[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