ML20236E303

Regional Procedures to Region III Manual,Including Procedure 0400A, Preparation & Issuance of Escalated Enforcement Actions, Procedure 0400B, Disputed Violations, Procedure 0400C, Confimatory Action Ltrs & Procedure 0400D

ML20236E303
Person / Time
Issue date:	07/29/1987
From:	NRC
To:
Shared Package
ML20236E266	List: ML20236E262 ML20236E303
References
FOIA-87-450 PROC-870729, NUDOCS 8707310304
Download: ML20236E303 (50)

Text

. e r RP 0400A REGION III MANUAL )

REGIONAL PROCEDURE 0400A i i

PREPARATION AND ISSUANCE OF ESCALATED ENFORCEMENT ACTIONS  !

Scope This procedure provides guidance for convening Enforcement Boards, preparing i Enforcement Board Briefing Packages, preparing documentation for escalated I enforcement actions, and issuance of escalated enforcement actions. The  !

purpose of this procedure is to ensure that escalated enforcement packages are i prepared accurately, expeditiously, and in accordance with the NRC Enforcement Policy. Users of this procedure are expected to familiarize themselves with IE MC 0400 (Enforcement Program).

Procedure A. Enforcement Board ,

If an inspection or investigation identifies a violation (s) that appears )

to provide a basis for escalated enforcement action (Enforcement j Conference, Civil Penalty, Order, etc.), an Enforcement Board shall be )

convened to evaluate the findings and decide on an appropriate enforcement l action. The Enforcement Board shall meet not later than SIX working days after the last date of the inspection or investigation in which the violation (s) was identified.

An Enforcement Board is comprised of the following:

1. Regional Administrator, or Deputy Regional Administrator, or their designee.

2. Enforcement Coordinator and/or Enforcement Specialist.

3. Cognizant Division Director (s).

4. Regional Counsel.

5. Any additional Region III staff who present information that will assist the Enforcement Board in making its decision.

The Cognizant Division shall schedule the Enforcement Board meetings.

This is accomplished by contacting the Administrator's or the Deputy Administrator's secretary who will schedule the meeting.

Contact:

W. H. Schultz December 20, 1985 9707310304

^

FoI4 U- M FOIA 870729 g

PDR GUILDB7-450 ppR rr[/

l l

. RP 0400A 2

(

1 The following examples illustrate the types of cases that should be presented to a Board for review:

1. All cases involving violations that appear to be properly classified at Severity Level I, II, or III,

2. All cases involving Technical Specification Limiting Conditions for Operation (LCO) where the action statement has not been met and there is a question whether the violation fits a Severity Level IV or III definition.

I

3. Cases involving numerous Severity Level IV violations which, when taken in the aggregate, demonstrate a significant breakdown in management control systems, maintenance, inspection and testing, etc.

At least one day before the Board meets, the cognizant Division shall prepare an Enforcement Board Briefing Package. The Division shall ensure that Board attendees receive this package at least one working day before the meeting so they can familiarize themselves with the details of the  !

case. (E1CS - 2 copies, RA or DRA - 1 copy, Regional Counsel - I copy, and Divisions - copies as required.)

A briefing Package shall contain the following:

1. A cover sheet that identifies the Licensee, License No.(s), Docket No.(s), Date of Enforcement Board, and other pertinent information.

(See attachment for sample cover sheet.)

l

2. A chronology of the problem or event, what occurred, when did it I I

occur, who was involved, who identified the problem, was it reported, etc. (see Attachment 1.) This can also include an assessment of past performance or SALP assessment and prior notice of similar events within the past two years. '

3. The apparent violation (s) that was identified. This should include i the regulatory requirement as well as the " Contrary to" statement that describes how the requirement was violated. (This information will be used by the Enforcement Staff to prepare the Notice of Violation.)

4. A summary statement that focuses on the root cause of the violation (s) and any actions (s) the licensee took before or after the violation (s) was identified. (This information will be used by the Enforcement Staff to prepare the transmittal letter for the Notice of Violation.)

December 20, 1985

l RP 0400A l I

3 l l

5. All supporting documentation that sets forth regulatory requirements i not contained in the Title 10 Code of Federal Regulations. This  !

includes: Technical Specifications, Operating Procedures, l Administrative Procedures, etc. Note: Only the specific page(s)

~

of a document that relates to the violation (s) should be included, I not the entire document. This documentation is an essential part  !

of an escalated enforcement package and the IE:HQ Enforcement Staff i will not review a package until this documentation has been submitted. l!

B. Enforcement Board Findings .

I The Board will recommend a proposed enforcement action after considering  !

all available information. The recommendation may range from a finding of no violation (s) of regulatory requirements to an Order Suspending licensed activities. If the Board concludes that no violation (s) occurred, the Region III Enforcement Staff will write a summary outlining the facts that i led to the Board's recommendation. A copy of this summary will be provided i l to the Cognizant Division and the original will be attached to the l Enforcement Briefing Package. The complete package will be placed in the i Enforcement Files for review an/or audit.

If the Board concludes t'he violation (s) constitutes a Severity Level IV problem, the Region III Enforcement Staff will write a summary outlining the facts that led to the Board's conclusion. A copy of the summary will be provided to the Cognizant Division and the original will be attached to the Enforcement Briefing Package. The complete package will be placed in the Enforcement Files for review and/or audit. The Notice of Violation, the transmittal letter, and the inspection report will be completed by the Division and the package will be issued as a routine enforcement action.

If the Board concludes the violation (s) constitutes a Severity Level I, II, or III problem, with or without a civil penalty, the entire escalated enforcement package, with the exception of the inspection / investigation report (s), will be drafted by the Enforcement Staff. The package will be prepared from information contained in the Enforcement Board Briefing  ;

Package and from information developed during the Enforcement Board. i The completed package will be forwarded to the Cognizant Division Director,

• Regional Counsel, the Deputy Administrator, and the Administrator for concurrence before it is submitted to the Director, Enforcement Staff, IE. 4 In addition, the Region III Enforcement Staff will write a summary l outlining the facts that led to the Board's conclusion. A copy of the .

summary will be provided to the Cognizant Division and the original will  !

be attached to the Enforcement Briefing Package and will be placed in the  !

Region III Enforcement Files for review and/or audit.

1 December 20, 1985 1

______________________U

RP 0400A 4

C. Enforcement Conference Enforcement conferences are normally held for Severity Level I, II, and III violations and may be held for Severity Level IV violations which, if repeated, could lead to escalated enforcement action. All scheduling of .

enforcement conferences shall be made by the Cognizant Division after l coordinating with the Regional Administrator's Office. For limited scope escalated enforcement cases, the conference may be conducted by telephone provided prior approval is obtained from the Regional or Deputy Regional Administrator, The Region III Enforcement Staff will normally attend Enforcement Conferences and will write an " Enforcement Conference" paragraph for inclusion in the Inspection Report. This paragraph will be provided to the Cognizant Division within one day after the Enforcement Conference.

When the Region III Enforcement Staff is not present, the cognizant Division will provide the " Enforcement Conference" paragraph (e.g.,

conferences held at a licensee's facility).

D. Delayed Escalated Enforcement i Escalated enforcement action is sometimes delayed because an investigation j is pending, is in process, or for other compelling reasons. In such cases i when the Inspection Report is sent to the licensee, the Report transmittal J 1etter shall state that a decision on the enforcement action is pending l and the licensee will be notified of the results of the decision. The l transmittal of such Reports will be handled on a case-by-case basis and j will be coordinated by the Region III Enforcement Staff. '

E. Timeliness of Enforcement Actions i

To emphasize the significance of escalated enforcement actions and to I deter recurrence of serious violations, it is essential that such actions be timely. Since many individuals are involved in the enforcement process, each must complete his part of the effort in a timely manner. The following schedule illustrates the preparation of an enforcement package:

1. The cognizant Division prepares and distributes the Enforcement Board Briefing Package < = 5 days after last date of inspection or investigation.

2. Enforcement Board < = 6 days after last date of inspection or investigation.

3. Dreft inspection report completed < = 20 days af ter last date of inspection or investigation.

December 20, 1985

l RP 0400A l

l 5 , l

)

4. Enforcement Conference, if applicable, < = 20 days after last dhte of inspection or investigation.

5. Enforcement Staff forwards " Enforcement Conference" paragraph ito Division for inclusion in inspection report < = 1 day after Enforcement Conference.

6. Issue inspection report < = 23 days after last date of inspection l or investigation. '

7. Enforcement Staff completes escalated enforcenter.t package and circulates it for concurrence / comments < = 24 days after last date of inspection or investigation. l l

8. Concurrence / comments completed < = 27 days after last date of inspection or investigation. j

9. Completed escalated enforcement package sent to Director, Enforcement Staff, IE < = 30 days after last date of inspection or investigation.

F. Issuance of Escalated Enforcement Actions After an escalated enforcement package is approved by the Enforcement ^

Staff and Legal Staff in Headquarters, the Director, Office of Inspection and Enforcement will authorize the Regional Administrator to issue the package to the licensee. The enforcement package is finalized and prepared for distribution by the Region III Enforcement Staff and the secretarial staff of the Regional Administrator's office. This applies to all cases except Safeguards cases; those are distributed by NMSS.

G. Licensee's Response to a Proposed Civil Penalty A licensee has 30 days from the date of issuance of an escalated enforcement action in which to respond to the NRC. Any request for an extension must be coordinated through the Enforcement Staff. The licensee has two options in its response:

1. Admit the violation (s) occurred as stated in the Notice of Violation and Proposed Imposition of Civil Penalty, describe the corrective action that was or will be taken, and pay the civil penalty.

Headquarters will then send the licensee a letter acknowledging receipt of the payment and stating that the corrective actions described in the licensee's response will be examined during future inspections (Attachment 2).

December 20, 1985

RP 0400A 6

i 2. Challenge the NRC's facts or conclusions regarding the proposed escalated enforcement actions. j

a. Dispute one or more of the violations.

b. Challenge the NRC's conclusion regarding the significance or Severity Level of the violation (s).

c. Request mitigation of the proposed civil penalty.

