[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: 9CFR121.11]

[Page 748-749]
 
                  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.  121.11  Restricting access to biological agents and toxins.

    (a) An individual may not have access to biological agents or toxins 
listed in Sec.  121.3 unless approved by APHIS or CDC. APHIS will grant, 
limit, or deny access of individuals to listed agents or toxins. APHIS 
or CDC will grant, limit, or deny access of individuals to overlap 
agents or toxins.
    (b) The responsible official is responsible for ensuring that only 
approved individuals within the entity have access to any agents or 
toxins listed in Sec.  121.3. The responsible official must request such 
access for only those individuals who have a legitimate need to handle 
or use agents or toxins, and who have the appropriate training and 
skills to handle such agents or toxins.
    (c) The responsible official must provide appropriate training in 
biosafety, containment, and security procedures to all individuals with 
access to agents and toxins listed in Sec.  121.3.
    (d) For each individual identified by the responsible official as 
having a legitimate need to handle or use agents or toxins, the 
responsible official must submit that individual's name and identifying 
information to APHIS and the Attorney General. For overlap agents or 
toxins, the responsible official must submit this information to either 
APHIS or CDC and the Attorney General.
    (e) In addition, the responsible official must submit information 
about the individual's training and skills to APHIS or, for overlap 
agents or toxins, APHIS or CDC (e.g., curriculum vitae

[[Page 749]]

for principal investigators and researchers, and a description of 
training completed by support personnel).
    (f) APHIS may expedite the access approval process for individuals 
upon request by the responsible official and a showing of good cause 
(e.g., public health or agricultural emergencies, national security, 
impending expiration of a research grant, a short-term visit by a 
prominent researcher).
    (g) APHIS will notify the responsible official if an individual is 
granted full or limited access, or denied access to listed agents or 
toxins. APHIS will also notify the individual if he/she is denied access 
or granted only limited access. For overlap agents or toxins, APHIS or 
CDC will provide the necessary notification.
    (h) APHIS may deny or limit access of an individual to listed agents 
or toxins if:
    (1) The Attorney General identifies the individual as within any of 
the categories described in 18 U.S.C. 175b;
    (2) The Attorney General identifies the individual as reasonably 
suspected by any Federal law enforcement or intelligence agency of 
committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing 
involvement with an organization that engages in domestic or 
international terrorism (as defined in 18 U.S.C. 2331) or with any other 
organization that engages in intentional crimes of violence; or being an 
agent of a foreign power as defined in 50 U.S.C. 1801;
    (3) The individual does not have a legitimate need to handle listed 
agents or toxins;
    (4) The individual does not have the necessary training or skills to 
handle listed agents or toxins;
    (5) The Administrator determines that such action is necessary to 
protect animal health or animal products.
    (i) For overlap agents or toxins, APHIS or CDC will deny an 
individual access to such agents or toxins if the Attorney General 
identifies the individual as within any of the categories described in 
18 U.S.C. 175b. APHIS or CDC may also deny or limit access of an 
individual for the reasons set forth in paragraphs (f)(2) through (f)(5) 
of this section.
    (j) An individual may appeal the Administrator's decision to deny or 
limit access under Sec.  121.17.
    (k) Access approval is valid for 5 years; thereafter, the 
responsible official shall request renewal of access approval every 5 
years for as long as the individual needs access to agents or toxins 
listed in Sec.  121.3.
    (l) The responsible official must immediately notify APHIS or, for 
overlap agents or toxins, APHIS or CDC, when an individual's access to 
agents or toxins listed in Sec.  121.3 is terminated by the entity and 
the reasons therefore.