ML20245H098
| ML20245H098 | |
| Person / Time | |
|---|---|
| Issue date: | 06/26/1989 |
| From: | Kammerer C NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Vernon T COLORADO, STATE OF |
| References | |
| NUDOCS 8906290396 | |
| Download: ML20245H098 (12) | |
Text
_ _ _ - _ _ _ _ _ _ _ _ - - -
'o UNITED STATES g
.[ ) =
p, NUCLEAR REGULATORY COMMISSION
- ?
g E WASHINGTON, D. C. 20555 e
t June 26, 1989 i
Thomas A. Vernon, M.D.
Executive Director Department of Health 4210 East lith Avenue Denver, Colorado 80220
Dear Dr. Vernon:
This confirms the exit briefing Mr. R. J. Doda held with Mr. R. M. Quillin, Director, Radiation Control Division, on April 7, 1989 following our review of the Colorado Radiation Control program. One other NRC staff member, D. M. Sollanberger, was present at this meeting. Our no-mal practice is to ho'id our sumary meeting with you but we understand that previous comitments prevented this.
As a result of our review, coments and recommendations were developed, which included three significant coments concerning Category I Indicators. They are Status of Regulations, Technical Quality of Licensing Actions, and Enforcement Procedures. The State radiation protection regulations need to be updated to maintain compatibility.
In the licensing area we found that the State has authorized physicians to conduct nuclear medicine procedures which they may not be qualified to conduct. With respect to Enforcement Procedures, the State is not dispatching enforcement letters in a timely manner following inspections.
In view of these findings, we cannot offer a finding of adequacy and compatibility of the program until after we have reviewed sod evaluated the State's response to our specific technical comments and recommendations. Therefore, I would appreciate your review of our recommendations and receiving your plans to address these rrogram areas. contains other comments regarding the program and you may wish to have Mr. Quillin respond directly to these comments. An explanation of our policies and practices for reviewing Agreement State programs is attached as Enclosure 2.
Our review disclosed that other program indicators were within NRC guidelines. Also, a number of other technical matters were discussed with the radiation control staff and resolved during the course of the review. This year's review used a team approach, which involved eight NRC staff members and the State of Texas Agreement State Program Director at various times during the review. This allowed more time for individual discussions with members of the division's staff, an in-depth examination of the various program areas, and it provided a team of experts. During the course of the review, we were able to hold meetings with your staff in six different subject areas, which were of current interest to both the State and the NRC.
0 8906290396 890626 PDR STPRG ESGCO
[I PDC l
June 26, 1989 3
Thomas A. Vernon, M.D.-
2 We reviewed the consent agreements for both the Cotter and the Uravan uranium mills. We comend the State for the extensive efforts in achieving these agreements and, in particular, for the assignment of a senior geologist to monitor the progress at each site with respect to the requirements of each separate agreement.
I appreciate the courtesy and cooperation you and your staff extended to Mr. Doda and the other NRC reviewers during the review. Also, I am enclosing a copy of this letter for placement in the State Public Document Room cr to otherwise be made available for review.
I am looking forward to your responses regarding the State's regulations, licensing and enforcement, and Mr. Quillin's responses to the technical coments.
Sincerely, ori inal sij;ned by Carlton Kammerer E
Carlton Kamerer, Director State, Local and Indian Tribe Programs Office of Governmental and Public Affairs
Enclosures:
As stated cc:
V. Stello, Jr., Executive Director for Operations R. D. Martin, Regional Administrator, RIV R. M. Quillin, Director, Radiation Control Division A. J. Hazle, State Liaison Officer NRC Public Document Room State Public Document Room bec: Chairman Zech Distribution:
Concissioner Roberts SA RF HDenton Commissioner Carr Dir RF CKammerer
~
Commissioner Rogers RMartin SSchwartz Commissioner Curtiss ABeach VMiller WBrown JLubenau WFisher DCD(SP01)
CHackney EDO RF JGilliland Colorado file RDoda
- See previous concurrence A //~
O
- RIV:5A0
- 5LITP:AD
- 5LITP:DD
- 5LI
- RV:RA
- GPA
/
j..FC AME :RJDoda
- VMiller
- SSchwartz
- C. am r
- RDMartin
- HR n
1 ATE :5/19/89*
- 5/30/89*
- 6/1/89*
- 6/ S /89
- 5/19/89*
- 6/ & /89
- 6/l
/89 f
Ah
1, ENCLOSURE 1 TECHNICAL COMMENTS AND RECOMMENDATIONS FOR THE COLORADO RADIATION CONTRDL PROGRAM This program review was conducted during the periods of March 20-24, 1989, and April 3-7, 1989, in Denver, Colorado.
