```

[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Proposed Rules]
[Pages 61206-61226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25427]

[[Page 61205]]

Vol. 76

Monday,

No. 191

October 3, 2011

Part IV

Department of Health and Human Services

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42 CFR Part 73

Possession, Use, and Transfer of Select Agents and Toxins; Biennial 
Review; Proposed Rule

Federal Register / Vol. 76 , No. 191 / Monday, October 3, 2011 / 
Proposed Rules

[[Page 61206]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2011-0012]

42 CFR Part 73

RIN 0920-AA34

Possession, Use, and Transfer of Select Agents and Toxins; 
Biennial Review

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Response Act), 
the Centers for Disease Control and Prevention (CDC) located within the 
Department of Health and Human Services (HHS) has reviewed the list of 
biological agents and toxins that have the potential to pose a severe 
threat to public health and safety and is proposing to amend and 
republish the list as required by the Bioterrorism Response Act. 
Further, on July 2, 2010, the President signed Executive Order 13546, 
``Optimizing the Security of Biological Select Agents and Toxins in the 
United States'' that directed the Secretaries of HHS and Agriculture 
(USDA) to designate a subset of the select agents and toxins list (Tier 
1) that presents the greatest risk of deliberate misuse with the most 
significant potential for mass casualties or devastating effects to the 
economy, critical infrastructure; or public confidence; explore options 
for graded protection for these Tier 1 agents and toxins to permit 
tailored risk management practices based upon relevant contextual 
factors; and consider reducing the overall number of agents and toxins 
on the select agents and toxins list. E.O. 13546 also established the 
Federal Experts Security Advisory Panel (FESAP) to advise the HHS and 
USDA Secretaries on the designation of Tier 1 agents and toxins, 
reduction in the number of agents on the Select Agent List, 
establishment of suitability standards for those having access to Tier 
1 select agents and toxins, and establishment of physical security and 
information security standards for Tier 1 select agents and toxins. The 
tiering of the select agents and toxins list will allow the application 
of more optimized security measures for those select agents or toxins 
which pose a higher risk to public health and safety should they be 
stolen or otherwise misused.
    In addition to addressing the FESAP recommendations in this Notice 
of Proposed Rulemaking (NPRM), we are also proposing to add two agents, 
Lujo and Chapare viruses to the list; adding definitions; and 
clarifying language concerning security, training, biosafety, and 
incident response. These changes will increase the usability of the 
select agents and toxins regulations as well as providing for enhanced 
program oversight.

DATES: Comments should be received on or before December 2, 2011.

ADDRESSES: You may submit comments, identified by Regulatory 
Information Number (RIN), 0920-AA34 in the heading of this document by 
any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Centers for Disease Control and Prevention, Select 
Agent Program, 1600 Clifton Road, NE., Mailstop A-46, Atlanta, Georgia 
30333, Attn: RIN 0920-AA34.
    Instructions: All submissions received must include the agency name 
and RIN for this rulemaking. All relevant comments received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided.
    Docket Access: For access to the docket to read background 
documents or comments received or to download an electronic version of 
the NPRM, go to http://www.regulations.gov. Comments will be available 
for public inspection Monday through Friday, except for legal holidays, 
from 9 a.m. until 5 p.m. at 1600 Clifton Road, NE., Atlanta, GA 30333. 
Please call ahead to 1-866-694-4867 and ask for a representative in the 
Division of Select Agents and Toxins to schedule your visit. Our 
general policy for comments and other submissions from members of the 
public is to make these submissions available for public viewing on the 
Internet as they are received and without change.

FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of 
Select Agents and Toxins, Centers for Disease Control and Prevention, 
1600 Clifton Road, NE., Mailstop A-46, Atlanta, Georgia 30333. 
Telephone: (404) 718-2000.

SUPPLEMENTARY INFORMATION: The Preamble to this notice of proposed 
rulemaking is organized as follows:

I. Background
II. Proposed Changes to 42 CFR Part 73, Including Responses to 
Comments to the ANPRM
    A. Modifications to the List of HHS Select Agents and Toxins
    B. Modifications to the List of Overlap Select Agents and Toxins
    C. Tiering
    D. Responses to Other Comments and Other Proposed Changes
    i. Exclusions
    ii. Security
    iii. Select Agent Inventory
    iv. Definitions
    v. Recombinant/Synthetic Nucleic Acids
    vi. Toxins
    vii. Responsible Official
    viii. Access to Select Agents and Toxins
    ix. Security Plan
    x. Biosafety Plans
    xi. Restricted Experiments
    xii. Incident Response
    xiii. Training
    xiv. Transfers
    xv. Records
    xvi. Administrative Review
    xvii. Guidance Documents
III. Required Regulatory Analyses
    A. Executive Order 12866 and 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Executive Order 12988: Civil Justice Reform
    E. Executive Order 13132: Federalism
    F. Plain Writing Act of 2010
IV. References

I. Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, Subtitle A (Department of Health and Human 
Services) of Title II (Enhancing Controls on Dangerous Biological 
Agents and Toxins) of Public Law 107-188 (June 12, 2002) (42 U.S.C. 
262a) (the Bioterrorism Response 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 the 
agent and the methods by which the 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. The 
current list of HHS select agents and toxins can be found at 42 CFR 
73.3 (HHS select agents and toxins) and 42 CFR 73.4 (Overlap select 
agents and toxins). The list of HHS and Overlap select agents and 
toxins is available at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html. The Bioterrorism Response 
Act requires that the HHS Secretary review and republish the list of 
select

[[Page 61207]]

agents and toxins on at least a biennial basis. See 42 U.S.C. 
262a(a)(2).
    The HHS Secretary last republished the HHS select agents and toxins 
list in the Federal Register on October 16, 2008 (73 FR 61363). The HHS 
select agents and toxins list is divided into two sections. The select 
agents and toxins listed in Sec.  73.3 (HHS select agents and toxins) 
are those regulated only by HHS under the authority of the Bioterrorism 
Response Act. The select agents and toxins listed in Sec.  73.4 
(Overlap select agents and toxins) are those regulated by HHS under the 
authority of the Bioterrorism Response Act and regulated by the USDA 
under the authority of the Agricultural Bioterrorism Protection Act of 
2002 (7 U.S.C. 8401).
    To fulfill this statutory mandate, the Center for Disease Control 
and Prevention's (CDC) Division of Select Agents and Toxins (DSAT) 
initiated its biennial review process, which included consultation with 
CDC's Intragovernmental Select Agents and Toxins Technical Advisory 
Committee (ISATTAC) and other subject matter experts. The ISATTAC is 
comprised of Federal government employees from the CDC, the National 
Institutes of Health (NIH), the Food and Drug Administration (FDA), the 
USDA/Animal and Plant Health Inspection Service (APHIS), USDA/
Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary 
Biologics), the Department of Homeland Security (DHS), the Department 
of Defense (DOD), and the Biomedical Advanced Research and Development 
Authority (BARDA) within the Office of the Assistant Secretary for 
Preparedness and Response in HHS.
    CDC also published an ANPRM in the Federal Register (75 FR 42363) 
(July 21, 2010 ANPRM) inviting comments concerning potential changes to 
part 73 of Title 42 of the Code of Federal Regulations (the select 
agent regulations). We solicited comments regarding (1) the 
appropriateness of the current HHS list of select agents and toxins; 
(2) whether there are other biological agents or toxins that should be 
added to the HHS list; (3) whether biological agents or toxins 
currently on the HHS list should be deleted from the list; (4) whether 
the HHS select agents and toxins list should be tiered based on the 
relative bioterrorism risk of each biological agent or toxin; and (5) 
whether the security requirements for select agents or toxins in the 
highest tier should be further stratified based on type of use or other 
factors. We requested recommendations regarding the criteria to use to 
designate high risk select agents and toxins and those recommendations 
were included in the interagency working group discussions on the 
matter. Relevant issues raised by the comments are discussed below in 
``II. Proposed Changes to 42 CFR part 73.''
    On July 2, 2010, President Obama signed Executive Order (E.O.) 
13546: ``Optimizing the Security of Biological Select Agents and Toxins 
in the United States'' that directed the Secretaries of HHS and USDA to 
(1) designate a subset of the select agents and toxins list (Tier 1) 
that presents the greatest risk of deliberate misuse with the most 
significant potential for mass casualties or devastating effects to the 
economy, critical infrastructure; or public confidence; (2) explore 
options for graded protection of Tier 1 agents and toxins to permit 
tailored risk management practices based upon relevant contextual 
factors; and (3) consider reducing the overall number of agents and 
toxins on the select agents and toxins list. E.O. 13546 also 
established the FESAP to advise the HHS and USDA Secretaries on the 
designation of Tier 1 agents and toxins, reduction in the number of 
agents on the Select Agent List, establishment of personnel reliability 
standards for those having access to Tier 1 select agents and toxins, 
and establishment of physical security and information security 
standards for Tier 1 select agents and toxins. E.O. 13546 is available 
at: http://edocket.access.gpo.gov/2010/pdf/2010-16864.pdf. The FESAP 
provided its recommendations to the HHS and USDA Secretaries on 
November 2, 2010. The FESAP recommendations addressed the reduction of 
the list of select agents and toxins, the identification of a subset of 
the list that includes those that presents the greatest risk of 
deliberate misuse with the most significant potential for mass 
casualties or devastating effects to the economy, critical 
infrastructure; or public confidence; and the optimization of security 
programs at registered entities. In drafting its recommendations to 
modify and stratify the list of select agents and toxins, the FESAP 
utilized expert knowledge of the agents, combined with information from 
the DHS's Material Threat Determinations of biological agents and 
toxins. Care was used to balance risks identified with the 
Congressional mandate to ensure the availability of select agents and 
toxins for research and educational activities.
    Other sources of input that we have considered in the drafting of 
this Proposed Rule include the following: The National Science Advisory 
Board for Biosecurity, the National Academies, and comments received 
from professional societies and the public in response to the CDC ANPRM 
published on July 21, 2010.
    The purpose of this notice of proposed rulemaking is to seek public 
comment on (1) the appropriateness of the current HHS and Overlap list 
of select agents and toxins including whether there are other agents or 
toxins that should be added to the HHS or Overlap list or whether 
agents or toxins currently on the HHS or Overlap list should be deleted 
from the list; (2) the appropriateness of the proposed tiering of the 
select agents and toxins list; (3) whether minimum standards for 
personnel reliability, physical and cyber security should be prescribed 
for identified Tier 1 agents; and (4) any other aspect of the proposed 
amendments to the select agent regulations.

II. Proposed Changes to 42 CFR Part 73

                   Proposed Changes to 42 CFR Part 73
------------------------------------------------------------------------
       Section No.               Current                 Change
------------------------------------------------------------------------
73.0.....................  Applicability and    No change.
                            related
                            requirements.
73.1.....................  Definitions........  Definitions added:
                                                 Adjudicated as a mental
                                                 defective; alien;
                                                 committed to any mental
                                                 institution; controlled
                                                 substance; crime
                                                 punishable by
                                                 imprisonment for a term
                                                 exceeding 1 year;
                                                 indictment; information
                                                 security; lawfully
                                                 admitted for permanent
                                                 residence; mental
                                                 institution;
                                                 occupational exposure;
                                                 recombinant and
                                                 synthetic nucleic
                                                 acids; restricted
                                                 person; unlawful use of
                                                 any controlled
                                                 substance.
73.2.....................  Purpose and scope..  No change.
73.3.....................  HHS select agents    Designates Tier 1 select
                            and toxins.          agents and toxins; adds
                                                 select agents and
                                                 toxins; clarifies
                                                 language; deletes from
                                                 the HHS list.

[[Page 61208]]

 
73.4.....................  Overlap select       Designates Tier 1 select
                            agents and toxins.   agents and toxins; adds
                                                 select agents and
                                                 toxins; clarifies
                                                 language; deletes from
                                                 the overlap list.
73.5.....................  Exemptions for HHS   Amends the immediate
                            select agents and    notification list to
                            toxins.              Tier 1 agents.
73.6.....................  Exemptions for       Amends the immediate
                            overlap select       notification list to
                            agents and toxins.   Tier 1 agents.
73.7.....................  Registration and     No change.
                            related security
                            risk assessments.
73.8.....................  Denial, revocation,  Clarifies language.
                            or suspension of
                            registration.
73.9.....................  Responsible          Redesignates paragraphs;
                            Official.            adds new paragraphs
                                                 (a)(3), (a)(6).
73.10....................  Restricting access   Redesignates paragraphs;
                            to select agents     adds new paragraph (e);
                            and toxins;          adds clarifying
                            security risk        language.
                            assessments.
73.11....................  Security...........  Revises regulatory text--
                                                 paragraph (b), (c)(2).
                                                 Redesignates
                                                 paragraphs; adds new
                                                 paragraphs (c)(8),
                                                 (c)(9), (c)(10), (e).
73.12....................  Biosafety..........  Revises paragraphs (a)
                                                 and (c)(1); replaces
                                                 ``url'' in paragraph
                                                 (c)(3); redesignates
                                                 paragraph (d); adds new
                                                 paragraph (d).
73.13....................  Restricted           Clarifies language.
                            experiments.
73.14....................  Incident response..  Redesignates paragraphs;
                                                 adds new paragraphs (d)
                                                 and (e).
73.15....................  Training...........  Revises paragraph (a);
                                                 redesignates
                                                 paragraphs; adds new
                                                 paragraph (b).
73.16....................  Transfers..........  Redesignates paragraphs;
                                                 adds new paragraphs
                                                 (f), (h), (l).
73.17....................  Records............  Revises paragraph
                                                 (a)(1); redesignates
                                                 paragraphs; adds new
                                                 paragraph (a)(2).
73.18....................  Inspections........  No changes.
73.19....................  Notification of      No changes.
                            theft, loss, or
                            release.
73.20....................  Administrative       Revises paragraphs.
                            review.
73.21....................  Civil money          No changes.
                            penalties.
------------------------------------------------------------------------

A. Modifications to the List of HHS Select Agents and Toxins

    The following changes to the list of HHS select agents and toxins 
are proposed based on comments received in response to the July 21, 
2010 ANPRM, recommendations from the FESAP and ISATTAC, and our review 
of current scientific data regarding select agents and toxins. As we 
discuss below, we are proposing to remove 6 select agents, add 2 select 
agents, and identify 11 select agents and toxins as ``Tier 1'' agents 
to the HHS list of select agents and toxins.
Proposed Addition of Lujo and Chapare Viruses
    On August 19, 2009 (74 FR 41829), we proposed the addition of 
Chapare virus to the HHS list of select agents and toxins; we did not 
receive any comments regarding that proposal. Based on scientific data 
and risks associated with this virus, the ISATTAC recommended the 
addition of Chapare virus to the HHS list of select agents and toxins. 
The determination to add Chapare virus to the HHS list of select agents 
and toxins was based on the following scientific information. The HHS 
list currently includes members of the arenaviridae family (Junin, 
Machupo, Sabia, Flexal, Guanarito, and Lassa). Arenaviruses are rodent-
borne viruses, some of which can be associated with large hemorrhagic 
fever outbreaks, and untreated case fatalities can be in excess of 30 
percent. Chapare virus is a recently described New World arenavirus 
that is associated with fatal hemorrhagic fever syndrome and is most 
closely related to Sabia virus, an HHS select agent (Ref 1). Based on 
the ISATTAC recommendation and our examination of the current 
scientific data and risks associated with this virus, we are proposing 
to add Chapare to the HHS list.
