[Federal Register Volume 62, Number 102 (Wednesday, May 28, 1997)]
[Notices]
[Pages 28899-28906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13865]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-01786, License No. 19-00296-10, EA No. 96-027]
Department of Health and Human Services, National Institutes of
Health Bethesda, Maryland; Order Imposing a Civil Monetary Penalty
I
The National Institutes of Health (NIH or Licensee), part of the
United States Department of Health and Human Services, is the holder of
Byproduct Materials License No. 19-00296-10 (license) issued by the
former Atomic Energy Commission on December 7, 1956, and most recently
renewed by the Nuclear Regulatory Commission (NRC or Commission) on May
19, 1990. The license is currently under timely renewal. 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 Bethesda, Rockville, Poolesville, and Baltimore,
Maryland.
II
Inspections of the Licensee's activities were conducted by the NRC
Augmented Inspection Team (AIT) from June 30 through November 15, 1995,
and by a Special Inspection Team on October 23-24, and November 6-10,
1995, at the Licensee's facility located in Bethesda, Maryland. The
results of these inspections 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 August 23, 1996.
The Notice states the nature of the violations, the provisions of the
NRC requirements that the Licensee had violated, and the amount of the
civil penalty proposed for one of the violations (Violation I). The
Licensee responded to the Notice in a letter dated September 23, 1996.
In its response, the Licensee disputes Violation I as well as the
severity level associated with the violation, and requests withdrawal
of the civil penalty.
III
After consideration of the Licensee's response and the statements
of fact, explanation, and argument contained therein, the NRC staff has
determined, as set forth in the Appendix to this Order, that the
Licensee has not provided an adequate basis for withdrawing Violation I
or mitigating the severity level of this violation, or for mitigating
the civil penalty associated with this violation. Therefore, a civil
penalty in the amount of $2,500 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 $2,500 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, Maryland 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 I, 475 Allendale Road, King of Prussia, PA 19406.
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 Violation I of the Notice referenced in
Section II above, and
(b) Whether on the basis of this violation, this Order should be
sustained.
Dated at Rockville, Maryland this 20th day of May 1997.
For the Nuclear Regulatory Commission.
Edward L. Jordan,
Deputy Executive Director for Regulatory Effectiveness, Program
Oversight, Investigations and Enforcement.
Appendix
Evaluations and Conclusion
On August 23, 1996, a Notice of Violation and Proposed Imposition
of Civil Penalty (Notice) was issued for violations identified during
two NRC inspections conducted at the Licensee's facility. The Licensee
responded to the Notice in a letter dated September 23, 1996. In its
response, the Licensee disputes Violation I, for which the civil
penalty was assessed, disputes the severity level of the violation, and
requests withdrawal of the civil penalty. The NRC's evaluation and
conclusions regarding the Licensee's requests are as follows:
I. Restatement of Violation I
10 CFR 20.1801 requires that the licensee secure from unauthorized
removal or access licensed materials that are stored in controlled or
unrestricted areas. As defined in 10 CFR 20.1003, unrestricted area
means an area, access to which is neither limited nor controlled by the
licensee.
Contrary to the above:
(a) On July 6, 1995, the licensee did not secure from unauthorized
removal or limit access to licensed material stored in laboratory 5D12
of Building 37, an unrestricted area. Specifically, a member of the NRC
AIT found the licensed material inside an unlocked refrigerator that
was located within the unlocked laboratory 5D12, and no one was present
to control access to this material. The licensed material consisted of
approximately 20 millicuries of tritium (H-3) and 2.5 millicuries of
carbon-14 (C-14).
(b) On October 23, 1995, the licensee did not secure from
unauthorized removal or limit access to licensed material stored in
laboratories 4D25,
[[Page 28900]]
4D06, 4B03, 6C13, 1B03, and 3C01 of Building 37, unrestricted areas.
Specifically, members of the NRC Special Inspection Team found the
licensed material inside unlocked refrigerators located in unlocked
laboratories, and no one was present to control access to this
material. The licensed material consisted of 234 microcuries of
phosphorus-32 (P-32) and 720 of microcuries of sulphur-35 (S-35) in Lab
4D25; 20 microcuries of P-32 in Lab 4D06; 3.4 millicuries of H-3 in
4B03; 900 microcuries of S-35 in Lab 6C13; 200 microcuries of S-35,
1140 microcuries of P-32, and 3.7 millicuries of chromium-51 (Cr-51) in
Lab 1B03; and 41 microcuries of P-32 and 250 microcuries of S-35 in Lab
3C01.
II. Summary of Licensee's Response to Violation I
NIH disputes that a violation occurred because, according to NIH,
``there is no definition of the term `secured from unauthorized removal
or access' within the NRC regulations.'' NIH also disputes that this
violation should be categorized at Severity Level III, and in support
references its May 23, 1996 submission (``Specific Responses of NIH to
the Apparent Violations Found in Inspection Reports 030-01786/95-002
(REDACTED) and 030-01786/950203'' at pages 1-3 and 21-25, and ``Factors
for Consideration in Determining Severity Levels of Apparent
Violations.'')
In particular, NIH contends that Violation I was not
``significant'' such as to constitute a Severity Level III violation
under Supplement IV.C.12 of the Enforcement Policy, NUREG-1600,
because:
(1) According to NIH, it maintained control of licensed material
through posting laboratories at all times and storage in posted
refrigerators in properly labeled containers, and the period of time
during which materials were not under surveillance was brief. NIH
contends that this degree of control had been acceptable to the NRC for
many years, that the violations arose because of the adoption of more
stringent enforcement standards, and that the violations occurred
within three months of the adoption of NIH's final security policy
responding to these more stringent enforcement standards.
