Possession, Use, and Transfer of Select Agents and Toxins, 13294-13325 [05-5216]

Agencies

• Office of Inspector General
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 52 (Friday, March 18, 2005)]
[Rules and Regulations]
[Pages 13294-13325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5216]



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Part III





Department of Health and Human Services





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42 CFR Parts 72 and 73



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Office of Inspector General

42 CFR Part 1003



Possession, Use, and Transfer of Select Agents and Toxins; Final Rule

Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules 
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Parts 72 and 73

Office of Inspector General

42 CFR Part 1003

RIN 0920-AA09


Possession, Use, and Transfer of Select Agents and Toxins

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

ACTION: Final rule.

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SUMMARY: This document establishes a final rule regarding possession, 
use, and transfer of select agents and toxins. The final rule 
implements provisions of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 and is designed to protect public 
health and safety.
    In a companion document published in this issue of the Federal 
Register, the United States Department of Agriculture has established 
corresponding final rules designed to protect animal and plant health 
and animal and plant products.

DATES: The final rule is effective April 18, 2005.

FOR FURTHER INFORMATION CONTACT: Mark Hemphill, Chief of Policy, Select 
Agent Program, Centers For Disease Control and Prevention, 1600 Clifton 
Rd., MS E-79, Atlanta, GA 30333. Telephone: (404) 498-2255.

SUPPLEMENTARY INFORMATION: This document establishes a final rule 
regarding possession, use, and transfer of select agents and toxins. 
The final rule is based on the interim final rule, as amended (amended 
interim final rule). The initial interim final rule was published in 
the Federal Register on December 13, 2002 (67 FR 76886). It was amended 
by a second interim final rule published in the Federal Register on 
November 3, 2003 (68 FR 62245). The initial interim final rule 
established a comprehensive set of regulations that included 
requirements concerning registration and security risk assessments. The 
second interim final rule amended the first interim final rule by 
allowing for the issuance of provisional certificates of registration 
and provisional grants of access to select agents and toxins, subject 
to completion of security risk assessments, and compliance with all of 
the requirements of the initial interim final rule. The final rule, 
which is set forth at 42 FR part 73, implements provisions of the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Act) and is designed to protect public health and safety.
    In general, this final rule contains provisions that apply to 
academic institutions and biomedical centers; commercial manufacturing 
facilities; federal, state, and local laboratories, including clinical 
and diagnostic laboratories; and research facilities.
    For the initial interim final rule, we provided for a 60-day 
comment period for written comments that ended February 11, 2003. We 
also held a public meeting on December 16, 2002. Relevant issues raised 
by the comments (oral comments made at the public meeting and 110 
written comments) are discussed below. For the second interim final 
rule, we provided for a 60-day comment period for written comments that 
ended January 2, 2004. We received no comments in response to the 
second interim final rule. Based on the rationale set forth in the 
initial interim final rule, the second interim final rule, and this 
document, we are affirming the provisions of the amended interim final 
rule as a final rule with changes discussed below.
    The final rule is designed to implement authorities under the Act 
to protect public health and safety. The United States Department of 
Agriculture (USDA) has established corresponding sets of regulations 
designed to protect animal and plant health and animal and plant 
products (9 CFR part 121 and 7 CFR part 331).

42 CFR Part 1003

    The initial interim final rule amended 42 CFR part 1003 to 
establish delegations of authority and other provisions involving the 
Office of Inspector General (OIG) of HHS. In addition to adding a new 
paragraph (b)(16) to Sec.  1003.102 to authorize the imposition of 
civil money penalties for violations of the regulatory provisions, the 
interim final rule also sought public comments on the possible 
inclusion of specific factors that might be used to assess specific 
penalty amounts. The amended interim final rule had no effect on the 
OIG amendments and we received no comments regarding these amendments. 
However, since amendatory language to the OIG regulations addressing 
determinations regarding the amount of a penalty was not originally 
included in the initial interim final rule, we are now revising Sec.  
1003.106(a)(1) to reference the newly codified Sec.  1003.102(b)(16) 
and the factors to be taken into account when the OIG assesses civil 
money penalties. We are affirming all other amendments set forth in the 
interim final rule.

42 CFR 72.6 and Its Accompanying Appendix A

    The provisions of the final rule supersede all of the provisions at 
42 CFR 72.6 (captioned ``Additional requirements for facilities 
transferring or receiving select agents'') and its accompanying 
Appendix A. However, the provisions of 18 U.S.C. 175b include 
prohibitions that are based on the list of select agents in Appendix A 
of 42 CFR part 72 and exemptions to such list in Sec.  72.6(h). 
Accordingly, we have deleted the superseded provisions and in their 
place have added language to indicate that for purposes of 18 U.S.C. 
175b the list of select agents are set forth in Sec. Sec.  73.3 and 
73.4 and the exemptions are set forth in Sec. Sec.  73.5 and 73.6.