    The ISATTAC also recommended the addition of Lujo virus to the HHS 
list of select agents and toxins. Based on this recommendation and our 
examination of the current scientific data and risks associated with 
this virus, we are also proposing to add Lujo virus. The scientific 
determination was based on the fact that the Lujo virus caused a fatal 
outbreak of hemorrhagic fever, has an unprecedented high case fatality 
rate of 80 percent, has been phylogenetically identified as an 
arenavirus and is related to those members of the Old World 
arenaviridae family (Junin, Machupo, Sabia, Flexal, Guanarito, and 
Lassa) listed as HHS select agents that cause hemorrhagic fever and 
pose a significant risk to public health and safety (Ref 2).
Proposed Removal of Cercopithecine Herpesvirus 1 (Herpes B Virus)
    Commenters acknowledged in response to the July 21, 2010 ANPRM that 
(1) the Herpes B virus naturally infects many species of macaques; and 
(2) can produce a serious, often fatal, infection in humans when not 
treated. However, the commenters argued that Herpes B virus should not 
be included as a select agent based on the following assertions:
     The inclusion of the virus on the list will produce no 
significant improvements in safety for the American public.
     Given the high prevalence of infection in non-human 
primates and the relatively few human infections that have been 
recorded, it suggests that the virus is not easily transmitted to 
humans.
     The virus is capable of being treated with several 
available licensed antiviral compounds.
     The virus does not present a sufficient risk of infection 
by the aerosol route.
     The virus is a highly unlikely candidate for a 
bioterrorism agent due to its environmental instability and the need 
for direct contact for infection. The argument is further enhanced by 
the absence of the virus listed on the NIH's National Institute of 
Allergy and Infectious Diseases lists of Category A, B & C Priority 
Pathogens or the CDC's Category A, B & C Bioterrorism Agents lists.
     The virus is widely available in nature.
    The ISATTAC and the FESAP also recommended the removal of 
Cercopithecine herpesvirus 1 (Herpes B virus) from the HHS list of 
select agents and toxins. We agreed with the

[[Page 61209]]

commenters, ISATTAC, and FESAP and propose to remove Cercopithecine 
herpesvirus 1 (Herpes B virus) from the HHS list of select agents and 
toxins. Our rationale for this proposal is based on the facts that this 
virus is not easily transmitted to humans, the person-to-person 
transmission risk is small, the numbers of recorded human infections 
are low, and multiple licensed antiviral treatments for Herpes B 
infections are available.
Proposed Removal of Coccidioides posadasii/Coccidioides immitis
    Commenters to our July 21, 2010 ANPRM argued that Coccidioides 
posadasii/Coccidioides immitis should not be included as a select agent 
based on the following reasons:
     The characteristics of Coccidioides species do not provide 
convincing properties of an effective agent of bioterrorism.
     The fungi are endemic in the southwestern United States, 
but do not cause large epidemics even with high prevalence in the air 
during wind storms.
     Infections caused by the fungi are easily treatable by 
licensed antifungal medicines, especially early in disease.
     The difficulty to use Coccidioides species as a bioweapon, 
and hence the need for strict regulation under the select agent 
regulations, is exemplified by their non-communicability, lack of 
history of use or development as successful biological weapons, and a 
relatively low incidence of symptomatic disease following natural 
infection.
     Coccidioides species would not be an effective 
bioterrorism weapon because the percentage of deaths and 
hospitalizations are low considering the number of people infected.
    The FESAP also recommended removal of Coccidioides posadasii/
Coccidioides immitis from the HHS list of select agents and toxins. We 
agreed with the commenters and FESAP and propose to remove Coccidioides 
posadasii/Coccidioides immitis from the HHS list of select agents and 
toxins. The scientific determination was based on the availability of 
licensed treatments for Coccidioides infection and a lowering of our 
assessment of the impact of Coccidioides infection on human health, as 
indicated by the high proportion of subclinical cases observed in 
endemic areas (Ref 3).
Proposed Retention of Coxiella burnetii
    Commenters to the July 21, 2010 ANPRM argued that Coxiella burnetii 
(Q fever) should be removed from the select agents and toxins list 
based on the following assertions:
     Q fever is not contagious and is effectively treated with 
licensed antibiotics.
     It is generally a self-limiting infection with potential 
control by licensed vaccination.
     The ubiquitous nature of Coxiella burnetii means that it 
can be easily acquired from environmental sources and calls into 
question the effectiveness and procedures for maintaining inventories 
of select agents.
     Person-to-person transmission of the disease is rare and 
is fatal less than one percent of the time.
     A vaccine is available for this agent internationally, but 
not domestically.
     The agent is commonly found in animal populations within 
the United States.
    However, FESAP and ISATTAC did not recommend removing this 
bacterium from the HHS list of select agents and toxins. We agreed with 
the FESAP and ISATTAC recommendations and propose to retain Coxiella 
burnetii on the HHS select agents and toxins list. The determinations 
to retain this agent on the HHS list are its robust environmental 
stability, ease of transmission to humans, extremely low infectious 
dose, and prior association of this agent with offensive programs. CDC 
invites comments regarding retaining this agent on the HHS list of 
select agents and toxins.
Proposed Removal of South American Genotypes of Eastern Equine 
Encephalitis Virus (EEEV)
    Commenters on the July 21, 2010 ANPRM regarding the proposed 
inclusion of EEEV on the list of select agents and toxins argued that 
EEEV should not be included as a select agent based on the following 
reasons:
     The virus occurs naturally in the environment.
     Direct person-to-person transmission does not occur.
     Local and State health departments and mosquito control 
agencies routinely release information regarding the location of 
arboviral activity in the community, so upholding strict biosecurity 
measures in a laboratory has little or no impact on reducing a 
terrorist's ability to acquire this agent.
     Only North American strains of EEEV should be regulated 
because transmission patterns limit the distribution and epidemic 
potential of South American strains, which are less pathogenic.
    We examined the current scientific data and noted that strains of 
EEEV can be categorized into two distinct genotypes primarily based 
upon geographic distribution: North American genotype (NA EEE) and 
South American genotype (SA EEE). The NA EEE genotype consists of 
strains obtained from North America and the Caribbean while SA EEE 
genotype viruses originate in Central and South America. Viruses in the 
two genotypes are distinctly different in their genetics, epidemiology, 
and pathogenicity. NA EEE, which are the strains responsible for human 
and equine disease, are all genetically very similar to each other 
(less than 3% divergence at the nucleotide level) and can be easily 
distinguished from SA EEE genotype strains by sequencing. NA EEE 
genotype strains differ from SA EEE viruses by greater than 20% at the 
nucleotide level and approximately 10% at the amino acid level. Since 
FESAP agreed with our scientific assessment that SA EEE genotypes 
should be removed from the HHS list of select agents and toxins, we are 
proposing to remove SA EEE genotypes from the HHS list of select agents 
and toxins (Ref 4).
Proposed Removal of Flexal Virus
    Commenters that responded to the July 21, 2010 ANPRM felt that 
Flexal virus should be removed from the HHS list of select agents and 
toxins based on the lack of severity of disease and the lack of 
significant outbreaks of disease associated with infection with this 
virus in humans. FESAP also recommended that Flexal virus be removed 
from the list. Since our research found a lack of significant outbreaks 
of disease associated with Flexal virus in humans and that this virus 
would be a highly unlikely candidate for a bioterrorism agent, we are 
proposing to remove Flexal virus from the HHS list of select agents and 
toxins.
Proposed Retention of Monkeypox Virus
    Commenters to the July 21, 2010 ANPRM recommended that Monkeypox 
virus should not be included as a select agent based on the following 
assertions:
     An effective licensed vaccine is available.
     Promising antivirals are in advanced stages of 
development.
     The virus is inefficiently transmitted from person-to-
person.
    We examined the current scientific data and noted that there is an 
increased incidence of Monkeypox virus in humans as well as studies 
identifying the virus being easily transmitted in Gambian rats. A 
recent study on an outbreak in Sudan indicates there is much strain 
variation in level of infectivity and severity of disease. Concern over 
the detection of new lineages with increased pathogenesis has been 
expressed. Another recent

[[Page 61210]]

outbreak of Monkeypox virus in the United States suggested numerous 
animals could become infected complicating the understanding of 
zoonotic maintenance of the virus (Ref 29-33).
    While there has been documented cross protection against Monkeypox 
virus by Vaccinia virus vaccine, the decrease in the number of 
individuals with any immunity to the virus is drastically declining 
(since smallpox vaccination no longer occurs). Further, even though 
there is a stockpile of Vaccinia virus vaccine available, the vaccine 
has numerous undesirable side-effects that make it less than optimal 
for mass vaccination. There are also several antiviral treatments for 
Monkeypox in advanced stages of development, but they are not currently 
available. Thus, there is currently no specific treatment (Ref 29-33).
    FESAP recommended keeping Monkeypox virus on the HHS list of select 
agents and toxins.
    Based on the scientific determination outlined above, we are 
proposing to retain Monkeypox virus on the HHS list of select agents 
and toxins. We will continue to monitor progress in the development of 
antivirals and other means of prevention and control of Monkeypox virus 
infections and invite comments on removing a certain clade of Monkeypox 
virus (i.e., West African clade of Monkeypox virus) from the HHS list 
of select agents and toxins.
Proposed Reorganization of Tick-Borne Encephalitis Complex Viruses 
(TBEV)
    Even though we received no comments to the July 21, 2010 ANPRM 
regarding the removal of these viruses from the HHS list of select 
agents and toxins, we are proposing the removal of TBEV Central 
European subtype from the HHS list of select agents and toxins for the 
following scientific reasons:
     The TBEV Central European Tick-borne subtype has been 
shown to be less virulent in humans than the Far Eastern subtype (Ref 
5).
     No TBEV vaccines are licensed or available in the United 
States; however two safe, effective inactivated TBEV vaccines are 
available internationally.
    FESAP also recommended the removal of the TBEV Central European 
subtype from the HHS list of select agents and toxins.
    In addition to removing the TBEV Central European subtype from the 
HHS list of select agents and toxins, we propose to reorganize the 
listing of the TBEV to reflect the current nomenclature given by the 
International Committee on Taxonomy of Viruses. For TBEV proper, there 
are now just three recognized subtypes: Central European, Far Eastern, 
and Siberian. The Russian Spring and Summer encephalitis designation is 
no longer recognized (Ref 6). Two other viruses on the HHS list of 
select agents and toxins, Kyasanur Forest disease virus and Omsk 
Hemorrhagic fever virus, are no longer classified as TBEV. In 
recognition of these taxonomic changes, we are proposing to include 
these viruses on the HHS list of select agents and toxins as follows:

Tick-borne encephalitis virus
    Far Eastern subtype
    Siberian subtype
Kyasanur Forest disease virus
Omsk Hemorrhagic fever virus
Proposed Retention of Rickettsia prowazekii and Rickettsia Rickettsii
    Commenters that responded to the July 21, 2010 ANPRM argued that 
Rickettsia prowazekii and Rickettsia rickettsii should be removed from 
the HHS list of select agents and toxins based on the following 
assertions:
     Mimicking transmission by arthropod vectors in an effort 
to disperse these pathogens with the intent to disrupt society would be 
challenging and technologically unlikely to be successful.
     Common and readily available licensed antibiotics are 
highly effective, and contagion is not a threat because spread is 
determined by contact with the vectors, not through person-to-person 
contact.
     Although Rickettsia prowazekii may be a pathogen of 
military significance, Rickettsia rickettsii is not. According to the 
commenter, propagation of the pathogens requires growth in cultured 
host cells and natural infection occurs by parenteral inoculation 
through a tick vector, so mass exposure by aerosolization or 
contamination of food sources is unlikely to result in disease.
     The potential to use this agent as a platform to construct 
a genetically engineered new pathogen would be extremely difficult.
     The primary disease associated with Rickettsia rickettsii 
is Rocky Mountain Spotted Fever, and the symptoms are recognizable and 
marketed diagnostics and treatment are readily available.
     Rickettsia rickettsii should be removed because generation 
of even moderate amounts of infectious material is exceedingly 
difficult and requires specialized equipment.
     Rickettsiae are not spread directly from person-to-person, 
would not survive if dispersed into the environment, and are 
susceptible to a number of readily available licensed antibiotics. In 
addition, there is no possibility of eliminating their presence in the 
environment.
     Potential benefits of lessening restriction on research 
include improved diagnostic capabilities and better potential for 
vaccine development.
    The FESAP and ISATTAC recommended keeping Rickettsia prowazekii and 
Rickettsia rickettsii on the HHS list of select agents and toxins. 
Since we agreed with these expert panels, we are proposing to retain 
Rickettsia prowazekii and Rickettsia rickettsii on the HHS select 
agents and toxins list based on our scientific determination regarding 
the environmental stability, low infectious dose, aerosol transmission, 
and clinical significance of infection with these organisms.
Proposed Retention of Yersinia pestis
    Commenters that responded to the July 21, 2010 ANPRM argued that 
Yersinia pestis should not be included as a select agent based on the 
following assertions:
     Yersinia pestis is naturally occurring and does not 
survive for long outside of its rodent host because of susceptibility 
to heat and sunlight.
     Decontamination of surfaces is highly effective in 
limiting its spread.
     Licensed treatments are readily available for those who 
may become exposed.
    The FESAP and ISATTAC recommended that Yersinia pestis remain on 
the HHS list of select agents and toxins.
    We agree with the FESAP and ISATTAC, and are proposing to keep 
Yersinia pestis on the HHS select agents and toxins list based on our 
scientific conclusion regarding the bacterium's high mortality rate, 
ease of dissemination and production, and person-to-person transmission 
of Yersinia pestis infections.
Proposed Reorganization of Staphylococcal Enterotoxins
    Commenters to the July 21, 2010 ANPRM suggested that the 
regulations needed a clear statement concerning staphylococcal 
enterotoxins (SEs) and staphylococcal enterotoxin-like toxins (SEls). 
Commenters stated that SEs and SEls have been distinguished from each 
other on the basis of emetic activity (Ref 12). Commenters were 
confused regarding whether the intent of the select agent regulations 
is to acknowledge this difference and not regulate SEls or to regulate 
both SEs and SEls.

[[Page 61211]]

    ISATTAC recommended that we amend the HHS list of select agents and 
toxins to specifically include Staphylococcal enterotoxins A, B, C, D, 
and E in the HHS list of select agents and toxins. We agree with the 
commenters and the ISATTAC recommendation, and propose to amend the 
select agents and toxins list from ``Staphylococcal enterotoxins'' to 
specifically include ``Staphylococcal enterotoxins A, B, C, D, and E'' 
in the HHS list of select agents and toxins (Ref 7-14). Serotypes G, H, 
and I should not added to the HHS list of select agents and toxins 
because serotypes G, H, and I are at least 10 fold less of a risk than 
SEE and SEA (Ref 15-16.) According to the International Nomenclature 
Committee for Staphylococcal Superantigens, emesis in a primate model 
within five hours post-feeding must be observed to classify an exotoxin 
as an enterotoxin (Ref 12). If emesis is not observed in this period of 
time, the exotoxin should be classified as enterotoxin-like rather than 
enterotoxin. Based on this internationally accepted standard, we are 
proposing serotypes J, K, L, M, N, O, P, Q, T, U, U2 and V should be 
designated staphylococcal enterotoxin-like rather than enterotoxin 
because these serotypes have been shown to either not cause emesis in a 
primate model or have not been tested for emesis (Ref 17-26). 
