[Federal Register Volume 62, Number 219 (Thursday, November 13, 1997)]
[Notices]
[Pages 60923-60929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29886]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-31373; License No. 12-16559-01; EA 97-207]


In the Matter of Conam Inspection, Inc. Itasca, IL; Order 
Imposing Civil Monetary Penalty

I

    Conam Inspection, Inc. (Conam or Licensee) is the holder of 
Byproduct Materials License No. 12-16559-01 issued by the Nuclear 
Regulatory Commission (NRC or Commission) on January 2, 1990. The 
license authorizes the Licensee to possess and use certain byproduct 
materials in accordance with the conditions specified therein at the 
Licensee's facilities in Columbus, Ohio; Gary, Indiana; Reading, 
Pennsylvania; Gallipolis, Ohio; and at temporary job sites anywhere in 
the United States where the NRC maintains jurisdiction for regulating 
the use of licensed material.

II

    An inspection and investigation of the Licensee's activities were 
conducted between March 28, 1996 and November 12, 1996. The results of 
the inspection and investigation indicated that the Licensee had not 
conducted its activities in full compliance with NRC requirements. A 
written Notice of Violation and Proposed Imposition of Civil Penalty 
(Notice) was served upon the Licensee by letter dated June 9, 1997. The 
Notice states the nature of the violations, the provisions of the NRC's 
requirements that the Licensee had violated, and the amount of the 
civil penalty proposed for three of the violations in the aggregate 
(Violations I.A, I.B, and I.C).
    The Licensee responded to the Notice in a letter dated July 7, 
1997. In its response, the Licensee denied Violations I.B and I.C, and 
requested remission or full mitigation of the civil penalty.

III

    After consideration of the Licensee's response and arguments for 
mitigation contained therein, the NRC staff has determined, as set 
forth in the Appendix to this Order, that the Licensee did not provide 
an adequate basis for withdrawing Violations I.B and I.C, or mitigating 
the severity level of Violations I.A, I.B, and I.C in the aggregate, or 
mitigating the civil penalty associated with Violations I.A, I.B, and 
I.C. Therefore, a civil penalty in the amount of $16,000 should be 
imposed.

IV

    In view of the foregoing and pursuant to Section 234 of the Atomic 
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, 
it is hereby ordered that: 

    The Licensee pay a civil penalty in the amount of $16,000 within 
30 days of the date of this Order, by check, draft, money order, or 
electronic transfer, payable to the Treasurer of the United States 
and mailed to James Lieberman, Director, Office of Enforcement, U.S. 
Nuclear Regulatory Commission, One White Flint North, 11555 
Rockville Pike, Rockville, MD 20852-2738.

V

    The Licensee may request a hearing within 30 days of the date of 
this Order. Where good cause is shown, consideration will be given to 
extending the time to request a hearing. A request for extension of 
time must be made in writing to the Director, Office of Enforcement, 
U.S. Nuclear Regulatory Commission Washington, D.C. 20555, and include 
a statement of good cause for the extension. A request for a hearing 
should be clearly marked as a ``Request for an Enforcement Hearing'' 
and shall be addressed to the Director, Office of Enforcement, U.S. 
Nuclear Regulatory Commission Washington, D.C. 20555, with a copy to 
the Commission's Document Control Desk, Washington, D.C. 20555. Copies 
also shall be sent to the Assistant General Counsel for Hearings and 
Enforcement at the same address and to the Regional Administrator, NRC 
Region III, 801 Warrenville Road, Lisle, IL 60532.
    If a hearing is requested, the Commission will issue an Order 
designating the time and place of the hearing. If the Licensee fails to 
request a hearing within 30 days of the date of this Order (or if 
written approval of an extension of time in which to request a hearing 
has not been granted), the provisions of this Order shall be effective 
without further proceedings. If payment has not been made by that time, 
the matter may be referred to the Attorney General for collection.
    In the event the Licensee requests a hearing as provided above, the 
issues to be considered at such hearing shall be:
    (a) Whether the Licensee was in violation of the Commission's 
requirements as set forth in Violations I.B and I.C of the Notice 
referenced in Section II above, and
    (b) Whether, on the basis of such violations and the additional 
violations set forth in the Notice of Violation that the Licensee 
admitted, this Order should be sustained.

    For the Nuclear Regulatory Commission.


[[Page 60924]]


    Dated at Rockville, Maryland this 5th day of November 1997.

James Lieberman,
Director, Office of Enforcement.

