[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.10]

[Page 748]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121_POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND 
TOXINS--Table of Contents
 
Sec.  121.10  Responsibilities of the responsible official.

    (a) The responsible official is responsible for ensuring compliance 
with the regulations, including:
    (1) Developing and implementing a Biosafety and Security Plan in 
accordance with Sec.  121.12;
    (2) Allowing only approved individuals within the entity to have 
access to any agents or toxins listed in Sec.  121.3 in accordance with 
Sec.  121.11;
    (3) Providing appropriate training in biosafety, containment, and 
security procedures for all personnel in accordance with Sec.  121.13;
    (4) Transferring agents or toxins only to registered individuals or 
entities in accordance with Sec.  121.14;
    (5) Ensuring that all visitors are informed of and follow the 
entity's security requirements and procedures;
    (6) Notifying APHIS or, for overlap agents or toxins, APHIS or CDC, 
of changes in circumstances in accordance with Sec.  121.7;
    (7) Providing timely notice of any theft, loss, or release of a 
biological agent or toxin in accordance with Sec.  121.17;
    (8) Maintaining detailed records of information necessary to give a 
complete accounting of all of the activities related to agents or toxins 
listed in Sec.  121.3 in accordance with Sec.  121.15.
    (b) In addition to the requirements in paragraph (a) of this 
section, the responsible official for a diagnostic laboratory or other 
entities possessing, using, or transferring agents or toxins listed in 
Sec.  121.3 that are contained in specimens presented for diagnosis must 
immediately report the identification of such agents or toxins to the 
Administrator and to other appropriate authorities when required by 
Federal, State, or local law.\10\ During agricultural emergencies or 
outbreaks, or in endemic areas, the Administrator may require less 
frequent reporting.
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    \10\ A diagnostic laboratory or other entity must immediately notify 
APHIS by faxing (301) 734-3652.
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    (c) In addition to the requirements in paragraph (a) of this 
section, the responsible official must ensure that the following 
experiments are not conducted unless approved by the Administrator, 
after consultation with experts:
    (1) Experiments utilizing recombinant DNA that involve the 
deliberate transfer of a pathogenic trait or drug resistance trait to 
biological agents that are not known to acquire the trait naturally, if 
such acquisition could compromise the use of the drug to control disease 
agents in humans, veterinary medicine, or agriculture.
    (2) Experiments involving the deliberate formation of recombinant 
DNA containing genes for the biosynthesis of toxins lethal for 
vertebrates at an LD50<100 ng/kg body weight.