EA-96-027 - Health & Human Services, Department of

August 23, 1996

EA 96-027

Michael M. Gottesman, M.D.
Deputy Director for Intramural Research
Department of Health and Human Services
National Institutes of Health
NIH Building 1, Room 114
9000 Rockville Pike
Bethesda, Maryland 20892

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,500 (NRC Inspection Report Nos. 030-01786/95-002 (REDACTED) AND 030-01786/95-203)

Dear Dr. Gottesman:

This letter refers to the NRC inspection conducted by the NRC Augmented Inspection Team (AIT) between June 30 and November 15, 1995, and to the NRC Special Team inspection conducted on October 23-24 and November 6-10, 1995, at your Bethesda, Maryland facilities. The purposes of these inspections were to conduct an independent evaluation of events at your facilities in June and July 1995 in which a pregnant researcher and 26 additional NIH staff were contaminated with phosphorus-32, and to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. Although review of the exposure events is continuing, and may result in additional enforcement action at a later date, the NRC did, during the inspections, identify several apparent violations of NRC requirements. These apparent violations were described in the report of the Special Team inspection transmitted with our letter dated December 21, 1995, and in our letter dated January 29, 1996, which transmitted the results of our review of the redacted AIT inspection report.

In the January 29, 1996 letter, the NRC staff advised you of its intent to hold a predecisional enforcement conference with you on February 26, 1996, to discuss the apparent violations and your corrective and preventive actions. However, you ultimately declined a conference based on your concern that the conference, which was scheduled to be open for public observation, would interfere with the various ongoing investigations regarding the phosphorus-32 contamination event. In lieu of a conference, Ms. Harriet S. Rabb, General Counsel, Department of Health and Human Services, informed the NRC, by letter dated April 16, 1996, that NIH would address the apparent violations in a written response. NIH provided a response to the NRC in a letter dated May 23, 1996.

Based on the information developed during the inspections and on your response of May 23, 1996, the NRC has determined that violations of NRC requirements occurred for which enforcement action is appropriate at this time. These violations are described in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice). The violation described in Section I of the enclosed Notice involved the failure to secure from unauthorized removal or limit access to licensed materials that were stored in unrestricted areas. Specifically, on July 6 and October 23, 1995, licensed radioactive material (including millicurie quantities of various isotopes) in seven laboratories in Building 37 was not secured from unauthorized removal, nor was access limited. The NRC is particularly concerned with the number of examples of this violation and the fact that violations of security requirements previously were identified during prior NRC inspections conducted during April through May 1994, and in June 1995. Even though security violations were the subject of an Enforcement Conference held on July 24, 1994, as well as Confirmatory Action Letters (CALs 1-94-006 and 1-95-011), it is apparent that your corrective actions were not adequate to prevent similar violations from occurring, as evidenced by the results of the inspection on October 23, 1995.

It is a significant regulatory concern that NRC inspectors repeatedly have been able to gain access to licensed material at your facility without challenge, because it indicates that members of the public may do so as well. Given the repetitive<1> nature and number of examples of the violation, the violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of escalated enforcement action in the past two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. For the Severity Level III violation, credit was considered for your corrective actions, which were described in your letter dated May 23, 1996, and its attachments. These actions included immediate confiscation of unsecured radioactive materials, amendment of your security policy and adoption of an enforcement policy on October 26, 1995, and initiation of a security surveillance program on October 26, 1995. However, credit for corrective actions is not warranted because your corrective actions, judged from the time that you were made aware of the July 6, 1995 repetitive security violation, were not appropriately comprehensive to prevent recurrence. Specifically, the NRC inspection conducted October 23 through 24, 1995, and the NRC's subsequent issuance of CAL 1-95-018, were necessary to further focus your corrective process. For example, the NRC's October 1995 inspection included tours that coincided with lunch periods and after normal daytime working hours, a practice which you subsequently adopted in your internal security audit program. In addition, although not cited in the enclosed Notice, on November 7 through 9, 1995, the NRC inspection identified three instances in which unattended licensed material was not secured by locking. While the quantities of the unattended materials are not specifically known, the corrective actions undertaken by the Radiation Safety Committee on October 26, 1995,<2> required that any unattended radioactive material is required to be secured by locking.

Therefore, to emphasize the importance of maintaining appropriate security and control of licensed radioactive material at the facility, and promptly identifying and correcting unsecured conditions when they occur, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $2,500, for the Severity Level III violation cited in the Notice.

Several other violations that are being cited at this time are described in Section II of the enclosed Notice. The violations consist of: (1) workers not wearing extremity dosimetry, or returning film badges and ring badges promptly each month, as required; (2) users obtaining radioactive materials without providing required information regarding the identity of the intended user(s) or the signature of an authorized investigator; (3) researchers performing licensed activities without first receiving the required training; and (4) failure to perform thyroid bioassay measurements of researchers who handled millicurie quantities of volatile iodine-125. Regarding the issue of researchers performing licensed activities without first receiving the required training, it is not acceptable under your current license to permit individuals to use licensed material before receipt of the course "Radiation Safety in the Laboratory." Each of these violations has been classified individually at Severity Level IV in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

An additional apparent violation was discussed in our January 29, 1996 letter which involved a failure to perform adequate surveys, including evaluation of radiological conditions and potential hazards as required by 10 CFR 20.1501. This apparent violation is related to the exposure of individuals to phosphorous-32 and will be considered for enforcement action in conjunction with that issue at a later date.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. Your response should include actions taken or planned to improve management control to ensure lasting corrective action in the future. Your response may reference or include previously docketed correspondence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If redactions are required, a proprietary version containing brackets placed around the proprietary, privacy, and/or safeguards information should be submitted. In addition, a non-proprietary version with the information in the brackets redacted should be submitted to be placed in the PDR.