Appendix A--Evaluations and Conclusion

    On June 9, 1997, the NRC issued to Conam Inspection, Inc., 
(Licensee or Conam) a Notice of Violation and Proposed Imposition of 
Civil Penalty (Notice) in the amount of $16,000 for violations 
identified during an NRC inspection and investigation conducted from 
March 28 through November 12, 1996. The Licensee responded to the 
Notice by letter dated July 7, 1997. With regard to the violations 
assessed a civil penalty, the Licensee admitted Violation I.A; denied 
Violations I.B and I.C; and requested remission or full mitigation of 
the civil penalty. The NRC's evaluations and conclusion regarding the 
Licensee's requests are as follows:

Restatement of Violation I.B

    I.B  10 CFR 34.43(b) requires, in part, a licensee to ensure that a 
survey with a calibrated and operable radiation survey instrument is 
made after each radiographic exposure to determine that the sealed 
source has been returned to its shielded position. The survey must 
include the entire circumference of the radiographic exposure device 
and any source guide tube.
    Contrary to the above, on February 27, 1996, at Eli Lilly, 
Indianapolis, IN, a Licensee radiographer did not perform an adequate 
survey after each radiographic exposure to determine that the sealed 
source had been returned to its shielded position, in that the survey 
did not include the entire circumference of the radiographic exposure 
device and the source guide tube.

Summary of Licensee's Response to Violation I.B

    The Licensee, in its response, denies Violation I.B and states that 
on February 28, 1996, the day following the incident, the radiographer 
expressly stated to the Licensee's Radiation Safety Officer (RSO) that 
he had performed a full 360-degree circumferential survey of the 
radiographic exposure device.

NRC Evaluation of Licensee's Response to Violation I.B

    The specific issue addressed in Violation I.B is whether the 
radiographer performed the required survey to determine that the source 
had completely been withdrawn into the radiographic exposure device. 
This requires, among other things, that the radiographer be aware of 
the results of the survey, especially the dose rate measured at the 
exit port (front) of the radiographic exposure device. As noted on page 
7 of the Licensee's reply to the Notice, the Licensee states (regarding 
the radiographer's survey) that: ``He then failed to properly read his 
survey meter when he performed a radiation survey in a 360-degree 
motion around the camera.'' The fact that the radiographer improperly 
read the survey meter means that he failed to properly determine: (1) 
Whether the source had been completely withdrawn into the radiographic 
exposure device; and (2) the radiological conditions and potential 
hazards incident to use of radioactive material.
    In addition, during the investigation conducted by the NRC's Office 
of Investigations, the radiographer stated that he surveyed the 
radiographic exposure device, but only on the sides. He also stated to 
the investigator that because of the position of the radiographic 
exposure device, he did not survey the front part. This conflicts with 
the information provided by the radiographer to the Licensee's RSO, but 
appears to be more in line with the facts of the case given the 
elevated exposure result to the radiographer's film badge.
    In either case, whether the radiographer improperly read the survey 
meter or whether the radiographer failed to survey the front part, the 
NRC concludes that Violation I.B occurred as stated in the Notice.

Restatement of Violation I.C

    I.C  10 CFR 20.1201(a)(1)(i) requires, with exceptions not 
applicable here, that a licensee control the occupational dose to 
individual adults to an annual dose limit of 5 rems total effective 
dose equivalent.
    Contrary to the above, the Licensee did not limit the annual 
occupational dose to an adult radiographer to 5 rems, total effective 
dose equivalent. Specifically, the individual received a radiation dose 
of a minimum of 6 rems, total effective dose equivalent, during an 
event on February 27, 1996.