Changes in Structure in Part 73

    With respect to the sections in part 73, we changed the final rule 
to make the structure and format of the HHS regulations and the USDA 
regulations at 9 CFR part 121 more similar. The following chart shows 
the changes.

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       Amended interim final rule                   Final rule
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73.1 Definitions.......................  73.1 Definitions.
73.2 Purpose and scope.................  73.2 Purpose and scope.
73.3 General prohibition...............  73.3 HHS select agents and
                                          toxins.
73.4 HHS select agents and toxins......  73.4 Overlap select agents and
                                          toxins.
73.5 Overlap select agents and toxins..  73.5 Exemptions for HHS select
                                          agents and toxins.
73.6 Exemptions from requirements under  73.6 Exemptions for overlap
 this part.                               select agents and toxins.
73.71 Registration.....................  73.7 Registration and related
                                          security risk assessments.
73.8 Security Risk Assessments.........  73.8 Denial, revocation, or
                                          suspension of registration.
73.9 Responsible Official..............  73.9 Responsible Official.

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73.10 Safety...........................  73.10 Restricting access to
                                          select agents and toxins;
                                          security risk assessments.
73.11 Security.........................  73.11 Security.
73.12 Emergency response...............  73.12 Biosafety.
73.13 Training.........................  73.13 Restricted experiments.
73.14 Transfers........................  73.14 Incident response.
73.15 Records..........................  73.15 Training.
73.16 Inspections......................  73.16 Transfers.
73.17 Notification for theft, loss, or   73.17 Records.
 release.
73.18 Administrative review............  73.18 Inspections.
73.19 Civil money penalties............  73.19 Notification of theft,
                                          loss, or release.
73.20 Criminal penalties...............  73.20 Administrative review.
73.21 Submissions and forms............  73.21 Civil money penalties.
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Section 73.0 Applicability and Related Requirements

    Under the provisions of Sec.  73.0 of the initial interim final 
rule, a number of the provisions became applicable on February 7, 2003, 
while other provisions became applicable at subsequent scheduled times 
on or before November 12, 2003. A number of commenters requested that 
different applicability dates be established, but no commenters 
requested that applicability dates be later than November 12, 2003. As 
noted above, the interim final rule was amended allowing, subject to 
completion of security risk assessments and compliance with all other 
requirements set forth in the initial interim final rule, for the 
issuance of provisional certificates of registration and provisional 
grants of access to select agents and toxins. These security risk 
assessments have been completed.
    Accordingly, we are removing all of the provisions of Sec.  73.0. 
They have served their purpose by implementing the statutorily mandated 
principles of protecting public health and safety while minimizing 
disruption or termination of research or educational projects.
``Access'' and ``Area''
    Commenters argued that the terms ``area'' and ``access'' are 
unclear. In response, we have eliminated references to area and used it 
in the regulations only when we believe it is clear in context. Also, 
consistent with many suggestions by commenters, we have provided 
language in Sec.  73.10(b) to clarify that ``An individual will be 
deemed to have access at any point in time if the individual has 
possession of a select agent or toxin (e.g., ability to carry, use, or 
manipulate) or the ability to gain possession of a select agent or 
toxin.'' In addition, we clarified the language that an individual with 
``access approval from the HHS Secretary or Administrator'' is an 
individual who has been granted access to select agents or toxins from 
the HHS Secretary or Administrator following a security risk 
assessment.

Section 73.1 Definitions

    We added definitions of ``Administrator'', ``Animal and Plant 
Health Inspection Service (APHIS)'', ``Attorney General'', 
``Responsible Official'' and ``State'', made corrections to the 
definitions of ``HHS Secretary'', ``Proficiency testing'', and ``United 
States'', and deleted the definition of ``USDA Secretary.'' Also, we 
changed the definitions of ``diagnosis'' and ``verification'' to more 
fully reflect their common meanings in the regulated community. 
Moreover, we added a definition of ``specimen'' to reflect its common 
meaning in the regulated community. All terms not defined in this 
section shall have the meaning that is commonly understood in the 
scientific community based on the context in which those terms appear 
in this part.
Entity
    One commenter stated the definition of ``entity'' does not include 
``person'' or ``individual.'' To prevent legal confusion and arguments, 
the commenter recommended that in ``Sec.  73.1--Definitions the term 
`entity' be redefined to include a `person' and/or an `individual' and 
that the same defined term(s) be used in all section''. We made no 
changes in the definition section based on this comment. However, for 
clarification purposes, we have added ``individual or entity'' language 
throughout the document.
    Another commenter claimed that the term ``entity'' is subject to 
interpretation. The commenter stated that it does not make sense for a 
large multi-campus university to base cumulative limits on toxins or 
the designation of the Responsible Official on the entity when the 
actual labs are separated by hundreds of miles. We made no changes in 
the definition section based on this comment. The issue is addressed 
below in the registration section.
Responsible Official
    Commenters recommended that CDC add the APHIS definition for 
Responsible Official, which reads, ``The individual designated by an 
entity to act on its behalf. This individual must have the authority 
and control to ensure compliance with the regulations in this Part.'' 
We agreed with the commenters that CDC and APHIS adopt a common 
definition for the term ``Responsible Official.'' Accordingly, we are 
adding the definition for ``Responsible Official''.

