The Food and Drug Administration Generally Complied With Federal Requirements for the Preparation and Receipt of Select Agent Shipments

Submitting OIG:

Department of Health & Human Services OIG

Report Description:

The Food and Drug Administration (FDA) is one of several Federal agencies that ship and receive select agents. Select agents are biological agents or toxins that HHS and the Department of Agriculture have determined pose a threat to humans, animals, plants, or the environment. In 2015, another Federal agency found that one of its facilities had inadvertently shipped live Bacillus anthracis, a select agent which causes the deadly disease anthrax, to 194 laboratories in the United States and other countries. In response to these events, we initiated a review of the policies, procedures, and protocols FDA implemented to ensure the safe shipment of select agents to and from its laboratories.

Date Issued:

Wednesday, June 26, 2019

Agency Reviewed / Investigated:

Department of Health & Human Services

Submitting OIG-Specific Report Number:

A-03-16-00354

Component, if applicable:

Food and Drug Administration

Location(s):

Agency-Wide

Type of Report:

Audit

Number of Recommendations:

View Document:

Attachment	Size
31600354.pdf	1.64 MB

Additional Details Link:

https://oig.hhs.gov/oas/reports/region3/31600354.asp

Recommendation Number	Recommendation Status	Significant Recommendation
267080	Open	No
We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent shipment is not received within 48 hours after the expected time of delivery.
267081	Open	No
We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent package is received damaged to the extent that a release of the select agent may have occurred.
267082	Open	No
We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent shipment will not be completed within 30 calendar days after transfer authorization issuance.
267083	Open	No
We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent transfer authorization becomes void because the facts supporting the authorization changed.
267084	Open	No
We recommend that FDA ensure that its registered entities verify and maintain documentation to assure that employees who are required to have select agent training understand the training received.
267085	Open	No
We recommend that FDA Update its policies for shipping inactivated select agents to require that its registered entities record a description of the viability testing protocol used, the names of the personnel who inactivated the select agent, and the location of the inactivation.

Recommendation Number

Recommendation Status

Significant Recommendation

Additional Details

267080

Open

We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent shipment is not received within 48 hours after the expected time of delivery.

267081

Open

We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent package is received damaged to the extent that a release of the select agent may have occurred.

267082

Open