Rule2023-04323
Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins
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
March 3, 2023
Effective
March 3, 2023
Issuing agencies
Health and Human Services Department
Abstract
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has amended the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS- CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. With this final rule, regulated entities are required to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.
Full Text
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<title>Federal Register, Volume 88 Issue 42 (Friday, March 3, 2023)</title>
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[Federal Register Volume 88, Number 42 (Friday, March 3, 2023)]
[Rules and Regulations]
[Pages 13322-13328]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04323]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
[Docket No. CDC-2021-0119]
RIN 0920-AA79
Possession, Use, and Transfer of Select Agents and Toxins--
Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any
Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids
Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents
and Toxins
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) located
within the Department of Health and Human Services (HHS) has amended
the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2
chimeric viruses resulting from any deliberate manipulation of SARS-
CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors to the list of HHS select agents and toxins. With this final
rule, regulated entities are required to obtain prior approval from CDC
to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic
acids coding for SARS-CoV virulence factors because these chimeric
viruses have the potential to pose a severe threat to public health and
safety.
DATES: Effective March 3, 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#87ebf5f4e6f3c7e4e3e4a9e0e8f1"><span class="__cf_email__" data-cfemail="97fbe5e4f6e3d7f4f3f4b9f0f8e1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The final rule is organized as follows:
I. Background and Legal Authority
II. Summary of Public Comments and Response to Comments
III. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. Paperwork Reduction Act of 1995
D. E.O. 12988: Civil Justice Reform
E. E.O. 13132: Federalism
F. Plain Language Act of 2010
I. Background and Legal Authority
On November 17, 2021, HHS/CDC published an interim final rule (IFR)
(86 FR 64075) that amended the select agents and toxins regulations to
add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate
manipulation of SARS-CoV-2 to incorporate nucleic acids coding for
SARS-CoV virulence factors \1\ to the list of HHS select agents and
toxins. The IFR also required the regulated entity obtain prior
approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to
incorporate nucleic acids coding for SARS-CoV virulence factors and
vice versa, because these chimeric viruses have the potential to pose a
severe threat to public health and safety.
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\1\ Virulence factors are genes or gene modifications that are
associated with virulence. Virulence factors determine a pathogen's
ability to replicate, modify host defenses, spread within the host
and to other individuals, and produce products that are toxic to the
host. These factors may impact infectivity, transmissibility,
immunity, vaccine sensitivity, pathogenicity, and disease severity.
Viral virulence factors (e.g., structures, molecules, and regulatory
systems) can impact features of viral pathogenicity including
infectivity, replication, host tropism, the ability to evade the
host response, and/or resistance to medical countermeasures, among
other viral characteristics.
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Legal Authority:
[[Page 13323]]
HHS/CDC is promulgating this rule under the authority of sections
201-204 and 221 of Title II of Public Law 107-188(42 U.S.C. 262a).
Title II, Subtitle A, of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a),
requires HHS to regulate the possession, use, and transfer of
biological agents or toxins that have the potential to pose a severe
threat to public health and safety (select agents and toxins).
Accordingly, HHS has promulgated regulations requiring individuals or
entities that possess, use, or transfer select agents and toxins to
register with CDC. See 42 CFR part 73.
II. Summary of Public Comments and Response to Comments
The IFR solicited public comments, based on the following criteria,
regarding whether SARS-CoV/SARS-CoV-2 chimeric viruses resulting from
any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids
coding for SARS-CoV virulence factors should be regulated as a select
agent:
(1) The effect on human health of exposure to the agent;
(2) The degree of contagiousness of the agent and the methods by
which the agent is transferred to humans;
(3) The availability and effectiveness of pharmacotherapies and
immunizations to treat and prevent any illness resulting from infection
by the agent; and
(4) Any other criteria, including the needs of children and other
vulnerable populations that the commenter considers appropriate.
In addition, HHS/CDC invited comments specifically on any virulence
factors found in SARS-CoV that would increase virulence in SARS-CoV-2.
HHS/CDC received three comments regarding the IFR.
