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The development and use of decision support framework for informing selection of select agent toxins with modelling studies to inform permissible toxin amounts

Journal Article · · Frontiers in Bioengineering and Biotechnology
 [1];  [2];  [2];  [2];  [3];  [2];  [4]
  1. US Food and Drug Administration (USFDA), Silver Spring, MD (United States)
  2. Sandia National Laboratories (SNL-CA), Livermore, CA (United States)
  3. US Dept. of Homeland Security (DHS), Washington, DC (United States)
  4. Centers for Disease Control and Prevention (CDC), Atlanta, GA (United States)
+ Show Author Affiliations
Many countries have worked diligently to establish and implement policies and processes to regulate high consequence pathogens and toxins that could have a significant public health impact if misused. In the United States, the Antiterrorism and Effective Death Penalty Act of 1996 (Public Law 104-132, 1996), as amended by the Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188, 2002) requires that the Department of Health and Human Services (HHS) [through the Centers for Disease Control and Prevention (CDC)] establish a list of bacteria, viruses, and toxins that have the potential to pose a severe threat to public health and safety. Currently, this list is reviewed and updated on a biennial basis using input from subject matter experts (SMEs). We have developed decision support framework (DSF) approaches to facilitate selection of select toxins and, where toxicity data are known, conducted modelling studies to inform selection of toxin amounts that should be excluded from select agent regulations. Exclusion limits allow laboratories to possess toxins under an established limit to support their research or teaching activities without the requirement to register with the Federal Select Agent Program. Fact sheets capturing data from a previously vetted SME workshop convened by CDC, literature review and SME input were developed to assist in evaluating toxins using the DSF approach. The output of the DSF analysis agrees with the current select toxin designations, and no other toxins evaluated in this study were recommended for inclusion on the select agent and toxin list. To inform the selection of exclusion limits, attack scenarios were developed to estimate the amount of toxin needed to impact public health. Scenarios consisted of simulated aerosol releases of a toxin in high-population-density public facilities and the introduction of a toxin into a daily consumable product supply chain. Using published inhalation and ingestion median toxic dose (TD50) and median lethal dose (LD50) values, where available, a range of toxin amounts was examined to estimate the number of people exposed to these amounts in these scenarios. Based on data generated by these models, we proposed toxin exclusion values corresponding to levels below those that would trigger a significant public health response (i.e., amounts estimated to expose up to ten people by inhalation or one hundred people by ingestion to LD50 or TD50 levels of toxin in the modeled scenarios).
Research Organization:
Sandia National Laboratories (SNL-CA), Livermore, CA (United States)
Sponsoring Organization:
US Department of Homeland Security (DHS); USDOE National Nuclear Security Administration (NNSA)
Grant/Contract Number:
NA0003525
OSTI ID:
2471771
Journal Information:
Frontiers in Bioengineering and Biotechnology, Journal Name: Frontiers in Bioengineering and Biotechnology Vol. 10; ISSN 2296-4185
Publisher:
Frontiers Media S.A.Copyright Statement
Country of Publication:
United States
Language:
English

References (7)

Paralytic shellfish toxins in clinical matrices: Extension of AOAC official method 2005.06 to human urine and serum and application to a 2007 case study in Maine journal May 2014
Rapid screening of tetrodotoxin in urine and plasma of patients with puffer fish poisoning by HPLC with creatinine correction journal January 2010
Ergot: from witchcraft to biotechnology journal June 2009
Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021 journal May 2021
Public Health Investigation After the Discovery of Ricin in a South Carolina Postal Facility journal April 2007
Pathogen Security-Help or Hindrance? journal January 2015
Application of Multi-Criteria Decision Analysis Techniques for Informing Select Agent Designation and Decision Making journal June 2022

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Related Subjects

60 APPLIED LIFE SCIENCES
Biotechnology & Applied Microbiology
Engineering
decision support framework
permissible toxin limits
public health impact
select agents and toxins
select toxins