If the licensee chooses Option 1, the case will be closed after the licensee's corrective actions have been reviewed by the cognizant Division. If the licwsee's corrective action is acceptable, the cognizant Division shall notify the RIII Enforcement Staff. If the corrective action is not acceptable, the cognizant Division shall take appropriate action in coordination with the Enforcement Staff.

If the licensee chooses Option 2, the cognizant Division will review the

licensee's response and prepare a written evaluation of that response.

i The evaluation will address all points made by the licensee and will include a restatement of each violation, a summary of the licensee's position concerning each violation, the NRC's evalustion of the licensee's position and the NRC conclusion (Attachment 3).

This evaluation will be included as an Appendix to the final enforcement action and will accompany the Order that imposes the civil penalty. In some instances the NRC staff may conclude that one or more of the violations should be modified or deleted and that the amount of the proposed civil penalty should be modified.

The Region III Enforcement Staff will prepare a transmittal letter to the licensee and an Order imposing the civil penalty. T'iese two documents and the Appendix prepared by the cognizant Division will be forwarded to Headquarters for review, concurrence, and issuance. Orders are signed and issued by the Director, Office of Inspection and Enforcement and not by the Regional Administrator.

All reviews of licensee's responses should be completed within thirty I days of receipt in the Region III office.

Attachments:

1. Sample Enforcement Board Package i

2. Acknowledgment Letter from Headquarters Appendix, Evaluations I 3.

and Conclusions (evaluation of licensee's i response)  !

I I

December 20, 1985 l

.- 1

RP 0400A ENFORCEMENT BOARD BRIEFING '

.I Licensee: Kay-Ray, Incorporated License No.: 12-11184-01

.J Docket No.: 030-04214

'Date of Enforcement Board: July 11,1985 ,

Date(s) of Inspection: March 19, 20, 22, 1985 Division: DRSS Division

Contact:

J. Lynch q 1 '

Description of Event: Apparent 19.61 rem extremity dose in second quarter:

of 1985 - See Attachment. ,

Enforcement History: See Attachment.

Division's Recommended Acticn: Severity Level III with Civil Penalty Basis for Mitigation or Escalation: None Chronology May 30, 1985 - The licensee was notified by R. S. Landauer that the TLD ring of a Kay-Ray employee had received a dose of 19.42 rem. The ring was worn by the source loading supervisor from May 13 to May 19, 1985 on his right hand.-. Another TLD worn at eye level during the same period received a dose of 40 millirem. His whole body film badge registered only minimal exposure (<10 millirem). These lower exposures are expected because'of source loading station shielding. During the week in question, the employee.

loaded 24 cesium-137 source capsules ranging in activity.

from 50 mil 11 curies to 500 mil 11 curies. He also, loaded.

three 500 millicurie americium-241 beryllium sources.

]

June 18, 1985 - The NRC was notified of the apparent overexposure by ..

letter. The letter stated that the exposure was presumed to be deliberate and to the dosimeter only. Some employee dissension was evident around the time of the incident,  !

which led to this' conclusion. -

J Attachment 1 4

j i

RP 0400A June 26,1985 - .The NRC performed an onsite inspection to investigate the apparent overexposure.

one 28, 1985 - Kay-Ray submitted a re-evaluation-of the incident after a I technical review with the NRC inspector. This letter. '

details a change in Kay-Ray's position from one of a deliberately exposed dosimeter to a position.that an '

actual extremity exposure to the individual may have occurred. Kay-Ray thought initially that a deliberate TLD exposure was the most likely explanation for the high reading. Upon consultation with the NRC, it was realized that' the exposure could have occurred in only a few ,

seconds if close contact with the source.was made (see- 1 attached calculations). This information prompted the l change in position.

Inspection History I i

A. Routiu Safety Inspection: March 19, 29, 22, 1986 ~

i Results: One violation ,

j B. Special Safety Inspection: October 18, 1983 ,

Results: One violation j Comments: Missing sources i C. Special Safety Inspection: June 8 and 10, August 1, 1983 1

Results: Three violations )

Order Suspending License and To Show Cause (Order in effect from August 15, J983 to September 16,1983)

$1800 Civil Penalty _

Comments: Whole body and extremity overexposure D. Routir:L Safety Inspection: April :.2-13,1983 Results: Four violations Comments: Apparent whole body overexposure Summ,ay s This appears to be an isolated incident caused by an employee error. Although the apparent overexposure exceeds the regulatory limit by only 0.86 rem (4.6%)

and the licensee acted promptly and correctly to identify the situation and reduce the possibility'of recurrence, a civil penalty as prescribed by 10 CFR Part 2 is deemed appropriate.

Attachmtnt 1 ,

Page 2 of'3 pages 2 _ _

RP 0400A PROPOSED NOTICE OF VIOLATION 10 CFR 20.101(al states, "No licensee shall possess, use, or transfer licensed material in sucn a manner as to cause any individual in a restricted area to receive in any period of one calendar quarter, from radioactive material and I other sources of radiation, a total occupational dose in excess of 18.75 rems  ;

to the hands and forearms." l Contrary to the 3bove, a Kay-Ray, Incorporated employee working in a restricted I area, received an apparent hand exposure of 19.61 rem during the second quarter )

of 1985.

This is a Severity Level III violation (Supplement IV).

Recommended Course of Action We recommend that a L:eil Penalty be issued with the following considerations:

1. Prompt Notification and Reporting The licensee reported the apparent overexposure promptly as required by 10 CFR 20.405.

2. . Corrective Action to Prevent Recurrence The individual was immediately removed from source handling duties upon notification of the apparent overexposure. Additional training has been provided to all tource loaders regarding the high exposure potential of cesium-137 sources.

3. Enforcement Histor,y Although a number of overexposure incidents were reported in the past, no overexposure have occurred in the past two years. The licensee's radiation safety program has significantly improved since the 1983 enforcement actions. j I

l f

I L

I l

l Attachment 1 Page 3 of 3 pages ]

l 1

1 United States NUCLEAR REGULATORY COMMISSION Washington, D.C. 20555 April 26, 1985 Docket Nos. 50-373; 50-374 License Nos. NPF-11; NPF-18 i EA 85-26

' Commonwealth Edison Company j ATTN: Mr. James J. O' Conner j President j Post Office Box.767 .i Chicago, IL 6C690 )

l Gentlemen:  !

This will acknowledge receipt of youe letter dated April 19, 1985 and your check for 525,000 in payment for the civil penalties proposed by NRC in j

a letter dated March 21, 1985. The corrective' actions described in your i I

letter will be examined during future inspections. J Sincerely, Jane A. Axelrad, Director Enforcement Staff i Office of Inspection and Enforcement i l

l l

~i 4

Attachment 2

RP 0400A Appendix EVALUATIONS AND CONCLUSIONS In a letter dated October 18, 1985, the licensee responded to the Notice of Violation and Proposed Imposition of Civil Penaltias dated September 5,1985.

In its response, the licensee admits certain violations occurred as described in the Notice, denies other violations, requests mitigation of the civil penalties and provides reasons why it believes that mitigation of the l penalties is appropriate. Provided below are (1) a restatement of each  :

violation, (2) the licensee's assertion regarding each violation, (3) NRC's  !

evaluation of each licensee assertion, (4) a summary of the licensee's i arguments in support of mitigation of the proposed penalties, and (5) NRC's evaluation and conclusion.

I. Restatement of Violations, Licensee Assertions, and NRC's Response A. Restatement of Violation A 10 CFR 20.101(a) provides that no licensee shall possess, use, or i transfer licensed material in such a manner as to cause any individual I in a restricted area to receive in any period of one calendar quarter i from radioactive material and other sources of radiation a total i occupational dose in excess of 18.75 rems to the hands and forearms. I Contrary to the above, on June 14, 1985, during the second calendar quarter of 1985, a radiographer's assistant received a calculated hand dose of greater than 75 rems.

Licensee's Assertion  !

The licensee does not agree that the radiographer's assistant received a calculated hand dose of 75 rems. However, the licensee does agree that 1.2 percent of the individual's hand may have received over 75 rem and less than 9 percent of the hand may have received over 18.75 rem. The licensee calculated, with the aid of time and distance measurements made during reenactments, the average radiation dose to selected areas of the iridividual's hand. From this data the licensee concluded that, since only parts of the hand received doses in excess of regulatory limits, it did not constitute a violation.

NRC Response The licensee's analysis would tend to show what kinds of biological damage one might expect to see over localized areas of the hand.

However, 10 CFR 20.101(a) makes no allowance for averaging extremity doses. Also, this regulation does not support the conclusion that because only part of an extremity is exposed in excess of regulatory l limits a violation has not occurred. Accordingly, no basis has been provided for withdrawal of this violation.

Attachment 3 Page 1 of 7

RP 0400A L

B. Restatement of Violation B l 10 CFR 34.43(b) requires that a survey with a radiation survey instrument shall be made efter each radiographic exposure to determine that the sealed source has been returned to its shielded position. The entire circumference of the radiographic exposure device shall be surveyed. If the radiographic exposure device has a source guide tube, the survey shall include the guide tube.

Contrary to the above, on June 14, 1985, a radiographer's assistant ,

failed to perform a radiation survey after a radiographic exposure '

to determine that the sealed had been returned to its shielded i i position, j Licensee's Assertion The licensee admits a survey was not made after each radiographic. 1' exposure and states the violation occurred because the radiographer's assistant made a personal decision, contrary to NRC and Calumet Testing Services, Inc. (CTS) procedures, not to make a survey. In ,

addition, the licensee listed seven corrective actions that were '

taken after this violation was identified. Four of these actions' related.to personnel training, one related to unannounced audits, one related to modifying tha locks on the cameras, and one addressed )

l action that will be taken against individuals who commit violations l in the future.

-l ,

NRC Response

, The licensee asserts the radiographer's assistant is responsible for the violation because he made a personal decision to violate NRC rules and CTS procedures. It should be noted that Commissior, policy holds a l

licensee responsible for violations committed by an employee even in the absence of a finding that management contributed to the violation. ,

Although the NRC does not dispute that corrective actions were i eventually taken by the licensee, it should be noted that when the .