Section 73.2 Purpose and Scope and Sec.  73.3 General Prohibition

    We received no comments concerning Sec. Sec.  73.2 and 73.3. Since 
the language in Sec.  73.3 is consistently addressed throughout the 
document, we deleted this section.

Section 73.3 HHS Select Agents and Toxins and Sec.  73.4 Overlap Select 
Agents and Toxins

    Some of the select agents and toxins regulated by HHS under part 73 
are also regulated by USDA under 9 CFR part 121. The select agents and 
toxins subject to regulation by both agencies are identified as 
``overlap select agents and toxins'' and those regulated solely by HHS 
are identified as ``HHS select agents and toxins.''
General
    Commenters recommended that the final rule include an appendix that 
would provide a summary of the risk assessment data that supports the 
listing of each select agent and toxin. Commenters argued that ``These 
data will heighten the awareness of individuals who possess and use a 
listed agent to the most important risk characteristics of the listed 
agents' and ``This knowledge will promote safe practices and 
proficiency in the handling of a listed agent.''

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    Commenters also argued that this will help affected entities make 
assessments for the future. CDC did not include risk assessment data in 
the regulations but did provide such information in the rule's 
preamble. We do not believe it is necessary to provide a summary of the 
risk assessment data that supports the listing of each select agent or 
toxin in order to heighten awareness of the risk characteristics of 
such agents and toxins and promote safe practice and proficiency in 
handling of such agents and toxins. Information about the risk 
characteristics of a select agent or toxin and safe handling practices 
is available in scientific literature and other publications (e.g., the 
CDC/NIH publication, ``Biosafety in Microbiological and Biomedical 
Laboratories''). As noted in the preamble of the August 2002 interim 
rule, the Act requires the HHS Secretary to consider the following 
criteria in determining whether to list an agent or toxin: (1) The 
effect on human health of exposure to the agent or toxin; (2) the 
degree of contagiousness of the agent or toxin and the methods by which 
the agent or toxin is transferred to humans; (3) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent any illness resulting from infection by the agent or toxin; and 
(4) any other criteria, including the needs of children and other 
vulnerable populations, that the Secretary considers appropriate. The 
Secretary directed the CDC to convene an inter-agency working group to 
determine which biological agents and toxins required regulation based 
on the criteria noted above. In June 2002, CDC convened an interagency 
working group to review the current list of select agents and toxins 
and develop recommendations for a select agent list. Members of the 
working group included representatives from the Department of Health 
and Human Services/Office of the Secretary (DHHS/OS), the Centers for 
Disease Control and Prevention (CDC), the National Institutes of Health 
(NIH), the Food and Drug Administration (FDA), the Department of the 
Army (DoD/Army), the Department of the Navy (DoD/Navy), the Department 
of the Air Force (DoD/AF), the U.S. Department of Agriculture (USDA), 
the Environmental Protection Agency (EPA), the Agency for Toxic 
Substances and Disease Registry (ATSDR), the Department of Labor/
Occupational Safety and Health Administration (OSHA), the National 
Institute of Occupational Safety and Health (CDC/NIOSH), the Department 
of Transportation (DoT), the Department of Commerce (DoC), the 
Department of Energy (DoE), the Department of Justice (DoJ), the 
Federal Bureau of Investigation (FBI), the Central Intelligence Agency 
(CIA), the Defense Intelligence Agency (DoD/DIA), and the U.S. Postal 
Service (USPS). For these reasons, we are making no change based on 
this comment.
Prion Agents
    One commenter asserted that the Creutzfeldt-Jacob Disease and Kuru 
agents should be added to the list of HHS select agents and toxins. The 