(2) According to NIH, it has made extensive good faith corrective
efforts during the transition to more stringent enforcement standards
to ensure compliance, but human oversight has resulted in violations.
(3) According to NIH, the violations pose little or no risk of harm
because of the low levels of radioactivity involved. NIH claims that
there has been no more than minimum risk to health and safety and that
none of the violations resulted in any radiation exposure of an NIH
employee or a member of the public.
NIH contends that the violations do not constitute a failure to
control access to licensed materials for radiation purposes as
specified by NRC requirements, such as to constitute a Severity Level
III violation under Supplement VI.C.1 of the Enforcement Policy, for
two reasons: (1) NIH claims that this standard conflicts with the
``significant failure'' standard of Supplement IV.C.12 of the
Enforcement Policy; and (2) NIH argues that ``access* * * for radiation
purposes'' refers to access for medical treatment or diagnostic
purposes, which were not involved in the violations.
NIH argues that only Severity Level IV or greater violations can be
the basis for considering aggregation or repetition, and that to
categorize Violation I at Severity Level IV would be questionable. NIH
contends that escalating this violation to Severity Level III on the
basis of repetitive or aggregated violations is contrary to the
Enforcement Policy, because the number of violations is small compared
to the number of restricted use areas (0.2%) or to the number of
workers using radioactive material. NIH further maintains that this
violation should not be considered a repeat violation unless it occurs
in the same laboratory, because the cause of this violation is not a
failure of the NIH Radiation Safety Branch to train workers, promulgate
security requirements, or respond quickly to violations, but rather
lack of attention and carelessness by individual researchers. NIH
contends that under the Enforcement Policy, aggregation is appropriate
only where the violations have the same underlying cause or
programmatic deficiencies or the violations contributed to or were
unavoidable consequences of the underlying problem. NIH contends that
these were unconnected occurrences that have no fundamental underlying
cause or common cause that can be eliminated by NIH. NIH argues that
these violations are unconnected and are not an indication of the
adequacy of previous corrective actions, which should be judged on the
basis of their scope, content, and potential deterrent effect, and not
on the basis of whether they eliminate all human error.
NIH states that its corrective actions, described in its May 23,
1996 response, have made all researchers aware of, or they should be
aware of, security requirements. These corrective actions include: (1)
Confiscating the licensed material identified by the NRC AIT on July 6,
1995; (2) adopting the Interim Security Policy as permanent on July 20,
1995; (3) the RSO performing extensive surveillance and taking
appropriate enforcement action for violations of the NIH Security
Policy; and (4) conducting a follow-up investigation after the Special
Inspection of October 23-24 and November 6-10, 1995. NIH states that
full compliance has largely been achieved and that it will continue to
diligently pursue the current corrective actions. Further, NIH states
that the most reasonable and effective corrective action will be the
establishment of an enforcement policy that is directed toward
quantities of radioactive materials that pose a real risk of harm, thus
limiting the potential for human error by focusing on significant
safety risks that all will recognize as such.
III. NRC Evaluation of Licensee's Response to Violation I
The failures of NIH to secure licensed material from unauthorized
removal or access do constitute a violation. Contrary to NIH's
contentions, the meaning of the phrase ``secured from unauthorized
removal or access'' is abundantly clear. Among the common meanings of
the verb ``to secure'' is to guard, to shield from interference, or to
restrain or make fast. Webster's Third New International Dictionary
(unabridged) (1986). The statements of consideration for 10 CFR 20.1801
and 1802 and their predecessor requirements, 10 CFR 20.207 (a) and (b),
make it clear that Section 1801 and 1802 were intended to require
licensees to guard or make licensed material safe from unauthorized
removal or access, by use of physical restraint. For example, when Part
20 was first promulgated in 1957, section 20.207 required that
``[l]icensed materials stored in an unrestricted area shall be secured
against unauthorized removal from the place of storage.'' In 1975 the
Commission modified this requirement by an immediately effective rule,
explaining in the statements of consideration that the ``references to
`storage' might not convey clearly the intention that constant control
be maintained over all licensed radioactive materials in unrestricted
areas [emphasis added]'' (40 FR 26679, June 25, 1975). Section
20.207(b) was added, requiring that ``licensed materials in an
unrestricted area and not in storage shall be tended under the constant
surveillance and immediate control of the licensee.'' When 10 CFR
20.1801 and 1802 were promulgated, the statements of consideration
further discussed the need to secure even small
[[Page 28901]]
quantities of licensed materials (56 FR 23360 at 23379, May 21, 1991).
[Commenter]: * * * the requirement to secure small quantities of
licensed radioactive materials when they are not in use would
interfere with university research.
[Commission Response]: * * * locking radiotracer laboratories
when they are not being used is a small nuisance compared to the
consequences of unauthorized access to, or theft of, radioactive
materials, which could result in contamination of unrestricted areas
or exposure to individuals, as well as having to report a loss of
licensed material to the NRC.
Contrary to NIH's contention, Violation I was a ``significant
failure to control licensed material'' within the meaning of Supplement
IV.C.12 of the Enforcement Policy. The NRC acknowledges that NIH posted
rooms and refrigerators in which radioactive materials were stored, and
radioactive material was in properly labeled containers. Accordingly,
the NRC did not cite NIH for violation of NRC requirements for posting
or labeling radioactive material. However, NIH does not deny that
licensed material was left unattended inside unlocked refrigerators in
unlocked laboratories. While the measures taken by NIH provided a
method of warning individuals of the presence of radioactive material
and potential hazards, they did not secure licensed materials from
unauthorized removal or access, which is the requirement.
