ML20056D287

Provides mark-up Responses to Questions Posed in Re Activities of NRC in Regulation of Agreement States & Matls Licensees

ML20056D287
Person / Time
Issue date:	07/26/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Synar M HOUSE OF REP., GOVERNMENT OPERATIONS
Shared Package
ML20056D285	List: ML20056D281 ML20056D287 ML20056D300 ML20056G037 ML20056G039 ML20056G062 ML20056G067 ML20057A100 ML20057A126 ML20057A191 ML20057A236 ML20057A241
References
CCS, NUDOCS 9308110309
Download: ML20056D287 (10)

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July 26, 1993 The Honorable-Mike Synar,- Chairman Subcommittee on Environment, Energy,.and

' Natural Resources Committee on Go/ernment Operations i

United States House of Representatives 1

Washington, D.C.

20515 i

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Dear Mr. Chairman:

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h I am pleased to provide responses to the questions posed in the j

June 22, 1993 letter from your staff regarding'the activities of the NRC in

'f the regulation of Agreement States and materials licensees. Enclosed is the mark-up key of the June 22, 1993 letter with the new numbers. We will continue to renumber new questions sequentially.

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Sincerely, Originalsignedby i

James M. Taylor James M. Taylor i

Executive Director t

for Operations

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Enclosures:

As stated l

cc:

Rep. J. Dennis Hastert (w/ enclosures)

Distribution:

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DOCUMENT NAME:

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OVESTION 65.

The reviewer comments appended to the 1992 review of the Arizona program state that with the exception of the compatibility rule, the State's regulations are compatible.

First, the statement that the state's program is compatible is at odds with conclusion on page 1 of the report which says compatibility is being deferred until State adopts Decommissioning Rule and also at odds with August 5, 1992 letter from NRC to Arizona stating compatibility was being deferred until state has adopted decommissioning rule. Did the 1992 review find the program compatible and did the reviewer inform the state that it was compatible as stated in the comments? Second, what is the compatibility rule referred to in the reviewer's comments?

ANSWER.

As stated in the letter an-; report, during the 1992 review, compatibility was deferred. The reviewer did not inform the State that they were compatible as stated in his comments.

ihe reviewer informed the State that the finding of compatibility would be discussed with NOC management before a decision could be made as to the acceptability of the state progress on adopting the rule.

The rule referred to was the decommissioning rule.

When closely examined, the reviewer statement referenced in the question above is not at odds with the conclusion in the report and !etter that compatibility is being deferred. The reviewer's statement expresses that except for one Synar/0SP 07/22/93

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.i OVESTION 65.

(Continued)

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regulation which is a matter of compatibility, the remaining Arizona regulations are compatible with those of the NRC.

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However, the statement in the reviewer's comments which may have caused some i

q confusion is, "Because of the controversy encountered by NRC in enforcing the rule, and because of the State's efforts to adopt the changes, compatibility l

j was not withheld." Normally, the reviewer's comments are consistent with the i

j review letter and are not used by the reviewers to take differing positions on the review. This statement in the reviewer's comments was inadvertently left f

in and should have been changed.

Initially, the reviewer recommended to NRC management that a finding of compatibility should not be withheld for the 1

Arizona program. After the exit meeting between the reviewer and Arizona, NRC l

management determined, based on the information gathered during the review I

j that Arizona had not met the stipulations in the September 14, 1990 All 4

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Agretment States letter (Enclosure 1) which addressed compatibility with i

ll regard to the decommissioning rule. The September 14, 1990, letter provided f

i that if the State had initiated rulemaking in a timely manner, and the i

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l rulemaking was on track, as determined in NRC's next Agreement State review, l

1 the finding of compatibility would not be withheld. Arizona had only i

i developed a written plan at the time of the 1992 review and rulemaking had not i

been initiated; thus, the State did not meet the stipulations of the finding

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i of compatibility with regard to the decommissioning rule.

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Enclosure:

As stated l

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07/22/93 i

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OUEST10N 66.

In January 1993, NRC conducted a review of the California program. No letter from tFa NRC to California transmitting the findings of that review was provided.

Please provide copies of this letter and the state's response.

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ANSWER.

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Enclosed is the letter dated April 22, 1993, from NRC to the State of l

California transmitting the findings of the 27th regulatory program review 5

conducted on January 19-29, 1993 (Enclosure 1), and a response letter from the State of California to the NRC dated June 4,1993 (Enclosure 2).

In addition, we have enclosed a letter dated June 22, 1993 from the State of California, regarding their plan, with milestones to complete the overdue inspections referenced in their June 4, 1993 letter (Enclosure 3).

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Enclosures:

As stated

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Synar/OSP 07/15/93

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l OUESTION 67.

Please provide copies of NRC reviews conducted of the

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California program for 1985 and 1986.

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1 eMB.

I In response to this question, the following documents are provided.

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1.

Letter dated April 26, 1985 to Dr. Kenneth Kizer, Director, California Department of Health Services, from John B. Martin, i

Regional Administrator, NRC Region V (Enclosure 1).

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j 2.

Letter dated June 14, 1985 to John B. Martin, Regional l

Administrator, NRC Region V, from Dr. Kenneth Kizer, Director, California Department of Health Services, responding to John B.