commenter noted that the ``Arguments for omission include the 
difficulty of obtaining these agents, the extreme difficulty of 
replicating them, low infectivity by the oral route, and the absence of 
person-to-person infectivity.'' The commenter then argued that they 
should be included based on the conclusions ``that a single real or 
claimed incident of contaminating a childhood vaccine with a prion 
would cause indescribable anguish'' and that ``The difficulty of 
confirming or refuting a claim that prions had been added to a vaccine 
would cripple most legitimate public health programs and result in 
epidemics of preventable diseases.'' The commenter concluded by stating 
that ``In my judgment, the remote but extreme risk fully justifies the 
cost of including prions that are infectious to humans.'' We made no 
changes based on this comment. Based upon the criteria that the HHS 
Secretary must consider, it was the consensus of the Secretary's Select 
Agent and Toxin Working Group that Creutzfeldt-Jacob Disease (CJD) and 
Kuru agents should not be added to the list because the degree of 
contagiousness of prions are too low to pose a significant mass 
casualty threat. While they are infectious under some circumstances, 
such as cannibalism in New Guinea causing Kuru or Creutzfeldt-Jacob 
Disease by the consumption of infected bovine central nervous system 
tissue, there is no evidence of contact or aerosol transmission of 
prions from one human to another.
Viruses
    The amended interim final rule included Cercopithecine herpesvirus 
1 (Herpes B virus) on the list of viruses designated as HHS select 
agents and toxins. Commenters acknowledged that the virus naturally 
infects many species of macaques and can produce a serious, often 
fatal, infection in humans when not treated. 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.
     Human infections are extremely rare--this is evidenced by 
the finding that of the literally hundreds of thousands of people who 
have worked with macaques over the past seventy years, there have been 
at most 50 human cases establishing infections with 23 documented 
deaths (one commenter argued that the low number of human cases may 
reflect infrequent shedding in macaque hosts or difficulty in the 
transmission of the agent to humans).
     The virus is capable of being treated with several 
available antiviral compounds.
     The inclusion of the virus on the list will significantly 
complicate transport for biomedical and biodefense research of macaques 
that are healthy, but chronically infected with B virus.
     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.''
    Commenters further stated that if the intent of inclusion is to 
monitor laboratories that cultivate large volumes of the virus in vitro 
then the rule should only cover this aspect.
    We made no changes based on these comments. We have concluded that 
Cercopithecine herpesvirus 1 (Herpes B virus) has high morbidity, can 
be replicated in large concentrations, and can cause infections via the 
aerosol route. The regulations exclude ``any select agent or toxin that 
is in its naturally occurring environment provided that it has not been 
intentionally introduced, cultivated, collected, or otherwise extracted 
from its natural source.'' This would include species of macaques that 
have been naturally infected with Cercopithecine herpesvirus 1 (Herpes 
B virus) as long as the virus has not been intentionally introduced, 
cultivated, collected, or otherwise extracted from its natural source.
    The amended interim final rule included Eastern Equine Encephalitis 
virus on the list of viruses designated as overlap select agents and 
toxins. One commenter asserted that the South/Central American subtypes 
of the virus should be deleted from the list. This was based on the 
finding that ``The Naval Medical Research Center Detachment (Lima, 
Peru) has studied over 6,600 cases of febrile illness in Iquitos [sic] 
and surrounding areas since 1994, but has never detected a single case 
of human EEE despite repeated isolations of the virus (two of the three

