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. 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 . 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. 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 or toxin provided trator, Animal and Plant Health In- that such analysis is directly related to

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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

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(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 (subtypes A–E) § 73.2 Purpose and scope. T–2 toxin This part implements the provisions 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- virus ments for possession, use, and transfer Omsk haemorrhagic fever virus of select agents and toxins. The bio- Variola major virus ( virus) * logical agents and toxins listed in this Variola minor virus () * part have the potential to pose a severe * 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. The select agents and tox- (i) Can be expressed in vivo or in vitro, ins marked with an asterisk (*) are des- or ignated as Tier 1 select agents and tox- (ii) Are in a vector or recombinant ins and are subject to additional re- host genome and can be expressed in quirements as listed in this part. vivo or in vitro. (b) HHS select agents and toxins: (3) HHS select agents and toxins list- Abrin ed in paragraph (b) of this section that Botulinum neurotoxins* have been genetically modified. Botulinum neurotoxin producing species of (d) HHS select agents or toxins that Clostridium* Conotoxins (Short, paralytic alpha meet any of the following criteria are conotoxins containing the following amino excluded from the requirements of this acid sequence X1CCX2PACGX3X4X5X6CX7) part: (1) Any HHS select agent or toxin Crimean-Congo haemorrhagic fever virus that is in its naturally occurring envi- Diacetoxyscirpenol ronment provided the select agent or Eastern Equine Encephalitis virus toxin has not been intentionally intro- Ebola virus* duced, cultivated, collected, or other- * Lassa fever virus wise extracted from its natural source. Lujo virus (2) Non-viable HHS select agents or * nonfunctional HHS toxins. Monkeypox virus (3) Except as required in § 73.16(l), the Reconstructed replication competent forms aggregate amount of the toxin under of the 1918 pandemic influenza virus con- the control of a principal investigator, taining any portion of the coding regions treating physician or veterinarian, or of all eight gene segments (Reconstructed commercial manufacturer or dis- 1918 Influenza virus) tributor does not, at any time, exceed the following amounts: 100 mg of SARS-associated coronavirus (SARS-CoV) Abrin; 0.5 mg of Botulinum neurotoxins; 100 mg of Conotoxins

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(Short, paralytic alpha conotoxins con- subject to the requirements of this taining the following amino acid se- part. quence X1CCX2PACGX3X4X5X6CX7); (f) Any HHS select agent or toxin 1,000 mg of Diacetoxyscirpenol; 100 mg seized by a Federal law enforcement of Ricin; 100 mg of Saxitoxin; 5 mg of agency will be excluded from the re- Staphylococcal enterotoxins (subtypes quirements of this part during the pe- A–E); 1,000 mg of T–2 toxin; or 100 mg of riod between seizure of the select agent Tetrodotoxin. or toxin and the transfer or destruction (i) The amounts are transferred only of such agent or toxin provided that: after the transferor uses due diligence (1) As soon as practicable, the Fed- and documents that the recipient has a eral law enforcement agency transfers legitimate need (i.e., reasonably justi- the seized select agent or toxin to an fied by a prophylactic, protective, bona entity eligible to receive such agent or fide research, or other peaceful pur- toxin or destroys the agent or toxin by pose) to handle or use such toxins. Not- a recognized sterilization or inactiva- withstanding the provisions of para- tion process, graph (d) of this section, the HHS Sec- (2) The Federal law enforcement retary retains the authority to, with- agency safeguards and secures the out prior notification, inspect and copy seized select agent or toxin against or request the submission of the due theft, loss, or release, and reports any diligence documentation to the CDC. theft, loss, or release of such agent or toxin, and (ii) Reports to CDC if they detect a (3) The Federal law enforcement known or suspected violation of Fed- agency reports the seizure of the select eral law or become aware of suspicious agent or toxin to CDC or APHIS. activity related to a toxin listed in this (i) The seizure of Botulinum part. neurotoxins, Botulinum neurotoxin (4) An animal inoculated with or ex- producing species of Clostridium, Ebola posed to an HHS select toxin. viruses, Francisella tularensis, Marburg (5) Any South American genotypes of virus, Variola major virus (Smallpox Eastern Equine Encephalitis Virus and virus), Variola minor (Alastrim), or any West African Clade of Monkeypox Yersinia pestis must be reported within virus provided that the individual or 24 hours by telephone, facsimile, or e- entity can identify that the agent is mail. This report must be followed by within the exclusion category. submission of APHIS/CDC Form 4 with- (e) An attenuated strain of a select in seven calendar days after seizure of agent or a select toxin modified to be the select agent or toxin. less potent or toxic may be excluded (ii) For all other HHS select agents from the requirements of this part or toxins, APHIS/CDC Form 4 must be based upon a determination by the submitted within seven calendar days HHS Secretary that the attenuated after seizure of the agent or toxin. strain or modified toxin does not pose (iii) A copy of APHIS/CDC Form 4 a severe threat to public health and must be maintained for three years. safety. (4) The Federal law enforcement (1) To apply for exclusion, an indi- agency reports the final disposition of vidual or entity must submit a written the select agent or toxin by submission request and supporting scientific infor- of APHIS/CDC Form 4. A copy of the mation. A written decision granting or completed form must be maintained denying the request will be issued. An for three years. exclusion will be effective upon notifi- [70 FR 13316, Mar. 18, 2005, as amended at 70 cation to the applicant. Exclusions will FR 61049, Oct. 20, 2005; 73 FR 61365, Oct. 16, be listed on the National Select Agent 2008; 73 FR 64554, Oct. 30, 2008; 77 FR 61110, Registry Web site at http:// Oct. 5, 2012; 79 FR 26861, May 12, 2014] www.selectagents.gov/. (2) If an excluded attenuated strain § 73.4 Overlap select agents and toxins. or modified toxin is subjected to any (a) Except for exclusions under para- manipulation that restores or enhances graphs (d) and (e) of this section, the its virulence or toxic activity, the re- HHS Secretary has determined that sulting select agent or toxin will be the biological agents and toxins listed