This review used a team approach which allowed the NRC to have individual expertise in all areas of an Agreement State Program.
Periodic reviews of State regulatory programs for control of agreement materials cover the principal administrative and technical aspects of radiation control programs. An in-depth examination is made of the program's funding and personnel resources; the program's licensing, inspection and enforcement activities; the program's emergency response capabilities for agreement materials; and the status of the State's radiation control regulations.
These reviews use the " Guidelines for NRC Review of Agreement State Radiation Control Programs" which were published in the Federal Reaister on June 4,1987, as an NRC Policy Statement.
I.
Radiation Control Program Other than Uranium Mills A.
The following coments with our recommendations concern Category I Indicators and are of major significance.
1.
Status of Regulations Comment The review of the State's radiation control regulations disclosed that three regulatory amendments, which are matters of compatibility, have not been adopted by the State within a three-year period after adoption by the, NRC. These amendments are:
(1) elimination of glass ~
enamel frit; (2) radiation protection survey requirements; and (3) clarification of exemption for uranium shielding in shipping containers. Copies of the necessary amendments were provided to the division staff during the review meeting.
Also, NRC has supplied a diskette to the division which contains all the updated Suggested State Regulations. This should significantly aid the State's efforts to update its regulations.
Recommendation We recommend these three amendments, and any others approaching the three-year period allowed after NRC adoption, be promulgated as e#fective State radiation control regulations in the near future.
l I
2 2.
Technical Quality of Licensing A.tions Coment The division is granting broad authorizations on licenses for physicians who submitted qualification records that were appropriate for limited applications only.
Physicians, if certified by the American Board of Radiology (ABR) in diagnostic radiology, have been routinely granted authorization for diagnostic groups I (uptake, dilution and excretion studies), grou)s II and III (imaging and localizationstudies),andtierapeuticgroups.IVandV.
Physicians certified by the _ABR for diagnostic radiology should only be authorized for the diagnostic uses in groups I, II, and III. This could be a serious problem'for NRC and Agreement States using this licensing acknowledgement to add physicians to licenses. Additionally, individuals possessing certification by the ABR in therapeutic radiology were granted diagnostic groups I, II, and III.
This certification is only good for authorizing therapeutic groups IV and V.
Recommendation We recomend the division issue authorizations to physicians for medical applications of radioactive materials only for those procedures for which they have provided documentation of their qualifications. To correct past improper authorizations, we recommend the State develop a plan to identify such cases and as necessary amend the licenses.
3.
Enforcement Procedures Coment Our review disclosed that enforcement letters were not issued within the recommended 30 days following the inspection.
In some cases the enforcement letters were sent three to six months after the time of inspection.
It was also noted that the licensees' responses to enforcement letters were not always received within the recomended 20 day s.
This problem was found for uranium mill inspections also.
Recommendation It is recomended that management closely monitor the timeliness of prepstation of the inspection reports and j
l the issuance of enforcement and acknowledgement letters.
We noted the division's development of a tracking system to maintain up-to-date information on the status of j
i l
l 1
3 compliance and enforcement activities. The system should cover key milestones such as the date the enforcement letter was sent to the licensee, the date the licensee j
is requested to respond (usually 20-30 days), the date of the response, and whether each case is resolved or needs further attention.
This tracking system should provide a means to monitor individual enforcement actions and provide statistical information about the program.
B.
The following coments with our recommendations concern Category I Indicators and are of minor significance.
1.
Adequacy of Product Evaluations Comment OneSealedSourceandDevice(SSD)registrationhadbeen issued.during this review period, a custom source for Wedding & Associates that is manufactured by NEN. The source was listed as being authorized to be distributed to general licensees. After some discussion with the RCP staff, it was agreed that in the future that sources not be listed as generally licensed, rather that the device that the source is incorporated into be authorized to be distributed to general licensees. The basis of registrations includes a safety analysis. During the review of past registry documents, it was noted that not all registry sheets contained a safety analysis summa ry. A safety analysis sumary should be included in all sheets, even if brief, and if applicable should include the accident dose analysis for devices that will be distributed to general licensees.
Recommendation Tht registration for Wedding & Associates indicates thit the source may be distributed to general licensees.
