DATED: SEPTEMBER 18, 1995 SIGNED BY: RICHARD L. BANGART


Donald E. Williamson, M.D.


State Health Officer


Department of Public Health


434 Monroe Street


Montgomery, AL 36130-3017


Dear Dr. Williamson:


This is to transmit the results of the NRC review and evaluation of the


Alabama radiation control program. This review, which concluded on 


June 23, 1995, was conducted by Mr. Richard L. Woodruff, Regional State


Agreements Officer, Region II. The results of this review were discussed in a


meeting with Mr. James W. Cooper, Director, Bureau of Health Care Standards


and Mr. Kirksey E. Whatley, Director, Division of Radiation Control, on


June 23, 1995.


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


information between the NRC and the State, staff has determined that, at this


time, the Alabama program for regulation of certain Atomic Energy Act (AEA)


materials is adequate to protect the public health and safety. However, a


finding that the program is compatible with NRC's program is being withheld


because the State has not adopted the rule entitled "Quality Management


Program and Misadministrations" (QM) amendment, which was to be adopted by


January 27, 1995. We recognize that during the April 1995 Managers' Workshop


that NRC indicated the promulgation of the QM rule would be assessed as to


whether it should continue to be a basis for a finding of compatibility and


that your staff has deferred a final completion of the QM rule pending


completion of our assessment. The safety benefits of the QM rule and the need


for consistent requirements among NRC and Agreement State regulations indicate


the necessity for Agreement States to promulgate equivalent QM rules. 


Accordingly, the status of QM rule promulgation will continue to serve as a


basis for a finding of compatibility. The staff is, however, evaluating


methods to increase the flexibility of Agreement States in the implementation


of the QM rule such as flexibility to expand definitions in the QM rule to


include non-AEA radiation treatment modalities, to establish more restrictive


reporting requirements covering additional diagnostic misadministrations, to


determine the method by which a licensee would be required to submit its


quality management program and to determine the timing of that submittal.


Please note there has been a change in the format of this letter from our


previous review letters. This letter summarizes the findings regarding all


30 program indicators. Enclosure 1 contains an explanation of our policies


and practices for reviewing Agreement State programs. Enclosure 2 summarizes


the status of previous review findings and current review findings and 

D. E. Williamson	 - 2 ­


recommendations. We request specific responses from the State on the findings


and recommendations in Enclosure 2 within 30 days of this letter. Enclosure 3


presents a summary of the review findings where the State has adequately


satisfied the indicators. A response to the items in Enclosure 3 is not


required. 


We were pleased with the improvements that have been made in the program since


our last review. Specifically, we noted that the State does not have any


licensing or inspection backlogs, that the State promptly took action and


adopted compatible regulations following the 1993 review, and that other


recommendations from the 1993 review have been resolved.


I appreciate the courtesy and cooperation extended to Mr. Woodruff by your


staff during the review. 


Sincerely,


Richard L. Bangart, Director


Office of State Programs


Enclosures: 


1. 	Application of "Guidelines for NRC Review 


of Agreement State Radiation Control Programs"


2. 	Status of Previous Findings and Summary of 


Review Findings and Recommendations for the Alabama


 Radiation Control Program (July 23, 1993 


to June 23, 1995)


3. 	Summary of Assessment of Indicators Fully 


Satisfied by the Alabama Radiation Control Program 


(July 23, 1993 to June 23, 1995)


cc w/encl: 	K. Whatley


State Liaison Officer

D. E. Williamson	 - 2 ­


recommendations. We request specific responses from the State on the findings


and recommendations in Enclosure 2 within 30 days of this letter. Enclosure 3


presents a summary of the review findings where the State has adequately


satisfied the indicators. A response to the items in Enclosure 3 is not


required. 


We were pleased with the improvements that have been made in the program since


our last review. Specifically, we noted that the State does not have any


licensing or inspection backlogs, that the State promptly took action and


adopted compatible regulations following the 1993 review, and that other


recommendations from the 1993 review have been resolved.


I appreciate the courtesy and cooperation extended to Mr. Woodruff by your


staff during the review. 


Sincerely,


Richard L. Bangart, Director


Office of State Programs


Enclosures: 


1. 	Application of "Guidelines for NRC Review 


of Agreement State Radiation Control Programs"


2. 	Status of Previous Findings and Summary of 


Review Findings and Recommendations for the Alabama


 Radiation Control Program (July 23, 1993 


to June 23, 1995)


3. 	Summary of Assessment of Indicators Fully 


Satisfied by the Alabama Radiation Control Program 


(July 23, 1993 to June 23, 1995)


cc w/encl: 	K. Whatley


State Liaison Officer


bcc w/encl: The Chairman 


Commissioner Rogers


Distribution:


DIR RF EDO RF JMTaylor, EDO HLThompson, DEDS


RBangart PLohaus SDroggitis CMaupin


CPaperiello, NMSS FCameron, OGC HNewsome, OGC MSchwartz, OGC


TCombs, OCA RA, Region II RSAO, Region II RSLO, Region II


DCD (SPO1) PDR (Yes_X__ NO___) Alabama File


*See previous concurrence.


OFC ORA:RSAO* DRSS:RII* RA:RII* OSP:SPM* OSP:DD* 

NME RWoodruff BMallett SEbneter CHMaupin:vb PLohaus 

DTE 07/11/95* 7/12/95* 7/13/95* 08/16/95 08/18/95 

OFC NMSS:D* OGC* OSP:D* DEDS* 

NME CPaperiello FCameron RBangart HLThompson 

DTE 08/24/95 08/28/95 09/12/95 09/15/95 

G:\CHM\95LETTER.AL OSP CF CODE: SP-AG-1 
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. 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. Comments on Category I indicators that are not significant


will not be used as a basis for withholding of findings of adequacy or


compatibility.


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. Pursuant to


Section 274j of the Act, the Commission may terminate or suspend all or part


of its agreement with a State if the Commission finds such termination or


suspension is required to protect the public health and safety, or the State


has not complied with one or more requirements of section 274 of the Act. 


ENCLOSURE 1

STATUS OF PREVIOUS FINDINGS AND


SUMMARY OF REVIEW FINDINGS AND RECOMMENDATIONS


FOR THE ALABAMA RADIATION CONTROL PROGRAM


JULY 23, 1993, TO JUNE 23, 1995


SCOPE OF REVIEW


The 22nd regulatory program review with Alabama representatives was held


during the period of June 19-23, 1995, in Montgomery, Alabama. 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. The State's program was reviewed against the 30 program indicators


provided in the policy statement. The review included discussions with


program management and staff, technical evaluation of selected license and


compliance files, review of the State's policies and procedures, and the


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


the State in preparation for the review.