Martin's April 26, 1985 letter (Enclosure 2).

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Letter dated July 5,1985 to Dr. Kenneth Kizer, Director, California Department of Health Services, from John B. Martin, I

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Regional Administrator, NRC Region V, responding to Dr. Kizer's 4

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June 14, 1985 letter (Enclosure 3).

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Letter dated September 16, 1985 to Dr. Kenneth Kizer, Director, l

l California Department of Health Services, from John B. Martin, J

Regional Administrator, NRC Region V, transmitting the results of 1

a follow-up review that was conducted on August 23, 1985 (Enclosure 4).

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Synar/0SP l

07/21/93 i

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l OVESTION 67.

(Continued) 5.

A memorandum dated December 5,1985 to Donald A. Nussbaumer, 4

i Assistant Director for State Agreement Programs, Office of State Programs, from Jack W. Hornor, Region V State Agreements 1

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Representative, recommending that the next routine review be conducted in approximately six months (Enclosure 5).

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6.

A copy of the 23rd routine review for the period of December 10, i

I 1983 to February 15, 1985 (Enclosure 6).

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7.

A copy of the 24th routine review for the period of February 15, 1985 to March 14, 1986 (Enclosure 7). A copy of the 25th routine i

review for the period March 15, 1986 to March 14, 1987 was i

provided to the Subcommittee ir response to Question la.

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Enclosures:

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As stated i

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Synar/OSP 07/21/93 l

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i OUEST10N 68.

Please provide copies of NRC reviews conducted of the New Mexico program for 1984, 1985 and 1986.

ANS'JER.

7 In response to this question, enclosed is a copy of the 10th regulatory review, which covers the period November 4, 1983 to April 12, 1985 (Enclosure

1) and a copy of the lith regulatory program review which covers the period i

April 12, 1985 to September 15, 1986 (Enclosure 2). A copy of the 12th l

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regulatory program review which covers the period September 15, 1986 to April 12, 1988 was provided to the Subcommittee in response to Question la.

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Enclosures:

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As stated l

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i Synar/OSP 07/15/93

00ESTION 69.

The Summary of Assessments and Comments of the 1989 9

Regulatory Program Review for North Dakota refers to a July 8, 1988 State response to the previous program review l

conducted in 1987.

It also refers to a September 1,1988 l

NRC letter offering a finding of adequacy and compatibility 1

based on the commitments made by North Dakota in the July 8, i

i 1988 letter. Neither letter was provided to the Subcommittee.

Please provide both 1988 letters.

.1 ANSWER.

l Enclosed is a copy of the letter dated July 8,1988 from the State of North 1

l Dakota to NRC responding to the comments and recommerdations from the 1987 review of the North Dakota radiation control program (Enclosure 1). Also enclosed is a copy of the September 1, 1988 letter from the NRC to the State

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of North Dakota (Enclosure 2).

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Enclosures:

As stated 1

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Synar/OSP 07/15/93 4

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OVESTION 70.

In a January 28, 1992 letter from T. Frazee, Supervisor, Radiacactive Materials Section, State of Washington Department of Health to V. Miller, NRC State Agreements Program states that the State intends to drop QM program pending outcome of ACNP/SNM lawsuit, drop I-123 from misadministration reporting. Subsequently, on March 3, 1992, V. Miller informs the Director of the Washington I

program that the proposed regulations were compatible and on April 9, 1992, C. Kammerer wrote to Washington informing the State that its regulatory program was compatible.

Did Washington State include the QM rule and I-123 prior to final adoption or did NRC determine that the Washington regulations were compatible despite these variations.

ANSWER.

4 Please note that there were no variations between the Washington regulations I

and the NRC regulations when the review report was issued in April 1992.

In j

letter dated March 3, 1993, Enclosure 1, from 1. R. Strong, Director, Washington Division of Radiation Protection, to Carlton Kammerer, Director, i

State Programs, it indicates that the regulations had been reviewed by NRC and all our comments had been incorporated.

As noted in the letter, these regulations were adopted by the Department on March 23. 1992.

However, please j

note only the misadministration reporting requirements were adopted as part of the Washington rules. The State must adopt the remaining quality management portion of the rule by the January 1995 Agreement States adoption date.

If Synar/OSP 07/15/93 i

• 2 QUESTION 70.

(Continued)

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all the rule is not adopted at that time, then compatibility will be withheld with regard to this regulation.

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k'ith regard to the deletion of I-123 from the misadministration reporting, this radionuclide is not covered under the Atomic Energy Act because it is not t

byproduct material. Thus, it is not under NRC's jurisdiction and would not be j -

covered by NRC's current requirements for misadministration reporting.

l Enclosure.

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As stated l

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Synar/OSP 07/15/93 A

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CdMMITTEE ON GOVERNMENT OPERATIONS

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June 22, 1993 To:

Tom Combs, NRC Congressidnal Affairs From:

Dave Berick f

Re:

Agreement Stath Follow-Up This request Whould complete our review of the individual state files provided in response to Questions la and 1b.

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P /)izona program state that with the exception of the con:patibility The reviewer cohrnents appended to the 1992 review of the i

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rule, the State's :degulations are compatible.