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South American subtypes) from mosquitoes in the same locations (Douglas 
Watts, UTMB, unpublished).'' The commenters concluded that ``therefore, 
the South/Central American subtypes are probably completely avirulent 
for people and not a bioterrorism risk.'' We made no changes based on 
this comment. There are no published data supporting the commenters' 
assertion. Further, a literature search indicated that there are 
examples of South American EEE strains that are lethal in humans and 
studies of animal models have produced conflicting results.
Fungi
    The list of select agents includes Coccidioides posadasii and 
Coccidioides immitis. One commenter questioned whether either of these 
should be included on the list of select agents and toxins. We made no 
changes based on this comment. These agents cause high morbidity in 
humans, are highly infectious via the aerosol route, and sporulate 
easily in culture. Also, there is no vaccine available.
Toxins
    One commenter recommended that Mistletoe lectin I, Modeccin, and 
Volkensin be reviewed for inclusion in the list of select agents and 
toxins. The commenter argued that ``These toxins are toxicologically 
similar (LD50 and medical affect) to Ricin and Abrin [both are included 
as select toxins] and are readily available since they freely grow 
without cultivation.'' We made no changes based on this comment. Like 
ricin, these toxins have only moderate toxicity compared to other 
toxins on the list. However, unlike ricin, these toxins are not readily 
available in partially purified forms in sufficient quantities to pose 
a significant public health threat.
    The amended interim final rule included Diacetoxyscirpenol and T-2 
toxin on the list of select agents and toxins. One commenter asserted 
that it is pointless to include them on the list because they can 
easily be produced using readily available materials. The amended 
interim final rule also included conotoxins, saxitoxin, and 
tetrodotoxin on the list of select agents and toxins. One commenter 
asserted that the list of select agents should not include ``chemically 
fragile, small molecule/peptide neurotoxins (tetrodotoxin, saxitoxin, 
end u-conotoxin [sic]), that exhibit limited stability at room 
temperature.'' The commenter argued that ``conotoxins and agatoxins 
are, for example, very rapidly degraded in water because they are 
triple-disulfide bonded polypeptides that require reducing agents (beta 
mercaptoethanol or dithicthreitol [sic] on the bench, glutethione [sic] 
in the organism) to retain their proper folded, disulfide-bonded 
structure.'' The commenter further argued that ``The disulfide bonds 
are very readily oxidized and the oxidized toxin molecules have no 
toxic activity whatsoever'' and that ``Indeed, one of our headaches 
with these toxins is that shipments are sometimes useless because the 
toxin has become oxidized.'' We made no changes based on these 
comments. These toxins pose a significant public health threat because 
they have acute toxicity, could be produced in large quantities, and 
can be transferred by an aerosol method. We agreed with the commenter 
that once those toxins have been degraded, oxidized, or in any other 
form in which the toxic has become nonfunctional, they would be 
excluded from regulation under this part.
    The amended interim final rule included Staphylococcal enterotoxins 
on the list of select agents and toxins. One commenter asserted that it 
should be removed from the list based on the conclusion that even 
though ``Staph. food intoxication can make you wish you were dead for 
24 to 48 hours'' the ``general public death rate is only 0.03% and for 
the very young and very old it is 4.4%.'' We made no changes based on 
this comment. These toxins pose a significant public health threat 
because they have acute toxicity, could be produced in large 
quantities, and can be transferred by an aerosol method.
    The amended interim final rule included Botulinum neurotoxins on 
the list of select agents and toxins. However, under the amended 
interim final rule, botulinum neurotoxins are not regulated if the 
aggregate amount under the control of a principal investigator does 
not, at any time, exceed 0.5 mg. One commenter asserted that there 
should be no exemption for botulinum neurotoxins. The commenter argued 
that ``based on primate studies, the human lethal amount of botulinum 
toxin by intravenous exposure is 0.10 microgram, by aerosol exposure 
(inhalation) is 0.75 microgram, and by oral exposure (ingestion) is 
75.0 micrograms'' and concluded that ``the proposed 500 microgram 
amount of unregistered and unregulated botulinum toxin represents, 
respectively, 5000 intravenous lethal doses, 667 inhalational lethal 
doses, and 6.7 oral lethal doses.'' The commenter further asserted that 
Botulism Research Coordinating Committee and National Institute of 
Allergy and Infectious Disease's Blue Ribbon Technical Advisory Panel 
on Botulinum Toxin concluded without dissent that an exclusion should 
not be in effect. The commenter also argued ``increased funding for 
biodefense work may attract newcomers to the field, who lack previous 
experience in working with botulinum toxin and therefore are at greater 
risk of laboratory accident'' and that it might be possible for a 
``front laboratory or institution to order just under 500 micrograms of 
botulinum toxin from each of the several commercial vendors 
simultaneously and accumulate a cache of toxin that a terrorist might 
access.'' We made no changes based on this comment. This final rule 
represents a legislative mandate to balance the regulatory oversight of 
agents and toxins that have the potential to pose a severe threat to 
public health and safety while maintaining availability of these agents 
and toxins for research and educational activities. The amount of each 
toxin that could be possessed without regulation by a principal 
investigator, a treating physician or veterinarian, or a commercial 
manufacture or distributor was determined on the basis of toxin potency 
and how much one could safely possess without constituting a potential 
threat to public safety or raising concerns about use as a weapon that 
would have a widespread effect. The level specified in the rule was 
determined after consultation with subject matter experts on this 
toxin. The determination that a toxin posed a severe public health 
threat was based on the ability for the mass distribution of the toxin 
for mass casualty purposes.
    To address the commenter's concerns, the lethal amounts cited 
represent theoretical amounts extrapolated from primate studies based 
upon optimal conditions. The value of ``5,000 intravenous lethal 
doses'' requires a mode of delivery that is impractical for inflicting 
mass casualties. The value of ``667 aerosol lethal doses'' assumes 100% 
dissemination efficiency for a protein aerosol which is highly unlikely 
and does not take into consideration that botulinum neurotoxin is not 
very stable under ambient conditions. The public comment estimates that 
there are less than 7 oral human lethal doses in 0.5 mg of botulinum 
neurotoxin. However, the excluded amount of botulinum neurotoxin would 
have to be optimally disseminated to cause the estimated number of 
fatalities.
    As noted above, with certain exceptions, the amended interim final 
rule included Botulinum neurotoxins on the list of select agents and 
toxins. One commenter questioned whether there are Botulinum toxins 
that are not

