[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.9]

[Page 774]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 
of Contents
 
Sec. 121.9  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 for each laboratory 
where select agents or toxins are stored or used in order to determine 
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 
presented for diagnosis or verification.
    (1) The identification of any of the following select agents or 
toxins must be immediately reported by telephone, facsimile, or e-mail: 
African horse sickness virus, African swine fever virus, avian influenza 
virus (highly pathogenic), Bacillus anthracis, Botulinum neurotoxins, 
bovine spongiform encephalopathy agent, Brucella melitensis, classical 
swine fever virus, foot-and-mouth disease virus, Francisella tularensis, 
Hendra virus, Newcastle disease virus (velogenic), Nipah virus, Rift 
Valley fever virus, rinderpest virus, swine vesicular disease virus, and 
Venezuelan equine encephalitis virus. 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) To report the identification and final disposition of any other 
select agent or toxin, APHIS/CDC Form 4 must be submitted within 7 
calendar days after identification. A copy of the completed form must be 
maintained for 3 years.
    (3) Less stringent reporting may be required during agricultural 
emergencies or outbreaks, or in endemic areas.
    (d) The responsible official must report the identification and 
final disposition of any select agent or toxin contained in a specimen 
presented for proficiency testing. To report the identification and 
final disposition of a select agent or toxin, APHIS/CDC Form 4 must be 
submitted within 90 calendar days of receipt of the agent or toxin. A 
copy of the completed form must be maintained for 3 years.