Notice2023-02730
Policy Statement for Biosafety Level 4/Animal Biosafety Level 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
February 9, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the availability and implementation of the final Biosafety Level 4 (BSL-4)/ Animal BSL-4 (ABSL-4) verification policy. The policy statement assists 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 ABSL-4 laboratories are functioning as intended to meet the biosafety sufficiency requirement in the HHS/CDC select agent and toxin regulations.
Full Text
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<title>Federal Register, Volume 88 Issue 27 (Thursday, February 9, 2023)</title>
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[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Notices]
[Pages 8428-8431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02730]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0003]
Policy Statement for Biosafety Level 4/Animal Biosafety Level 4
Laboratory Verification; Notice of Availability
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), in the
Department of Health and Human Services (HHS), announces the
availability and implementation of the final Biosafety Level 4 (BSL-4)/
Animal BSL-4 (ABSL-4) verification policy. The policy statement assists
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 ABSL-4
laboratories are functioning as intended to meet the biosafety
sufficiency requirement in the HHS/CDC select agent and toxin
regulations.
[[Page 8429]]
DATES: The compliance date for this Policy is February 9, 2023.
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 H21-4, Atlanta, Georgia
30329. Telephone: (404) 718-2000. Email: <a href="/cdn-cgi/l/email-protection#b7dbc5c4d6c3f7d4d3d499d0d8c1"><span class="__cf_email__" data-cfemail="fc908e8f9d88bc9f989fd29b938a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On January 19, 2022, CDC published a notice
in the Federal Register (87 FR 2791) 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. HHS/CDC received
comment on the draft policy statement concerning BSL-4/ABSL-4
verification requirements from seven commenters. The commenters were
from academia, industry, city/local government, and the public.
Summary of Public Comments
In general, commenters supported the draft policy but had specific
suggestions on wording and revisions. Please see a summary of the
comments and our responses below.
Comment: One commenter suggested changing the subject to include
BSL-3 Agriculture.
Response: HHS/CDC notes that an established BSL-3/ABSL-3
Verification Policy already exists (<a href="https://www.cdc.gov/cpr/ipp/docs/Policy_Import_BSL3_ABSL3_Verification.pdf">https://www.cdc.gov/cpr/ipp/docs/Policy_Import_BSL3_ABSL3_Verification.pdf</a>). Thus, HHS/CDC made no
changes based on this comment.
Comment: One commenter recommended that Heating, Ventilation, and
Air Conditioning (HVAC) be referred to as ``Building and Mechanical,
Electrical, and Plumbing (MEP) systems.''
Response: HHS/CDC disagreed with this recommendation because the
term ``HVAC'' is more universally referenced. No changes were made to
the policy due to this comment.
Comment: HHS/CDC received comment regarding clarification and
testing of the HVAC system only after major changes or every ten years.
Response: HHS/CDC agreed with the commenter to provide the
clarification and has updated the policy to state that entities must
ensure HVAC verification is performed and documented ``after major
changes to ensure operational parameters are maintained.'' The policy
includes examples of major changes that can be referenced. HHS/CDC
disagreed with the other comments regarding increasing the testing
requirement to every ten years.
Comment: A commenter discussed primary and secondary fans versus
parallel HVAC fans and how setup depends on different facility
configurations.
Response: HHS/CDC agreed with the comment about configuration of
HVAC fans and included ``or failure of parallel fans depending on
facility configuration'' in the policy.
Comment: Commenters requested that examples be provided for major
changes and that HHS/CDC provide a list of repairs to HVAC control
system components that require verification testing.
Response: HHS/CDC agreed with providing examples and has updated
the policy to include examples of major changes that can be referenced.
Modifications include repairs or replacing a component to the HVAC to
ensure that the system is fully operational. HHS/CDC also revised the
policy to state ``systems'' instead of ``components.'' Entities should
ensure all HVAC systems are operational, and because systems vary, the
components of the system also vary from entity to entity; therefore,
HHS/CDC will not be providing a universal list of repair of HVAC
control system components.
Comment: Another commenter suggested using a risk assessment-based
approach to determine if failure testing is required after resolving a
major problem.
Response: HHS/CDC disagreed with the comment regarding a risk
assessment-based approach to determine if failure testing is required
after a major problem. As such, HHS/CDC made no updates to the policy.
HHS/CDC understands the commenters' concerns regarding a disruption due
to a major problem and then the need for the entity to perform HVAC
operational verification. However, HHS/CDC believes it is essential to
verify the system annually and after any significant modification to
ensure operational parameters are maintained during both normal
operating conditions and failure conditions to prevent air-flow
reversals into non-containment areas (e.g., outside the containment
boundary, hallways).
