cfr_sections
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20 rows where agency = "APHIS" and part_number = 331 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 7:7:5.1.1.1.9.0.47.1 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.1 Definitions. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61074, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6204, Jan. 19, 2017] | Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Attorney General. The Attorney General of the United States or any person authorized to act for the Attorney General. Biological agent. Any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing: (1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; (2) Deterioration of food, water, equipment, supplies, or material of any kind; or (3) Deleterious alteration of the environment. Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Diagnosis. The analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin, provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products. Entity. Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. HHS Secretary. The Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified. HHS select agent and/or toxin. A biological agent or toxin listed in 42 CFR 73.3. Import. To move into, or the act of movement into, the territorial limits of the United States. Information security. Protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide: (… | ||||||
| 7:7:5.1.1.1.9.0.47.10 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.10 Restricting access to select agents and toxins; security risk assessments. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61075, Oct. 5, 2012; 82 FR 6205, Jan. 19, 2017] | (a) An individual or entity required to register under this part may not provide an individual access to a select agent or toxin, and an individual may not access a select agent or toxin, unless the individual is approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General. (b) An individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin ( e.g. , carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin. (c) Each individual with access to select agents or toxins must have the appropriate education, training, and/or experience to handle or use such agents or toxins. (d) To apply for access approval, each individual must submit the information necessary to conduct a security risk assessment to the Attorney General. (e) A person with valid approval from the HHS Secretary or Administrator to have access to select agents or toxins may request, through his or her Responsible Official, that the HHS Secretary or Administrator provide their approved access status to another registered individual or entity for a specified period of time. A responsible official must immediately notify the responsible official of the visiting entity if the person's access to select agents or toxins has been terminated. (f) An individual's security risk assessment may be expedited upon written request by the responsible official and a showing of good cause ( e.g. , agricultural emergencies, national security, or a short-term visit by a prominent researcher). A written decision granting or denying the request will be issued. (g) An individual's access approval may be denied, limited, or revoked if: (1) The individual is within any of the categories described in 18 U.S.C. 175b; (2) The individual is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in dome… | ||||||
| 7:7:5.1.1.1.9.0.47.11 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.11 Security. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61075, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6205, Jan. 19, 2017; 83 FR 48202, Sept. 24, 2018] | (a) An individual or entity required to register under this part must develop and implement a written security plan. The security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release. (b) The security plan must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. A current security plan must be submitted for initial registration, renewal of registration, or when requested. (c) The security plan must: (1) Describe procedures for physical security, inventory control, and information systems control; (2) Contain provisions for the control of access to select agents and toxins, including the safeguarding of animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent, against unauthorized access, theft, loss or release. (3) Contain provisions for routine cleaning, maintenance, and repairs; (4) Establish procedures for removing unauthorized or suspicious persons; (5) Describe procedures for addressing loss or compromise of keys, keycards, passwords, combinations, etc. and protocols for changing access permissions or locks following staff changes; (6) Contain procedures for reporting unauthorized or suspicious persons or activities, loss or theft of select agents or toxins, release of select agents or toxins, or alteration of inventory records; (7) Contain provisions for ensuring that all individuals with access approval from the Administrator or the HHS Secretary understand and comply with the security procedures; (8) Describe procedures for how the Responsible Official will be informed of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select agents or toxins; and describe procedures for how the entity will notify the appropriate Federal, State, or local law enforcement agencies of such activity. (9) Contain provisions for… | ||||||
| 7:7:5.1.1.1.9.0.47.12 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.12 Biocontainment. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61076, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6205, Jan. 19, 2017] | (a) An individual or entity required to register under this part must develop and implement a written biocontainment plan that is commensurate with the risk of the select agent or toxin, given its intended use. 4 The biocontainment plan must contain sufficient information and documentation to describe the biocontainment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. The current biocontainment plan must be submitted for initial registration, renewal of registration, or when requested. The biocontainment plan must include the following provisions: 4 Technical assistance and guidance may be obtained by contacting APHIS. (1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biocontainment risk associated with laboratory procedures related to the select agent or toxin; (2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards; (3) Written procedures for each validated method used for disinfection, decontamination, or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, arthropod containment systems, extracted plant and/or arthropod tissues, laboratory surfaces and equipment, and effluent material; and (4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unin… | ||||||