[[Page 13298]]

neurotoxins and asserted that if the answer is yes the name should be 
changed to ``Botulinum toxins'' and if the answer is no the name should 
be changed to ``Botulinum neurotoxins only.'' We made no changes based 
on this comment. We are regulating the neurotoxins and the organism 
that produces the neurotoxin.
    The amended interim final rule states that the list of HHS select 
toxins subject to regulation ``does not include the following toxins 
(in the purified form or in combinations of pure and impure forms) if 
the aggregate amount under the control of a principal investigator does 
not, at any time, exceed the amount specified: 100 mg of abrin; 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; or 
100 mg of tetrodotoxin.'' The amended interim final rule states that 
the list of overlap select toxins subject to regulation ``does not 
include the following toxins (in the purified form or in combinations 
of pure and impure forms) if the aggregate amount under the control of 
a principal investigator does not, at any time, exceed the amount 
specified: 0.5 mg of botulinum neurotoxins; 5 mg of Staphylococcal 
enterotoxins; 100 mg of Clostridium perfringens epsilon toxin; 100 mg 
of shigatoxin; or 1,000 mg of T-2 toxin.''
    One commenter asserted that the regulations should not provide 
exemptions for any toxins based on an aggregate amount. We made no 
changes based on this comment. The quantity amounts exempted have been 
determined by subject matter experts and would not pose a significant 
public health threat.
    Also, as noted above, for toxins to be excluded they must be 
``under the control of a principal investigator.'' The term ``principal 
investigator'' is defined as ``the one individual who is designated by 
the entity to direct a project or program and who is responsible to the 
entity for the scientific and technical direction of that project or 
program.'' We are retaining these provisions but are broadening the 
list of those eligible to exercise such control to include not only 
principal investigators, but also treating physicians and 
veterinarians, and commercial manufacturers or distributors.
    Although the language of the exclusion provisions in the amended 
interim final rule focused on principal investigators, we did not 
intend to cause the possession or transport of otherwise excluded 
toxins to be covered by the amended interim final rule if the entity 
has a legitimate use for the toxin such as would be the case for 
treating physicians and veterinarians (including those providing off-
label use) or commercial manufacturers or distributors. In any event, 
we believe that the specified toxins at levels below the threshold 
levels do not meet the Act's criteria for inclusion as select agents or 
toxins (having the potential to pose a severe threat to public health 
and safety) regardless of whether they are under the control of a 
principal investigator, a treating physician or veterinarian, or a 
commercial manufacturer or distributor. To attempt to regulate these de 
minimus quantities would impose an unreasonable regulatory burden on 
the public. Accordingly, we changed the regulations to provide that the 
exclusions would apply if under the control of a principal 
investigator, a treating physician or veterinarian, or a commercial 
manufacturer or distributor.
Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms
    The provisions of the amended interim final rule concerning genetic 
elements, recombinant nucleic acids, and recombinant organisms include 
as select agents and toxins:
    (1) Select agent viral nucleic acids (synthetic or naturally 
derived, contiguous or fragmented, in host chromosomes or in expression 
vectors) that can encode infectious and/or replication competent forms 
of any of the select agent viruses.
    (2) Nucleic acids (synthetic or naturally derived) that encode for 
the functional form(s) of any of the toxins listed in paragraph (d) of 
this section if the nucleic acids:
    (i) Are in a vector or host chromosome;
    (ii) Can be expressed in vivo or in vitro; or
    (iii) Are in a vector or host chromosome and can be expressed in 
vivo or in vitro.
    (3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) 
through (d) of this section that have been genetically modified.
    Commenters recommended that for purposes of clarity paragraph (1) 
should state: ``Nucleic acids that can encode infectious and/or 
replication competent forms of any of the select agent viruses.'' One 
commenter recommended that the following should be added at the end of 
paragraph (1) in both Sec. Sec.  73.3 (e) and 73.4 (e): ``or a nucleic 
acid (synthetic or naturally derived) comprising at least 15% of the 
genome of a select agent.'' We agreed that clarification was needed and 
changed the language in paragraph (1) accordingly. The regulation now 
states that only nucleic acids (regardless of size) or replication 
competent forms of any select agent viruses that are subject to these 
regulations are those nucleic acids that can produce infectious select 
agent viruses.
    One commenter asserted that subparagraphs (i), (ii), and (iii) 
should be deleted from paragraph (2) based on the argument that nucleic 
acids in paragraph (2) covers all forms that encode for the functional 
forms. In response, we changed paragraph (2) to cover: ``Recombinant 
nucleic acids that encode for the functional form(s) of any HHS or 
overlap toxins listed in paragraph (b) of this section if the nucleic 
acids:
    (i) Can be expressed in vivo or in vitro; or
    (ii) Are in a vector or recombinant host genome and can be 
expressed in vivo or in vitro.''
    We believe this covers all of the functional forms.
    Commenters asserted that ``the government should require that 
service providers test for Select Agent sequences'' before they are 
made and transferred. The commenters argued that ``Although the Select 
Agent program covers transfer and possession of Select Agents, if DNA 
synthesis companies do not check the sequences they could inadvertently 
synthesize and transfer a Select Agent.'' We made no changes based on 
these comments. It is incumbent upon the entities that manufacture 
substances to know what they are manufacturing and to ensure that they 
comply with the provisions of the regulations in part 73 and 9 CFR part 
121.
    One commenter asserted that a database listing regulated genetic 
sequences should be created for the regulated community. We made no 
changes based on this comment. We believe that a database listing all 
the genetic sequences that can produce infectious forms of any of the 
select agent viruses or that can encode for the functional forms of any 
of the toxins listed is not practicable. However, the National Center 
for Biotechnology Information maintains a publicly available database 
(https://www.ncbi.nlm.nih.gov/) of nucleic acid sequence information 
that the regulated community could use as a resource in determining if 
the genetic sequence to be created is subject to this regulation.
Exclusions
    The amended interim final rule states that the list of select 
agents and toxins does not include any select agent or toxin that is 
``in its naturally occurring

