[Code of Federal Regulations]

[Title 7, Volume 5]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 7CFR331.9]



[Page 481-482]

 

                          TITLE 7--AGRICULTURE

 

 CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

PART 331_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 

of Contents

 

Sec. 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;

    (2) Be familiar with the requirements of this part;

    (3) Have authority and responsibility to act on behalf of the 

entity;

    (4) Ensure compliance with the requirements of this part; and

    (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.



[[Page 482]]



    (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.