ML20203F919
| ML20203F919 | |
| Person / Time | |
|---|---|
| Site: | 15000009 |
| Issue date: | 02/13/1998 |
| From: | Dan Collins NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Menker D AFFILIATION NOT ASSIGNED |
| References | |
| 15000009-97-02, 15000009-97-2, EA-98-077, EA-98-77, NUDOCS 9803020118 | |
| Download: ML20203F919 (4) | |
See also: IR 015000009/1997002
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February 13, 1998- i
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EA 98 77 l
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Radiation Consulting Associates. Inc. '
ATTN: Mr. Don Menker
- President / Radiation Safety Officer
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9921 N.W. 80th Avenue (1-J)
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. Hialeah Gardens, FL 33016 :
SUBJECT: NRC SPECIAL INSPECTION REPORT NO. 150 00009/97 02 AND NRC J'
- INVESTIGATION REPORT NO. 2 97 009
Dear Mr. Menker:
.a'-
This refers to the inspection conducted on March 17, 1997, at your Hialeah !
< . Gardens, Florida facility. The inspection included a review of activities i
l involving your use of byaroduct material in areas under NRC jurisdiction i
- (Kearny New Jersey and iinneapolis, Minnesota). NRC Inspection Report i
No. 150 00009/97 02 was sent to you by letter dated April 16, 1997. In that i
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' letter you were advised that the potential violations identified in the report !
were being reviewed by the NRC for further consideration and action. ;
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i- Between April 3. 1997, and December 16, 1997, an investigation was conducted -
by the NRC Office of Investigations (01) to determine whether Radiation -
Consulting Associates. Inc. (RCAl) deliberately failed to file for reciprocity '
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with the NRC. A copy of the synopsis to the 01 investigation report is
enclosed (Enclosure 1). The investigation concluded that neither RCAI nor an >
RCAl authorized user intentioaally or deliberately conducted unlicensed :
. activity in order to contravene NRC authority or, regulations. l
, Based on the results of the inspection and investigation, two apparent
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violations were identified and are being considered for escalated enforcement ;
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action in accordance with the " General Statement of Policy and Procedure for
NRC Enforcement Actions" (Enforcement Pelicy). NUREG-1600. The apparent ,
Lviolations relate to the performance of unlicensed activities, and a failure--
to file for reciprocity prior to performing licensed activities in areas of
NRC jurisdiction.
The circumstances surrounding these apparent-violations, the significance of ,
the issuesc and the need for lasting and effective corrective action were
. discussed with you at the inspection exit meeting on March 17, 1997. l
Subsecuently, you voluntarily-responded to these issues in letters dated i
MayId.andJuly 21. 1997, As a result, it may not be necessary to conduct a
-predecisional enforcement-conference in order to enable the NRC to make an
enforcement- decision. However, e Notice of Violation is not presently- being ;
issued for these: inspection findings. Before the NRC makes its enforcement ,
decision, we are providing you an additional opportunity to either:
(1) respond to the apparent violations addressed in the inspection report :
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Radiation Consulting Associates. Inc. 2 ,
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within 30 days of the date of this letter. or (2) request a predecisional ,
enforcement conference. Please contact Thomas R. Decker at (404) 562 4721
within seven days of the date of this letter to notify the NRC of your l
intended rcsponse.
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s if
' a "you Response chooseto to provideViolations
Apparent a response, your response
in Inspection Reportshould No. 150be clearly marked
00009/97 02" n *
i and should include for each apparent violation: (1) the reason for the -
- apparent violation, or, if contested, the basis for disputing the apparent
violation. (2) the corrective steps that have been taken and the results i
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achieved. (3) the corrective steps that will be taken to avoid further .
violations, and (4) the date when full compliance will be achieved. As ,
appropriate, your response may reference previously docketed correspondence. !