It is recomended that the registration be amended to indicate that the source be distributed to specific licensees and the device that the source is put into be authorized for distribution to general licensees. Also, we recomend that all future SSD registrations contain a safety analysis sumary.
s 2.
Status of Inspection Program Comment Our review disclosed that 11 priority 1, 2, or 3 licenses were overdue for inspection by more than 50% of the inspection frequency. We believe this is a coment of minor significance
4 since the division has a plan to eliminate these overdue inspections. The reasons for the backlog include:
(1) heavy resource commitments to special projects during the review period, and (2) inspection efforts were redirected early in 1988 to contamination surveys for the 3M static eliminator problem. During this review, we have noted improved managemcat control and data processing capability with respect to inspection status and plarming.
Recommendation We recommend that the division cot.plete its effort to bring all inspections, particularly priorities 1, 2, and 3 up to date.
C.
The following comments with our recommendations concern Category II Indicators.
1.
Administrative Procedures a.
Comment The indicator, " Administrative Procedures " includes a guideline which recommends that the radiation control program establish written internal procedures in order to assure that the staff performs its duties as required and ';rovides a high degree of uniformity and continuity in regulatory practices. We found that many of these tyses of written procedures exist as policy memoranda or otler documents in various locations or manuals used by the division, however, certain procedures were not available or not easily located by all staff members.
Recommendation We recorrend that the division's internal procedures 2 be reviewed and compiled in a manual (or manuals) that are easily referred to by all staff members in order to maintain consistency in staff licensing and compliance activities. The procedures should cover internal processing of license applications, scheduling and documenting inspections and enforcement activities, escalated enforcement action, and other functions required under the program.
(We i
provided a suggested outline for content of a procedures manual during the review meeting.)
~
.r 5
b.
Comment
~
-The State's lice
> termination procedure has limited applicability tt.
..:ense termination requests and is in need of~ upgrading.
I Recommendation We reconeend the division revise and upgrade their procedure-e for handling license termination requests. We also encourage the use'of license termination checklists and certificates.cf disposal for radioactive material when a license is terminated.
2.
Office Equipment and Support Service a.
Comment-Our review disclosed that insufficient clerical support may have contributed to delays in getting out enforcement correspondence.. The last two reviews have found that enforcement letters have frequently not been dispatched within 30 days.
Recommendation We recomend the' Department monitor the clerical support for the division.
In particular,. timeliness of correspondence including enforcement letters should be reviewed to assure that deadlines are met.
b.
Comment Our review disclosed that the division staff has encountered some difficulty in the use of data processing equipment for.
regulatory purposes. There is a lack of interchangeability of certain sof tware partly because some of the equipmeht is the staff's personal equipment that is used to supplement that provided by the State. The Wang printer has caused some inefficiency in licensee correspondence.
Recommendation i
We recomend the Departnent review the division's ADP capability. Additional State equipment should be h
obtained as needed.
t
?
3 6
y
'3.
Inspection Procedures:
,I a.
Coment It was noted during the compliance file review.that the' division does not-always address enforcement correspondence to licensee management.. In one case, the enforcement' letter which warned of a possible license suspension' action was not addressed to the University Administration but to a University radiation 4
i safety officer (RS0).
Recommendation Enforcement letters should be addressed to licensee management.
If the division wishes, copies of enforcement letters may be sent to the licensee RSO.
.b.
Comment Our review' disclosed that certain inspection policies were not documented.
Recommendation We recomend that written inspection policies be documented for:
(1) conducting unannounced inspections; (2) obtaining corrective actior;(3)followingupandclosingoutpreviousviolations; (4)assuringexitinterviewswithmanagement;and(5) issuing appropriate notification of violations of health and safety problems.
II. Radiation Control Program for Uranium Mills
-A.
Technical Quality of Licensing Actions is a Category I Indicator.
The following coment with our recommendations is made and is of J
minor significance.
1 Comment Our review of the State's implementation of groundwater standards, i.e., 40 CFR 192-as outlined in 10 CFR Part 40, Appendix A, indicated improvements can be made in their application by the staff to uranium mill licensees.
Recommendations The Colorado Department of Health must be certain that appropriate hazardous constituents are monitored. The State should assure:
The constituent is reasonably expected to be in or derived from the by-product material.
a 7
The constituent.is detecte6 in the uppermost aquifer.
The constituent is in the Criterion 13 list of hazardous constituents.
