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515 Part 73—Select Agents and Toxins Public Health Service, HHS § 73.1 PART 73—SELECT AGENTS AND spection Service, or any person author- TOXINS ized to act for the Administrator. Animal and Plant Health Inspection Sec. Service (APHIS) means the Animal and 73.0 Applicability and related requirements. Plant Health Inspection Service of the 73.1 Definitions. U.S. Department of Agriculture. 73.2 Purpose and scope. Attorney General means the Attorney 73.3 HHS select agents and toxins. General of the United States or any 73.4 Overlap select agents and toxins. person authorized to act for the Attor- 73.5 Exemptions for HHS select agents and ney General. toxins. Biological agent means any micro- 73.6 Exemptions for overlap select agents and toxins. organism (including, but not limited 73.7 Registration and related security risk to, bacteria, viruses, fungi, rickettsiae, assessments. or protozoa), or infectious substance, 73.8 Denial, revocation, or suspension of or any naturally occurring, bioengi- registration. neered, or synthesized component of 73.9 Responsible Official. any such microorganism or infectious 73.10 Restricting access to select agents and substance, capable of causing death, toxins; security risk assessments. disease, or other biological malfunc- 73.11 Security. tion in a human, an animal, a plant, or 73.12 Biosafety. 73.13 Restricted experiments. another living organism; deterioration 73.14 Incident response. of food, water, equipment, supplies, or 73.15 Training. material of any kind; or deleterious al- 73.16 Transfers. teration of the environment. 73.17 Records. CDC means Centers for Disease Con- 73.18 Inspections. trol and Prevention of the Department 73.19 Notification of theft, loss, or release. of Health and Human Services. 73.20 Administrative review. Conotoxins means short, paralytic 73.21 Civil money penalties. alpha conotoxins containing the fol- AUTHORITY: 42 U.S.C. 262a; sections 201–204, lowing amino acid sequence 221 and 231 of Title II of Public Law 107–188, X1CCX2PACGX3X4X5X6CX7, whereas: 116 Stat. 637 (42 U.S.C. 262a). (1) C = Cysteine residues are all present as SOURCE: 70 FR 13316, Mar. 18, 2005, unless disulfides, with the 1st and 3rd Cysteine, otherwise noted. and the 2nd and 4th Cysteine forming specific disulfide bridges; § 73.0 Applicability and related re- (2) The consensus sequence includes known quirements. toxins a-MI and a-GI (shown above) as All individuals and entities that pos- well as a-GIA, Ac1.1a, a-CnIA, a-CnIB; sess SARS-CoV, Lujo virus, or Chapare (3) X1 = any amino acid(s) or Des-X; virus must provide notice to CDC re- (4) X2 = Asparagine or Histidine; (5) P = Proline; garding their possession of SARS-CoV, (6) A = Alanine; Lujo virus, or Chapare virus on or be- (7) G = Glycine; fore December 4, 2012. Currently reg- (8) X3 = Arginine or Lysine; istered individuals and entities pos- (9) X4 = Asparagine, Histidine, Lysine, Argi- sessing SARS-CoV, Lujo virus, or nine, Tyrosine, Phenylalanine or Trypto- Chapare virus must meet all the re- phan; quirements of this part by December 4, (10) X5 = Tyrosine, Phenylalanine, or Tryp- tophan; 2012. All previously unregistered indi- (11) X6 = Serine, Threonine, Glutamate, viduals and entities possessing SARS- Aspartate, Glutamine, or Asparagine; CoV, Lujo virus, or Chapare virus must (12) X7 = Any amino acid(s) or Des X; and meet all of the requirements of this (13) ‘‘Des X’’ = ‘‘an amino acid does not have part by April 3, 2013. to be present at this position.’’ For ex- ample if a peptide sequence were [77 FR 61110, Oct. 5, 2012, as amended at 77 FR XCCHPA then the related peptide 71702, Dec. 4, 2012] CCHPA would be designated as Des-X. Diagnosis means the analysis of speci- § 73.1 Definitions. mens for the purpose of identifying or For purposes of this part: confirming the presence or characteris- Administrator means the Adminis- tics of a select agent or toxin provided trator, Animal and Plant Health In- that such analysis is directly related to 515 VerDate Sep<11>2014 09:29 Nov 18, 2014 Jkt 232186 PO 00000 Frm 00525 Fmt 8010 Sfmt 8010 Y:\SGML\232186.XXX 232186 rmajette on DSK2TPTVN1PROD with CFR § 73.1 42 CFR Ch. I (10–1–14 Edition) protecting the public health or safety, (2) Molecules that result from the animal health or animal products, or replication of those described in para- plant health or plant products. graph (1) of this definition. Entity means any government agency Responsible Official means the indi- (Federal, State, or local), academic in- vidual designated by an entity with the stitution, corporation, company, part- authority and control to ensure com- nership, society, association, firm, sole pliance with the regulations in this proprietorship, or other legal entity. part. HHS means the Department of Health Security barrier means a physical and Human Services. structure that is designed to prevent HHS Secretary means the Secretary of entry by unauthorized persons. the Department of Health and Human Select agent and/or toxin means unless Services or his or her designee, unless otherwise specified, all