ML20126E122

Forwards Region I Comments on Sections of Draft Enforcement Guidance Memo Re Identification & Past Performance Escalation & Mitigation Factors

ML20126E122
Person / Time
Issue date:	04/25/1990
From:	Martin T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	Lieberman J NRC OFFICE OF ENFORCEMENT (OE)
Shared Package
ML20126E011	List: ML20126E122
References
FOIA-92-67 NUDOCS 9212290014
Download: ML20126E122 (13)

Text

,..,

3 a

' 41 -

y/

. UNITED STATES

'S' NUCLEAR REGULATORY COMMISSION

-D 0

MEOlON'l

. yo 476 ALLENDALE ROAD KING OF PRUSSIA. PENNSYLVANIA 19404 April 25,1990 MEMORANDUM FOR: James Lieberman, Director, Office-of-Enforcement FROM:-

Thomas T. Martin, Regional Administrator, Region I

SUBJECT:

REGION I COMMENTS ON SECTIONS OF THE DRAFT ENFORCEMENT GUIDANCE MEMORANDUM CONCERNING THE IDENTIFICATION AND PAST PERFORMANCE ESCALATION AND MITIGATION FACTORS Enclosed are specific Region I comments on the. subject draf t EGM sent to us with your memorandum dated March 27, 1990. My primary concern with the draft guidance is that it creates. a policy whereby if_ the NRC identifies a' number of-Severity Level IV and V violations, and concludes that the number and nature -

of the violations represent a management breakdown,. then that single conclusion will result in 1.

the violations-being classified in the aggregate at-a higher Severity Level, namely, level III; 2.

the resultant penalty being escalated because the NRC identified-the violations (another: symptom of the management. breakdown)'; and 3.

a prohibition on mitigation of-the resultant penalty, r_egardless =

of whether_ the licensee's past performance, prior to.and during the previous inspections, was good or mediocre.

l-l' Sucn an approach, in my opinion, does not demonstrate a " firm but fair" policy.

on enforcement.

In fact, the licensee with the mediocre past (as measured by-the prior NRC inspections) will-be treated the same as the licensee with the good past.

If you have any questions on these comments, pleasefcontact me or D. Holody f_.

of my staff,

-m

_ Thomas T. Martin p

l.-

Regional Administrator

Enclosure:

As stated 9212290014 920619 PDR FOIA MALPHURS92-67.- PDR G /r

James Lieberman 2-cc w/ enc 1:

. Regional Administrators-RII. Rill, RIV,.RV J. Partlow, NRR J. Goldberg, OGC Enforcement Directors, RII-RIII Enforcement Officers, RIV-V b

j.

l l -:.

3 ENCLOSURE 1-COMMENTS ON DRAFT EGM ON IDENTIFICATION AND PAST PERFORMANCE COMMENT 1 (

Reference:

Page 1, Paragraph 1, Concerning Changes to Existing Enforcement Guidance)-

It appears that the only existing NRC guidance for applying the two referenced escalation / mitigation factors is the specific guidance set forth in the enforcement policy (10 CFR 2, Appendix C).

If this guidance needs to be revised (or clarified), then-it would appear to constitute policy changes, and therefore, require Commission consultation prior to revision.

COMMENT 2 (

Reference:

Page-1, Paragraph 2, Concerning Escalation of Civil Penalties for an Aggregate Severity Level III Problem (based on NRC Identification)

The concept of a " management breakdown in the control" of.a licensee's program seems rooted in the premise that a licensee's management has become ineffective, as evidenced by_the fact that (1) a significant number of. violations occurred, and (2) the licensee did not identify these violations, which were otherwise identifiable. Clearly, the NRC expects licensees to detect and correct problems in their own programs; the failure to do so is generally the staff's primary consideration -in concluding that a management breakdown has occurred.

Furthermore, the reason for a licensee's failure to recognize a breakdown in management control is generally due to the breakdown itself (i.e., management and supervisinn have not adequately monitored their staf f's performance to ensure tasks are performed, as required).