In presenting your corrective action, you should be aware that the promptness
and comprehensiveness of your actions will be considered in assessing any
civil penalty for the apparent violations. The guidance in the enclosed NRC
Information Notice 96 28. " SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND
IMPLEMENTATION OF CORRECTIVE ACTION." may be helpful. Your response should be
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submitted under oath or affirmation and may reference or include previously s
docketed correspondence. If the correspondence adequately addresses the ,
- required response, if an adequate response is not received within the time
specified or an extension of time has not been granted by the NRC, the NRC
will proceed with its enforcement decision or schedule a predecisional
enforcement conference.
Please be advised that the number and characterization of apparent violations
- described in the April 16. 1997, inspection report may change as a result of
further NRC review, You will be advised by separate correspondence of the
results of our deliberations on this matter.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice." a copy of >
this letter and enclosures will be placed in the NRC Public Document Room.
Should you have any questions concerning this letter, please contact us.
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Sincerely.
(original signed by
D.M. collins)
Douglas M. Collins, Director
Division of Nuclear Materials Safety
Docket No, 150-00009
License No. General License (10 CFR 150.20) -
Enclosures: 1. Investigative Synopsis.
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01 Case No. 2-97 009
2. Information Notice 96 28
cc w/encls:
State of-Florida
Distribution w/encls: -(see page 3)
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Radiation Consulting Associates. Inc. 3
)istribution w/encls:
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Ril Docket file. DNMS '
A. Boland. E!CS
J. Lieberman. OE
DE:EA File (B. Sumers. OE)
0. DeMiranda. ElCS
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SYNOPSIS
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This investigation was initiated by the U.S. Nuclear Regulatory Commission
. (NRC), Office of Investigations Region II, on April 3,1997, to determine
whether Radiation Consulting Associates. Inc. (RCAI), a State of Florida ,
(agreement state) licensee, and/or an authorized user included on RCAI's I
license deliberately conducted unlicensed activity under NRC jurisdiction in
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the non. agreement states of Minnesota and New Jersey on several occasions ,
l .between April 1994 and February 1997, by failing to file for reciprocity with !
! the NRC. l
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The evidence developed did not substantiate the allegation that RCAI, or an ,
! RCAI authorized user, intentionally or deliberately conducted unlicensed .
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activity in order to contravene NRC authority or regulations. !
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- NOT T0"TUSLIC- OISCLOSURE ','!TMOL7 pmgm_ nr w .
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- FICLO OFFICE DI".ECTOR, Off!CC Or IN'!:';TIGATIONS, REGIO'!JI
Case No. 2 97 009 1- Enclosure 1
-Approved for release s
- om January 27,~1990 *
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l UNITED STATES
i NUCLEAR REGULATORY COMMISSION
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0FFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUAROS '
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WASHINGTON, D.C. 20555
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May 1, 1996
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NRC INFORMATION HOTICE 96-28:
SUGGESTED GUIDANCE RELATING TO DEVELOP
IMPLEMENTATION OF CORRECTIVE AC710N
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Addressees
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, All material and fuel cycle licensees.
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- Purcose
' The U.S. Nuclear Regulatory Commission
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notice to provide addressees with guidan(NRC) is-issuing
ce relating to development this information
and
implementation of corrective actions that should be considered after
identification of violation
recipients will review this(s) of NRC requirements. it is expected that
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information for applicability to their facilities
and* consider actions, as aspropriate, to avoid similar problems.' However,
therefore, no specific action nor written response is required
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Backaround
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On June 30, 1995, NRC revised its Enforcement Policy
34281, to clarify the enforcement program's focus by,(NUREG-1600)' in part, emphasizing60 theFR
importance of identifying problems before events occur, and of taking prompt,-
comprehensive corrective action when problems are identified. Consistent with ,
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the revised Enforcement Policy, NRC encourages and expects identification and :
prompt, comprehensive correction of violations,
in many cases, licensees who identify and promptly correct non-recurring
Severity level IV violations, without NRC involvement, will not be subject to
formal enforcement action.
Such violations will be characterized as "non-
- cited" violations as provided in Section VII.B.1 of the Enforcement Policy.
Minor violations are not subject to formal enforcement action.
the root cause(s) of minor violations must be identified and appropriateNeverth
corrective action must be taken to prevent recurrence.