| 7:7:5.1.1.1.9.0.47.13 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.13 Restricted experiments. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61076, Oct. 5, 2012; 79 FR 26830, May 12, 2014] | (a) An individual or entity may not conduct or possess products resulting from the following experiments unless approved by and conducted in accordance with the conditions prescribed by the Administrator: (1) Experiments that involve the deliberate transfer of, or selection for, a drug or chemical resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture. (2) Experiments involving the deliberate formation of synthetic or recombinant nucleic acids containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50]<100 ng/kg body weight. (b) The Administrator may revoke approval to conduct any of the experiments in paragraph (a) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part. (c) To apply for approval to conduct any of the experiments in paragraph (a) of this section, an individual or entity must submit a written request and supporting scientific information to the Administrator. A written decision granting or denying the request will be issued. | ||||||
| 7:7:5.1.1.1.9.0.47.14 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.14 Incident response. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61076, Oct. 5, 2012; 82 FR 6206, Jan. 19, 2017] | 5 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations. (a) An individual or entity required to register under this part must develop and implement a written incident response plan 6 based upon a site specific risk assessment. The incident response plan must be coordinated with any entity-wide plans, kept in the workplace, and available to employees for review. The current incident response plan must be submitted for initial registration, renewal of registration, or when requested. 6 Technical assistance and guidance may be obtained by contacting APHIS. (b) The incident response plan must fully describe the entity's response procedures for the theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, and other natural and man-made events. (c) The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. (d) The incident response plan must also contain the following information: (1) The name and contact information ( e.g. , home and work) for the individual or entity ( e.g. , responsible official, alternate responsible official(s), biosafety officer, etc.); (2) The name and contact information for the building owner and/or manager, where applicable; (3) The name and contact information for tenant offices, where applicable; (4) The name and contact information for the physical security official for the building, where applicable; (5) Personnel roles and lines of authority and communication; (6) Planning and coordination with local emergency responders; (7) Procedures to b… | ||||||
| 7:7:5.1.1.1.9.0.47.15 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.15 Training. | APHIS | [77 FR 61076, Oct. 5, 2012, as amended at 82 FR 6206, Jan. 19, 2017] | (a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), and incident response to: (1) Each individual with access approval from the Administrator or HHS Secretary. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The training must be accomplished prior to the individual's entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the Administrator or the HHS Secretary for access, whichever is earlier. (2) Each individual not approved for access to select agents and toxins by the Administrator or HHS Secretary before that individual enters areas under escort where select agents or toxins are handled or stored ( e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). Training for escorted personnel must be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. The training must be accomplished prior to the individual's entry into where select agents or toxins are handled or stored ( e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). (b) [Reserved] (c) Refresher training must be provided annually for individuals with access approval from the HHS Secretary or Administrator or at such time as the registered individual or entity significantly amends its security, incident response, or biocontainment plans. (d) The responsible official must ensure a record of the training provided to each individual with access to select agents and toxins and each escorted individual (e.g., laboratory workers, visitors, etc.) is maintained. The record must include the name of the individual, the date of the training, a description of the training pro… | ||||||
| 7:7:5.1.1.1.9.0.47.16 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.16 Transfers. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012; 82 FR 6206, Jan. 19, 2017] | (a) Except as provided in paragraph (c) of this section, a select agent or toxin may only be transferred to an individual or entity registered to possess, use, or transfer that agent or toxin. A select agent or toxin may only be transferred under the conditions of this section and must be authorized by APHIS or CDC prior to the transfer. 7 7 The requirements of this section do not apply to transfers within a registered entity ( i.e. , the sender and the recipient are covered by the same certificate of registration). (b) A transfer may be authorized if: (1) The sender: (i) Has at the time of transfer a certificate of registration that covers the particular select agent or toxin to be transferred and meets all the requirements of this part; (ii) Meets the exemption requirements for the particular select agent or toxin to be transferred; or (iii) Is transferring the select agent or toxin from outside of the United States and meets all import requirements. (2) At the time of transfer, the recipient has a certificate of registration that includes the particular select agent or toxin to be transferred and meets all of the requirements of this part. (c) On a case-by-case basis, the Administrator may authorize a transfer of a select agent or toxin not otherwise eligible for transfer under this part under conditions prescribed by the Administrator. (d) To obtain authorization for a transfer, APHIS/CDC Form 2 must be submitted. (e) After authorization is provided by APHIS or CDC, the packaging of the select agent(s) and toxin(s) is performed by an individual approved by the HHS Secretary or Administrator to have access to select agents and toxins and is in compliance with all applicable laws concerning packaging. (f) The sender must comply with all applicable laws governing shipping. (g) Transportation in commerce starts when the select agent(s) or toxin(s) are packaged for shipment and ready for receipt by a courier transporting select agent(s) or toxin(s) and ends when the package is received by the intend… | ||||||