The State was represented by Mr. Kirksey E. Whatley, Director, Division of


Radiation Control (DRC), Bureau of Health Care Standards, Department of Public


Health; Mr. James L. McNees, Director, Radioactive Materials Compliance


Branch, DRC; and Mr. David K. Walter, Radioactive Materials Licensing Branch,


DRC. 


Selected license and compliance files were reviewed by Mr. Richard L.


Woodruff, Regional State Agreements Officer, Region II. Mr. Woodruff also


visited the Department of Environmental Management, Field Operations Division


Central Laboratory, on June 23, 1995. 


CONCLUSION


The State's program for regulation of certain Atomic Energy Act radioactive


materials is, at this time, adequate to protect the public health and safety. 


However, a finding that the program is compatible with NRC's program is being


withheld because the State has not adopted the rule entitled "Quality


Management Program and Misadministrations" (QM) amendment, which was to be


adopted by January 27, 1995. 


STATUS OF PROGRAM RELATED TO PREVIOUS NRC FINDINGS


The results of the previous review were reported to the State in a letter to


Dr. Williamson dated December 9, 1993. All comments and recommendations made


at that time were satisfactorily addressed and resolved, as documented during


our visit on July 26-28, 1994. 


CURRENT REVIEW FINDINGS AND RECOMMENDATIONS


All 30 indicators were reviewed and the State fully satisfies 29 of these


indicators. These 29 indicators are discussed in Enclosure 3. A


questionnaire containing the 30 indicators with specific questions pertaining


to each indicator was sent to the State prior to the review. 


1. Status and Compatibility of Regulations (Category I)


NRC Guidelines


The State must have regulations essentially identical to 10 CFR Part 19,


Part 20 (radiation dose standards, effluent limits, waste manifest rule and


ENCLOSURE 2

certain other parts), Part 61 (technical definitions and requirements,


performance objectives, financial assurances) and those required by UMTRCA, as


implemented by Part 40.


The State should adopt other regulations to maintain a high degree of


uniformity with NRC regulations.


For those regulations deemed a matter of compatibility by NRC, State


regulations should be amended as soon as practicable but no later than


3 years.


The radiation control program (RCP) has established procedures for effecting


appropriate amendments to State regulations in a timely manner, normally


within 3 years of adoption by NRC. 


Opportunity should be provided for the public to comment on proposed


regulation changes (required by UMTRCA for uranium mill regulation.)


Pursuant to the terms of the Agreement, opportunity should be provided for the


NRC to comment on draft changes in State regulations.


Assessment


The State adopts regulations in accordance with the State's Administrative


Procedure Act of 1981. The procedures provide for public hearings and


comments, and proposed regulations are also provided to the NRC for comment


prior to adoption. 


The Alabama regulations for Radiation Control, Chapter 420-3-26, were reviewed


for uniformity and compatibility during the July 1994 visit and prior to this


review. The Alabama regulations are compatible with the NRC's regulations up


to the provisions on "Quality Management Program and Misadministrations," 10


CFR Part 35 amendment (56 FR 34104) that became effective on January 27, 1992


and was to be adopted by January 27, 1995. However, a finding that the


program is compatible with NRC's program is being withheld because the State


has not adopted the rule entitled "Quality Management Program and


Misadministrations" (QM) amendment, which was to be adopted by January 27,


1995. We recognize that during the April 1995 Managers' Workshop that NRC


indicated the promulgation of the QM rule would be assessed as to whether it


should continue to be a basis for a finding of compatibility and that your


staff has deferred a final completion of the QM rule pending completion of our


assessment. The safety benefits of the QM rule and the need for consistent


requirements among NRC and Agreement State regulations indicate the necessity


for Agreement States to promulgate equivalent QM rules. Accordingly, the


status of QM rule promulgation will continue to serve as a basis for a finding


of compatibility. The staff is, however, evaluating methods to increase the


flexibility of Agreement States in the implementation of the QM rule. 


In addition, we would like to bring to the State's attention the following


regulations that will be needed for compatibility purposes:


! "Licenses and Radiation Safety Requirements for Irradiators," 10 CFR 

Part 36 (58 FR 7715) that became effective on July 1, 1993 and will need to 

be adopted by July 1, 1996. 

! "Decommissioning Recordkeeping, and License Termination: Documentation 

Additions," 10 CFR Parts 30, 40, 70, and 72 amendments (58 FR 39628) that 

became effective on October 25, 1993 and will need to be adopted by 

October 25, 1996. 

2 ENCLOSURE 2

! "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30, 40, 

and 70 amendments (58 FR 68726 and 59 FR 1618) that became effective on 

January 28, 1994, and will need to be adopted by January 28, 1997. 

! "Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30, 

40, and 70 amendments (59 FR 36026) that became effective on August 15, 

1994, and will need to be adopted by August 15, 1997. 

! "Preparation, Transfer for Commercial Distribution, and Use of Byproduct 

Material for Medical Use," 10 CFR Parts 30, 32, and 35 amendments (59 FR 

61767, 65243, and 60 FR 322) that became effective on January 1, 1995 and 

will need to be adopted by January 1, 1998. 

! "Frequency of Medical Examinations for Use of Respiratory Protection 

Equipment," 10 CFR Part 20 amendment (60 FR 7900) that became effective on 

March 13, 1995 and will need to be adopted by March 13, 1998. 

! "Low-Level Waste Shipment Manifest Information and Reporting", 10 CFR Parts 

20 and 61 amendments (60 FR 15649) that becomes effective on March 1, 1998 

and will need to be adopted by March 1, 1998. 

Recommendation


We recommend that DRC adopt the QM rule as soon as possible and any other


regulation needed for a compatibility finding.


SUMMARY OF DISCUSSIONS WITH STATE REPRESENTATIVES


A summary meeting regarding the results of the review was held


on June 23, 1995. The following persons were present during the summary


meeting: Mr. James W. Cooper, Director, Bureau of Health Care Standards; 


Mr. Kirksey E. Whatley, Director, Division of Radiation Control; and 


Mr. James L. McNees, Director, Radioactive Materials Compliance Branch. 