The significance of Violation I is based on the potential for harm,
which involves the type of licensed material left unsecured and
accessible by the public, the number of examples of the violation (i.e.
the number of times licensed radioactive material was identified to be
unsecured), and the repetitive nature of the violation. As stated in
NRC's August 23, 1996, letter ``[I]t is a significant regulatory
concern that NRC inspectors repeatedly have been able to gain access to
licensed material at your facility without challenge * * * Given the
repetitive nature and the number of examples of the violation, the
violation has been categorized in accordance with the ``General
Statement of Policy and Procedure for NRC Enforcement Actions''
(Enforcement Policy), NUREG-1600, at Severity Level III.''
Categorizing Violation I at Severity Level III is appropriate
pursuant to Sections IV.A. and IV.B. of the Enforcement Policy, based
on the number of examples of the violation and the repetitive nature of
the violation. NIH is correct that escalation of Severity Level IV
violations into a Severity Level III violation is based in part upon
the violations having a common underlying cause. Aggregating the
failures to control licensed material and characterizing them as a
Severity Level III violation is appropriate in this case because
numerous isotopes were left unsecured in numerous locations, not as a
result of isolated occurrences, but due to the same underlying cause,
which was the Licensee's failure to effectively oversee and ensure
compliance with security requirements by its employees. NIH also is
correct that in escalating Severity Level IV violations to Severity
Level III for repetitiveness, a factor to be considered is the adequacy
of corrective action for previous similar violations. Escalation of the
numerous failures to control licensed material to a Severity Level III
violation is also appropriate in this case because of the repetitive
nature of the violation. NIH had been cited previously for failures
involving security of licensed radioactive materials. Specifically,
security failures were identified by the NRC during an NRC inspection
conducted in April and May of 1994, which resulted in the issuance of
Confirmatory Action Letter 1-94-006 and subsequent issuance of a
Severity Level IV violation. As explained in the Notice of Violation, a
violation need not occur in the same laboratory in order for it to be
considered repetitive.
NIH argues that the number of violations in this case is small
compared to the total number of restricted use areas at NIH. However,
NRC did not inspect the total number of restricted use areas at NIH.
Additionally, NRC chose not to cite some of the security failures that
the NRC inspectors identified because, although the presence of
unsecured radioactive material was confirmed by survey meter, the
activity of the material was not known. See, for example, NRC
Inspection Report No. 030-011786/95-203 (December 21, 1995), Section
3.d. Moreover, the programmatic issue of significant regulatory concern
involves much more than just the number of violations. Specifically,
these violations, viewed in the context of the history of security
violations at NIH beginning in 1994, indicate that previous corrective
actions were not effective. Contrary to NIH's assertion that there is
no common underlying cause for the violations that can be eliminated by
NIH, the common root cause for these violations is NIH's failure to
effectively oversee its employees and ensure their compliance with
security requirements. NIH must recognize that, in order to assure that
public health and safety are protected, the Commission expects and
requires that its regulations be met by all licensee employees,
regardless of the licensee's size or the volume of the licensee's
activities. NRC licenses the entity. NRC does not separate licensee
management from licensee employees. Licensees are responsible for the
acts of their employees. In the matter of Atlantic Research
Corporation, (CLI-80-7), 11 NRC 413, 422 (1980).
Further, the violations do pose a credible risk of harm, given the
types and quantities of licensed material listed in the citation.
Radiation exposure and/or contamination may be posited through both
accidental and intentional pathways anytime a member of the public has
access to such materials. The purpose of the requirement is to prevent
access to such materials by unauthorized individuals because access
could result in unnecessary radiation exposure as well as harm to the
environment.
The violation did not arise from more stringent enforcement
standards, as claimed by NIH, but from the failure of NIH to
effectively ensure compliance with NRC requirements. NIH does not
identify new or more stringent NRC requirements or standards. The only
new policy identified by NIH was its July 1995 final security policy,
adopted as part of the Licensee's corrective action for previously
cited violations of security and control requirements of 10 CFR Part
20.
NIH offers no explanation for its contention that Supplements
IV.C.12 and VI.C.1 of the NRC Enforcement Policy conflict with each
other. Supplement IV.C.12 gives as an example of a Severity Level III
health physics violation, ``a significant failure to control licensed
material,'' and Supplement VI.C.2 gives as an example of a Severity
Level III fuel cycle and materials operation violation, ``a failure to
control access to licensed materials for purposes as specified by NRC
requirements.'' Supplement IV.C.12 concerns control of material and
Supplement VI.C.1 addresses access to material. A failure to control
access to licensed material is one type of a failure to control
licensed material. In the circumstances of this case, NIH's failure to
secure licensed material constitutes a Severity Level III violation
under both Supplements IV and VI.
NIH incorrectly asserts that Supplement VI.C.1. applies only to
violations concerning access to licensed material used for medical
treatment or diagnostic purposes. Supplement VI is titled ``Fuel Cycle
and Materials Operations'', and does not single out uses for medical or
diagnostic purposes, but refers by its title and content to all
[[Page 28902]]
uses of byproduct materials. Based on the above, the NRC concludes that
NIH did not provide an adequate basis to mitigate the Severity Level of
Violation I.
IV. Summary of Licensee's Request for Withdrawal of the Civil Penalty
The Licensee protests the proposed civil penalty based on the
following contentions: (1) Violation I was improperly categorized as an
escalated Severity Level III violation; (2) Violation I arose from
unconnected instances of human error, despite NIH's extensive, good
faith efforts to enforce more stringent NRC requirements during a
period of transition to those requirements; and (3) the NRC did not
apply the civil penalty assessment factors to Violation I in accord
with the Enforcement Policy, NUREG-1600. NIH contends that three of the
four civil penalty assessment factors favor no civil penalty because:
(a) NIH has not had any escalated enforcement action against it
during the past two years or past two inspections, whichever is longer;
in over three decades of using radioactive materials in research, NIH
has never before been the subject of escalated enforcement action by
the NRC and NIH's use of radioactive materials has never resulted in
any negative health consequences to workers or the public.