Comment: One commenter, from academia, asked whether there is a
need to create a new rule specific to SARS-CoV/SARS-CoV-2 chimeras
because the regulation of the chimeras is covered in the ``Guidance on
the Regulation of Select Agents and Toxin Nucleic Acids'' document. The
commenter also stated that they did not support the addition of SARS-
CoV/SARS-CoV-2 chimeric viruses to the HHS select agents list because
the action would be an incremental step that could result in decreased
scientific advances and thus reduced preparedness at the detriment of
public health broadly. Finally, the commenter stated that the IFR does
not adhere to federal standards set forth for rulemaking, and the goals
of the IFR can be accomplished using existing regulatory
infrastructure.
Response: HHS/CDC made no changes based on the comment. The
``Guidance on the Regulation of Select Agents and Toxin Nucleic Acids''
document includes information provided by HHS/CDC to assist registered
entities with achieving regulatory compliance with the select agent and
toxin regulations. SARS-CoV-2 is not a select agent and, previously,
the select agent and toxins regulations only applied to nucleic acids
capable of producing infectious select virus, which would be the
majority of the genome and not a gene in isolation. The select agent
and toxins regulations did not apply to specific genes or nucleic acids
in isolation or non-select agent viruses. The Guidance document
includes information on complying with the regulations for regulated
genetic material, not for unregulated material or the genetic
components of unregulated material. Further, a guidance document does
not have the force and effect of law.
The basis for listing SARS-CoV/SARS-CoV-2 chimeric viruses
resulting from any deliberate manipulation of SARS-CoV-2 to incorporate
nucleic acids coding for SARS-CoV virulence factors as an HHS select
agent is that:
<bullet> Virulence factors from SARS-CoV including, but not limited
to, those involved in inflammasome activation during infection could be
introduced into SARS-CoV-2 and create a chimeric virus with increased
virulence.
<bullet> There is significant potential risk of merging a select
agent virus and pandemic virus and creating a chimeric virus with the
transmissibility of SARS-CoV-2 and the pathogenicity of SARS-CoV.
Comment: Two commenters, one from academia and one from industry,
requested more robust definitions or guidance to clarify ``virulence
factor'' and ``chimera'' to explicitly define ``virulence factors of
concern.''
Response: HHS/CDC agreed with the commenters.
Virulence factors are genes or gene modifications that are
associated with virulence. Virulence factors determine a pathogen's
ability to replicate, modify host defenses, spread within the host and
to other individuals, and produce products that are toxic to the host.
These factors may impact infectivity, transmissibility, immunity,
vaccine sensitivity, pathogenicity, and disease severity.
SARS-CoV/SARS-CoV-2 chimeric viruses result from any intentional
manipulation of SARS-CoV-2 to include nucleic acids coding for SARS-CoV
virulence factors. They are select agents and entities are required to
obtain prior approval from CDC's Division of Select Agents and Toxins
(DSAT) to possess, use, or transfer these agents. Additionally,
experiments to create these chimeric viruses must be submitted to the
Federal Select Agent Program for prior approval.
Additional Guidance has also been developed that provides examples
of virulence factors found in SARS-CoV/SARS-CoV-2 and provides examples
of experiments that may meet the definition of a restricted experiment.
Guidance can be found at the Supporting Materials tab of the docket and
at <a href="http://www.selectagents.gov">www.selectagents.gov</a>.
II. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts of the final rule under Executive
Order 12866, Regulatory Planning and Review (58 FR 51735, October 4,
1993) and Executive Order 13563, Improving Regulation and Regulatory
Review, (76 FR 3821, January 21, 2011). Both Executive Orders direct
agencies to evaluate any rule prior to promulgation to determine the
regulatory impact in terms of costs and benefits to United States
populations and businesses. Further, together, the two Executive Orders
set the following requirements: quantify costs and benefits where the
new regulation creates a change in current practice; qualitatively
describe costs and benefits; choose approaches that maximize net
benefits; and support regulations that protect public health and
safety. HHS/CDC has analyzed the final rule as required by these
Executive Orders and has determined that it is consistent with the
principles set forth in the Executive Orders and the Regulatory
Flexibility Act, as amended by the Small Business Regulatory
Enforcement Fairness Act (SBREFA). We anticipate that the rule will
create minimal cost impact, but it could potentially result in benefits
to the extent that it could reduce the probability of an accidental or
intentional release of the SARS-CoV/SARS-CoV-2 chimeric viruses
resulting from any deliberate manipulation of SARS-CoV-2 to incorporate
nucleic acids coding for SARS-CoV virulence factors. Such an event is a
low probability but potentially an extremely high-cost outcome. This
rule has been determined to be a ``significant regulatory action'' as
defined by Executive Order 12866, section 3(f). However, this rule is
not an economically significant regulatory action, as it will not have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the
[[Page 13324]]
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. This rule has been reviewed by the Office of Management
and Budget (OMB) pursuant to Executive Orders 12866 and 13563.