President of CTS attended the Enforcement Conference at the NRC i Region III office on July 8,1985 (more than three weeks after the overexposure occurred) the only corrective action ~he identified was discussion of the event with other radiography personnel. The '

additional training of personnel, the repair of the locks on the

! radiographic exposure devices, and the program for'taking action l against individuals who violate NRC regulations and CTS procedures i l was implemented only after the NRC emphasized the importance of l taking such actions. Ther'efore, we do not support the position that the licensee's corrective actions were either prompt or extensive and in fact were the kinds of corrective actions that were required to preclude similar violations in the future. Accordingly, no basis has been provided for withdrawal of this violation.

Attachment 3 Page 2 of 7

RP 0400A C. Restatement'of Violation C 10 CFR 34.44 requires that whenever.a radiographer's assistant uses radiographic exposure devices, sealed sources or related source handling tools, or conducts radiation surveys required by 34.43(b) to determine that the sealed source-has returned to the shielded position after an exposure, he shall be under the personal supervision of a radiographer. The personal supervision shall include: (a) the radiographer's personal presence et the site where the sesled sources are being used,-(b) the ability of the radiographer to give immediate assistance if required, and (c) the radiographer's watching the assistant's performance of the operations referred to in this section.

Contrary to the above, on June 14, 1985, two radiographer's assistants performed thre'e radiographic operations without the personal presence of a radiographer. As a result, a radiographer would not have been able to give immediate assistance if required

and did not watch the assistants performing the operations.

Licensee' Assertion The licensee denies that radiographer's assistants were performing radiographic exposures without the personal presence'of a radiographer i and that a radiographer was not in a position to be of immediate- .j l assistance 2ince a radiographer was on site and was working on the-  !

l same boiler as the assistants. The licensee admits that the-  !

i radiographer did not actually watch the assistants while they were j l making radiographic exposures. j 1

NRC Response Although a radiographer was present at the building site, he was making radiographic exposures in another area and could not observe  ?

two radiographer's assistants while they were making radiographic exposures. As a result, the radiographer was not aware of any problem until after one of the radiographer's assistants re eived an extremity overexposure and until after the assistant notified him of the event. It should also be noted that after the radiographer's.

assistent discovered the radiography source was exposed he did not immediately contact the radiographer. Instead, accompanied by a i second radiographer's assistant, he reentered the restricted area, unlocked'the exposure device and retracted the. source to a proper s5ielded position. If the radiographer had. complied with the requirements of 10 CFR 34.44 he would have ensured that the radiographer's assistant did not. approach the exposure device after an exposure without making a complete radiation survey and after .

it was discovered that the radioactive source was-in an unshielded position.' ' Accordingly,. no basis has been provided for withdrawal of this violation.

Attachment'3

.Page-3 of 7

RP 0400A II. Licensee's Request for Mitigation l

The licensee offers eight reasons why it believes the proposed civil l penalty should be mitigated.

1. The event was promptly reported as it may have been an overexposure. l

2. The licensee cooperated with NRC requests.

3. The NRC inspected two job t,ites and found no problem with the quality of training.

4. The overexposure was not the result of improper training. Several examples are cited to support the claim that the radiographer's assistarit knew that surveys were required but made an individual decision not to make a survey. ,

a

5. The overexposure that occurred in June 1983 and resulted in a $4,000 l civil penalty that the licensee paid on September 1, 1983 occurred as )

a result of not surveying and was not due to insufficient supervision j of the assistant.

6. The radiographer 's assis* ant did not experience any high degree of serious radiation injury as evidenced by examinations, blood tests,  ;

and chromosome studies. I

7. The licensee quoted page 8585 of the Federal Register, dated March 8, 1984 which states, "a civil penalty can be fully mitigated for a first 1 offense in an area of concern or for an offense in an area in which no j previous offense had occurred for a period of at least two years." {

The licensee also noted, "the two incidents were just eight hours shy cf being two years apart."

I

8. The licensee had to write off a significant amount in bad debts and expects this amount to be even higher in 1985. The licensee stated, "A large penalty would cause considerable hardship as we are still in a difficult economic environment."

NRC Evaluation The following eva'uation will separately address each of the e Qht l reasons set forth by the licensee in support of mitigation. '

l

1. The NRC agrees that the licensee promptly reported the overexposure j (the day after the overexposure occurred). The NRC Enforcement t Policy, 10 CFR Part 2, Appendix C, Section V.B.1 (March 8, 1984) l states, " Reductions of up to 50% of the base civil penalty may be j given when a licensee identifies the violation and promptly reports the violation to the NRC.... No consideration will be given to this factor if the licensee does not take immediate action to correct the problem upon discovery. During the Enforcement Conference which l was conducted on July 8,1935 (more that three weeks after the overexposure occurred) the President of Calumet Testing Services, 1

1 Attachment 3 Page 4 of 7 j

RP 0400A l l

Inc. (CTS) stated nis immediate corrective action was limited to meeting with each of the radiographer and radiographer's assistants and emphasizing the importance of following safety procedures and NRC l regulations. Essentially all corrective actions that were ultimately l taken by the licensee were in response to suggestions from the NRC l staff during the Enforcement Conference. Therefore, we believe that a reduction of 25 percent of the base civil penalty is appropriate for the prompt identification and reporting. j l

2. The NRC agrees that the licensee cooperated with NRC requests; however, j it should he noted that corrective action is always required to meet i regulatory requirements and the NRC staff does not believe the licensee's )

level of cooperation was anything more than could be expected.

3. The NRC did not issue a citation for an inadequate training program.

It appeared; however, from statements made by the President of CTC during the Enforcement Conference that radiography personnel needed i to be retrained, but more importantly, retested, to evaluate their i understanding of NRC regulations and CTS procedures. Licensee's are expected to have quality training programs and a quality program is not a basis for mitigation of an enforcement action.

4. As stated in Item 3, above, the licensee was not cited for failure to have an adequate training program. The licensee stated the radiographer's assistant knew a survey was required but made an Inc. (CTS) stated his immediate corrective action was limited to meeting with each of the radiographer and radiographer's assistants i and emphasizing the importance of following safety procedures and NRC regulations. Essentially all corrective actions that were ultimately taken by the licensee were in response to suggestions from the NRC staff during the Enforcement Conference. Therefore, we believe that a reduction of 25 percent of the base civil penalty is appropriate for the prompt identification and reporting.

2. The NRC agrees that the licensee cooperated with NRC requests; however, it should be noted that corrective action is always required to meet regulatory requirements and the NRC staff does not believe the licensee's level of cooperation was anything more than could be expected.

3. The NRC dia not issue a citation for an inadequate training program.

It appeared; however, from statements made by the President of CTC during the Enforcement Conference that radiography personnel needed to be retrained, but more importantly, retested, to evaluate their understanding of NRC regulations and CTS procedures. Licensee's are expected to have quality training programs and a quality program is not a basis for mitigation of an enforcement action.

4. As stated in Item 3, above, the licensee was not cited for fail.ure to have an adequate training program. The licensee stated the radiographer's assistant knew a survey was required but made an individual decision not to conduct a survey. When an NRC license is issued, the licensee must assume full responsibility for conducting Attachment 3 Page 5 of 7

- RP 0400A all activities in accordance with NRC regulatory requirements.

Although a licensee may choose to rely on others for carrying out certain responsibilities, the re> possibility to assure that these activities are conducted in accordance with NRC requirements remains with the licensee. In this instance, the licensee completely delegated certain responsibilities for various activities to others and did not ensure that these activities were conducted in accordance with NRC requirements.

5. The NRC agrees that the principal cause of the overexposure was the failure to perform an adequate survey of the exposure device; however, it should be noted that at the tire the radiographer's assistant was making the inadequate survey the radiographer was inside the boiler i and was not observing the assistant.

6. The NRC believes that any radiation dose in excess of regulatory limits is a matter of serious concern and does not rely on physical damage as a criteria for evaluatin s overexposure. I

7. The NRC Enforcement Policy provides that a civil penalty can be fully l mitigated for an offense in an area in which no previous offense has i occurred for a period of at least two years. Conversely, the Policy provides for up to 100% escalation for poor performance in the area (

of concern. When the proposed civil penalty package was being drafted I the NRC staff considered that almost two years had elapsed since your last civil penalty. However, one of the principal factors that led to the June 14, 1985 overexposure was CTS management's decision to schedule two radiographer's assistants to work together without the supervision of a radiographer. This made it impossible for the radiographer who was working in another area at the job site to comply with the requirements of 10 CFR 34.44. The NRC staff considers the actions of licensee management to constitute poor performance in the general area of concern and because of this factor elected to increase the base civil penalty by 100 percent.

8. It is not the NRC's intention that the economic impact of a civil penalty be such that it puts a licensee out of business. The NRC staff has carefully reviewed the licensee's financial statement that was submitted with the October 18, 1985 response to the Notice of Violation and Proposed Imposition of Civil Penalties. It was concluded that the civil penalty as mitigated would not create an undue hardship for the licensee.

III. NRC Conclusion The NRC staff has concluded that all violations did occur as originally stated in the September 9, 1985 Notice of Violation and Proposed Imposition of Civil Peralties. These violations collectively represent a breakdown in iicensee management control of the radiation safety program. An example'of this is CTS man 6gement's scheduling of two radiographer's assistarts to work together without personal supervision of a radiographer, an action which is prohibited by 10 CFR 34.44. A sufficient basis was not provided Attachment 3 Page 6 of 7 .

RP 0400A for withdrawal of any violations;.however, the NRC staff has concluded that a 25 percer.t retiuction in the base civil penalty is appropriate because the licensee identified and promptly reported an overexposure.

Therefore, the NRC staff has concluded that a $14,000 civil penalty should be imposed.

4 l

l l

j 1

Attachment 3 Page 7 of 7

. RP 0400B 1

I REGION III MANUAL REGIONAL PROCEDURE 04008 l DISPUTED VIOLATIONS Scope This procedure provides guidance for handling cases in which violations are disputed by the licensee.

