Notice2022-00928
Draft Policy Statement for Biosafety Level 4 (BSL-4) and Animal BSL-4 (ABSL-4) Laboratory Verification; Notice of Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 19, 2022
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2791-2792]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00928]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>, 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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
<a href="http://www.regulations.gov">www.regulations.gov</a> 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
</pre></body>
</html>Indexed from Federal Register on January 19, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.