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in this section have the potential to (e) An attenuated strain of a select pose a severe threat to public health agent, or a select toxin modified to be and safety, to animal health, or to ani- less potent or toxic, may be excluded mal products. The select agents and from the requirements of this part toxins marked with an asterisk (*) are based upon a determination by the designated as Tier 1 select agents and HHS Secretary that the attenuated toxins and are subject to additional re- strain or modified toxin does not pose quirements as listed in this part. a severe threat to public health and (b) Overlap select agents and toxins: safety. Bacillus anthracis*; (1) To apply for exclusion, an indi- Bacillus anthracis (Pasteur strain); vidual or entity must submit a written Brucella abortus; request and supporting scientific infor- Brucella melitensis; mation. A written decision granting or Brucella suis; denying the request will be issued. An *; Burkholderia pseudomallei*; exclusion will be effective upon notifi- Hendra virus; cation to the applicant. Exclusions will Nipah virus; be listed on the National Select Agent virus; Registry Web site at http:// Venezuelan equine encephalitis virus www.selectagents.gov/. (c) Genetic Elements, Recombinant (2) If an excluded attenuated strain and/or Synthetic Nucleic Acids, and or modified toxin is subjected to any Recombinant and/or Synthetic Orga- manipulation that restores or enhances nisms: its virulence or toxic activity, the re- (1) Nucleic acids that can produce in- sulting select agent or toxin will be fectious forms of any of the overlap se- subject to the requirements of this lect agent viruses listed in paragraph part. (b) of this section. (f) Any overlap select agent or toxin (2) Recombinant and/or synthetic nu- seized by a Federal law enforcement cleic acids that encode for the func- agency will be excluded from the re- tional form(s) of any overlap toxins quirements of this part during the pe- listed in paragraph (b) of this section if riod between seizure of the select agent the nucleic acids: or toxin and the transfer or destruction (i) Can be expressed in vivo or in vitro, of such agent or toxin provided that: or (1) As soon as practicable, the Fed- (ii) Are in a vector or recombinant eral law enforcement agency transfers host genome and can be expressed in the seized select agent or toxin to an vivo or in vitro. (3) Overlap select agents and toxins entity eligible to receive such agent or listed in paragraph (b) of this section toxin or destroys the agent or toxin by that have been genetically modified. a recognized sterilization or inactiva- (d) Overlap select agents or toxins tion process, that meet any of the following criteria (2) The Federal law enforcement are excluded from the requirements of agency safeguards and secures the this part: seized select agent or toxin against (1) Any overlap select agent or toxin theft, loss, or release, and reports any that is in its naturally occurring envi- theft, loss, or release of such agent or ronment provided that the select agent toxin, and or toxin has not been intentionally in- (3) The Federal law enforcement troduced, cultivated, collected, or oth- agency reports the seizure of the over- erwise extracted from its natural lap select agent or toxin to CDC or source. APHIS. (2) Non-viable overlap select agents (i) The seizure of Bacillus anthracis, or nonfunctional overlap toxins. Burkholderia mallei and Burkholderia (3) Any subtypes of Venezuelan pseudomallei must be reported within 24 equine encephalitis virus except for hours by telephone, facsimile, or e- Subtypes IAB or IC provided that the mail. This report must be followed by individual or entity can identify that submission of APHIS/CDC Form 4 with- the agent is within the exclusion cat- in seven calendar days after seizure of egory. the overlap select agent or toxin.

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(ii) For all other overlap select (ii) For all other HHS select agents agents or toxins, APHIS/CDC Form 4 or toxins, APHIS/CDC Form 4 must be must be submitted within seven cal- submitted within seven calendar days endar days after seizure of the select after identification. agent or toxin. (iii) Less stringent reporting may be (iii) A copy of APHIS/CDC Form 4 required based on extraordinary cir- must be maintained for three years. cumstances, such as a widespread out- (4) The Federal law enforcement break. agency reports the final disposition of (iv) A copy of APHIS/CDC Form 4 the overlap select agent or toxin by the must be maintained for three years. submission of APHIS/CDC Form 4. A (b) Clinical or diagnostic laboratories copy of the completed form must be and other entities that possess, use, or maintained for three years. transfer a HHS select agent or toxin [70 FR 13316, Mar. 18, 2005, as amended at 73 that is contained in a specimen pre- FR 61366, Oct. 16, 2008; 77 FR 61111, Oct. 5, sented for proficiency testing will be 2012; 79 FR 26861, May 12, 2014] exempt from the requirements of this part for such agent or toxin contained § 73.5 Exemptions for HHS select agents and toxins. in the specimen, provided that: (1) Unless directed otherwise by the (a) Clinical or diagnostic laboratories HHS Secretary, within 90 calendar days and other entities that possess, use, or of receipt, the select agent or toxin is transfer a HHS select agent or toxin transferred in accordance with § 73.16 or that is contained in a specimen pre- destroyed on-site by a recognized steri- sented for diagnosis or verification will lization or inactivation process, be exempt from the requirements of this part for such agent or toxin con- (2) The select agent or toxin is se- tained in the specimen, provided that: cured against theft, loss, or release (1) Unless directed otherwise by the during the period between identifica- HHS Secretary, within seven calendar tion of the select agent or toxin and days after identification, the select transfer or destruction of such agent or agent or toxin is transferred in accord- toxin, and the theft, loss, or release of ance with § 73.16 or destroyed on-site by such agent or toxin is reported, and a recognized sterilization or inactiva- (3) The identification of the select tion process, agent or toxin, and its derivative, is re- (2) The select agent or toxin is se- ported to CDC or APHIS and to other cured against theft, loss, or release appropriate authorities when required during the period between identifica- by Federal, State, or local law. To re- tion of the select agent or toxin and port the identification of a select agent transfer or destruction of such agent or or toxin, APHIS/CDC Form 4 must be toxin, and any theft, loss, or release of submitted within 90 calendar days of such agent or toxin is reported, and receipt of the select agent or toxin. A (3) The identification of the select copy of the completed form must be agent or toxin is reported to CDC or maintained for three years. APHIS and to other appropriate au- (c) Unless the HHS Secretary issues thorities when required by Federal, an order making specific provisions of State, or local law. this part applicable to protect public (i) The identification of any of the health and safety, products that are, following HHS select agents or toxins bear, or contain listed select agents or must be immediately reported by tele- toxins that are cleared, approved, li- phone, facsimile, or e-mail: Botulinum censed, or registered under any of the neurotoxins, Botulinum neurotoxin following laws, are exempt from the producing species of Clostridium, Ebola provisions of this part insofar as their viruses, Francisella tularensis, Marburg use meets the requirements of such virus, Variola major virus (Smallpox laws: virus), Variola minor (Alastrim), or (1) The Federal Food, Drug, and Cos- Yersinia pestis. This report must be metic Act (21 U.S.C. 301 et seq.), followed by submission of APHIS/CDC (2) Section 351 of the Public Health Form 4 within seven calendar days Service Act pertaining to biological after identification. products (42 U.S.C. 262),

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(3) The Act commonly known as the of this part for such agent or toxin con- Virus-Serum-Toxin Act (21 U.S.C. 151– tained in the specimen, provided that: 159), or (1) Unless directed otherwise by the (4) The Federal Insecticide, Fun- HHS Secretary or Administrator, with- gicide, and Rodenticide Act (7 U.S.C. in seven calendar days after identifica- 136 et seq.). tion, the select agent or toxin is trans- (d) The HHS Secretary may exempt ferred in accordance with § 73.16 or 9 from the requirements of this part an CFR part 121.16 or destroyed on-site by investigational product that is, bears, a recognized sterilization or inactiva- or contains a select agent or toxin, tion process, when such product is being used in an (2) The select agent or toxin is se- investigation authorized under any cured against theft, loss, or release Federal Act and additional regulation during the period between identifica- under this part is not necessary to pro- tion of the select agent or toxin and tect public health and safety. transfer or destruction of such agent or (1) To apply for an exemption, an in- toxin, and any theft, loss, or release of dividual or entity must submit a com- such agent or toxin is reported, and pleted APHIS/CDC Form 5. (3) The identification of the select (2) The HHS Secretary shall make a agent or toxin is reported to CDC or determination regarding the applica- APHIS and to other appropriate au- tion within 14 calendar days after re- thorities when required by Federal, ceipt, provided the application meets State, or local law. all of the requirements of this section (i) The identification of any of the and the application establishes that following overlap select agents or tox- the investigation has been authorized ins must be immediately reported by under the cited Act. A written decision telephone, facsimile, or e-mail: Bacillus granting or denying the request will be anthracis, Burkholderia mallei and issued. Burkholderia pseudomallei. This report (3) The applicant must notify CDC or must be followed by submission of APHIS when an authorization for an APHIS/CDC Form 4 within seven cal- investigation no longer exists. This ex- endar days after identification. emption automatically terminates (ii) For all other overlap select when such authorization is no longer in agents or toxins, APHIS/CDC Form 4 effect. must be submitted within seven cal- (e) The HHS Secretary may tempo- endar days after identification. rarily exempt an individual or entity (iii) Less stringent reporting may be from the requirements of this part required based on extraordinary cir- based on a determination that the ex- cumstances, such as a widespread out- emption is necessary to provide for the break. timely participation of the individual (iv) A copy of APHIS/CDC Form 4 or entity in response to a domestic or must be maintained for three years. foreign public health emergency. With (b) Clinical or diagnostic laboratories respect to the emergency involved, the and other entities that possess, use, or exemption may not exceed 30 calendar transfer an overlap select agent or days, except that one extension of an toxin that is contained in a specimen additional 30 calendar days may be presented for proficiency testing will granted. be exempt from the requirements of [70 FR 13316, Mar. 18, 2005, as amended at 73 this part for such agent or toxin con- FR 61366, Oct. 16, 2008; 77 FR 61112, Oct. 5, tained in the specimen, provided that: 2012] (1) Unless directed otherwise by the HHS Secretary or Administrator, with- § 73.6 Exemptions for overlap select in 90 calendar days of receipt, the se- agents and toxins. lect agent or toxin is transferred in ac- (a) Clinical or diagnostic laboratories cordance with § 73.16 or 9 CFR part and other entities that possess, use, or 121.16 or destroyed on-site by a recog- transfer an overlap select agent or nized sterilization or inactivation proc- toxin that is contained in a specimen ess, presented for diagnosis or verification (2) The select agent or toxin is se- will be exempt from the requirements cured against theft, loss, or release

