[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Proposed Rules]
[Pages 61206-61226]
From the Federal Register Online via the Government Publishing 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.
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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
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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.
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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] < 100 ng/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 [email protected]. 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.
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2334-6.
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staphylococcal enterotoxin B. Biochemistry 4(6): 1011-6.
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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.
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(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.
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biological properties of Staphylococcal enterotoxin K. Infect Immun
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JK, Swayne DE, Palese P, Basler CF. Existing antivirals are
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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] < 100 ng/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.
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\2\ Nothing in this section is meant to supersede or preempt
incident response requirements imposed by other statutes or
regulations.
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(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