[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: 9CFR121.5]

[Page 769-770]
 
                  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. 121.5  Exemptions for VS select agents and toxins.

    (a) Diagnostic laboratories and other entities that possess, use, or 
transfer a VS 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, within 7 
calendar days after identification, the agent or toxin is transferred in 
accordance with Sec. 121.16 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 select agents and 
toxins must be immediately reported by telephone, facsimile, or e-mail: 
African horse sickness virus, African swine fever virus, avian influenza 
virus (highly pathogenic), bovine spongiform encephalopathy agent, 
classical swine fever virus, foot-and-mouth disease virus, Newcastle 
disease virus (velogenic), rinderpest virus, and swine vesicular disease 
virus. This report must be followed by submission of APHIS/CDC Form 4 
within 7 calendar days after identification.
    (ii) For all other VS 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) Diagnostic laboratories and other entities that possess, use, or 
transfer a VS 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, within 90 
calendar days of receipt, the agent or toxin is transferred in 
accordance with Sec. 121.16 or destroyed on-site by a recognized 
sterilization or inactivation process;

[[Page 770]]

    (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 a select agent 
or toxin, APHIS/CDC Form 4 must be submitted within 90 days of receipt 
of the agent or toxin. A copy of the completed form must be maintained 
for 3 years.
    (c) Diagnostic reagents and vaccines that are, bear, or contain VS 
select agents or toxins that are produced at USDA diagnostic facilities 
will be exempt from the requirements of this part.
    (d) Unless the Administrator by order determines that additional 
regulation is necessary to protect animal health or animal products, 
products that are, bear, or contain VS 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.).
    (e) The Administrator may exempt from the requirements of this part 
an experimental product that is, bears, or contains a VS 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. To apply for an exemption, an individual or entity must 
submit APHIS/CDC Form 5. A written decision granting or denying the 
exemption will be issued. The applicant must notify APHIS when an 
authorization for an investigation no longer exists. This exemption 
automatically terminates when such authorization is no longer in effect.
    (f) In addition to the exemptions provided in paragraphs (a) through 
(e) of this section, the Administrator may grant a specific exemption 
upon a showing of good cause and upon his or her determination that such 
exemption is consistent with protecting animal health or animal 
products. An individual or entity may request in writing an exemption 
from the requirements of this part. If granted, such exemptions are 
valid for a maximum of 3 years; thereafter, an individual or entity must 
request a new exemption. If a request for exemption is denied, an 
individual or entity may request reconsideration in writing to the 
Administrator. The request for reconsideration must state all of the 
facts and reasons upon which the individual or entity relies to show 
that the exemption was wrongfully denied. The Administrator will grant 
or deny the request for reconsideration as promptly as circumstances 
allow and will state, in writing, the reasons for the decision.