(b) NIH's corrective actions were prompt and comprehensive in the
context of transition to more stringent security standards and the
violations arose from human error that could not have been prevented by
prompt and comprehensive corrective action. NIH contends that the NRC
erroneously relied entirely on the occurrence of additional security
violations instead of focusing on the scope and content of earlier
corrective actions, in denying NIH credit for its corrective actions.
NIH further contends that the violations found by NRC in October 1995
cannot reasonably be considered recurring because, at that time, NIH
had not been informed that the July 1995 inspection finding was
considered a violation, and notification did not occur until the AIT
Report was forwarded to NIH on January 29, 1996. NIH also states that
its July 20, 1995 final security policy was instituted after the July
6, 1995, violation, and thus was prompt and comprehensive corrective
action. NIH argues that the root cause of Violation I is unrelated to
earlier similar violations, and that NUREG-1600 does not indicate that
the determinative factor in assessing the adequacy of corrective action
is whether similar violations occur after corrective action has been
taken. NIH further states that a civil penalty would penalize NIH for
fine-tuning and strengthening its newly-adopted more stringent security
policy, and is not consistent with the purpose of the Corrective Action
factor. According to NIH, that purpose is to encourage licensees to
take immediate action to address violations. Finally, NIH states that
there is no indication that the NRC considered the adequacy of NIH's
root cause analysis. NIH contends that it prevented recurrence of the
security violations because the laboratory involved in the July 6
violation was not the same as the laboratories involved in violations
after July 6.
(c) NRC should exercise its discretion under Section VII.B.6 of the
Enforcement Policy to refrain from imposing a penalty because of the
lack of safety significance of the violation, the overall sustained
excellent performance of NIH prior to the violation, and NIH's
comprehensive good faith corrective actions. NIH states that its
corrective actions were prompt and comprehensive when properly reviewed
in the context of the transition to more stringent security standards,
and that the violations arose from human error and could not have been
prevented by prompt and comprehensive corrective action.
NIH generally contends that contrary to the requirements of due
process, the NRC failed to explain why it accepted or rejected all
evidence and each argument presented by NIH in its May 23, 1996,
response to the AIT Report and Special Team Inspection (STI) Report
before issuing the August 23, 1996, Notice of Violation and Proposed
Imposition of Civil Penalty (Notice), and failed to indicate in any
meaningful way that it considered the May 23, 1996, submission before
issuing the Notice. In support, NIH cites Administrative Law Treatise,
Kenneth C. Davis, Volume II, Sec. 9.5 at p. 48 (3d ed. 1994) and Some
Kind of Hearing, Friendly, 123 U. Pa. L. Rev. 1267 (1975).
V. NRC Evaluation of Licensee's Request for Withdrawal of the Civil
Penalty
The Violation I failure to secure licensed material from
unauthorized removal was properly categorized as a Severity Level III
violation. See Section III, supra. The NRC's letter, dated August 23,
1996, transmitting the civil penalty, states that the base civil
penalty amount of $2,500 was warranted in this case because the
violation was identified by the NRC, and NIH's corrective actions were
not appropriately comprehensive to prevent recurrence after NIH was
made aware of the repetitive July 6, 1995, security violation, and were
not adequate to prevent similar violations from occurring as evidenced
by the results of the October 23, 1995, inspection. As a result, a
penalty of $2,500 was proposed. Violation I arose from NIH's failure to
implement effective corrective action to prevent recurrence of the
previously-cited Severity Level IV security and control failures, and
from the failure to implement effective corrective action to prevent
recurrence of the July 6, 1995, security violation, not from
``unconnected instances of human error.''
The NRC correctly applied the civil penalty assessment factors in
accordance with the Enforcement Policy. NIH misapprehends the basic
provisions of the Enforcement Policy. Because the NRC identified
Violation I and because NIH's corrective actions were inadequate to
prevent recurrence of the violation, even though NIH had not been the
subject of escalated enforcement action during the past two years or
past two inspections, the NRC correctly proposed the base civil penalty
of $2,500. See Enforcement Policy, NUREG-1600, Section VI.B.2.a.-c.
NIH erroneously contends that the occurrence of similar violations
after corrective action has been taken is not a factor in assessing the
adequacy of corrective action. The Enforcement Policy states that one
of the purposes of the corrective action factor is to encourage
licensees to implement lasting action that will ``prevent recurrence of
the violation at issue.'' In this case, the October 23, 1995, violation
is repetitive not only of the July 6, 1995, violation, but also of the
previously-cited Severity Level IV violations. The $2,500 proposed
civil penalty does not penalize NIH for fine-tuning or strengthening
its July 1995 final security policy, but rather is a result of the
Licensee's failure to effectively implement corrective actions to
prevent recurring violations. NIH is mistaken in contending that as
long as the same laboratories are not involved in security violations,
the violations cannot be considered recurring or repetitive. Finally,
NIH is mistaken in arguing that the October 23, 1995, example of the
violation cannot be considered recurring because NIH did not have
notice of the July 6, 1995, example of the violation until January
1996. NIH had notice of the July 6, 1995, example of the violation long
before January 1996. NIH claims, as one of its corrective actions, that
it confiscated the licensed material identified as unsecured by the AIT
on July 6, 1995. Further, the preliminary findings of the AIT
inspection were
[[Page 28903]]
discussed with NIH in a technical briefing held on August 8, 1995.