The scope of the review was discussed and the State was informed that the


review findings would be reported to the State in a letter signed by the


Director, Office of State Programs. The State was informed that Status of


Regulations is a Category 1 indicator, and that the findings regarding


compatibility for the medical QM rule would be determined by the Commission. 


The State was also informed that the absence of any other significant Category


I comments would indicate that the State's program is adequate to protect


public health and safety. The State was informed that the reviewer concurred


that there were no licensing or inspection backlogs, and that the previous


recommendations had been addressed and resolved.


In reply, Mr. Cooper related that he would pass the information along to 


Dr. Williamson and the State would respond to our written comments. 


3 ENCLOSURE 2

SUMMARY OF ASSESSMENT OF INDICATORS FULLY SATISFIED 


BY THE ALABAMA RADIATION CONTROL PROGRAM


JULY 23, 1993, TO JUNE 23, 1995


The assessments below are based upon the evaluation of the State's written


response to the questionnaire, comparison with previous review information,


discussions with the program managers and staff members, reviewer


observations, review of the State's policies and procedures, and licensing and


inspection casework file reviews. The State fully satisfies the following


indicators:


1. Legal Authority (Category I)


NRC 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.


States regulating the disposal of low-level radioactive waste in permanent


disposal facilities must have statutes that provide authority for the issuance


of regulations for low-level waste management and disposal. The statutes


should also provide regulatory program authority and provide for a system of


checks to demonstrate that conflicts of interest between the regulatory


function and the developmental and operational functions shall not occur.1


Assessment


The State's response to the questionnaire was reviewed and discussions were


held with the Director of the Division of Radiation Control (DRC) concerning


any changes to the State's statutory authority for the regulation of agreement


materials since the previous review. An updated copy of the Radiation Control


Act (Title 22, Chapter 14, Radiation) was obtained and reviewed. The Act was


revised in 1988 to allow the State to enter into a low-level waste compact and


for the regulation of low-level waste generators. The State Board of Health


is designated as the State radiation control agency responsible for protecting


public health and safety, including the development of regulations, collection


of fees, issuance of orders, determination of compliance, and impoundment of


sources. Copies are on file in the NRC Region II Office. 


1

The level of separation (e.g., separate agencies) should be determined


for each State individually.


ENCLOSURE 3

2.	 Location of the Radiation Control Program Within the State Organization


(Category II)


NRC Guidelines


The RCP should be located in a State organization parallel with comparable


health and safety programs. The Program Director should have access to


appropriate levels of State management.


Where regulatory responsibilities are divided between State agencies, clear


understandings should exist as to division of responsibilities and


requirements for coordination.


Assessment


A copy of the organizational charts were provided and reviewed. There have


been no changes in the organizational relationship between the Department of


Health and the Governor's Office since the previous review. The State Health


Officer is appointed by the State Committee of Public Health, serves as


chairman of the State Board of Health, and represents the State Board of


Health to the Governor. 


All Agreement State functions are contained within the Department of Public


Health, Bureau of Health Care Standards, DRC. The program is parallel to


other health and safety programs. The DRC is located in the Bureau of Health


Care Standards, along with the Division of Planning & Program Development, the


Division of Licensure & Certification, and the Division of Emergency Medical


Services. The DRC program director has appropriate access to Department


management. 


3.	 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, place appropriate emphasis on major program


functions, and provide specific lines of supervision from program management


for the execution of program policy.


Where regional offices or other government agencies are utilized, the lines of


communication and administrative control between these offices and the central


office (Program Director) should be clearly drawn to provide uniformity in


licensing and inspection policies, procedures and supervision.


Assessment


The internal organizational charts for DRC were received and reviewed. There


have been no changes in the organizational structure relative to the State


Health Department. The DRC is composed of five branches, the Radioactive


Materials Licensing Branch, the Radioactive Materials Compliance Branch, the


X-Ray Compliance Branch, the Emergency Planning and Environmental Monitoring


Branch, and the Naturally Occurring Radioactive Materials Branch. The


organization provides emphasis on major program functions, specific lines of


supervision and staff efficiency.


2	 ENCLOSURE 3

4. 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.


Assessment


The response to the questionnaire was reviewed and discussions relative to


legal assistance were held with management staff. Legal assistance is


available, as needed, from the General Counsel assigned to the Department of


Health, and management related that the support has been excellent. The


current counsel has been assigned to the Health Department for several years.


5. Technical Advisory Committees (Category II)


NRC Guidelines


Technical committees, Federal agencies, and other resource organizations


should be used to extend staff capabilities for unique or technically complex


problems.


A State Medical Advisory Committee should be used to provide broad guidance on


the uses of radioactive drugs in or on humans. The Committee should represent


a wide spectrum of medical disciplines. The Committee 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.


Assessment


The program utilizes two advisory committees, the Medical Radiation Advisory


Committee, and the Radiation Advisory Board of Health.


The Radiation Advisory Board of Health consists of 10 members appointed by the


Governor for staggered terms of 6 years. Membership comes from the fields of


Radiology, Medicine, Health Physics, Dentistry, Chiropractic medicine,


Veterinary medicine, and from the University of Alabama, Auburn University,


and the Associated Industries of Alabama. The committee meets at the


discretion of the State Health Officer who is also the chairman. There have


been no formal meetings of the Advisory Board since the 1993 review, as the


business can be handled through the mail. Program management related that


this method has been effective, and more efficient for the board members.


The Medical Radiation Advisory Committee has two members that are in addition


to the physicians on the Advisory Board. This committee is utilized to


evaluate medical uses and physician training and experience. The Committee


also usually handles business by mail and conference calls which allows for


licensing staff consultation with the committee on an as needed basis, thus


more efficient than periodic formal meetings. 


3 ENCLOSURE 3

6. Contractual Assistance (Category II)


NRC Guidelines


Because of the diversity and complexity of low-level radioactive waste


disposal licensing and regulation, States regulating the disposal of low-level


radioactive waste in permanent disposal facilities should have procedures and


mechanisms in place for acquisition of technical and vendor services necessary


to support these functions that are not otherwise available within the RCP.


The RCP should avoid the selection of contractors which have been selected to


provide services associated with the LLW facility development or operations.


Assessment


The State does not have a LLW site and is not a host State for a site;


therefore, this indicator is not currently applicable to the program review.


7. Quality of Emergency Planning (Category I)


NRC Guidelines


The State RCP should have a written plan in response to incidents at licensee


facilities which takes into account such incidents as spills, overexposures,


transportation accidents, fire or explosion, theft, etc. 


