[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\
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\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.
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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