| 7:7:5.1.1.1.9.0.47.17 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.17 Records. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012; 82 FR 6206, Jan. 19, 2017] | (a) An individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include: (1) An accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or lyophilized materials), including: (i) The name and characteristics ( e.g. , strain designation, GenBank Accession number, etc.); (ii) The quantity acquired from another individual or entity ( e.g. , containers, vials, tubes, etc.), date of acquisition, and the source; (iii) Where stored ( e.g. , building, room, and freezer or other storage container); (iv) When moved from storage and by whom and when returned to storage and by whom; (v) The select agent used, purpose of use, and, when applicable, final disposition; (vi) Records created under § 331.16 (Transfers); (vii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent, the quantity transferred, the date of transfer, the sender, and the recipient; and (viii) Records created under § 331.19 (Notification of theft, loss, or release); (2) An accurate, current accounting of any animals or plants intentionally or accidentally exposed to or infected with a select agent (including number and species, location, and appropriate disposition); (3) An accurate, current inventory for each toxin held, including: (i) The name and characteristics; (ii) The quantity acquired from another individual or entity ( e.g. , containers, vials, tubes, etc.), date of acquisition, and the source; (iii) The initial and current quantity amount ( e.g. , milligrams, milliliters, grams, etc.); (iv) The toxin used and purpose of use, quantity, date(s) of the use and by whom; (v) Where stored ( e.g. , building, room, and fre… | ||||||
| 7:7:5.1.1.1.9.0.47.18 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.18 Inspections. | APHIS | (a) Without prior notification, APHIS must be allowed to inspect any site at which activities regulated under this part are conducted and must be allowed to inspect and copy any records relating to the activities covered by this part. (b) Prior to issuing a certificate of registration to an individual or entity, APHIS may inspect and evaluate their premises and records to ensure compliance with this part. | |||||||
| 7:7:5.1.1.1.9.0.47.19 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.19 Notification of theft, loss, or release. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012] | (a) An individual or entity must immediately notify APHIS or CDC upon discovery of the theft or loss of a select agent or toxin. Thefts or losses must be reported even if the select agent or toxin is subsequently recovered or the responsible parties are identified. (1) The theft or loss of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided: (i) The name of the select agent or toxin and any identifying information ( e.g. , strain or other characterization information); (ii) An estimate of the quantity stolen or lost; (iii) An estimate of the time during which the theft or loss occurred; (iv) The location (building, room) from which the theft or loss occurred; and (v) The list of Federal, State, or local law enforcement agencies to which the individual or entity reported, or intends to report, the theft or loss. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days. (b) An individual or entity must notify APHIS or CDC immediately upon discovery of a release of a select agent or toxin outside of the primary barriers of the biocontainment area. (1) The release of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided: (i) The name of the select agent or toxin and any identifying information ( e.g. , strain or other characterization information); (ii) An estimate of the quantity released; (iii) The time and duration of the release; (iv) The location (building, room) from which the release occurred; and (v) The number of individuals potentially exposed at the entity; (vi) Actions taken to respond to the release; and (vii) Hazards posed by the release. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days. | ||||||
| 7:7:5.1.1.1.9.0.47.2 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.2 Purpose and scope. | APHIS | This part implements the provisions of the Agricultural Bioterrorism Protection Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The biological agents and toxins listed in this part have the potential to pose a severe threat to plant health or plant products. | |||||||
| 7:7:5.1.1.1.9.0.47.20 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.20 Administrative review. | APHIS | [77 FR 61077, Oct. 5, 2012] | (a) An individual or entity may appeal a denial, revocation, or suspension of registration under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 30 calendar days of the decision. (b) An individual may appeal a denial, limitation, or revocation of access approval under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 180 calendar days of the decision. (c) The Administrator's decision constitutes final agency action. | ||||||
| 7:7:5.1.1.1.9.0.47.3 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.3 PPQ select agents and toxins. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 77 FR 61075, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6204, Jan. 19. 2017; 83 FR 48201, Sept. 24, 2018; 89 FR 101845, Dec. 17, 2024] | (a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have been determined to have the potential to pose a severe threat to plant health or to plant products. (b) PPQ select agents and toxins are: (1) Coniothyrium glycines, (formerly Phoma glycinicola, Pyrenochaeta glycines ); (2) Ralstonia solanacearum; (3) Rathayibacter toxicus; (4) Sclerophthora rayssiae; (5) Synchytrium endobioticum; and (6) Xanthomonas oryzae. (1) Coniothyrium glycines, (formerly Phoma glycinicola, Pyrenochaeta glycines ); (2) Ralstonia solanacearum; (3) Rathayibacter toxicus; (4) Sclerophthora rayssiae; (5) Synchytrium endobioticum; and (6) Xanthomonas oryzae. (c) Genetic elements, recombinant and/or synthetic nucleic acids, and recombinant and/or synthetic organisms: (1) Nucleic acids that can produce infectious forms of any of the select agent viruses listed in paragraph (b) of this section. (2) Recombinant and/or synthetic nucleic acids that encode for the functional forms of any toxin listed in paragraph (b) of this section if the nucleic acids: (i) Can be expressed in vivo or in vitro ; or (ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro. (3) Select agents and toxins listed in paragraph (b) of this section that have been genetically modified. (d) Select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: (1) Any select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (2) Nonviable select agents or nontoxic toxins. (3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal. (4) A select agent or regulated nucleic acids that can produce infectious forms of … | ||||||
