[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Proposed Rules]
[Page 33401-33403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy09-21]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
Possession, Use, and Transfer of Select Agents and Toxins;
Proposed Addition of SARS-Associated Coronavirus (SARS-CoV)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The biological agents and toxins listed in Sec. 73.3 of Title
42 of the Code of Federal Regulations have been determined by the
Secretary of the U.S. Department of Health and Human Services (HHS
Secretary) to have the potential to pose a severe threat to public
health and safety. We are now proposing to add SARS-associated
coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We
are proposing this action because (1) SARS-CoV can cause significant
mortality, especially in the elderly; (2) the virus has the capability
of easily being transmitted from human to human; (3) there is currently
no vaccine or antiviral approved for the prevention or treatment of
infections caused by the SARS-CoV virus; and (4) it has been documented
that the virus may persist in the environment.
DATES: Written comments must be received on or before September 11,
2009. Comments received after September 11, 2009 will be considered to
the extent practicable.
ADDRESSES: Comments on the proposed addition of SARS-CoV to the list of
select agents and toxins should be marked ``SARS-CoV'' and mailed to:
Centers for Disease Control and Prevention, Division of Select Agents
and Toxins, 1600 Clifton Road, MS A-46, Atlanta, GA 30333. Comments may
be e-mailed to: SAPcomments@cdc.gov.
FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of
Select Agents and Toxins, Centers for Disease Control and Prevention,
1600 Clifton Road, MS A-46, Atlanta, GA 30333. Telephone: (404) 718-
2000.
SUPPLEMENTARY INFORMATION: The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, Subtitle A of Public Law 107-188
(42 U.S.C. 262a) (the Bioterrorism Act), requires the HHS Secretary to
establish by regulation a list of each biological agent and each toxin
that has the potential to pose a severe threat to public health and
safety. In determining whether to include an agent or toxin on the
list, the HHS Secretary considers the effect on human health of
exposure to an agent or toxin; the degree of contagiousness of an agent
and the methods by which an agent or toxin is transferred to humans;
the availability and effectiveness of pharmacotherapies and
immunizations to treat and prevent illnesses resulting from an agent or
toxin; the potential for an agent or toxin to be used as a biological
weapon; and the needs of children and other vulnerable populations.
SARS-associated coronavirus (SARS-CoV) causes a viral respiratory
illness, severe acute respiratory syndrome (SARS), which was first
reported in Asia in February 2003. According to the World Health
Organization (WHO)i, a total of 8,098 people worldwide
became sick with SARS during the 2003 outbreak, resulting in 774
deaths. SARS-CoV is thought to be transmitted most readily by
respiratory droplets (droplet spread) produced when an infected person
coughs or sneezes. The virus also can spread when a person touches a
surface or object contaminated with infectious droplets and then
touches his or her mouth, nose, or eye(s). In addition, it is possible
that SARS-CoV might be spread more broadly through the air (airborne
spread) or by other ways that are not now known. There is currently no
known SARS transmission anywhere in the world. The last known human
cases of SARS-CoV infection as reported by the World Health
Organization occurred in China in April 2004 in an outbreak resulting
from laboratory-acquired infections.
After consulting with subject matter experts from the CDC, the
National Institutes of Health (NIH), the Food and Drug Administration
(FDA), the United States Department of Agriculture (USDA)/Animal and
Plant Health Inspection Service (APHIS), USDA/Agricultural Research
Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the
Department of Defense (DOD)/United States Army Medical Research
Institute for Infectious Diseases (USAMRIID) and conducting a review of
relevant published studies, we are proposing that SARS-CoV should be
added to the list of HHS select agents and toxins because:
The virus causes significant mortality, especially in the
elderly.ii iii
The virus has the capability of easily being transmitted
from human-to-human.iv
There is currently no method to treat infections caused by
the virus.v
It has been demonstrated that the virus may persist in the
environment.
We will consider comments that are received within 60 days of
publication of this notice in the Federal Register. After the comment
period closes, we will publish another document in the Federal
Register. The document will include a discussion of any comments we
receive and any changes to the list of HHS select agents and toxins.
Compliance Dates
We recognize that there may be some individuals and/or entities
that are not currently registered under either the HHS or USDA Select
Agent Programs, but that do possess SARS-CoV and would therefore be
required to register
[[Page 33402]]
with HHS should this proposed amendment be finalized.