Summary of Licensee's Response to Violation I.C

    The Licensee, in its response, denies Violation I.C, states that 
the NRC's methodology in determining the total effective dose 
equivalent is flawed, and does not agree with the intent of the 
regulations. The Licensee contends that using conventional dose 
assessment models, consensus industry standards, and the NRC's own 
definitions, the maximum likely Total Effective Dose Equivalent (TEDE) 
incurred by the radiographer during the event was 2.9 rems, based upon 
the radiographer's description of time and motion.
    As a basis for its argument, the Licensee asserts that while the 
Licensee's consultant calculated a dose to the right thigh of 9.369 
rems, this dose does not constitute the TEDE. The Licensee states that 
the dose limits are based on the 1976 [1977] recommendations of the 
International Commission on Radiological Protection (ICRP), which 
states that there is a predictable relationship between irradiation of 
the whole body and biological effects. The Licensee argues that the 
dose to the radiographer's thigh is not an appropriate predictor of 
biological effects, and thus should not be compared to the primary dose 
limit in 10 CFR 20.1201.
    The Licensee asserts that the ICRP recommendations should take 
precedence in determining how the TEDE is computed. As such, in 
calculating the TEDE, the Licensee uses weighting factors for each 
tissue area which are derived from ICRP Publication 26. The Licensee 
believes this is an acceptable approach because the Statements of 
Consideration for the issuance of the revised 10 CFR Part 20 included, 
as reasons for the revision, the need to incorporate updated scientific 
information, to reflect changes in the basic philosophy of radiation 
protection, and to put into practice recommendations from ICRP 26 and 
subsequent ICRP publications. The Licensee asserts that sections 10 CFR 
20.1003, which defines the TEDE, and 10 CFR 20.1201(a), which specifies 
exposure limits, conform with ICRP 26 recommendations.
    The Licensee maintains that the NRC's guidance on interpretation of 
10 CFR 20.1201(c) permits use of external dose weighting factors. 
However, the Licensee argues that the language in 10 CFR 20.1201(c): 
(1) Conflicts with the definition of deep-dose equivalent provided in 
10 CFR 20.1003; (2) is inconsistent with the ICRP recommendations; and 
(3) deviates from the fundamental principles underlying the dose limits 
in 10 CFR Part 20.
    The Licensee does note that the specific use of weighting factors 
other than 1.0 for all organs was not approved by 10 CFR Part 20; 
rather, 10 CFR 20.1003 states that ``[f]or the purpose of weighting the 
external whole-body dose (for adding it to the internal dose), a single 
weighting factor, Wt=1.0, has been specified. The use of other 
weighting factors for external exposures will be approved on a case-by-
case basis until such time as specific guidance is issued.'' The 
Licensee notes that the NRC has not yet issued specific

[[Page 60925]]

guidance in interpreting this issue; however, since the American 
National Standards Institute (ANSI) has issued N13.41, ``Criteria for 
Performing Multiple Dosimetry,'' the Licensee believes that it should 
be able to use this methodology in computing its TEDE value. This 
guidance was utilized and the resulting TEDE was 2.9 rems.
    The Licensee asserts that in light of the conflicting regulatory 
language in 10 CFR Part 20 regarding non-uniform exposure of the whole 
body, and the fact that 10 CFR 20.1003 allows weighting factors to be 
considered, the dose determined for the radiographer using ANSI N13.41 
protocol was appropriate and consistent with the rationale underlying 
the occupational dose limits.