| 7:7:5.1.1.1.9.0.47.4 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.4 [Reserved] | APHIS | ||||||||
| 7:7:5.1.1.1.9.0.47.5 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.5 Exemptions. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 82 FR 6204, Jan. 19, 2017] | (a) Diagnostic laboratories and other entities that possess, use, or transfer a select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 331.16 or destroyed on-site by a recognized sterilization or inactivation process. (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported. (3) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification. (b) In addition to the exemption provided in paragraph (a) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting plant health or plant products. An individual or entity may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and wil… | ||||||
| 7:7:5.1.1.1.9.0.47.6 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.6 [Reserved] | APHIS | ||||||||
| 7:7:5.1.1.1.9.0.47.7 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.7 Registration and related security risk assessments. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 82 FR 6205, Jan. 19, 2017] | (a) Unless exempted under § 331.5, an individual or entity shall not possess, use, or transfer any select agent or toxin without a certificate of registration issued by the Administrator. (b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use, or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxins currently in its possession. (c) As a condition of registration, each entity must designate an individual to be its responsible official. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, the individual will be considered the responsible official. (d)(1) As a condition of registration, the following must be approved by the Administrator or the HHS Secretary based on a security risk assessment by the Attorney General: (i) The individual or entity; (ii) The responsible official; and (iii) Unless otherwise exempted under this section, any individual who owns or controls the entity. (2) Federal, State, or local governmental agencies, including public accredited academic institutions, are exempt from the security risk assessments for the entity and the individual who owns or controls such entity. (3) An individual will be deemed to own or control an entity under the following conditions: 1 1 These conditions may apply to more than one individual. (i) For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity. (ii) For entities… | ||||||
| 7:7:5.1.1.1.9.0.47.8 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.8 Denial, revocation, or suspension of registration. | APHIS | (a) An application may be denied or a certificate of registration revoked or suspended if: (1) The individual or entity, the responsible official, or an individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b; (2) The individual or entity, the responsible official, or an individual who owns or controls the entity is reasonably suspected by any Federal law enforcement or intelligence agency of: (i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or (ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or (iii) Being an agent of a foreign power as defined in 50 U.S.C. 1801; (3) The individual or entity does not meet the requirements of this part; 3 or 3 If registration is denied for this reason, we may provide technical assistance and guidance. (4) It is determined that such action is necessary to protect plant health or plant products. (b) Upon revocation or suspension of a certificate of registration, the individual or entity must: (1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order; (2) Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and (3) Comply with all disposition instructions issued by the Administrator for each select agent or toxin covered by the revocation or suspension. (c) Denial of an application for registration and revocation or suspension of registration may be appealed under § 331.20. However, any denial of an application for registration or revocation or suspension of a certificate of registration will remain in effect until a final agency decision has been rendered. | |||||||
| 7:7:5.1.1.1.9.0.47.9 | 7 | Agriculture | III | 331 | PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS | § 331.9 Responsible official. | APHIS | [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61075, Oct. 5, 2012; 82 FR 6205, Jan. 19, 2017] | (a) An individual or entity required to register under this part must designate an individual to be the responsible official. The responsible official must: (1) Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General. (2) Be familiar with the requirements of this part. (3) Have authority and responsibility to act on behalf of the entity. (4) Ensure compliance with the requirements of this part. (5) Have a physical (and not merely a telephonic or audio/visual) presence at the registered entity to ensure that the entity is in compliance with the select agent regulations and be able to respond in a timely manner to onsite incidents involving select agents and toxins in accordance with the entity's incident response plan. (6) Ensure that annual inspections are conducted of each registered space where select agents or toxins are stored or used in order to ensure compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected and the corrections documented. (7) Ensure that individuals are provided the contact information for the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any biosafety/biocontainment or security concerns related to select agents and toxins. (8) Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the responsible official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives any report of any inactivation failure after the movement of material to another location, the responsible official must report immediately by telephone or email the inactivation or viable agent removal method failure to APHIS or CDC. (9) Review, and revise as necessary, each of the entity's validate… |
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