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during the period between identifica- under the cited Act. A written decision tion of the select agent or toxin and granting or denying the request will be transfer or destruction of such agent or issued. toxin, and the theft, loss, or release of (3) The applicant must notify CDC or such agent or toxin is reported, and APHIS when an authorization for an (3) The identification of the select investigation no longer exists. This ex- agent or toxin, and its derivative, is re- emption automatically terminates ported to CDC or APHIS and to other when such authorization is no longer in appropriate authorities when required effect. by Federal, State, or local law. To re- (e) The HHS Secretary may exempt port the identification of an overlap se- an individual or entity from the re- lect agent or toxin, APHIS/CDC Form 4 quirements of this part based on a de- must be submitted within 90 calendar termination that the exemption is nec- days of receipt of the select agent or essary to provide for the timely par- toxin. A copy of the completed form ticipation of the individual or entity in must be maintained for three years. response to a domestic or foreign pub- (c) Unless the HHS Secretary issues lic health emergency. The HHS Sec- an order making specific provisions of retary may extend the exemption once this part applicable to protect public for additional 30 days. health and safety, products that are, (f) Upon request of the Adminis- bear, or contain listed select agents or trator, the HHS Secretary may exempt toxins that are cleared, approved, li- an individual or entity from the re- censed, or registered under any of the quirements, in whole or in part, of this following laws, are exempt from the part for 30 calendar days if the Admin- provisions of this part insofar as their istrator has granted the exemption for use meets the requirements of such agricultural emergency. The HHS Sec- laws: retary may extend the exemption once (1) The Federal Food, Drug, and Cos- for an additional 30 calendar days. metic Act (21 U.S.C. 301 et seq.), [70 FR 13316, Mar. 18, 2005, as amended at 73 (2) Section 351 of the Public Health FR 61366, Oct. 16, 2008; 77 FR 61112, Oct. 5, Service Act pertaining to biological 2012; 79 FR 26862, May 12, 2014] products (42 U.S.C. 262), (3) The Act commonly known as the § 73.7 Registration and related secu- Virus-Serum-Toxin Act (21 U.S.C. 151– rity risk assessments. 159), or (a) Unless exempted under § 73.5, an (4) The Federal Insecticide, Fun- individual or entity shall not possess, gicide, and Rodenticide Act (7 U.S.C. use, or transfer any HHS select agent 136 et seq.). or toxin without a certificate of reg- (d) The HHS Secretary, after con- istration issued by the HHS Secretary. sultation with Administrator, may ex- Unless exempted under § 73.6 or 9 CFR empt from the requirements of this part 121.6, an individual or entity shall part an investigational product that is, not possess, use, or transfer overlap se- bears, or contains an overlap select lect agents or toxins, without a certifi- agent or toxin, may be exempted when cate of registration issued by the HHS such product is being used in an inves- Secretary and Administrator. tigation authorized under any Federal (b) As a condition of registration, Act and additional regulation under each entity must designate an indi- this part is not necessary to protect vidual to be its Responsible Official. public health and safety. While most registrants are likely to be (1) To apply for an exemption, an in- entities, in the event that an indi- dividual or entity must submit a com- vidual applies for and is granted a cer- pleted APHIS/CDC Form 5. tificate of registration, the individual (2) The HHS Secretary shall make a will be considered the Responsible Offi- determination regarding the applica- cial. tion within 14 calendar days after re- (c)(1) As a condition of registration, ceipt, provided the application meets the following must be approved by the all of the requirements of this section HHS Secretary or Administrator based and the application establishes that on a security risk assessment by the the investigation has been authorized Attorney General:

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(i) The individual or entity, To apply for a certificate of registra- (ii) The Responsible Official, and tion that does not cover only HHS se- (iii) Unless otherwise exempted under lect agents or toxins (i.e., covers at this section, any individual who owns least one overlap select agent and/or or controls the entity. toxin, or covers any combination of (2) Federal, State, or local govern- HHS select agents and/or toxins and mental agencies, including public ac- USDA select agents and/or toxins), an credited academic institutions, are ex- individual or entity must submit the empt from the security risk assess- information requested in the registra- ments for the entity and the individual tion application package (APHIS/CDC who owns or controls such entity. Form 1) to CDC or APHIS, but not (3) An individual will be deemed to both. own or control an entity under the fol- (e) Prior to the issuance of a certifi- lowing conditions: 1 cate of registration, the Responsible (i) For a private institution of higher Official must promptly provide notifi- education, an individual will be deemed cation of any changes to the applica- to own or control the entity if the indi- tion for registration by submitting the vidual is in a managerial or executive relevant page(s) of the registration ap- capacity with regard to the entity’s se- plication. lect agents or toxins or with regard to (f) The issuance of a certificate of the individuals with access to the se- registration may be contingent upon lect agents or toxins possessed, used, or inspection or submission of additional transferred by the entity. information, such as the security plan, (ii) For entities other than institu- biosafety plan, incident response plan, tions of higher education, an individual or any other documents required to be will be deemed to own or control the prepared under this part. entity if the individual: (g) A certificate of registration will (A) Owns 50 percent or more of the be valid for one physical location (a entity, or is a holder or owner of 50 per- room, a building, or a group of build- cent or more of its voting stock, or (B) Is in a managerial or executive ings) where the Responsible Official capacity with regard to the entity’s se- will be able to perform the responsibil- lect agents or toxins or with regard to ities required in this part, for specific the individuals with access to the se- select agents or toxins, and for specific lect agents or toxins possessed, used, or activities. transferred by the entity. (h) A certificate of registration may (4) An entity will be considered to be be amended to reflect changes in cir- an institution of higher education if it cumstances (e.g., replacement of the is an institution of higher education as Responsible Official or other personnel defined in section 101(a) of the Higher changes, changes in ownership or con- Education Act of 1965 (20 U.S.C. trol of the entity, changes in the ac- 1001(a)), or is an organization described tivities involving any select agents or in 501(c)(3) of the Internal Revenue toxins, or the addition or removal of Code of 1986, as amended (26 U.S.C. select agents or toxins). 501(c)(3)). (1) Prior to any change, the Respon- (5) To obtain a security risk assess- sible Official must apply for an amend- ment, an individual or entity must sub- ment to a certificate of registration by mit the information necessary to con- submitting the relevant page(s) of the duct a security risk assessment to the registration application. Attorney General. (2) The Responsible Official will be (d) To apply for a certificate of reg- notified in writing if an application to istration that covers only HHS select amend a certificate of registration has agents or toxins, an individual or enti- been approved. Approval of the amend- ty must submit the information re- ment may be contingent upon an in- quested in the registration application spection or submission of additional in- package (APHIS/CDC Form 1) to CDC. formation, such as the security plan, biosafety plan, incident response plan, 1 These conditions may apply to more than or any other documents required to be one individual. prepared under this part.