Accordingly, as a result of this rule, an individual or entity that
currently possesses SARS-CoV, if they are not already a registered
entity, would have to either transfer the SARS-CoV to an individual or
entity that was registered to possess SARS-CoV or become a registered
individual or entity themselves. We recognize that an individual or
entity that chooses to become registered for possession of SARS-CoV
will need time to come into full compliance with the requirements of
the regulations, including the granting of individual access through
the security risk assessment process. To minimize the disruption of
research, educational projects (e.g., teaching demonstrations), or
other important activities involving SARS-CoV that might be underway as
of the effective date of these proposed regulations, we are also
proposing to provide that any unregistered individual or entity
possessing SARS-CoV as of the effective date (current unregistered
possessors) will be afforded time to reach full compliance with the
select agent regulations (42 CFR part 73). Therefore, we are proposing
that any current possessor of SARS-CoV must be fully registered and in
full compliance with all provisions of the Select Agent Regulations not
later than 180 days after the effective date of a final rule.
The Responsible Official for currently registered individuals or
entities that possess SARS-CoV would be required to provide notice in
the form of an amendment to their registration to HHS or USDA regarding
their possession of SARS-CoV not later than 15 days after the effective
day of this proposed amendment.
Regulatory Analyses
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
Executive Order 12866 and Regulatory Flexibility Act
This rule will add SARS-CoV to the HHS select agent list. The
purpose of the regulation of select agents and toxins is to reduce the
potential for these agents and toxins to pose a severe threat to public
health and safety by establishing Federal requirements for biosafety,
security, training, and personnel surety. Should any select agent or
toxin be intentionally or accidentally introduced into the population
of the United States, the consequences could be significant. The
individuals and entities most likely to be affected by this proposed
rule are those individuals at laboratories and other institutions
conducting research and related activities that involve the use of
SARS-CoV.
Based on CDC data, there are 138 entities that currently possess
SARS-CoV. Of those 138 entities, 73 entities are registered with the
select agent program of either HHS or USDA. The majority of the non-
registered entities are commercial entities.
Costs. Our estimate of the long-term cost of implementing the
select agent regulations is based on the actual costs incurred by
registering entities implementing the interim final rule that became
fully applicable on November 12, 2003. Additionally, before the interim
final rule was issued in December 2002, CDC contacted a number of
entities to assess existing practices. Because many of the laboratories
that will register under this proposal are already substantially in
compliance with the required practices, the costs of the rule should be
limited.
Benefits. The benefits to public health and safety from
implementation of the rule are clear, although difficult to quantify.
The benefits of the final rule will be the decreased risk of accidental
or intentional release of a select agent derived from the establishment
of Federal requirements for biosafety, security, training, and
personnel surety. The cost of such an event in human life could be very
high. The release of a select agent or toxin could result in a public
health emergency requiring an extensive and expensive response. This
effort could include extensive public health measures, such as
quarantine, preventative treatment and health 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.
The impacts resulting from the October 2001 anthrax attacks provide
an example of the costs that a release could incur. The anthrax attacks
caused five fatalities and 17 illnesses, disrupted business and
government activities, and caused widespread apprehension and changes
in behavior. Costs included more than $23 million to decontaminate one
Senate office building; approximately $2 billion in revenues lost to
the postal service, and as much as $3 billion in additional costs to
the postal service for cleanup of contamination and procurement of mail
sanitizing equipment.\1\ Substantial costs due to lost productivity
throughout the economy and from ongoing costs of the investigations
into the incident are additional impacts.
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\1\ Regulatory Impact Analysis for 42 CFR Part 73: Possession,
Use, and Transfer of Select Biological Agents and Toxins Final Rule.
Centers for Disease Control and Prevention, Department of Health and
Human Services. February 3, 2005.
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Implementation of this rule will continue to provide a means for
the registration of those who possess select agents; ensure that their
transfer, storage, and use can be tracked; provide for the screening of
personnel with access to such agents; and require that entities in
possession of such agents 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
select agents or the consequent avoidance of costs associated with such
a release.
Impacts resulting from the costs of the rule should not be
significant. The annualized cost on small entities would not exceed one
percent of sales or revenue stream and the initial cost would not
exceed three percent of sales or revenue stream, according to the
economic analysis, ``Regulatory Impact Analysis, 42 CFR part 73,
Possession, Use, and Transfer of Select Biological Agents and Toxins
Final Rule.'' To request a copy of this report, send an e-mail to
SAPcomments@cdc.gov. The HHS Secretary hereby certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Insert on Small Entity Impact
The Regulatory Flexibility Act (RFA) of 1980, as amended by the
Small Business Regulatory Enforcement Fairness Act of 1996, requires
agencies to prepare an initial regulatory flexibility analysis for any
rule subject to notice and comment rulemaking unless the agency is able
to certify that the rule will not have a significant economic impact on
a substantial number of small entities.