First, the statement that the sbate's program is compatible is at odds with conclusion on page 1 of the report which says compatibility is being deferred until state adopts Decommissioning Rule and also at odds with August 5,

1992 letter from imC to Arizona stating compatibility was being deferred until state has adopted decc=issioning rule.

Did the 1992 review find the program t

i corpatible and did the reviewer inform the state that it was corpatible as stated in the comments?

Second, what is the compatibility rule referred to in the reviewer's comments?

6kfr)ogram. January In 1993, NRC conducted a review of the California p

No letter from the NRC to California transmitting the 4

findings of that review was provided.

Please provide ccpies of this letter.g.n.i the state's response.

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Please provide : copies of NRC reviews conducted of the 1

California progra:a fof 1985 and 1986.

b ? 4)

Pleaco provide copies of the NRC reviews conducted of the New f4exico program for 1984, 1985 and 1986.

d, Program Review for Ndrth DakotaThe Su=::ary of Ass essments and Comments of th

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5) refers to a July 8, 1988 State response to the previous program review conducted in 1987. It also refers to a September 1, 1988 NRC letter offering a finding of adequacy and compatibility based on the commitments made by North Dakota in the July 8, 1988 letter.

Neither letter was provided to the Subco=ittee.

P14ase provide both 1988 letters.

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In a January 28, 1992 letter f rom T.

Frazee, Supervisor, s

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Radioactive Materiale Section, State of Washington Department of l

Health to V. Mi2.'er, NRC State Agreements Program states that the i

State intends te drop QM program pending outcome of ACNP/SNM

lawsuit, drop I-123 from misadministration reporting.

Subsequently, on March 3,1992, V. Miller infoms the Director of the the Washington program that the proposed regulations were v

compatible and on April 9, 1992, C. Kart:nerer wrote to Washington infoming the State that its regulatory program was concatible.

Did Washington State include the QM rule and I-123 prior to final adoption or did NRC determine that the Washington regulations were cor.patible despite these variations.

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QUESTION 65 i'

Ref: SP/JL ALL AGREEMENT STATES DATE FOR ADOPTION OF THE DEC0fft!SSIONING RULE (SP-90-157)

On July 12, 1988 we advised the Agreement States of the need to adopt the Decomissioning Rule as a matter of compatibility (enclosure). That I

noticc erroneously informed the Agreement States that the effective date for State regulations to maintain compatibility would be July 27, 1993 rather than July 27, 1991 which would be consistent with the three year interval called for by the NRC Policy Statement. This error was rewntly brought tc our attention. Our conclusion is that the three-year interval called for by the Policy Statement should be applied. We also concluded that because NRC had provided incorrect guidance on the date that the regulations needed to be adopted by the States, the States should not be penalized by withholding a compatibility finding on this account if they do not meet the three. year target date.

1 State Programs plans to include a formal commer.t in its review letters to eny State that has not adopted the Decommissicning Rule by the j

three. year target cate.

If the State has oct initiated timely rulemaking l

for this purpose, a finding of compatibility will be withheld.

If the State has initiated rulemaking in a timely manner, and the rulemaking is on track, as determined in our next review of their program, the finding will not be categorized as of majer significance and a firding of compatEility will r.ot be withheld.

We understano that some States have concerns over the technical and financial aspects of the rule. Uc plan to discus the rule at the upcoming All Agreement Stetes Meeting. This will he an opportunity to ventilate their concerns.

If you are interested in participating in a panel discussicn on this topic, please Tet me know, od;;hd sigred by Vmtf L IS.'cf Vandy L. Miller, Assistant Director for State Agreements Program State Programs Office of Governnental and Public Affairs

Enclosure:

As stated Distribution SA RF FConts Decomissioning File Dir RF SA Staff CKarrrerer RSA0s YMiller ALL AS File A

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UNITED STATES

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DECCT.ISSIONING - FINAL RULE En:lesed is the final rule on'the " General Requirecents for Decomissiening Nuclear Eacilities.* This rule was published en June 27, ISEB and will beca effective on July 27, 1988.

Please n:te that these portforis of the rule that apply to r.aterials

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fa:ilities are a r.atter of coe.patibility for Agreennt States. The HPC willbeginutilizin$7,1990.these standards en each helder of a specific a

licerse af ter July Pursuant to our guidelines, the Agree ent States should ade::t this rule no later than July 27,1993(3 years) in ceder to

r. air.tain es ;atibility. We urge yeu to begin werx en anending your reggiatiens as se:n as pessible.

If y.y have any cuestiens en,this catter, please centact Mrs. Kathleen Scht.e:ter at (301) 492-0320.

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4e-D:nald A. Hussbaumer Assistant' Director for State Acree.ents Pr:gran State, Leial ar.d Indian Tribe P :gra.s Er:lesu e:

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Question 66 l

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UNITED STATES

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WASHINGTON, D.C. MEgH001

%,.... + ad April 22, 1993 Dr. Molly Joel Coya, Director California Department of Health Services 714/744 P Street Sacramento, CA 94234-7320

Dear Dr. Coye:

i This letter confirms the discussion Mr. Jack Hornor and our review team held with Mr. Ron Joseph, Mr. John Vadnais, and Dr. Harvey Collins on January 29, 1993, following our review of the State's radiation control program.