Therefora; once the NRC has decided to classify a numberlof NRC-identified Severity Level IV and/or V violations in the aggregate at Severity Level III based on the premise of a management breakdown, as frequently happens in the materials area, it would appear to constitute a " double bang" if the NRC also escalates the civil penalty.for

' essentially the same reason.

Every " bang" (be it a _ higher Severity Level classification or application of?an escalation factor) should send a distinct message which can be clearly articulated in the letter to the. licensee.

Since-a " double bang" serves no useful purpose other than to send the'same message twice, we recommend that civil penalties in such cases not be escalated because the NRC identified the violations.

COMMENT 3 (

Reference:

Page 1, Paragraph 3, Concerning the Prohibition on Mitigation of a Civil Penalty-for Good Past Performance When the Violations Represent a Management Breakdown)

If.the licensee has demonstrated, during prior inspections, that it has established and maintained a good licensed program, that factor should be considered when determining enforcement action for any violations identified during the most recent inspection (just as that past performance would be considered if the prior inspections demonstrated that the licensee's program T

m

4 2

was poor or mediocre). Otherwise, although penalties will be escalated for licensees with prior poor histories, there will be no distinction between the licensee who demonstrated a " good past" (as measured by the NRC inspections) and the licensee who demonstrated a " mediocre past."

COMMENT 4 -(

Reference:

Page 2, Paragraphs 1, 2, and 3, Concerning Prohibition of Mitigation of Civil Penalties for Good Past Performance when the Violations are Willful)

Although the enforcement policy does state that a civil penalty is "normally" assessed for any willful violation at any severity level, the policy-also states that civil penalties are "normally" issued for Severity Level I, II and III violations.

In these latter cases, the NRC still applies the escalation and mitigation f actors in determining whether to assess a civil penalty, and in some cases, no penalty is assessed.

Clarification should be sought from the Commission to determine whether the reference to "normally issuing a civil penalty for willful violations" is meant to exclude any consideration of mitigating factors when willful violations ( e involved, or whether it should be interpreted to mean that a civil penalty is normally issued for willful violations " absent any mitigating factors." If the proper interpretation is the former, it would be inconsistent with the following cases in which mitigating factors, including past good performance, were considered-in not issuing a civil penalty-for willful violations:

EA 90-005 Saint Mary's Hospital

+

EA 90-007 Humana Hospital Greenbrior Valley EA 88-285 Cooper EA 88-216 South Texas

+

As an additional consideration, the NRC should-encourage, to the maximum extent possible, licensee identification, investigation, correction, and reporting of all issues, including willful violations.

If the NRC precludes the consideration of any mitigating factors simply because a violation was willful, that fact may undermine the-licensee's incentive to root out and correct such problems-at the various levels within its organization.

With respect to SECY 88-19 (Milford Hospital), the related Commission paper states that further escalation of the civil penalty in that case was inappro-priate in consideration of the licensee's past good performance. Although that Commission paper does not describe whether any consideration was given to mitigating the penalty based on the licensee's past good performance, mitigation was not warranted since the RSO had been f alsifying the Radiation Safety Committee meeting minutes for several years, and therefore, the facts of that particular case did not warrant mitigation.

In its response, dated February 29, 1988, concerning the Milford Hospital case, the Commission did state that all violations of a similar nature [to the Milford case] should receive sanctions to the maximum extent possible.

However, the Commission's response did not state, nor, in our opinion, did it imply that a willful violation may not be mitigated based on the licensee's good past performance.

a

l 3

Furthermore, since willful violations, by their nature, tend to be isolated to a specific incident or program area, and specific individuals, it would appear to be inconsistent with the intent of the enforcement policy to focus only on the specific willful violation and not consider the licensee's overall and past performance in determining an appropriate enforcement action.