NRC Evaluation of Licensee's Response to Violation I.C

    The specific issue addressed in Violation I.C is whether the 
radiographer's total effective dose equivalent as defined in the 
regulations exceeded the regulatory limits. The Licensee's use of ICRP 
26 and ANSI N13.41 (i.e., use of a compartmentalization methodology to 
sum the effective dose equivalents for various areas of the whole body) 
was neither approved by the NRC nor in accordance with NRC 
requirements, for the reasons described below.
1. NRC Basis for Violation I.C
    As noted in the Notice, 10 CFR 20.1201(a)(1)(i) requires, in part, 
that a licensee control the occupational dose to individual adults to 
an annual dose limit of 5 rems total effective dose equivalent. In 
addition, 10 CFR 20.1201(c) requires, in part, that the assigned deep-
dose equivalent must be for the part of the body receiving the highest 
exposure and that the deep-dose equivalent may be assessed from surveys 
or other radiation measurements for the purpose of demonstrating 
compliance with the occupational dose limits, if the individual 
monitoring device was not in the region of highest potential exposure. 
As defined in 10 CFR 20.1003, Whole body means: ``for purposes of 
external exposure, head, trunk (including male gonads), arms above the 
elbow, or legs above the knee.'' \1\
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    \1\ The NRC's definition is based, in part, on the fact that 
these portions of the whole body contain blood-forming organs.
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    Based on the findings in the NRC inspection report dated November 
18, 1996, the NRC concluded, as described in the Notice, that the 
radiographer received a TEDE of 6 rems. The conclusion was based on: 
(1) Measurements of time and distances as re-enacted by the 
radiographer and the Licensee's film badge dose; and (2) the dose to 
the part of the body receiving the highest exposure (i.e., upper left 
thigh), given that the individual monitoring device was not in the 
region of highest potential exposure, the dose field from the 
radiographic exposure device was non-uniform, and the position of the 
radiographer and his film badge in relationship to the radiographic 
exposure device.
2. The Licensee's Use of ICRP 26 and ANSI N13.41
    The NRC agrees that the dose limits in 10 CFR Part 20 are based on 
the ICRP 26 recommendations and acknowledges that the radiographer's 
thigh may not be an appropriate predictor of biological effects. 
However, the Licensee's use of ICRP 26 and the draft ANSI N13.41 for 
calculating the radiographer's whole-body dose is inappropriate in this 
case.
    While the ICRP 26 recommendations in principle permit the use of 
external weighting factors, no specific recommendations were included 
concerning the use of weighting factors for external dose because there 
are practical problems with such use. The application of weighting 
factors also entails calculation of organ doses instead of whole-body 
doses from external radiation. One component of this calculation is the 
estimation of radiation attenuation as a function of the depth in the 
body. Therefore, as noted in the NRC's Statement of Consideration for 
10 CFR Part 20 (56 FR 23369), the Commission decided that ``application 
of weighting factors for external exposures will be evaluated on a 
case-by-case basis until more guidance and additional weighting factors 
(such as for the head and the extremities) are recommended * * * The 
use of other weighting factors for external exposure may be approved on 
a case-by-case basis upon request to the NRC.'' (emphasis added). This 
means that, if a licensee proposes to use other weighting factors for 
external use, the licensee needs to develop the basis and technical 
justification for its request, submit the request to the NRC, and await 
approval of its request before using any modified weighting factors. To 
date, the Licensee has not submitted to the Commission such a request 
for an exemption of 10 CFR 20.1201.
    With regard to ANSI N13.41, this is a draft standard that has been 
neither approved by ANSI, nor reviewed and approved by the Commission 
for use by NRC licensees. Moreover, ANSI N13.41 is not applicable 
because this case falls outside of the scope of that standard. This is 
evident from the standard itself, which states, under Scope, page 9, 
that ``this standard contains criteria applicable to routine 
occupational activities (emphasis added) for when and how to use 
multiple dosimeters to monitor the body and extremity of individuals 
exposed to sources of ionizing radiation.'' The next paragraph under 
this section goes on to state, ``Sudden or unexpected changes in the 
radiation environment as might occur during accidents are beyond the 
scope of this standard'' (emphasis added).
    The dose calculated by the consultant to the radiographer's right 
thigh was 9.369 rems. As noted in the Licensee's response, the footnote 
attached to 10 CFR 20.1003 specifies that a single weighting factor, 
Wt=1.0, be used for external exposures.
    However, rather than using this weighting factor, the Licensee 
applied the factors provided in ANSI N13.41 (which are less than 1.0) 
to calculate exposures of portions of the whole body to arrive at the 
overall dose determination. The Licensee's use of weighting factors (on 
the basis that the NRC has not issued new weighting factors) without 
prior NRC approval is contrary to NRC requirements. Given the above, 
the Licensee's method for calculating the radiographer's exposure is 
incorrect.
3. Arguments Concerning Deep-Dose Equivalent
    10 CFR 20.1201(c) requires, in part, that the assigned deep-dose 
equivalent must be for the part of the body receiving the highest 
exposure. 10 CFR 20.1003 defines deep-dose equivalent as the dose 
equivalent at a tissue depth of 1 cm (1000 mg/cm\2\) [regardless of the 
part of the whole body that is exposed]. Given that ICRP 26 did not 
include specific recommendations concerning the use of weighting 
factors for external dose, and the fact that there are practical 
problems in using weighting factors to assess external exposure as 
noted above, the NRC disagrees with the Licensee's argument that 10 CFR 
20.1201(c) is inconsistent with the ICRP recommendations and that 10 
CFR 20.1201(c) deviates from the fundamental principles underlying the 
dose limits in 10 CFR Part 20.
4. Use of the Consultant Results and Part 20 Weighting Factors
    The NRC bases its enforcement actions on its regulations as 
codified in Title 10, Code of Federal Regulations. In this case, 10 CFR 
20.1003 defines the weighting factor for the whole body as 1.0. As 
noted in the Licensee's response, the NRC has not approved the use of

[[Page 60926]]

other weighting factors for external exposures nor has the NRC issued 
specific guidance on the use of other weighting factors. The 
regulations do allow for the use of a different methodology, but only 
after review and prior approval by the NRC. In this case, such approval 
was not obtained by the Licensee. Because the thigh (right or left) is 
an area of the body meeting the definition for whole body, the 
appropriate weighting factor per the regulations is 1.0. Therefore, if 
the Licensee chooses to use the consultant's results in conjunction 
with the Part 20 weighting factors, the radiographer's TEDE for the 
event would be:

Dose to right thigh (9.369 rems)  x  weighting factor (1.0) = 9.369 
rems

    The Licensee correctly notes that the limit for whole-body exposure 
in 10 CFR 20.1201(a)(1)(i) is a TEDE of 5 rems. 10 CFR 20.1003 defines 
the TEDE as the sum of the deep-dose equivalent (external exposure) and 
committed effective dose equivalent (internal exposure). In this case, 
the TEDE can be considered to be equal to the deep-dose equivalent, 
because there was no internal exposure involved.
    The circumstances surrounding the exposure, as described in the 
inspection report and by the radiographer during the conduct of the 
NRC's investigation, demonstrated that the radiographer's body was 
between the radiographic exposure device and the radiographer's film 
badge. As noted in the radiographer's and RSO's description of the 
Licensee's time-motion study, no props were used--the event was 
discussed at a table with the radiographer describing to the RSO what 
occurred. During this time-motion discussion, it was not clear that the 
radiographer's film badge was at the point nearest the source. It was 
clear that the beam from the exit port of the radiographic exposure 
device would be very directional and non-uniform. Later, on April 11, 
1996, a re-enactment of the event by the radiographer in the presence 
of the Licensee's RSO and NRC personnel was performed and appropriate 
props were used. The radiographer was asked to demonstrate his 
activities at the time the exposure occurred. This re-enactment 
provided information that the Licensee had not obtained during its 
verbal time-motion discussion, namely, that the radiographer's leg was 
significantly closer to the source than was his film badge. For the 
sake of argument, the NRC has chosen to utilize the Licensee's dose 
calculation based on its verbal characterization, and the resulting 
dose obtained to the right thigh. If the Licensee chooses to use the 
consultant's results (which utilized variables from the NRC's re-
enactment) in conjunction with the Part 20 weighting factors, the 
radiographer's TEDE for the event would be:

Dose to left thigh (42.075 rems)  x  weighting factor (1.0) = 42.075 
rems

    10 CFR 20.1201(c) states that ``the assigned deep-dose equivalent 
and shallow-dose equivalent must be for the part of the body receiving 
the highest exposure. The deep-dose equivalent, eye dose equivalent and 
shallow-dose equivalent may be assessed from surveys or other radiation 
measurements for the purpose of demonstrating compliance with the 
occupational dose limits, if the individual monitoring device was not 
in the region of highest potential exposure, or the results of 
individual monitoring are unavailable.'' In this case, the individual 
monitoring device was not in the region of highest potential exposure, 
given the non-uniform nature of the dose field from the radiographic 
exposure device and the position of the radiographer and his film badge 
in relationship to the radiographic exposure device. Therefore, per 
this requirement, the assigned deep-dose equivalent must be for the 
right thigh (using the Licensee's computation), as it is part of the 
whole body. This results in an assigned deep-dose equivalent of 9.369 
rems. As noted above, the TEDE consists of the sum of the deep-dose 
equivalent and committed effective dose equivalent. In this case, it is 
equal to the deep-dose equivalent, 9.369 rems, a value that is in 
excess of the limit specified in 10 CFR 20.1201(a)(1)(i).
    Given the above, the NRC concludes that: (a) The Licensee has not 
provided a basis to substantiate that the radiographer's TEDE was below 
5 rems; and (b) Violation I.C occurred as stated in the Notice.

Summary of Licensee's Request for Remission or Mitigation and 
Reconsideration of Severity Level

    The Licensee offered several arguments in support of its request 
for remission or mitigation of the proposed penalty. Below is a summary 
listing of the Licensee's arguments that are related to its request for 
remission or mitigation, some of which have been consolidated. The 
NRC's evaluation follows each argument.

Appendix A

1. Licensee's Argument
    The Licensee asserts that violations cited in Section I of the 
Notice should not be considered willful, for the following reasons:
     Based on the Licensee's discussion of the event on 
February 28, 1996, between the RSO and the radiographer, the Licensee 
concluded that the radiographer was negligent in failing to rotate the 
selector ring from the ``operate'' to the ``lock'' position and failing 
to depress the plunger mechanism of the radiographic exposure device.
     This act was not the result of deficiencies in the 
Licensee's Radiation Safety Program, nor did it follow other incidents 
of a similar nature. As evidence for its argument, the Licensee notes 
that seven prior unannounced NRC inspections had not identified any 
violations of applicable regulations.
     The Licensee disputes the fact that it was a ``typical'' 
practice of Conam radiographers to rely upon the automatic locking 
mechanism of their radiographic exposure devices rather than locking 
them in the manner required by the Licensee's radiation safety 
procedures.
     The Licensee believes that ``[b]ecause the NRC's 
conclusion that a ``willful'' violation has occurred is influenced by 
its erroneous conclusion that a violation of the occupational exposure 
limit occurred, its characterization of the violation as ``willful'' is 
flawed.''