NIH's argument that the NRC did not indicate that it considered the
adequacy of NIH's root cause analysis does not provide a basis to
disturb the proposed civil penalty. The NRC did not deny credit for
corrective action because of an inadequate root cause analysis, but
because of the failure to implement effective corrective actions to
prevent recurrence of the violations between the time of the repetitive
July 6, 1995, violation and the October 23, 1995, violations. For
example, during the October 1995 STI, NRC inspectors found that the
Licensee's staff lacked a complete understanding of the Licensee's
Enhanced Interim Security Policy (EISP), confirmed by the NRC in
Confirmatory Action Letter 1-95-011 on July 21, 1995. As noted in NRC
Inspection Report No. 030-01786/95-203 (December 21, 1995), Section
3.b:
The degree of understanding of how the EISP was to be
implemented varied among the individuals interviewed. In general,
individuals understood that the EISP called for certain materials to
be locked, but there was not a clear understanding of what
quantities were to be locked and when. A common understanding was
that laboratories were to be locked at night when unattended * * *
However, individuals interviewed stated that laboratory locking was
not required if an individual's absence was of short duration for a
break or while the researcher was working in a nearby laboratory * *
* Many researchers stated that they thought it was acceptable to
leave laboratories open under these circumstances.
In addition, at the time of the October 1995 STI, NIH was not
conducting security audits during lunch periods and after normal
working hours, which are times when non-compliance logically may be
expected to occur. Additional procedures to address these shortcomings
had to be confirmed in Confirmatory Action Letter 1-95-018, issued by
the NRC staff on October 23, 1995. Under these circumstances, the NRC
staff cannot conclude that NIH implemented effective corrective action.
NIH fails to demonstrate a basis for the NRC to exercise discretion
to refrain from imposing a civil penalty. As explained in Section III,
supra, Violation I is a significant regulatory concern. Additionally,
the Licensee's corrective actions were not sufficiently comprehensive
to prevent recurrence until after the recurring violations were
identified by the STI on October 23, 1995, and the NRC staff took
additional measures by issuing Confirmatory Action Letter 1-95-018 on
October 27, 1995. Comprehensive corrective action is a necessary
element in considering the exercise of discretion.
NIH erroneously contends that due process requirements were
violated because the NRC did not explain why it accepted or rejected
the evidence and arguments presented by NIH in its May 23, 1996,
response to the AIT Report and SIT Inspection Report before issuing the
August 23, 1996, Notice of Violation and Proposed Imposition of Civil
Penalty. In essence, NIH argues that before even proposing a civil
penalty, the NRC must issue the equivalent of an initial decision
weighing all evidence and argument presented at a ``hearing.'' The
Licensee's argument rests upon a fundamental misapprehension of the
procedural steps in NRC's enforcement process and the nature of a
Notice of Violation and Proposed Imposition of Civil Penalty. The
authority cited by NIH does not mandate a ``hearing'' meeting the basic
requirements of due process before an agency may merely propose a civil
penalty.
The August 23, 1996, Notice merely proposes a civil penalty. In
accordance with the Enforcement Policy, NIH was offered, by letter
dated January 29, 1996, from Charles W. Hehl, Director, Division of
Nuclear Materials Safety, U.S. NRC Region I, the opportunity to attend
a predecisional enforcement conference, the very purpose of which is to
provide an opportunity for the licensee to present information
concerning the facts associated with the apparent violations,
corrective action taken or planned, and the significance of the
apparent violations. NIH, however, by letter dated April 16, 1996, from
Harriet S. Rabb, General Counsel, Department of Health and Human
Services, declined this opportunity. Instead, NIH contested the NRC's
identification of apparent violations and their significance by
responding in writing to NRC inspection reports on May 23, 1996. That
submission was considered by the NRC staff before issuance of the
August 23, 1996, Notice of Violation and Proposed Imposition of Civil
Penalty. Additionally, NIH responded to the August 23, 1996, Notice by
its September 23, 1996, written submission, the factual and legal
arguments of which have been considered and evaluated herein. Finally,
under the Commission's regulations, NIH may request a hearing to
contest this Order Imposing Civil Monetary Penalty. NIH has been
provided all the process that is due at this stage of the proceeding.
VI. NRC Conclusion
The NRC staff concludes that the Licensee did not provide an
adequate basis for mitigating either the Severity Level of Violation I
or the civil penalty for Violation I. Accordingly, an order imposing a
civil penalty in the amount of $2,500 should be issued.
Evaluation of Violations Not Assessed a Civil Penalty
Of the violations not assessed a civil penalty, the Licensee admits
Violation II.A in part; admits Violation II.B; denies the first and
second examples of Violation II.A; denies Violations II.C and II.D; and
disputes the severity level assigned to Violations II.A and II.B and
the first example of Violation II.C.
Restatement of Violation II.A
Condition 29 of License No. 19-00296-10 requires, in part, that the
licensee conduct its program in accordance with the statements,
representations, and procedures contained in the application dated July
28, 1986.
Attachment 10-D of the July 28, 1986, application, requires, in
part, that an extremity monitor be worn when using greater than 0.5
millicuries of phosphorus-32 (P-32), and that film badges and ring
badges be returned promptly each month.
Contrary to the above, during 1995:
1. The licensee did not supply extremity dosimetry to eight
individuals who worked with greater than 0.5 millicuries of P-32; and
2. Five individuals did not wear the extremity dosimetry that was
issued to them while working with greater than 0.5 millicuries of P-32;
and
3. Numerous individuals failed to return the monitoring devices
(film badges and ring badges) monthly.
