[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: 7CFR331.3]



[Page 478-479]

 

                          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. 331.3  PPQ select agents and toxins.



    (a) Except as provided in paragraphs (d) and (e) of this section, 

the Administrator has determined that the biological agents and toxins 

listed in this section have been determined to have the potential to 

pose a severe threat to plant health or to plant products.

    (b) PPQ select agents and toxins:

    Candidatus Liberobacter africanus;

    Candidatus Liberobacter asiaticus;

    Peronosclerospora philippinensis;

    Ralstonia solanacearum, race 3, biovar 2;

    Sclerophthora rayssiae var. zeae;

    Synchytrium endobioticum;

    Xanthomonas oryzae pv. oryzicola;

    Xylella fastidiosa (citrus variegated chlorosis strain).

    (c) Genetic elements, recombinant nucleic acids, and recombinant 

organisms:

    (1) Nucleic acids that can produce infectious forms of any of the 

select agent viruses listed in paragraph (b) of this section.

    (2) Recombinant nucleic acids that encode for the functional forms 

of any toxin listed in paragraph (b) of this section if the nucleic 

acids:

    (i) Can be expressed in vivo or in vitro; or

    (ii) Are in a vector or recombinant host genome and can be expressed 

in vivo or in vitro.

    (3) Select agents and toxins listed in paragraph (b) of this section 

that have been genetically modified.

    (d) Select agents or toxins that meet any of the following criteria 

are excluded from the requirements of this part:

    (1) Any select agent or toxin that is in its naturally occurring 

environment, provided that the agent or toxin has not been intentionally 

introduced, cultivated, collected, or otherwise extracted from its 

natural source.

    (2) Nonviable select agents or nonfunctional toxins.

    (e) An attenuated strain of a select agent or toxin may be excluded 

from the requirements of this part based upon a determination that the 

attenuated strain does not pose a severe threat to plant health or plant 

products.

    (1) To apply for an exclusion, an individual or entity must submit a 

written request and supporting scientific information. A written 

decision granting or denying the request will be issued. An exclusion 

will be effective upon notification of the applicant. Exclusions will be 

published periodically in the notice section of the Federal Register and 

will be listed on the Internet at http://www.aphis.usda.gov/programs/

ag--selectagent/index.html.

    (2) If an excluded attenuated strain is subjected to any 

manipulation that restores or enhances its virulence, the resulting 

select agent or toxin will be subject to the requirements of this part.

    (3) An individual or entity may make a written request to the 

Administrator for reconsideration of a decision denying an exclusion 

application. The written request for reconsideration must state the 

facts and reasoning upon which the individual or entity relies to show 

the decision was incorrect. 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.

    (f) Any select agent or toxin seized by a Federal law enforcement 

agency will be excluded from the requirements of this part during the 

period between seizure of the agent or toxin and the



[[Page 479]]



transfer or destruction of such agent or toxin provided that:

    (1) As soon as practicable, the Federal law enforcement agency 

transfers the seized agent or toxin to an entity eligible to receive 

such agent or toxin or destroys the agent or toxin by a recognized 

sterilization or inactivation process.

    (2) The Federal law enforcement agency safeguards and secures the 

seized agent or toxin against theft, loss, or release, and reports any 

theft, loss, or release of such agent or toxin.

    (3) The Federal law enforcement agency reports the seizure of the 

select agent or toxin to APHIS or CDC. The seizure must be reported 

within 24 hours by telephone, facsimile, or e-mail. This report must be 

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

seizure of the select agent or toxin. A copy of the completed form must 

be maintained for 3 years.

    (4) The Federal law enforcement agency reports the final disposition 

of the select agent or toxin to APHIS or CDC by submission of APHIS/CDC 

Form 4. A copy of the completed form must be maintained for 3 years.