[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.7]

[Page 760-761]
 
                  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. 121.7  Registration; general provisions.

    (a) Unless exempted under Sec. Sec. 121.4 or 121.5, an individual 
or entity shall not possess, use, or transfer any agent or toxin listed 
in Sec. 121.3 without a certificate of registration issued by APHIS or 
CDC.
    (b) A certificate of registration may be issued upon:
    (1) Approval of the responsible official; the alternate responsible 
official, where applicable; the entity; and, where applicable, the 
individual who owns or controls the entity following a security risk 
assessment by the Attorney General; \7\ and
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    \7\ The security risk assessment of the entity and the individual 
who owns or controls such entity may be waived for Federal, State, or 
local governmental agencies.
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    (2) Approval of the biosafety, containment, and security of the 
entity. The entity's biosafety, containment, and security procedures 
must be commensurate with the risk of the agent or toxin, given its 
intended use. APHIS or CDC will review the Biosafety and Security Plan, 
and may inspect and evaluate the premises and records to determine 
compliance with the regulations and the biosafety, containment, and 
security requirements; and
    (3) A determination by the Administrator that the individual or 
entity seeking to register has a lawful purpose to possess, use, or 
transfer such agents or toxins.
    (c) For overlap agents, APHIS and CDC will review applications for 
registration and amendments to a certificate of registration, and a 
certificate of registration or amendment to a certificate of 
registration will only be issued if APHIS and CDC concur.
    (d) A certificate of registration will be valid for only the 
specific agents or toxins listed in the certificate and specific 
activities and locations. A certificate of registration may cover more 
than one listed agent or toxin, and it may be amended to cover 
additional listed agents or toxins.
    (e) A certificate of registration may be amended to reflect changed 
circumstances (e.g., replacement of the responsible official, changes in 
ownership or control of the entity,\8\ changes in the activities 
involving the agent or toxin). The responsible official must immediately 
notify the agency that issued the certificate of registration, either 
APHIS or CDC, of such changes in circumstances that occur after 
submission of the application for registration or after receipt of a 
certificate of registration.
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    \8\ Any change in ownership or control of an entity will require a 
security risk assessment for the new individual(s) who owns or controls 
the entity.
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    (f) If a responsible official wishes to discontinue possessing, 
using, or transferring a particular agent or toxin, the responsible 
official may inactivate the agent or toxin or he/she may transfer the 
agent or toxin to a registered individual or entity in accordance with 
Sec. 121.13. The responsible official must notify APHIS or, for overlap 
agents or toxins, APHIS or CDC, 5 business days prior to the planned 
inactivation so that we may have the opportunity to observe the 
inactivation of the agents or toxins. APHIS or CDC will notify

[[Page 761]]

the responsible official if we wish to observe the inactivation of the 
agents or toxins.
    (g) A certificate of registration will be valid for a maximum of 3 
years.