Source: https://www.law.cornell.edu/cfr/text/42/73.3
Timestamp: 2017-04-27 11:34:43
Document Index: 186110744

Matched Legal Cases: ['art 73', '§ 73', '§ 73', 'art 73', 'art 73', 'art 73', 'art 73', 'art 73', 'art 73']

42 CFR 73.3 - HHS select agents and toxins. | US Law | LII / Legal Information Institute
CFR › Title 42 › Chapter I › Subchapter F › Part 73 › Section 73.3 42 CFR 73.3 - HHS select agents and toxins.
§ 73.3 HHS select agents and toxins.
Link to an amendment published at 82 FR 6290, January 19, 2017.
This amendment was delayed until March 21, 2017, at 82 FR 10863, Feb. 16, 2017.
Bacillus cereus Biovar anthracis*”
Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)
Variola major virus (Smallpox virus) *
Variola minor virus (Alastrim) *
(2) Recombinant and/or Synthetic nucleic acids that encode for the functional form(s) of any of the toxins listed in paragraph (b) of this section if the nucleic acids:
(2) Non-viable HHS select agents or nonfunctional HHS toxins.
(3) Except as required in § 73.16(l), the aggregate amount of the toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed the following amounts: 100 mg of Abrin; 0.5 mg of Botulinum neurotoxins; 100 mg of Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7); 1,000 mg of Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 5 mg of Staphylococcal enterotoxins (subtypes A-E); 1,000 mg of T-2 toxin; or 100 mg of Tetrodotoxin.
(i) The amounts are transferred only after the transferor uses due diligence and documents that the recipient has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Notwithstanding the provisions of paragraph (d) of this section, the HHS Secretary retains the authority to, without prior notification, inspect and copy or request the submission of the due diligence documentation to the CDC.
(4) An animal inoculated with or exposed to an HHS select toxin.
(5) Any South American genotypes of Eastern Equine Encephalitis Virus and any West African Clade of Monkeypox virus provided that the individual or entity can identify that the agent is within the exclusion category.
(i) The seizure of Botulinum neurotoxins, Botulinum neurotoxin producing species of Clostridium, Ebola viruses, Francisella tularensis, Marburg virus, Variola major virus (Smallpox virus), Variola minor (Alastrim), or Yersinia pestis must be reported within 24 hours by telephone, facsimile, or e-mail. This report must be followed by submission of APHIS/CDC Form 4 within seven calendar days after seizure of the select agent or toxin.
[ 70 FR 13316, Mar. 18, 2005, as amended at 70 FR 61049, Oct. 20, 2005; 73 FR 61365, Oct. 16, 2008; 73 FR 64554, Oct. 30, 2008; 77 FR 61110, Oct. 5, 2012; 79 FR 26861, May 12, 2014; 81 FR 63143, Sept. 14, 2016]
Title 42 published on 2015-11-28The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 73 after this date.2017-03-10; vol. 82 # 46 - Friday, March 10, 201782 FR 13259 - Select Agents and Toxins
2017-02-16; vol. 82 # 31 - Thursday, February 16, 201782 FR 10864 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review and Enhanced Biosafety Requirements; Delay of Effective Date
2017-01-19; vol. 82 # 12 - Thursday, January 19, 201782 FR 6278 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements
typeregulations.gov FR Doc.2017-00726 RIN0920-AA59 Docket No.CDC-2015-0006 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. Effective February 21, 2017. 42 CFR Part 73 SummaryIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.
2016-09-14; vol. 81 # 178 - Wednesday, September 14, 201681 FR 63138 - Possession, Use, and Transfer of Select Agents and Toxins—Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins
typeregulations.gov FR Doc.2016-22049 RIN0920-AA64 CDC Docket No.CDC-2016-0045 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Interim final rule and request for comments. Effective date: The interim final rule is effective on October 14, 2016. Public comment period: Written or electronic comments must be submitted by November 14, 2016. Applicability dates: By October 14, 2016, any individual or entity that possesses B. cereus Biovar anthracis must provide notice to the CDC&apos;s DSAT regarding their possession of this agent and must secure the agent against theft, loss, release, or unauthorized access; and by March 13, 2017, an individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with 42 CFR part 73 or amend their current registration in accordance with 42 CFR 73.7(h) and meet all of the requirements of select agent regulations (42 CFR part 73). 42 CFR Part 73 SummaryThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.
2016-01-19; vol. 81 # 11 - Tuesday, January 19, 201681 FR 2805 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements
typeregulations.gov FR Doc.2016-00758 RIN0920-AA59 Docket No.CDC-2015-0006 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Notice of Proposed Rulemaking (NPRM). Submit written or electronic comments by March 21, 2016. 42 CFR Part 73 SummaryIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, we are proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.
42 CFR 73.1 — Definitions.
42 CFR 73.16 — Transfers.