42 CFR Part 73 - SELECT AGENTS AND TOXINS

On September 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published in the Federal Register (81 FR 63138) an interim final rule and request for comments which added Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. CDC received two comments, both of which supported the rule change.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a delay in the effective date of the final rule titled “Possession, Use, and Transfer of Select Agents and Toxins, Biennial Review and Enhanced Biosafety Requirements” that published on January 19, 2017. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) is making a parallel change in the effective date of their final rule. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled “Regulatory Freeze Pending Review.”

In 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.

The 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.

In 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.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins. Specifically, we are proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. We have determined that these influenza viruses have the potential to pose a severe threat to public health and safety.

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A (Department of Health and Human Services) of Title II (Enhancing Controls on Dangerous Biological Agents and Toxins) of Public Law 107-188 (June 12, 2002) (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has initiated the review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. We are considering whether to propose amending the HHS list by removing six biological agents.

In a final rule that was published in the Federal Register on October 5, 2012, we amended and republished the list of select agents and toxins that have the potential to pose a severe threat to public health and safety; reorganized the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human health (designation of Tier 1); and amended the regulations in order to add definitions and clarify language concerning security, training, biosafety, biocontainment, and incident response. In that final rule, all of our regulatory language was not precisely aligned with that used by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA) in their parallel select agent regulations published on the same day in the Federal Register . This document corrects inconsistencies in language between the HHS/CDC and USDA/APHIS regulations. We are also correcting an improper term used in those sections of the regulations associated with identification of a viral strain or subspecies that is excluded from the requirements of the regulations, modifying the terms used when a select toxin is excluded from the regulations, clarifying those parts of the regulations that deal with temporary exemptions granted during periods of public health or agricultural emergencies, and adding language to specify that individuals not approved for unescorted access to registered space for activities not related to select agents or toxins (e.g., routine cleaning, maintenance, and repairs) would not have to be continuously escorted by an approved individual so long as those non-approved persons would not be able to gain access to select agents or toxins.

With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the re-opening of a public comment period for a request for information and comment published on October 17, 2012. The request for information sought information and comments from the public regarding whether highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We are reopening the comment period to allow interested persons additional time to prepare and submit comments.

The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on October 5, 2012 (77 FR 61084). The document updated the list of HHS and overlap biological agents and toxins and designated certain select agents and toxins as Tier 1 agents.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. This information will be considered in a determination of whether such viruses should be listed as HHS select agents, by revising the HHS Select Agent Regulations (42 CFR Part 73).