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(3) No change may be made without (1) Immediately stop all use of each such approval. select agent or toxin covered by the (i) An entity must immediately no- revocation or suspension order, tify CDC or APHIS if it loses the serv- (2) Immediately safeguard and secure ices of its Responsible Official. In the each select agent or toxin covered by event that an entity loses the services the revocation or suspension order of its Responsible Official, an entity from theft, loss, or release, and may continue to possess or use select (3) Comply with all disposition in- agents or toxins only if it appoints as structions issued by the HHS Secretary the Responsible Official another indi- for the select agent or toxin covered by vidual who has been approved by the the revocation or suspension. HHS Secretary or Administrator fol- (c) Denial of an application for reg- lowing a security risk assessment by istration and revocation of registration the Attorney General and who meets may be appealed under § 73.20. However, the requirements of this part. any denial of an application for reg- istration or revocation of a certificate (j) A certificate of registration will of registration will remain in effect be terminated upon the written request until a final agency decision has been of the entity if the entity no longer rendered. possesses or uses any select agents or toxins and no longer wishes to be reg- § 73.9 Responsible Official. istered. (a) An individual or entity required (k) A certificate of registration will to register under this part must des- be valid for a maximum of three years. ignate an individual to be the Respon- sible Official. The Responsible Official § 73.8 Denial, revocation, or suspen- must: sion of registration. (1) Be approved by the HHS Secretary (a) An application may be denied or a or Administrator following a security certificate of registration revoked or risk assessment by the Attorney Gen- suspended if: eral, (1) The individual or entity, the Re- (2) Be familiar with the requirements sponsible Official, or an individual who of this part, owns or controls the entity is within (3) Have authority and responsibility any of the categories described in 18 to act on behalf of the entity, U.S.C. 175b, (4) Ensure compliance with the re- (2) The individual or entity, the Re- quirements of this part, sponsible Official, or an individual who (5) Have a physical (and not merely a owns or controls the entity as reason- telephonic or audio/visual) presence at ably suspected by any Federal law en- the registered entity to ensure that the forcement or intelligence agency of: entity is in compliance with the select (i) Committing a crime specified in 18 agent regulations and be able to re- U.S.C. 2332b(g)(5), spond in a timely manner to onsite in- cidents involving select agents and tox- (ii) Knowing involvement with an or- ins in accordance with the entity’s in- ganization that engages in domestic or cident response plan, and international terrorism (as defined in (6) Ensure that annual inspections 18 U.S.C. 2331) or with any other orga- are conducted for each laboratory nization that engages in intentional where select agents or toxins are crimes of violence, or stored or used in order to determine (iii) Being an agent of a foreign compliance with the requirements of power (as defined in 50 U.S.C. 1801). this part. The results of each inspec- (3) The individual or entity does not tion must be documented, and any defi- meet the requirements of this part, or ciencies identified during an inspection (4) It is determined that such action must be corrected. is necessary to protect public health (b) An entity may designate one or and safety. more individuals to serve as an alter- (b) Upon revocation or suspension of nate Responsible Official, who acts for a certificate of registration, the indi- the Responsible Official in his/her ab- vidual or entity must: sence. These individuals must have the

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authority and control to ensure com- HHS Secretary or Administrator, fol- pliance with the regulations when act- lowing a security risk assessment by ing as the Responsible Official. the Attorney General. (c) The Responsible Official must re- (b) An individual will be deemed to port the identification and final dis- have access at any point in time if the position of any select agent or toxin individual has possession of a select contained in a specimen presented for agent or toxin (e.g., ability to carry, diagnosis or verification. use, or manipulate) or the ability to (1) The identification of any of the gain possession of a select agent or following select agents or toxins must toxin. be immediately reported by telephone, (c) Each individual with access to se- facsimile, or e-mail: Bacillus anthracis, lect agents or toxins must have the ap- Botulinum neurotoxins, Botulinum propriate education, training, and/or neurotoxin producing species of Clos- experience to handle or use such agents tridium, Burkholderia mallei, or toxins. Burkholderia pseudomallei Francisella (d) To apply for access approval, each tularensis, Ebola viruses, , Marburg individual must submit the informa- virus, Variola major virus (Smallpox tion necessary to conduct a security virus), Variola minor (Alastrim), or risk assessment to the Attorney Gen- Yersinia pestis. The final disposition of eral. the agent or toxin must be reported by (e) A person with a valid approval submission of APHIS/CDC Form 4 with- from the HHS Secretary or Adminis- in seven calendar days after identifica- trator to have access to select agents tion. A copy of the completed form and toxins may request, through his or must be maintained for three years. her Responsible Official, that the HHS (2) To report the identification and Secretary or Administrator provide final disposition of any other select their approved access status to another agent or toxin, APHIS/CDC Form 4 registered individual or entity for a must be submitted within seven cal- specified period of time. endar days after identification. A copy (f) An individual’s security risk as- of the completed form must be main- sessment may be expedited upon writ- tained for three years. ten request by the Responsible Official (3) Less stringent reporting may be and a showing of good cause (e.g., pub- required based on extraordinary cir- lic health or agricultural emergencies, cumstances, such as a widespread out- national security, or a short term visit break. by a prominent researcher). A written (d) The Responsible Official must re- decision granting or denying the re- port the identification and final dis- quest will be issued. position of any select agent or toxin (g) An individual’s access approval contained in a specimen presented for will be denied or revoked if the indi- proficiency testing. To report the iden- vidual is within any of the categories tification and final disposition of a se- described in 18 U.S.C. 175b, lect agent or toxin, APHIS/CDC Form 4 (h) An individual’s access approval must be submitted within 90 calendar may be denied, limited, or revoked if: days of receipt of the agent or toxin. A (1) The individual is reasonably sus- copy of the completed form must be pected by any Federal law enforcement maintained for three years. or intelligence agency of committing a [70 FR 13316, Mar. 18, 2005, as amended at 77 crime specified in 18 U.S.C. 2332b(g)(5), FR 61112, Oct. 5, 2012] knowing involvement with an organi- zation that engages in domestic or § 73.10 Restricting access to select international terrorism (as defined in agents and toxins; security risk as- 18 U.S.C. 2331) or with any other orga- sessments. nization that engages in intentional (a) An individual or entity required crimes of violence, or being an agent of to register under this part may not a foreign power (as defined in 50 U.S.C. provide an individual access to a select 1801), or agent or toxin, and an individual may (2) It is determined such action is not access a select agent or toxin, un- necessary to protect public health and less the individual is approved by the safety.

