[Code of Federal Regulations]
[Title 7, Volume 5]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR331.6]

[Page 423]
 
                          TITLE 7--AGRICULTURE
 
 CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 331_POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND TOXINS
--Table of Contents
 
Sec. 331.6  Registration; general provisions.

    (a) Unless exempted under this part, an individual or entity shall 
not possess, use, or transfer any agent or toxin listed in Sec. 331.3 
without a certificate of registration issued by APHIS.
    (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 controls the entity following a security risk assessment 
by the Attorney General; \4\ and
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    \4\ 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 containment and security of the entity. The 
entity's containment and security procedures must be commensurate with 
the risk of the agent or toxin, given its intended use. APHIS will 
review the Biocontainment and Security Plan, and may inspect and 
evaluate the premises and records to determine compliance with the 
regulations and the 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) A certificate of registration will be valid for only the 
specific agents or toxins listed on 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.
    (d) 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,\5\ changes in the activities 
involving the agent or toxin). The responsible official must immediately 
notify APHIS 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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    \5\ 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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    (e) 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 individuals or entities in accordance 
with Sec. 331.12. The responsible official must notify APHIS 5 business 
days prior to the planned inactivation so that we may have the 
opportunity to observe the inactivation of the agents or toxins. We will 
notify the responsible official if we wish to observe the inactivation 
of the agents or toxins.
    (f) A certificate of registration will be valid for a maximum of 3 
years.