling


incidents.


3.	 Staffing level is a Category II Indicator


Guideline Statement


Professional staffing level should be approximately 1-1.5 person-years


per 100 licenses in effect. The RCP must not have less than two


professionals available with training and experience to operate the RCP


in a way which provides continuous coverage and continuity. The two


professionals available to operate the RCP should not be supervisory or


management personnel.


Comment


The radioactive materials program is currently staffed at a level of


approximately 0.9 person-years/100 licenses. Presently, the State has


only one professional staff person other than the program manager. The


staff deficiency is contributing to the significant finding in the


Category I Indicator, Status of Inspection Program.


Recommendation


We strongly recommend that one additional professional person be added


to the Maine staff. The radiation control program (RCP) must not have


less than two professionals available with training and experience to


operate the RCP in a way which provides continuous coverage and


continuity. 


4.	 Staff Supervision is a Category II Indicator


Guideline Statement


! Supervisory personnel should be adequate to provide guidance and 

review the work of senior and junior personnel. 
4


! Senior personnel should review applications and inspect licenses 

independently, monitor work of junior personnel, and participate 

in the establishment of policy. 

! Junior personnel should be initially limited to reviewing license 

applications and inspecting small programs under close 

supervision. 

Comment


During the onsite review of selected license and compliance files, it


was not evident from the review of the files whether or not the action


being taken had the benefit of supervisory review in all cases.


Recommendation


We recommend that a selected sample of all license and compliance


actions be reviewed in depth by the program manager. We suggest the use


of a checklist for consistency and documentation purposes.


5.	 Training is a Category II Indicator


Guideline Statement


! Senior personnel should have attended NRC core courses in 

licensing orientation, inspection procedures, medical practices 

and industrial radiography practices. 

! The RCP should have a program to utilize specific short courses 

and workshops to maintain an appropriate level of staff technical 

competence in areas of changing technology. 

! The RCP staff should be afforded opportunities for training that 

is consistent with the needs of the program. 

Comment


The technical staff is currently restricted from traveling for more than


14 days annually out-of-State. Specialized training in regulatory


health physics requires that new personnel have at least 11 weeks of


basic courses over a two year period. Beyond this, senior personnel are


expected to attend periodic workshops, seminars and National meetings.


Recommendation


We recommend that the out-of-State travel restrictions be lifted for


radiation control personnel to permit staff to attend necessary training


courses to establish and maintain technical competence and NRC sponsored


workshops and meetings.


6.	 Technical Advisory Committees is a Category II Indicator


Guideline Statement


! Technical committees, Federal agencies, and other resource 

organizations should be used to extend staff capabilities for 

unique or technically complex problems. 
6


! A State Medical Advisory Committee should be used to provide broad 

guidance on the uses of radioactive drugs in or on humans. The 

committee should represent a wide spectrum of medical disciplines. 

The committee should advise the RCP on policy matters and 

regulations related to use of radioisotopes in or on humans. 

! Procedures should be developed to avoid conflict of interest, even 

though committees are advisory. This does not mean that 

representatives of the regulated community should not serve on 

advisory committees or not be used as consultants. 

Comment


The radiological health program does not currently have a Technical


Advisory Committee for general radiation matters, nor a Medical Advisory


Subcommittee for medical radiation matters.


Recommendation


The State should take steps to establish a Technical Advisory Committee


and also name a Medical Advisory Subcommittee. These committees will


prove themselves to be invaluable in their input on draft regulations


and a backup in handling radiation incidents.


7.	 Administrative Procedures is a Category II Indicator


Guideline Statement


The RCP should establish written internal policy and administrative


procedures to assure that program functions are carried out as required


and to provide a high degree of uniformity and continuity in regulatory


practices. These procedures should address internal processing of


license applications, inspection policies, decommissioning and license


termination, fee collection, contact with communication media, conflict


of interest policies for employees, exchange-of-information and other


functions required of the program. Administrative procedures are in


addition to the technical procedures utilized in licensing, inspection


and enforcement.


Comment


During this review meeting it was noted that the program staff was


diligently at work drafting administrative procedures. A comment on the


need for such procedures was expressed during the initial visit in


September 1992.