The Statements of Consideration for the revision to policy in October 1988 reflects an intent to permit greater consideration of overall licensee performance in assessing past performance. We agree that when considering good past performance for any sillful violation, a f actor in the assessment should be whether the past good performance is in some way attributable to previously undiscovered willful violations (such as falsification of records), as was the case at Milford Hospital. However, when the violations occurred subsequent to previcus inspections which had demonstrated good performance, that prior good perferrance (as measured by the NRC inspections) should be considered in determining wnetner a civil penalty should be issued, or in determining the amount of the penalty.

..a.

2.'d.

O,,

UNITED STATES f

j.

NUCLEAR REGULATORY COMMISSION -

REQlON 1

['

476 ALLENDALE ROAD KING OF PMUSSIA, PENNSYLVANIA 19404 MEMORANDUM FOR:

William T.. Russell,. Regional _ Administrator, Region I--

Stewart 0~. Ebneter, Regional Administrator,-Region II A. Bert Davis, Regional Administrator, Region ~III Robert 0.-Martin,. Regional Administrator, Region IV Jack 8. Martin, Regional Administrator, Region V Dennis M. Crutchfield, Associate Director for Special Projects, NRR FROM:

James Lieberman, Director Office Of Enforcement

SUBJECT:

ORAFT ENFORCEMENT GUIDANCE MEMORANDUM (EGM) ON-IDENTIFICATION AND PAST PERFORMANCE ESCALATION AND MITIGATION FACTORS Please review the enclosed draf t EGM and provide comments by April 11,1990.

Please plan on having your regional enforcement staff discuss their personal views at the counterpart meeting.

James Lieberman, Director -

Office of-Enforcement cc:

H. Thompson, DEDS J. Partlow, NRR

.R.

Cunningham, NMSS J. Goldberg, OGC i

l:

I

I-f l

k

~

ORAFT' EGM 90-:

MEMORANDUM-FOR:

Thomas T. Martin, Regional: Administrator,--Region I-Stewart D. Ebneter, Regional Administrator,-Region II.

A.,Bert Davis, Regional Administrator, Region III-Robert D. Martin, Regional Administrator, Region:IV Jack B. Martin, Regional - Administrator,: Region V Dennis M. Crutchfield, As_sociate'Oirector for Special:

Projects,NRR FROM:

James Lieberman, Director Office Of Enforcement

SUBJECT:

ESCALATION AND MITIGATION FOR IDENTIFICATION AND PAST PERFORMANCE FACTORS

. As a_ result of several recent cases that have been reviewed by the OE staff, C# "~

d

.it appears that the existing guidance on applying the escalation and mitigation _.

factors for past performance and identification and reporting needs-to be J'

revised.

I propose we adopt the following guidance:

The previous position of not~ escalating a civil penalty for NRC. identification _- ~

when a' num::er of Severity Level IV and V violations are considered collectively

~ be --

to represent a breakdown in the control of the program and are' classified as a g

Severity Level III problem is being rescinded. The rational-for this change is that we expect licensees to detect and recognize breakdowns in-the control of their programs.

Our philosophy has been and continues to be that if the'NRC~can perform inspections on an audit basis and determine that a breakdown of signifi-cant regulatory concern has occurred, licensees should befable to_ reach the same conclusic.t Therefore, a civil _ penalty for breakdowns in the control of a program may oe escalated for NRC identification even though NRC identification may have beet a consideration in categorizing the individual Severity Level IV

. violations as an aggregate Severity Level III.

The mitigation of. civil penalties for good past performance has come in to question for cases involving breakdowns in control-over licensed activities or'

~

willful violations.

For those cases that involve breakdowns in the' control of licensed activities, past performance has been permitted as t a mitigation factor

%w under the present guidance. This has been reconsidered. ' This factor is-f intended to permit relatively isolated failures to be offset by good past performance. The issue that should be considered is-whether the' violation-at issue is reflective of overall. performance considering present _ and past-activi--

ti e s.- When there is a significant breakdown in control resulting in-extensive violations, the violations are not isolated, but are reflective of overall' performance.

