EA-97-143 - Navy, Department of the
Department of the Navy
Chief of Naval Operations (N-45)
Navy Radiation Safety Committee
ATTN: RADM J. Totushek
Washington, D. C. 20350-2000
SUBJECT: NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 45-23645-01NA/97-03)
Dear Admiral Totushek:
This letter refers to the inspection conducted at the Navy Drug Screening Laboratory in Jacksonville, Florida on March 12, 1997. The inspection included a review of the facts and circumstances surrounding the February 28, 1997, shipment of a package containing iodine-125 (I-125) from the Navy Drug Screening Laboratory which arrived at Brooks Air Force Base in San Antonio, Texas on March 3, 1997, leaking its radioactive contents. The results of the inspection were discussed with you at the exit meeting on March 19, 1997, and formally transmitted to you by letter dated April 4, 1997. An open, predecisional enforcement conference was conducted in the Region II office on May 1, 1997, with members of your staff to discuss the apparent violations, the root causes, and corrective actions to preclude recurrence. A list of conference attendees and a copy of the NRC's and Navy's presentation materials are enclosed.
Based on the information developed during the inspection and the information
that was provided at the conference, the NRC has determined that violations
of NRC requirements occurred. The violations are cited in the enclosed
Notice of Violation (Notice), and the circumstances surrounding them are
described in detail in the subject inspection report. Violation A.1 involves
the failure of the Navy Drug Testing Laboratory staff to prepare a limited
quantity package containing iodine-125 (I-125) such that it would maintain
its integrity during transport. As a result of inadequate packaging, two
glass bottles, containing 125 microcuries each of I-125, broke during
transport and leaked their contents outside the containment of the shipping
package. As determined by secondary surveys of the truck floor where the
package was located during transport, non-fixed contamination levels on
the external surface of the package were in excess of 650 times the regulatory
limits (Violation A.2). Contamination from the leaking package was also
found on the truck driver's shoe, other packages in the truck, and the
surfaces at Brooks Air Force Base where the package had been placed at
delivery. Although the violations were the result of inadequate training
of the individual preparing the material for transport, the root cause
was inadequate oversight of transportation activities by Naval oversight
groups. At the conference, you admitted the violation and acknowledged
that inadequate management oversight was a root cause of the violations.
The NRC recognizes that due to the radiological and chemical properties
of the radionuclide involved in this incident, the actual safety consequences
of the violations are low. However, the violations are of significant
regulatory concern in that multiple management and oversight barriers
failed permitting this incident to occur. These barriers included: (1)
the Radiation Safety Officer (RSO) who was unaware that material was being
transported from the Navy Drug Screening Laboratory; (2) the Navy permitting
and inspection process which failed to address transportation activities
of this type; and (3) the individual responsible for preparing and shipping
the package who lacked specialized training in U. S. Department of Transportation
requirements. At the conference, your staff reaffirmed these concerns
and stated that shipments of this nature were not isolated to this particular
facility. Approximately one to two shipments of this material occurred
each year at the other two Navy drug testing laboratories which had similar
deficiencies in RSO knowledge, guidance, and training. Additionally, failures
of this nature could have had substantial public health and safety implications
had the materials involved and/or the conditions of transport been different.
Therefore, collectively, Violations A.1 and A.2 are classified in the
aggregate in accordance with the "General Statement of Policy and Procedures
for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity
Level III problem.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2250 is considered for a Severity Level III problem occurring after November 12, 1996, (61 Federal Register 53554). Because the Navy Drug Screening Laboratory in Jacksonville, Florida has not been the subject of escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in
Section VI.B.2 of the Enforcement Policy. At the conference you stated
that the corrective actions taken and/or planned included: (1) suspension
of radioactive material shipments from all three Navy drug screening laboratories
effective March 4, 1997; (2) initiation of an investigation into the incident;
(3) issuance of an Info-Notice to all Navy permittees describing the incident,
providing a questionnaire addressing historical shipping practices, and
requiring the RSO to approve/control all transfers and receipt of radioactive
material; (4) an increase in the frequency of inspection of the Navy drug
screening laboratories and a commitment to inspect all Navy permit medical
laboratories in 1997; (5) revision of the initial and renewal medical
permitting process to address transportation of radioactive materials; (6) completion of transportation training for appropriate personnel by
June 1, 1997; (7) revision of inspection criteria to emphasize radioactive
material transportation requirements and training by May 1997; and (8)
assignment of an additional individual to the Navy Environmental Health
Center to accommodate increased inspection focus. Based on the above,
the NRC determined that your corrective actions were prompt and comprehensive,
and credit was warranted for this factor.
Therefore, to encourage timely and comprehensive corrective action for
violations, I have been authorized not to propose a civil penalty in this
case. However, significant violations in the future could result in a
Violations B, C, and D have been categorized at Severity Level IV and
are described in the enclosed Notice. These violations also related to
the February 28, 1997, shipment and involve the failure to include the
required notice with the package, the failure to provide function-specific
training to the package preparer, and the failure to properly verify that
the recipient of the material was authorized to receive it. Although these
violations have been categorized at a lesser severity level, they are
of concern because they are symptomatic of the oversight deficiencies
discussed above, and the training violation directly contributed to the
package breach/contamination event and other violations cited in the Notice.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will consider your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room.