Comment: A commenter requested that HHS/CDC require an HVAC design
verification process for ``primary containment (suit and cabinet room's
primary barrier equipment)'' instead of secondary containment.
Response: HVAC is part of the facility safeguards, which is a
secondary barrier; therefore, HHS/CDC will not be referring to this as
primary containment. Secondary containment is defined by the 6th
edition of the Biosafety in Microbiological and Biomedical Laboratories
(BMBL) as the design and construction of the laboratory facility that
provides a means of secondary containment of hazardous biological
agents and toxins to protect personnel, the surrounding community, and
the environment from possible exposure to hazardous biological agents
and toxins.
Comment: A commenter recommended excluding small repairs, like-for-
like replacement of smaller components, and minor automation system
logic programming changes.
Response: HHS/CDC made no changes to the policy and agreed with the
commenter that minor changes and small repairs mentioned above would
not be considered major repairs.
Comment: Commenters suggested specific references be added to the
list of systems to be tested/verified annually such as chemical shower,
alarms, power source, communications, access systems, Air Pressure
Resistant (APR) door gaskets, positive-pressure suits, water supply,
and manual overrides tested (e.g., between mechanical and electronic
door interlocks).
Response: HHS/CDC agreed with the commenters and updated the policy
to reference these items.
Comment: Commenters requested the term ``uninterrupted power
supply'' be changed to adequately reflect the meaning.
Response: HHS/CDC agreed with the commenters and changed the term
to ``automatically activated backup.''
Comment: A commenter asked if room air pressure trend lines
captured from the Building Automation System (BAS) could be used to
demonstrate the absence of air reversal.
Response: HHS/CDC agreed and revised the policy to state that
entities may use BAS records to demonstrate no airflow reversal from
the BSL-4/ABSL-4 laboratory during transition from normal power to the
automatically activated backup, emergency power supply.
Comment: Another commenter suggested the inclusion of emergency
power stand-by systems (emergency generator and automatic transfer
switch), uninterruptible power supply, and critical equipment with
internal batteries (e.g., programmable logic control devices) to the
minimum verification requirement for back-up power systems for HVAC.
Response: HHS/CDC agreed with the comment and revised the policy to
include ``routine maintenance programs and backup, power systems'' to
[[Page 8430]]
succinctly summarize the minimum verification requirements.
Comment: Commenters requested term ``power failure'' be changed to
adequately reflect the meaning.
Response: HHS/CDC agreed with commenters and changed the term to
``emergency power status.''
Comment: A commenter stated that ``only modifications in the
programming sequence that affect how the laboratory reacts in failure
conditions should be required to be re-tested.'' The commenter further
suggested that changes or updates such as ``tuning PID loops, updates
on coefficients that are imbedded in the sequence of operation, or the
optimization of the logic to reduce the traffic of data in the system,
should not require re-verification.''
Response: HHS/CDC made no changes based on this comment. HHS/CDC is
primarily interested in ensuring that all systems are working as
designed after any major changes, which is a normal practice to ensure
the system is fully operational.
Comment: A commenter suggested that the addition or removal of
hard-ducted equipment (e.g., biological safety cabinets [BSCs], Class
III BSC, or decontamination systems) without affecting the airflow
balance of the room does not affect the operations, therefore no re-
verification should be required.
Response: HHS/CDC made no changes based on the comment. Additions
or removals should be tested to ensure repairs were effective even if
one component was replaced.
Comment: A commenter stated that the methods for verification of
primary containment integrity is unclear and needs to be clarified
(specifically for primary containment of centrifuges and animal caging
systems). The commenter further requested that the policy state what
documentation or testing is needed for the verification.
Response: HHS/CDC made no changes to the policy based on the
comment since there are no specific tests to determine integrity.
Centrifuges need to have safety cups and no leaks in the washers to
ensure integrity of primary containment inside the centrifuge (BMBL 6th
edition, Inadvertent Toxin Aerosols). Animal cages need to be designed
to allow recirculation of air into the room after high-efficiency
particulate air (HEPA) filtration (BMBL 6th edition, Part 3: Biological
Safety Cabinets). While there are no specific tests to determine
integrity, HHS/CDC recommends that the entity verifies the animal
caging systems and centrifuge, and its components, are working as
designed.
Comment: Commenters requested to clarify the meaning of BSCs with
an HVAC connection ``not working properly.'' A commenter asserted that
the observation or evidence that the BSC is not working properly is
more of an issue with the certification and maintenance of the
equipment and not the HVAC system, therefore, it is not a major problem
and does not require re-verification.