Procedure

1. At the conclusion of each inspection or investigation, an exit meeting with licensee management should be conducted as prescribed in inspection module 30703. This meeting should clearly identify apparent violations, as well as other matters of concern to the inspector. The basis l

l (regulation, license condition, or technical specification) for each violation should be identified and the facts supporting that violation i should be presented. The inspector should obtain the licensee's position j regarding each of the findings. It should be noted that this is a  !

preliminary position since the licensee has an opportunity to review the i Notice of Violation before a formal written response must be made.

2. If the licensee disagrees with an apparent violation, the reason for this j disagreement should be pursued. If the basis for the violation involves j statements made by licensee staff, the inspector should verify that these i statements represent the licensee's official position. To the extent ,

! possible, differences should be pursued and resolved before leaving the  !

I licensee's facility. j l j l 3. If the inspector is uncertain about a violation, this should be made known to the licensee at the exit meeting. The n.atter should be resolved by the inspector with assistance from Regional or Headquarters Staff and the  !

l conclusion should be communicated to the licensee by telephone before  ;

l issuing any enforcement correspondence.  !

4. If a licensee disagrees with a violation because of a different '

understanding of the requirements, the inspector should inform the licensee that the requirements will be clarified. Any new interpretation that differs from one previously given the licensee may be a plant specific backfit and should be handled in accordance l with RP 0514. If a review wit.nin the Division fails to resolve the matter, it should be brought to the attention of the Regional Enforcement Staff who will act as a liaison between the Regional and cognizant 1

l i

Contact:

W. H. Schultz Revised 12/12/85 l Foz H 7 950 l l #/,1 !

l

RP 0400B

.r-i 2

Headquarters staffs. The Notice of Violation (NOV) that sets forth other violations should not be delayed pending resolution of'this matter.

The NOV should be issued promptly and.the transmittal letter-should  ;

identify the matter being resolved and state that the licensee will receive subsequent correspondence. Inspectors should assure proper and timely followup of such items. When such matters are resolved, a copy of the letter to the licensee together with any enclosures addressing the matters should be sent to the Regional Enforcement Staff. A copy should also be sent to the Director, Enforcement Staff, IE, for information.

If the Regional Office receives a request from a licensee for an interpretation of a specific regulatory requirement and it is not related to an inspection effort, the Region should respond to the i licensee and attempt to provide the information. Any interpretation f given to the-licensee should be consistent with 10 CFR 20.6, 50.3, l and similar regulations.

5. If the licensee agrees with the inspector's_ interpretation of a 1 requirement but refuses to take corrective action, the inspector

, should promptly discuss the matter by telephone with the inspector's Section Chief and/or other cognizant Regional staff to determine the appropriate course of action.

I l

o Revised 12/12/85 l

l

~

, , ,s - RP 0400C l i

i REGION III MANUAL REGIONAL PROCEDURE 0400C i

i CONFIRMATORY ACTION LETlERS Scope This procedure provides guidance for the issuance of Confirmatory Action Letters (CAL).

Procedure

1. Confirmatory Action Letters are letters confirming a licensee's agreement to take certain actions to remove significant concerns about health and safety, safeguards, or the environment and should be issued as soon as practical after the identification of a significant condition that requires corrective action by a licensee. The bases for issuance of a 1 CAL is set forth in 10 CFR Part 2. j I 2. The Division having responsibility for the licensed activity under  !

! concern shall prepare the CAL. In accordance with EDO policy on control  !

of draft reports and documents, draft letters should not be provided to the licensee. This does not preclude oral discussion to confirm the actions that the licensee plans to take. The letter should describe the i specific action the licensee has agreed to take, the date when it is to be completed, the individuals who have been contacted, and the date of the contact. Headquarters should be contacted by telephone, for other than " routine" cases, to solicit their comments prior to issuing the l

letter to the licensee.

3. Concurrences on CALs shall be as stated in RP 0955,

4. In addition to the normal distribution, a copy should be sent to the Director, Enforcement Staff, IE and the appropriate IE Division Director for information.

5. The draft letter should be stamped or identified as a CAL. This sill  ;

enable the Word Processing Unit to affix " Confirmatory Action Let 9..'" '

at the tap of the letter where it is readily identifiable by the 1.. ma.

6. A licensee may find it necessary to make changes in a proposed method of rarrying out an act&on that has been addressed in a Confirmatory Action Letter. To accomplish this the licensee may contact Regional personnel in person, by telephone, or by letter and negotiate such changes. Any modification, rescission, or interpretation of the Confirmatory Action

Contact:

W. H. Schultz Revised 12/12/85 Fora-87-Wo 4/3 1 l

,.M- RP 04000 2

Letter shall be made only after approval by all original concurees and shall be confirmed in writing. If time is critical, the approval for a modification in the terms of a CAL may be granted.or an interpretation may be rendered by telephone; however, the details of the approval or interpretation must be documented and transmitted to the licensee as soon as possible.

l

)

Revised 12/12/85

RP 0400D REGION III MANUAL REGIONAL PROCEDURE 0400D VIOLATION WHICH RESULTS FROM LICEN3ET'S FAILURE TO MAINTAIN RECORDS j 1

l l

_ Scope A citation for a licensee's failure to perform a required action is clearly 1

)

more serious than a citation for failure to maintain adequate records to l document an action performed. This procedure provides guidance for determining I whether a violation involving missing or incomplete records is to be treated as l a failure to perform the required action or as a failure to maintain proper '

records.

Procedure

1. When adequate documentation is not available to substantiate that a regulatory requirement has been met, responsible licensee personnel l should be questioned and an attempt made to determine if the action  !

which satisfies the regulatory requirement was performed.

2. If it cannot be determined that the requirement was met, the citation should be for failure to perform the required action not for failure to maintain a record.

3. If the licensee insists the requirement was met but a record was not properly maintained or was lost, the citation should be for failure to maintain a record.

l

\

4 l

I i

! i l l

Contact:

W. H. Schultz Revised 12/12/85 )

Fore- ? 7-4R i

)

!?/4V \

1 t________- _ _ _ _ - - - _ _ _ - - _ - - _ _ 2

=

i e RP 0400E l REGION III MANUAL REGIONAL PROCEDURE 0400E ACKNOWLEDGEMENT OF LICENSEE'S RESPONSE TO NOTICE OF VIOLATION Scope This procedure provides gtidance for preparing written acknowledgement of licensee's response to Notice of Violation for non-escalated enforcement  ;

actions. 1 Procedure

1. The licensee's response to a Notice of Violation should be reviewed by j the cognizant Division within fifteen days of receipt.

2. If the licensee's response is adequate, no acknowledgement letter should '

be issued. I

a. The cognizant Division shnuld ensure that the original response is notated with the appropriate nIDS code and forwarded to the Document Management Branch (DMB) in accordance with Regional Procedure 9924.

b. The cognizant Division should forward a copy of the licensee's response to the Region III Information Management Section and should distribute all other internal copies as required by the division.

3. If the licensee's response has minor omissions (e.g. , date of completion of corrective action) or if clarification is required, a telephone call should be made to the licensee to get resolution or clarification. If the licensee's response has major omissions, the licensee should be contacted by telephone or in writing and requested to provic'e the required additional information in a second response letter. (See Exhibits A and B for examples.)

a. A copy of all correspondences should be routed to Division of Reactor Projects (DRP) for all reactor cases.

b. The cognizant Division should ensure that the acknowledgement letter and response is notated with the appropriate RIDS code and forwarded to DMB in accordance with Regional Procedure 9924.

c. The cognizant Division shuuld forward a copy of the acknowledgement letter and response to (1) Region III Files and (2) the Information Management Section, and should distribute all other internal copies as required by the division.

Contact:

W. H. Schultz Revised 12/12/85 Fou - 87450 A/C

i 1

^

RP 0400E I I

2 1 I

4. After receiving the licensee's second response, Step 3 should be followed, y as appropriate. If successful resolution of the problem cannot be l achieved, the cognizant Division Director should meet with Regional Management to discuss possible actions, l

5. For those cases where a licensee's response takes issue with the Notice {

of Violation or is not considered responsive to the identified concerns, the acknowledgment letter must deal with the issues. If ^<e licensee challenges a violation, the acknowledgement should clearly indicate whether we agree with the licensee based on the new information he has provided, (see Exhibit C for example), or if we continue to believe a violation occurred. (See Exhibit D for example.)- Exhibit E shows the l type of letter to be used when the licensee's corrective action is to l apply for a license amendment.

l

6. The acknowledgement of the licensee's response in those cases which i involve an escalated enforcement action is sent by IE Headquarters.

l

Enclosures:

Exhibits A through E i

R I

l l

I Revised 12/12/85 l

. RP 0400E l

i

)

Gentlemen: l Thank you for your letter dated October 2,1981, informing us of the steps l you have taken to correct the violation (s) identified in our letter dated i September 21, 1981. We have no further questions regarding your response to I Items 1 and 3.

Regarding Item 2, your response did not specifically show the date that corrective action will be completed. As a result of the telephone conversations with your Mr. Jones, Administrative Assistant, on October 8 and 9,1981, we understand that packing on the valves will be verified to be adequate or the valves will be replaced by December 15, 1981. As an interim measure, we understand that the Unit 2 X-area will be visually checked for steam leaks by the operator during daily rounds. This surveillance will continue until the new packing on valves 2-220-90 is verified to be adequate or until the 2-220-90 valves are replaced.

We will examine your corrective action during a future inspection. Your  ;

cooperation with us is appreciated.  !

Sincerely, l

l l

l

)

l 1

1 I

I i I

J Exhibit A l Revised 12/12/85 l i

l I

i RP 0400E  ;

i i

Gentlemen-This will acknowledge receipt of your letter dated October 2, 1981, informing us of 'he steps you have taken to correct the violation (s) identified in our letter dated September 21, 1981. We have no further questions regarding your  !

response to Items No. 1, 3, 4, and 6. l Your response to Item No. 2 refers to an Engineering Change Notice (ECN) which modified the requirements for curing of concrete test cylinders to state that s

. . .the temperature requirements need not be satisfied so long as the '

cylinders are cured in curing boxes as equipped a:; described in ASTM C31. . . ."