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(i) An individual may appeal the HHS proval from the HHS Secretary or Ad- Secretary’s decision to deny, limit, or ministrator understand and comply revoke access approval under § 73.20. with the security procedures. (j) Access approval is valid for a max- (8) Describe procedures for how the imum of three years. Responsible Official will be informed of (k) The Responsible Official must im- suspicious activity that may be crimi- mediately notify CDC or APHIS when nal in nature and related to the entity, an individual’s access to select agents its personnel, or its select agents or or toxins is terminated by the entity toxins; and describe procedures for how and the reasons therefore. the entity will notify the appropriate [70 FR 13316, Mar. 18, 2005, as amended at 77 Federal, State, or local law enforce- FR 61112, Oct. 5, 2012] ment agencies of such activity. (9) Contain provisions for informa- § 73.11 Security. tion security that: (a) An individual or entity required (i) Ensure that all external connec- to register under this part must de- tions to systems which manage secu- velop and implement a written security rity for the registered space are iso- plan. The security plan must be suffi- lated or have controls that permit only cient to safeguard the select agent or authorized and authenticated users; toxin against unauthorized access, (ii) Ensure that authorized and au- theft, loss, or release. thenticated users are only granted ac- (b) The security plan must be de- cess to select agent and toxin related signed according to a site-specific risk information, files, equipment (e.g., assessment and must provide graded servers or mass storage devices) and protection in accordance with the risk applications as necessary to fulfill of the select agent or toxin, given its their roles and responsibilities, and intended use. A current security plan that access is modified when the user’s must be submitted for initial registra- roles and responsibilities change or tion, renewal of registration, or when when their access to select agents and requested. toxins is suspended or revoked; (c) The security plan must: (1) Describe procedures for physical (iii) Ensure that controls are in place security, inventory control, and infor- that are designed to prevent malicious mation systems control, code (such as, but not limited to, com- (2) Contain provisions for the control puter virus, worms, spyware) from of access to select agents and toxins in- compromising the confidentiality, in- cluding the safeguarding of animals tegrity, or availability of information (including arthropods) or plants inten- systems which manage access to spaces tionally or accidentally exposed to or registered under this part or records in infected with a select agent, against § 73.17;\ unauthorized access, theft, loss or re- (iv) Establish a robust configuration lease. management practice for information (3) Contain provisions for routine systems to include regular patching cleaning, maintenance, and repairs, and updates made to operating systems (4) Establish procedures for removing and individual applications; and unauthorized or suspicious persons, (v) Establish procedures that provide (5) Describe procedures for addressing backup security measures in the event loss or compromise of keys, passwords, that access control systems, surveil- combinations, etc. and protocols for lance devices, and/or systems that changing access numbers or locks fol- manage the requirements of section 17 lowing staff changes, of this part are rendered inoperable. (6) Contain procedures for reporting (10) Contain provisions and policies unauthorized or suspicious persons or for shipping, receiving, and storage of activities, loss or theft of select agents select agents and toxins, including doc- or toxins, release of select agents or umented procedures for receiving, toxins, or alteration of inventory monitoring, and shipping of all select records, and agents and toxins. These provisions (7) Contain provisions for ensuring must provide that an entity will prop- that all individuals with access ap- erly secure containers on site and have

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a written contingency plan for unex- been altered or otherwise com- pected shipments. promised, and (d) An individual or entity must ad- (8) Separate areas where select here to the following security require- agents and toxins are stored or used ments or implement measures to from the public areas of the building. achieve an equivalent or greater level (e) Entities must conduct complete of security: inventory audits of all affected select (1) Allow access only to individuals agents and toxins in long-term storage with access approval from the HHS when any of the following occur: Secretary or Administrator, (1) Upon the physical relocation of a (2) Allow individuals not approved for collection or inventory of select agents access from the HHS Secretary or Ad- or toxins for those select agents or tox- ministrator to conduct routine clean- ins in the collection or inventory; ing, maintenance, repairs, or other ac- (2) Upon the departure or arrival of a tivities not related to select agents or principal investigator for those select toxins only when continuously es- agents and toxins under the control of corted by an approved individual if the that principal investigator; or potential for access to select agents or (3) In the event of a theft or loss of a toxins exists, select agent or toxin, all select agents (3) Provide for the control of select and toxins under the control of that agents and toxins by requiring freezers, principal investigator. refrigerators, cabinets, and other con- (f) In addition to the requirements tainers where select agents or toxins are stored to be secured against unau- contained in paragraphs (c) and (d) of thorized access (e.g., card access sys- this section, the security plan for an tem, lock boxes), individual or entity possessing a Tier 1 (4) Inspect all suspicious packages select agent or toxin must also: before they are brought into or re- (1) Describe procedures for con- moved from the area where select ducting a pre-access suitability assess- agents or toxins are used or stored, ment of persons who will have access (5) Establish a protocol for intra-en- to a Tier 1 select agent or toxin; tity transfers under the supervision of (2) Describe procedures for how an an individual with access approval entity’s Responsible Official will co- from the HHS Secretary or Adminis- ordinate their efforts with the entity’s trator, including chain-of-custody doc- safety and security professionals to en- uments and provisions for safeguarding sure security of Tier 1 select agents against theft, loss, or release, and toxins and share, as appropriate, (6) Require that individuals with ac- relevant information; and cess approval from the HHS Secretary (3) Describe procedures for the ongo- or Administrator refrain from sharing ing assessment of the suitability of with any other person their unique personnel with access to a Tier 1 select means of accessing a select agent or agent or toxin. The procedures must toxin (e.g., keycards or passwords), include: (7) Require that individuals with ac- (i) Self- and peer-reporting of inci- cess approval from the HHS Secretary dents or conditions that could affect an or Administrator immediately report individual’s ability to safely have ac- any of the following to the Responsible cess to or work with select agents and Official: toxins, or to safeguard select agents (i) Any loss or compromise of keys, and toxins from theft, loss, or release; passwords, combination, etc., (ii) The training of employees with (ii) Any suspicious persons or activi- access to Tier 1 select agents and tox- ties, ins on entity policies and procedures (iii) Any loss or theft of select agents for reporting, evaluation, and correc- or toxins, tive actions concerning the assessment (iv) Any release of a select agent or of personnel suitability; and toxin, and (iii) The ongoing suitability moni- (v) Any sign that inventory or use toring of individuals with access to records for select agents or toxins have Tier 1 select agents and toxins.

