Regulations and Standard Interpretations

Purpose

Regulations for importing infectious or suspected infectious biological agents, substances, and vectors, and standard interpretations of specific provisions regarding the Import Permit regulations.

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Regulations for importing infectious or suspected infectious biological agents, substances, and vectors, and standard interpretations of specific provisions regarding the Import Permit regulations.

Standard Interpretations

Below is an official interpretation as a written explanation of the meaning of a specific provision regarding the Import Permit Regulations.

Date and Conditions of the Import Permit

BSL-3/ABSL-3 HVAC and Facility Verification

It is the policy of the Centers for Disease Control and Prevention that a BSL-3/ABSL-3* facility is required to have a ducted air ventilation system. (*Note: This policy statement is only applicable to entities working in a BSL-3 laboratory with an organism that requires BSL-3 containment. This policy does not apply to entities working in a BSL3 laboratory with an organism that does not require BSL-3 containment.) This system must provide sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas. The laboratory shall be designed such that under failure conditions the airflow will not be reversed.

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