, If violations of more than a minor concern are identified by the NRC during an
inspection
provide a w-licensees will be subject to a Notice of Violation and may need to
ritten response, as required by 10 CFR 2.201, addressing the causes
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of the violations and corrective actions taken to prevent recurrence. In some
cases, minor violations are documented on Form 591 (for materials licensees)
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940429M93- (, -
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'CopiesofNUREG-1600canbeobtainedbycalli$gthecontactslistedat
the end of the Information Notice.
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Enclosure 2
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May 1, 1996
Page 2 of 6
' which canstitutes a notice of violation that requires corrective action but
does not require a written response. if a significant violation is involved,
a predecisional enforcement conference may be held to discuss those actions.
The quality of a licensee's root cause analysis and plans for correcti"e
actions may affect the NRC's decision regarding both the need to hold a
predecisional enforcement conference with the licensee and the level of
sanction proposed or imposed.
Discussion
1
Comprehensive corrective action is required for all violations. In most
cases, NRC does not propose impasition of a civil penalty where the licensee
promptly identifies and compreaensively corrects violations. However, a
Severity Level til violation will almost always result in a civil penalty if a
licensee does not take prompt and comprehensive corrective actions to address
the violation.
It is important for licensees, upon identification of a violation, to take the
necessary corrective action to address the noncompliant condition and to
prevent recurrence of the violation and the occurrence of similar violations.
Prompt comprehensive action to improve safety is not only in the public
interest, but is also in the interest of licensees and their employees. In
addition, it will lessen the likelihood of receiving a civil pen'alty. Compre-
hensive corrective action cannot be developed without a full understanding of
the root causes of the violation.
Therefore, to assist licensees, the NRC staff has prepared the following
guidance, that may be used for developing and implementing corrective action.
Corrective action should be appropriately comprehensive to not only prevent
recurrence of the violation at issue, but also to prevent occurrence of
similar violations, The guidance should help in focusing corrective actions
broadly to the general area of concern rather than narrowly to the specific
violations. The actions that need to be taken are dependent on the facts and
circumstances of the particular case.
The corrective action process should involve the following three steps:
1. Conduct a complete and thorouah review of the circumstances that led to
the violation. Typically, such reviews include:
Interviews with individuals who are either directly or indirectly
involved in the violation, including management personnel and those
responsible for training or procedure development / guidance.
Particular attention should be paid to lines of communication
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between supervisors and workers.
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IN 96-28 i
Hay 1, 1996
Page 3 of 6 !
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- Tours and observations of the area where the violation occurred, i
partic'ularly when those reviewing the incident do not have day-to-
day contact with the oLeration under review. During the tour, !
individuals should look for items that may have contributed to the !
violation as well as those items that may result in future '
violations. Reenactments (without use of radiation sources, if they
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were involved in the original incident) may be warranted to better
understand what actually occurred.
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Review of programs, procedures, audits, and records that relate ;
directly or indirectly to the violation. The program should be "
reviewed to ensure that its overall objectives and requirements are
clearly stated and implemented. Procedures should be reviewed to
determine whether they are complete, logical, understandable, and. l
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! meet their objectives (i.e., taey should ensure compliance with the -
current requirements). Records should be reviewed to determine .
Whether there is sufficient documentation of necessary tasks to i
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provide an auditable record and to determine whether similar
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violations have occurred previously. Particular attention should be
, paid to training and qualification records of individuals involved
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with the violation.
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2. Jdentify the root cause of the violation.
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Corrective action is not comprehensive unless it addresses the root
cause(s) of the violation. It is essential, therefore, that the root
cause(s) of a violation be identified so that appropriate action can be
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taken to prevent further noncompliance in this area, as well as other
potentially affected areas. Violations typically have direct and
indirect cause(s). As each cause is identified, ask what other factors
could have contributed to the cause. When it is no longer possible to
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identify other contributing factors, the root causes probably have been
identified. For example, the direct cause of a violation may be a
' failure to follow procedures; the indirect causes may be inadequate
training, lack of attention to detail, and inadequate time to carry out
an activity. Dese fatton may have been caused by a lack of staff
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" resources that, in turn, are indicative of lack of management support. '
Each of these factors must be addressed before corrective action is
considered to be comprehensive.
