[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: 9CFR121.4]

[Page 757-758]
 
                  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. 121.4  Exemptions for overlap agents or toxins.

    (a) Clinical or diagnostic laboratories and other entities 
possessing, using, or transferring overlap agents or toxins that are 
contained in specimens presented for diagnosis or verification will be 
exempt from the requirements of this part, provided that:
    (1) The identification of such agents or toxins is immediately 
reported to APHIS or CDC, and to other appropriate authorities when 
required by Federal, State, or local law; and
    (2) Within 7 days after identification, the agents or toxins are 
transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or 
CDC.\4\ During agricultural emergencies or outbreaks, or in endemic 
areas, the Administrator may require less frequent reporting. A

[[Page 758]]

copy of the completed form must be maintained for 3 years.
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    \4\ A clinical or diagnostic laboratory, or other entity, may 
immediately notify APHIS by faxing (301) 734-3652. APHIS Form 2040 may 
be obtained by calling APHIS at (301) 734-3277 or by calling CDC at 
(404) 498-2265. The form is also available on the Internet at http://
www.aphis.usda.gov/vs/ncie.bta.html or http://www.cdc.gov/od/ohs/
lrsat.htm. The completed form may be mailed or faxed to APHIS or CDC, as 
provided in footnote 3.
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    (b) Clinical or diagnostic laboratories and other entities 
possessing, using, or transferring overlap agents or toxins that are 
contained in specimens presented for proficiency testing will be exempt 
from the requirements of this part, provided that:
    (1) The identification of such agents or toxins, and their 
derivatives, is immediately reported to the APHIS or CDC, and to other 
appropriate authorities when required by Federal, State, or local law; 
and
    (2) Within 90 days of receipt, the agents or toxins are transferred 
or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. 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 or plant 
health, or animal or plant products, an individual or entity possessing, 
using, or transferring products that are, bear, or contain overlap 
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) An individual or entity possessing, using, or transferring 
investigational products that are, bear, or contain overlap agents or 
toxins may be exempt from the requirements of this part 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 or plant health, and animal or plant 
products.
    (1) An individual or entity possessing, using, or transferring such 
investigational products may apply for an exemption from the 
requirements of this part by submitting APHIS Form 2042 to APHIS or CDC.
    (2) For investigational products authorized under any of the Federal 
laws specified in paragraph (c) of this section, the Administrator shall 
make a determination regarding an exemption within 14 days after receipt 
of the application and notification that the investigation has been 
authorized under a Federal law.
    (e) The Administrator may exempt an individual or entity from the 
requirements of this part, in whole or in part, for 30 days if it is 
necessary to respond to a domestic or foreign agricultural emergency 
involving an overlap agent or toxin. The Administrator may extend the 
exemption once for an additional 30 days.
    (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, in whole or in part, for 30 days if the Secretary of 
Health and Human Services has granted an exemption for a public health 
emergency involving an overlap agent or toxin. The Administrator may 
extend the exemption once for an additional 30 days.