Therefore, we are proposing serotypes J, K, L, M, N, O, P, Q, T, U, U2 
and V should not added to the HHS list of select agents and toxins.

B. Modifications to the List of Overlap Select Agents and Toxins

    The following changes to the list of Overlap select agents and 
toxins are proposed based on comments received to the July 21, 2010 
ANPRM, recommendations from the FESAP and ISATTAC, and our review of 
current scientific data regarding select agents and toxins.
Proposed Retention of Bacillus anthracis (Pasteur Strain)
    A commenter to the July 21, 2010 ANPRM stated that the Pasteur 
strain of Bacillus anthracis should not be considered a select agent 
because the strain is attenuated and used for quality control testing 
in Laboratory Response Network (LRN) laboratories. The commenter argued 
that changing the status of the Pasteur strain would alleviate the 
burden of recordkeeping for quality control and proficiency testing 
activities.
    We made no changes based on this comment. It should be noted that 
we excluded Bacillus anthracis Sterne strain in 2003 because the 
attenuated strain was determined to not pose a severe threat to public 
health and safety, animal health, or animal products. We have not 
excluded the plasmid-negative Pasteur variant in order to prevent the 
combination of plasmids from Sterne and Pasteur-types of strains to 
create a wild type phenotype.
Proposed Retention of Brucella abortus, Brucella melitensis, and 
Brucella suis
    Commenters to the July 21, 2010 ANPRM recommended that Brucella 
abortus, Brucella melitensis, and Brucella suis be removed from the 
Overlap list of select agents and toxins for the following reasons:
     The benefits of removal far exceed any risk mitigated by 
continuing the listing. In the years since the organism was first 
listed, research and development has been greatly diminished.
     As currently regulated, existing BSL-3 facilities do not 
have the capacity to conduct brucellosis research with sufficient 
numbers of animals to generate statistically valid research results, 
and it is too expensive to construct and maintain enough high capacity 
BSL-3 facilities to conduct the necessary research. The commenter 
contended that any risk currently mitigated by the listing is fully 
manageable without such listing.
     Brucella abortus and Brucella suis should be removed 
because the organisms are adversely affected by environmental 
conditions and can be diagnosed and controlled in animals and readily 
treated in humans. The classification of these bacteria as select 
agents has hampered research that could result in vaccines that would 
protect susceptible animal populations. Although brucellosis will 
remain a disease of agricultural significance, Brucella abortus and 
Brucella suis are not ideal biological weapons. The commenter 
suggested, however, that Brucella melitensis remain on the list because 
it is a foreign animal disease and the most infectious of all the 
species.
     Brucella species should have their listed status 
reconsidered because human infection is rarely fatal, acute brucellosis 
can be readily treated with available antibiotics, human-to-human 
transmission is extremely rare, and wildlife carriers in the United 
States often come into contact with humans without significant 
transmission.
     Naturally occurring substances such as Brucella should be 
removed because infections regularly occur from natural exposures.
     The primary mode of transmission for Brucella abortus is 
through contact with contaminated fluids/tissues, its pathogenicity is 
moderate, and infections are routinely treated with antibiotics that do 
an effective job. The commenter recommended removal of Brucella abortus 
strain 1119-3 because the strain is identical using conventional typing 
tests to strain 19 and is used as an antigen strain in diagnostic 
tests. Strain 19 and RB51 have been excluded as licensed vaccine 
products, but other research strains have not been excluded.
     Another commenter supported downgrading the risk 
assessment for vaccine strains of Brucella. The commenter was concerned 
that the only criterion the ISATTAC accepts for exclusion is licensed 
drug status, but such a high standard is disadvantageous to research on 
this pathogen.
    The FESAP and ISATTAC recommended that Brucella abortus, Brucella 
melitensis, and Brucella suis remain on the Overlap list of select 
agents and toxins. We made no changes based on these comments because 
we agreed with these expert panels that Brucella abortus, Brucella 
melitensis, and Brucella suis remain on the Overlap list of select 
agents and toxins based on the bacteria's ease of production, high 
infectivity via the aerosol route, low infectious dose, and no 
brucellosis vaccines are currently available for humans in the United 
States.
Proposed Retention of Burkholderia mallei and Burkholderia pseudomallei
    Commenters to the July 21, 2010 ANPRM contended that Burkholderia 
mallei and Burkholderia pseudomallei should not be included as select 
agents based on the following reasons:
     The agents do not rise to the same level of public health 
threat or feasibility for weaponization that the other agents on the 
list do.
     Burkholderia mallei and Burkholderia pseudomallei are 
endemic in a number of areas of the world.
     Disease resulting from Burkholderia mallei and 
Burkholderia pseudomallei is treatable with low mortality.
     It is questionable how they would be used as bioweapons.
    The FESAP and ISATTAC recommended that Burkholderia mallei and 
Burkholderia pseudomallei remain on the Overlap list of select agents 
and toxins. We made no changes based on these comments because we 
agreed with these expert panels that Burkholderia mallei and 
Burkholderia pseudomallei should remain on the Overlap list of select 
agents and toxins based on our scientific determination that the 
bacteria

[[Page 61212]]

can be produced in large quantity; transmitted via aerosol; and 
Burkholderia pseudomallei is highly stable in the environment. The 
mortality rate for untreated cases of both melioidosis and glanders is 
high, and given the rarity of these diseases in the United States, 
experience in their diagnosis and treatment is limited.
Proposed Reorganization of Venezuelan Equine Encephalitis Virus (VEEV)
    Commenters to the July 21, 2010 ANPRM contended that VEEV subtypes 
ID and IE should not be included as select agents based on the 
following reasons:
     Inclusion of VEEV subtypes as select agents should be 
based solely on their ability to cause an epidemic or epizootic 
following a bioterrorism event. This would require inclusion of only 
varieties 1AB and 1C VEEV which have been shown to have epidemic/
epizootic potential.
     The reasons for excluding 1D and 1E VEEVs from the select 
agent list are: (1) No subtype 1D or 1E VEEV have ever caused large 
equine epizootics; (2) Inclusion of 1D viruses because they might be 
precursors to 1C viruses is not sufficient for making 1D viruses select 
agents. Essentially all of this evidence is laboratory based. The 
possibility of a 1D virus mutating to a 1C virus following a 
bioterrorism event is unlikely because 1D viruses are unlikely to 
establish epidemic or epizootic transmission cycles in the US. Natural 
transmission cycles would likely be needed for any evolution from 1D to 
1C to occur in nature; (3) Emergency vaccination of equines with 
currently approved equine vaccines or humans with IND vaccines (e.g. 
TC-83) would interdict or greatly dampen a 1D or a 1E epizootic, based 
on antigenic cross-reactivities of subtype 1 viruses; and (4) The 
currently available humanized or human anti-VEEV monoclonal antibodies 
that could be produced for emergency use would also have prophylactic, 
and possibly therapeutic efficacy for all VEEV subtype 1 infections 
with which they cross react (includes 1D and 1E viruses).
    The FESAP and ISATTAC recommended removal of certain subtypes of 
Venezuelan equine encephalitis virus from the Overlap list of select 
agents and toxins. Since we agreed with commenters and expert panels 
recommendations, we are proposing to clarify that only VEEV subtypes 
IAB and IC should remain on the Overlap list of select agents and 
toxins because these subtypes contain the only recognized strains of 
Venezuelan equine encephalitis that have demonstrated the ability to 
cause epidemics or epizootics. The remaining subtypes, ID and IE, are 
strains prevalent among the existing animal populations and do not 
represent the same type of risk. Other viruses within the Venezuelan 
equine encephalitis complex (subtypes IF and II through IV) are 
separate viruses and are not included in the HHS and USDA overlap list 
of select agents and toxins.

C. Tiering

    E.O. 13546 specifies that a subset of the Select Agent List be 
categorized as ``Tier 1'' because these agents and toxins present the 
greatest risk of deliberate misuse with the most significant potential 
for mass casualties or devastating effects to the economy, critical 
infrastructure, or public confidence. All but one of the commenters to 
the July 21, 2010 ANPRM who addressed the idea of a tiering system 
based on the relative bioterrorism risk of each agent or toxin favored 
the use of tiers. Several commenters mentioned specific criteria for 
tiering. A few commenters expressed the concern that tiering could 
create confusion, especially for facilities with multiple Biological 
Select Agents and Toxins (BSAT) and had concerns about additional 
requirements that would be placed on some laboratories. Some commenters 
identified specific Tier 1 candidates from the BSAT listed in 42 CFR 
73.3 and Sec.  73.4. Most of these commenters included Variola major 
virus and Variola minor virus, as well as Reconstructed 1918 Influenza 
virus, Ebola viruses, and Marburg virus in their Tier 1 list. Two 
commenters also suggested Bacillus anthracis and Lassa fever virus. 
Other commenters suggested Francisella tularensis, South America 
hemorrhagic fever viruses, Brucella species, Coxiella burnettii, 
Botulinum neurotoxin, and Ricin as candidates for Tier 1.
    Based on E.O. 13546, a FESAP recommendation and our agreement with 
the comments received, we are proposing to amend the select agent 
regulations to establish a number of select agents and toxins as Tier 1 
select agents and toxins within the lists of HHS and Overlap select 
agents and toxins. All select agents and toxins were scored against 20 
criteria by over 60 Subject Matter Experts representing the Federal 
life sciences, public health, law enforcement, security, and 
intelligence communities, which included:
     The relative ease with which a particular select agent or 
toxin might be disseminated or transmitted from one human to another or 
into the environment where it could produce a deleterious effect upon 
human health;
     The potential for a high mortality rate;
     The potential for a major human health impact;
     Select agents or toxins whose misuse might result in 
public panic or other social or economic disruption; and
     Select agents or toxins whose use might require Federal, 
State, and/or local officials to take special action in planning for 
major human health disasters.
    The select agents that we propose will be designated as Tier 1 are 
the following:
HHS
     Ebola virus
     Francisella tularensis
     Marburg virus
     Variola major virus
     Variola minor virus
     Yersinia pestis
     Botulinum neurotoxin
     Toxin-producing strains of Clostridium botulinum
OVERLAP
     Bacillus anthracis
     Burkholderia mallei
     Burkholderia pseudomallei
    Regarding the Reconstructed 1918 Influenza virus, recent studies 
have increased our understanding of the public health risks associated 
with this agent. Current reports indicate that 60 percent of the 
population in the United States is immune to the 1918 Influenza virus 
and that antiviral treatments exist (Ref 27-28). Based on this 
information we propose to retain the Reconstructed 1918 Influenza virus 
on the HHS list of select agents and toxins, but not to include it in 
Tier 1 of this list.
    Based on the information currently available, we conclude that the 
adoption of the Tier 1 designation would not result in significant 
economic effects to the regulated community. However, we are asking for 
any additional data or comments on the potential effects of designating 
the above agents as Tier 1.

D. Responses to Other Comments and Other Proposed Changes

    With respect to the remainder of the sections outlined below, we 
are proposing the following changes based on comments received in 
response to the July 21, 2010 ANPRM and recommendations from the FESAP. 
We are proposing to update the Web address throughout the document as 
all information concerning the Federal Select Agent Program is now 
centralized on the National Select Agent Registry Web site at http://www.selectagents.gov/ gov/. We also are proposing non-substantive changes 
throughout the

[[Page 61213]]

regulations for purposes of clarity. In addition, HHS/CDC and USDA/
APHIS made the language similar to ensure consistency between the 
regulations.
Exclusions
    In order to update the regulations to accurately reflect the way in 
which we handle the listing of exclusions, we are proposing to remove 
the language stating that exclusions will be published in the Federal 
Register. This change is necessary because, while we anticipated 
publication of exclusions both in the Federal Register and on the 
Internet at the time the regulations were initially created, we have 
found that publication on the select agent Web site only has served to 
provide the most up-to-date information to the regulated community.
Security
    Commenters that responded to the July 21, 2010 ANPRM suggested 
security requirements include laboratory handling only by certified, 
trained individuals; physical security systems; restricted access; and 
security risk assessments. Commenters also identified some criteria for 
stratifying, such as making the requirements risk-based, considering 
the type of work done at the facility, acknowledging that many threats 
are from disgruntled insiders, requiring review of the stratification 
by subject matter experts, and taking into account the needs of the 
researchers at the facility.
    Based on our agreement with the comments received, and input from 
the FESAP and stakeholder groups, we are proposing more specific 
minimum security standards for Tier 1 select agents or toxins. These 
additional requirements would be added as section 73.11(e). We believe 
these proposed minimum security standards for Tier 1 select agents 
would serve to further mitigate the potential for deliberate misuse of 
these select agents and toxins that could result in mass casualties or 
devastating effects to the economy, critical infrastructure, or public 
confidence.
    These proposed changes are based on established security industry 
standards with respect to securing high risk material and developed in 
accordance with the experience and expertise of the Federal Select 
Agent Program and in consultation with DOD, FBI, and DHS security 
experts. They are necessary in order to further ensure the safety and 
security of those select agents and toxins that are proposed to be 
deemed Tier 1 agents. The requirements for working with all other 
select agents and toxins would remain unchanged with the exception of 
certain miscellaneous changes that are detailed below.
Security of Variola Major Virus and Variola Minor Virus
    In recognition of the special public health risks associated with 
Variola major virus and Variola minor virus, we are also proposing to 
require additional physical security measures over and above those 
proposed for Tier 1. These additional requirements would be added as 
section 73.11(e)(5) (Security). We believe this change is necessary 
because Variola major virus and Variola minor virus were determined to 
pose a significantly higher public health risk than the other agents 
and toxins that were proposed for the Tier 1 select agents and toxins 
list. We also believe that it would not be appropriate to require that 
the special security procedures appropriate for Variola major virus and 
Variola minor virus be made applicable to other agents or toxins on a 
Tier 1 list.
Select Agent Inventory
    Many commenters to the July 21, 2010 ANPRM pointed out that the 
requirement to account for individual vials of each pathogen is 
inappropriate for replicating biological agents. Commenters stated that 
this is a costly and burdensome responsibility for laboratories and 
their staff and that this requirement should be abolished except for 
Tier 1 agents.
    We are not proposing any changes to the select agent regulations 
based on these comments. Currently, the select agent regulations state 
that an accurate, current inventory for each select agent (including 
viral genetic elements, recombinant nucleic acids, and recombinant 
organisms) held in long-term storage (placement in a system designed to 
ensure viability for future use, such as in a freezer or lyophilized 
materials) must be maintained. The requirement to account for 
individual vials of each pathogen in long term storage is necessary to 
ensure the biosecurity of select agents and toxins. Further guidance on 
this requirement can be found at http://www.selectagents.gov.
Definitions
    In order to improve the clarity of the HHS Select Agent 
Regulations, we are proposing to add the following definitions to 42 
CFR 73.1, to clarify the terms related to the identification of a 
Restricted person: Adjudicated as a mental defective, Alien, Crime 
punishable by imprisonment for a term exceeding 1 year, Committed to 
any mental institution, Controlled substance, Indictment, Information 
security; Lawfully admitted for permanent residence, Mental 
institution, and Unlawful user of any controlled substance. We believe 
that these definitions will assist Responsible Officials as well as 
those seeking approval to access select agents and toxins to better 
understand what status or activities, past or present, might prohibit 
such access.