In those' cases good past performance should not offset-current unacceptable performance caused by management failures to take charge of their licensed activities. Therefore, if NRC identifies a significant breakdown in '

the control of licensed activities, the fact that in the past, management was effectively controlling or overseeing the program should not be_ a mitigating

' factor.

It is still appropriate to consider escalation for_ poor past

/

performance.

s 6

Multiple Addressees DRAFT m

For cases involving willful violations, OE has reviewed the case history for the past three years and found that for various reasons we have generally not mitigated the base civil penalty for good past performance. The Enforcement Policy in Section V.B states that, " Civil penalties will normally be assessed for knowing and conscious violations of the reporting requirements of Section 206 of the Energy Reorganization Act, and for any willful violation of any Commission requirement including those at any severity level.

In addition, in SECY-88-19 (EA 87-189, Milford Hospital) the staff gave no mitigation to the I

licensee for its recognized good past performance because it was inappropriate.

The Commission in response to SECY-88-19 stated that the actions taken in this h ~a case should be a guide for the future, and all violations of a similar nature should receive sanctions to the maximum extent permitted by the Commission's regulations.

The Statements of Consideration for the October 13, 1988, changes in the Enforcement Policy states that for past performance "

, this factor has been cnanged to provide more flexibility in considering past performance in the assessment process. Currently past performance focuses on prior performance in the area of concern though overall performance can be considered. The effect of deleting the reference to general area of concern is to permit greater consiceration of overall performance.

With the change, both overall performance and performance in the area of concern may be considered."

In light of ti.e above, OE has reconsidered past performance for willful violations.

Since willful violations raise the issue of integrity anc integri y t

goes to the heart of the regulatory process, willful violations are never acceotable. Therefore, it is not appropriate to mitigate civil penalties for gooc past performance when a willful violation is involved. Whether the base civil penalty should be mitigated based on the cast performance factor will be nanclec on a case-cy-case basis.

/

While we are applying the above guidance on a case-by-case basis, please provide comments, if any, to OE within 30 days.

James Lieberman, Director Office Of Enforcement cc:

H. Thomoson, OEDS J. Partlow, NRR R. Cunningham, NMSS J. Golcberg, OGC l

I b!?W

1 i NRC

' u aw., # 0 m 218

< ws U.s. kuct,taa as cuLAfone c wue!4 CATE

.uS

///z c/1, TELEPHONE OR VERBAL CONVERSATION RECORD

/g #

(,

O O INCOMING CALL UTGOING CALL O visit I(

PE ASON CA LLING OF FICE/ADDptSS.

PHONE NUMSER EXTEN53ON 1

PE RSON CALLAD OFFicF./ADMESS PHONE NUMSER EXTEN$l0N 4

& PGs I, CoS L/k ALG J1 R~s R3

• 92//

CONVERSAil6N SUSA CT MSOA.dNn SUMMAR Y l{g j h P( pa k % d M [4bd b M' O be L o rr d/r>

$% d W lo t s-he d Ln slany Sn m. l en medallc ret ~

N 4+lb 4.4J

-Fb+

l< &

wl, / &c 4+ %.h e

l' N

4. M -/.,. L u[4s -fla d agetf A wA*$4 j

Nd d<

N.

% s - )}s., -l

-lc 3.}n.'. ),),.. n.f &

s.

pu y REFER. RED TO:

C ADVISE ME OF ACTION R EQUESTED ACTION TAKEN.

INITIALS s/ E DATE

.\\

l//2 r 9o 1 ACTION TAKEN INITIALS '

t cATE G/R.-

WCC F OAM 213 14 76)

... ~, _..,

DEPARTMENT OF Memorandum VETERANS AFFAIRS November 26, 1990 w

Acting Radiation Safety officer (115) r.

