[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 42CFR73.9]



[Page 446-447]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 73_SELECT AGENTS AND TOXINS--Table of Contents

 

Sec.  73.9  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 HHS Secretary or Administrator 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.



[[Page 447]]



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: 

Bacillus anthracis, Botulinum neurotoxins, Brucella melitensis, 

Francisella tularensis, Ebola viruses, Hendra virus, Marburg virus, 

Lassa fever virus, Nipah virus, Rift Valley fever virus, South American 

Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito), 

Variola major virus (Smallpox virus), Variola minor (Alastrim), 

Venezuelan equine encephalitis virus, 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.

    (2) To report the identification and final disposition of any other 

select agent or toxin, APHIS/CDC Form 4 must be submitted within seven 

calendar days after identification. A copy of the completed form must be 

maintained for three years.

    (3) Less stringent reporting may be required based on extraordinary 

circumstances, such as a widespread outbreak.

    (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 three years.