331.9—Responsible official.
(a)
An individual or entity required to register under this part must designate an individual to be the responsible official. The responsible official must:
(1)
Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General;
(5)
Ensure that annual inspections are conducted of each laboratory where select agents or toxins are stored or used in order to ensure compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected.
(b)
An entity may designate one or more individuals to be an alternate responsible official, who may act for the responsible official in his/her absence. These individuals must have the authority and control to ensure compliance with the regulations when acting as the responsible official.
(c)
The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen for diagnosis or verification.
(1)
The identification of the select agent or toxin must be immediately reported by telephone, facsimile, or e-mail. The final disposition of the agent or toxin must be reported by submission of APHIS/CDC Form 4 within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years.
(2)
Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas.