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CDC generally met its inspection goals for the federal select agent program: however, opportunities exist to strengthen oversight

Series Title(s):
Data brief (United States Department of Health and Human Services, Office of Inspector General)
Contributor(s):
United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2017
Language(s):
English
Format:
Text
Subject(s):
Government Regulation
Security Measures
Toxins, Biological
Federal Government
Laboratories -- standards
Risk Assessment
Risk Management
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)
Genre(s):
Technical Report
Abstract:
In this data brief, we examine how the Division of Select Agents and Toxins (DSAT)--part of the Centers for Disease Control and Prevention (CDC)--oversees the Federal Select Agent Program (FSAP). We did this by reviewing DSAT's inspections and observations; Theft, Loss, or Release (TLR) events reported by entities that handle select agents and toxins; and compliance actions from 2013 through 2015. Biosafety and biosecurity incidents at laboratories involving select agents and toxins have raised concerns regarding DSAT oversight of entities that handle such substances, as well as the potential impact to public health and safety. For instance, in May 2015, the Department of Defense acknowledged that one of its laboratories inadvertently shipped live anthrax-causing bacteria. This event helped spur a July 2015 congressional hearing on oversight concerns related to the FSAP. This data brief will help strengthen the FSAP by providing new analyses that DSAT can use to enhance its oversight. It is intended to complement the 2015 Annual Report of the Federal Select Agent Program, which was issued in June 2016, as well as the forthcoming 2016 annual report, which is expected to be issued in June 2017.1 This data brief is the first of two reports by the Department of Health and Human Services (HHS), Office of Inspector General (OIG), on DSAT's oversight of entities registered with the FSAP. The second report will provide DSAT with information on the oversight of FSAP-registered laboratories by responsible officials--the individuals at each entity who are accountable for compliance with regulations for select agents and toxins.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (41 pages))
Illustrations:
Illustrations
NLM Unique ID:
101737763 (See catalog record)
Series Title(s):
Data brief (United States Department of Health and Human Services, Office of Inspector General)
Contributor(s):
United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2017
Language(s):
English
Format:
Text
Subject(s):
Government Regulation
Security Measures
Toxins, Biological
Federal Government
Laboratories -- standards
Risk Assessment
Risk Management
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)
Genre(s):
Technical Report
Abstract:
In this data brief, we examine how the Division of Select Agents and Toxins (DSAT)--part of the Centers for Disease Control and Prevention (CDC)--oversees the Federal Select Agent Program (FSAP). We did this by reviewing DSAT's inspections and observations; Theft, Loss, or Release (TLR) events reported by entities that handle select agents and toxins; and compliance actions from 2013 through 2015. Biosafety and biosecurity incidents at laboratories involving select agents and toxins have raised concerns regarding DSAT oversight of entities that handle such substances, as well as the potential impact to public health and safety. For instance, in May 2015, the Department of Defense acknowledged that one of its laboratories inadvertently shipped live anthrax-causing bacteria. This event helped spur a July 2015 congressional hearing on oversight concerns related to the FSAP. This data brief will help strengthen the FSAP by providing new analyses that DSAT can use to enhance its oversight. It is intended to complement the 2015 Annual Report of the Federal Select Agent Program, which was issued in June 2016, as well as the forthcoming 2016 annual report, which is expected to be issued in June 2017.1 This data brief is the first of two reports by the Department of Health and Human Services (HHS), Office of Inspector General (OIG), on DSAT's oversight of entities registered with the FSAP. The second report will provide DSAT with information on the oversight of FSAP-registered laboratories by responsible officials--the individuals at each entity who are accountable for compliance with regulations for select agents and toxins.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (41 pages))
Illustrations:
Illustrations
NLM Unique ID:
101737763 (See catalog record)