of the biologi- otherwise specified. cal agents or toxins listed in §§ 73.3 and HHS select agent and/or toxin means a 73.4. biological agent or toxin included in Specimen means samples of material § 73.3. from humans, animals, plants or the Information security means protecting environment or isolates or cultures information and information systems from such samples for the diagnosis, from unauthorized access, use, disclo- verification, or proficiency testing. sure, disruption, modification, or de- State means any of the several States struction in order to provide— of the United States, the Common- (1) Integrity, which means guarding wealth of the Northern Mariana Is- against improper information modi- lands, the Commonwealth of Puerto fication or destruction, and includes Rico, the District of Columbia, Guam, ensuring information authenticity; the Virgin Islands of the United States, (2) Confidentiality, which means pre- or any other territory or possession of serving authorized restrictions on ac- the United States. cess and disclosure, including means Synthetic nucleic acids means: for protecting personal privacy and (1) Molecules that are chemically or proprietary information; and by other means synthesized or ampli- (3) Availability, which means ensur- fied, including those that are chemi- ing timely and reliable access to and cally or otherwise modified but can use of information. base pair with naturally occurring nu- Occupational exposure means any rea- cleic acid molecules (i.e., synthetic nu- sonably anticipated skin, eye, mucous cleic acids) or membrane, parenteral contact, or res- (2) Molecules that result from the piratory aerosol exposure to select replication of those described in para- agents or toxins that may result from graph (1) of this definition. the performance of an employee’s du- Toxin means the toxic material or ties. product of plants, animals, microorga- Overlap select agent and/or toxin nisms (including, but not limited to, means a biological agent or toxin list- bacteria, viruses, fungi, rickettsiae, or ed in § 73.4 and 9 CFR part 121.4. protozoa), or infectious substances, or Principal investigator means the one a recombinant or synthesized mol- individual who is designated by the en- ecule, whatever their origin and meth- tity to direct a project or program and od of production, and includes any poi- who is responsible to the entity for the sonous substance or biological product scientific and technical direction of that may be engineered as a result of that project or program. biotechnology, produced by a living or- Proficiency testing means the process ganism; or any poisonous isomer or bi- of determining the competency of an ological product, homolog, or deriva- individual or laboratory to perform a tive of such a substance. specified test or procedure. United States means all of the States. Recombinant nucleic acids means: USDA means the United States De- (1) Molecules that are constructed by partment of Agriculture. joining nucleic acid molecules and that Verification means the demonstration can replicate in a living cell or of obtaining established performance 516 VerDate Sep<11>2014 09:29 Nov 18, 2014 Jkt 232186 PO 00000 Frm 00526 Fmt 8010 Sfmt 8010 Y:\SGML\232186.XXX 232186 rmajette on DSK2TPTVN1PROD with CFR Public Health Service, HHS § 73.3 (e.g., accuracy, precision, and the ana- South American Haemorrhagic Fever vi- lytical sensitivity and specificity) ruses: specifications for any procedure used Chapare for diagnosis. Guanarito Junin [70 FR 13316, Mar. 18, 2005, as amended at 77 Machupo FR 61110, Oct. 5, 2012] Sabia Staphylococcal enterotoxins (subtypes A–E) § 73.2 Purpose and scope. T–2 toxin This part implements the provisions Tetrodotoxin of the Public Health Security and Bio- Tick-borne encephalitis virus Far Eastern subtype terrorism Preparedness and Response Siberian subtype Act of 2002 setting forth the require- Kyasanur Forest disease virus ments for possession, use, and transfer Omsk haemorrhagic fever virus of select agents and toxins. The bio- Variola major virus (Smallpox virus) * logical agents and toxins listed in this Variola minor virus (Alastrim) * part have the potential to pose a severe Yersinia pestis * threat to public health and safety, to (c) Genetic Elements, Recombinant animal health, or to animal products. and/or Synthetic Nucleic Acids, and Overlap select agents and toxins are Recombinant and/or Synthetic Orga- subject to regulation by both CDC and nisms: APHIS. (1) Nucleic acids that can produce in- § 73.3 HHS select agents and toxins. fectious forms of any of the select agent viruses listed in paragraph (b) of (a) Except for exclusions under para- this section. graphs (d) and (e) of this section, the (2) Recombinant and/or Synthetic nu- HHS Secretary has determined that cleic acids that encode for the func- the biological agents and toxins listed tional form(s) of any of the toxins list- in this section have the potential to ed in paragraph (b) of this section if pose a severe threat to public health the nucleic acids: and safety.
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