For demonstrating compliance with 40 CFR 192 or 10 CFR Part 40, Appendix A, or the Colorado Department of Health groundwater regulations, to be appropriate, compliance points need to be established by the licensee in the uppermost aquifer at the downgradient edge of the disposal area.
For the NRC to concur on a closure plan, from a groundwater viewpoint, compliance with appropriate grounde ter protection standards must be shown. These standards are one of the following: background, the drinking water standard as published in Appendix VIII, 40 CFR 264, (EPA) er an alternate concentration limit.
Remediating the grcenu ater for a predetermined number l
of years cannot be considered as a closure standard, regardless of comitments made in the consent decrees.
The agricultural standards that have been agreed to as concentration limits which will allow termination of groundwater remediation may indeed represent appropriate limits; however, an alternate concentration limit proposal-needs to be submitted by the licensee and reviewed by the Department as outlined in the draft NRC guidance dated June 1988.
At sites where leakage is suspected or known to exist, but indicator parameters are not elevated, the Department should establish groundwater protection standards for those hazardous constituents reasonably expected to be derived from the by-product material and related processing.
i B.
Administrative Procedures is a Category II Indicator. The following comments with our recommendations are made.
All of the coments (4) in this section were developed on Colorado's surety program for uranium mills. The NRC's " Technical Position on Financial Assurances for Reclamation', Decommissioning, and Long-term Surveillance and Control of Uranium Recovery facilities,"
dated October 1988 was used as a reference.
l
p a
8 1.
Comment We determined during the review of the State files that the surety instruments are held in the State Treasurer's Office for safekeeping. During our review, the surety documents.
for the Uravan uranium mill could not be found by the division staff and the Maybe11 surety instrument was missing from the State Treasurer's Office.
Recommendation We recomend thesh two surety instruments be located or reproduced from the licensee's file and filed in the State Trear ~er's Office and such other locations as the division f...Js necessary.
2.
Coment The State's surety procedures do not call for a single management position within the division to be responsible for assuring that surety amounts specified in the instruments are updated annually and filed.
Recommendation We recomend that the State's surety procedures assign a management position within the division for assuring that surety instruments be updated annually and filed.
3.
Coment
~ Colorado' regulations (similartoNRC's)requirethat uranium mill sureties provide for long-term care (LTC) funds of $250,000 (in 1978 dollars) in addition to reclamation and decommissioning costs. Not all oc Colorado's surety instruments have taken this fact J
into account.
Recommendation We recomend the State take into account the requirement for LTC funds in the amount of $250,000 (in 1978 dollars) in addition to reclamation and decommissioning costs for each f acility.
4.
Comment The sureties accepted by the State do not contain language in all cases considered acceptable by NRC.
j n+
1 j
9 i
I Recommendation j
i
.The NRC's " Technical Position on Financial Assurances for Reclamation,. Decommissioning, and Long-term Surveillance and Control of Uranium Recovery Facilities," dated October.
1988, was developed using precise legal language for surety requirements. The State staff should be aware of this i
model language since it is acceptable to most legal authorities and utilize it to the maximum extent possible.
III. General Observations - Colorado Program Review of April 7, 1989 A.
Due to heavy. workload, the Colorado radiation control staff often I
takes work home. At times this may include licensees' files from the office. The division management should be aware of this practice and of the potential.for the loss of a licensee' file.
B.
The division, in answering questions for this program review, used a newly generated tracking system for inspection reports and compliance actions. This system, when fully implemented, should provide the division director with an' ideal management tool for all compliance actions.
C.
The division uses typed narrative inspection reports, except for gauge inspections. This practice requires increased report preparation time and review time compared to the use of field forms. The need for typing has also contributed to a delay in dispatching enforcement correspondence in a timely manner. Nearly all Agreement States and the NRC use field forms for documenting most routine materials inspections, and Colorado may wish to consider this practice for the purpose of efficiency.
D.
NRC Form 591 is used for informing licensees in writing of.
inspection results when the inspections involve no violations or minor violetions. A number of Agreement States use a sfmilar form. A copy was provided to the division staff. Colorado may wish to consider adopting the use of a similar form to ease the.
clerical staff workload.
_m
J-4 I
ENCLOSURE 2 j
i Application of " Guidelines for NRC Review of Agreement State Radiation Control Programs" 1
The " Guidelines for NRC Review of Agreement State Radiation Control Programs,"
were published in the Federal Register on June 4,1987, as an NRC Policy i
Statement. The Guidelines provide 29 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 proolems 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 wed 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 for 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 te 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 oeveloped, 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.
.