The plan should define the responsibilities and actions to be taken by State


agencies. The plan should be specific as to persons responsible for


initiating response actions, conducting operations and cleanup.


Emergency communication procedures should be adequately established with


appropriate local, county, and State agencies. Plans should be distributed to


appropriate persons and agencies. NRC should be provided the opportunity to


comment on the plan while in draft form.


The plan should be reviewed annually by program staff for adequacy and to


determine that content is current. Periodic drills should be performed to


test the plan.


Assessment


Based upon discussions with management staff and emergency response personnel


located in the DRC, the program has a comprehensive emergency plan for all


types of radiological emergencies. The Radiological Emergency Response Plan


was revised effective May 19, 1994 and utilizes the Alabama Emergency


Management Agency, and County and City governments. A copy of the plan is on


file in the Region II Office.


The plan is tested during exercises around the Browns Ferry, Bellefonte, and


Farley nuclear power facilities. The last full scale test was for the Farley


plant on December 14-15, 1994. A practice exercise was conducted on the


Browns Ferry facility on June 14, 1995, and a DRC critique of the exercise was


conducted on Monday, June 19, 1995 in the DRC Office.


The emergency communication list is updated as needed, and the current listing


is dated June, 1995. A copy was obtained and reviewed. Copies of this


listing are mailed to all licensees and other interested parties. The program


has a 24 hour pager number, and each manager/supervisor is on the list and is


expected to respond as appropriate to the type of incident. All of the


licensing and materials staff are experienced and have been trained in


4 ENCLOSURE 3

responding to incidents. Materials incidents are normally supervised by a


supervisor or a senior inspector. A review of the incident files indicated


that the response to incidents was timely, appropriate to the type of


incident, and utilized persons trained in the response plan. 


8. Budget (Category II)


NRC Guidelines


Operating funds should be sufficient to support program needs, such as staff


travel necessary to the conduct of an effective compliance program, including


routine inspections, follow-up or special inspections, (including pre­


licensing visits) and responses to incidents and other emergencies,


instrumentation and other equipment to support the RCP, administrative costs


in operating the program including rental charges, printing costs, laboratory


services, computer and/or word processing support, preparation of


correspondence, office equipment, hearing costs, etc., as appropriate. States


regulating the disposal of low-level radioactive waste facilities should have


adequate budgetary resources to allow for changes in funding needs during the 


LLW facility life cycle. After appropriations, the sources of program funding


should be stable and protected from competition from or invasion by other


State programs.


Principal operating funds should be from sources which provide continuity and


reliability, i.e., general tax, license fees, etc. Supplemental funds may be


obtained through contracts, cash grants, etc.


Assessment


A review of the questionnaire response and discussions with the program


managers indicated that the program has sufficient monetary resources


($1,603,450) for carrying out the regulatory program. Currently, the


materials program ($327,103) is 100% funded through fees. The fee schedule is


coded in the Alabama regulations, and by law, Alabama can assess fees at 75%


of those fees assessed by NRC. Thus, the Alabama fees will fluctuate as the


NRC fees are adjusted.


Program managers related that the NRC proposal to eliminate inspection fees


for materials license inspections, could have a negative impact on the DRC


funds being recovered from inspection fees. The Program Director related that


this issue had been discussed with the State Health Officer (SHO), and that


the SHO had agreed in principle to adjusting future DRC monies with


appropriated funds, if needed.


9. Laboratory Support (Category, II)


NRC Guidelines


The RCP should have laboratory support capability in house, or readily


available through established procedures, to conduct bioassays, analyze


environmental samples, analyze samples collected by inspectors, etc., on a


priority established by the RCP.


In addition, States regulating the disposal of low-level radioactive waste in


permanent disposal facilities should have access to laboratory support for


radiological and non-radiological analyses associated with the licensing and


regulation of low-level waste disposal, including soils testing, testing of


environmental media, testing of engineering properties of waste packages and


5 ENCLOSURE 3

waste forms, and testing of other engineering materials used in the disposal


of low-level radioactive waste. Access to laboratory support should be


available on an "as needed" basis for nonradiological analyses to confirm


licensees' and applicants' programs and conditions for nonradiological testing


should be prescribed in plans or procedures.


Assessment


Laboratory support is provided under contract with the State of Alabama


Department of Environmental Management Laboratory (ADEM) located adjacent to


the EPA, Eastern Environmental Radiation Facility, Montgomery, Alabama. An


Agreement between the Health Department and ADEM provides for radiological


analyses to be performed at the ADEM Central Laboratory, and specifies the


monetary terms, scope of the services, and a quality assurance program


associated with the analyses. Based upon a visit to the laboratory, the ADEM


laboratory has technical procedures and equipment to analyze all types of


environmental media for alpha, beta, and gamma emitters. Samples can be


shared with EPA and NRC as appropriate. 


A review of the questionnaire response and discussions with the DRC managers


indicate that the ADEM Laboratory provides timely and accurate results on


confirmatory measurement samples. 


The DRC has also completed a State wide survey of selected sanitary sewer


systems. The results of this survey project are under preparation, and will


be provided to the Region II Office when completed. 


10. Administrative Procedures (Category II)


NRC Guidelines


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,


contacts with communication media, conflict of interest policies for


employees, exchange-of-information, and other functions required of the


program. Administrative procedures are in addition to the technical


procedures utilized in licensing, and inspection and enforcement.


Assessment


The DRC maintains administrative procedures prepared by the Department and the


Bureau, and also maintains procedures developed in the DRC. The DRC updates


the procedures as needed. The Program Director related that the only changes


occurred on January 5, 1994 with the addition of procedures for "Handling of


Misadministration Reports and Investigations of Misadministrations" number


255, and number 256 "Handling Allegations From Members of the Public and


Licensees." These procedures were reviewed during the 1994 review-visit. The


updated Procedures Manual Index was obtained for the Regional files. Based


upon the response to the questionnaire, discussions with the staff, the cross


check of the Procedures Manual Index and the Manual, and the review of


procedures number 255 and 256, it was determined that the DRC meets the


requirements of this guideline.


6 ENCLOSURE 3

11. Management (Category II)


NRC Guidelines


Program management should receive periodic reports from the staff on the


status of regulatory actions (backlogs, problem cases, inquiries, regulation


revisions). 


RCP management should periodically assess workload trends, resources and


changes in legislative and regulatory responsibilities to forecast needs for


increased staff, equipment, services, and funding. 