    Although these terms were undefined in the Bioterrorism Response 
Act, it is evident that Congress modeled many of them after the 
disqualifiers that are used by the Bureau of Alcohol, Tobacco, 
Firearms, and Explosives (ATF) when enforcing the Gun Control Act of 
1968. Because the purpose of the Select Agent Program differs from 
ATF's enforcement actions under the Gun Control Act, we do not believe 
that these terms must be defined exactly the same. The Gun Control Act 
regulates access to firearms, while the Bioterrorism Response Act 
regulates access to biological agents and toxins that the government 
has recognized as having the potential to be used as weapons of mass 
destruction by the wrong hands.
    Nevertheless, we looked at the statutory and regulatory definitions 
of these terms under the Gun Control Act when drafting our definitions. 
With the exception of the term ``crime punishable by imprisonment for a 
term exceeding 1 year,'' we decided to adopt the applicable definitions 
used by ATF.
    We are proposing to define a ``crime punishable by imprisonment for 
a term exceeding 1 year'' as ``any Federal, State, or foreign offense 
for which the maximum penalty, whether or not imposed, is capital 
punishment or imprisonment in excess of 1 year. What constitutes a 
conviction of such a crime shall be determined in accordance with the 
law of the jurisdiction in which the proceedings were held. Any 
conviction that has been set aside or nullified as a matter of law or 
for which a person has been pardoned shall not be considered a 
conviction for purposes of this part.'' Contrary to definition of this 
term used under the Gun Control Act, we have decided that foreign 
offenses should be considered a disqualifier. In doing so we are aware 
of the Supreme Court's decision in Small v. United States, 544 U.S. 385 
(2005) in which the court, interpreting the provisions of 18 U.S.C. 
922(g)(1), held that phrase ``convicted in any court'' refers only to 
U.S. courts, not to foreign courts. In its opinion interpreting the Gun 
Control Act, the court stated that ``the statute itself and its history 
offer only congressional silence'' as to whether Congress considered 
whether the statutory

[[Page 61214]]

language included foreign convictions. In the case of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 
(Bioterrorism and Response Act), we believe Congress spoke clearly 
about their desire to limit or deny access to select agents and toxins 
for those who have committed serious crimes regardless of where 
committed.
    We believe that in light of the threat of bioterrorism attacks, 
Congress would not want to exclude an individual convicted of a U.S. 
offense from having access to BSAT, but still allow access to an 
individual convicted in a foreign court of a similar offense.
    As a part of the safeguard and security section of the Bioterrorism 
Response Act, Congress not only put select agents and toxins off limits 
to a ``restricted person,'' as that term is defined by 18 U.S.C. 175b, 
but to those who are ``reasonably suspected by any Federal law 
enforcement or intelligence agency of'' (1) committing a ``Federal 
crime of terrorism'' transcending national boundaries (18 U.S.C. 
2332b), (2) the knowing involvement with an organization that engages 
in domestic or international terrorism or with any other organization 
that engages in international crimes of violence; or (3) being an agent 
of a foreign power. We believe it would be an inconsistent reading of 
statutory authority to allow the Secretary to limit or deny access to 
select agents and toxins to someone identified by the Attorney General 
as being reasonably suspected of committing a Federal crime of 
terrorism transcending national boundaries but to be powerless in cases 
where a person had actually been convicted of a serious crime in a 
foreign country. We also believe that the instances of regulation can 
be distinguished in that with regard to the Gun Control Act of 1968, 
the government is regulating access to guns while with respect to the 
Bioterrorism Response Act, the government is regulating access to 
biological agents and toxins that the government has recognized as 
having the potential to be used in the wrong hands as weapons of mass 
destruction.
    We specifically request comments on the use of a foreign conviction 
as a predicate for denying access to select agents and toxins. We 
recognize that there can be significant differences between foreign 
convictions and domestic convictions. For example, foreign legal 
systems may not provide the same due process safeguards afforded to 
citizens of the United States, including impartial tribunals and jury 
trials. Additionally, foreign countries may punish conduct that is 
permitted under domestic law or may require more severe penalties than 
under domestic law. We note that in the past, courts have applied the 
criteria set forth in Section 482 of the Restatement (third) of Foreign 
Relations Law of the United States (1986) in determining whether a 
foreign judgment should be recognized in the United States. That 
Section provides that a court in the United States may not recognize a 
judgment of the court of a foreign state if the judgment was rendered 
under a judicial system that does not provide impartial tribunals or 
procedures compatible with due process of law or the court that 
rendered the judgment did not have jurisdiction over the defendant in 
accordance with the law of the rendering state. It further provides 
that a court in the United States need not recognize a judgment of the 
court of a foreign state if the court that rendered the judgment did 
not have jurisdiction of the subject matter of the action, the 
defendant did not receive notice of the proceedings in sufficient time 
to enable him to defend, the judgment was obtained by fraud, the cause 
of action on which the judgment was based, or the judgment itself, is 
repugnant to the public policy of the United States or of the State 
where recognition is sought, the judgment conflicts with another final 
judgment that is entitled to recognition, or the proceeding in the 
foreign court was contrary to an agreement between the parties to 
submit the controversy on which the judgment is based to another forum. 
We are seeking comment on whether these criteria should be applied in 
considering whether access to select agents and toxins should be denied 
based on a foreign conviction or whether other criteria or factors 
would be appropriate to consider.
    Also, contrary to the definition used by ATF, we are proposing that 
a state offense classified by the laws of that state as a misdemeanor, 
but which has a term of imprisonment exceeding one year, should be 
considered a disqualifier--even though an individual convicted of the 
same offense would not be disqualified under the Gun Control Act. 
Finally, we are proposing to permit access to BSAT to individuals who 
have been convicted of a disqualifying offense if their convictions 
have been set aside or nullified as a matter of law or they have been 
pardoned. Although such language was not specifically included in the 
Bioterrorism Response Act, we believe that we should take into account 
certain post-conviction actions when determining whether we should deny 
an individual access to BSAT.
    We are proposing to add a definition for Occupational exposure 
based on the definition used in the Occupational Safety and Health 
Administration (OSHA) regulations found in 29 CFR 1910.1030. In 
addition, we are proposing to add the definitions for Recombinant and 
Synthetic Nucleic Acids to clarify the existing regulations, as the 
term ``recombinant nucleic acids'' is employed but not defined, and 
synthetic nucleic acids are not currently addressed in the HHS Select 
Agent Regulations.
Recombinant/Synthetic Nucleic Acids
    In addition to adding the proposed definition for Recombinant and 
Synthetic Nucleic Acids, we are also proposing to add the phrase ``and/
or synthetic'' after the word ``Recombinant'' throughout 73.3 (c) and 
73.4 (c). Current regulations regarding recombinant nucleic acids and 
recombinant organisms focus solely on the use of recombinant technology 
in the generation of these genetic elements. Since synthetic DNA 
technology may also be used to generate such genetic elements, we are 
proposing to expand the category of genetic elements to include 
recombinant and/or synthetic DNA.
Toxins
    Sections in Sec. Sec.  73.3 and 73.4 of 42 CFR contain provisions 
for toxins regulated by HHS under part 73. In 42 CFR 73.3(e) and 
73.4(e), we are proposing to clarify that the ``inactive form of a 
select toxin'' may be excluded from regulation since the current term, 
``attenuated strain of toxin'' is scientifically inaccurate. 
``Attenuated'' is a term that is applied to living organisms and toxins 
are not living organisms. Since ``Inactive form of a select toxin'' is 
a more accurate term, we are proposing to amend the regulations to 
include the correct terminology.
    Section 42 CFR 73.3(d)(3) specifies the permissible select toxin 
amounts under the control of a principal investigator, treating 
physician or veterinarian, or commercial manufacturer or distributor 
that are excluded from the requirements of the select agent 
regulations. We are proposing to require that the person transferring 
toxins in amounts which would otherwise be excluded from the provisions 
of the select agent regulations would be excluded only if the 
transferor: (1) Can show that the transferor used due diligence (i.e., 
reasonably justified by a prophylactic, protective, bona fide research, 
or other peaceful purpose) to assure that the recipient has a 
legitimate need to handle

[[Page 61215]]

or use such toxins; and (2) reports to CDC if they detect a known or 
suspected violation of Federal law or become aware of suspicious 
activity related to the toxin. The HHS Secretary would also retain the 
authority to, without prior notification, inspect and copy or request 
the submission of the due diligence documentation. It should be noted 
that this proposed requirement would not apply to toxins exempted under 
Section 42 CFR 73.5(c).
    We are proposing to add 42 CFR 73.3(d)(4) which would state, 
``Notwithstanding section (i) above, an animal inoculated with or 
exposed to an HHS select toxin.'' The current regulations consider that 
an animal injected with or exposed to (e.g., by inhalation, dermal 
absorption, or ingestion) a select toxin is a ``select toxin'' itself 
and would need to be housed in a registered space. This change would 
allow animals injected with or exposed to a select toxin to not be 
considered a ``select toxin.'' Therefore, the animals would not need to 
be housed in a registered space. This change will eliminate an 
unnecessary burden on a registered entity because recovering the toxin 
from within an animal subject is highly difficult and such removal is 
unlikely to produce a reasonable yield of recovery. In addition, there 
is uncertainty as to whether the toxin would remain active when 
recovered from the animal. For these reasons, it is highly unlikely 
that once introduced into an animal, sufficient toxin would be able to 
be recovered to pose a significant hazard to public health.
Exemptions
    The regulations found in 42 CFR 73.5 and 73.6 requires identified 
select agents listed on the CDC's Category A Bioterrorism Agents list 
(i.e., agents that pose a risk to national security because they can be 
easily disseminated or transmitted from person to person; result in 
high mortality rates and have the potential for major public health 
impact; might cause public panic and social disruption; and require 
special action for public health preparedness) contained in a specimen 
presented for diagnosis or verification to be immediately reported to 
APHIS or CDC by telephone, facsimile, or e-mail.
    We are proposing to amend this immediate notification to only those 
select agents and toxins identified as Tier 1 agents because these 
agents and toxins present the greatest risk of deliberate misuse with 
the most significant potential for mass casualties.
Responsible Official
    The regulations found in 42 CFR 73.9 set out requirements for 
entities requesting to work with select agents and toxins to designate 
a Responsible Official, who ensures that the entity meets the 
requirements of the regulations.
    We are proposing to add a specific requirement that all Responsible 
Officials possess the appropriate training or expertise to execute 
their required duties. We are also proposing to add a requirement that 
the Responsible Official's regular place of employment or principal 
duty station must be collocated in close proximity with the physical 
location of the registered entity entered in section 1A of APHIS/CDC 
Form 1 (Application for Registration for Possession, Use, and Transfer 
of Select Agents and Toxins OMB Control No. 0579-0213, OMB Control No. 
0920-0576, Expiration Date 12/31/2011). We believe that the Responsible 
Official should have a physical (and not merely a telephonic or audio/
visual) presence at the entity to ensure that the entity is in 
compliance with the select agent regulations and be able to quickly 
respond to on-site incidents involving select agents and toxins.
    We are also proposing to clarify the role of Alternate Responsible 
Official in order to definitively establish that the Alternate 
Responsible Official must have the knowledge and authority to act for 
the Responsible Official in his/her absence.
Access to Select Agents and Toxins
    We are proposing to amend the regulations in 42 CFR 73.10. These 
regulations establish parameters for restricting access to select 
agents and toxins and the process by which individuals may be approved 
by HHS/CDC or USDA/APHIS for access to select agents and toxins after 
the completion of a security risk assessment by the Attorney General. 
Specifically, we are proposing to add new provisions by which 
individuals may have access to select agents and toxins at entities 
other than the individual's ``home'' entity.
    We are also proposing to decrease the maximum length of time in 
which a security risk assessment will be valid from five years to three 
years in order to more expeditiously identify individuals who may have 
fallen into one of the prohibited or restricted categories.
Security Plan
    The regulations in 42 CFR 73.11 establish the requirements for 
developing and implementing a security plan sufficient to safeguard 
select agents or toxins against unauthorized access, theft, loss, or 
release. The regulations currently require that the security plan must 
be submitted by all regulated entities upon request. We are proposing 
to amend Sec.  73.11 to require that the security plan be submitted for 
initial registration and renewals of registration.
    Since we believe animals and plants exposed to or infected with a 
select agent should be handled as a select agent and safeguarded in the 
same manner as a select agent, we are proposing to require that the 
security plan include provisions to address safeguarding of animals or 
plants intentionally or exposed to or infected with select agents 
against unauthorized access, theft, loss or release. We are not 
requiring this plan to address procedures concerning animals exposed to 
toxins because, as discussed above, it is highly unlikely that once 
introduced into an animal, sufficient toxin can be recovered to pose a 
significant hazard to public health and safety. We are additionally 
proposing to add a requirement that the security plan include 
procedures for the Responsible Official to immediately notify the 
Federal Bureau of Investigation (FBI) of suspicious activity that may 
be criminal in nature and related to the entity, its personnel, or its 
select agents or toxins. We believe that any criminal activity of this 
kind should be immediately and directly reported to the FBI so they can 
initiate an investigation or other appropriate response.
    We are proposing that the security plans of entities with select 
agents and toxins must include provisions for information security. 
These information security provisions would include network 
connectivity monitoring, restriction of user permissions so that only 
mission-specific files and applications may be accessed, measures to 
prevent network infiltration by malicious code, configuration 
management including regular patching and system and software updates, 
and backup security measures in the event that access control systems 
and/or surveillance devices are rendered inoperable. We believe that 
information security enhancements are important because the security of 
records or information systems that could allow an individual to gain 
access to the select agents or toxins should be safeguarded to prevent 
unauthorized access, theft, loss, or release of these materials.
    We are proposing to codify current practices for shipping, 
receiving, and storage of select agents and toxins to ensure that the 
entity has documented

[[Page 61216]]

processes for securing and monitoring the shipment, receipt, and 
storage of these items. These changes would serve to decrease the 
chance that such materials would be made available to an unauthorized 
individual or an individual without a legitimate use for the material.
    We are also proposing to remove the reference in 73.11(e), 
``Laboratory Security and Emergency Response Guidance for Laboratories 
Working with Select Agents'' in Morbidity and Mortality Weekly Report 
(December 6, 2002) because we posted a security information guidance 
document in March 2007 that supersedes this reference.
Biosafety Plan
    We are proposing to amend the regulations in 42 CFR 73.12 to 
require that a regulated entity's biosafety plan address procedures 
concerning animals or plants accidentally or intentionally exposed to 
or infected with a select agent. We are not requiring this plan to 
address procedures concerning animals exposed to toxins. As stated 
previously, this is because it is highly unlikely that once introduced 
into an animal, sufficient toxin can be recovered to pose a significant 
hazard to public health, agriculture or agriculture products.
    We are also proposing that the biosafety plan must include 
provisions for the implementation of an occupational health program for 
individuals with access to Tier 1 select agents and toxins. We believe 
aspects of an individual's health may be relevant to their suitability 
to access biological select agents and toxins; identification of 
potential health problems and review of medication or treatment that 
may affect security and safety is paramount; and, occupational health 
programs should inform scientists of the types of medications and 
treatments that might have a potential deleterious effect on working 
safely and securely with select agents and toxins.