This regulatory impact section presents the anticipated costs and
benefits that are quantified where possible. Where quantification is
not possible, a qualitative discussion is provided of the costs and/or
benefits that HHS/CDC anticipates from this regulation.
Analysis of Costs and Benefits
Costs
As of September 7, 2022, CDC has not received any requests from
already registered entities to amend their registration to work with
this agent. In addition, CDC has not received any applications from new
entities to register with CDC and work with this agent. Thus, as of
this date, CDC has not observed any costs associated with the IFR or
for this final rule. If an entity chooses to work with this agent in
the future, the below estimates of costs and benefits would apply.
In the following analysis, HHS/CDC looked at two different types of
entities that may incur additional costs because of this rulemaking.
They are described below as: (1) A registered entity that applies to
amend its registration to add the agent; or (2) An unregistered entity
that seeks to register to work with the agent. HHS/CDC also estimated
the costs for CDC to work with an entity to amend its registration or
to register because of this final rule. All costs and benefits for this
analysis are reported in 2020 U.S. dollars. Further, HHS/CDC assumed
that all costs would be incurred within a one-year time period
corresponding to the expected period of time in which experiments with
these chimeric viruses would be performed.
(1) A registered entity that applies to amend its registration for
the agent.
As of September 7, 2022, none of the entities already registered
with CDC to work with select agents and toxins have amended their
registries to work with this agent. This final rule requires an entity
to amend its registration using relevant portions of APHIS/CDC Form 1
(Registration for Possession, Use, and Transfer of Select Agents and
Toxins). The estimated time to apply for an amendment using this form
is one hour for one select agent (Table 1). To account for uncertainty
in the estimate, a range of 75% to 125% of this estimate is used as the
lower bound and the upper bound estimates, respectively. HHS/CDC used a
median hourly respondent labor rate of $49.83 for managerial staff
(occupation code 11-1021 general and operations manager) as the upper
bound estimate and $16.98 for clerical staff (occupation code 43-9061
office clerks, general) as the lower bound estimate. These rates were
obtained from the Bureau of Labor Statistics, 2020 Occupational
Employment Statistics Survey by Occupation (<a href="http://www.bls.gov/oes/">http://www.bls.gov/oes/</a>).
HHS/CDC assumed that the hourly burden would be evenly split between
managerial staff and clerical staff as a base case. The hourly
respondent labor rate for the base case was the average of these two
figures ($33.41 per hour). The base salary is multiplied by an overhead
multiplier of 100% to account for non-wage benefits and other overhead
costs for supporting each employee. The estimated cost per already
registered entity to amend their registration for this agent was $66.81
(range: $25.47 to $124.58).
The additional time for HHS/CDC's review of the amended
registration for the already registered entities will also generate
additional costs. HHS/CDC estimated that one staff at the GS-13 (step
5) level is required to review the amended registration application.
The hourly wage of a Federal Employee at GS-13 (step 5) from the 2020
General Schedule (GS) locality pay table for Atlanta (where CDC has its
headquarters), $52.20 per hour, was used to estimate the hourly base
salary (Table 1). The base salary is multiplied by an overhead
multiplier of 100% to account for non-wage benefits and other overhead
costs for supporting each employee. HHS/CDC estimated that the review
of the amendment application takes two hours (range: 1.5 hours to 2.5
hours) for HHS/CDC. The cost of having HHS/CDC amend an entity's
registration for the agent is estimated to be $209 (range: $157 to
$261).
