[Federal Register Volume 74, Number 132 (Monday, July 13, 2009)]
[Proposed Rules]
[Pages 33401-33403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16536]


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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: [email protected].

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 
[email protected]. 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