[[Page 13299]]

environment provided it has not been intentionally introduced, 
cultivated, collected, or otherwise extracted from its natural 
source.'' One commenter requested clarification regarding what was 
meant by ``natural environment.'' The commenter asked ``For example, 
are milk samples that contain Coxiella burnetii, or macque [sic] tissue 
with Herpes B virus a natural environment?'' and ``Is an entity 
required to report the ``identification'' of a select agent from these 
samples, or is the entity exempted based on natural environment?'' 
Consistent with this comment, commenters asserted that naturally 
occurring wild-type shiga toxin-producing E. coli strains should not be 
included in the list of select agents and toxins. We made no changes 
based on these comments. Wild-type shiga toxin-producing E. coli 
strains are not subject to this part. However, Shigatoxin and Shiga-
like ribosome inactivating proteins produced by this agent are subject 
to this part. Select agents in their naturally occurring environment 
could include animals that are naturally infected with a select agent 
or toxin (e.g., macaques that are naturally infected with 
Cercopithecine herpesvirus 1 or milk samples that contain Coxiella 
burnetti). However, a select agent or toxin that has been intentionally 
introduced, cultivated, collected, or otherwise extracted from its 
natural source, including tissues from animals or agents or toxins 
obtained from milk samples that have been naturally infected with a 
select agent or toxin, is subject to this part and in such a case the 
entity is required to report the select agent or toxin upon 
identification.
    One commenter asserted that the regulations should exclude fixed 
tissues that are, bear, or contain select agents or toxins. We made no 
changes based on this comment. The amended interim final rule excluded 
non-viable select agents and nonfunctional toxins. This includes such 
fixed tissues provided the agents that may be present are rendered non-
viable.
    Under the amended interim final rule, non-viable select agents or 
nonfunctional toxins are excluded from regulation. One commenter 
requested that we add definitions of ``non-viable'' and 
``nonfunctional'' based on the assertion that ``Some organisms can 
survive in nature, others only with laboratory conditions, while others 
will not grow under any conditions.'' We made no changes based on this 
comment. Regardless of the environment in which an organism can or 
cannot survive, the standard established by the regulations is whether 
the organism is viable, or whether the toxin is functional, based on 
the plain meaning of the words. Further, the regulations are clear in 
that they exclude ``any select agent or toxin that is in its naturally 
occurring environment provided that it has not been intentionally 
introduced, cultivated, collected, or otherwise extracted from its 
natural source.'' The regulations also exclude ``non-viable select 
agents or nonfunctional toxins.''
    The amended interim final rule excluded from the regulation certain 
toxins (in the purified form or in combinations of pure and impure 
forms) if the aggregate amount under the control of a principal 
investigator does not, at any time, exceed specified amounts. One 
commenter asserted that the term ``aggregate amount'' is unclear and 
questioned whether it means ``weight of pure plus weight of impure'' or 
``weight of pure plus weight of pure in impure''? The commenter 
recommended that it be defined to mean the latter. For clarification 
purposes, we have deleted the language ``in the purified form or in 
combinations of pure and impure forms'' so that it is clear that the 
regulations are dealing with the total amount of the toxins regardless 
of the form.
    The amended interim final rule provided that the HHS Secretary may 
exclude attenuated strains of select agents or toxins upon a 
determination that they do not pose a severe threat to public health 
and safety. The amended interim final rule also provided that in 
response to an application submitted to the HHS Secretary, the HHS 
Secretary will provide a written decision granting the request, in 
whole or in part, or denying the request. It further stated that an 
exclusion will be effective upon notification to the applicant and that 
exclusions would be published in the notice section of the Federal 
Register and listed on the CDC Web site at https://www.cdc.gov/. In 
addition, it stated that the list would be included in the rule.
    After consultations with subject matter experts, review of relevant 
published studies, and review of information provided by the 
applicants, a number of attenuated strains have been excluded from the 
list of select agents and toxins based on the criteria that these 
agents do not pose a severe threat to public health and safety. One 
commenter asserted that ``Given the cost of compliance with these 
regulations, the appropriate list of select agents, including a list of 
exempted [sic] strains, should be in place at the time the regulations 
are implemented.'' In response, we note that a number of excluded 
attenuated strains are identified on the CDC Web site. We also listed 
them in the amended interim final rule. To minimize the potential 
delays related to rulemaking, in this final rule we are providing that 
excluded attenuated strains of select agents or toxins will be 
periodically published in the Federal Register notice and maintained on 
the Internet at https://www.cdc.gov. We believe these measures will 
provide sufficient notice to the public. Therefore, we are making no 
change based on this comment.
    Commenters asserted that specific criteria for evaluating 
exclusions for attenuated strains of select agents and toxins should be 
added to the regulations and further asserted that the broad 
microbiological community, not just government agency representatives, 
must be involved in this process. We made no changes based on these 
comments. The Act sets the criteria for excluding attenuated strains, 
i.e., they may be excluded if they do not pose a severe threat to 
public health and safety, (42 U.S.C. 262a(a)). We will consult with 
appropriate Federal departments and agencies and with scientific 
experts representing appropriate professional groups depending on the 
attenuated strain being considered.
    A number of commenters asserted that the government should ensure 
that prompt determinations are made in response to applications for 
exclusions. One commenter suggested that a timeline for responses be 
established. We made no changes based on these comments. We will do our 
best to make prompt determinations, but the highest priority is to 
protect public health and safety.
    For clarification, we added the language that if an excluded 
attenuated strain is subjected to any manipulation that restores or 
enhances its virulence, the resulting select agent or toxin will be 
subject to the requirements of this part.
    In addition, in this final rule, we are adding a new paragraph (f) 
to 42 CFR 73.3 and 73.4 to address concerns raised by Federal law 
enforcement agencies related to seizures (i.e., possession) of known 
select agents or toxins. Paragraph (f) provides that any known select 
agent or toxin seized by a Federal law enforcement agency will be 
excluded from the requirements of the regulations during the period 
between seizure of the agent or toxin and the transfer or destruction 
of such agent or toxin provided that (1) as soon as practicable, the 
Federal law enforcement agency transfers the seized agent or toxin to 
an entity eligible to receive such agent or toxin or destroys

