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This document outlines the requirements and procedures for researching and handling select agents at Florida Atlantic University, ensuring compliance with federal regulations regarding the use of
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How to fill out select agent program
How to fill out Select Agent Program
01
Visit the U.S. Centers for Disease Control and Prevention (CDC) Select Agent Program website.
02
Create an account or log in to the Select Agent Registration System.
03
Complete the registration form, providing information about your institution and its purpose.
04
List all select agents and toxins that will be used or stored at your facility.
05
Develop and submit a comprehensive security plan outlining how the agents will be secured.
06
Provide information on personnel who will handle select agents, including their training and background checks.
07
Review and submit the application for approval.
Who needs Select Agent Program?
01
Research laboratories working with select agents and toxins.
02
Universities conducting studies involving select agents.
03
Biotechnology companies developing products that utilize select agents.
04
Any facility involved in the storage, handling, or transfer of select agents.
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What is a Tier 1 select agent?
Tier 1 Select agents and toxins – A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public
What are the 4 types of biological agents?
Biological agents include bacteria, viruses, fungi, other microorganisms and their associated toxins.
Is Veev a select agent?
Because it can affect both animals and humans, VEEV is listed as an overlap select agent in § 121.4(b) of the regulations and therefore is subject to regulation by both APHIS and CDC.
What viruses are classified as bioweapon tier 1 select agents?
The list of Tier 1 select agents and toxins includes: Bacillus anthracis. Bacillus cereus Biovar anthracis. Botulinum neurotoxins. Botulinum neurotoxin producing species of Clostridium. Burkholderia mallei. Burkholderia pseudomallei. Ebolavirus. Foot-and-mouth disease virus.
What is tier 1 select agent?
Tier 1 Select agents and toxins – A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public
What is an example of a select agent?
Examples of select agents and toxins include the organisms that cause anthrax, smallpox, and foot-and-mouth disease, the plant pathogen Ralstonia solanacearum, as well as the toxin ricin.
What is a select agent in the NIH grant?
Select agents are hazardous biological agents and toxins that have been identified by HHS or the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products.
What is a select agent in the NIH grant?
Select agents are hazardous biological agents and toxins that have been identified by HHS or the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products.
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What is Select Agent Program?
The Select Agent Program is a regulatory framework managed by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) under the U.S. Department of Agriculture (USDA) to oversee the possession, use, and transfer of select agents and toxins that pose a significant risk to public health, agriculture, or animal health.
Who is required to file Select Agent Program?
Individuals and entities that possess, use, or transfer select agents and toxins must register with the Select Agent Program. This includes laboratories, research institutions, and organizations that handle these materials.
How to fill out Select Agent Program?
To fill out the Select Agent Program registration, entities must submit a detailed application that includes information about the organization, personnel, security measures, and the select agents and toxins they plan to handle. It is essential to follow the specific guidelines provided in the application instructions.
What is the purpose of Select Agent Program?
The purpose of the Select Agent Program is to safeguard public health and safety, as well as animal and plant health, by ensuring that select agents and toxins are used in a manner that prevents misuse and reduces the risk of biological threats.
What information must be reported on Select Agent Program?
Entities are required to report information such as the identity and quantity of select agents and toxins they possess, the purpose for which they are used, security measures in place, and details regarding personnel who handle these materials.
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