Restricted Experiments
    The regulations in 42 CFR 73.13 concern restricted experiments that 
may not be performed unless approved by the HHS Secretary. We are 
proposing to add language in order to expand the current ``restricted 
experiment'' approval requirement to include all experiments involving 
the creation of drug resistant select agents that are not known to 
acquire the resistance naturally, if such acquisition could compromise 
the use of the drug to control disease agents in humans, veterinary 
medicine, or agriculture and not just those involving recombinant DNA. 
The regulations in 42 CFR 73.13 concern restricted experiments which 
may not be performed unless approved by the HHS Secretary. Furthermore, 
we are proposing to state that, in addition to the existing prohibition 
on conducting restricted experiments without express approval, entities 
may not possess the products (i.e., creation of drug resistant select 
agents that are not known to acquire the resistance naturally, if such 
acquisition could compromise the use of the drug to control disease 
agents in humans, veterinary medicine, or agriculture, or recombinant 
and or synthetic DNA containing genes for the biosynthesis of select 
toxins lethal for vertebrates at an LD[50] kg body weight 
resulting from restricted experiments) resulting from restricted 
experiments without the express approval of the HHS Secretary. We are 
also proposing to remove recombinant technology as the only determining 
factor for a restricted experiment. Current regulations regarding 
restricted experiments focus solely on the use of recombinant 
technology in the generation of drug resistant select agents or 
biosynthesis of toxins lethal to vertebrates. Since synthetic DNA 
technology or selection in sublethal exposures may also be used to 
generate such products, we are proposing to expand the category of 
restricted experiments to include passive selection, recombinant and/or 
synthetic DNA.
Incident Response
    The regulations in 42 CFR 73.14 contain requirements for 
development of incident response plans. We are proposing to specify 
that each entity's incident response plan be based upon a site-specific 
risk assessment. We believe this change would further ensure the 
specificity and quality of the plan. In addition, we are proposing that 
the incident response procedures contain specific provisions concerning 
animals or plants accidentally or intentionally exposed to or infected 
with a select agent. We are not requiring this plan to address 
procedures concerning animals exposed to toxins. As stated previously, 
this is because it is highly unlikely that once introduced into an 
animal, sufficient toxin can be recovered to pose a significant hazard 
to public health, agriculture or agriculture products.
Training
    We are proposing to amend the regulations in 42 CFR 73.15 that 
contain provisions of mandatory training for staff and visitors who 
work in or visit areas where select agents or toxins are handled or 
stored to provide security awareness and incident response training. We 
believe these additional training initiatives are needed to ensure that 
(1) personnel will be better trained to safeguard select agents and 
toxins from thefts, losses, intentional releases, or unauthorized 
access and (2) personnel will be better trained to ensure that select 
agents and toxins are safeguarded during exigent circumstances that 
include natural and man-made disasters. We are also proposing to 
clarify the language regarding the level of training that staff and 
visitors would be required to receive in order to establish that 
training for escorted personnel based on the risk associated with 
accessing areas where select agents and toxins are used and/or stored. 
Currently, refresher training is required to be provided once a year. 
We are proposing to require that such training also be provided if a 
registered entity's security, incident response, or biosafety plans are 
substantively altered. Finally, we are proposing to specify that the 
Responsible Official ensure maintenance of training records. Currently, 
there is no particular person designated as the entity's required 
record keeper, only that a training record must be kept.
Transfers
    The transportation in commerce of hazardous materials, including 
select agents and toxins, is governed by the United States Department 
of Transportation's Hazardous Material Regulations found in Title 49 of 
the Code of Federal Regulations, parts 100-185. The regulations in 42 
CFR 73.16 do not impose requirements on the transportation in commerce 
of select agents or toxins. We are proposing to clarify when 
``transportation in commerce'' begins and ends to better allow 
registered individuals and entities to adequately address those 
situations when a select agent or toxin is (1) ready to be packaged for 
transportation, (2) packaged for shipment, or (3) received and handled 
by a person with approval to access select agents and toxins. In 
addition, we are proposing language to codify policies and practices 
into a standard for shipping, receiving, and storage of select agents 
and toxins to ensure that the entity has documented processes for 
securing and monitoring the shipment, receipt, and storage of select 
agents and toxins that make it extremely unlikely that such materials 
would be made available to an unauthorized individual or an individual 
without a legitimate use for the material. We note the concerns 
identified in two HHS Office of Inspector General (OIG) audits 
regarding

[[Page 61217]]

vulnerabilities that may occur during the shipment of select agents and 
toxins. HHS/CDC reviewed how entities ship select agents and toxins and 
evaluated ways to improve this process to ensure they are not only 
safeguarded against unauthorized access, but also against theft, loss, 
or release. We believe that the proposed amendments will help address 
OIG's concerns.
Records
    The regulations in 42 CFR 73.17 address recordkeeping requirements 
for regulated entities as those records that relate to select agents 
and toxins. We are proposing to clarify the current language that an 
accurate, current inventory needs to be maintained for each select 
agent that the entity possesses including synthetic select agent 
organisms and any animals or plants intentionally or unintentionally 
exposed to or infected with a select agent (including number and 
species, location and appropriate disposition). We believe this 
clarification is needed to ensure that accurate, current records are 
maintained for all select agents that the entity possesses. We are 
currently soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. Please send written comments to Daniel 
Holcomb, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-
D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Please state 
that your comments refer to Possession, Use, and Transfer of Select 
Agents and Toxins (OMB Control No. 0920-0576).
    As previously stated, we are not proposing to require regulated 
entities to keep records regarding animals exposed to toxins because it 
is highly unlikely that once introduced into an animal, sufficient 
toxin can be recovered to pose a significant hazard to public health, 
agriculture or agriculture products.
Administrative Review
    We are proposing to amend the regulations in 42 CFR 73.20 that 
addresses the administrative review of an individual or entity's 
denial, revocation, or suspension of registration and access approval. 
Specifically, we are proposing to modify the current regulations in 
order to allow individuals more time to gather the necessary components 
of their appeal following the denial, limitation, or revocation of 
access approval. Currently, this process must be initiated in 30 
calendar days. We are proposing to extend the deadline to 180 calendar 
days. We believe this change would provide individuals with sufficient 
time to gather all documents necessary to support an appeal. Finally, 
we are proposing to remove the provision ``Where the denial, 
revocation, or suspension of an individual's access approval is based 
upon identification by the Attorney General, the request for review 
will be forwarded to the Attorney General'' to provide clarification 
that the decision regarding the appeal is determined by the HHS 
Secretary.
Guidance Documents
    We are specifically requesting comments from the regulated 
community and any other interested persons on the development of one or 
more guidance documents that would serve to provide assistance in the 
interpretation of the select agent regulations.
    The areas where guidance documents may be developed in relation to 
the select agent regulations include, but are not limited to:
    1. Aspects of the required security plan. These may include, but 
are not limited to:
     Standards for information security;
     Development of suitability or personnel reliability 
practices, including pre-access and ongoing assessment processes of 
persons who will have access to Tier 1 select agents or toxins;
     Procedures for the method by which an entity's Responsible 
Official will coordinate his or her efforts with the entity's safety 
and security professionals to ensure security of Tier 1 select agents 
or toxins and have access to relevant information from all 
professionals dealing with biological select agents and toxins safety 
and security;
     Development of a self- and peer-reporting program to track 
incidents or conditions that could affect an individual's ability to 
safely access or work with Tier 1 select agents and toxins; and
     Layered physical security protection of assets for 
entities housing Tier 1 select agents and toxins.
    2. Aspects of the required biosafety plan, e.g., components of an 
occupational health program for individuals with access to Tier 1 
select agents and toxins; and
    3. Aspects of the required training, e.g., best practices for 
development of a security awareness training program.
    We welcome public comment on the use of Web sites, articles, or 
other sources that may be used to develop such documents, in addition 
to suggestions as to what elements should be included as useful 
examples. These documents would serve as a resource to the regulated 
community as a whole.

III. Required Regulatory Analyses

a. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    Under E.O. 12866 HHS must determine whether a regulatory action is 
``significant.'' A ``significant regulatory action'' under E.O. 12866 
is defined as (1) an action that is likely to result in a rule that may 
have an annual effect on the economy of $100 million or more, or 
adversely and materially affects a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or state, 
local or tribal governments or communities (or an economically 
significant action); (2) creates a serious inconsistency or otherwise 
interferes with an action taken or planned by another agency; (3) 
materially alters the budgetary impact of entitlements, grants, user 
fees or loan programs or the rights and obligations of recipients; or 
(4) raises novel legal or policy issues. Because this rulemaking 
proposes changes to how a subset of select agents and toxins are 
protected, this rule is has been determined to be ``significant'' under 
E.O. 12866 and, therefore, has been reviewed by the Office of 
Management and Budget (OMB).
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by E.O. 12866, 
and an initial regulatory flexibility analysis (See III.b.) that 
examines the potential economic effects of this proposed rule on small 
entities, as required by the Regulatory Flexibility Act. The economic 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Federal Select Agent Program Web site at: http://www.selectagents.gov/ or on the public docket at http://www.regulations.gov.

[[Page 61218]]

Summary of the Regulatory Impact Analysis
    Certain pathogens or biological toxins that are released 
intentionally or accidentally can result in disease, wide-ranging and 
devastating impacts on the economy, disruption to society, diminished 
confidence in public and private institutions, and large-scale loss of 
life. People or livestock can be exposed to these agents from 
inhalation, through the skin, or by the ingestion of contaminated food, 
feed, or water. Similarly, crops can be exposed to biological pathogens 
in several ways--at the seed stage, in the field, or after harvest.
    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188) (the Act) provides for the 
regulation of certain biological agents and toxins that have the 
potential to pose a severe threat to both human and animal health, to 
plant health, or to animal and plant products. APHIS and CDC have the 
primary responsibility for implementing the provisions of the Act 
within USDA and HHS, respectively. Within APHIS, Veterinary Services 
(VS) select agents and toxins are those that have been determined to 
have the potential to pose a severe threat to animal health or animal 
products, and Plant Protection and Quarantine (PPQ) select agents and 
toxins are those that have been determined to have the potential to 
pose a severe threat to plant health or plant products. HHS select 
agents and toxins are those that have been determined to have the 
potential to pose a severe threat to human health. APHIS and CDC 
coordinate regulatory activities for overlap select agents and toxins 
that have been determined to pose a severe threat to human and to 
animal health or animal products.
    Sections 201 and 212(a)(2) of the Act requires a biennial review 
and republication of the select agent and toxin list, with revisions as 
appropriate in accordance with this law. See 42 U.S.C. 262a(a)(2) and 7 
U.S.C. 8401(a)(2), respectively. This rule would implement the 
recommendations of the third biennial review of the list. Furthermore, 
revision of these regulations would incorporate the recommendations 
developed as a result of E.O. 13546, ``Optimizing the Security of 
Biological Select Agents and Toxins in the United States,'' which 
requires that the HHS and USDA Secretaries publish proposed regulations 
to establish risk-based tiering of the select agent list, and revise 
the regulations, rules, and guidance to accommodate a tiered select 
agent list no later than October 2011.
    In addition, we are proposing several amendments to the 
regulations, including the addition of definitions and clarification of 
language concerning security, training, biosafety/biocontainment, and 
incident response. These changes would increase the applicability and 
effectiveness of the select agent regulations and provide for enhanced 
program oversight. This rule would update the USDA, HHS, and overlap 
select agent and toxin lists. The regulation of select agents and 
toxins is intended to prevent their misuse and thereby reduce the 
potential for those pathogens to harm humans, animals, animal products, 
plants or plant products in the United States. Should any select agent 
or toxin be intentionally or unintentionally released into the 
environment, the consequences would be significant. Consequences could 
include disruption of markets, difficulties in sustaining an adequate 
food and fiber supply, and the potential spread of disease infestations 
over large areas. The entities most likely to be affected by this rule 
would be those laboratories and other institutions conducting research 
and related activities that involve the use of the newly categorized 
Tier 1 select agents and toxins. The impact of the changes to the 
regulations is expected to be minimal. Based on information obtained 
through site-specific inspections, we believe that very few entities 
would incur significant costs for compliance. Many of the proposed 
changes to the regulations would impose an added time cost to measures 
already required for compliance, with respect to security, 
biocontainment/biosafety, and incident response plans, information 
security, and ongoing background checks. While the total cost of the 
proposed regulations is estimated to range between $4.9 million and 
$6.4 million, we believe many of these costs are currently incurred by 
affected entities as generally recognized practices. Costs actually 
incurred would depend upon the number of computers and facility systems 
that require the proposed enhanced security. The expected benefits of 
strengthened safeguards against the unintentional or deliberate release 
of a select agent or toxin exceed the estimated costs of the proposed 
measures. Based on the information we have, there is no reason to 
conclude that adoption of this proposed rule would result in any 
significant economic effect on a substantial number of small entities. 
The entities are those laboratories and other institutions conducting 
research and related activities entities in possession of Tier 1 select 
agents or toxins, and, to a somewhat lesser extent, those entities 
possessing the newly added select agents and toxins. The economic 
analysis presents categories and information from the Department of 
Commerce and the Small Business Administration for those entities we 
have identified as most likely to be affected by this rule. While we 
believe affected entities are contained within these categories, we are 
seeking further information regarding how many entities fall 
specifically into each category, and are therefore, inviting comments 
on potential effects. In particular, we are interested in determining 
the number and kind of small entities that may incur benefits or costs 
from the implementation of this proposed rule.
    This proposed rule would update the APHIS, CDC, and overlap select 
agent and toxin lists. The regulation of select agents and toxins is 
intended to prevent their misuse and thereby reduce the potential for 
those pathogens to harm humans, animals, animal products, plants or 
plant products in the United States. Should any select agent or toxin 
be intentionally or unintentionally released into the environment, the 
consequences would be significant. Consequences could include 
disruption of markets, difficulties in sustaining an adequate food and 
fiber supply, and the potential spread of disease infestations over 
large areas. The entities most likely to be affected by this rule would 
be those laboratories and other institutions conducting research and 
related activities that involve the use of the newly categorized Tier 1 
select agents and toxins. The impact of the changes to the regulations 
is expected to be minimal, however. Based on information obtained 
through site-specific inspections, indications are that very few 
entities would incur significant costs for compliance. Many of the 
proposed changes to the regulations would impose an added cost of the 
time spent on documenting measures already required for compliance, 
with respect to security, biocontainment/biosafety, and incident 
response plans, information security, and ongoing background checks. 
While the total costs imposed by the proposed regulations are estimated 
to range between $5.30 million and $6.95 million, including costs to 
government, we believe many of these costs are incurred through 
observance of generally recognized industry standards. Costs actually 
incurred would depend upon the extent to which current facility

[[Page 61219]]

practices will need to be enhanced based on the proposed requirements. 
The expected benefits of strengthened safeguards against the costs 
associated with unintentional or deliberate release of select agents or 
toxins would greatly exceed the estimated costs of the proposed 
measures. The cost associated with a single outbreak have been known to 
exceed $100 million as outlined in the Regulatory Impact Analysis. 
Deliberate introduction greatly increases the probability of a select 
agent or toxin becoming established and causing wide-ranging and 
devastating impacts on an economy, loss of market access for consumer 
goods and services, disruption to society, and diminished confidence in 
public and private institutions.
    This analysis reviews expected benefits and costs of the proposed 
rule in accordance with Executive Orders 12866 and 13563. Possible 
impacts for small entities are also considered as required by the 
Regulatory Flexibility Act, which requires agencies to prepare and make 
available for public comment an initial regulatory flexibility analysis 
that describes expected impacts of a proposed rule on small businesses, 
small organizations and small governmental jurisdictions.