Program management should perform periodic reviews of selected license cases


handled by each reviewer and document the results. Complex licenses (major


manufacturers, low-level radioactive waste disposal facilities, large scope,


Type A Broad, and those which have the potential for significant releases to


the environment) should receive second party review (supervisory, committee,


consultant). Supervisory review of inspections, reports, and enforcement


actions should also be performed. 


For the implementation of very complex licensing actions, such as initial


license review, license renewals and licensing actions associated with a low­


level radioactive waste disposal facility, there should be an overall Project


Manager responsible for the coordination and compilation of the diverse


technical reviews necessary for the completion of the licensing action. The


Project Manager should have training or experience in one or more of the main


disciplines related to the technical reviews which the Project Manager will be


coordinating, such as health physics, engineering, earth science, or


environmental science. 


When regional offices or other government agencies are utilized, program


management should conduct periodic audits of these offices.


Assessment


The Compliance Branch Director and the materials license reviewer prepare


monthly reports concerning the status of the inspection activities and


licensing actions. The Program Director reviews and signs all licensing


actions after consultation with the license reviewer. The Compliance Branch


Director reviews and signs all compliance letters and the inspection reports


after consultation with the respective inspector. The Compliance Branch


Director also maintains a log of the inspector accompaniments including a


summary of the activity, and a memorandum is placed in the inspector's


personnel file. Staff meetings are held on a weekly basis or as necessary to


resolve issues and for informational purposes. 


Based upon the response to the questionnaire, discussions with program


managers and staff, review of reports, review of casework files, review of the


accompaniment log and crosschecks with the compliance files, and attendance at


a staff meeting, the reviewer determined that the criteria of this guideline


indicator were being satisfied. 


12. 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 (greater than 300-400 licenses) programs. Similar


services should be available to regional offices, if utilized.


7 ENCLOSURE 3

States should have a license document management system that is capable of


organizing the volume and diversity of materials associated with licensing and


inspection of radioactive materials.


Professional licensing, inspection, and enforcement staff should not be used


for fee collection and other clerical duties. 


Assessment


Each DRC clerical staff member, each manager and supervisor, and the materials


licensing staff and inspection staff have a personal computer (PC). 


Currently, the PCs are not on a "network"; however, the Program Director


related that the Department would be moving to a new office building in 1996,


and plans are to have all employees on a network, and the DRC would have


communications capability for the internet system and other systems as


appropriate. Several word processing and database software programs are


available to the staff. Collection of fees are handled by a specific


administrative person, and in accordance with Health Department procedures.


The response to the questionnaire, discussions with administrative and


technical staff, demonstrations of the technical staff on their knowledge and


use of the computers, and work performed by the administrative staff during


the review, demonstrated that the program meets the requirements of this


guideline indicator. 


13. Public Information (Category II)


NRC Guidelines


Inspection and licensing files should be available to the public consistent


with State administrative procedures. It is desirable, however, that there be


provisions for protecting from public disclosure proprietary information and


information of a clearly personal nature. 


Opportunity for public hearings should be provided in accordance with UMTRCA


and applicable State administrative procedure laws during the process of major


licensing actions associated with UMTRCA and low-level radioactive waste in


permanent disposal facilities.


Assessment


The State's response to the questionnaire, discussions with staff, and


observations, confirmed that inspection and licensing files are available to


the public under Alabama procedures. Proprietary information, personal and


medical information can be withheld as appropriate. The DRC maintains a


locked safe for proprietary information. Press releases are prepared and


released with the assistance of, and through the Department's Public


Information staff.


14. 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, including the director of the


radiation protection program, should be commensurate with the type of licenses


issued and inspected by the State. For States regulating uranium mills and


mill tailings, staff training and experience should also include hydrology,


8 ENCLOSURE 3

geology, and structural engineering.2 For programs which regulate the


disposal of low-level radioactive waste in permanent facilities, staff


training and experience should include civil or mechanical engineering,


geology, hydrology, and other earth science, and environmental science. In


both types of materials, staff training and experience guidelines apply to


available contractors and resources in State agencies other than the RCP. 


Written job descriptions should be prepared so that professional


qualifications needed to fill vacancies can be readily identified.


Assessment


The qualifications of the technical staff were reviewed and all technical


staff members involved with the materials licensing and inspection activities


have at least a Bachelor of Science degree in the physical and/or life


sciences. The Program Director and Compliance Branch Director have master


degrees and two other managers have engineering and master degrees. The


written job descriptions have been previously reviewed, and the Program


Director related that no changes have occurred in the descriptions since the


previous review. The review of the questionnaire response, discussions with


managers, and documentation on file confirmed that the program meets the


criteria of this guideline indicator. 


15. Staffing Level (Category II)


NRC Guidelines


Professional staffing level should be approximately 1-1.5 person-years per 100


licenses in effect. RCP must not have less than two professionals available


with training and experience to operate RCP in a way which provides continuous


coverage and continuity. The two professionals available to operate the RCP


should not be supervisory or management personnel. 


For States regulating uranium mills and mill tailings, current indications are


that 2-2.75 professional person-years of effort, including consultants, are


needed to process a new mill license (including in situ mills) or major


renewal, to meet requirements of Uranium Mill Tailings Radiation Control Act


of 1978. 


States which regulate the disposal of low-level radioactive waste in permanent


disposal facilities should allow a baseline RCP staff effort of 3-4


professional technical person-years (in addition to the two professionals for


the basic RCP indicated in the first bullet of this indicator). However, in


some cases, the level of site activity may be such that a lower level is


adequate, particularly if contractor support is on call. In any event, staff


resources should be adequate to conduct inspections on a routine basis during


operations of the LLW facility, including inspection of incoming shipments and


licensee site activities and to respond to emergencies associated with the


site. During periods of peak activity, additional staff or specialty


consultants should be available on a timely basis. 


2
 Additional guidance is provided in the Criteria for Guidance of States


and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof


by States Through Agreement (46 FR 7540, 36969 and 48 FR 33376).


9 ENCLOSURE 3

Assessment


A review of the response to the questionnaire and discussions with the Program


Director and the Compliance Branch Director confirmed that the program has


adequately trained staff to carry out the regulatory functions of the DRC. 