This response is considered to be unsatisfactory in that the curing temperature during the first 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> can affect the later cylinder test strength, and the requirement that the curing box be ". . . equipped as described in ASTM C31. . ." j is not sufficient by itself to assure that the equipment is utilized to maintain the temperature within an acceptable range. For your information in this regard  !

we have enclosed a copy of an American Concrete Institute (ACI) paper, Title i No. 77-55, " Low Initial Curing Temperature Improves the Strength of Concrete Test Cylinders," dated December 1977.

Your response to Item NO. 5 did not include in your revised procedures a specific schedule or date of completion for training of the QC inspectors.

During a telephone conversation on October 9, 1981, between Mr. Jones of my j staff and Mr. Smith of your staff, Mr. Smith agreed that a revised response to j Items 2 and 5 will be provided to this office by October 15, 1981. i Your cooperation with us is appreciated.

J Sincerely, l

l l.

l l

l Exhibit B Revised 12/12/85

. RP 0400E Gentlemen:

Thank you for your letter dated October 2,1981, informing us of the steps you have taken to correct the violation (s) identified in our letter dated September 21, 1981.

After reviewing your letter, we agree with your conclusion that Item No. 2 of the September 21, 1981, Notice of_ Violation did not constitute a violation.

This infonnation was not available to our inspector during the inspection.

-Accordingly, we will adjust our records to reflect that no violation of regulatory requirements occurred with respect to Item No. 2.

Your corrective action associated with Item No. 1 will be reviewed during future inspections.

Your cooperation with us is appreciated.

l Sincerely, i

l l

l l

l l

Exhibit C Revised 12/12/85

RP 0400E Gentlemen:

This will acknowledge receipt of your letters. dated October 2 and 28,1981, informing us of the steps you have taken to correct the security matters which we brought to your attention in our letter dated September 21, 1981.

Except for your responses to Item No.1 and Item No. 6 we have no further questions or comments and the other items will be reviewed during subsequent inspections.

Regarding Item No. 1, our position on this matter continues to be as stated in the enclosures to our letter dated September 21, 1981. This position has been concurred in by the Office of Nuclear Reactor Regulation. You state that a i firm response to this violation will be made by December 10, 1981. We will-review this matter further at that time. With respect to Item No. 6, it should be noted that compliance with the provisions of the existing security plan is required until changes are approved by the Office of Nuclear Reactor Regulation.

Y'cr comments regarding Regulatory Guides indicate, in our view, a lack of understanding in this matter. Commitments contained in your security plan are legally binding and, as such, must be implemented. In this regard, -it is our belief that your security plan commits you to follow Regulatory Guide 5.20.

Should you have any questions concerning these matters we will be glad to discuss them with you.

Sincerely, i

1 i

Exhibit D Revised 12/12/85

RP 0400E Gentlemen:

Thank you for your letter dated October 2,1981, informing us of the steps you have taken to correct the violation identified in our letter dated September 21, 1981. While your letter states that you have filed an application for an appropriate amendment to achieve corrective action for the violation, only activities specifically authorized in an NRC license are in accord with NRC regulatory requirements. Steps should be taken to ensure that NRC-Licensed Edterials are hereafter possessed and used only as authorized by your license. ,

'We will examine this matter during a future inspection. l Your cooperation with us is appreciated. ]

Sincerely, i

j

.l l

l l

Exhibit E l

Revised 12/12/85 l

p2880uq UNITED STATES l

+ k.<, NUCLEAR REGULATORY COMM!sslON

[9 S

8 mEGION lli ne noosavatt noao i f ou~ utvu. itu~ois ..m  !

February 4, 1986 J. A. GROBE

.FE_8.121986 HEMORANDUM FOR: Region III Technical Staff FROM: T. N. Tambling, Director, Enforcement and Investigation Coordination Staff

SUBJECT:

UPGRADING ENFORCEMENT PACKAGES After reviewing several enforcement packages, A. Bert Davis met with the Enforcement and Investigation Coordination Staff to critique several of them.

We concluded that our enforcement packages, NOVs, and supp e ting inspection reports were not of the highest quality and could stand improvement.

While our discussion was primarily aimed at escalated enforcement packages, it was felt that our findings also apply to NOVs for Severity Level IVs and Vs.

Therefore, I have sumarized our findings and conclusions to share with you.

Consistent applications of the attached guide should help raise the overall 3 quality of both our escalated and routine enforcement packages.

l i

One critical comment was that there is often a disconnect between our enforcement package and the inspection report that supports it. The reports do not contain sufficient technical details to support and elaborate upon the specific requirements and when and how they were violated. Therefore, when the inspection report is written make sure that you coordinate your effort with the Enforcement Coordinator to ensure that the inspection report and the escalated enforcement package support and complement each other.

T. N. T%

T. N. Tambling, Director i

Enforcement and Coordination i Staff  !

Attachment:

Guide for Writing Enforcement Packages f01 N ~ D- $

e  ;

ATTACHMENT GUIDES FOR WRITING ENFORCEMENT PACKAGES

1. Writing the Citation for the Violation A. Requirement

1. List the specific reference to the requirement first, e.g., l Technical Specification 3.5.2 requires . . . , or 10 CFR '

Part 50, Appendix B, Criterion VI, as implemented by the  :

Commonwealth Edison Company's Quality Assurance Manual, Quality Requirement 6.1, requires . . .

2. Use the licensee's full name.

3. Do not use quotes. Start by saying Technical Specification 3.3.3.6 requires . . . . The requirement may then be paraphrased, but only to the extent for grammatical clarity and for identifying or limiting the statement to the specific requirements.

4. Make sure that enough detail is captured to provide a positive identification of the requirements. For example: Technical Specification 3.3.3.b requires that with one or more Emergency CoreCoolingSystem(ECCS)actuationinstrumentationchannels inoperable, take the action required by Table 3.3.3.1. Table 3.3.3.1 in Action 30 requires that when the number of operable channels is less than the required minimum of two, place the i inoperable channel in the tripped condition within one hour or declare the associated system inoperable.

B. Violation

1. Don't stretch a proposed violation. If you can't match it to a requirement, don't.

However, if you can't find a requirement to match your problem or concern, don't drop it. There may be another wa with it (e.g., the transmitting letter, a 50.54(f) yletter, to deala backfit, a CAL, an Order, etc.).

2. Start each violation with the words, " Contrary to the above,".

, 3. Next provide the date or dates of the violation and then a i description of how the requirement was violated. For example:

1

H

" Contrary to the above, from June 5,1985 until June 10, 1985 when the number of. operable channel was less than the required i minimum of two, the inoperable ECCS actuation instrumentation' channel was not placed in the tripped condition within one hour and the associated system was not declared inoperable."

4. If the ' actual time (or' times) of the violation is critical include it with the date.

5. Make sure that the description of. the violation matches what the requirement is. If the requirement says a minimum of two, make cure that the description says there was less than the required minimum of two. If the requirement is to have a given procedure at the work station, the description must say that l procedure "x" was_not at the work station. Make sure you play ']

l back how each requirement was not met by covering when, what, and how.

6. Keep the description short, one or two minimum length sentences.

II Grouping Violations A. Whenever possible, group violations that depict a. connon problem or ,

concern so that the letter transmitting the NOV can address them, l Avoid a shotgun approach of listing the violations.

III. Preparing the Transmitting Letter Note: While the Enforcement Coordinator prepares the letter for escalated enforcement packages, he needs to have this type of. detailed information furnished:

A. When we issue the NOV and propose imposition of a Civil Penalty, we want a sentence that captures the problems and what we are expecting the licensee to correct. For example: "To' emphasize the need for you to ensure that modifications performed on' safety-related systems have adequate controls so that system operability is not jeopardized, and to ensure that an effective program for performing operability tests is implemented . .. . " However, in summarizing make sure you  !

cover the key elements and don't leave some significant element out.  ;

I B. The letter should contain suninary statements ob the violations that i put our perspective on them. The violations may be explained as'a group, groupings, or singly by discussing the whats, whys, and hows:

- What's involved?

- What are the past histories and relationships?

What caused it?

- Why is-it significant?

- How are the violations related to the key concerns?

2 l

s'&e' 4

9ht'TI' / IMAGE EVALUATION

/o/

j g TEST TARGET (MT-3) ///[// MQp

/

+ s I.O lF M IM

((((l kWlE I.I i." lll5 l.8 1.25 1.4 1.6 4 150mm >

< 6" >

4ff'si, zzz['( #'I[;;h&

s.

4 O

1. o9, P 9

'pr*p Q) IMAGE EVALUATION q,

\////7 'i'f xN\f>/ TEST TARGET (MT-3) /6Ig ,A(gg/g g

\pf77p yk3 #

x+ 4 l.0 tM M

'slj llWild i,i p HM 1.8 1.25 1.4 1.6 4 150mm >

< 6" >

4% #

+ //4

• %f #4 %f  %<y(4 C

i:_._._____:_____..__..___1____________:_:.J. _ _ _ . . __ .___._2

W' +

For example:

" Item I described in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty involves loss of automatic initiation capebility of the Emergency Core Cooling System (ECCS) in response to a low-low-low reactor vessel water level signal between June 5-10, 1985 while Unit 2 was in cold shutdown. The violation resulted from the failure of your staff to ensure that modifications perfcnned on safety-related systems were adequately controlled so that system operability was not jeopardized. In addition, from 3:30 a.m. on June 5 until 5:30 p.m. on June 8, 1985, secondary containment was neither established nor maintained as required by Technical Specifications when Emergency Core Cooling capability is lost.

The circumstances leading to the violations are described below.

