[Code of Federal Regulations]
[Title 7, Volume 5]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR331.4]

[Page 422]
 
                          TITLE 7--AGRICULTURE
 
 CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 331_POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND TOXINS
--Table of Contents
 
Sec. 331.4  Exemptions.


    (a) Diagnostic laboratories \1\ 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:
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    \1\ However, diagnostic laboratories and other persons will still be 
required to obtain a permit under part 330 of this chapter in order to 
import or move interstate any listed agent or toxin.
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    (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.\2\ 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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    \2\ A diagnostic laboratory or other person must immediately notify 
APHIS by calling (301) 734-5519. APHIS Form 2040 may be obtained by 
calling (301) 734-5519 or faxing a request to (301) 734-8700. The form 
is also available on the Internet at http://www.aphis.usda.gov/ppq/
permits. The completed form may be mailed to Biological and Technical 
Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-
1236; or faxed to (301) 734-8700.
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    (b) In addition to the exemption provided in paragraph (a) 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 or plant health, and animal or plant 
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.\3\
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    \3\ A request for exemption may be mailed to biological and 
Technical Services, PPQ, APHIS, 4700 River road Unit 133, Riverdale, MD 
20737-1236; or faxed to (301) 734-8700.
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