[Code of Federal Regulations]

[Title 7, Volume 5]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 7CFR331.5]



[Page 479]

 

                          TITLE 7--AGRICULTURE

 

 CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

PART 331_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 

of Contents

 

Sec. 331.5  Exemptions.



    (a) Diagnostic laboratories and other entities that possess, use, or 

transfer a 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. 331.16 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 immediately reported 

to APHIS or CDC by telephone, facsimile, or e-mail. This report must be 

followed by submission of APHIS/CDC Form 4 within 7 calendar days after 

identification. Less stringent reporting may be required during 

agricultural emergencies or outbreaks, or in endemic areas. A copy of 

APHIS/CDC Form 4 must be maintained for 3 years.

    (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 plant health or plant 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.