Unscheduled NRC Inspection - 11/20/90 w

ACOS, Research and Development (15!)

w 20-21, 1990. The As you know, we were inspected by the NRC on November I

1.following is a list of items which were found to bc in non-compliance in Research Servicet Evidence of food and beverage consumption in several of the labs was found.

A.

Some personnel were not wearing film badges.

B.

Room 627B has been modified to a storage t rea and gacuna counting room C.

A microwave oven prior notification of the Radiation Safety Officer.

without was also noted 1.1 this area.

Inventory sheets posted on refrigerator doors are not up to date.

D.

Some researchers have not been surveying their hands before leaving E.

'the radiation work areas.

There is a discrepancy of sewer disposal records for 1988. Figures F.

(Suggestion reported by Research Service do not agree with those of RSO.

a log sheet posted in front of sewer drain was made by inspector that would provide an instant record).

All principal investigators are responsible to take corrective actions 2.

te the Radiation Safety Of ficer.

icunediately and report Your assistance in correcting these deficiencies is appreciated. As you 3.

the cooperation of all personnel is necessary to create a safe work

know, environment.

Please contact me if you have any questions.

l f?Jfin-

. A. FANG, M.D.

1

--.-__m.

Veterans h Administration Memorandum 0"

November 28, 1990 Min-Fu Tsan, M.D., Ph.D, Chief, ACOS/R&D Result of Nuclear Regulatory Commission Inspection 5""

of November 20, 1990 10 All Princ! pal Investigators 1.

The Research Service was inspected by the Nuclear Regulatory Commission on November 20 and 21, 1990.

We have been cited for e number of deficiencies as indicated in the attached memo from the Acting Radiation Safety officer, dated November 26, 1990.

It in nandatory that you take corrective actions immediately and report to the Radiation Safety Officer no later than December 10, 1990.

2.

I strongly urge you and your staff to strictly adhere to the Radiation Safety guidelines for the safety of your employees and your privilege to continue to use radioactive tracers in research.

3.

Please let me know if you have any questions.

Thank you for your cooperation.

51

• f Min-Fu

'n, M.D., Ph.D.

e ACOS/R&D

Attachment:

Ltr Dated 11/26/90 i

4 DEPARTNIENT OF Memorandum VETERANS AFFAIRS om December 5, 1990 From:

S-Charles A. Hall and Richard C.

Chu Suu

.nspection (11/20/90) to S.A.

Kang, M.D.,

Chief Nuclear Medicine

1. Necessaty corrective actions will be taken pertaining to our laboratory as you have indicated in yourmemo, 11/26/90.

2. Radiatien safety guidelines will be strictly followed to ensure safety of our workers and others.

b!IbY YQ (.C

p x1; narc..

.nu,rn.u.

unar;.es n.

naat,

...v.

ii-t l.

I

4 K Veterans

. N Administration Memorandum December 3, 1990 oci.

s,.m Chief, Heurology Service (127)

Your memorandum concerning the unscheduled NRC Inspection of hw November 20, 1990 Acting Radiation Safety Officer (115) r.

1.

The neurochemistry research laboratory is located in room 610A but does not occupy a segregated suite of rooms.

2.

No infractions against the listed rules and regulations were identified in that area.

However, we have no provision for " surveying hands".

Also, the hospital does not provide an area for persons who wish to eat their " brown bag" lunches.

The cafeteria in the basement is not intended for that purpose and at the usual lunch hour it is all far too crowded.

3.

The neurochemistry staff wishes to be acknowledged for the high quality radiation safety measures.

I wish to

.' specially commend Mr. Andrew Dickson f or his meticulous care in this matter.

He came to this laboratory from the production plant of the Sterling Company in Rensselaer, New York, where he was usedto weekly FDA inspections.

/

'a'-

^

ARNULF H. KOEpPEN,'A."DI 7 cc:

ACCC/R&D (151) 1 l

~

_ __V_!O'M_e_nar ____-- ____-_-__---_ _ _-____ _________ _

___