[Code of Federal Regulations] [Title 9, Volume 1] [Revised as of January 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR121.3] [Page 756-757] 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. 121.3 List of biological agents and toxins. (a) Except as provided in paragraphs (f) and (g) 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 both human and animal health, to animal health, or to animal products. (b) Overlap agents and toxins. Bacillus anthracis Botulinum neurotoxins Botulinum neurotoxin producing species of Clostridium Brucella abortus Brucella melitensis Brucella suis Burkholderia mallei Burkholderia pseudomallei Clostridium botulinum 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 of overlap agents or toxins: (1) Biological agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the biological agent viruses. (2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in paragraph (b) of this section, if the nucleic acids: (i) Are in a vector or host chromosome; (ii) Can be expressed in vivo or in vitro; or (iii) Are in a vector or host chromosome and can be expressed in vivo or in vitro. (3) Viruses, bacteria, fungi, and toxins listed in paragraph (b) of this section that have been genetically modified. (d) Animal agents and toxins. African horse sickness virus African swine fever virus Akabane virus Avian influenza virus (highly pathogenic) Bluetongue virus (exotic) Bovine spongiform encephalopathy agent Camel pox virus Classical swine fever virus Cowdria ruminantium (Heartwater) Foot-and-mouth disease virus Goat pox virus Japanese encephalitis virus Lumpy skin disease virus Malignant catarrhal fever virus (exotic) Menangle virus Mycoplasma capricolum/M. F38/M. mycoides capri (contagious caprine pleuropneumonia) Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia) Newcastle disease virus (VVND) Peste des petits ruminants virus Rinderpest virus Sheep pox virus Swine vesicular disease virus Vesicular stomatitis virus (exotic) (e) The Administrator has determined that it would be impractical to regulate a biological agent or toxin that is in its naturally occurring environment. Therefore, any biological agent or toxin listed in this section that is in its naturally occurring environment will not be subject to the requirements of this part, provided that the biological agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (f) The Administrator has determined that biological agents or toxins that meet any of the following criteria do not have the potential to pose a severe threat to both human and animal health, or to animal health or animal products. Therefore, an individual or [[Page 757]] entity that only possesses, uses, or transfers an agent or toxin that meets any of the following criteria will not be subject to the requirements of this part: (1) Nonviable agents or fixed tissues that are, bear, or contain agents or toxins listed in this section.\1\ --------------------------------------------------------------------------- \1\ However, the importation and interstate movement of these genetic elements or subunits of listed agents or toxins are still subject to the permit requirements under part 122 of this subchapter. --------------------------------------------------------------------------- (2) Genetic elements or subunits of agents or toxins listed in paragraph (d) of this section, if the genetic elements or subunits are not capable of causing disease.\2\ --------------------------------------------------------------------------- \2\ See footnote 1. --------------------------------------------------------------------------- (3) Overlap toxins under the control of a principal investigator (or equivalent), if the total aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins (types A-G), 100 mg of Clostridium perfringens epsilon toxin, 100 mg of Shigatoxin, 5 mg of Staphylococcal enterotoxins, and 1,000 mg of T-2 toxin. (g) Attenuated strains. Attenuated strains of biological agents listed in this section may not have the potential to pose a severe threat to both human and animal health, to animal health, or to animal products. Thus, an individual or entity may request review by the Administrator to determine whether a specific attenuated strain poses a severe threat to both human and animal health, or to animal health or animal products. For overlap agents, an individual or entity may request review by APHIS or CDC. (1) If APHIS or CDC determines that a specific attenuated strain does not pose a severe threat to human and animal health, or to animal health or animal products, an individual or entity will not be subject to the requirements of this part. This determination will be limited to the specific attenuated strain and to the specific activities involving that attenuated strain. (2) An individual or entity may request a review by writing to the Administrator or, for overlap agents, by writing to the Administrator or CDC.\3\ --------------------------------------------------------------------------- \3\ A request to review an attenuated strain 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. For overlap agents, a request for review may be mailed to the above address or to Select Agent Program, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mail Stop E 79, Atlanta, GA 30333; or faxed to (404) 498-2265. --------------------------------------------------------------------------- (3) If it is determined that a specific attenuated strain does not pose a severe threat, APHIS or CDC will notify the applicant and publish a notice in the Federal Register. (4) An individual or entity may request reconsideration of an adverse decision in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies upon 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. If there is a conflict as to any material fact, the individual or entity may request a hearing to resolve the conflict.