Division III of the ECCS was removed from service in March 1985 for nonnal maintenance. Between April and June 1985, due to inadequate controls in the design, inspection, and testing areas, the piping to two reactor vessel water level actuation switches in Division I of the Unit 2 Emergency Core Cooling Systerr (ECCS) was installed backwards and, as a result, the Division I ECCS pumps would not have initiated as required on a low-low-low-low reactor vessel water level trip signal. At 3:30 a.m. on June 5, 1985, while unaware that Division I was inoperable, you removed Division II of the ECCS from service. Since you had removed Division III frc=

service in March 1985, the three ECCS divisions were inoperable and automatic initiation capability of the ECCS in response to a low-low-low reactor vessel water level signal was lost until the problem was discovered and corrected on June 10, 1985. The cause of this event was the lack of adequate design document, inspection, and testing controls in your modification program.

i While we recognize that when these violations occurred LaSalle Unit 2 was in cold shutdown, we consider this violation particularly significant because of its similarity to a violation identified in April and for which you were cited in July and to several other recent events for which violations are cited in the enclosed Notice.

On April 17, 1985, while performing monthly functional tu ts on LaSalle Unit 1, your staff determined that two switches for the Unit 1 Automatic Depressurization System (ADS) were miswired, making the trip system "B" for ADS initiation itaperable. This matter was discussed l with you during a May 28, 1985 Enforcement Conferener and a Notice cf Violation was sent to you on July 18, 1985 for inadequacies in your design and test controls (reference NRC Inspection Reports 50-373/85017 and50-374/85017). The causes of the ADS problem were almost identical to the causes of the Unit 2 ECCS problem, even though the trip system "A" for ADS initiation was wired correctly and would have been able to initiate if required."

l 1

I 3

J Revision Responsibility - ORA Region V Instruction No. 0201 HANDLING OF REGION V ENFORCEMENT ACTIONS A. Purpose To establish guidance and procedures for evaluating and processing identified violations of regulatory requirements and other identified matters involving safety issues related to a licensed activity and ensure that the provisions of IE Manual Chapter 0400 are appropriately implemented. The provisions of the manual chapter are controlling.

Therefore, all responsible individuals should be familiar with provisions of that chapter.

B. Objective To ensure appropriate enforcement actions are taken against licensees for violations of regulatory requirements to provide an incentive for licensees to achieve maximum compliance with commission requirements.

C. Responsibilities

1. Regional Administrator The Regional Administrator is directly responsible to the Executive Director of Operations for proper execution of the NRC Enforcement Policy as published in 10 CFR Part 2, Appendix C and for proper implementation of the provisions of IE Manual Chapter 0400. All proposed escalated enforcement actions must have the concurrence of the Regional Administrator.

)

- 2. Division Directors -

The Division Directors and their respective staffs responsible for

• inspection and licensing are directly responsible to the Regional Administrator for analysis and evaluation of identified safety matters and violations of regulatory requirements. This responsibility also includes the preparation of the necessary documents to inititate and impose appropriate sanctions for said violations pursuant to the NRC Enforcement Policy and in accordance with the provisions of IE Manual Chapter 0400.

3. Enforcement Officer The Enforcement Officer is directly responsible to the Regional Administrator for managing and directing the enforcement activities within the Regional Office and ensure that proposed enforcement actions are consistent with NRC enforcement policy and the provisions of IE Manual Chapter 0400. He speaks for the Regional Administrator on enforcement matters. All enforcement actions mnst Revision 3, gg.ff-W6 NOV { M ge-

I l

2 have the concurrence of the Enforcement Officer or in the Officer's absence, the concurrence of the Regional Administrator. The Enforcement Officer shall keep the Public Information Officer and the State Liaison Officer informed of any pending escalated enforcement action so that an appropriate press release can be made and State Officials can be notified shortly after escalated enforcement documents are mailed to a licensee. Additionally, the Enforcement Officer shall promptly inform the Director, 01, RV field office of any suspected Material Felse Statements. Matters referred I to OI should be coordinated with 01 prior to advising a licensee of the potential referral. Upon receiving a response from a license pertaining to escalated enforcement action the enforcement officer shall notify the IE enforcement staff of same.

D. Definitions

1. NRC Regulatory Requirements are:

a. Atomic Energy act of 1954, as amended

b. Energy Reorganization Act of 1974, as amended

c. CFR Title 10, Energy

d. NRC License Terms and Conditions

' e. NRC Orders

2. Enforcement Actions (10 CFR Part 2, Appendix C) are: *

a. Notice of Violation

b. Notice of Deviation -

c. Enforcement Conference ,

d. Confirmatory Action Letter

e. Bulletins, Circulars, ar.d Information Notices

f. Orders:  !

(1) Civil Penalty (2) Modification (3) Suspension (4) Revocation (5) Cease and Desist Revision 3, Instruction No. 0201 NOV 121986

3

[6) Show Cause (7) Specific Action

3. Violation is a term used to characterize an act or omission resulting in the failure to comply with a legal obligation and violates an NRC Regulatory Requirement. An NRC Regulatory Requirement is a legal obligation imposed by a statute, rule, .

regulation, license, or an order.

4. Deficiency is a term used in 10 CFR 50.54(s) (2)(ii) to characterize a violation of a NRC regulatory requirement or a standard imposed under 10 CFR 50.54(r) and (s). The term is also used in i 10 CFR 50.55(e) to describe a failure to satisfy established '

criteria in the design and construction of a nuclear power plant.

5. Deviation is a term defined in 10 CFR 21.3(e) as "a departure from technical requirements included in procurement documents." The term is also used in 10 CFR 2, Appendix C, IV, to describe a licensee's or vendor's failure to satisfy a commitment.

6. Commitment is a term used to describe a promise made by a licensee, in writing or recorded at the time (e.g. , during a ASLB hearing or NRC inspection) that certain equipment, procedures, guides, controls or other actions will be installed or implemented, but the promise was never made an NRC regulatory requirement.

7. Refer to IE Manual Chapter 0400 for additional definitions.

E. Processing an Identified Violation of an NRC Requirement 4

Whenever a member of the Region V staff becomes aware of facts that

" indicate or may indicate that a licensee or other person (s) has violated or intends to violate an NRC Regulatory Requirement, the matter shall be ,

handled as follows. j

1. If the apparent violation be identified other than during an inspection activity, the individual aware of the matter shall immediately notify the cognizant Section or Branch Chief or the Division Director responsible for inspection of'the type of licensed activity involved, or the Enforcement Officer, to ensure that the r matter'is appropriately handled during a future inspection or as otherwise directed.

2. If the apparent violation be identified during an inspection, the Inspector should gather all of the relevant facts and circumstances surrounding the violation as set forth in paragraph 05.02 of IE Manual Chapter 0400. The Inspector shall discuss and confirm the 3 facts with licensee management during the exit interview.

Revision 3, Instruction No. 0201 NOV 121966 l

4 Corrective actions taken or planned by the licensee should also be obtained. During discussions'with a licensee of an apparent violation (s) that may become the subject of an escalated enforcement action, members of the Region V staff should not state or otherwise disclose the severity level and/or which violations will be proposed for escalated action without prior approval of the Enforcement Officer or the Regional Administrator.

3. In addition to gathering all relevant facts, if the Inspector believes that a violation is of the type that may be categorized as Severity Level I, II or III, the Inspector shall immediately notify the responsible Section or Branch Chief of the apparent violation.

Subsequently, if the supervisor also believes that the violation may require escalated enforcement action, the Inspector shall, thereafter, obtain copies of all documents pertaining to the matter including, but not limited to: procedures, logs, checklists, instrument records, audit reports, problem reports, maintenance

! records, surveillance reports, calibration records, survey records, I

results of reviews and evaluations, records of safety committee action, and etc., as appropriate to the circumstances. Normally, the enforcement officer and a member of Region V management will independently review the matter at the facility site.

4. A Severity Level I, II, or III violation shall be evaluated in accordance with the NRC Enforcement Policy paragraph 05.03 of IE Manual Chapter 0400, and, if appropriate, sn order and/or a civil l penalty shall be proposed against the responsible licensee or person (s). Final disposition of such violations shall be subject to the concurrence and approval of the Director IE. -

Within ten (10) working days following an inspection or subsequent to becoming otherwise aware of a Severity Level I,'II, or III violation, a documentation package consisting of a Letter to the Licensee, Notice of Violation, Notice of Proposed imposition of Civil Penalty, and/or other Orders'shall be prepared by the ,

responsible inspection staff and forwarded to the Director.

• Enforcement Staff, IE, by the Enforcement Officer as prescribed in paragraph 04.02 of IE Manual Chapter 0400. Along with this package, the Enforcement Officer shall select other available supporting documents to transmit with the package. Copies of any and all documents sent to IE shall 1so be sent at the same time to OELD.

An enforcement conference should be scheduled with the licensee to discuss the violation (s) between 15 and 20 days subsequent to the I decision that escalated enforcement action may be appropriate. (See section J of this Instruction for additional detail.) A typical document package for escalated enforcement action are attached as Appendices to IE Manual Chapter 0400 and should be followed regarding format and use of boilerplate paragraphs, as indicated.

Also, the quarterly NUREG-0940, Enforcement Actions may be used as references.

Revision 3, Instruction No. 0201 NOV 121906

5

5. Severity level IV or V violations shall be evaluated by the ,

responsible inspection staff in accordance with the NRC Enforcement Policy and a determination made as to: (1) whether the number and type of violations identified during a particular inspection constitute a breakdown of management control, or lack thereof, of {

j the type to be of a significant safety concern to the NRC, or l (2) whether the namber and type of violations were isolated )

instances of personnel failing to follow established procedures, but I do not represent a substantial breakdown in control of licensed I activities.

If the violations and surrounding circumstances, constitute a breakdown of control and are a significant safety concern, the items should be the' subject of an enforcement conference and consideration j should be given to the advisability of proposing escalated J enforcement action. As indicated in the policy, violations of a repetitive nature accompanied by a corresponding failure to take effective corrective measures to prevent recurrence should be given  ;

due consideration during the evaluation and decision process.

For isolated instances of Severity Level IV or V violations not )

constituting a significant safety concern, and not otherwise associated with escalated enforcement action, the licensee shall be notified of the violations by letter with an accompanying Notice of Violation. Typical letters and Notice of Violations are attached to IE Manual 0400 as appendices and generally should be followed regarding fortnat and use of boilerplate paragraphs, as indicated.