Summary of Licensee's Response to Violation II.A
NIH disputes that this violation should be classified at Severity
Level IV, and also denies Examples 1 and 2 of the violation. In
support, NIH references its May 23, 1996, submission (``Specific
Responses of NIH to the Apparent Violations Found in Inspection Reports
030-01786/95-002 (REDACTED) and 030-01786/950203'' at pages 29-33).
NIH states that records of the NIH Radiation Safety Branch (RSB) do
not support Examples 1 and 2 of the violation. NIH contends that a RSB
investigation found that all 13 users had been issued badges, that all
but one researcher was wearing the dosimetry, and that researcher was
not required to wear dosimetry because of the small amount of P-32 (
0.047 microcuries) he was using.
Additionally, NIH states that Example 3 of the violation is not of
sufficient significance to warrant the Severity
[[Page 28904]]
Level IV classification, particularly given that persons using P-32 at
NIH are not required to wear dosimetry, the RSB identified the failure
to return badges, and no measurable exposures were detected.
NIH further contends that Violation II.A. is of minor safety or
environmental concern and should be treated as a Non-Cited Violation
and not formalized into a Notice of Violation based on the Special Team
Inspection (STI) Report and NRC Information Notice No. 90-01. NIH
states that the STI Report concluded that the NIH dosimetry program was
in compliance with 10 CFR Part 20, Subpart C, and was effective in
monitoring occupational external doses. NIH notes that NRC Information
Notice No. 90-01 (January 12, 1990) states: ``NRC will not generally
issue a Notice of Violation for a non-repetitive Severity Level IV or V
violation that is self-identified, properly corrected and reported (if
required).'' NIH states that corrective action for this self-identified
violation had been completed at the time of the NRC Special Team
Inspection and will prevent further violations, and that there was no
continuing violation.
NRC Evaluation of Licensee's Response to Violation II.A
NIH failed to support its denial of Examples 1 and 2 of Violation
II.A. with the documentation which NIH claims disprove those
violations. Accordingly, the NRC staff concludes that the violation
occurred as stated in the Notice. Additionally, NIH asserts that
persons using P-32 at NIH are not required to use dosimetry, but does
not dispute that Condition 29 of the License and Attachment 10-D of the
July 28, 1996, application require extremity dosimetry to be worn by
individuals using more than 0.5 millicuries of P-32.
NRC chose to treat Violation II.A. as a cited violation in order to
highlight interrelated concerns over failures to supply, wear, and
return dosimetry, particularly as related to the use of P-32. Under the
Enforcement Policy, NRC may refrain from citing a violation under
certain circumstances, but is not compelled to do so. See NUREG-1600,
Section VII.B.
NIH mischaracterizes the STI Report, NRC Inspection Report No. 030-
01786/95-203 (December 20, 1996) by implying that the Special
Inspection Team found perfect compliance with NRC requirements. To the
contrary, the STI Report concluded that ``one apparent violation was
identified involving the failure to issue, wear and return individual
monitoring devices [Violation II.A. herein]. Otherwise, the licensee's
external dosimetry program was in compliance with Subpart C of 10 CFR
Part 20, and was effective in monitoring occupational external dose.''
The Licensee's failure to meet its commitments, formalized by
license condition, regarding extremity dosimetry for individuals who
work with greater than 0.5 millicuries of P-32 does involve potential
safety significance and therefore is appropriately classified as a
Severity Level IV violation.
Restatement of Violation II.B
Condition 29 of License No. 19-00296-10 requires, in part, that the
licensee conduct its program in accordance with the statements,
representations, and procedures contained in the application dated July
28, 1986.
Item 10.6 of the July 28, 1986, application requires, in part, that
the Authorized User provide to the Radiation Safety organization a
completed Form NIH 88-1, ``Request for Purchase and Use of Radioactive
Materials'', for each incoming shipment before the materials will be
released to the investigator. Form NIH 88-1 was provided as Attachment
10-F to the July 28, 1986, application. Form NIH 88-1 requires, in
part, that the radiation safety identification number and names of all
persons who will use the radioactive material, the name of the
authorized investigator, and the signature of the authorized
investigator, be entered on the form.
Contrary to the above:
Users did not provide the Radiation Safety organization with a
completed Form NIH 88-1 for each incoming shipment before the materials
were released to the investigator. Specifically, between October 3 and
November 20, 1995, the licensee allowed users to request the purchase
of radioactive materials electronically without the signature of the
authorized investigator.
An NIH 88-1 form, submitted for purchase and use of radioactive
materials received on September 9, 1994, did not include the radiation
safety identification number and names of all persons who were intended
to use the radioactive material. Specifically, the NIH 88-1 form listed
as the only user an individual who had left NIH.
Summary of Licensee's Response to Violation II.B
NIH disputes that Violation II.B. is a Severity Level IV violation.
In support, NIH references its May 23, 1996 submission (``Specific
Responses of NIH to the Apparent Violations Found in Inspection Reports
030-01786/95-002 (REACTED) and 030-01786/950203'' at pages 8-10 and 26-
28, or ``May 23, 1996, submission''). NIH asserts that the two examples
of Violation II.B. individually and collectively posed only minor
safety or environmental concerns below the significance for Severity
Level IV violations, and thus should not have been formalized in a
Notice of Violation. NIH states that full compliance was achieved
through its corrective actions.