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.

b. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) 
requires an agency to consider the potential impact of its regulations 
on small entities, including small businesses, small governmental 
units, and small not-for-profit organizations. We certify that this 
rule will not have a significant economic impact on a substantial 
number of small entities within the meaning of the RFA. Therefore, a 
regulatory flexibility analysis as provided for under the RFA is not 
required.

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 this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket Nos. APHIS-
2009-0070 and CDC-2011-0012. Please send a copy of your comments to: 
(1) Docket Nos. APHIS-APHIS-2009-0070 and CDC-2011-0012, Regulatory 
Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road 
Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, 
USDA, room 404-W, 14th Street and Independence Avenue, SW., Washington, 
DC 20250. A comment to OMB is best assured of having its full effect if 
OMB receives it within 30 days of publication of this proposed rule.
    The Bioterrorism Preparedness Act is designed to prevent, prepare 
for and respond to bioterrorism and other public health emergencies. 
The law requires individuals possessing agents or toxins deemed a 
severe threat to human, animal, or plant health, or to animal or plant 
products, to be registered with the Secretary of Agriculture or the 
Secretary of Health and Human Services, unless they have been 
specifically exempted.
    This proposed rule entails the use of a number of separate forms 
designed to obtain critical information concerning individuals or 
entities in possession of certain agents or toxins, as well as the 
specific characteristics of the agents or toxins--including name, 
strain, and genetic information. This data is needed, in part, to allow 
APHIS and CDC to determine the biosafety level of an entity as well as 
the entity's biosecurity situation. This, in turn, helps APHIS and CDC 
ensure that appropriate safeguard, containment, and disposal 
requirements commensurate with the risk of the agent or toxin are 
present at the entity, thus preventing access to such agents and toxins 
for use in domestic or international terrorism. Facilities containing 
select agents will be required to maintain records on animals and 
plants, and revise their Biosafety/Biocontainment Plan and Incident 
Response Plan for review by APHIS and CDC upon request.
    Information to determine that individuals seeking to register have 
a lawful purpose to possess, use, or transfer agents or toxins will 
also be requested as part of the registration process. In addition, we 
will be requesting submission of their Security Plan for our review.
    APHIS and CDC are asking OMB to approve, for 3 years, the use of 
these information collections, associated with its efforts to more 
closely regulate select agents or toxins that could be used to commit 
acts of domestic or international terrorism. We are soliciting comments 
from the public (as well as affected agencies) concerning this 
information collection activity. APHIS and CDC need this outside input 
to help accomplish the following:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2.3187883 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, commercial manufacturers, non-profit institutions, 
diagnostic laboratories and other interested parties who possess, use, 
or transfer agents or toxins deemed a severe threat to human, animal or 
plant health, or to animal or plant products.
    Estimated annual number of respondents: 386.
    Estimated annual number of responses per respondent: 12.230569.
    Estimated annual number of responses: 4,721.
    Estimated total annual burden on respondents: 10,947 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)

[[Page 61220]]

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
            Section                 Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
9 CFR 121.5 and 6, 7 CFR        Report of                    161               3               1             299
 331.5, 43 CFR 73.5 and 6.       Identification
                                 of a Select
                                 Agent or Toxin.
Sec.   121.7, Sec.   331.7,     Application for                7               1               5              35
 Sec.   73.7.                    Registration.
Sec.   121.7, Sec.   331.7,     Amendment to a               380               7               1           1,955
 Sec.   73.7.                    Certificate of
                                 Registration.
Sec.   121.11, Sec.   331.11,   Security Plan...             380               1               5           1,900
 Sec.   73.11.
Sec.   121.12, Sec.   331.12,   Biosafety/                   380               1               8           3,040
 Sec.   73.12.                   Biocontainment
                                 Plan.
Sec.   121.13, Sec.   331.13,   Request                      160               1               2             320
 Sec.   73.13.                   Regarding a
                                 Restricted
                                 Experiment.
Sec.   121.14, Sec.   331.14,   Incident                     380               1               5           1,900
 Sec.   73.14.                   Response Plan.
Sec.   121.15, Sec.   331.15,   Training........             380               1               1             380
 Sec.   73.15.
Sec.   121.16, Sec.   331.16,   Request to                   290               1               2             580
 Sec.   73.16.                   Transfer Select
                                 Agents and
                                 Toxins.
Sec.   121.17, Sec.   331.17,   Records.........             295               1             0.5             148
 Sec.   73.17.
Sec.   121.19, Sec.   331.19,   Notification of              195               1               2             390
 Sec.   73.19.                   Theft, Loss, or
                                 Release.
----------------------------------------------------------------------------------------------------------------

    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

d. Executive Order 12988: Civil Justice Reform

    This proposed rule has been reviewed under E.O. 12988, Civil 
Justice Reform. If this proposed rule is adopted: (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. Executive Order 13132: Federalism

    This rule has been reviewed under E.O. 13132, Federalism. The rule 
does not impose any regulation that would preempt State, local, and 
Indian Tribe requirements, or that would have any substantial direct 
effects on the States, or on the distribution of power and 
responsibilities among the various levels of government.

f. Plain Writing Act of 2010

    Under Public Law 111-274 (October 24, 2010), executive branch 
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 has attempted to 
use plain language in promulgating the proposed rule consistent with 
the Federal Plain Writing Act guidelines.

IV. References

1. Delgado, Erickson, et al., 2008. Chapare virus, a newly 
discovered arenavirus isolated from a fatal hemorrhagic fever case 
in Bolivia. PLoS Pathogens 4:e1000047.
2. Briese T, Paweska JT, McMullan LK, Hutchison SK, Street C, 
Palacios G, Khristova ML, Weyer J, Swanepoel R, Egholm M, Nichol ST, 
Lipkin WI. Genetic detection and characterization of Lujo virus, a 
new hemorrhagic fever-associated arenavirus from southern Africa. 
PLoS 2009 May; 5(5):e1000455. Epub 2009 May 29. Available at http://www.plospathogens.org.
3. Galgiani, J.N. 1999. Coccidiomycosis: a regional disease of 
national importance. Ann Intern. Med. 130:293-298.
4. Arrigo NC, Adams AP, Weaver SC. Evolutionary patterns of eastern 
equine encephalitis virus in North versus South America suggest 
ecological differences and taxonomic revision. J Virol. 2010 Jan; 
84(2):1014-25.
5. Gres[iacute]kov[aacute] M, Kaluzov[aacute] M, 1997. Biology of 
tick-borne encephalitis virus. Acta Virol. Apr; 41(2):115-24.
6. Ecker M, Allison SL, Meixner T, Heinz FX, 1999. Sequence analysis 
and genetic classification of tick-borne encephalitis viruses from 
Europe and Asia. J Gen Virol. Jan; 80 (Pt 1):179-85.
7. Bergdoll, M. S., 1988. Monkey feeding test for staphylococcal 
enterotoxin. Methods Enzymol 165: 324-33.
8. Bergdoll, M. S., C. R. Borja, et al., 1971. Identification of 
enterotoxin E. Infect Immun 4(5): 593-5.
9. Borja, C. R. and M. S. Bergdoll, 1967. Purification and partial 
characterization of enterotoxin C produced by Staphylococcus aureus 
strain 137. Biochemistry 6(5): 1467-73.
10. Chintagumpala, M. M., J. A. Mollick, et al., 1991. 
Staphylococcal toxins bind to different sites on HLA-DR. J Immunol 
147(11): 3876-81.
11. Chu, F. S., K. Thadhani, et al., 1966. Purification and 
characterization of staphylococcal enterotoxin A. Biochemistry 
5(10): 3281-9.
12. Lina, G., G.A. Bohach, et al., 2004. Standard nomenclature for 
the superantigens expressed by Staphylococcus. J Infect Dis 189(12): 
2334-6.
13. Schantz, E.J., W.G. Roessler, et al., 1965. Purification of 
staphylococcal enterotoxin B. Biochemistry 4(6): 1011-6.
14. Wang, S., Y. Li, et al., 2008. A broad-spectrum inhibitory 
peptide against staphylococcal enterotoxin superantigen SEA, SEB and 
SEC. Immunol Lett 121(2): 167-72.
15. Munson, S.H., M.T. Tremaine, et al., 1998. Identification and 
characterization of staphylococcal enterotoxin types G and I from 
Staphylococcus aureus. Infect Immun 66(7): 3337-48.
16. H.Su, Y.C. and A.C. Wong, 1995. Identification and purification 
of a new staphylococcal enterotoxin. Appl Environ Microbiol 61(4): 
1438-43.
17. Zhang, S., J.J. Iandolo, et al., 1998.The enterotoxin D plasmid 
of Staphylococcus aureus encodes a second enterotoxin determinant 
(sej). FEMS Microbiol Lett 168(2): 227-33.
18. Orwin, P.M., J.R. Fitzgerald, et al., 2003. Characterization of 
Staphylococcus aureus enterotoxin L. Infect Immun 71(5): 2916-9.
19. Orwin, P.M., D.Y. Leung, et al., 2001. Biochemical and 
biological properties of Staphylococcal enterotoxin K. Infect Immun 
69(1): 360-6.
20. Orwin, P.M., D.Y. Leung, et al., 2002. Characterization of a 
novel staphylococcal enterotoxin-like superantigen, a member of the 
group V subfamily of pyrogenic toxins. Biochemistry 41(47): 14033-
40.
21. Jarraud, S., M.A. Peyrat, et al., 2001. Egc, a highly prevalent 
operon of enterotoxin gene, forms a putative nursery of 
superantigens in Staphylococcus aureus. J Immunol 166(1): 669-77.
22. Kuroda, M., T. Ohta, et al., 2001. Whole genome sequencing of 
meticillin-resistant Staphylococcus aureus. Lancet 357(9264): 1225-
40.
23. Omoe, K., K. Imanishi, et al., 2004. Biological properties of 
staphylococcal enterotoxin-like toxin type R. Infect Immun 72(6): 
3664-7.
24. Ono, H.K., K. Omoe, et al., 2008. Identification and 
characterization of two novel staphylococcal enterotoxins, types S 
and T. Infect Immun 76(11): 4999-5005.

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25. Letertre, C., S. Perelle, et al., 2003. Identification of a new 
putative enterotoxin SEU encoded by the egc cluster of 
Staphylococcus aureus. J Appl Microbiol 95(1): 38-43.
26. Thomas, D.Y., S. Jarraud, et al., 2006. Staphylococcal 
enterotoxin-like toxins U2 and V, two new staphylococcal 
superantigens arising from recombination within the enterotoxin gene 
cluster. Infect Immun 74(8): 4724-34.
27. Medina RA, Manicassamy B, Stertz S, Seibert CW, Hai R, Belshe 
RB, Frey SE, Basler CF, Palese P, Garc[iacute]a-Sastre A. Pandemic 
2009 H1N1 vaccine protects against 1918 Spanish influenza virus. Nat 
Commun. 2010 Jun 15;1:28. doi: 10.1038/ncomms1026.
28. Tumpey TM, Garc[iacute]a-Sastre A, Mikulasova A, Taubenberger 
JK, Swayne DE, Palese P, Basler CF. Existing antivirals are 
effective against influenza viruses with genes from the 1918 
pandemic virus. Proc Natl Acad Sci U S A. 2002 Oct 15;99(21):13849-
54. Epub 2002 Oct 4.
29. Xiao Y, Isaacs SN. Therapeutic Vaccines and Antibodies for 
Treatment of Orthopoxvirus Infections. Viruses. 2010 Oct;2(10):2381-
2403.
30. Rimoin AW, Mulembakani PM, Johnston SC, Lloyd Smith JO, Kisalu 
NK, Kinkela TL, Blumberg S, Thomassen HA, Pike BL, Fair JN, Wolfe 
ND, Shongo RL, Graham BS, Formenty P, Okitolonda E, Hensley LE, 
Meyer H, Wright LL, Muyembe JJ. Major increase in human monkeypox 
incidence 30 years after smallpox vaccination campaigns cease in the 
Democratic Republic of Congo. Proc Natl Acad Sci U S A. 2010 Sep 
14;107(37):16262-7. Epub 2010 Aug 30.
31. Reynolds MG, Carroll DS, Olson VA, Hughes C, Galley J, Likos A, 
Montgomery JM, Suu-Ire R, Kwasi MO, Jeffrey Root J, Braden Z, Abel 
J, Clemmons C, Regnery R, Karem K, Damon IK. A silent enzootic of an 
orthopoxvirus in Ghana, West Africa: evidence for multi-species 
involvement in the absence of widespread human disease. Am J Trop 
Med Hyg. 2010 Apr;82(4):746-54.
32. Di Giulio DB, Eckburg PB. Human monkeypox: an emerging zoonosis. 
Lancet Infect Dis. 2004 Jan;4(1):15-25.
33. Hutson CL, Lee KN, Abel J, Carroll DS, Montgomery JM, Olson VA, 
Li Y, Davidson W, Hughes C, Dillon M, Spurlock P, Kazmierczak JJ, 
Austin C, Miser L, Sorhage FE, Howell J, Davis JP, Reynolds MG, 
Braden Z, Karem KL, Damon IK, Regnery RL. Monkeypox zoonotic 
associations: insights from laboratory evaluation of animals 
associated with the multi-state US outbreak. Am J Trop Med Hyg. 2007 
Apr;76(4):757-68.

List of Subjects in 42 CFR Part 73

    Biologics, Incorporation by reference, Packaging and containers, 
Penalties, Reporting and recordkeeping requirements, Transportation.

    For the reasons stated in the preamble, the Centers for Disease 
Control and Prevention, United States Department of Health and Human 
Services, proposes 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. Section 73.1 is amended by adding, in alphabetical order, 
definitions of Adjudicated as a mental defective, Alien, Committed to 
any mental institution, Controlled substance, Crime punishable by 
imprisonment for a term exceeding 1 year, Indictment, Information 
security, Lawfully admitted for permanent residence, Mental 
institution, Occupational exposure, Recombinant and synthetic nucleic 
acids, Restricted person, and Unlawful user of any controlled substance 
to read as set forth below.

Sec.  73.1  Definitions.

* * * * *
    Adjudicated as a mental defective. A determination by a court, 
board, commission, or other lawful authority that a person, as a result 
of marked subnormal intelligence, or mental illness, incompetency, 
condition, or disease is a danger to himself/herself or to others or 
lacks the mental capacity to contract or manage his/her own affairs. 
The term includes a finding of insanity by a court in a criminal case 
and those persons found incompetent to stand trial or found not guilty 
by reason of lack of mental responsibility pursuant to articles 50a and 
72b of the Uniform Code of Military Justice, 10 U.S.C. 850a, 876b.
    Alien. Any person not a citizen or national of the United States.
* * * * *
    Committed to any mental institution. A formal commitment of a 
person to any mental institution by a court, board, commission, or 
other lawful authority. The term includes a commitment to a mental 
institution involuntarily. The term includes commitment for mental 
defectiveness or mental illness. It also includes commitments for other 
reasons, such as for drug use. The term does not include a person in a 
mental institution for observation or a voluntary admission to a mental 
institution.