HHS guidance on the treatment of small entities suggests that a
``substantial number'' should be considered to mean 5 percent or more
of the affected small entities within an identified industry. The U.S.
Small Business Administration (SBA) has established size standards for
all for-profit industries based on either the
[[Page 33403]]
number of employees or annual revenue, depending on the North American
Industry Classification System (NAICS) classification. Most affected
entities would be considered part of NAICS code 5417102 Research and
Development in Life Sciences. Per the SBA's Table of Small Business
Size Standards, the Research and Development entities in NAICS code
5417102 are considered small if they have fewer than 500 employees.\2\
According to the Economic Census, there are 4,674 life sciences
research and development establishments that are categorized as
``small'' using this standard.\3\ Based on CDC data, there are 138
entities that are known to currently possess SARS-Co-V, and even if all
138 entities were considered small, less than 3 percent of the small
facilities in NAICS code 5417102 would be affected by the rule.
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\2\ U.S. Small Business Administration. Table of Small Business
Size Standards Matched to North American Industry Classification
System Codes. August 22, 2008. Available at: http://www.sba.gov/idc/
groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf.
\3\ http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_
id=&-fds_name=EC0200A1&_-skip=800&-ds_name=EC0254SSSZ5&_-
lang=en.
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Furthermore, the HHS guidance defines a ``significant economic
impact'' as an average annual impact of 3 to 5 percent or more of total
costs or revenues. The 65 entities that are not registered with the
select agent program must comply with the select agent regulations,
including becoming registered and ensuring adequate biosafety and
containment measures, physical security, training, and recordkeeping.
The average cost for a facility to register with CDC and otherwise
comply with 42 CFR part 73 is estimated to range from $15,300 to
$170,000 (70 FR 13315, March 18, 2005). The 73 entities that are
already registered because they possess other listed select agents or
toxins would need to amend their registrations, but they are likely to
already have adequate physical security, training programs, and
recordkeeping systems to enable them to safely and securely possess and
use SARS-CoV. The average revenue for the small establishments in NAICS
code 5417102 is about $3,493,000, so the average annual impact for
facilities to comply with the rule would range from less than 1 percent
to less than 5 percent.
Therefore, the HHS Secretary has certified that the final rule will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This Notice of Proposed Rulemaking has been reviewed under
Executive Order 12988, Civil Justice Reform. This rule: (1) Would
preempt all State and local laws and regulations that are inconsistent
with this rule; (2) would have no retroactive effect; and (3) would not
require administrative proceedings before parties may file suit in
court challenging this rule.
List of Subjects in 42 CFR Part 73
Biologics, Incorporation by reference, Packaging and containers,
Penalties, Reporting and recordkeeping requirements, Transportation.
Dated: June 9, 2009.
Kathleen Sebelius,
Secretary.
For the reasons stated in the preamble, we are proposing to amend
42 CFR part 73 as follows:
PART 73--SELECT AGENTS AND TOXINS
1. The authority citation for part 73 continues to read as follows:
Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of
Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).
2. Amend paragraph (b) of Sec. 73.3 by adding the following entry
in alphabetical order to read as follows:
Sec. 73.3 HHS select agents and toxins.
* * * * *
(b) * * *
SARS-associated coronavirus (SARS-CoV)
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\i\ World Health Organization, SARS: How a global epidemic was
stopped. 2006.
\ii\ Poutanen SM, Low DE, Henry B, et al. Identification of
severe acute respiratory syndrome in Canada. N Engl J Med 2003;
348:1995-2005.
\iii\ Lee N, Hui D, Wu A, et al. A major outbreak of severe
acute respiratory syndrome in Hong Kong. N Engl J Med 2003;
348:1986-1994.
\iv\ Ksiazek TG, Erdman D, Goldsmith CS, et al. A novel
coronavirus associated with severe acute respiratory syndrome. N
Engl J Med 2003; 348:1953-1966.
\v\ Holmes KV. SARS coronavirus: a new challenge for prevention
and therapy. J Clin Invest 2003; 111:1605-9.
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[FR Doc. E9-16536 Filed 7-10-09; 8:45 am]
BILLING CODE 4163-18-P