As a result of our review of the State's program and the routine exchange of information-between the Nuclear Regulatory Commission (NRC) and the State of California, we are unable to offer l

findings of adequacy.for the State's program for regulating agreement materials and compatibility with the regulatory l

programs of the NRC.

The findings of adequacy and compatibility are being withheld until the State's radiation control regulations have been amended and improvements have been made in two other Category I Indicators, Status of Inspection Program and Enforcement Procedures.

Status and Compatibility of Regulations is a Category I Indicator.

For those regulations deemed a matter of' compatibility by the NRC, State regulations should be amended as soon as practicable but no later than three years.

The NRC decomuissioning rule was amended on July 27, 1988.

This decommissioning amendment is a matter of compatibility.

We understand this regulation is avaiting legislative approval.

Uniformity among regulatory agencies is an important part of the Agreement State Program and we urge your staff to make every effort to expedite the final adoption of this rule and the others identified in Enclosure 2.

Status of Inspection Program is a Category I Indicator.

At the end of 1992, the State had 46 high priority inspections which were overdue and the number is expected to increase.

In our opinion, this backlog relates directly to the failure-of the State to maintain a staffing level adequate to set the expected inspection frequencies for the agreement materials.

Since the hiring process appears to be impeded by long standing policies of the Department of Personnel Administration and the State Personnel Board, we recommend DHS management resolve this issue at the Department level.

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Dr. Molly Joel Coye 2

AEt3 2 2 1.911 Enforcement Procedures is a Category I Indicator.

The program

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does not use uniform policies or procedures for escalated i

enforcement, resulting in several cases where more severe regulatory action would appear to have been appropriate.

These are described in further detail in Enclosure 2.

We recommend i

that management take a more active role in escalated enforcement proceedings.

We also recommend that specialized legal counsel be provided to the Division of Environmental Health in this area so that legal cases and administration penalties receive prompt action.

i contains an explanation of our policies and practices for reviewing Agreement State programs. contains our summary of the review findings which were discussed during meetings with the staff.

At the exit meeting we explained that we request specific responses to the comments and recommendations.

You may wish to ask Dr. Collins to respond to Enclosure 2.

In accordance with NRC practice, I am also enclosing a copy of this letter for placement in the State's Public Document Room or otherwise to be made available for public review.

I appreciate the courtesy and cooperation extended the NRC staff during the review.

Because of the serious nature of the findings, a follow-up review is planned in approximately 9 to 12 months.

I am looking forward to your response to our comments regarding the Category I Indicators, Status and Compatibility of Regulations, Status of Inspection Program, and Enforcement Procedures, and to your staff responses to the Enclosure 2 comments and recommendations.

Sincerely, priginal signed by Carlton Kammeret l

Carlton Kammerer, Director Office of State Programs

Enclosures:

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Dr. Molly Joel Coye 3

cc w/ enclosures:

l Dr. Harvey Collins, Chief, j

California Environmental Health Division l

J. M. Taylor, Executive Director for Operations, NRC John B. Martin, Regional Administrator, NRC Region V Charles Imbrecht, State Liaison officer State Public Document Room NRC Public Document Room bec w/encls:

The Chairman Commissioner Rogers Commissioner Curtiss Commissioner Remick Commissioner de Planque Distribution:

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ADD 1ication of " Guidelines for NRC Review of Aareement State Radiation Control Procrams"

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The " Guidelines for NRC Review of Agreement State Radiation control Programs," were published in the Federal Reaister on May 28, 1992, as an NRC Policy Statement.

The Guidelines provide 30 indicators for evaluating Agreement State program areas.

Guidance as to their relative importance to an Agreement State 1

program is provided by categorizing the indicators into two 1

1 categories, i

Category I indicators address program functions which directly relate to the.~. tate's ability to protect the public health and safety.

If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.

Category II indicators address program functions which provide essential technical and administrative support for the primary l

program functions.

Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program

areas, i.e.,

those that fall under Category I indicators.

Category II indicators frequently can be used to identify l

underlying problems that are causing, or contributing to, i

difficulties in Category I indicators.

It is the NRC's intention to use these categories in the following manner.

In reporting findings to State management, the NRC will indicate the category of each comment made.

If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.

If one or more significant Category I comments are provided, the State will be notified that the program deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvement in particular program areas is critical.

If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of adcquacy and i

compatibility as appropriate or defer such offering until the StLte's actions are examined and their effectiveness confirmed in a tubsequent review.

If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.

NRC staff may hold a special meeting with appropriate State representatives.

No significant items will be left unresolved over a prolonged period.

The commission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC Public Document Room.

If the State program does not improve or if additional significant Category I deficiencies have developed, a

staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or f

part of the Agreement in accordance with Section 274j of the Act, as amended.

i Enclosure I y

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SUMMARY

OF ASSESSMENTS AND COMMENTS FOR THE CALIFORNIA RADIATION CONTROL PROGRAM JANUARY 19, 1991 TO JANUARY 29, 1993 L

SCOPE OF REVIEW i

This program review was conducted in accordance with the Commission's Policy Statement for reviewing Agreement State Programs published in the Federal Register on May 28, 1992, and the internal procedures established by the Office of State Programs, State Agreements Program.

The State's program was reviewed against the 30 program indicators provided in the Guidelines.