The Materials program has five full time technical staff in addition to the


Program Director, three persons in the Emergency Planning and Environmental


Monitoring Branch, and two engineers in the Naturally Occurring Radioactive


Materials Branch. Information provided indicates that 4.35 FTEs were utilized


in 401 specific materials licenses, or a ratio of approximately 1.1 FTE per


100 licenses. The engineers and some of the emergency response personnel are


being cross trained to perform materials inspections if needed. 


16. Staff Supervision (Category II)


NRC Guidelines


Supervisory personnel should be adequate to provide guidance and review the


work of senior and junior personnel. 


Senior personnel should review applications and inspect licenses


independently, monitor work of junior personnel, and participate in the


establishment of policy. 


Junior personnel should be initially limited to reviewing license applications


and inspecting small programs under close supervision.


Assessment


A review of the questionnaire response, casework files, and discussions with


staff confirmed that all licenses are signed by the Program Director, and that


all enforcement actions are reviewed and signed by the Compliance Branch


Director. During the review, several instances were noted where the technical


staff discussed licensing and compliance issues with each other and the


managers, and provided confirmation of good communication among the staff


concerning policy and regulatory issues. Documentation in the files confirmed


that junior personnel are not allowed to perform work independently until


approved by the supervisor for that level of work.


17. Training (Category II)


NRC Guidelines


Senior personnel should have attended NRC core courses in licensing


orientation, inspection procedures, medical practices, and industrial


radiography practices. 


The RCP should have a program to utilize specific short courses and workshops


to maintain appropriate level of staff technical competence in areas of


changing technology. 


The RCP staff should be afforded opportunities for training that is consistent


with the needs of the program.


Assessment


A listing of all personnel by training courses was received and evaluated. 


All of the senior materials licensing and inspection personnel have attended


the NRC core courses, the five week health physics course, and numerous


workshops. The junior personnel also have attended the core courses and are


10 ENCLOSURE 3

attending other NRC courses as they become available. All personnel have also


received training in emergency planning and in use of the various computer


software programs utilized by staff. A review of the response to the


questionnaire and discussions with staff confirms that the program meets the


criteria of this guideline indicator. 


18. Staff Continuity (Category II)


NRC Guidelines


Staff turnover should be minimized by combinations of opportunities for


training, promotions, and competitive salaries. 


Salary levels should be adequate to recruit and retain persons of appropriate


professional qualifications. Salaries should be comparable to similar


employment in the geographical area. 


The RCP organization structure should be such that staff turnover is minimized


and program continuity maintained through opportunities for promotion. 


Promotion opportunities should exist from junior level to senior level or


supervisory positions. There also should be opportunity for periodic salary


increases compatible with experience and responsibility.


Assessment


The program reported that no turn over in staff has occurred since the last


review and this was confirmed with a comparison of the organizational charts. 


All personnel received an increase in salary in 1994. The salaries were


confirmed to be comparable to equivalent positions in other Agreement States


in the geographical area. 


19. Technical Quality of Licensing Actions (Category I)


NRC Guidelines


The RCP should assure that essential elements of applications have been


submitted to the agency, and that these elements 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. 


Additionally, in States which regulate the disposal of low-level radioactive


waste in permanent disposal facilities, the RCP should assure that essential


elements of waste disposal applications meet State licensing requirements for


waste product and volume, qualifications of personnel, facilities and


equipment, operating and emergency procedures, financial qualifications and


assurances, closure and decommissioning procedures, and institutional


arrangements in a manner sufficient to establish a basis for licensing action. 


Licensing activities should be adequately documented, including safety


evaluation reports, product certifications, or similar documentation of the


license review and approval process. 


Pre-licensing visits should be made for complex and major licensing actions. 


Licenses should be clear, complete, and accurate as to isotopes, forms,


quantities, authorized uses, and permissive or restrictive conditions. 


The RCP should have procedures for reviewing licenses prior to renewal to


assure that supporting information in the file reflects the current scope of


the licensed program.


11 ENCLOSURE 3

Assessment


Sixteen license files were selected for casework review. The program


currently has 401 licenses, of which 19 are considered major licenses. The


review sample included all new major licenses that have not been reviewed, and


consisted of four nuclear pharmacy, one broad academic, one broad medical, one


generally licensed device (GL) distribution, one decontamination facility, two


industrial radiography including fixed and temporary locations, three


institutional medical, one mobile nuclear medicine, one private nuclear


medicine (cardiology), and one private therapy facility with a High Dose Rate


(HDR) unit. From the review of the casework, it was determined that essential


elements of the applications and the backup documentation met the current


regulatory guidance to establish the basis for issuance of licenses. The DRC


does not have a licensing backlog, and all licenses are issued by one license


reviewer, with consultation and approval by the Program Director. All major


licenses receive a pre-license visit before the license is issued. 


20. Adequacy of Product Evaluations (Category I)


NRC Guidelines


RCP evaluations of manufacturer's or distributor's data on sealed sources and


devices outlined in NRC, State, or appropriate ANSI Guides, should be


sufficient to assure integrity and safety for users. 


The RCP should review manufacturer's information on labels and brochures


relating to radiation health and safety, assay, and calibration procedures for


adequacy. 


Approval documents for sealed source or device designs should be clear,


complete and accurate as to isotopes, forms, quantities, uses, drawing


identifications, and permissive or restrictive conditions. 


Approval documents for radioactive waste packages, solidification and


stabilization media, or other vendor products used to treat radioactive waste


for disposal should be complete and accurate as to the use, capabilities,


limitations, and site specific restrictions associated with each product.


Assessment


The program has not performed any product evaluations during this review


period. Therefore, no product evaluation, source, or device files were


reviewed. Discussions were held with the sealed source and device (SS&D)


reviewer in DRC concerning reference materials and checklist provided by NRC


for SS&D reviews, and it was confirmed that these referenced materials and


procedures were available and would be followed for review of SS&Ds. 


21. Licensing Procedures (Category II)


NRC Guidelines


The RCP should have internal licensing guides, checklists, and policy


memoranda consistent with current NRC practice. 


In States which regulate the disposal of low-level radioactive waste in


permanent disposal facilities, the RCP should have program specific licensing


guides, plans, and procedures for license review and policy memoranda which


relate to specific aspects of waste disposal. The program should include the


preparation of safety evaluation reports, product certifications, or similar


documentation of license review and approval process. 


12 ENCLOSURE 3

License applicants (including applicants for renewals) should be furnished


copies of applicable guides and regulatory positions. 


The present compliance status of licensees should be considered in licensing


actions. 


