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Get the free Statement of Eligibility to Handle Select Biological Agents or Toxins - sfasu

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This document is used to determine an individual's eligibility to handle select biological agents or toxins, requiring personal information and answers to specific legal and criminal history questions.
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How to fill out Statement of Eligibility to Handle Select Biological Agents or Toxins

01
Obtain the Statement of Eligibility form from the appropriate regulatory body.
02
Fill out the applicant's information, including name, address, and contact information.
03
Provide details about the organization or institution, including its address and type of facility.
04
Specify the select biological agents or toxins you intend to handle.
05
Include information about your training and experience related to handling biological agents and toxins.
06
Detail the security measures in place at your facility to prevent unauthorized access.
07
Sign and date the application to certify that the information provided is accurate.
08
Submit the completed application to the designated regulatory authority.

Who needs Statement of Eligibility to Handle Select Biological Agents or Toxins?

01
Researchers and scientists who plan to work with select biological agents or toxins.
02
Laboratories and institutions that conduct experiments involving hazardous biological materials.
03
Individuals seeking employment or training in facilities that handle select agents.
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You must receive annual refresher training after you have received initial training on select agents and toxins. If the entity makes significant changes to the biosafety, security or incident response plans then the entity needs to update their training programs and provide training to the staff.
Records required to comply with the select agent regulations must be maintained for 3 years, following final disposition of material.
Infectious agents and toxins considered by the Department of Health and Human Services (HHS) or the Department of Agriculture (USDA) as having the potential to pose a severe threat to human, animal, or plant health are regulated as select agents.
Biological agents include bacteria, viruses, fungi, other microorganisms and their associated toxins. They have the ability to adversely affect human health in a variety of ways, ranging from relatively mild, allergic reactions to serious medical conditions — even death.
Infectious agents and toxins considered by the Department of Health and Human Services (HHS) or the Department of Agriculture (USDA) as having the potential to pose a severe threat to human, animal, or plant health are regulated as select agents.
Select agents are biological agents and toxins that have the potential to pose a severe threat to both human and animal health, plant health, or to animal and plant products. These materials are regulated by the Federal Select Agent Program, under 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.
Renewals of SRAs How long is the SRA valid? An SRA for individuals that will have access to select agents and toxins and RO, ARO, individuals that own or control an entity, and non-exempted entities is valid for a period not to exceed three years.

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The Statement of Eligibility to Handle Select Biological Agents or Toxins is a declaration that certifies an individual or organization is qualified to manage specific biological agents or toxins that are regulated due to their potential threat to human health or safety.
Individuals or organizations that wish to handle select biological agents or toxins must file the Statement of Eligibility. This includes laboratories, research institutions, and entities involved in the production or research of these agents.
To fill out the Statement of Eligibility, applicants must provide personal and organizational information, details about the biological agents or toxins they intend to handle, and any relevant credentials that demonstrate their qualifications and safety protocols.
The purpose of the Statement of Eligibility is to ensure that only qualified individuals and organizations can handle select biological agents or toxins, thereby safeguarding public health and ensuring compliance with regulatory standards.
The information that must be reported includes the applicant's identity, the specific agents or toxins they intend to handle, risk management strategies, and descriptions of facilities, equipment, and training that ensure safe handling practices.
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