[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.6]

[Page 770-772]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 
of Contents
 
Sec. 121.6  Exemptions for overlap select agents and toxins.

    (a) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer an overlap select agent or toxin that is 
contained in a specimen presented for diagnosis or verification will be 
exempt from the requirements of this part for such agent or toxin 
contained in the specimen, provided that:
    (1) Unless directed otherwise by the Administrator or the HHS 
Secretary, within 7 calendar days after identification, the agent or 
toxin is transferred in accordance with Sec. 121.16 or 42 CFR 73.16 or 
destroyed on-site by a recognized sterilization or inactivation process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported; and
    (3) The identification of the agent or toxin is reported to APHIS or 
CDC.
    (i) The identification of any of the following overlap select agents 
and toxins must be immediately reported by telephone, facsimile, or e-
mail: Bacillus anthracis, Botulinum neurotoxins,

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Brucella melitensis, Francisella tularensis, Hendra virus, Nipah virus, 
Rift Valley fever virus, and Venezuelan equine encephalitis virus. This 
report must be followed by submission of APHIS/CDC Form 4 within 7 
calendar days after identification.
    (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 
must be submitted within 7 calendar days after identification.
    (iii) Less stringent reporting may be required during agricultural 
emergencies or outbreaks, or in endemic areas.
    (iv) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
    (b) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer an overlap select agent or toxin that is 
contained in a specimen presented for proficiency testing will be exempt 
from the requirements of this part for such agent or toxin contained in 
the specimen, provided that:
    (1) Unless directed otherwise by the Administrator or the HHS 
Secretary, within 90 days of receipt, the agent or toxin is transferred 
in accordance with Sec. 121.16 or 42 CFR 73.16 or destroyed on-site by 
a recognized sterilization or inactivation process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported; and
    (3) The identification of the agent or toxin, and its derivative, is 
reported to APHIS or CDC. To report the identification of an overlap 
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 3 years.
    (c) Unless the Administrator by order determines that additional 
regulation of a specific product is necessary to protect animal health 
or animal products, products that are, bear, or contain overlap select 
agents or toxins will be exempt from the requirements of this part if 
the products have been cleared, approved, licensed, or registered 
pursuant to:
    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.);
    (2) Section 351 of Public Health Service Act (42 U.S.C. 262);
    (3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
    (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 131 et seq.).
    (d) After consultation with the HHS Secretary, the Administrator may 
exempt from the requirements of this part an investigational product 
that is, bears, or contains an overlap select agent or toxin if such 
product is being used in an investigation authorized by any Federal law 
and the Administrator determines that additional regulation under this 
part is not necessary to protect animal health or animal products.
    (1) To apply for an exemption, an individual or entity must submit 
APHIS/CDC Form 5.
    (2) The Administrator will make a determination regarding an 
exemption within 14 calendar days after receipt of the application and 
notification that the investigation has been authorized under a Federal 
law. A written decision granting or denying the exemption will be 
issued.
    (3) The applicant must notify APHIS or CDC when an authorization for 
an investigation no longer exists. This exemption automatically 
terminates when such authorization is no longer in effect.
    (e) The Administrator may exempt an individual or entity from the 
requirements of this part for 30 calendar days if it is necessary to 
respond to a domestic or foreign agricultural emergency involving an 
overlap select agent or toxin. The Administrator may extend the 
exemption once for an additional 30 days. An individual or entity may 
apply for this exemption by submitting APHIS/CDC Form 5. A written 
decision granting or denying the exemption will be issued.
    (f) Upon request of the Secretary of Health and Human Services, the 
Administrator may exempt an individual or entity from the requirements 
of this part for 30 calendar days if the Secretary of Health and Human 
Services has granted an exemption for a public health emergency 
involving an overlap

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select agent or toxin. The Administrator may extend the exemption once 
for an additional 30 days.