Sincerely, Original Signed by B. S. Mallett Luis A. Reyes Regional Administrator
Docket No. 030-29462
License No. 45-23645-01NA
1. Notice of Violation
2. Conference Attendees
3. NRC Presentation Materials
4. Licensee Presentation Materials
Commonwealth of Virginia
State of Florida
HQ Human Systems Center (AFMC)
ATTN: Robert P. Belihar, Brigadier General
USAF, MC, CFS
2510 Kennedy Circle
Brooks Air Force Base, Texas 78235-5120
Department of the Navy Docket No. 030-29462 Navy Drug Screening Laboratory License No. 45-23645-01NA Jacksonville, Florida EA 97-143
During an NRC inspection conducted on March 12, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violations are listed below:
10 CFR 71.5(a) requires that a licensee who transports licensed material outside the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.
A. 49 CFR 173.421(a) permits the shipment of certain quantities of radioactive materials as "limited quantity", excepted from the specification packaging, marking, labeling and, if not a hazardous substance or hazardous waste, the shipping paper and certification requirements of subpart H, 49 CFR Part 173, provided the package meets the requirements specified in that part.1. 49 CFR 173.421(a)(1) requires that each limited quantity package meets the general design requirements of 49 CFR 173.410.
49 CFR 173.410(f) requires, in part, that the package be capable of withstanding the effects of any acceleration, vibration or vibration resonance that may arise under normal conditions of transport without any deterioration in the integrity of the package as a whole.
Contrary to the above, on February 28, 1997, the licensee delivered to a carrier for transport a package containing 375 microcuries of iodine-125 (I-125) which was prepared for shipment as a limited quantity package, and the package did not maintain its integrity as a whole when subjected to the effects that arose under normal conditions of transport. Specifically, on March 3, 1997, the package was delivered to the addressee, Brooks Air Force Base, San Antonio, Texas, by a common carrier and some of the package contents, including two glass bottles containing 125 microcuries of I-125 each, were broken and leaking outside of the package. (01013)
2. 49 CFR 173.421(a)(3) requires that the non-fixed (removable) radioactive surface contamination on the external surface of the package does not exceed the limits specified in 49 CFR 173.443(a).
49 CFR 173.443(a)(1) requires, in part, with exceptions not applicable here, that for beta-gamma emitting contaminants, the level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment, when averaged over the surface wiped, not exceed 22 disintegrations per minute per square centimeter (dpm/cm2) at any time during transport.
Contrary to the above, on February 28, 1997, the licensee delivered to a carrier for transport a package which upon arrival at its destination on March 3, 1997, was determined to have non-fixed contamination caused by I-125, a beta-gamma emitting radionuclide, in excess of that permitted by 49 CFR 173.443(a)(1). The maximum level of contamination deposited on the delivery truck floor from the package surface was approximately 14,700 dpm/cm2 averaged over 100 cm2. (01023)
This is a Severity Level III problem (Supplement V).
B. 49 CFR 173.421(a)(6) requires, in part, that a limited quantity package of radioactive material be prepared for shipment as specified in 49 CFR 173.422.
49 CFR 173.422 requires, in part, that packages prepared for shipment under 49 CFR 173.421 be certified as being acceptable for transportation by having a notice enclosed in or on the package, included with the packing list, or otherwise forwarded with the package. This notice must include the following statement: "This package conforms to the conditions and limitations specified in 49 CFR 173.421 for radioactive material, excepted package-limited quantity of material, UN2910".
Contrary to the above, on February 28, 1997, the licensee delivered to a carrier for transport a package containing 375 microcuries of I-125, which was prepared as a limited quantity package as described in
49 CFR 173.421, and the licensee did not include the required notice with the package. (02014)
This is a Severity Level IV violation (Supplement V).
C. 49 CFR 172.704(a)(2)(i) requires, in part, that each hazmat employee shall be provided function-specific training concerning requirements of subchapter A of Chapter I of Title 49, or exemptions issued under subchapter A of Chapter I, which are specifically applicable to the functions the employee performs.
Contrary to the above, on February 28, 1997, a licensee employee prepared a package of limited quantity radioactive material for transport by a commercial carrier, and the employee had not been provided function-specific training on how to properly prepare a limited quantity package of radioactive material for transport. Specifically, the individual prepared a package containing three 500 milliliter glass bottles of I-125 in liquid form (125 microcuries each), for transport by a common carrier, and the individual was not trained on the requirements of 49 CFR 173.421 for the transport of limited quantity packages of radioactive material. (03014)
This is a Severity Level IV violation (Supplement V).
D. 10 CFR 30.41(c) requires that, prior to transferring byproduct material, the licensee verify that the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred. 10 CFR 30.41(d) specifies acceptable methods for this verification which include: (1) receipt of a copy of the transferee's specific license or registration certificate; (2) receipt of a written certification from the transferee that he is authorized to receive the byproduct material; (3) receipt of oral certification from the transferee, confirmed in writing within 10 days, for emergency shipments; (4) obtaining other sources of information compiled by a reporting service from official records of the Commission or Agreement States as to the scope and expiration date of the license and registration of the transferee; and (5) obtaining record confirmation from the Commission an Agreement State that the transferee is licensed to receive the byproduct material.
Contrary to the above, on February 28, 1997, the licensee transferred 375 microcuries of I-125 to the U. S. Air Force Drug Screening Laboratory at Brooks Air Force Base, San Antonio, Texas, and prior to the transfer, the licensee did not verify by an acceptable method that the transferee's license authorized receipt of this material. (04014)
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, the Department of the Navy is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region II, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previously docketed correspondence, if the correspondence adequately addresses the required response. 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
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 Atlanta, Georgia
this 7th day of May 1997