NRC Evaluation

    In its Notice, the NRC did not conclude that the violations in 
Section I were willful; rather, the NRC concluded that only Violation 
I.A was willful. In this regard, Section IV.C of the NRC Enforcement 
Policy defines willful violations to encompass not merely deliberate 
acts but acts of careless disregard as well. As part of the NRC's 
evaluation of this event, an investigation was conducted by the NRC's 
Office of Investigations (OI). That investigation concluded that the 
Licensee's radiographer willfully failed to follow the Licensee's 
procedures while operating the radiographic exposure device. The 
radiographer, who was knowledgeable of the requirement but failed to 
perform it due to being ``lax,'' demonstrated careless disregard for 
NRC requirements, a condition that clearly meets the NRC's definition 
of a willful violation.
    Given the results of the OI investigation, the problem with failing 
to follow procedures was not isolated. As noted both in the November 
18, 1996 inspection report and during the subsequent Predecisional 
Enforcement Conference, the Licensee's policy for performing field 
audits did not

[[Page 60927]]

encompass multiple exposures or other situations where the potential 
existed for a radiographer to fail to properly rotate the selector ring 
and depress the plunger. A single radiographic shot was often used, 
where this act would be performed prior to moving the radiographic 
exposure device. As such, the Licensee was unaware of the problem until 
it manifested itself in the exposure event that occurred on February 
27, 1996, although a better field auditing technique may have allowed 
the Licensee to identify the problem prior to the February event. 
Therefore, the Licensee's arguments (i.e., lack of deficiencies in its 
radiation safety program and the lack of NRC findings during prior 
unannounced NRC inspections) do not alter the NRC's conclusion 
concerning the willful act of the radiographer.
    When questioned by the OI investigator, approximately 25% of the 
Licensee's radiographers at the Gary, Indiana facility, including the 
radiographer associated with the event, admitted that on or prior to 
February 28, 1996, they failed on occasion to rotate the selector ring 
from the ``operate'' to the ``lock'' position and failed to depress the 
plunger mechanism as required by the Licensee's operating procedures. 
They stated to the investigator that they had been ``lax,'' but that 
they were knowledgeable of the requirement. They also stated that after 
the memo was issued by the RSO discussing the event and the need to 
follow procedures, they no longer violated this requirement.
    In determining whether the radiographer willfully failed to lock 
the radiographic exposure device, the NRC based its conclusion on 
interviews with the radiographer as noted above. The Licensee's belief 
that the NRC's conclusion concerning willfulness was influenced by 
whether a violation of the occupational exposure limit occurred is 
simply incorrect.
2. Licensee's Argument
    The Licensee asserts that the NRC improperly denied identification 
and corrective action credit under the terms of the NRC Enforcement 
Policy, Section VI.B.2.b and c, by ignoring essential facts. The 
Licensee asserts that while the incident was identified through an 
event, this fact does not preclude identification credit where the 
problem arose from a single incident of negligence by a radiographer in 
violation of well-publicized Conam safety procedures, where the 
Licensee's quarterly radiation safety compliance audit program was 
demonstrably adequate, and where there were no prior deficient 
occurrences to identify the problem.
    In addition, the Licensee argues that its corrective actions were 
also prompt and comprehensive and should result in credit. The Licensee 
believes that the incident was promptly and comprehensively addressed 
and corrected by the Licensee's RSO through his analysis of the film 
badge, his issuance of a February 29, 1996, memorandum reminding all 
Conam radiographic personnel of the proper procedure for operating 
radiographic exposure devices, his withdrawal of the radiographer from 
further radiographic duties, and the suspension of the radiographer 
without pay for one week.
    The Licensee disagrees with the NRC's position, as described in the 
Notice, that credit should not be given because the Licensee did not 
confirm that each radiographer had received the February 29, 1996, 
memorandum from the RSO, nor had the Licensee instituted any 
monitoring/auditing program to evaluate the effectiveness of the 
memorandum. The Licensee states that there is no evidence that the 
radiographers did not receive the memorandum, and that there has been 
no repetition of the problem since the February event's occurrence. The 
Licensee believes that the NRC's dismissal of credit for identification 
and corrective action ignores the fact that the February event was the 
only one of its kind against a record of no violations whatsoever 
during seven prior NRC inspections, and no that subsequent violations 
since the event have been identified by NRC inspections.

