APHIS/CDC Select Agent Program Audit

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

An individual or entity required to register under this part must designate an individual to be the Responsible Official. The Responsible Official must: CFR: Section 9(a)

• Be approved by the HHS Secretary or Administrator following a security risk<br>assessment by the Attorney General. CFR: Section 9(a)(1)

  Yes

  No

  N/A

• Be familiar with the requirements of this part.. CFR: Section 9(a)(2)

  Yes

  No

  N/A

• Have authority and responsibility to act on behalf of the entity. CFR: Section 9(a)(3)

  Yes

  No

  N/A

• Ensure compliance with the requirements of this part. CFR: Section 9(a)(4)

  Yes

  No

  N/A

• Have a physical (and not merely a telephonic or audio/visual) presence at the registered entity to ensure that the entity is in compliance with the select agent regulations and be able to respond in a timely manner to onsite incidents involving select agents and toxins in accordance with the entity's incident response plan, and CFR: Section 9(a)(5)

  Yes

  No

  N/A

• Ensure that annual inspections are conducted for each laboratory where select agents or toxins are stored or used in order to determine compliance with the requirements of this part. CFR: Section 9(a)(6)

  Yes

  No

  N/A

• The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected. CFR: Section 9(a)(6)

  Yes

  No

  N/A

• An entity may designate one or more individuals to serve as an alternate Responsible Official, who acts for the Responsible Official in his/her absence. CFR: Section 9(b)

  Yes

  No

  N/A

• These individuals must have the authority and control to ensure compliance with the regulations when acting as the Responsible Official. 7 CFR 331: CFR:9 CFR 121: Section 9(b)

  Yes

  No

  N/A

The Responsible Official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification. CFR: Section 9(c)

• The identification of the any of the following select agents or toxins must be immediately reported by telephone, facsimile, or e-mail: Bacillus anthracis, Botulinum neurotoxins, Botulinum neurotoxin producing species of Clostrdium Burkholderia mallei, Burkholderia pseudomallei, Francisella tularensis, Ebola viruses, Marburg virus, Variola major virus (Smallpox virus), Variola minor (Alastrim), or Yersinia pestis. The final disposition of the agent or toxin must be reported by submission of APHIS?CDC Form 4 within seven calendar days after identification. A copy of the completed form must be maintained for three years. 42 CFR 73: Section 9(c)(1)

  Yes

  No

  N/A