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(4) Entities with Tier 1 select agents not exceed 15 minutes where the re- and toxins must prescribe the following sponse time is measured from the time security enhancements: of an intrusion alarm, or report of a se- (i) Procedures that will limit access curity incident, to the arrival of the re- to a Tier 1 select agent or toxin to only sponders at the first security barrier those individuals who are approved by or; the HHS Secretary or Administrator, (B) Provide security barriers that are following a security risk assessment by sufficient to delay unauthorized access the Attorney General, have had an en- until the response force arrives in tity-conducted pre-access suitability order to safeguard the select agents assessment, and are subject to the enti- and toxins from theft, intentional re- ty’s procedures for ongoing suitability lease, or unauthorized access. The re- assessment; sponse time is measured from the time (ii) Procedures that limit access to of an intrusion alarm, or report of a se- laboratory and storage facilities out- curity incident, to the arrival of the re- side of normal business hours to only sponders at the first security barrier. those specifically approved by the Re- (5) Entities that possess Variola sponsible Official or designee; major virus and Variola minor virus (iii) Procedures for allowing visitors, must have the following additional se- their property, and vehicles at the curity requirements: entry and exit points to the registered (i) Require personnel with inde- space, or at other designated points of pendent unescorted access to Variola entry to the building, facility, or com- major or Variola minor virus to have a pound that are based on the entity’s Top Secret security clearance; site-specific risk assessment; (ii) Require Variola major or Variola (iv) A minimum of three security minor virus storage locations to be barriers where each security barrier under the surveillance of closed circuit adds to the delay in reaching secured television that is monitored; areas where select agents and toxins (iii) After hours access procedures for are used or stored. One of the security Variola major or Variola minor virus barriers must be monitored in such a must require notification of the enti- way as to detect intentional and unin- ty’s security staff prior to entry into tentional circumventing of established the Variola laboratory and upon exit; access control measures under all con- (iv) Require that observation zones ditions (day/night, severe weather, etc.) be maintained in outdoor areas adja- The final barrier must limit access to cent to the physical barrier at the pe- the select agent or toxin to personnel rimeter of the entity and be large approved by the HHS Secretary or Ad- enough to permit observation of the ac- ministrator, following a security risk tivities of people at that barrier in the assessment by the Attorney General. event of its penetration; (v) All registered space or areas that (v) Provide for a minimum of four reasonably afford access to the reg- barriers for the protection of the istered space must be protected by an Variola major or Variola minor virus, intrusion detection system (IDS) un- one of which must be a perimeter less physically occupied; fence; (vi) Personnel monitoring the IDS (vi) Require a numbered picture must be capable of evaluating and in- badge identification subsystem to be terpreting the alarm and alerting the used for all individuals who are author- designated security response force or ized to access Variola major or Variola law enforcement; minor without escort; (vii) For powered access control sys- (vii) Require the use, at all times, of tems, describe procedures to ensure properly trained and equipped security that security is maintained in the force personnel able to interdict event of the failure of access control threats identified in the site specific systems due to power disruption affect- risk assessment; ing registered space; (viii) Identify security force per- (viii) The entity must: sonnel designated to strengthen onsite (A) Determine that the response time response capabilities, and that will be for security forces or local police will onsite and available at all times to

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carry out their assigned response du- tion and documentation to describe the ties; biosafety and containment procedures (ix) Provide for security patrols to for the select agent or toxin, including periodically check external areas of any animals (including arthropods) or the registered areas to include physical plants intentionally or accidentally ex- barriers and building entrances; posed to or infected with a select (x) Require that all on-duty security agent. force personnel shall be capable of (b) The biosafety and containment maintaining continuous communica- procedures must be sufficient to con- tion with support and response assets tain the select agent or toxin (e.g., by way of security operations center; physical structure and features of the (xi) Require that Variola major and entity, and operational and procedural Variola minor material in long term safeguards). storage be stored in tamper-evident (c) In developing a biosafety plan, an systems; individual or entity should consider: (xii) Require that all spaces con- (1) The CDC/NIH publication, ‘‘Bio- taining working or permanent Variola safety in Microbiological and Bio- major or Variola minor stocks be medical Laboratories.’’ This document locked and protected by an intrusion is available on the National Select alarm system that will alarm upon the Agent Registry Web site at http:// unauthorized entry of a person any- www.selectagents.gov. where into the area; (2) The Occupational Safety and (xiii) Require that alarms required Health Administration (OSHA) regula- pursuant to this section annunciate in tions in 29 CFR parts 1910.1200 and a continuously manned security oper- 1910.1450. This document is available on ations center located within the facil- the National Select Agent Registry ity; and Web site at http://www.selectagents.gov. (xiv) Require that the security oper- (3) The ‘‘NIH Guidelines for Research ations center shall be located within a Involving Recombinant DNA Mol- building so that the interior is not visi- ecules,’’ (NIH Guidelines). This docu- ble from the perimeter of the protected ment is available on the National Se- area. lect Agent Registry Web site at http:// (g) In developing a security plan, an www.selectagents.gov. individual or entity should consider (d) The biosafety plan must include the document entitled, ‘‘Security Guid- an occupational health program for in- ance for Select Agent or Toxin Facili- dividuals with access to Tier 1 select ties.’’ This document is available on agents and toxins, and those individ- the National Select Agent Registry at uals must be enrolled in the occupa- http://www.selectagents.gov/. tional health program. (h) The plan must be reviewed annu- (e) The plan must be reviewed annu- ally and revised as necessary. Drills or ally and revised as necessary. Drills or exercises must be conducted at least exercises must be conducted at least annually to test and evaluate the effec- annually to test and evaluate the effec- tiveness of the plan. The plan must be tiveness of the plan. The plan must be reviewed and revised, as necessary, reviewed and revised, as necessary, after any drill or exercise and after any after any drill or exercise and after any incident. incident. [70 FR 13316, Mar. 18, 2005, as amended at 77 [70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61112, Oct. 5, 2012; 79 FR 26862, May 12, FR 61114, Oct. 5, 2012] 2014] § 73.13 Restricted experiments. § 73.12 Biosafety. (a) An individual or entity may not (a) An individual or entity required conduct, or possess products resulting to register under this part must de- from, the following experiments unless velop and implement a written bio- approved by and conducted in accord- safety plan that is commensurate with ance with the conditions prescribed by the risk of the select agent or toxin, the HHS Secretary: given its intended use. The biosafety (1) Experiments that involve the de- plan must contain sufficient informa- liberate transfer of, or selection for, a

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drug resistance trait to select agents actions to contain such select agent or that are not known to acquire the trait toxin, including any animals (including naturally, if such acquisition could arthropods) or plants intentionally or compromise the control of disease accidentally exposed to or infected agents in humans, veterinary medicine, with a select agent. or agriculture. (d) The incident response plan must (2) Experiments involving the delib- also contain the following information: erate formation of synthetic or recom- (1) The name and contact informa- binant DNA containing genes for the tion (e.g., home and work) for the indi- biosynthesis of select toxins lethal for vidual or entity (e.g., responsible offi- vertebrates at an LD[50] <100 cial, alternate responsible official(s), (b) The HHS Secretary may revoke biosafety officer, etc.), approval to conduct any of the experi- (2) The name and contact informa- ments in paragraph (a) of this section, tion for the building owner and/or man- or revoke or suspend a certificate of ager, where applicable, registration, if the individual or entity (3) The name and contact informa- fails to comply with the requirements tion for tenant offices, where applica- of this part. ble, (c) To apply for approval to conduct (4) The name and contact informa- any of the experiments in paragraph (a) tion for the physical security official of this section, an individual or entity for the building, where applicable, must submit a written request and sup- (5) Personnel roles and lines of au- porting scientific information. A writ- thority and communication, ten decision granting or denying the (6) Planning and coordination with request will be issued. local emergency responders, [70 FR 13316, Mar. 18, 2005, as amended at 77 (7) Procedures to be followed by em- FR 61114, Oct. 5, 2012; 79 FR 26862, May 12, ployees performing rescue or medical 2014] duties, § 73.14 Incident response. (8) Emergency medical treatment and first aid, (a) An individual or entity required (9) A list of personal protective and to register under this part must de- emergency equipment, and their loca- velop and implement a written inci- tions, dent response plan based upon a site (10) Site security and control, specific risk assessment.2 The incident (11) Procedures for emergency evacu- response plan must be coordinated with ation, including type of evacuation, any entity-wide plans, kept in the exit route assignments, safe distances, workplace, and available to employees and places of refuge, and for review. (b) The incident response plan must (12) Decontamination procedures. fully describe the entity’s response pro- (e) Entities with Tier 1 select agents cedures for the theft, loss, or release of and toxins must have the following ad- a select agent or toxin; inventory dis- ditional incident response policies or crepancies; security breaches (includ- procedures: ing information systems); severe (1) The incident response plan must weather and other natural disasters; fully describe the entity’s response pro- workplace violence; bomb threats and cedures for failure of intrusion detec- suspicious packages; and emergencies tion or alarm system; and such as fire, gas leak, explosion, power (2) The incident response plan must outage, and other natural and man- describe procedures for how the entity made events. will notify the appropriate Federal, (c) The response procedures must ac- State, or local law enforcement agen- count for hazards associated with the cies of suspicious activity that may be select agent or toxin and appropriate criminal in nature and related to the entity, its personnel, or its select 2 Nothing in this section is meant to super- agents or toxins. sede or preempt incident response require- (f) The plan must be reviewed annu- ments imposed by other statutes or regula- ally and revised as necessary. Drills or tions. exercises must be conducted at least