NRC Evaluation

    The NRC Enforcement Policy, Section VI.B.2.b, discusses the 
criteria to be considered when deciding if a licensee should be given 
credit for actions related to identification. These circumstances 
include: (i) Whether the problem requiring corrective action was NRC-
identified, licensee-identified, or revealed through an event; and (ii) 
for a problem revealed through an event, the ease of discovery, the 
licensee's self-monitoring effort, the degree of licensee initiative in 
identifying the problem requiring corrective action, and whether prior 
opportunities existed to identify the problem (Section VI.B.2.b(2)(ii) 
of the Enforcement Policy).
    The NRC and the Licensee both agree that the problem requiring 
corrective action was revealed through an event. Therefore, the 
criteria in Section VI.B.2.b(2)(ii) of the Enforcement Policy are 
applicable in this case. Regarding the ease of discovery, as well as 
the Licensee's self-monitoring effort, the radiographer involved in the 
incident reported the problem to the Licensee's RSO; and the problem 
was not identified through any self-monitoring action of the Licensee's 
RSO or management, such as an audit. Regarding the degree of licensee 
initiative in identifying the problem requiring corrective action, the 
Licensee's initiative does not deserve credit, as described below. 
Regarding the existence of prior opportunities to identify the problem, 
as stated earlier, the OI investigation revealed that approximately 25% 
of the Licensee's radiographers and assistant radiographers at the 
Gary, Indiana facility admitted that on or prior to February 28, 1996, 
they on occasion failed to rotate the selector ring from the 
``operate'' to the ``lock'' position and failed to depress the plunger 
mechanism as required by the Licensee's operating procedures. Thus, the 
problem with failing to follow procedures was not isolated. The 
Licensee performs quarterly field audits of its radiographers. As noted 
in the inspection report and during the Predecisional Enforcement 
Conference, the Licensee's policy for performing field audits did not 
encompass multiple exposures or other situations where the potential 
existed for a radiographer to fail to properly rotate the selector ring 
and depress the plunger. Therefore, numerous prior opportunities 
existed to identify the problem, yet the problem was not identified 
prior to the February 27, 1996 incident. Thus, credit for 
identification is not warranted.
    The NRC Enforcement Policy, Section VI.B.2.c, discusses the 
criteria to be considered when deciding if a licensee should be given 
credit for prompt and comprehensive corrective actions. These criteria 
include: (i) The timeliness of the corrective action, (ii) the adequacy 
of the licensee's root cause analysis for the violation, and (iii) the 
comprehensiveness of the corrective action. As stated in the inspection 
report, the NRC acknowledges the Licensee's prompt action in issuing a 
memorandum to all radiation safety supervisory personnel advising all 
radiography staff to complete a full and accurate survey of the 
radiographic exposure device, collimator, guide tube, and connector 
after each exposure and to secure the source assembly in accordance 
with the Licensee's procedures. However, although the issuance of the 
memorandum was timely, it does not constitute a comprehensive 
corrective action.
    Specifically, after the Licensee received the vendor's report 
indicating the radiographer's dose, the Licensee

[[Page 60928]]

did not perform an exact time-motion study at the scene of the event to 
determine the locations of the whole body, film badge and radiographic 
exposure device exit port. Photographs of the scene that were obtained 
later did not include the position of the radiographer. In addition, 
the Licensee could not confirm that each radiographer had received the 
memorandum, nor had the Licensee instituted any monitoring/auditing 
program to evaluate the effectiveness of the memorandum. The Licensee's 
argument that there is no evidence that the radiographers did not 
receive the memorandum is not persuasive; a comprehensive corrective 
action would ensure that each radiographer had received, reviewed, and 
understood the memorandum, and would monitor the radiographers' 
understanding of and compliance with the memorandum. Such comprehensive 
corrective actions were not implemented by the Licensee.
    Finally, the fact that no violations had been identified during 
seven NRC inspections prior to the February 27, 1996 event, although 
commendable, is not relevant as far as credit for corrective action is 
concerned. Further, in accordance with Section VI.B.2.c of the NRC 
Enforcement Policy, the adequacy of a licensee's corrective actions is 
judged at the time of the enforcement conference, not on the basis of 
whether subsequent violations following the event have been identified 
by the NRC. Given the above, the NRC concludes that while the Licensee 
took some timely actions, on balance, such actions did not address the 
root cause of the violations and were not comprehensive. Thus, credit 
for prompt and comprehensive corrective actions is not warranted.
3. Licensee's Argument
    The Licensee asserts that the NRC Enforcement Policy should find, 
at worst, that the February 27,1996 incident involved two non-willful 
Severity Level III violations which, with appropriate identification 
and corrective action credit, do not justify any civil penalty. The 
Licensee asserts that to aggregate the violations cited in Section I of 
the Notice and assign a Severity Level II ``problem'' to this 
collection is not consistent with the NRC's Enforcement Policy 
published in 60 FR 34381 (June 30, 1995). The Licensee believes that 
the NRC's Notice compounds that error by determining that the Severity 
Level II problem was willful, and on that basis justifying a 100% 
escalation of the $8,000 Severity Level II base penalty.