The review included inspector accompaniments, discussions with program management and staff, technical evaluation of selected license and compliance files, and the i

evaluation of the State's responses to an NRC questionnaire that was sent to the State in preparation for the review.

The 27th regulatory program review meeting with California representatives was held from January 19-29, 1993, in Sacramento.

The State was represented by Harvey Collins, Ph.D.,

Chief, Environmental Health Division, Edgar Bailey, Chief, Radiologic Health Branch (RHB), and Don Womeldorf, Chief, Environmental Management Branch (EMB).

L Selected license and compliance files were reviewed by Jack Hornor, State Agreements' Officer, Region V, assisted by i

James Lynch, State Agreements Officer, Region III, Lloyd Bolling, Health Physicist, Office of State Programs, Jim Montgomery, Senior Materials Radiation Specialist, Region V, and Jack W.

Taylor, Investigative Team Leader, Office of Inspector General.

Prior 'o the review meeting, Mr. Horner visited regional and contract offices as follows:

Orange County November 23,24, 1992 Los Angeles County November 25 San Diego County November 30-December 1 RHB, Southern California Region December 2,3 RHB, Northern California Region December 15,16 The Counties were represented by Frank Bold, Senior Health Physicist, San Diego County, James Hartranft, Supervising Public Health Physicist, Orange County, and Kathleen Kaufman, Director of Radiation Management, Los Angeles County.

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Field accompaniments of four inspectors were made by Mr. Hornor on November 23, December 2 and 15, 1992, and January 22, 1993.

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A summary meeting to present the results of the review was held with Ron Joseph, Chief Deputy, Director of Operations, Department of Health Services, John Vadnais, Assistant Deputy, Director of Prevention Services, and Dr. Collins on January 29, 1993.

CONCLUSION A finding of adequacy and compatibility is being withheld until the State's radiation control regulations have been amended and improvements have been made in three category I Indicators, Status and Compatibility of Regulations, Status of Inspection Program and Enforcement Procedures.

STATUS OF PROGRAM RELATED TO PREVIOUS NRC FINDINGS l

The results of the previous review were reported to the State in a letter to Dr. Kenneth Kizer dated March 20, 1991.

With the exception of Licensing Procedures, all comments made at that time were satisfactorily resolved and closed out prior to our visit ending January 24, 1992.

However, during this review, repeat deficiencies were again noted in Licensing Procedures, and in 2

Inspection Procedures and Inspection Reports.

These repeat findings are identified in current review comments.

CURRENT REVIEW COMMENTS AND RECOMMENDATIONS

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All 30 program indicators were reviewed and the State fully satisfies 21 of these indicators.

Specific comments and recommendations for the remaining nine indicators are as follows:

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Status and Compatibility of Regulations is a Category I J

Indicator.

We consider the following comment to be significant.

Guideline Statenent For those regulations deemed a matter of compatibility by the NRC, State regulations should be amended as soon as practicable but no later than three years.

i Comment The review of the State's radiation control regulations disclosed that the State's regulations are compatible with the NRC regulations up to the 10 CFR Parts 30, 40, and 70 amendments on decommissioning that became effective on July 27, 1988.

This decommissioning amendment is a matter of compatibility.

In a letter dated September 14, 1990, we informed the States that the Commission planned to include a formal comment in its review letters to any State that has

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not adopted the Decommissioning Rule by the three year i

target date, i.e.,

July 27, 1991.

3 4

other regulations have been adopted by NRC that are also matters of compatibility.

These regulations are identified l

below with the Federal Recister (FR) notice and the date that the State needs to adopt the regulation to maintain compatibility.

" Emergency Planning Rule," 10 CFR Parts 30, 40, and 70 e

amendments (54 FR 14051) needed by April 7, 1993.

" Standards for Protection Against Radiation," 10 CFR e

j Part 20 amendment (56 FR 61352) needed by January 1, 1994.

" Safety Requirements for Radiographic Equipment," 10 CFR Part 34 amendment (55 FR 843) needed by January 10, 1994.

(California has adopted this regulation.)

" Notification of Incidents," 10 CFR Parts 20, 31, 34, e

39, 40, and 70 amendments (55 FR 40757) needed by October 15, 1994.

" Quality Management Program and Misadministrations," 10 a

CFR Part 35 amendment (56 FR 153) needed by January 27, 1995.

Recorrendation We understand the State is awaiting the legislative approval i

necessary for statutory changes having a financial impact on licensees.

We recommend the State initiate the process of revising regulations with sufficient lead time to meet the target date.

We also suggest the State use the Succested State Peculations (SSR) provided by the NRC and Conference of Radiation Control Program Directors to expedite future regulation promulgation.

II.

Status of Inspection Program is a Category I Indicator.

We consider the following comment to be significant.

Guideline Statement 4

The State Radiation Control Program (RCP) should maintain an i

inspection program adequate to assess licensee compliance l

with State regulations and license conditions.

When

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i backlogs occur, management should develop and implement a j

plan to reduce the backlog.

1 Comrent Forty-six Priority 1 through 3 and initia) inspections were i

overdue by more than 50% of their inspection frequency as of December 31, 1992.

The number of overdue inspections is expected to increase monthly, and the State has no viable l

plan to eliminate the backlog without additional staff.

