[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2791-2792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2022-0003]


Draft Policy Statement for Biosafety Level 4 (BSL-4) and Animal 
BSL-4 (ABSL-4) Laboratory Verification; Notice of Availability

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of availability and comment.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) announces the opening of 
a docket to obtain comment on a draft policy statement regarding 
Biosafety Level 4 (BSL-4)/Animal Biosafety Level 4 (ABSL-4) 
verification requirements. The policy statement, once finalized, will 
assist individuals and entities in verifying that the facility design 
parameters and operational procedures, including heating, ventilation, 
and air conditioning (HVAC) systems, in BSL-4 and/or ABLS-4 
laboratories are functioning as intended to meet the biosafety 
sufficiency requirement in the HHS/CDC select agent regulations.

DATES: Submit written or electronic comments by March 21, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0003, by either of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Select Agents and Toxins, Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21-7, 
Atlanta, Georgia 30329.
    Instructions: All submissions received must include the Agency name 
and Docket No. CDC-2022-0003. All relevant comments received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided. Do not send comments by email. CDC does 
not accept comments by email.
    Docket Access: For access to the docket to read background 
documents or comments received, or to download

[[Page 2792]]

an electronic version of the draft policy statement, go to http://www.regulations.gov. Please be aware that comments and other 
submissions from members of the public are made available for public 
viewing without changes.

FOR FURTHER INFORMATION CONTACT: Samuel S. Edwin Ph.D., Director, 
Division of Select Agents and Toxins, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE, Mailstop H21-7, Atlanta, Georgia 
30329. Telephone: (404) 718-2000.

SUPPLEMENTARY INFORMATION:

A. Legal Authority

    HHS/CDC is issuing this draft policy under the authority of 
sections 201-204 and 221 of Title II of Public Law 107-188, (42 U.S.C. 
262a).

B. Background

    For entities that possess select agents and toxins, the HHS select 
agent and toxin regulations (42 CFR part 73) require that ``biosafety 
and containment procedures must be sufficient to contain the select 
agent or toxin (e.g., physical structure and features of the entity, 
and operational and procedural safeguards)'' (42 CFR 73.12(b)). BSL-4 
and ABSL-4 laboratory facility specifications and operational 
procedures are used for work with dangerous and exotic biological 
agents that could easily be aerosol transmitted within the laboratory, 
cause severe to fatal disease in humans, and typically do not have 
available vaccines or treatments. Therefore, these laboratories must 
implement and maintain the highest level of biosafety precautions for 
containment.
    HHS/CDC reviews how entities that maintain BSL-4 and/or ABSL-4 
laboratories have verified that the design and operational parameters, 
including HVAC, are functioning properly when determining if entities 
have met the sufficiency requirement in section 12(b) of the HHS select 
agent and toxin regulations. In developing a biosafety plan, an 
individual or entity should consider requirements found in the 
Biosafety in Microbiological and Biomedical Laboratories (BMBL) (42 CFR 
73.12(c)). HHS/CDC has developed a draft policy statement for BSL-4 and 
ABSL-4 laboratory verification based on the standards found in the 6th 
edition of the BMBL:
     BSL-4 D16(a): The ventilation system is designed to 
maintain the laboratory at negative pressure to surrounding areas and 
to provide differential pressure or directional airflow as appropriate 
between adjacent areas within the laboratory.
     ABSL-4 D16(a): The supply and exhaust components of the 
ventilation system are designed to maintain the ABSL-4 facility at 
negative pressure to surrounding areas and to provide differential 
pressure or directional airflow as appropriate between adjacent areas 
within the facility.
     BSL-4 D20: The facility design parameters and operational 
procedures are documented. The facility is tested to verify that the 
design and operational parameters have been met prior to operation. 
Facilities are also re-tested annually or after significant 
modification to ensure operational parameters are maintained. 
Verification criteria are modified, as necessary, by operational 
experience.
     ABSL-4 D21: The ABSL-4 facility design parameters and 
operational procedures are documented. The facility is tested to verify 
that the design and operational parameters have been met prior to 
operation. Facilities are also re-tested annually or after significant 
modification to ensure operational parameters are maintained. 
Verification criteria are modified, as necessary, by operational 
experience.
    HHS/CDC is requesting public comment on a draft policy statement on 
BSL-4/ABSL-4 laboratory verifications standards, including HVAC, to aid 
individuals and entities in verifying that these laboratories are 
properly functioning. We are making this policy document available to 
the public in the Supplementary Materials tab of the docket at 
www.regulations.gov for review and comment. All comments, such as items 
related to the appropriate acceptance criteria used to ensure systems 
are functioning as intended and documentation to demonstrate the 
sufficiency requirement has been met, that we receive on or before 
March 21, 2022 will be carefully reviewed and considered.

    Dated: January 13, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-00928 Filed 1-18-22; 8:45 am]
BILLING CODE 4163-18-P