Get the free Select Agent Written Plan Acknowledgement Document

Written Plan Acknowledgement Document Location (Building Name, Room Number): Principal Investigator (PI): I, the undersigned, hereby certify that: I have carefully read and fully understand the written

How to fill out select agent written plan

How to fill out a select agent written plan:

1. Start by familiarizing yourself with the requirements outlined in the select agent regulations. These regulations are administered by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS).
2. Review the specific components that must be included in the written plan. This may vary depending on the select agent and the nature of your research or work involving it. Common components may include risk assessments, security measures, training programs, incident response procedures, and transportation protocols.
3. Identify the select agent responsible official (RO) within your organization. This is the individual who will oversee and ensure compliance with the select agent regulations. The RO will be responsible for completing and submitting the written plan.
4. Assemble a team of experts or individuals with relevant knowledge to help complete the written plan. This may include biosafety officers, security personnel, research scientists, and other relevant stakeholders.
5. Conduct a thorough risk assessment of your select agent activities. This involves identifying potential hazards, assessing the likelihood and consequences of accidents or incidents, and determining appropriate mitigation strategies. Document your findings and incorporate them into the written plan.
6. Develop security measures to prevent unauthorized access to select agents. This may include physical barriers, controlled access procedures, surveillance systems, and personnel background checks. Document these measures and explain how they will be implemented and maintained.
7. Establish a training program to ensure that all personnel handling or working with select agents are properly trained on the associated risks, procedures, and regulations. Outline the training requirements, frequency, and documentation process in the written plan.
8. Develop incident response procedures to address emergencies, accidents, or security breaches involving select agents. These procedures should include steps to mitigate risks, report incidents to the appropriate authorities, and communicate with relevant personnel. Document and include these procedures in the written plan.
9. Include transportation protocols in the written plan if your select agent activities involve the shipping or transport of these agents. This may include requirements for secure packaging, labeling, and documentation during transit.
10. Make sure to regularly review and update the select agent written plan as necessary. Regulations or guidelines may change over time, and it is essential to stay up-to-date and maintain compliance.

Who needs a select agent written plan?

1. Laboratories or facilities that possess, use, or transfer select agents or toxins are required to have a written plan in accordance with select agent regulations.
2. Researchers, scientists, or other individuals who work with select agents must ensure they are following the guidelines set forth by the select agent regulations, which includes having a written plan.
3. Organizations or institutions that receive, store, or handle select agents are responsible for developing and implementing a written plan to ensure the safe and secure handling of these agents.

For pdfFiller’s FAQs

What is select agent written plan?

A select agent written plan is a document that outlines the procedures and protocols for the handling, storage, and disposal of select agents in a laboratory setting.

Who is required to file select agent written plan?

Any laboratory that is registered with the Select Agent Program and is in possession of select agents is required to file a select agent written plan.

How to fill out select agent written plan?

To fill out a select agent written plan, laboratories must carefully review the requirements outlined by the Select Agent Program and ensure that all procedures and protocols are accurately documented.

What is the purpose of select agent written plan?

The purpose of a select agent written plan is to ensure that laboratories have clear guidelines in place for the safe and secure handling of select agents to minimize the risk of accidental release or intentional misuse.

What information must be reported on select agent written plan?

A select agent written plan must include details on the training of personnel, the security measures in place, the procedures for access control, and the protocols for handling select agents.

How do I edit select agent written plan online?

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Can I create an electronic signature for signing my select agent written plan in Gmail?

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How do I fill out select agent written plan on an Android device?

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