In regard to the first example, NIH states that its electronic
system for ordering radioactive materials collects the same data as did
the Form 88-1, but in electronic form without a signature of an
authorized user, and that the failure to provide a signature of the
ordering authorized user was a technical violation resulting from
implementation of the electronic system one month before NRC approval
of the license amendment permitting use of the electronic system. NIH
argues that since the NIH license amendment adopting the electronic
system was approved one week after submission, the violation is not of
more than minor significance and cannot be a Severity Level IV
violation. NIH asserts in its August 23, 1996, response that by
approving a license amendment which permitted continuation of the same
practice for which NIH is being cited, the lack of the authorized
users' signatures cannot raise a significant regulatory concern. NIH
states that no apparent unauthorized use of radioactive materials or
unnecessary exposure to radiation resulted.
In regard to the second example, NIH states in its May 23, 1996,
submission that there is no NRC regulation requiring the use of NIH
Form 88-1 or for collection of the information contained therein. NIH
further states that Form 88-1 is an internal mechanism used to verify
that users of materials have proper training and dosimetry, and that
the single inadvertent failure to list the proper user on Form 88-1 is
a technical violation that did not result in use of materials by
untrained users.
NRC Evaluation of Licensee's Response to Violation II.B
With respect to the first example of the violation, the NRC
acknowledges that a license amendment was approved that authorized an
electronic method of ordering licensed radioactive material without the
signature of an authorized user. However, the NRC approved this
amendment only after receiving specific commitments from NIH that the
electronic process would provide the same level of control of licensed
material that Form 88-1 did, such that materials would be released and
used
[[Page 28905]]
only by qualified or authorized individuals. For a licensee to take it
upon itself to decide that it may proceed in violation of a license
condition without a safety review by the NRC licensing authority is of
more than minor regulatory concern in and of itself.
With regard to the second example of Violation II.B, the Licensee's
procedures for ordering licensed radioactive material are not a mere
internal mechanism. Those procedures are incorporated into the NIH
license by license condition, and as a result, constitute regulatory
requirements. Violation II.B is of more than minor regulatory concern
because individuals who have not been trained, and therefore, not
authorized, could have obtained licensed material, which could have
resulted in improper use or disposal of the material.
Restatement of Violation II.C
Condition 29 of License No. 19-00296-10 requires, in part, that the
licensee conduct its program in accordance with the statements,
representations, and procedures contained in the application dated July
28, 1986.
Item 10.3 of the July 28, 1986, application states that all
radioactive material users are required to successfully complete an
initial training course entitled, ``Radiation Safety in the
Laboratory''.
Contrary to the above:
1. One or two researchers working in Laboratory 5D18 of Building 37
did not successfully complete the initial training course entitled,
``Radiation Safety in the Laboratory'' prior to their use of
radioactive material. Specifically, during the month of October 1994,
the researcher(s) used sulfur-35, phosphorous-32 and phosphorous-33,
but did not receive ``Radiation Safety in the Laboratory'' training
until November 29, 1994.
2. During the months of October and November 1995, an individual
worked with microcurie quantities of C-14 in a Building 10 clinical
pathology laboratory, and as of November 10, 1995, this individual had
not completed the ``Radiation Safety in the Laboratory'' training.
Summary of Licensee's Response to Violation II.C
NIH denies the first and second examples of Violation II.C. In
support, NIH references its May 23, 1996, submission (``Specific
Responses of NIH to the Apparent Violations Found in Inspection Reports
030-01786/95-002 (REACTED) and 030-01786/950203'') at pages 11-13 and
38-41.
In regard to Example 1 of Violation II.C., NIH contends that the
Notice does not accurately state the violation, and states that to the
extent there was any violation, it was a technical violation of failing
to certify the provision of orientation training in accordance with its
license, which was a technical violation that did not amount to a
Severity Level IV violation. NIH asserts that no NRC regulation or NIH
license condition requires researchers to complete the formal Radiation
Safety in the Laboratory training prior to their use of radioactive
materials, and that the AIT Report recognized at pages 21-22 that the
NIH license permits the use of radioactive materials by individuals
under the supervision of an Authorized User (AU) before receipt of
formalized training as long as the AU certifies to training described
in the ``Radiation Safety Orientation for New Personnel Planning to Use
Radioactive Material'' packet. On March 23, 1994, the NRC approved a
license amendment to modify the NIH Radiation Safety Training Program,
such that individuals working with radioactive materials must receive
the ``Initial Orientation; Entry Level or Advanced `Radiation Safety in
the Laboratory course.' '' Accordingly, NIH concludes that the
violation was a failure by the AU to certify such orientation training,
which is of minor regulatory concern and not appropriate for formal
enforcement action.
In regard to Example 2 of Violation II.B, NIH states that the
individual involved was working with BacTec vials containing 10
microcuries of carbon-14, which under 10 CFR 31.11(a)(3) was subject to
a general license and thus not subject to the training requirements
applicable to materials subject to a specific license, because 10 CFR
31.11(f) excludes such generally licensed materials from the
requirements of 10 CFR Parts 19 and 20. NIH contends that neither NIH
license conditions nor NRC regulations required training of this
individual.
NRC Evaluation of Licensee's Response to Violation II.C
With respect to the first example of Violation II.C, the NRC
concludes that the violation occurred as stated. Condition 29 of NIH's
license and Item 10.3 of the July 28, 1986 application require that all
radioactive material users successfully complete an initial training
course entitled ``Radiation Safety in the Laboratory''. Contrary to
NIH's assertions, the license amendment issued on November 23, 1994,
did not permit individuals to begin using radioactive materials prior
to taking the ``Radiation Safety in the Laboratory'' if they had
received orientation training. The language of the license amendment
and of the February 14, 1994 amendment request refer to the orientation
training as part of the NIH training program, not as an alternative to
the required ``Radiation Safety in the Laboratory'' course. Condition
29 of the NIH license, which incorporates Item 10.3 of the July 28,
1986, application, was not modified by the license amendment issued on
November 23, 1994. The AIT Report mistakenly stated that the NIH
license permits the use of radioactive materials by individuals under
the supervision of an Authorized User (AU) before receipt of formalized
training, as long as the AU certifies to provision of orientation
training.