When Severity Level IV or V violations are identified'along with Severity Level I, II, or III violations, the licensee generally should be notified of such violations as shown in the Appendices to ,

IE Manual Chapter 0400.

)

F. " Processing a Notice of Deviation Notice of Deviations are written notices describing a licensee's or

• vendor's failure to satisfy a commitment. The main difference between a Notice of Deviation and a Notice of Violation is that in the Notice of Deviation NRC requests the licensee or vendor to provide a written explanation or statement describing corrective steps taken (or planned),

the results achieved, and the date when corrective action will be completed. A typical Notice of Deviation is attached as Appendix A to this instruction for guidance as to format and style.

G. Processing a Confirmatory Action Letter l

A confirmatory action letter is a letter to a licensee confirming and documenting a licensee's agreement to take actions to remove significant concerns about health and safety, safeguards, or the environment. A I

typical confirmatory action letter is attached as Appendix B to this instruction for guidance as to format and style.

Revision 3, Instruction No. 0201 NOV 12 E6

l

. 6 O

Whenever a Division Director deems that a confirmatory action letter is appropriate 'to document a licensee's oral agreement to take certain actions, an appropriate draft letter should be prepared by the responsible Division Director for the Regional Administrator's signature.

Thereafter, the Administrator or his_ designee will discuss the matter with a corporate officer or other equivalent management official of the licensee and assure that the agreement accurately represents the understanding of both the Management of the Regional Office and the Management of the Licensee. Copies of all issued confirmatory action letters shall be sent to the Director of Enforcement Staff and OELD at the same time the letter is mailed to the licensee. l I

H. Processing Bulletins, Circulars, and Information Notices 1 Whenever a member of the Regional staff becomes aware of an adverse safety, safeguards or environmental condition related to licensed activities that may be of interest to other licensees engaged in a similar type of activity, the individual should discuss the matter with the Section Chief responsible for inspection of that type of activity and determine whether or not the matter should be recommended as the subject of a Bulletin, Circular or Information Notice. IE Manual Chapter 1125 provides the detailed instructions for preparation, approval and issuance of Bulletins, Circulars and Information Notices.

I. Processing Orders j

1 Only certain designated NRC Office Directors have been delegated j authority to issue orders. Normally, as the NRC principle enforcement officer, the Director of IE will issue orders involving civil penalties and those otherwise advisable to ensure that safety, safeguards and environmental projections and standards are maintained.

Whenever the Regional staff determines that an order should be issued to

- protect the public health, safety or interest, the Enforcement Officer shall coordinate the' recommendations of the regional staff and proposed orders with the Director of Enforcement Staff, IE and also with OELD.

Examples of orders may be obtained from the Enforcement Officer or IE Enforcement Staff.

J. Handling of aa Enforcement Conference An enforcement conference is a meeting held by NRC with licensee management to discuss safety, safeguards or environmental problems; licensee's compliance with regulatory requirements; a licensee's proposed corrective measures (including schedules for implementation); and enforcement options available to the NRC. An enforcement conference should be held whenever Severity Levels I, II or III Violations are identified or when safety, safeguards or environmental problems of similar significance are identified for which issuance of an appropriate order may be necessary to ensure proper action by a licensee.

Revision 3, Instruction No. 0201 NOV 12 EB

7 For Severity Level IV and V Violations, enforcement conferences should be held whenever the facts and circumstance surrounding the violation (s) indicate a significant breakdown in the management control of licensed activities and/or a programmatic problem; rather, than an isolated case involving oversight on the part of a particular individual. Repetitive i violations of a similar type may indicate a programmatic p problem or a )

careless disregard of the requirement and, therefore, should be evaluated  !

and acted upon as circumstances dictate.

When an inspector believes that the' above mentioned condition (s) n.ay exist, the matter should be evaluated by the management of the Cognizant Division and recommendations discussed with the Enforcement Officer. If both the Division Director and the Enforcement Officer agree that an enforcement conference would be inappropriate, no further anion will be initiated. If otherwise, the matter, including appropriate recommendations, shall be presented by the Division Director and Enforcement Officer to the Regional Administrator who will thereaf ter render a decision of (1) whether or not an enforcement conference will be held (2) who will represent NRC, (3) level of licensee management required to be present, (4) when and where the conference will be held and (5) what should be the main topics and thrust of the action.

An enforcement conference must be held, if one is planned, before issuance of a Notice of Violation and should be held within four weeks after completion of the inspection or issuance of an investigation report. The licensee should be informed of the enforcement conference at least three working days in advance, unless the licensee agrees to a shorter period. The licensee must be told that the meeting is an enforcement cenference and should be provided a copy of the inspection i report in advance, unless doing so would significantly delay the  :

i conference and prevent expeditious issuance of the enforcement action. j Immediately after scheduling an enforcement conference the cognizant

' Division Director shall:

I (a) Issue a " Notice of Significant Licensee Meeting" pursuant to IE 1 i

Manual Chapter 1425, to be reissued as Manual Chapter 1100.

1 (b) Prepare a brief agenda for the conference. l l

(c) Send a letter to the licensee confirming the time and place of the conference. The agenda will be included or be attached to the letter. An example is attached as Appendix C.

(d) For an escalated action, prepare the appropriate enforcement documents. The Enforcement Officer will discuss the matter with the IE Enforcement Director prior to the conference. A representative of IE will normally attend an enforcement conference that may {

involve a major action. Immediately after a conference involving a major action, the Regional Administrator and the IE Representative will decide on the appropriate course of action.

Revision 3 Instruction No. 0201  !

fiGV 121986

8 Subsequent'to a conference the cognizant Division Director shall issue a short report of the conference in a form similar to an inspection report.

An example is attached as Appendix D.

The Region V goal for issuance of escalated enforcement actions is 30 days from the date of identification or exit interview following an inspection whichever is appropriate.

K. Issuing of Press Releases The Region V Enforcement Officer shall inform the regional Public Affairs I Officer (RPAO) when an escalated enforcement action is about to be issued. The RPA0 will prepare a press release and provide copies to IE and to the regional staff for concurrence. Af ter the enforcement action has been signed, the RPA0 will verify that the licensee has been notified of the action and has received a copy. The NRC press release will be issued 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the region has verified that the licensee has received the action. In unusual circumstances, such as when the licensee issues its own press release during the grace period, the RPA0 may obtain the concurrence of the Director, IE, to issue a press release during the 24-hour grace period. All press releases should include information on the initiation and progress of corrective actions and an assessment by the Regional Administrator of the facility's operating status and recent operating history to present a complete and balanced account to the public, APPROVED: do wfQ

. .artin -A yW Regional Administrate Date: N OV 1 2 togs 1

I l

[ Revision 3,

( Instruction No. 0201  ;

NOV 12 iggs

O APPEND 1X A INSTRUCTION NO. 0201 FEB 181983 Docket No. 50-397 Washington Public Power Supply System P. O. Box 968 Richland, Washington 99352 Attention: Mr. R. G Matlock

. Program Director Gentlemen:

Subject:

HRC Inspection This refers to the inspection conducted by Mr. A. Toth of this office, during January 1-31,1983, of activities authorized by HRC Construction Pemit flo. CPPR-93, and to the discussion of findings held by Mr. Teth with Mr. C. Carlisle and members of your staff at the conclusion of the inspection.

Areas examined during this inspection are described in the enclosed inspection report. Within these areas, the inspection consisted of selective examination of procedures and representative records, interviews with personnel, and observations by the inspector.

Based on the results of this inspection, one of your activities appeared to deviate from your commitments to the NRC, as set forth in the Notice of Deviation, enclosed herewith as Appendix A. Please respond to this notice as requested in the Appendix.

In accordance with 10 CFR 2.790(a), a copy of this letter and the enclosure will be placed in the NRC Public Document Room unless you notify this office, by telephone, within ten days of the date of this letter and sutait written application to withhold infomation contained therein within thirty days of the date of this letter. Such application must be consistent with the requirements of 2.790(b)(1). .

OCT 2 51985

. APPENDIX A

- INSTRUCT'ON NO 0201

..( .

.n.cr ) .. ..-..%., ,, - . ...............,,,,, ,,,,,,,,,,,,,,,,,,,,,,,,

sunu:mi) ,_,, .,_,, .,_.

........g...., ,, ,,,,,,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,,,,,,,,,,,, , , , , , , , , , , , , , , , , , , , , , , , ,

Datt D . . , .

%. .-.cr.o nm cmo c_ -

., 'a APPENDIX A INSTRUCTION NO. 0201 Washington Public Power Supply System 00s i The responses directed by this letter (and the accompanying Notice) are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980. PL 96-511. '

Should you have any questions concerning this inspection, we will be glad to discuss them with you. .

Sincerely, D. M. Sternberg, Chief l Reactor Projects Branch 1

Enclosure:

A. Appendix A - Notice of Deviation B. Inspection Report No. 50-397/83-03 ,

cc w/ enclosures:

R. B. Glasscock' '

C. S. Carlisle-G. C. Sorensen .

bec: RSB/ Document Control Desk (RIDS)

Distributed by RV:

1 State of WA (Lewis)

Residentinspector(Feil)

Engelken(1tr) 001 z 51935

(

( APPENDIX A INSTRUCTION N0. 0201

APPEND 1X A INSTRUCTION NO. 0201 <

'i APPENDIX A l

NOTICE OF DEVIATION Washington Public Power Supply System Docket No. 50-397 P. O. Box 968 Construction Pemit No. CPPR-93 Richland, Washington 99352 -

1 As a result of the inspection conducted on January 1-31, 1983, and in  !

accordance with the NRC Enforcement Policy,10 CFR Part 2, Appendix C. ,

47 FR 9887 (March 9,1982), the following deviation was identified:

l Section 2.6 of the Supply System's July 17, 1980 response to the  !

Commission's 10 CFR 50.54(f) request for infonnation dated June 17, 1980, requires documentation and analysis of deficiencies identified during the perfomance of record reviews of contractor's work.