NRC Evaluation

    As described above, the NRC has determined that Violation I.A was 
willful, that Violations I.A, I.B, and I.C occurred as described in the 
inspection report, and that credit for identification and corrective 
action is not warranted. The NRC Enforcement Policy, Section IV.A, 
states, in part, that the purpose of aggregating violations is to focus 
the licensee's attention on the fundamental underlying causes for which 
enforcement action appears warranted and to reflect the fact that 
several violations with a common cause may be more significant 
collectively than individually and may, therefore, warrant a more 
substantial enforcement action. As noted in the Notice, in 
consideration of the willfulness involved, the relationship of these 
violations to a single incident, and the fact that two safety barriers 
were breached, the violations are of very significant regulatory 
concern. Therefore, consistent with Section IV.A of the Enforcement 
Policy, the violations in Section I of the Notice were combined to 
reflect that, collectively, they are more significant than individually 
and, therefore, warrant a more substantial enforcement action.
    As to the Licensee's argument concerning escalation of the $8,000 
base penalty, the NRC did not escalate the civil penalty on the basis 
of a willful violation. The base amount for a Severity Level II problem 
is $8,000. Credit was not warranted for the identification and 
corrective action factors. Therefore, in accordance with the civil 
penalty assessment process described in Section VI.b.2, the civil 
penalty for the Severity Level II problem is twice the base amount 
(i.e., $16,000).

NRC Conclusion

    The NRC concludes that the Licensee did not provide an adequate 
basis for withdrawing Violations I.B and I.C, for mitigating the 
severity level of Violations I.A, I.B, and I.C in the aggregate, or for 
mitigating the civil penalty associated with Violations I.A, I.B, and 
I.C. Therefore, the proposed civil penalty in the amount of $16,000 
should be imposed by order.

Appendix B Evaluation of Violations Not Assessed a Civil Penalty

    Of the violations not assessed a civil penalty, the Licensee 
admitted violation II.B and denied Violation II.A.

Restatement of Violation II.A

    II.A  10 CFR 20.2203(a)(2)(i) requires, in part, that a licensee 
submit a written report within 30 days after learning of a dose in 
excess of the occupational dose limits for adults as defined in 10 CFR 
20.1201.
    Contrary to the above, on April 11, 1996, the Licensee learned of 
an event that caused an adult radiographer to receive a total effective 
dose equivalent of more than 5 rems total effective dose equivalent and 
did not submit a written report within 30 days as required.

Summary of Licensee's Response to Violation II.A

    The Licensee, in its response, denies Violation II.A and states 
that, because the radiographer was not exposed to a dose in excess of 5 
rems, total effective dose equivalent, no reporting obligation arose 
under applicable regulations.

NRC Evaluation of Licensee's Response to Violation II.A

    The specific issue raised by Violation II.A was whether the 
Licensee was required to submit a report to the NRC after learning of a 
dose in excess of the occupational dose limits for adults as defined in 
10 CFR 20.1201. In this case, the Licensee's evaluation of the 
circumstances did not appear to be adequate in that the Licensee did 
not complete an exact time/motion study at the scene of the event to 
determine the locations of the whole body, film badge, and radiography 
exposure device. As a result, the Licensee did not conclude that an 
exposure in excess of the dose limits occurred.\2\
---------------------------------------------------------------------------

    \2\ For details concerning the Licensee's evaluation, see 
Summary of the Licensee's Response to Violation I.C and the NRC's 
Evaluation of the Licensee's Response to Violation I.C.
---------------------------------------------------------------------------

    By letter dated June 23, 1997, the Licensee did submit the report 
required by 10 CFR 20.2203(a)(2)(i), but solely on the basis that the 
NRC's letter transmitting the Notice of Violation and Proposed 
Imposition of Civil Penalty specifically stated that the Licensee was 
required to make such a report. As noted above, the Licensee still 
contends that an exposure in excess of regulatory limits did not occur 
based on the Licensee's unapproved methodology it used to compute the 
TEDE.
    Given that the Licensee did not learn that the radiographer's 
exposure was in excess of regulatory limits, and that, after being 
informed by the NRC of the radiographer's exposure, the Licensee 
submitted a report per the requirements of 10 CFR 20.2203(a)(2)(i), the 
NRC concludes that Violation II.A should be withdrawn.

NRC Conclusion

    The NRC staff concludes that the Licensee provided an adequate 
basis for

[[Page 60929]]

withdrawing Violation II.A. Therefore, Violation II.A should be 
withdrawn.

[FR Doc. 97-29886 Filed 11-12-97; 8:45 am]
BILLING CODE 7590-01-P