    Controlled substance. A drug or other substance, or immediate 
precursor, as defined in section 102 of the Controlled Substances Act, 
21 U.S.C. 802. The term includes, but is not limited to, marijuana and 
scheduled depressants, stimulants, and narcotic drugs. The term does 
not include distilled spirits, wine, malt beverages, or tobacco, as 
those terms are defined or used in Subtitle E of the Internal Revenue 
Code of 1986, as amended.
    Crime punishable by imprisonment for a term exceeding 1 year. Any 
Federal, State, or foreign offense for which the maximum penalty, 
whether or not imposed, is capital punishment or imprisonment in excess 
of 1 year. What constitutes a conviction of such a crime shall be 
determined in accordance with the law of the jurisdiction in which the 
proceedings were held. Any conviction that has been set aside or 
nullified as a matter of law or for which a person has been pardoned 
shall not be considered a conviction for purposes of this part.
* * * * *
    Indictment. A formal written accusation originating with a 
prosecutor and issued by a grand jury against a party charged with a 
crime. For the purpose of these regulations the term indictment 
includes any ``information'' that is a formal accusation of a crime, 
differing only in that it is being presented by a competent public 
officer on his oath of office, instead of a grand jury.
    Information security. Protecting information and information 
systems from unauthorized access, use, disclosure, disruption, 
modification, or destruction in order to provide--
    (1) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information 
nonrepudiation and authenticity;
    (2) Confidentiality, which means preserving authorized restrictions 
on access and disclosure, including means for protecting personal 
privacy and proprietary information; and
    (3) Availability, which means ensuring timely and reliable access 
to and use of information.
* * * * *
    Lawfully admitted for permanent residence. The status of having 
been lawfully accorded the privilege of residing permanently in the 
United States as an immigrant in accordance with the immigration laws, 
such status not having changed.
    Mental institution. Includes mental health facilities, mental 
hospitals, sanitariums, psychiatric facilities, and other facilities 
that provide diagnoses by licensed professionals of mental retardation 
or mental illness, including a psychiatric ward in a general hospital.
* * * * *

[[Page 61222]]

    Occupational exposure. Any reasonably anticipated skin, eye, mucous 
membrane, or parenteral contact with blood or other potentially 
infectious materials or toxins that may result from the performance of 
an employee's duties.
* * * * *
    Recombinant and synthetic nucleic acids.
    (1) Recombinant nucleic acid molecules that are constructed by 
joining nucleic acid molecules and that can replicate in a living cell;
    (2) Synthetic nucleic acid molecules that are chemically, or by 
other means, synthesized or amplified nucleic acid molecules that may 
wholly or partially contain functional equivalents of nucleotides; or
    (3) Molecules that result from the replication of those described 
in paragraphs (1) or (2) of this definition.
* * * * *
    Restricted person. An individual who:
    (1) Is under indictment for a crime punishable by imprisonment for 
a term exceeding 1 year;
    (2) Has been convicted in any court of a crime punishable by 
imprisonment for a term exceeding 1 year;
    (3) Is a fugitive from justice;
    (4) Is an unlawful user of any controlled substance (as 
``controlled substance'' is defined in section 102 of the Controlled 
Substances Act (21 U.S.C. 802));
    (5) Is an alien illegally or unlawfully in the United States;
    (6) Has been adjudicated as a mental defective or has been 
committed to any mental institution;
    (7) Is an alien (other than an alien lawfully admitted for 
permanent residence) who is a national of a country as to which the 
Secretary of State, pursuant to section 6(j) of the Export 
Administration Act of 1979 (50 U.S.C. App. 2405(j)), section 620A of 
chapter 1 of part M of the Foreign Assistance Act of 1961 (22 U.S.C. 
2371), or section 40(d) of chapter 3 of the Arms Export Control Act (22 
U.S.C. 2780d), has made a determination (that remains in effect) that 
such country has repeatedly provided support for acts of international 
terrorism; or
    (8) Has been discharged from the Armed Services of the United 
States under dishonorable conditions.
* * * * *
    Unlawful user of any controlled substance. For purposes of this 
part, a person who uses a controlled substance and has lost the power 
of self-control with reference to the use of that controlled substance; 
and any person who is a current user of a controlled substance in a 
manner other than as prescribed by a licensed physician. Such use is 
not limited to the use of drugs on a particular day, or within a matter 
of days or weeks before, but rather that the unlawful use has occurred 
recently enough to indicate that the individual is actively engaged in 
such conduct. A person may be an unlawful current user of a controlled 
substance even though the substance is not being used at the precise 
time the person seeks to have access to a select agent or toxin. An 
inference of current use may be drawn from evidence of a recent use or 
possession of a controlled substance or a pattern of use or possession 
that reasonably covers the present time, e.g., a conviction for use or 
possession of a controlled substance within the past year; multiple 
arrests for such offenses within the past 5 years if the most recent 
arrest occurred within the past year, or persons found through a drug 
test to use a controlled substance unlawfully, provided that the test 
was administered within the past year. For a current or former member 
of the Armed Forces, an inference of current use may be drawn from 
recent disciplinary or other administrative action based on confirmed 
drug use, e.g., court-martial conviction, nonjudicial punishment, or an 
administrative discharge based on drug use or drug rehabilitation 
failure.
* * * * *
    3. Section 73.3 is amended as follows:
    a. By adding a sentence to the end of paragraph (a) to read as set 
forth below.
    b. By revising paragraph (b) to read as set forth below.
    c. In paragraph (c), in the introductory text, by adding the phrase 
``and/or Synthetic'' after the word ``Recombinant'' each time it 
appears.
    d. In paragraph (c)(2) introductory text, by adding the phrase 
``and/or synthetic'' after the word ``Recombinant''.
    e. By revising paragraph (d)(3) to read as set forth below.
    f. By adding a new paragraph (d)(4) to read as set forth below.
    g. By revising paragraph (e) to read as set forth below.
    h. In paragraph (f)(3)(i), by removing the words ``Lassa fever 
virus, South American Haemorrhagic Fever virus (Junin, Machupo, Sabia, 
Flexal, Guanarito)'' and by adding the words ``Botulinum neurotoxin 
producing species of Clostridium.''

Sec.  73.3  HHS select agents and toxins.

    (a) * * * The select agents and toxins marked with an asterisk (*) 
are designated as Tier 1 select agents and toxins and are subject to 
additional requirements as listed in this part.
    (b) HHS select agents and toxins: \1\

    \1\ Including all toxin derivatives, both naturally occurring 
and synthetic, that retain function.
---------------------------------------------------------------------------

Abrin
Botulinum neurotoxins*
Botulinum neurotoxin producing species of Clostridium*
Chapare
Clostridium perfringens epsilon toxin
Conotoxins
Coxiella burnetii
Crimean-Congo haemorrhagic fever virus
Diacetoxyscirpenol
Eastern Equine Encephalitis virus (North American genotypes)
Ebola virus*
Francisella tularensis*
Lassa fever virus
Lujo
Marburg virus*
Monkeypox virus

    Reconstructed replication competent forms of the 1918 pandemic 
influenza virus containing any portion of the coding regions of all 
eight gene segments (Reconstructed 1918 Influenza virus)

Ricin
Rickettsia prowazekii
Rickettsia rickettsii
Saxitoxin
Shiga-like ribosome inactivating proteins
Shigatoxin
South American Haemorrhagic Fever viruses
Guanarito
Junin
Machupo
Sabia
Staphylococcal enterotoxins (SE) A-E (SEA, SEB, SEC, SED, SEE)
T-2 toxin
Tetrodotoxin
Tick-borne encephalitis virus
Far Eastern subtype
Siberian subtype
Kyasanur Forest disease virus
Omsk hemorrhagic fever virus
Variola major virus (Smallpox virus)*
Variola minor virus (Alastrim)*
Yersinia pestis*
* * * * *
    (d) * * *
    (3) Except as required in Sec.  73.16(l), HHS toxins under the 
control of a principal investigator, treating physician or 
veterinarian, or commercial manufacturer or distributor, if:
    (i) The aggregate amount does not, at any time, exceed the 
following amounts: 100 mg of Abrin; 0.5 mg of Botulinum neurotoxins; 
100 mg of Clostridium

[[Page 61223]]

perfringens epsilon toxin; 100 mg of Conotoxins; 1,000 mg of 
Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 100 mg of 
Shiga-like ribosome inactivating proteins; 100 mg of Shigatoxin; 5 mg 
of Staphylococcal enterotoxins; 1,000 mg of T-2 toxin; or 100 mg of 
Tetrodotoxin.
    (ii) Amounts of toxins equal to or less than the amounts identified 
in paragraph (d)(3)(i) of this section are transferred only after the 
transferor uses due diligence and documents that the recipient has a 
legitimate need (i.e. reasonably justified by a prophylactic, 
protective, bona fide research, or other peaceful purpose) to handle or 
use such toxins. Notwithstanding the provisions of paragraph (d) of 
this section, the HHS Secretary retains the authority to, without prior 
notification, inspect and copy or request the submission of the due 
diligence documentation to the CDC.
    (iii) The transfer of amounts of toxins equal to or less than the 
amounts identified in paragraph (d)(3)(i) of this section reports to 
CDC if they detect a known or suspected violation of Federal law or 
become aware of suspicious activity related to a toxin listed in 
section of this part.
    (4) Notwithstanding paragraph (d)(3)(i) of this section, an animal 
inoculated with or exposed to an HHS select toxin.
    (e) An attenuated strain of a select agent or an inactive form of a 
select toxin may be excluded from the requirements of this part based 
upon a determination by the HHS Secretary that the attenuated strain or 
inactivated toxin does not pose a severe threat to public health and 
safety.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will 
be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
    (2) If an excluded attenuated strain or inactivated toxin is 
subjected to any manipulation that restores or enhances its virulence 
or toxic activity, the resulting select agent or toxin will be subject 
to the requirements of this part.
* * * * *
    4. Section 73.4 is amended as follows:
    a. By adding a sentence to the end of paragraph (a) to read as set 
forth below.
    b. By revising paragraph (b) to read as set forth below.
    c. In paragraph (c), in the introductory text, by adding the phrase 
``and/or synthetic'' after the word ``Recombinant'' each time it 
appears.
    d. In paragraph (c)(2), by adding the phrase ``and/or synthetic'' 
after the word ``Recombinant''.
    e. By revising paragraph (e) to read as set forth below.
    f. In paragraph (f)(3)(i), by removing the words ``Brucella 
melitensis, Hendra virus, Nipah virus, Rift Valley fever virus, and 
Venezuelan equine encephalitis virus'' and adding the words 
``Burkholderia mallei and Burkholderia pseudomallei'' in their place.

Sec.  73.4  Overlap select agents and toxins.

    (a) * * * The select agents and toxins marked with an asterisk (*) 
are designated as Tier 1 select agents and toxins and are subject to 
additional requirements as listed in this part.
    (b) Overlap select agents and toxins:
    Bacillus anthracis;*
    Brucella abortus;
    Brucella melitensis;
    Brucella suis;
    Burkholderia mallei;*
    Burkholderia pseudomallei;*
    Hendra virus;
    Nipah virus;
    Rift Valley fever virus;
    Venezuelan equine encephalitis virus: Epizootic Subtypes IAB, IC.
* * * * *
    (e) An attenuated strain of a select agent or an inactive form of a 
select toxin may be excluded from the requirements of this part based 
upon a determination by the HHS Secretary or Administrator that the 
attenuated strain or inactivated toxin does not pose a severe threat to 
public health and safety, to animal health or to animal products.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will 
be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
    (2) If an excluded attenuated strain or inactivated toxin is 
subjected to any manipulation that restores or enhances its virulence 
or toxic activity, the resulting select agent or toxin will be subject 
to the requirements of this part.
* * * * *

Sec.  73.5  [Amended]

    5. Section 73.5(a)(3)(i) is amended by removing the words ``Lassa 
fever virus, South American Haemorrhagic Fever virus (Junin, Machupo, 
Sabia, Flexal, Guanarito)'' and by adding the words ``Botulinum 
neurotoxin producing species of Clostridium'' in their place.

Sec.  73.6  [Amended]

    6. Section 73.6(a)(3)(i) is amended by removing the words 
``Brucella melitensis, Hendra virus, Nipah virus, Rift Valley fever 
virus, and Venezuelan equine encephalitis virus'' and adding the words 
``Burkholderia mallei and Burkholderia pseudomallei'' in their place.

Sec.  73.8  [Amended]

    7. Section 73.8 (a)(1) is amended by removing the words ``within 
any of the categories described in 18 U.S.C. 175b'' and adding the 
words ``a restricted person'' in their place.
* * * * *
    8. Section 73.9 is amended as follows:
    a. By redesignating paragraphs (a)(3) through (a)(5) as paragraphs 
(a)(4) through (a)(6) respectively.
    b. By adding a new paragraph (a)(3) to read as set forth below.
    c. In newly redesignated paragraph (a)(5), by removing the word 
``and''.
    d. By further redesignating newly redesignated paragraph (a)(6) as 
paragraph (a)(7).
    e. By adding a new paragraph (a)(6) to read as set forth below.
    f. By revising the first sentence of paragraph (b) to read as set 
forth below.
    g. In paragraph (c)(1), by removing the words ``Bacillus anthracis, 
Botulinum neurotoxins, Brucella melitensis, Francisella tularensis, 
Ebola viruses, Hendra virus, Marburg virus, Lassa fever virus, Nipah 
virus, Rift Valley fever virus, South American Haemorrhagic Fever 
viruses (Junin, Machupo, Sabia, Flexal, Guanarito), Variola major virus 
(Smallpox virus), Variola minor (Alastrim), Venezuelan equine 
encephalitis virus and Yersina pestis'' and adding the words ``Bacillus 
anthracis, Botulinum neurotoxins, Botulinum neurotoxin producing 
species of Clostridium, Burkholderia mallei, Burkholderia pseudomallei, 
Francisella tularensis, Ebola viruses, Marburg virus, Variola major 
virus (Smallpox virus), Variola minor (Alastrim), and Yersinia pestis'' 
in their place.
    (a) * * *
    (3) Have the appropriate training and expertise to competently 
implement and manage the requirements of this part;
* * * * *
    (6) Have their principal duty station at the physical location of 
the entity; and
* * * * *
    (b) An entity may designate one or more individuals to serve as an 
alternate Responsible Official, who acts for the Responsible Official 
in his/her absence. * * *
* * * * *

[[Page 61224]]

    9. Section 73.10 is amended as follows:
    a. By redesignating paragraphs (e) through (j) as paragraphs (f) 
through (k) respectively.
    b. By adding a new paragraph (e) to read as set forth below.
    c. In newly redesignated paragraph (g), by removing the words 
``within any of the categories described in 18 U.S.C. 175b'' and adding 
the words ``a restricted person'' in their place.
    d. In newly redesignated paragraph (j), by removing the word 
``five'' and adding the word ``three'' in its place.

Sec.  73.10  Restricting access to select agents and toxins; security 
risk assessments.

* * * * *
    (e) A person who has a valid approval from the HHS Secretary or 
Administrator for access to a select agent or toxin may request the HHS 
Secretary or Administrator to provide the person's approval status to 
another registered individual or entity for a specified period of time.
* * * * *
    10. Section 73.11 is amended as follows:
    a. By revising paragraph (b) to read as set forth below.
    b. By revising paragraph (c)(2) to read as set forth below.
    c. By adding new paragraphs (c)(8), (c)(9), and (c)(10) to read as 
set forth below.
    d. By redesignating paragraphs (e) and (f) as paragraphs (f) and 
(g), respectively and by revising redesignated paragraph (f) to read as 
set forth below.
    e. By adding a new paragraph (e) to read as set forth below.

