[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: 9CFR121.5]

[Page 744-745]
 
                  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.  121.5  Exemptions for animal agents and toxins.

    (a) Diagnostic laboratories and other entities possessing, using, or 
transferring 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 the Administrator 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 the 
Administrator.\5\ During agricultural emergencies or outbreaks, or in 
endemic areas, the Administrator may require less frequent reporting. A 
copy of the completed form must be maintained for 3 years.
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    \5\ A diagnostic laboratory or other entity must immediately notify 
APHIS by faxing (301) 734-3652. APHIS Form 2040 may be obtained by 
calling (301) 734-3277. The form is also available on the Internet at 
http://www.aphis.usda.gov/vs/ncie.bta.html. The completed form may be 
mailed to National Center for Import and Export, VS, APHIS, 4700 River 
Road Unit 40, Riverdale, MD 20737-1231; or faxed to (301) 734-3652.
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    (b) Diagnostic laboratories and other entities possessing, using, or 
transferring 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 Administrator, and to other 
appropriate authorities when required by Federal, State, or local law; 
and
    (2) Within 90 days of receipt, the agent or toxins are transferred 
or inactivated, and APHIS Form 2040 is submitted to the Administrator. A 
copy of the completed form must be maintained for 3 years.
    (c) An individual or entity receiving diagnostic reagents and 
vaccines that are, bear, or contain listed agents or toxins, also known 
as high consequence livestock pathogens or toxins, that are produced at 
USDA diagnostic facilities

[[Page 745]]

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, an 
individual or entity possessing, using, or transferring products that 
are, bear, or contain listed 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) An individual or entity possessing, using, or transferring 
experimental products that are, bear, or contain listed 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. An individual or entity possessing, using, or transferring 
such experimental products may apply for an exemption from the 
requirements of this part by submitting APHIS Form 2042 to APHIS.
    (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 and animal 
products. An individual or entity that possesses, uses, or transfers 
agents or toxins 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. If there is a conflict as to any 
material fact, the individual or entity may request a hearing to resolve 
the conflict.\6\
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    \6\ A request for exemption may be mailed to National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 
20737-1231; or faxed to (301) 734-3652.
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