Table 1--Estimated Costs per Already Registered Entity To Amend Their Registration for the Agent
[2020 U.S. dollars]
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Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Entity
Number of employees working on the amendment (A)............ 1 1 1
Hourly wage (B)............................................. $33.41 $16.98 $49.83
Overhead multiplier (C)..................................... 100% 100% 100%
Time required per staff (hours) (D)......................... 1 0.75 1.25
Estimated costs per entity (E) = (A) x (B) x ((C) + 1) x (D) $66.81 $25.47 $124.58
HHS/CDC
Number of staff required for the review of the amendment 1 1 1
application (F)............................................
Hourly wage (G)............................................. $52.20 $52.20 $52.20
Overhead multiplier (H)..................................... 100% 100% 100%
Time required for the amendment per staff (hour) (I)........ 2 1.5 2.5
Estimated costs per entity (J) = (F) x (G) x ((H) + 1) x (I) $209 $157 $261
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(2) An unregistered entity will apply to register in order to work
with the agent (The entity is NOT currently registered).
As of September 7, 2022, no unregistered entities notified CDC, as
required by the IFR, that they plan to work with select agents and
toxins and have amended their registries to work with this agent. For
unregistered entities, which will register for working with the agent,
HHS/CDC expects per facility costs to vary based on the entity type,
laboratory size, and biosafety level (BSL). The first-year cost per
facility for a medium-size BSL-\2/3\ research institute to register to
work with the agent is estimated at $59,600. This estimate from the
Regulatory Impact Analysis for the 2005 Select Agent Regulations Final
Rule \2\ was adjusted to 2020 U.S. dollars value using the Consumer
Price Index
[[Page 13325]]
(CPI) Inflation Calculator.\3\ This results in an adjusted value of
$78,994 for each additional registered, medium-size BSL-\2/3\ research
institute laboratory (range: $41,087 to $936,528) (Table 2).
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\2\ Regulatory Impact Analysis, 42 CFR part 73: Possession, Use,
and Transfer of Select Agents and Toxins Final Rule, Centers for
Disease Control and Prevention, February 3, 2005.
\3\ <a href="https://www.bls.gov/data/inflation_calculator.htm">https://www.bls.gov/data/inflation_calculator.htm</a>.
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Two HHS/CDC staff, GS-12 (step 5) would perform the initial review
of the application with the final review conducted by GS-13 (step 5).
HHS/CDC estimated the upper bound hourly wage for a Federal Employee at
the GS-13 (step 5) from the 2020 General Schedule (GS) locality pay
table for Atlanta, $52.20 per hour. The lower bound was estimated using
the hourly wage for a GS-12 (step 5) employee, $43.90 per hour (Table
2). The mean of these two wage rates was used as the base case. The
base salary is multiplied by an overhead multiplier of 100% to account
for non-wage benefits and other overhead costs for supporting each
employee. HHS/CDC estimated that the review of an application would
take two hours (range: 1.5 hours to 2.5 hours). The estimated HHS/CDC
cost per entity to review an application was $384 (range: $263 to
$522).
Registration also will require an inspection by CDC to assess the
applicant's ability to comply with the select agents and toxins
regulations. HHS/CDC assumed that two CDC investigators, GS-12 (step 5)
or GS-13 (step 5) would travel to the laboratory and that the visit
would require 3 days (1 day for outbound trip to the laboratory, 1 day
for the investigation, and 1 day for the return trip) and 8 work hours
per day inclusive of report writing. The estimated travel costs were
$1,200 per trip for two CDC investigators. The total estimated costs
associated with laboratory investigation per entity are $5,183 (range:
$5,414 to $6,211). The estimated total costs for CDC per registered
entity are $6,197 (range: $5,678 to $6,733) for application review and
laboratory investigation.
HHS/CDC assumed that all costs associated with the final rule will
occur during the first year after the final rule is published and that
the final rule will not affect costs for registered entities in
following years. This may result in an over-estimate of the costs to
register an entity if that entity were to decide to continue to work
with select agents and toxins in future years.