With respect to the second example of Violation II.C, the NRC
agrees that NIH is not required by license condition to provide
training to individuals who use BacTec vials that were obtained under
the provisions of a general license issued pursuant to NRC regulations.
Therefore, the NRC is hereby withdrawing this example of the violation.
Restatement of Violation II.D
Condition 29 of License No. 19-00296-10 requires, in part, that the
licensee conduct its program in accordance with the statements,
representations, and procedures contained in the application dated July
28, 1986.
Item 10.9.2 of the July 28, 1986, application requires that the
licensee conduct its bioassay program in accordance with Regulatory
Guide 8.20, ``Applications of Bioassay for Iodine-125 and Iodine-131''.
Section C.1.a. of Regulatory Guide 8.20 states that routine bioassay is
necessary when, over any 3 month period, an individual handles in open
form unsealed quantities of radioactive iodine exceeding those in Table
1. Table 1 of Regulatory Guide 8.20 states that bioassay is necessary
for activity levels greater than 10 mCi of iodine-125 used in processes
within a fume hood.
Contrary to the above, the licensee failed on two occasions to
conduct bioassay measurements after workers handled greater than 10 mCi
of volatile iodine-125 in an open unsealed form in gloveless
containment boxes located in a fume hood. Specifically, as of November
10, 1995, two researchers had not received a thyroid bioassay
measurement after handling 17 mCi and 15 mCi of volatile iodine-125 on
June 21 and September 18, 1995, respectively.
[[Page 28906]]
Summary of Licensee's Response to Violation II.D
NIH denies Violation II.D. In support, NIH references its May 23,
1996, submission (``Specific Responses of NIH to the Apparent
Violations Found in Inspection Reports 030-01786/95-002 (REDACTED) and
030-01786/950203'') at pages 34-37.
NIH argues that Section C.4.c. of Regulatory Guide 8.20,
``Applications of Bioassay for 1-125 and 1-131'' (September 1979), does
not require when, but only makes recommendations as to when, quarterly
bioassay measurements are to be taken, because of the use of the word
``should'' rather than ``shall'': ``For individuals placed on a
quarterly bioassay schedule, the sampling should be randomly
distributed over the quarter, but should be done within one week after
a procedure involving the handling of
I-125 or I-131. This will provide a more representative assessment of
exposure conditions.'' NIH claims that both researchers were bioassayed
within the calendar quarters in which they handled iodine-125, and that
the fact that both researchers did additional iodination work within
the quarter is irrelevant because there is no requirement that there be
a bioassay after the additional iodination work. NIH states that a
bioassay at one week post-iodination is unnecessary, based upon the
detection capabilities of the NIH thyroid analysis system and because
air monitoring is performed for each and every iodination. NIH further
states that in the case of the two researchers, the actual airborne
concentrations were so low that follow-up bioassays were not necessary
to assess possible internal dose.
NIH further argues that 10 CFR 20.1204 requires that for purposes
of determining compliance with occupational dose limits, the licensee
shall make suitable and timely measurements of either concentrations of
radioactive material in air in work areas, or quantities of
radionuclides in the body, or quantities of radionuclides excreted from
the body, or a combination of these measurements, and thus the air
sampling conducted was sufficient to satisfy 10 CFR 20.1204.
NRC Evaluation of Licensee's Response to Violation II.D
NIH does not dispute that License Condition 29 and Reg. Guide 8.21
require bioassay of individuals working with the quantities of I-125
involved. Regarding NIH's explanation that both researchers were
bioassayed within the calendar quarters in which they handled iodine-
125, Section C.4.b of Reg. Guide 8.21 does allow quarterly bioassays if
initial bioassays are performed within 72 hours after use of iodine for
the first three month period and provided that the use falls within
certain quantities specified in the Guide. After the initial three
month period, the Guide allows the Licensee to change the frequency to
quarterly provided that other conditions specified in the Guide are
met. NIH did not submit documentation to the NRC to show that all of
the conditions necessary to move to a quarterly bioassay frequency were
met. Even if the Licensee had met the conditions for a quarterly
bioassay schedule, Section C.4.c. of Reg. Guide 8.21 provides that for
individuals placed on a quarterly schedule, bioassay samples should be
done within one week after a procedure involving the handling of I-125
or I-131 in order to provide a more representative assessment of
exposure conditions. NIH has not provided the dates on which the
workers were bioassayed to demonstrate that they were in fact conducted
during the quarter or within one week after handling I-125.
NIH's argument that no violation occurred because of the detection
capabilities of the NIH thyroid analysis system and because air
monitoring is performed for each and every iodination is incorrect.
Reg. Guide 8.21, which the Licensee agreed to follow, does not carve
out an exception to the necessity of performance of bioassays for
licensees, depending upon the quality of their thyroid analysis system
or air sampling program. NIH's air sampling program does not support
NIH's denial of the violation. NIH conducts its air sampling program to
ensure compliance with 10 CFR 20.1204. The air sampling program does
not address the requirements of License Condition 29 and Reg. Guide
8.21, which are concerned solely with criteria for conducting bioassays
of individuals working with I-125 and I-131.
Accordingly, the NRC staff concludes that Violation II.D. occurred
as stated.
[FR Doc. 97-13865 Filed 5-27-97; 8:45 am]
BILLING CODE 7590-01-U