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annually to test and evaluate the effec- the means used to verify that the em- tiveness of the plan. The plan must be ployee understood the training. reviewed and revised, as necessary, [77 FR 61114, Oct. 5, 2012] after any drill or exercise and after any incident. § 73.16 Transfers. [70 FR 13316, Mar. 18, 2005, as amended at 77 (a) Except as provided in paragraphs FR 61114, Oct. 5, 2012] (c) and (d) of this section, a select agent or toxin may only be transferred § 73.15 Training. to individuals or entities registered to possess, use, or transfer that agent or (a) An individual or entity required toxin. A select agent or toxin may only to register under this part must pro- be transferred under the conditions of vide information and training on bio- this section and must be authorized by safety, security (including security CDC or APHIS prior to the transfer. 4 awareness), and incident response to: (b) A transfer may be authorized if: (1) Each individual with access ap- (1) The sender: proval from the HHS Secretary or Ad- (i) Has at the time of transfer a cer- ministrator before that individual has tificate of registration that covers the such access to select agents and toxins. particular select agent or toxin to be The training must address the par- transferred and meets all requirements ticular needs of the individual, the in this part, work they will do, and the risks posed (ii) Meets the exemption require- by the select agents or toxins; and ments for the particular select agent or (2) Each individual not approved for toxin to be transferred, or access to select agents and toxins by (iii) Is transferring the select agent the HHS Secretary or Administrator or toxin from outside the United States and meets all import requirements. before that individual enters areas (2) At the time of transfer, the recipi- where select agents or toxins are han- ent has a certificate of registration dled or stored (e.g., laboratories, that includes the particular select growth chambers, animal rooms, green- agent or toxin to be transferred and houses, storage areas, shipping/receiv- meets all of the requirements of this ing areas, production facilities, etc.). part. Training for escorted personnel must (c) A select agent or toxin that is be based on the risk associated with ac- contained in a specimen for proficiency cessing areas where select agents and testing may be transferred without toxins are used and/or stored. prior authorization from CDC or (b) Entities with Tier 1 select agents APHIS provided that, at least seven and toxins must conduct annual insider calendar days prior to the transfer, the threat awareness briefings on how to sender reports to CDC or APHIS the se- identify and report suspicious behav- lect agent or toxin to be transferred iors. and the name and address of the recipi- (c) Refresher training must be pro- ent. vided annually for individuals with ac- (d) On a case-by-case basis, the HHS cess approval from the HHS Secretary Secretary may authorize a transfer of a or Administrator or at such time as select agent or toxin, not otherwise eli- the registered individual or entity sig- gible for transfer under this part under nificantly amends its security, incident conditions prescribed by the HHS Sec- response, or biosafety plans. retary. (e) To obtain authorization for trans- (d) The Responsible Official must en- fer, APHIS/CDC Form 2 must be sub- sure a record of the training provided mitted. to each individual with access to select (f) After authorization is provided by agents and toxins and each escorted in- APHIS or CDC, the packaging of the dividual (e.g., laboratory workers, visi- tors, etc.) is maintained. The record 4 This section does not cover transfers must include the name of the indi- within an entity when the sender and the re- vidual, the date of the training, a de- cipient are covered by the same certificate of scription of the training provided, and registration.

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select agent(s) and toxin(s) is per- activity related to a toxin listed in formed by an individual approved by § 73.3(d) of this part. the HHS Secretary or Administrator to [70 FR 13316, Mar. 18, 2005, as amended at 77 have access to select agents and toxins FR 61115, Oct. 5, 2012; 79 FR 26862, May 12, and is in compliance with all applica- 2014] ble laws concerning packaging. (g) The sender must comply with all § 73.17 Records. applicable laws governing packaging (a) An individual or entity required and shipping. to register under this part must main- (h) Transportation in commerce tain complete records relating to the starts when the select agent(s) or activities covered by this part. Such toxin(s) are packaged for shipment and records must include: ready for receipt by a courier trans- (1) An accurate, current inventory porting select agent(s) or toxin(s) and for each select agent (including viral ends when the package is received by genetic elements, recombinant and/or the intended recipient who is an indi- synthetic nucleic acids, and organisms vidual approved by the HHS Secretary containing recombinant and/or syn- or Administrator to have access to se- thetic nucleic acids) held in long-term lect agents and toxins, following a se- storage (placement in a system de- curity risk assessment by the Attorney signed to ensure viability for future General. use, such as in a freezer or lyophilized (i) The recipient must submit a com- materials), including: pleted APHIS/CDC Form 2 within two (i) The name and characteristics business days of receipt of a select (e.g., strain designation, GenBank Ac- agent or toxin. cession number, etc.), (j) The recipient must immediately (ii) The quantity acquired from an- notify CDC or APHIS if the select other individual or entity (e.g., con- agent or toxin has not been received tainers, vials, tubes, etc.), date of ac- within 48 hours after the expected de- quisition, and the source, livery time, or if the package con- (iii) Where stored (e.g., building, taining select agents or toxins has been room, and freezer), damaged to the extent that a release of the select agent or toxin may have oc- (iv) When moved from storage and by curred. whom and when returned to storage (k) An authorization for a transfer and by whom, shall be valid only for 30 calendar days (v) The select agent used and purpose after issuance, except that such an au- of use, thorization becomes immediately null (vi) Records created under § 73.16 and and void if any facts supporting the au- 9 CFR 121.16 (Transfers), thorization change (e.g., change in the (vii) For intra-entity transfers (send- certificate of registration for the send- er and the recipient are covered by the er or recipient, change in the applica- same certificate of registration), the tion for transfer). select agent, the quantity transferred, (l) A registered individual or entity the date of transfer, the sender, and transferring an amount of a HHS toxin the recipient, and otherwise excluded under the provi- (viii) Records created under § 73.19 sions of § 73.3(d) must: and 9 CFR part 121.19 (Notification of (1) Transfer the amounts only after theft, loss, or release), the transferor uses due diligence and (2) An accurate, current accounting documents that the recipient has a le- of any animals or plants intentionally gitimate need (i.e., reasonably justified or accidentally exposed to or infected by a prophylactic, protective, bona fide with a select agent (including number research, or other peaceful purpose) to and species, location, and appropriate handle or use such toxins. disposition); (2) Report to CDC if they detect a (3) Accurate, current inventory for known or suspected violation of Fed- each toxin held, including: eral law or become aware of suspicious (i) The name and characteristics,