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4 Recorrendation f

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Three root causes for the deterioration of the inspection program were considered in naking our recommendations:

A.

The RHB, already below the recommended staffing level, i'

has been operating throughout the past year with 70% of the authorized inspection staff.

Three inspector positions are currently vacant.

We understand one candidate has accepted an inspector position, but final hiring papers have been waiting several months for i

Personnel Office processing.

We recommend every effort be made to fill these positions without further delay.

B.

Overdue inspections in Los Angeles and San Diego counties accounted for 38 of the 46 total overdue.

We recommend the State re-evaluate the practice of contracting inspections and investigations to county agencies, and if continued, future contracts should hold the counties accountable for work not performed.

C.

The State's inspection schedule is planned around the

" overdue date" which allows for a grace period of 50%

of the scheduled inspection frequency.

By basing the inspection schedule on this overdue date, licensees are actually inspected at a rate that is 50% less than the scheduled frequency.

Not only is this contrary to the guidelines, inspections can become seriously overdue when circumstances such as those encountered during i

this review period force the State to fall behind the already extended inspection schedule.

We recommend that the State develop inspection schedules which strictly adhere to the established inspection priority frequencies.

The pl,an should establish target dates and milestones for assessing progress.

III. Enforcement Procedures is a Category I Indicator.

We consider the following comments to be significant.

Guideline Statement Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements.

Written procedures should exist for handling escalated enforcement cases of varying degrees.

Comment 3.a Although the State took appropriate escalated enforcement actions in several cases, the review team identified a number of cases which did not result in appropriate escalated enforcement action.

In these examples, RHB failed to follow their own procedures in dealing with violations.

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A.

Issues raised during the renewal of a hospital license triggered an inspection in which multiple items of non-compliance were identified.

The licensee challenged f

the enforcement letter and during a subsequent enforcement conference a requirement for independent audits was -reduced to a suggestion.

There has been no attempt to verify that independent audits are being l

made of the hospital, and no follow-up inspection is

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planned.

Within a few months, the hospital was cited i

for losing Ir-192 seeds.

No escalated enforcement j

action was taken.

1 B.

A licensee was cited for unauthorized possession of Xe-133.

After promising to comply, the licensee again received Xe-133 twice within days.

After documents refuted the licensee's denials of receipt, a second citation was issued.

The regional compliance l

supervisor twice recommended license suspension following the licensee's failure to comply, failure to appear at hearings, and failure to meet the time commitment for hiring an independent auditor as agreed to during the enforcement conference.

No further action has been taken against the licensee and no follow-up inspection 5as been made to re-evaluate the licensee.

C.

In two investigations, the violation points exceeded the level requiring automatic escalated enforcement action.

In both cases the escalated enforcement required the licensee to submit to follow-up inspections.

The follow-up inspections were not performed.

D.

A radiographer inspection conducted in February 1991 resulted in an enforcement letter citing four " serious" violations. The licensee challenged the violations in the response letter; however, the State did not follow up.

Following an inspection conducted in March 1992, the State failed to act when the licensee's response to the enforcement letter did not describe corrective actions to be taken.

In June 1992 a serious overexposure occurred at the same company.

There is no evidence of escalated enforcement a.lthough the severity of the incident exceeded the level requiring automatic escalated enforcement.

Timeliness of escalated enforcement actions are in need of improvement.

As an exa=ple, a hospital technician performing a reinfusion procedure mistakenly injected the wrong patient with blood containing Indium-111.

The incident drew a good deal of nedia attention and the RHB took appropriate enforcement action.

However, the escalated action has been pending approval by the Department of Health Services (DHS) Office of Legal Counsel since November 4, 1992.

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All escalated enforcement appeared to be the sole 4

responsibility of the Senior Health Physicist, Materials

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Inspection, who was personally required to prepare every escalated enforcement action for referral.

In the first two cases above, in particular, responsibility should have been escalated to management level.

RHB has two procedures for escalated enforcement policy, l

IPM-88-4, dated October 18, 1988, and the enforcement manual entitled, " Radioactive Materials Inspection Procedures Manual", dated September 6, 1991.

Although both of these sources supposedly apply to the same enforcement procedure, j

i they offer different guidance to inspectors.

For instance, the 1988 version accurately reflects RHB's current category of four " Classes" for civil penalties.

The 1991 version, i

however, described a system of five " Severity Levels" of violations.

In addition, there were inconsistent factors 1

assigned to the correlating categories of violations found l

in these two documents.

l Mecorrendation f

We recommend that the State develop a single, uniform policy I

j for managing escalated enforcement actions.. Written procedures to implement the policy should contain action levels triggering specific escalated enforcement actions.

The procedures should also provide guidance as to which i

levels and circumstances Branch, Division and Department management should become involved in escalated enforcement.

We also recommend that adequate specialized legal support be provided to the Division so that legal cases and administrative penalties receive prompt action and that management become more involved in the escalated enforcement proceedings.

It was poted that some rare but highly significant cases involve willful violation of the State's statutes.

It is recommended that inspectors and supervisors be given l

introductory training that would enable them to identify those circumstances when a criminal investigation is appro-priate, the state criminal code as it applies to RCP, and i

related training which would provide a general understanding i

of law enforcement responsibilities.