Table 2--Estimated Costs per Entity, Which Will Register To Work With the Agent
[2020 U.S. dollars]
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Base case Lower bound Upper bound
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Entity
Estimated costs for registration per entity (A) \4\......... $78,994 $41,087 $936,528
HHS/CDC
Application review (time) costs per entity..................
Number of staff required for the review of the 2 2 2
application (B)........................................
Hourly wage (C)......................................... $48.05 $43.90 $52.20
Overhead multiplier (D)................................. 100% 100% 100%
Time required for the application per staff (hour) (E).. 2 1.5 2.5
Estimated costs associated with a registration $384 $263 $522
application review (F) = (B) x (C) x ((D) + 1) x (E)...
Lab investigation costs per entity..........................
Number of staff required for the lab investigation (G).. 2 2 2
Hourly wage (H)......................................... $48.05 $43.90 $52.20
Overhead multiplier (I)................................. 100% 100% 100%
Time required for the amendment per staff (hour) (J).... 24 24 24
Estimated time costs for lab investigation per entity $4,613 $4,214 $5,011
(K) = (G) x (H) x ((I) + 1) x (J)......................
Number of trips required per lab investigation (L)...... 1 1 1
Travel-associated costs per trip (M).................... $1,200 $1,200 $1,200
Travel-associated costs per lab investigation (N) = (L) $1,200 $1,200 $1,200
x (M)..................................................
Estimated costs associated with lab investigation (O) = $5,813 $5,414 $6,211
(K) + (N)..............................................
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Estimated total costs for HHS/CDC per entity (P) = (F) + (O) $6,197 $5,678 $6,733
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As of September 7, 2022, none of the entities already registered
with CDC to work with select agents and toxins have amended their
registries to work with this agent. The base case is the assumption for
the final rule that only one registered entity would amend their
registration for the agent and no unregistered entities would undergo
the registration process to work with this agent. The lower bound is
the same as the base case. For the upper bound, HHS/CDC assumed that
two registered entities would amend their registration to work with
this agent and one unregistered entity would undergo the registration
process to work with this agent (Table 3).
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\4\ The estimates from the Regulatory Impact Analysis for the
2005 Select Agent Regulations Final Rule (Regulatory Impact
Analysis, 42 CFR Part 73: Possession, Use, and Transfer of Select
Agents and Toxins Final Rule, Centers for Disease Control and
Prevention, February 3, 2005) was adjusted to 2020 U.S. dollars
value using the Consumer Price Index (CPI) Inflation Calculator
(<a href="https://www.bls.gov/data/inflation_calculator.htm">https://www.bls.gov/data/inflation_calculator.htm</a>).
Table 3--Numbers of Entities That Will Be Affected by the Final Rule
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Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Registered entities, which want to amend the registration for 1 1 2
the agent......................................................
Unregistered entities, which want to be registered for the agent 0 0 1
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[[Page 13326]]
The total costs associated with the final rule for the entities
working with this agent are estimated at $67 (range: $25 to $936,777)
(Table 4).
Table 4--Total Estimated Costs for Entities To Work With the SARS-CoV/SARS-CoV-2 Chimeric Viruses Associated
With the Final Rule
[2020 U.S. dollars]
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Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Registered entities, which want to amend their registrations to
work with the agent
Number of entities (A)...................................... 1 1 2
Estimated costs per entity (B).............................. $67 $25 $125
Estimated costs (C) = (A) x (B)............................. $67 $25 $249
Unregistered entities, which would pursue registration to work
with this agent
Number of entities (D)...................................... 0 0 1
Estimated costs per entity (E).............................. $78,994 $41,087 $936,528
Estimated costs (F) = (D) x (E)............................. $0 $0 $936,528
-----------------------------------------------
Total estimated costs for entities to comply with HHS/ $67 $25 $936,777
CDC requirements to work with this agent (G) = (C) +
(F)....................................................
----------------------------------------------------------------------------------------------------------------
The total estimated costs for HHS/CDC to review applications to
amend registrations or to register unregistered entities to work with
this agent, which are associated with the final rule are $209 (range:
$156 to $7,255) (Table 5).