Contrary to the above, Supply System restart .sk force RCSW management failed to act on a record discret cy for valve SW-V-71B i

that was identified by a task force member in a memorandum dated l October 29, 1980. The record discrepancy related to repair work by unidentified personnel, unfounded correction of the nondestructive  ;

examination report, and acceptance of the repaired area without the required control documentation. -

This is a deviation.

Please submit to this office within thirty days of the date of this notice a written statement or explanation regarding the above item, describing corrective steps taken, the results achieved (or corrective steps that are planned), and the date when corrective action will be completed.

Date R. T. Dodds Chief Reactor Project Section 1 APPENDIX A INSTRUCTION NO. 0201 I

s Ef C

[a y) .-(

o,,,

UNITEo STATES NUCLEAR REGULATORY COMMISSION

7 ((/ [

8 REGION V 1450 M ARIA L ANE, $UIT E 210

%, ' 4.' ,0 U

WALNUT CREEK, CALIFORNIA 94596

. bG 261985 APPENDIX B INSTRUCTION N0. 0201 Docket No. 50-312 License No. DPR -54 CONFIRMATORY ACTION LETTER 1

Sacramento Municipal Utility District P.O. Box 15830 Sacramento, California 95813 Attention: Mr. R. J. Rodriguez

Subject:

Return of Rancho Seco to Power Operations from Current Outage Gentlemen:

We are in receipt of your letter of August' 21, 1985, in which you identify the additional actions you plan to take, prior to the restart of Rancho Seco.

Therefore, it is our understanding that prior to restart of Rancho Seco from it's current outage you will: (1) complete the items identified in your letter of August 6,1985, as referenced in our letter to you of August 9,1985, and (2) complete the actions identified in your letter of August 21, 1985, as referenced above.

In addition to the above, it is also our understanding that prior to restart of Rancho Seco, you will brief the NRC of all organizational changes being planned within SMUD that could affect the operation of the Rancho Seco facility.

If our understanding concerning , our proposed actions, as sumarized above, is not correct, you should promptly notify this office in writing.

m ,11 A ,

fev}J.B.artin ~~

Regional Administrator cc:

L. G. Schwieger, SML'D P. Oubre'. SMUD '

State of CA OCT 2 51985 APPENDIX B INSTRUCTION NO. 0201

e j

l APPENDIX C INSTRUCTION NO. 0201 l 1 License No. 04-00421-05 \

A L 1%3 Veterans Administration Medical Center ..

4150 Clement Street

l San Francisco, California 94121 -

i Attention: Ms. Perry C. Norman, Associate Director I 1

i Centlemen:

l I

I

Subject:

NRC Enforcement Conference '

i l

This vill confirm the telephone conversation between you and Mr. R. Thomas of l my staff on May 13, 1983, concerning the scheduling of an enforcement

!- conference to be held between NRC canagement and the management of the V.A. Medical Center.

l May 24, 1983. We vill arrive at your office at 9:30 A.H. on Tuesday, ,

The following matters vill be discussed.  !

. ' i

1. Results of the last inspection l i 2. NRC enforcement options I

i 3. NRC concerns

4. , Licensee management responsibilities i We anticipate that the entire meeting vill take approximately one hour.

, Sincerely, l b lj .

l John B. Martin Regional Administrator cc: Veterans Administration Department of Medicine and Surgery Washington, D.C. 20420 Atta: James J. Smith, M.D. .

Nuclear Medicine Services (112 ' H) 4 OCT 2 51985 APPENDIX C .

INSTRUCTION N0. 0201

[ o,, UNUED STATES 83 e

., Ik e, l NUCLEAR REGULATORY COMMISSION REGION V

/ 145o MARIA LANE, suf7E 210 APPENDIX D

% * . . . * ,d WALNUT CREEK.cALIFoRNI A 945a6 INSTRUCTION NO. 0201 AUG 081983 ..

License No. 04-00421-05 Veterans Administration Hospital 42nd Avenue and Clement Street San Francisco, California 94121 Attention: Dr. L. V. Foye, Director Gentlemen:

This refers to the enforcement conference held with members of your staff at the 1983.Veterans Administration Hospital, San Francisco, California on May 24, licenseThe conference listed above. was related to activi+.ies conducted under the NRC in the report which is enclosed for your information. Subjects discussed during that mee No response to this letter is required.

this report, please contact R. D. Thomas onIf you have any questions concerning 415-943-3700.

Sincerely, H. E. Book, Chief Radiological Safety Branch -

OCT 2 51985 APPENDIX D INSTRUCTION NO. 0201

1 I

e * . l l

APPENDIX D INSTRUCTION NO. 0201 U.S. NUCLEAR REGULATORY COMMISSION i OFFICE OF INSPECTION AND ENFORCEMENT REGION V Report No. 83-02 License No. 04-00421-05 Priority G1 Category 2 --

Licensee: Veterans Administration Hospital 1 42nd Avenue and Clement Street San Francisco, California 94121 i Facility Name: Veterans Administration Hospital Location: Licensee's Facility '

4 Conference conducted: May 24, 1983

Participants:

K. A. Scarano, Director

- - ----- / MJ Date Signed Division of diological Safety and i Safegu s4 ograms l . Y A. D. Jo s6n, Enforcement Officer D4te/ Signed m

R. D. Thomas, Chief

~

M

. Di(te' Signed Materials Radiation Protection Inspection and Licensin Section Approved by: .

H. E. Book, Chief, Radiological Safety Branch Date Shaned .

Summary:

Enforcement Conference on May 24, 1983 (Report No. 83-02)

The following matters were discussed:

1.

Licensee's 20-22, 1983 enforcement history and violations associated with the April inspection.

2. NRC enforcement policies and procedures.

3. NRC actions to be taken in the present situation.

4. Possible future actions by the NRC.

5. Other matters of concern to NRC.

This enforcement conference involved a total of two hours on-site by three NRC representatives.

~

001 26 1955 APPENDIX 0 INSTRUCTION N0. 0201

I l

l l

l APPENDIX D g INSTRUCTION NO. 0201

1. Enforcement Conference Participants R. Cline, Acting Medical Center Director R. S. Goldsmith, Chief of Staff B. Lyden, Assistant Chief of Staff R. R. Cavalieri, Chief, Nuclear Medicine T. Engler, Safety Manager 1 D. McCartney, Administrative Officer /Research R. Allen, Chief Engineer l

W. L. Wagner, Radiation Safety Officer '

R. A. Scarano, Director, Division of Radiological Safety and Safeguards Programs, NRC l i .

A. D. Johnson, Enforcement Officer, NRC l R. D. Thomas, Chief, Materials ~ Radiation Protection Inspection and ,

l Licensing Section, NRC l l

2. Enforcement Conference l On May 24, 1983, an enforcement conference was held at the Veterans Administration Medical Center, San Francisco, California with the individuals listed above participating. The enforcement conference was related to the special safety inspection which was an early reinspection of the activities authorized by NRC License Number 04-00421-05 for the nuclear medicine service and research laboratories. The inspection was conducted on April 20-22, 1983. The enforcement conference was i

announced in a letter to the licensee dated May 16, 1983. A copy of that letter is attached.

A copy of the inspection report (83-01) which was sent to the licensee ,

on May 30, 1983 had been received. A copy of the inspection report is attached.

Mr. R. Scarano, NRC, stated that the purpose of this enforcement conference was based upon the results of the early reinspection and the number of violations identified. Of the nine violations identified, four were directly repetitive which would indicate the corrective actions taken after the previous inspection were ineffective. Mr.

Scarano stressed the need for a strong management commitment in the overall program.

Dr. R. Goldsmith discussed certain corrective actions which had been taken function.since the April 1983 inspection to enhance the management control

• These actions were stated in correspondence to Mr. R. Thomas dated May 16, 1983. A copy of that letter is attached.

Mr. R. Thomas, NRC, reviewed the past enforcement history of the licensee. The individual violations which were identified during the last inspection were discussed.

Mr. Thomas stated that the number of

( violations, some of which were repetitive, found during the last inspection were indicative of an ineffective radiation safety program OCT 2 51985 APPENDIX 0 INSTRUCTION NO. 0201

' APPENDIX D INSTRUCTION NO. 0201 i

and associated management control audits.

Mr. Thomas stressed NRC's concern for a strong day-by-day radiation safety program in conjunction with an active Radiation Safety Committee. The need for strong Participation on the part of management to cottrol the overall licensed .

program was stressed as one of the most significant requirements in maintaining an acceptable radiological safety program.' Mr. Thomas also f stated that as a result of the inspection and associated enforcement conference an early reinspection would be conducted by the NRC. j j

Mr. A. Johnson, NRC, explained the enforcement policies and procedures of the NRC as published in 10 CDt 2, Appendix C. Copies of the enforcement policy were given to the licensee. ,

Escalated enforcement l actions such as civil penalties, orders to modify, suspend, or revoke licenses, and orders to cease and desist were discussed. The relative  !

significance of the different severity levels was explained, and it was pointed out that any violations of this license would fall into

. Supplements IV and VI, Appendix C, 10 CFR 2.  !

Mr. Johnson, NRC, informed the licensee that due to the number of repetitive violations identified during the last inspection, and the apparent ineffectiveness of the radiation safety control program, j consideration was being given by the Regional Office to propose to the IE Headquarters enforcement staff that escalated enforcement action should i l

l be taken in this case. Mr. Johnson also stated that if the proposed i

enforcement action was going to be taken, the licensee would be notified  !

officially of the final disposition in this matter.

Dr. R. Cavalieri stated that one of the violations noted in the inspection report was in error since some bicassay records, which were missing during the inspection, had been found.

Mr. R. Thomas, NRC, asked that a copy of the bioassay records be sent to the Regional Office so the matter could be discussed with the inspector. .

Mr. Thomas stated that if the bicassay records fulfilled the requirement, the violation would be dropped.

3. _ Conclusions The licensee's rer ponse to the enforcement conference was acceptable.

Comitments for strongerwere supported by management radiologic made. si safety and audit control programs adjourned at 11:30 a.m. The enforcement conference was l

OCI 2 51985 APPENDIX D INSTRUCTION NO. 0201 k.

-