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(ii) The quantity acquired from an- years and promptly produced upon re- other individual or entity (e.g., con- quest. tainers, vials, tubes, etc.), date of ac- [70 FR 13316, Mar. 18, 2005, as amended at 77 quisition, and the source, FR 61115, Oct. 5, 2012] (iii) The initial and current quantity amount (e.g., milligrams, milliliters, § 73.18 Inspections. grams, etc.), (a) Without prior notification, the (iv) The toxin used and purpose of HHS Secretary, shall be allowed to in- use, quantity, date(s) of the use and by spect any site at which activities regu- whom, lated by this part are conducted and (v) Where stored (e.g., building, room, shall be allowed to inspect and copy and freezer), any records relating to the activities (vi) When moved from storage and by covered by this part. whom and when returned to storage (b) Prior to issuing a certificate of and by whom including quantity registration to an individual or entity, amount, the HHS Secretary may inspect and (vii) Records created under § 73.16 and evaluate the premises and records to 9 CFR part 121.16 (Transfers), ensure compliance with this part. (viii) For intra-entity transfers (sender and the recipient are covered § 73.19 Notification of theft, loss, or re- lease. by the same certificate of registra- tion), the toxin, the quantity trans- (a) Upon discovery of the theft or loss ferred, the date of transfer, the sender, of a select agent or toxin, an individual and the recipient, or entity must immediately notify CDC (ix) Records created under § 73.19 and or APHIS and appropriate Federal, 9 CFR part 121.19 (Notification of theft, State, or local law enforcement agen- loss, or release), and cies. Thefts or losses must be reported (x) If destroyed, the quantity of toxin even if the select agent or toxin is sub- destroyed, the date of such action, and sequently recovered or the responsible parties are identified. by whom, (1) The theft or loss of a select agent (4) A current list of all individuals or toxin must be reported immediately that have been granted access approval by telephone, facsimile, or e-mail. The from the HHS Secretary or Adminis- following information must be pro- trator, vided: (5) Information about all entries into (i) The name of the select agent or areas containing select agents or tox- toxin and any identifying information ins, including the name of the indi- (e.g., strain or other characterization vidual, name of the escort (if applica- information), ble), and date and time of entry, (ii) An estimate of the quantity lost (6) Accurate, current records created or stolen, under § 73.9 and 9 CFR part 121.9 (Re- (iii) An estimate of the time during sponsible Official), § 73.11 and 9 CFR which the theft or loss occurred, part 121.11 (Security), § 73.12 and 9 CFR (iv) The location (building, room) part 121.12 (Biosafety), § 73.14 and 9 CFR from which the theft or loss occurred, part 121. 14 (Incident response), and and § 73.15 and 9 CFR part 121.15 (Training), (v) The list of Federal, State, or local and law enforcement agencies to which the (7) A written explanation of any dis- individual or entity reported, or in- crepancies. tends to report the theft or loss. (b) The individual or entity must im- (2) A completed APHIS/CDC Form 3 plement a system to ensure that all must submitted within seven calendar records and data bases created under days. this part are accurate, have controlled (b) Upon discovery of a release of an access, and that their authenticity agent or toxin causing occupational ex- may be verified. posure or release of a select agent or (c) All records created under this toxin outside of the primary barriers of part must be maintained for three the area, an individual

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or entity must immediately notify CDC delegation of authority includes all or APHIS. powers contained in section 6 of the In- (1) The release of a select agent or spector General Act of 1978 (5 U.S.C. toxin must be reported by telephone, App.). facsimile, or e-mail. The following in- (b) The administrative law judges in, formation must be provided: assigned to, or detailed to the Depart- (i) The name of the select agent or mental Appeals Board have been dele- toxin and any identifying information gated authority to conduct hearings (e.g., strain or other characterization and to render decisions in accordance information), with 42 CFR part 1005 with respect to (ii) An estimate of the quantity re- the imposition of civil money pen- leased, (iii) The time and duration of the re- alties, as authorized by the Public lease, Health Security and Pre- (iv) The environment into which the paredness and Response Act of 2002 release occurred (e.g., in building or (Pub. L. 107–188). This delegation in- outside of building, waste system), cludes, but is not limited to, the au- (v) The location (building, room) thority to administer oaths and affir- from which the release occurred, mations, to subpoena witnesses and (vi) The number of individuals poten- documents, to examine witnesses, to tially exposed at the entity, exclude or receive and give appropriate (vii) Actions taken to respond to the weight to materials and testimony of- release, and fered as evidence, to make findings of (viii) Hazards posed by the release. fact and conclusions of law, and to de- (2) A completed APHIS/CDC Form 3 termine the civil money penalties to be must be submitted within seven cal- imposed. endar days. (c) The Departmental Appeals Board of the Department of Health and § 73.20 Administrative review. Human Services is delegated authority (a) An individual or entity may ap- to make final determinations with re- peal a denial, revocation, or suspension spect to the imposition of civil money of registration under this part. The ap- penalties for violations of the regula- peal must be in writing, state the fac- tions of this part. tual basis for the appeal, and be sub- mitted to the HHS Secretary within 30 calendar days of the decision. PART 75—STANDARDS FOR THE (b) An individual may appeal a de- ACCREDITATION OF EDU- nial, limitation, or revocation of access CATIONAL PROGRAMS FOR AND approval under this part. The appeal THE CREDENTIALING OF must be in writing, state the factual RADIOLOGIC PERSONNEL basis for the appeal, and be submitted to the HHS Secretary within 180 cal- Sec. endar days of the decision. 75.1 Background and purpose. (c) The HHS Secretary’s decision con- 75.2 Definitions. stitutes final agency action. 75.3 Applicability. [77 FR 61115, Oct. 5, 2012] APPENDIX A TO PART 75—STANDARDS FOR AC- CREDITATION OF EDUCATIONAL PROGRAMS § 73.21 Civil money penalties. FOR RADIOGRAPHERS (a) The Inspector General of the De- APPENDIX B TO PART 75—STANDARDS FOR AC- partment of Health and Human Serv- CREDITATION OF DENTAL RADIOGRAPHY ices is delegated authority to conduct TRAINING FOR DENTAL HYGIENISTS investigations and to impose civil APPENDIX C TO PART 75—STANDARDS FOR AC- CREDITATION OF DENTAL RADIOGRAPHY money penalties against any individual TRAINING FOR DENTAL ASSISTANTS or entity in accordance with regula- APPENDIX D TO PART 75—STANDARDS FOR AC- tions in 42 CFR part 1003 for violations CREDITATION OF EDUCATIONAL PROGRAMS of the regulations in this part, as au- FOR NUCLEAR MEDICINE TECHNOLOGISTS thorized by the Public Health Security APPENDIX E TO PART 75—STANDARDS FOR AC- and Bioterrorism Preparedness and Re- CREDITATION OF EDUCATIONAL PROGRAMS sponse Act of 2002 (Pub. L. 107–188). The FOR RADIATION THERAPY TECHNOLOGISTS

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