[Code of Federal Regulations] [Title 9, Volume 1] [Revised as of January 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR121.4] [Page 768-769] TITLE 9--ANIMALS AND ANIMAL PRODUCTS CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PART 121_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table of Contents Sec. 121.4 Overlap 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 the potential to pose a severe threat to public health and safety, to animal health, or to animal products. (b) Overlap select agents and toxins: Bacillus anthracis; Botulinum neurotoxins; Botulinum neurotoxin producing species of Clostridium; Brucella abortus; Brucella melitensis; Brucella suis; Burkholderia mallei; Burkholderia pseudomallei; Clostridium perfringens epsilon toxin; Coccidioides immitis; Coxiella burnetii; Eastern equine encephalitis virus; Francisella tularensis; Hendra virus; Nipah virus; Rift Valley fever virus; Shigatoxin; Staphylococcal enterotoxins; T-2 toxin; Venezuelan equine encephalitis virus. (c) Genetic elements, recombinant nucleic acids, and recombinant organisms: (1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph (b) of this section.\3\ --------------------------------------------------------------------------- \3\ The importation and interstate movement of overlap select agents or toxins listed in paragraphs (c)(1) through (c)(3) of this section may be subject to the permit requirements under part 122 of this subchapter. --------------------------------------------------------------------------- (2) Recombinant nucleic acids that encode for the functional forms of any overlap 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) Overlap select agents and toxins listed in paragraph (b) of this section that have been genetically modified. (d) Overlap select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: (1) Any overlap 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 overlap select agents or nonfunctional overlap toxins.\4\ --------------------------------------------------------------------------- \4\ However, the importation and interstate movement of these nonviable overlap select agents may be subject to the permit requirements under part 122 of this subchapter. --------------------------------------------------------------------------- (3) Overlap toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor, if the aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins, 100 mg of Clostridium perfringens epsilon toxin, 100 mg of Shigatoxin, 5 mg of Staphylococcal enterotoxins, and 1,000 mg of T-2 toxin. (e) An attenuated strain of an overlap 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 public health and safety, to animal health, or to animal 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 overlap 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 [[Page 769]] request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. (f) Any overlap 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 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 overlap select agent or toxin to APHIS or CDC. (i) The seizure of any of the following overlap select agents and toxins must be reported within 24 hours by telephone, facsimile, or e- mail: Bacillus anthracis, Botulinum neurotoxins, Brucella melitensis, Francisella tularensis, Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan equine encephalitis virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the overlap select agent or toxin. (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin. (iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years. (4) The Federal law enforcement agency reports the final disposition of the overlap select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years.