Recommendation


We recommend the establishment of administrative and office procedures. 


However, in view of the staff resource problem and the inspection


backlog, we recommend that as an interim measure the staff utilize NRC


procedures where possible and postpone procedure writing until the


inspection backlog is satisfactorily reduced. 

7


SUMMARY DISCUSSION WITH STATE REPRESENTATIVES


A summary meeting to present the results of the regulatory program review was


held on April 30, 1993, with Dr. Graham, Mr. Bartlett and Mr. Toppan. The


review team explained the background and obligations of the Agreement State


Program, the history of the Maine radiation control program, the scope of the


current review. 


The details of the findings in the Category I Indicators, as well as those


found in the five Category II Indicators identified in this enclosure, were


discussed at length. The review team pointed out that the root cause for the


inspection backlog is the program management failure to maintain the target


inspection schedule of approximately 40 inspections per year. An adequate


staffing level is critical to meeting this target.


Mr. Toppan, the Maine program director, stated that the inspection schedule


had in fact been allowed to build up. He attributed this to a staffing


shortage, both technical and secretarial, and the focus that they placed on


writing procedures. The NRC staff stated that while operating procedures are


important, we would advise that the Maine staff utilize NRC procedures where


possible in order to concentrate on pending casework (licensing and


compliance). This comment also extends to the other Category I Indicator


regarding procedures for handling allegations.


A Category II Indicator regarding the establishment of technical and medical


advisory committees was of interest to Dr. Graham. Dr. Graham agreed that


these committees could be of use to the State's radiation control program and


indicated that she would review the path needed to activate them. 


Regarding the staffing shortfall, Mr. Toppan stated that a replacement for the


secretary that they lost was already hired and would start work on June 10,


1993. Additionally, the need for a technical position was anticipated by the


State. However, as a result of the findings of this review, Mr. Toppan


indicated that he would file the required paperwork to accelerate the hiring


process. Dr. Graham was responsive to our comment on the State's restriction


(14 days per year) regarding out-of-State travel and she indicated that she


would try to get this restriction lifted.


The review team leader expressed appreciation for the cooperation given to the


team by the State staff. It was also explained that Mr. Carlton Kammerer,


Director, Office of State Programs, will submit the final results of the


review in a letter to Dr. Graham, and that the State will be expected to


respond to the comments in the letter and this enclosure. Due to the serious


nature of the findings, it was explained that the State should expect a


follow-up review within the next three to nine months to review program


progress. 

Application of "Guidelines for NRC Review


of Agreement State Radiation Control Programs"


The "Guidelines for NRC Review of Agreement State Radiation Control Programs,"


were published in the Federal Register on May 28, 1992, as an NRC Policy


Statement. The Guidelines provide 30 indicators for evaluating Agreement


State program areas. Guidance as to their relative importance to an Agreement


State program is provided by categorizing the indicators into two 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 comment made. If no significant Category I comments are provided, this


will indicate that the program is adequate to protect the public health and


safety and is compatible with the NRC's program. If one or more significant


Category I comments are provided, the State will be notified that the program


deficiencies may seriously affect the State's ability to protect the public


health and safety and that the need of improvement in particular program areas


is critical. If, following receipt and evaluation, the State's response


appears satisfactory in addressing the significant Category I comments, the


staff may offer findings of adequacy and compatibility as appropriate or defer


such offering until the State's actions are examined and their effectiveness


confirmed in a subsequent review. If additional information is needed to


evaluate the State's actions, the staff may request the information through


follow-up correspondence or perform a follow-up or special, limited review. 


NRC staff may hold a special meeting with appropriate State representatives. 


No significant items will be left unresolved over a prolonged period. The


Commission will be informed of the results of the reviews of the individual


Agreement State programs and copies of the review correspondence to the States


will be placed in the NRC Public Document Room. If the State program does not


improve or if additional significant Category I deficiencies have developed, a


staff finding that the program is not adequate will be considered and the NRC


may institute proceedings to suspend or revoke all or part of the Agreement in


accordance with Section 274j of the Act, as amended. 


ENCLOSURE 1