Nuclear Regulatory Commission

Office of Public Affairs

Washington DC 20555

Telephone: 301/415-8200 -- E-mail: opa@nrc.gov

No. 97-140

September 19, 1997

NRC RESPONDS TO REQUESTS FOR ENFORCEMENT ACTION

AGAINST NIH FOR CONTAMINATION EVENT

The Nuclear Regulatory Commission staff has denied a petition

from Dr. Maryann Wenli Ma and her husband, Dr. Bill Wenling

Zheng, to revoke or suspend the nuclear materials license of the

National Institutes of Health following a 1995 contamination

event there involving radioactive phosphorous-32 (P-32), but

granted the petitioner’s request for other actions.

During the incident, Dr. Ma, then a pregnant NIH researcher, was

exposed to radiation in excess of NRC occupational limits. Dr.

Zheng, who also worked at that time at NIH, and 25 others, were

exposed to radiation from a contaminated water cooler. One of

the 25 individuals, classified as a non-radiation worker,

received an exposure in excess of NRC limits for members of the

public.

The P-32 contamination was the subject of an NRC augmented

inspection team (AIT) inspection and two special NRC team

inspections, as well as investigations performed by the NRC

Office of Investigations (OI), in cooperation with the Federal

Bureau of Investigation, the Health and Human Services Office of

the Inspector General and the NIH Police Department. A redacted

report and its associated exhibits from the NRC’s AIT was issued
on January 29, 1996, and a full report on January 13 of this

year. The report from the NRC’s OI investigation, "National

Institutes of Health: Wrongful Administration of P-32, Case No.

1-96-033," was released on September 17, 1997.

NRC investigators concluded that the contamination was deliberate

but could not definitively identify who caused the contamination

with P-32. Also, the NRC did not definitively identify the means

of administering the phosphorous-32 to Dr. Ma.

Normally, radiation overexposures of this sort would be subject

to significant enforcement action by NRC. However, in this case,

the Commission decided to exercise enforcement discretion because

there is no evidence that NIH contributed directly or indirectly

to the deliberate misuse of licensed material; because NIH could

not reasonably have foreseen that an employee would maliciously

misuse licensed material as appears to have been done in this

case; and because NIH cooperated fully in the investigation.

Although the NRC denied the petition to suspend or revoke NIH's

license, it has granted the petitioners' request that NRC take

other appropriate actions. NRC granted the petitioners' request

for enforcement action against NIH for violations of NRC security

and control requirements and for violation of NRC requirements

related to radiation safety training, ordering radioactive

materials, inventory control of radioactive materials,

monitoring, and the issuance, use, and collection of dosimetry.

In addition, the NRC’s Region I office in King of Prussia,

Pennsylvania, issued a notice of violation (without a civil

penalty) to NIH on September 17, for failure to submit a written

report to NRC within 30 days after learning that Dr. Ma received

an occupational radiation dose in excess of NRC limits.

Other NRC actions included a series of Confirmatory Action

Letters between July 1995 and June 1996. They confirmed that NIH

had agreed to take various corrective measures, such as (1)

reduction of the possibility of further ingestion of radioactive

material by NIH employees, (2) determination of the full scope of

the personnel contaminations at NIH, (3) further enhancement and

training of NIH staff regarding security of radioactive material,

(4) documentation of corrective actions with respect to

enforcement of a new NIH security policy, and (5) modifications

to the surveillance plan for NIH laboratories.
The NRC has determined that NIH has made significant efforts to

improve its control of radioactive material. This has included

NIH staff meetings, training and audits. NIH also completed a

comprehensive physical inventory of radioactive materials that

now serves as the baseline for on-line, real-time tracking of all

radioactive materials. NRC concluded that additional enforcement

action for security and control violations was not warranted.

Copies of the OI report and exhibits, the letter to NIH, and the

director’s decision will be available for public inspection and

copying at the NRC Public Document Room, 2120 L Street, NW,

Washington, DC 20555; telephone: 202/634-3273. All but the OI

report and exhibits have been placed on the NRC Internet homepage

at www.nrc.gov.

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