Transmissible Spongiform Encephalopathies Advisory Committee
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Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) was an advisory body to the FDA, focusing on diseases like BSE and vCJD. It provided guidance on the management and regulation of products potentially affected by TSEs, ensuring safety in food, drugs, and biological products.
Mission
TSEAC's mission was to offer scientific and public health advice on TSEs, which are fatal neurodegenerative disorders. The committee reviewed data and provided recommendations on risk assessments, regulatory measures for animal feeds, pharmaceuticals, and biological products to prevent the spread of these diseases.[1]
Parent organization
TSEAC was managed by the U.S. Food and Drug Administration (FDA), which is part of the United States Department of Health and Human Services (HHS). The FDA regulates food, drugs, medical devices, and other products to ensure public safety.[2]
Legislation
The committee was not established by specific legislation but operated under the FDA's authority to form advisory committees as needed under the Federal Advisory Committee Act (FACA).
Partners
- USDA for coordination on animal health issues
- CDC for public health surveillance and research
- Academic and research institutions specializing in TSEs[3]
Number of employees
TSEAC did not have permanent employees; it was composed of appointed experts who served in advisory roles.
Organization structure
The committee included experts in fields like neurology, epidemiology, animal health, virology, and public health policy.
Leader
The committee was led by a Chair, appointed to lead meetings and report recommendations to the FDA.
Divisions
TSEAC did not have formal divisions but could form subcommittees for specific issues:
- Subcommittees might have been established for topics like feed bans, drug safety, or diagnostic methods.
List of programs
- Advising on the regulation of animal feed to prevent BSE transmission
- Recommendations on the safety of blood and blood products
- Guidance on the use of materials from animals in pharmaceuticals and medical devices
Last total enacted budget
The budget for TSEAC was not publicly specified; it operated within the broader FDA budget for advisory committees.
Staff
The committee did not have dedicated staff; support was provided by FDA personnel.
Funding
Funding for TSEAC's activities was part of the FDA's budget for managing advisory committees.
Services provided
TSEAC provided advisory services to help the FDA develop policies, regulations, and guidelines to protect public health from TSEs, including BSE and vCJD.
Regulations overseen
While TSEAC did not directly oversee regulations, its recommendations influenced FDA's regulatory frameworks regarding TSEs, particularly in areas like animal feed, pharmaceuticals, and biological products.
Headquarters address
10903 New Hampshire Avenue, Silver Spring, MD 20993, United States
History
TSEAC was active until its termination in 2016. It played a significant role in advising on the management of BSE outbreaks and in formulating policies to reduce the risk of TSE transmission to humans. Its functions are now covered by other FDA advisory committees like the Blood Products Advisory Committee (BPAC).[4]
External links
References
- ↑ U.S. Food and Drug Administration. "Transmissible Spongiform Encephalopathies Advisory Committee". FDA, https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/default.htm (accessed February 8, 2025).
- ↑ U.S. Food and Drug Administration. "About FDA". FDA, https://www.fda.gov/about-fda (accessed February 8, 2025).
- ↑ Posts found on X discussing TSEAC's role and partnerships.
- ↑ U.S. Food and Drug Administration. "Termination Notice for TSEAC". Federal Register, https://www.federalregister.gov/documents/2016/06/09/2016-13705/transmissible-spongiform-encephalopathies-advisory-committee-termination (accessed February 8, 2025).