Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, 61206-61226 [2011-25427]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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: https://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 https://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 https://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: https://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: https://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
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       Section No.               Current                 Change
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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 https://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 https://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 cri