Table 5--Total Estimated Costs for HHS/CDC To Review Entities' Applications To Amend Their Registrations or To
Register Unregistered Entities To Work With the SARS-CoV/SARS-CoV-2 Chimeric Viruses Associated With the Final
Rule
[2020 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Registered entities, which want to amend the registration for
the agent
Number of entities (A)...................................... 1 1 2
Estimated costs per entity (B).............................. $209 $157 $261
Estimated costs (C) = (A) x (B)............................. $209 $157 $522
Unregistered entities, which want to be registered for the agent
Number of entities (D)...................................... 0 0 1
Estimated costs per entity (E).............................. $6,197 $5,678 $6,733
Estimated costs (F) = (D) x (E)............................. $0 $0 $6,733
-----------------------------------------------
Total estimated costs for HHS/CDC (G) = (C) + (F)....... $209 $156 $7,255
----------------------------------------------------------------------------------------------------------------
Summary of Costs
In summary, the total estimated costs associated with the final
rule are $276 (range: $182 to $944,032) (Table 6). All costs are one-
time costs, and the follow-up costs are assumed to be minimal. The
upper bound cost estimate includes the cost to register an unregistered
entity to work with select agents and toxins, which may not be pursued.
Even this upper bound estimate is less than $1 million.
Table 6--Summary of Total Estimated Costs Associated With the Final Rule To Add the SARS-CoV/SARS-CoV-2 Chimeric
Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-
CoV Virulence Factors to HHS/CDC's List of Select Agents and Toxins
[2020 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Total estimated costs to entities working with the agent (A).... $67 $25 $936,777
Total estimated costs to HHS/CDC (B)............................ 209 157 7,255
Total estimated costs (C) = (A) + (B)........................... 276 182 944,032
----------------------------------------------------------------------------------------------------------------
Benefits:
The agents and toxins placed on the HHS/CDC select list have the
potential to pose severe threats to public health and safety. The
benefits of the HHS/CDC rule derive from the strengthened prevention
against the accidental or intentional release of SARS-CoV/SARS-CoV-2
chimeric viruses resulting from any deliberate manipulation of SARS-
CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors. The provisions of this rule will reduce the risk of human
exposure to these chimeric viruses by ensuring that laboratory
facilities employ adequate security and safety measures including:
(1) Develop and implement a written biosafety plan and measures in
place that are commensurate with the risk of the agent given its
intended use,
[[Page 13327]]
(2) Develop and implement a written security plan and measures in
place that are sufficient to safeguard the agent against unauthorized
access, theft, loss, or release,
(3) Develop and implement a written incident response plan based
upon a site-specific risk assessment,
(4) Have an adequate training program for handling select agents,
and
(5) Maintain an inventory of select agents.
The benefits to public health and safety from the implementation of
the rule result from the strengthened prevention of either accidental
or intentional release of the modification of a non-select agent with
nucleic acids from a select agent, however, the benefits are difficult
to quantify. The cost of such an event in morbidity and mortality could
be very high. In addition, a release of such a chimera or chimeric
virus that is composed of the modification of a non-select agent with
nucleic acids from a select agent may require a complicated and
expensive emergency response effort. This effort could include
extensive public health measures, such as quarantine, preventative
treatment, and diagnostic testing for large numbers of potentially
exposed persons, and extensive decontamination. Substantial costs could
be incurred by hospitals and other medical facilities and institutions
of government at all levels. A release, or widespread fear of one, also
would create significant secondary effects. It could disrupt business,
transportation, and many other aspects of normal behavior, on both a
short-term and potentially a long-term basis.
HHS/CDC is unable to predict the potential infectiousness or
virulence of the SARS-CoV/SARS-CoV-2 chimeric viruses that are
regulated according to the provisions of this final rule. However,
implementation of the final rule will provide a means of determining
where the modification of a non-select agent with nucleic acids from a
select agent is taking place; ensure that transfer, storage, and use of
the agent can be tracked; provide for the screening of personnel with
access to such agent; and require that entities in possession of such
agent develop and implement effective means of biosafety and physical
security. The benefit of these provisions is a reduced likelihood of
either an accidental or intentional release of the agent and the
consequent avoidance of costs associated with such a release.