Under the NRC Exchange-of-Information program, evaluation sheets, service


licenses, and licenses authorizing distribution to general licensees and


persons exempt from licensing should be submitted to NRC on a timely basis. 


Standard license conditions comparable with current NRC standard license


conditions should be used to expedite and provide uniformity in the licensing


process. 


Files should be maintained in an orderly fashion to allow fast, accurate


retrieval of information and documentation of discussions and visits.


Assessment


The DRC utilizes State licensing guides patterned after NRC policy guidance


and procedures for the evaluation of applications and the writing of the


license document. The guides and standard conditions were determined to be


equivalent to those utilized by NRC. Updated licensing policies and standard


conditions utilized by NRC were provided electronically to the State license


reviewer. The casework was reviewed for technical adequacy of application


review, significant errors and omissions, utilization of licensing procedures


and appropriate license conditions, consideration of the applicable licensee's


enforcement history and status, and documentation. The casework review


confirmed that the licensing procedures are adequate to protect public health


and safety and are consistent with NRC policies.


22. Status of Inspection Program (Category I)


NRC Guidelines


The State RCP should maintain an inspection program adequate to assess


licensee compliance with State regulations and license conditions. The


inspection program in all States should provide for the inspection of


licensee's waste generation activities under the State's jurisdiction. 


In States which regulate the disposal of low-level radioactive waste in


permanent disposal facilities, the RCP should include provisions for pre­


operational, operational, and post-operational facility inspections. The


inspections should cover all program elements which are relevant at the time


of the inspection and be performed independently of any resident inspector


program. In addition, inspections should be conducted on a routine basis


during the operation of the low-level radioactive waste facility, including


inspection of incoming shipments and licensee site activities. 


The RCP should maintain statistics which are adequate to permit Program


Management to assess the status of the inspection program on a periodic basis. 


Information showing the number of inspections conducted, the number overdue,


the length of time overdue and the priority categories should be readily


available. 


At least semiannual inspection planning should be done for the number of


inspections to be performed, assignments to senior versus junior staff,


assignments to regions, identification of special needs and periodic status


reports. When backlogs occur, the program should develop and implement a plan


13 ENCLOSURE 3

to reduce the backlog. The plan should identify priorities for inspections


and establish target dates and milestones for assessing progress.


Assessment


The program's computerized licensing and inspection data system was reviewed. 


The program does not have any inspection backlog as determined from a review


of the computer file and a spot check of information from the casework files. 


All inspections are planned on a quarterly basis, and the status of the


inspection program is assessed each month. A review of the casework and the


system verified that licenses and inspections are coded properly and the


information from inspections promptly entered into the tracking system.


In addition to the questionnaire response, the State reported receiving


26 license reciprocity requests during the period since the 1993 review. The


requests included 14 radiography, 17 portable gauge, 6 well logging, 4 gauge


service, 3 teletherapy and HDR service, 1 calibration service, and 2 waste


pick-up licenses. Of these reciprocity requests, the DRC conducted 10


inspections, of which 6 of the 14 radiography licenses were inspected. It


should be noted that under Alabama regulations, licensees can operate under


reciprocity in State jurisdictional areas for only 30 days in any calendar


year, after which the licensee must obtain an Alabama license.


23. Inspection Frequency (Category I)


NRC Guidelines


The RCP should establish an inspection priority system. The specific


frequency of inspections should be based upon the potential hazards of


licensed operations, e.g., major processors, broad licensees, and industrial


radiographers should be inspected approximately annually. Smaller or less


hazardous operations may be inspected less frequently. The minimum inspection


frequency, including for initial inspections, should be no less than the NRC


system.


Assessment


A comparison was made of the inspection frequencies utilized by the DRC and


those utilized by NRC. The DRC frequencies were verified to be the same as


the NRC frequencies utilized in 1994. An electronic copy of the Manual


Chapter 2800 dated April 17, 1995 was provided to the Compliance Branch


Director. This material dated April 17, 1995 apparently had not been sent to


the State for their use. The Compliance Branch Director related that the


inspection frequencies would be adjusted in their inspection system. 


24. 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. 


For the inspection of complex licensed activities such as permanent low-level


radioactive waste disposal facilities, a multidisciplinary team approach is


desirable to assure a complete compliance assessment. 


14 ENCLOSURE 3

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.


Assessment


All materials inspectors have been accompanied by supervisors since the last


review as verified from the review of the State's Inspector Accompaniment Log


and spot checked in the inspector reports. The junior inspectors train with 


the senior inspectors on team inspections, as verified by the casework


documentation and discussions with the staff. All materials inspectors have


been accompanied by NRC during the past three reviews, except for one


inspector that is still in training. All other inspectors (including the


supervisors) were previously determined to be adequately trained to evaluate


health and safety problems, and determine compliance with the regulations in


accordance with State procedures.


25. 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 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 in-depth reviews of circumstances and should be


completed on a high priority basis. When appropriate, investigations should


include reenactments and time-study measurements (normally within a few days). 


Investigation (or inspection) results should be documented and enforcement


action taken when appropriate. 


State licensees and the NRC should be notified of pertinent information about


any incident which could be relevant to other licensed operations (e.g.,


equipment failure, improper operating procedures). 


Information on incidents involving failure of equipment should be provided to


the agency responsible for evaluation of the device for an assessment of


possible generic design deficiency. 


The RCP should have access to medical consultants when needed to diagnose or


treat radiation injuries. The RCP should use other technical consultants for


special problems when needed.


15 ENCLOSURE 3

Assessment


All of the incident reports for the calendar years 1993 and 1994 have been


previously provided to the Office of State Programs (OSP), and all of these


events were reviewed prior to transmittal to OSP. Documentation shows that


all incidents are entered into a written log book, and summarized. The


detailed report when completed is filed in the respective license file and


also in a separated incident file. Only four (4) reportable incidents have


occurred during the first 6 months of 1995 that meet NRC's reporting criteria. 


In addition, the State related that eight (8) misadministrations were reported


to the State in 1993, nine (9) reported in 1994, and nine (9) have been


reported to the State through June 6, 1995. All of the misadministration


reports have been diagnostic, and do not meet the misadministration reporting


criteria currently in effect at NRC. The Compliance Branch Director (a


certified health physicist) related that he evaluated each event and


misadministration upon receipt, to determine the significance of the event and


the actions to be taken. This action (assessment) was verified to be


documented in the event reports.