Sec.  73.11  Security.

* * * * *
    (b) The security plan must be designed according to a site-specific 
risk assessment and must provide graded protection in accordance with 
the risk of the select agent or toxin, given its intended use. A 
current security plan must be submitted for initial registration, 
renewal of registration, or when requested.
    (c) * * *
    (2) Contain provisions for the control of access to select agents 
and toxins, including the safeguarding of animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent, against unauthorized access, theft, loss or release.
* * * * *
    (8) Describe procedures for how the Responsible Official will be 
informed of suspicious activity that may be criminal in nature and 
related to the entity, its personnel, or its select agents or toxins; 
and how the Responsible Official will notify the Federal Bureau of 
Investigation (FBI) of such activity,
    (9) Contain provisions for information security that:
    (i) Ensure that all external connections to systems which control 
security of the facility are isolated or have controls that permit and 
monitor for only authorized and authenticated user access;
    (ii) Ensure that authorized and authenticated users are only 
granted access to select agent and toxin related information, files, 
equipment (e.g., servers or mass storage devices) and applications as 
necessary to fulfill their roles and responsibilities, and that access 
is modified when the user's roles and responsibilities change or when 
their access to select agent and toxin is suspended or revoked;
    (iii) Ensure that controls are in place that are designed to 
prevent malicious code (such as, but not limited to, computer virus, 
worms, spyware) from compromising the confidentiality, integrity, or 
availability of information systems;
    (iv) Establish a robust configuration management practice for 
information systems to include regular patching and updates made to 
operating systems and individual applications; and
    (v) Establish procedures that provide backup security measures in 
the event that access control systems and/or surveillance devices are 
rendered inoperable.
    (10) Contain provisions and policies for shipping, receiving, and 
storage of select agents and toxins, including documented procedures 
for receiving, monitoring, and shipping of all select agents and 
toxins. These provisions must provide that an entity will properly 
secure containers on site and have a written contingency plan for 
unexpected shipments.
* * * * *
    (e) In addition to the requirements contained in paragraphs (c) and 
(d) of this section, the security plan for an individual or entity 
possessing a Tier 1 select agent or toxin must also:
    (1) Describe procedures for conducting a pre-access suitability 
assessment of persons who will have access to a Tier 1 select agent or 
toxin;
    (2) Describe procedures for how an entity's Responsible Official 
will coordinate their efforts with the entity's safety and security 
professionals to ensure security of Tier 1 select agents and toxins and 
share, as appropriate, relevant information; and
    (3) Describe procedures for the ongoing assessment of the 
suitability of personnel with access to a Tier 1 select agent or toxin. 
The procedures must include:
    (i) Self- and peer-reporting of incidents or conditions that could 
affect an individual's ability to safely have access to or work with 
select agents and toxins, or to safeguard select agents and toxins from 
theft, loss, or release;
    (ii) The training of all entity employees on entity policies and 
procedures for reporting, evaluation, and corrective actions concerning 
the assessment of personnel suitability to access Tier 1 agents and 
toxins; and
    (iii) The ongoing suitability monitoring of individuals with access 
to Tier 1 select agents and toxins.
    (4) Entities with Tier 1 select agents and toxins must prescribe 
and/or implement the following security enhancements:
    (i) Procedures that will limit access to registered space only to 
those approved by the HHS Secretary or the Administrator and meet the 
criteria of the entity's program that will ensure individuals with 
access approval to select agents and toxins are trustworthy and 
behaving in a manner that upholds public health and safety, security, 
and the integrity of the scientific enterprise.
    (ii) Procedures that limit access to laboratory and storage 
facilities outside of normal business hours to only those specifically 
approved by the Responsible Official or designee;
    (iii) Procedures for allowing visitors, their property, and 
vehicles at the entry and exit points to the registered space, or at 
other designated points of entry to the building, facility, or compound 
based on the entity's site-specific risk assessment;
    (iv) A minimum of three barriers where each subsequent barrier is 
different and adds to the delay in reaching secured areas where select 
agents and toxins are used or stored. Barriers must be monitored in 
such a way as to detect and assess intentional and unintentional 
circumventing of established access control measures under all 
conditions (day/night, severe weather, etc.);
    (v) All registered space or areas that reasonably afford access to 
the registered space must be protected by an intrusion detection system 
(IDS) unless physically occupied;
    (vi) Personnel monitoring the IDS must be capable of evaluating and 
interpreting the alarm and alerting the designated security response 
force or law enforcement;
    (vii) Provide backup power and energy sources to power information 
security networks and integrated access

[[Page 61225]]

controls and related systems during emergencies;
    (viii) Response time for security forces or local police must not 
exceed 15 minutes from the time of an intrusion alarm or report of a 
security incident;
    (ix) Entities must conduct complete inventory audits of all Tier 1 
select agents and toxins in long-term storage when any of the following 
occur:
    (A) Upon the physical relocation of a collection or inventory of 
select agents or toxins for those Tier 1 select agents or toxins in the 
collection or inventory;
    (B) Upon the departure or arrival of a principal investigator for 
those Tier 1 select agents and toxins under the control of that 
principal investigator; or
    (C) In the event of a theft or loss of a Tier 1 select agent or 
toxin.
    (5) Entities that possess Variola major virus and Variola minor 
virus must have the following additional security requirements:
    (i) Require personnel with access to Variola major or Variola minor 
virus to have a Top Secret security clearance,
    (ii) Require Variola major or Variola minor virus storage locations 
be under the surveillance of closed circuit television that is 
monitored,
    (iii) After hours access procedures for Variola major or Variola 
minor virus must require notification of the entity's security staff 
prior to entry into the Variola laboratory and upon exit,
    (iv) Require that observation zones be maintained in outdoor areas 
adjacent to the physical barrier at the perimeter of the entity and be 
large enough to permit observation of the activities of people at that 
barrier in the event of its penetration,
    (v) Provide for a minimum of four barriers for the protection of 
the Variola major or Variola minor virus, one of which must be a 
perimeter fence,
    (vi) Require a numbered picture badge identification subsystem to 
be used for all individuals who are authorized to access Variola major 
or Variola minor without escort,
    (vii) Require the use, at all times, of properly trained, and 
equipped security force personnel able to interdict threats identified 
in the site specific risk assessment,
    (viii) Identify security force personnel designated to strengthen 
onsite response capabilities, and that will be onsite and available at 
all times to carry out their assigned response duties,
    (ix) Provide for security patrols to periodically check external 
areas of the registered areas to include physical barriers and building 
entrances,
    (x) Require that all on-duty security force personnel shall be 
capable of maintaining continuous communication with support and 
response assets by way of security operations center,
    (xi) Require that Variola major and Variola minor material in long 
term storage be stored in tamper-indicating containers,
    (xii) Require that all spaces containing working or permanent 
Variola major or Variola minor stocks be locked and protected by an 
intrusion alarm system that will alarm upon the unauthorized entry of a 
person anywhere into the area,
    (xiii) Require that alarms required pursuant to this section 
annunciate in a continuously manned security operations center located 
within the facility,
    (xiv) Require that the security operations center shall be located 
within a building so that the interior is not visible from the 
perimeter of the protected area.
    (f) In developing a security plan, an individual or entity should 
consider the documents entitled, ``Select Agents and Toxins Security 
Information Document'' and ``Select Agents and Toxins Security Plan 
Template.'' These documents are available on the Internet at http://www.selectagents.gov/.
* * * * *
    11. Section 73.12 is amended as follows:
    a. By revising paragraph (a) to read as set forth below.
    b. By revising paragraph (c)(1) to read as set forth below.
    c. In paragraph (c)(3), by removing the URL ``http://www.cdc.gov/'' 
and adding in its place ``http://www.selectagents.gov''.
    d. By redesignating paragraph (d) as paragraph (e).
    e. By adding a new paragraph (d) to read as set forth below.

Sec.  73.12  Biosafety.

* * * * *
    (a) An individual or entity required to register under this part 
must develop and implement a written biosafety plan that is 
commensurate with the risk of the select agent or toxin, given its 
intended use. The biosafety plan must contain sufficient information 
and documentation to describe the biosafety and containment procedures 
for the select agent or toxin, including any animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent.
* * * * *
    (c) * * *
    (1) The CDC/NIH publication, ``Biosafety in Microbiological and 
Biomedical Laboratories.'' This document is available on the Internet 
at http://www.selectagents.gov.
* * * * *
    (d) The biosafety plan must include an occupational health program 
for individuals with access to Tier 1 select agents and toxins, and 
those individuals must be enrolled in the occupational health program. 
The occupational health program may also be made available to 
individuals without access to Tier 1 select agents and toxins.
* * * * *

Sec.  73.13  [Amended]

    12. Section 73.13 is amended as follows:
    a. In paragraph (a), in the introductory text, by adding the phrase 
``, or possess products (i.e. select agents that are not known to 
acquire the resistance naturally, if such acquisition could compromise 
the use of the drug to control disease agents in humans, veterinary 
medicine, or agriculture, or recombinant and or synthetic DNA 
containing genes for the biosynthesis of select toxins lethal for 
vertebrates at an LD[50] kg body weight) resulting from,'' 
after the word ``conduct'' both times it appears.
    b. In paragraph (b)(1), by removing the words ``Experiments 
utilizing recombinant DNA that involve the deliberate transfer of'' and 
replacing them with the words ``Experiments that involve the deliberate 
transfer of, or selection for,''.
    c. In paragraph (b)(2), by adding the words ``synthetic or'' before 
the word ``recombinant.''
    13. Section 73.14 is amended as follows:
    a. By revising paragraph (a) to read as set forth below.
    b. By revising paragraph (b) to read as set forth below.
    c. By redesignating paragraph (c) and (d) as paragraphs (d) and (f) 
respectively.
    d. By adding a new paragraph (c) to read as set forth below.
    e. By adding a new paragraph (e) to read as set forth below.

Sec.  73.14  Incident response.

    (a) An individual or entity required to register under this part 
must develop and implement a written incident response plan based upon 
a site specific risk assessment.\2\ The incident response plan must be 
coordinated with any entity-wide plans, kept in the

[[Page 61226]]

workplace, and available to employees for review.
---------------------------------------------------------------------------

    \2\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.
---------------------------------------------------------------------------

    (b) The incident response plan must fully describe the entity's 
response procedures for the theft, loss, or release of a select agent 
or toxin; inventory discrepancies; security breaches (including 
information systems); severe weather and other natural disasters; 
workplace violence; bomb threats and suspicious packages; and 
emergencies such as fire, gas leak, explosion, power outage, etc.
    (c) The response procedures must account for hazards associated 
with the select agent or toxin and appropriate actions to contain such 
select agent or toxin, including any animals or plants intentionally or 
accidentally exposed to or infected with a select agent.
* * * * *
    (e) Entities with Tier 1 select agents and toxins must have the 
following additional incident response policies or procedures:
    (1) The incident response plan must fully describe the entity's 
response procedures for failure of intrusion detection or alarm system; 
and
    (2) The incident response plan must describe notification 
procedures for the FBI in the event of a theft or suspicious activity 
that may be criminal in nature involving a Tier 1 select agent or 
toxin.
* * * * *
    14. Section 73.15 is revised to read as follows:

Sec.  73.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biosafety, security (including 
security awareness) and incident response:
    (1) To each individual with access approval from the HHS Secretary 
or Administrator before that individual has such access to select 
agents and toxins. The training must address the particular needs of 
the individual, the work they will do, and the risks posed by the 
select agents or toxins.
    (2) To each individual not approved for access to select agents and 
toxins by the HHS Secretary or Administrator before that individual 
enters areas where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage 
areas, shipping/receiving areas, production facilities, etc.). Training 
for escorted personnel must be based on the risk associated with 
accessing areas where select agents and toxins are used and/or stored.
    (b) Entities with Tier 1 select agents and toxins must conduct 
annual insider threat awareness briefings on how to identify and report 
suspicious behaviors.
    (c) Refresher training must be provided annually or at such time as 
the registered individual or entity significantly amends its security, 
incident response, or biosafety plans.
    (d) The Responsible Official must ensure a record of the training 
provided to each individual with access to select agents and each 
escorted individual (e.g., laboratory workers, visitors, etc.) is 
maintained. The record must include the name of the individual, the 
date of the training, a description of the training provided, and the 
means used to verify that the employee understood the training.
    15. Section 73.16 is amended as follows:
    a. By redesignating paragraph (f), (g), (h), and (i) as paragraphs 
(i), (j), (k), and (g) respectively.
    b. In redesignated paragraph (g), by removing the words ``packaging 
and''.
    c. By adding a new paragraph (f) to read as set forth below.
    d. By adding a new paragraph (h) to read as set forth below.
    e. By adding a new paragraph (l) to read as set forth below.

Sec.  73.16  Transfers.

* * * * *
    (f) After authorization is provided by APHIS or CDC, the select 
agent(s) and toxin(s) are packaged for shipment in compliance with all 
applicable laws concerning packaging by an individual approved by the 
HHS Secretary or Administrator to have access to select agents and 
toxins, following a security risk assessment by the Attorney General.
* * * * *
    (h) Transportation in commerce starts when the select agent(s) or 
toxin(s) are packaged for shipment and ready for receipt by a courier 
transporting select agent(s) or toxin(s) and ends when the package is 
received by the intended recipient who is an individual approved by the 
HHS Secretary or Administrator to have access to select agents and 
toxins, following a security risk assessment by the Attorney General.
* * * * *
    (l) A registered individual or entity transferring an amount of a 
HHS toxin otherwise excluded under the provisions of Sec.  73.3(d) of 
this part must:
    (1) Transfer the HHS toxin only after using due diligence and 
documenting that the recipient has a legitimate need (reasonably 
justified by a prophylactic, protective, bona fide research, or other 
peaceful purpose) to handle or use such toxins. The HHS Secretary 
retains the authority to, without prior notification, inspect and copy 
or request the submission of the due diligence documentation to the 
CDC.
    (2) Report to CDC any known or suspected violation of Federal law 
or suspicious activity related to the toxin.
    16. Section 73.17 is amended as follows:
    a. By revising paragraph (a)(1) introductory text to read as set 
forth below.
    b. By redesignating paragraphs (a)(2) through (a)(6) as paragraphs 
(a)(3) through (a)(7) respectively.
    c. By adding a new paragraph (a)(2) to read as set forth below.

Sec.  73.17  Records.

    (a) * * *
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
recombinant and/or synthetic organisms) held in long-term storage 
(placement in a system designed to ensure viability for future use, 
such as in a freezer or lyophilized materials), including:
* * * * *
    (2) An accurate, current inventory of any animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent (including number and species, location, and appropriate 
disposition);
* * * * *
    17. Section 73.20 is revised to read as set forth below.

Sec.  73.20  Administrative review.

    (a) An individual or entity may appeal a denial, revocation, or 
suspension of registration under this part. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to 
the HHS Secretary within 30 calendar days of the decision.
    (b) An individual may appeal a denial, limitation, or revocation of 
access approval under this part. The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the HHS Secretary 
within 180 calendar days of the decision.
    (c) The HHS Secretary's decision constitutes final agency action.

    Dated: September 21, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-25427 Filed 9-30-11; 8:45 am]
BILLING CODE 4163-18-P
```