The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96.511.

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 030-01786
License No. 19-00296-10

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
State of Maryland

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Department of Health and Human Services National Institutes of Health Bethesda, MD

Docket No. 030-01786 License No. 19-00296-10 EA 96-027

During an NRC Augmented Inspection Team (AIT) inspection conducted between June 30 and November 15, 1995, and an NRC Special Team inspection conducted on October 23-24, and November 6-10, 1995, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are listed below:

I. Violation of Security Requirements

10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. As defined in 10 CFR 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above:

(a) On July 6, 1995, the licensee did not secure from unauthorized removal or limit access to licensed material stored in laboratory 5D12 of Building 37, an unrestricted area. Specifically, a member of the NRC AIT found the licensed material inside an unlocked refrigerator that was located within the unlocked laboratory 5D12, and no one was present to control access to this material. The licensed material consisted of approximately 20 millicuries of tritium (H-3) and 2.5 millicuries of carbon-14 (C-14).

(b) On October 23, 1995, the licensee did not secure from unauthorized removal or limit access to licensed material stored in laboratories 4D25, 4D06, 4B03, 6C13, 1B03, and 3C01 of Building 37, unrestricted areas. Specifically, members of the NRC Special Inspection Team found the licensed material inside unlocked refrigerators located in unlocked laboratories, and no one was present to control access to this material. The licensed material consisted of 234 microcuries of phosphorus-32 (P-32) and 720 of microcuries of sulphur-35 (S-35) in Lab 4D25; 20 microcuries of P-32 in Lab 4D06; 3.4 millicuries of H-3 in 4B03; 900 microcuries of S-35 in Lab 6C13; 200 microcuries of S-35, 1140 microcuries of P-32, and 3.7 millicuries of chromium-51 (Cr-51) in Lab 1B03; and 41 microcuries of P-32 and 250 microcuries of S-35 in Lab 3C01. (01013)

This is a repeat violation.

This is a Severity Level III violation (Supplements IV and VI).
Civil Penalty - $2,500.

II. Other Violations of NRC Requirements

Condition 29 of License No. 19-00296-10 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated July 28, 1986.

A. Attachment 10-D of the July 28, 1986, application, requires, in part, that an extremity monitor be worn when using greater than 0.5 millicuries of P-32, and that film badges and ring badges be returned promptly each month.

Contrary to the above, during 1995:

1. the licensee did not supply extremity dosimetry to eight individuals who worked with greater than 0.5 mCi of P-32; and
2. five individuals did not wear the extremity dosimetry that was issued to them while working with greater than 0.5 millicuries of P-32; and
3. numerous individuals failed to return the monitoring devices (film badges and ring badges) monthly. (02014)

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

B. Item 10.6 of the July 28, 1986, application requires, in part, that the Authorized User provide to the Radiation Safety organization a completed Form NIH 88-1, "Request for Purchase and Use of Radioactive Materials", for each incoming shipment before the materials will be released to the investigator. Form NIH 88-1 was provided as Attachment 10-F to the July 28, 1986, application. Form NIH 88-1 requires, in part, that the radiation safety identification number and name of all persons who will use the radioactive material, the name of the authorized investigator, and the signature of the authorized investigator, be entered on the form.

Contrary to the above:

1. Users did not provide the Radiation Safety organization with a completed Form NIH 88-1 for each incoming shipment before the materials were released to the investigator. Specifically, between October 3 and November 20, 1995, the licensee allowed users to request the purchase of radioactive materials electronically without the signature of the authorized investigator.
2. An NIH 88-1 form, submitted for purchase and use of radioactive materials received on September 9, 1994, did not include the radiation safety identification number and names of all persons who were intended to use the radioactive material. Specifically, the NIH 88-1 form listed as the only user an individual who had left NIH. (03014)

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

C. Item 10.3 of the July 28, 1986, application states that all radioactive material users are required to successfully complete an initial training course entitled, "Radiation Safety in the Laboratory".

Contrary to the above:

1. One or two researchers working in Laboratory 5D18 of Building 37 did not successfully complete the initial training course entitled, "Radiation Safety in the Laboratory" prior to their use of radioactive material. Specifically, during the month of October 1994, the researcher(s) used sulfur-35, phosphorous-32 and phosphorous-33, but did not receive "Radiation Safety in the Laboratory" training until November 29, 1994.
2. During the months of October and November 1995, an individual worked with microcurie quantities of C-14 in a Building 10 clinical pathology laboratory, and as of November 10, 1995, this individual had not completed the "Radiation Safety in the Laboratory" training. (04014)

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

D. Item 10.9.2 of the July 28, 1986, application requires that the licensee conduct its bioassay program in accordance with Regulatory Guide 8.20, "Applications of Bioassay for Iodine-125 and Iodine-131". Section C.1.a. of Regulatory Guide 8.20 states that routine bioassay is necessary when, over any 3 month period, an individual handles in open form unsealed quantities of radioactive iodine exceeding those in Table 1. Table 1 of Regulatory Guide 8.20 states that bioassay is necessary for activity levels greater than 10 mCi of iodine 125 used in processes within a fume hood.

Contrary to the above, the licensee failed on two occasions to conduct bioassay measurements after workers handled greater than 10 mCi of volatile iodine-125 in an open unsealed form in gloveless containment boxes located in a fume hood. Specifically, as of November 10, 1995, two researchers had not received a thyroid bioassay measurement after handling 17 mCi and 15 mCi of volatile iodine-125 on June 21 and September 18, 1995, respectively. (05014)

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

Pursuant to the provisions of 10 CFR 2.201, The Department of Health and Human Services, National Institutes of Health (Licensee), is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved.

If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation(s) listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at King of Prussia, Pennsylvania
this 23rd day of August 1996