26. Enforcement Procedures (Category I)


NRC Guidelines


Enforcement procedures should be sufficient to provide a substantial deterrent


to licensee noncompliance with regulatory requirements. Provisions for the


levying of monetary penalties are recommended. 


Enforcement letters should be issued within 30 days following inspections and


should employ appropriate regulatory language clearly specifying all items of


noncompliance and health and safety matters identified during the inspection


and referencing the appropriate regulation or license condition being


violated.


Enforcement letters should specify the time period for the licensee to


respond, indicating corrective actions and actions taken to prevent recurrence


(normally 20-30 days). The inspector and compliance supervisor should review


licensee responses. 


Licensee responses to enforcement letters should be promptly acknowledged as


to adequacy and resolution of previously unresolved 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.


Assessment


A review of the State's regulations (Chapter 420-3-26, Radiation Control)


confirmed that the regulations contain provisions in Rule 420-3-26-.13


(Administrative Procedures) for enforcement actions. They contain provisions


on Organization and Method of Conducting Business, Hearings, Guidance


Documents of Division of Radiation Control, the Routing of Radioactive


Material Shipments, Criteria for Determining Enforcement Actions, and Appendix


A, General Statement of Policy and Procedures for Enforcement Actions.


16 ENCLOSURE 3

A review of the casework confirmed that the enforcement actions were


appropriate and in accordance with the published procedures in the


regulations. The enforcement correspondence was timely, contained clear


regulatory language on the items of non-compliance and specific references,


specified the time period for response, and requested corrective actions to be


detailed in the response. All responses are reviewed by the inspector and his


supervisor prior to acknowledgement of the licensee response. 


Under Alabama rules, the Department can assess civil penalties for up to


$10,000 per violation per day. The State reported issuing four civil


penalties during the reporting period.


27. Inspection Procedures (Category II)


NRC Guidelines


Inspection guides consistent with current NRC guidance, should be used by


inspectors to assure uniform and complete inspection practices and provide


technical guidance in the inspection of licensed programs. NRC guides may be


used if properly supplemented by policy memoranda, agency interpretations,


etc. 


Written inspection policies should be issued to establish a policy for


conducting unannounced inspections, obtaining corrective action, following up


and closing out previous violations, interviewing workers and observing


operations, assuring exit interviews with management, and issuing appropriate


notification of violations of health and safety problems. 


Procedures should be established for maintaining licensees' compliance


histories. 


Oral briefing of supervision or the senior inspector should be performed upon


return from nonroutine inspections. 


For States with separate licensing and inspection staffs, procedures should be


established for feedback of information to license reviewers.


Assessment


The DRC utilizes the Inspection Guidance and Procedures provided by NRC


Inspection Manual, Inspection Procedure 87100 and Manual Chapter 2800. 


Updated copies were provided on diskette to the Compliance Branch Director


during the review. The DRC procedures, guides, and casework review verify


that the inspection procedures are consistent with NRC guidance, and are


adequate to provide complete and uniform technical guidance to the staff


inspectors. The casework review verified that the procedures are being


followed.


17 ENCLOSURE 3

28. Inspection Reports (Category II)


NRC Guidelines


Findings of inspections should be documented in a report describing the scope


of inspections, substantiating all items of noncompliance and health and


safety matters, describing the scope of licensees' programs, and indicating


the substance of discussions with licensee management and licensee's response.


Reports should uniformly and adequately document the results of inspections,


including confirmatory measurements, status of previous noncompliance, and


identify areas of the licensee's program which should receive special


attention at the next inspection. Reports should show the status of previous


noncompliance and the independent physical measurements made by the inspector.


Assessment


Twelve compliance files were selected for the casework review. The inspection


casework was selected from those license casework files having current


inspections (including pre-license inspections) to verify continuity between


the licensing program and the inspection program. The compliance casework


sample contained inspections performed by each inspector. The casework sample


consisted of 3 nuclear pharmacies, 1 broad medical, 1 broad academic, 1 GL


distribution, 1 decontamination facility, 1 industrial radiography, 1


institutional medical, 2 private medical, and 1 mobile nuclear medicine file. 


The reports uniformly documented the scope of the inspections, scope of the


licensee's program, substantiated all items of non-compliance and health and


safety matters, confirmatory measurements and indicated the substance of


discussions with licensee management. 


All inspection data are collected in the field and then placed in the computer


format in the office.


29. Confirmatory Measurements (Category II)


NRC Guidelines


Confirmatory measurements should be sufficient in number and type to ensure


the licensee's control of materials and to validate the licensees'


measurements. In States which regulate the disposal of low-level radioactive


waste in permanent disposal facilities, access to testing should be available


on an "as needed" basis for confirming licensees' and applicants' programs for


measurements related to nonradiological aspects of facility operations, such


as soils and materials testing and environmental sampling and analysis, to


demonstrate compliance with 10 CFR Part 61 or compatible Agreement State


regulations and ensure facility performance. Conditions for nonradiological


testing should be prescribed in plans or procedures. 


RCP instrumentation should be adequate for surveying license operations (e.g.,


survey meters, air samplers, lab counting equipment for smears, identification


of isotopes, etc.). 


RCP instrumentation should include the following types: GM Survey Meter, 


0-50 mR/hr; Ion Chamber Survey Meter, several R/hr; micro-R-Survey meter;


Neutron Survey Meter, Fast & Thermal; Alpha Survey Meter, 0-1,000,000 c/m; Air


Samplers, Hi and Low Volume; Lab Counters, Detect 0.001 μCi/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


18 ENCLOSURE 3

should not be used unless under a service contract. Exceptions for other


State agencies, e.g., a State University, may be made. 


Agency instruments used for surveys and confirmatory measurements should be


calibrated within the same time interval as required of the licensee being


inspected.


Assessment


The inspection reports were reviewed for documentation concerning confirmatory


measurements and independent measurements and were found to be consistent with


NRC practices and sufficient to document licensee performance. The reports


documented the instrumentation used during the inspection and the calibration


date of the instrument. The State utilizes a DRC cesium-137 calibration


source for the calibration of portable survey instruments. The staff provided


a listing of portable equipment for use during inspections and incident


evaluations. The listing documents numerous ion chambers, sodium-iodide


detectors, GM tubes, micro-R meters, a neutron ball, pancake detectors, single


channel analyzers, and velometers. It was determined that the State had


sufficient instrumentation capabilities for routine inspections, and for the


evaluation of events. 


19 ENCLOSURE 3