Response: HHS/CDC agreed with the commenters to clarify the meaning
of ``not working properly'' and revised the policy to read
``observation or evidence that BSCs with an HVAC connection (hard duct
or thimble) are not working as designed.'' HHS/CDC disagreed with the
commenter regarding reverification. When major repairs are made to the
BSC including replacing components of the BSC, the entity should test
the system to ensure repair was effective and does not compromise the
functionality of the HVAC system.
Comment: Commenters requested clarification on verifying BAS-
programmed alarm communication as part of the BSL-4/ABSL-4 facility
verification. One commenter recommended that verification of BAS
programmed alarms should be tested only initially.
Response: HHS/CDC did not make any changes based on the comments.
Verification of the BAS-programmed alarm communication should include
assurance that if an alarm occurs, the strobes, lights, or audibles are
activated. Testing annually ensures all parameters that are important
to maintain containment have a functioning alarm.
Comment: A commenter provided editorial changes for clarity to
paragraph A, Effluent, tissue, autoclave, and decontamination systems,
under section 3 (confirmation that decontamination systems are
operating as designed [e.g., autoclave, room decontamination systems,
tissue digesters, liquid effluent systems, and chemical showers]).
Specifically, the commenter recommended:
<bullet> 3. A. i: Change to Annual verification that system
operational parameters have not changed from biologically validated
conditions (e.g., volume, pressure, temperature settings)
<bullet> 3. A. iii: Change to Annual certification testing of
associated HEPA filters, if applicable (e.g., operating vent, pressure
relief vent, chamber effluent/vent)
<bullet> 3. A. iv: Change to Annual verification that system
failure, emergency communication systems are operating as designed
(e.g., alarms, leak detection)
<bullet> 3. A. v: Change to Verify appropriate filter media is
selected and maintained annually (e.g., HEPA, polytetrafluoroethylene
[PTFE])
Another commenter agreed that 3. A. v. should be rewritten for
clarity and stated that the sentence should refer to ``HEPA, however,
it should instead be revised in terms of efficiency and particle size
since HEPA filters are at least 99.97% of airport particles 0.3
micrometers, while PTFE filters have 99.99% efficiency of airborne
particles 2.5micrometers in diameter.''
<bullet> 3. A. vi: Another commenter stated that this was unclear
and needs to be clarified to state specifically what document/test
needs to be provided to meet this requirement.
Response: HHS/CDC agreed with the editorial changes, updated the
policy based on these changes, and clarified 3. A. v. to read ``v.
Verify appropriate filter media is selected and maintained annually
(e.g., HEPA, PTFE).'' However, HHS/CDC disagreed with suggestion to
revise 3. A. iv. ``annual verification that system failure alarms are
operating as designed'' because the language is clear as written and
communication is more encompassing than alarms. HHS/CDC agreed with the
commenter to clarify 3. A. vi. to read, ``Implementation of risk-based
preventative maintenance for other equipment that is critical to
containment components, but is not specifically included above (e.g.,
cook tanks, etc.).''
Comment: A commenter requested to clarify decontamination systems
by adding decontamination rooms and chambers.
Response: HHS/CDC made no changes to the policy based on the
comment because some facilities may not have these rooms or chambers.
Comment: A commenter responded that room decontamination should be
validated upon each use and not rely on annual verifications as a
substitution, since parameters can shift slightly from use to use
(i.e., atmospheric moisture or room temperature).
Response: HHS/CDC agreed with commenter; however, no changes were
made based on this comment since the policy notes that this is an
annual verification of the room decontamination system and biological
indicators are already mentioned for this reason.
Comment: Commenters suggested wording changes for annual
verification requirement for certification of laboratory HVAC, plumbing
vent line, and decontamination system filters, stating that there are
no written standards by which to certify BSL-4/ABSL-4 laboratories.
[[Page 8431]]
Response: HHS/CDC agreed with the commenters and made the change to
the policy.
Comment: A commenter requested that ``established'' specifications
be changed to ``approved design'' specifications.
Response: HHS/CDC agreed with the commenter and revised the policy.
Comment: Commenters requested adding the verification requirement
for ``pressure decay testing.''
Response: HHS/CDC agreed with the commenters and included that
pressure decay testing may be used to identify and confirm proper
operation of various BSL-4/ABSL-4 containment boundary points of
failure (e.g., penetrations, cracks, breaks, APR doors, HEPA isolation
dampers, etc.).
Where can this document be found?
This policy document is available at the Federal Select Agent
Program website at <a href="http://www.selectagents.gov">www.selectagents.gov</a>.
Legal Authority
HHS/CDC is issuing this policy under the authority of sections 201-
204 and 221 of Title II of Public Law 107-188, (42 U.S.C. 262a).
Tiffany Brown,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-02730 Filed 2-8-23; 8:45 am]
BILLING CODE 4163-18-P
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