This final rule addresses a risk associated with substantial
economic consequences. The likelihood of these negative outcomes under
a baseline scenario of no further regulatory action are low but also
highly uncertain and difficult to characterize. Based on this analysis,
HHS/CDC believes the expected benefits of this final rule are likely to
exceed the estimated costs associated with this final rule.
B. The Regulatory Flexibility Act (RFA), as Amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA)
We have examined the impacts of the final rule under the Regulatory
Flexibility Act (5 U.S.C. 601-612). The Regulatory Flexibility Act
(RFA), as amended by the Small Business Regulatory Enforcement Fairness
Act (SBREFA), requires agencies to analyze regulatory options that
would minimize any significant economic impact of a rule on small
entities. Based on our current knowledge of who may possess this agent,
we certify that this final rule will not have a significant economic
impact on a substantial number of small entities within the meaning of
the RFA.
This regulatory action is not a major rule as defined by section
804 of the SBREFA. This final rule will not result in an annual effect
on the economy of $100,000,000 or more; a major increase in cost or
prices; or significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United
States-based companies to compete with foreign-based companies in
domestic and export markets.
C. Paperwork Reduction Act of 1995
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in the current regulations are
approved by the Office of Management and Budget (OMB) under OMB Control
Number 0920-0576, expiration date 1/31/2024. This rulemaking includes a
request for a nonmaterial/non-substantive change to account for small,
potential increases in burden for a limited number of entities to
submit amendments to their registrations.
We estimate that only one to five registered entities may add the
select agent to their registration or transfer the select agent to
another registered entity. Therefore, we calculate that there is no
increase in the number of respondents that need to apply for
registration. This represents a non-material/non-substantive change in
burden for respondents to this approved information collection. The
burden is outlined in the table below.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Section Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Section 7..................... Application for 3 1 5 15
Registration.
----------------------------------------------------------------------------------------------------------------
D. E.O. 12988: Civil Justice Reform
This rule has been reviewed under E.O. 12988, Civil Justice Reform.
Once the rule was in effect, HHS/CDC notes that: (1) All State and
local laws and regulations that are inconsistent with this rule will be
preempted; (2) No retroactive effect will be given to this rule; and
(3) Administrative proceedings will not be required before parties may
file suit in court challenging this rule.
E. E.O. 13132: Federalism
HHS/CDC has reviewed this final rule in accordance with Executive
Order 13132 regarding Federalism and has determined that it does not
have ``federalism implications.'' The rule does not ``have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
F. Plain Language Act of 2010
Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13,
2010), executive Departments and Agencies are required to use plain
language in documents that explain to the public how to comply with a
requirement the Federal Government administers or enforces. HHS/CDC has
attempted to use plain language in announcing this rule consistent with
the Federal Plain Writing Act guidelines.
[[Page 13328]]
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers, Penalties, Reporting and
Recordkeeping requirements, Transportation.
0
For the reasons stated above in the preamble, HHS/CDC adopts the
interim final rule which was effective November 17, 2021 (86 FR 64075)
as final without change. In accordance with the interim final rule,
SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate
manipulation of SARS-CoV-2 to incorporate nucleic acids coding for
SARS-CoV virulence factors are an HHS select agent. Any individual or
entity that possesses SARS-CoV/SARS-CoV-2 chimeric viruses on or after
November 17, 2021 must provide notice to CDC regarding their possession
and must secure the agent against theft, loss, release, or unauthorized
access; and by November 17, 2021, an individual or entity that intends
to continue to possess, use, or transfer this agent is 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). Further,
experiments that involve the creation of SARS-CoV/SARS-CoV-2 chimeric
viruses resulting from any deliberate manipulation of SARS-CoV-2 to
incorporate nucleic acids coding for SARS-CoV virulence factors or vice
versa are restricted experiments and require prior approval in
accordance with 42 CFR 73.13(a)(3).
Dated: February 27, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-04323 Filed 3-2-23; 8:45 am]
BILLING CODE 4163-18-P
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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.