This training could be i

separately conducted by State of California law enforcement j

officials and the NRC Office of Investigations staff.

The i

course curriculum should be designed by RCP staff and law j

enforcement instructors who agree upon the RCP's needs.

Guideline Statement 1

Enforcement letters should employ appropriate regulatory language clearly specifying all items of noncompliance and health and safety matters identified during the inspection.

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Licensee responses to enforcement letters should be promptly l

-- - - _ -. - - - - ~ _ _. _. _ _, - -

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i acknowledged as to accuracy and resolution of previously unresolved items.

Corrent 3.b One county agency had changed the regulatory language in the i

standard acknowledge =ent letter, omitting required l

statements pertaining to the adequacy of the licensee's a

response and future inspections.

j Recomrendation

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We recommend that a more thorough review of enforcement correspondence be done to prevent unwarranted deviation from

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procedure.

t IV.

Management is a Category II Indicator.

f Guideline Statement i

Program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions) j Comment 4.a A.

While reviewing enforcement actions, it was determined

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that RCP headquarters has no tickler file or other r.ethod to ensure planned follow-up inspections are i

conducted.

B.

In two cases, more than 30 days elapsed while completed SS&D registry sheets were awaiting supervisory signature.

l Eecorrendation We recommend that a system be developed to track pending follow-up inspections.

We also recommend monthly status reports be submitted to program management by senior and supervising health physicists.

These reports should i

describe open investigations, and matters awaiting signature or other action.

Guideline Staterent Program management should perform periodic reviews of selected license cases handled by each reviewer and document the results.

Supervisory review of inspections, reports and i

enforcement actions should also be performed.

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4 Corrent 4.b

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California's internal procedures require supervisory review of all licensing actfons and inspection reports.

However, j

four of the comments made during this review relate directly to the failure to identify and correct problems during j

supervisory reviews.

Fifteen of the 54 representative sa=ples of licensing actions had deficiencies which should l

have been corrected during appropriate supervisory review.

All supervisory reviews were performed by senior health l

i physicists rather than the supervising health physicist.

Recorrendation l

i We recommend that supervising health physicists be required to perform a specific number of reviews of cases handled by each senior health physicist.

The results should be l

documented and submitted to the Branch Chief.

j Guideline Statement f

l The compliance supervisor should conduct annual field

~ cvaluations of each inspector to assess performance and assure application of appropriate and consistent policies

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i and guides.

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Corrent 4.c I

i During the two-year review period, nine inspector i

accompaniments were made by the three senior health I

i physicists.

No inspector was accompanied nore than once and i

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one inspector was not accompanied at all during the two-year i

1 interval.

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Eccomrendation i

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i We recommend _that each regional supervisor conduct annual accompaniments of each inspector under their supervision.

The results of the accompaniments should be submitted periodically to program management.

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V.

Office Equipment and Support Services is a Category II Indicator.

i Guideline Statement

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The RCP should have adequate secretarial and clerical l

support.

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i Corrent 5.a t

l According to staff interviews and observations of the review l

l team, typing backlogs have delayed licensing actions and other program functions.

At one time during the review j

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period there were over 100 licer sing documents waiting to be l

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a

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typed.

Personal computers are in the process of being purchased for all technical staff.

i i

3 Recommendation 4

We recommend the use of pre-typed templates for different types of licenses, SS&D sheets, and compliance documents to make more efficient use of staff resources.

Clerical i

vacancies should also be filled promptly.

l Euideline Staterent States should have a license document management system that 4

4 is capable of organizing the volume and diversity of l

materials associated with licensing and inspection of radioactive materials.

Corrent 5.b The review team found several problems in the licensing and compliance tracking systems.

A.

In two cases licenses had been allowed to expire while apparently still possessing and using radioactive material.

Their reinstatement and renewcl cost the program lost fees and extra staff effort.

B.

The most current RHB tracking report reflected 62 opea investigations.

However, a spot check of eight incident files disclosed that two open cases had actually been closed.

Also, two cases were closed through investigations of subsequent, related complaints but remained in the "open" file.

As minor as the problem seems, it is an indicator of a weak tracking and reporting system.

C.

Previous data in the licensee Cata base is deleted each time a new licensing or compliance action is entered.

2 This makes it impossible to study historical trends.

D.

RHB has no computer system for tracking or triggering follow-up inspections.

l Recorrendation We recommend the document control problems cited above be 3

addressed in the new computer system presently being j

designed by RHB staff.

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-n.

10 VI.

Staffing Level is a Category II Indicator.

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Guideline Statement The professional staffing level should be approximately 1 to 1.5 person-years per 100 licenses in effect.

Comment Throughout the two-year review period, the professional staffing level has been below the minimum guidelines, with the staff / license ratio averaging approximately 0.94.

The current figure is 0.92, and if all vacancies were filled, the ratio would be 1.3.

The State has been unable to maintain an adequate inspection program, and sel-ious backlogs have developed in licensing where 322 renewals are now awaiting action.

The review team noted that many deficiencies found in other program indicators related i

directly to the State's failure to maintain an adequate techniccl stalfing level.

E_ecorrendation First, we understand candidates have accepted offers for four of the seven open positions, but final hiring has been delayed by the Personnel Office.