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3. Take promot and comorehensive corrective action that wi'l address the
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- immediate concerns and Drevent recurrence of the violati on.
} lt is important to take immediate corrective action to address the
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specific findings of the violation, for example, if the violation was ,
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issued because radioactive material was found in an unrestricted area,
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' immediate corrective action must be taken to place the material under
licensee control in authorized locations. After the immediate safety
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concerns have been addressed, timely action must be taken to prevent
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future recurrence of the violation. Corrective action is sufficiently i
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comprehensive when corrective action is broad enough to reasonably
prevent recurrence of the specific violation as well as prevent similar
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violations.
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i In evaluating the root causes of a violation and developing effective
corrective action, consider the following:
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1. Has management been informed of the violation (s)? ,
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. 2. Have the programmatic implications of the cited violation s and the !
' , potential presence of similar weaknesses in other program (ar)eas been
considered in formulating corrective actions so that both areas are
adequately addressed? -
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3. Have precursor events been considered and factored into the corrective
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actions?
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i 4. In the event of loss of radioactive material, should security of
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radioactive material be enhanced?
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S. Has your staff been adequately trained on the applicable requirements?
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6. Should personnel be re-tested to determine whether re-training should be
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emphasized for a given area? Is testing adequate to ensure
understanding of requirements and procedures? '
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7. Has your staff been notified of the violation and of the applicable
j corrective action?
- 8. ' Are audits sufficiently detailed and frequently performed? Should the '
frequency of periodic audits be increased?
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Hay 1, 1996
Page 5 of 6 l
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9. Is there a need for retaining an independent technical consultant to
audit the area of concern or revise your procedures?
10.
Are the procedures consistent with current NRC requirements, should they {
be clarified, or should new procedures be developed?
11. Is a system in place for keeping abreast of new or modified NRC
requirements?
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Does your staff appreciate the need to consider safety in approaching
daily assignments? !
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13. Are resources adequate to perform, and maintain control over, the ;
licensed activities? Has the radiation safety officer been provided '
sufficient time and resources to perform his or her oversight duties?
14. Have work hours affected the employees' ability to safely perform the
job?
15.
' Should organizational changes be made (e.g., changing the reporting
relationship of the radiation safety officer to provide increased
independence)? .
16. -
Are management and the radiation safety officer adequately involved in
' oversight and implementation of the licensed activities? Do supervisors
adequately observe new employees and difficult, unique, or new
operations?
17.
Has management established a work environment that encourages employees
to raise safety and compilance concerns?
18. Has management placed a premium n production over compliance and
safety? Does management demonst te a commitment to compliance and
safety?
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19.
Has management communicated its expectations for safety'and compliance?
20. Is there a published discipline policy for safety violations, and are
employees aware of it? Is it being followed?
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, This information notice requires no specific action nor written response. If
yed have any questions about the information in this notice, please contact
one of the technica'l ' contacts' ilsted below.
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Elizabeth Q. Ten Eyck, Director Donald A. Cool, Ofrector
Olvision of Fuel Cycle Safety Olvision of Industrial
and Safeguards and Medical Safety
Office of Nuclear Haterial Safety Office of Nuclear Haterial Safety
and Safeguards and Safeguards
Technical contacts: Nader L. Hamish, OE Daniel J. Holody, RI '
(301) 415-2740 (610) 337-5312
Internet:nlm9nrc. gov Internet:djh0nrc. gov
Bruno Uryc, Jr., Ril Bruce L. Burgess, Rlli
(404)331-$505 (708) 829-9666
Internet:bxuenrc. gov Internet:b1benrc. gov
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Gary F. Sanborn, RlY '
(817) 860-8222 *
Internet:gfsenrc. gov
Attachments:
1. List of Recently Issued NHSS Information Notices
2. List of Recently issued NRC Information Notices
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