We recommend hiring procedures be changed to allow prompt action in filling vacancies.

Second, California is a large State with many complex licenses and sealed source and device evaluations, and thus the 1.5 person-years per 100 licenses may be needed to properly administer the program.

We recommend that this staffing level be used in. determining staffing needs.

VII. Licensing Procedures is a Category II Indicator.

The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice.

Standard license conditions comparable with current NRC standard license conditions should be used to expedite and provide uniformity in the licensing process.

Cornent 7.a California's standard license conditions do not include the NRC condition requiring sealed source physical inventories in medical and radiopharmacy licenses.

Recommendation We recommend that the State add this requirement as a standard condition.

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Corrent 7.b l

In some cases, the final disposition of radioactive material could not be determinee in termiraated license files.

Vorm 2558 (Request to Terminate Radioactive Material License) was found in some files, but not in others.

The State's written termination procedures do not reference this form nor provide instructions on its use.

This form, properly used, ensures that the State is aware of the final disposition of all radioactive material.

Recorrendation We recommend that the procedures be revised to provide guidance for using the form.

Corrent 7.c Although timeliness is not specifically addressed in the guidelines, 48 timely renewals had been pending in-house for two years or more.

This comment was noted in our past review and the backlog has increased since that time.

j Pecorrendation We recommend that supervisors set specific goals for l

elininating this backlog, d'.scuss the priorities with the licensing staff and develop a system to track backlogged casework.

VIII. Inspection Procedures is a Category II Indicator.

4 Guideline Statement Inspection guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the inspection of licensed programs.

1 Eprrent 8.a The fcres used to inspect nuclear pharmacies are designed for medical licenses.

These forms do not cover some i

elements of pharmacy licenses such as transportation practicer.

The Northern Califorr.ia regional office adds 1

their own p:4armacy supplement to the medical form, but this practice is not uniform.

Again, the need to add the transportation element to pharmacy inspections was not identified in supervisory review.

Fecorrendation I

We recommend specific pharmacy inspection forms be developed and used uniformly.

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Guideline Statement I

f For States with separate licensing and inspection staffs, I

procedures should be established for feedback of information to license reviewers.

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f Comment 8.b In four compliant:e files, the review team found no indication in the file that the inspector had notified i

licensing staff of changes in the licensee's status.

Recorrendation l

1 Although the current procedures require inspectors to notify licensing when changes are found, a system should be developed to ensure the necessary forms are received and processed by licensing.

Also, omissions such as this should be corrected during the supervisory review.

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IX.

Inspection Reports is a Category II Indicator.

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Guideline Statement i

Reports should uniformly and adequately document'the result of inspections including confirmatory measurements and l

4 status of previous noncompliance and identify areas of the

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licensee's program which should receive special attention at l

3 the next inspection.

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l Corrent 4

Inspection forms are not used correctly and uniformly by all d

agencies and inspectors.

The following deficiencies in the inspection reports resulted from the incorrect or incomplete I

i use of the inspection form.

i A.

In three cases, there was inadenuate, documentation that previous items of non-complia 1 ne' been closed out.

l This is a repeat finding.

B.

In two cases, there was nc evidence that incidents that' i

j had occurred since the previous inspection had been_

i reviewed during the inspection.

This is a repeat l

finding.

t C.

In two cases, violations cited in the enforcement letter were not included in the inspection report.

i Apparently none of these deficiencies were identified during supervisory review.

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13 Recommendation i

Supervisors should require all inspectors to use the forms

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in the manner prescribed its the procedures.

The State had no problem meeting the new guidelines for the low-level waste program.

SUMMARY

DISCUSSION WITH STATE REPRESENTATIVES A summary meeting to present the results of the regulatory program review was held on January 29, 1993, with Mr. Joseph, Mr. Vadnais and Dr. Collins.

The review team explained the background and obligations of the Agreement State Program, the history of the California radiation control program, the scope of the current review, and the seriousness of the three significant findings in Category I Indicators.

The details of the findings in these category I Indicators, as well as those found in the six Category II Indicators identified in this enclosure, were discussed at length.

The review team pointed out that root causes for the problems included the State's failure to provide a staffing level adequate to control the use of radioactive material, the lack of a modern computer system capable of managing license and compliance documents, and the failure of branch management to closely monitor the status of the program in order to provide proper guidance and follow-through.

The importance of adopting the compatibility regulations was also stressed.

The managers representing the State stated they were only partially aware of the RHB internal problems and that they will resolve the problens as quick 19 as resources allow.

They are optimistic that many of their needs will be met after the program becomes self-funded on July 1, 1993.

They also said they appreciated our review and concern for the program, and that the NRC can be assured California is eager to return to their status of adequacy and compatibility as soon as possible.

i The NRC review team leader expressed appreciation for the cooperation given to the team by the State staff.

He explained that Mr. Kammerer will submit the final results of the review in a letter to Dr. Holly Joel Coye, and that the State will be expected to respond to the comments in the letter and this l

enclosure.

He also explained that because of the seriousness of the findings, a follow-up review is planned in approximately 9 to s

12 months.

We will schedule a follow-up review within the next 12 months to monitor the progress of the State to correct the deficiencies.

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