[[Page 13300]]

the agent or toxin by a recognized sterilization or inactivation 
process; (2) the Federal law enforcement agency safeguards and secures 
the seized agent or toxin against theft, loss, or release and reports 
any theft, loss, or release of such agent or toxin; and (3) the Federal 
law enforcement agency reports the seizure of the select agent or toxin 
by submitting the APHIS/CDC Form 4.
    This provision will allow Federal law enforcement agencies to 
conduct certain law enforcement activities (e.g., collecting evidence 
from a laboratory crime scene) without being in violation of the 
regulations. We note, however, that this provision does not authorize 
the seizure of a select agent or toxin by a Federal law enforcement 
agency; rather, it establishes the conditions under which a Federal law 
enforcement agency may seize a known select agent or toxin without 
violating the regulations. Any seizure of a known select agent or toxin 
by a Federal law enforcement agency must be conducted in accordance 
with all applicable laws and regulations.
    To address concerns raised by Federal law enforcement agencies 
related to seizures (i.e., possession) of select agents or toxins, in 
this final rule we are adding a new paragraph (f) to Sec. Sec.  73.6(a) 
and 73.7(a) to address situations in which the select agents or toxins 
have been identified prior to seizure. In the event that a Federal law 
enforcement agency seizes a suspected select agent or toxin or unknown 
material, this material will be regarded as a specimen presented for 
diagnosis or verification and, therefore, will not be subject to the 
regulations until it has been identified as a select agent or toxin.

Sections 73.5 and 73.6 Exemptions for HHS and Overlap Select Agents and 
Toxins and Diagnosis, Verification, or Proficiency Testing

    The amended interim final rule provided that an individual or 
entity is exempt from the provisions of part 73, other than transfer 
provisions, if the entity only conducted activities with select agents 
or toxins that were contained in specimens presented for diagnosis, 
verification, or proficiency testing. We clarified the language to 
state ``Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer a select agent or toxin that is contained in 
a specimen presented for diagnosis or verification will be exempt from 
the requirements of this part for such agent or toxin contained in the 
specimen''. This clarification was made in recognition that in certain 
cases regulated individuals and entities may also be conducting non-
regulated activities.
    The exemption provisions apply only if, among other things, the 
individual or entity within specified time periods (seven calendar days 
after identification of select agents and toxins used for diagnosis or 
verification; within 90 calendar days after receipt of select agents or 
toxins used for proficiency testing) submits a completed form regarding 
the disposition of the select agents or toxins. We have added language 
stating that less stringent reporting may be required based on 
extraordinary circumstances, such as a widespread outbreak. This will 
help prevent large numbers of reports in those instances when such 
reports would not be useful for taking action to protect the public's 
health and safety. In addition, CDC and APHIS have combined their 
immediate notification list for overlap select agents and toxins 
(Bacillus anthracis, Botulinum neurotoxins, Francisella tularensis, 
Brucella melitensis, Hendra virus, Nipah virus, Rift Valley fever 
virus, and Venezuelan equine encephalitis virus). Therefore, entities 
will be able to immediately notify either agency.
    One commenter asserted that the exemption provisions should not 
exist based on the argument that select agents and toxins may be 
obtained from the environment and those conducting diagnosis, 
verification, or proficiency testing are capable of isolating and 
growing them. The commenter further asserted that at the very least all 
clinical and diagnostic laboratory employees should be subject to the 
security risk assessments. We made no changes based on this comment. 
Such changes would be contrary to the exemption provisions mandated by 
the Act (42 U.S.C. 262a).
    Commenters argued that the exemption provisions should contain 
safeguarding requirements that would apply to select agents and toxins 
from the time they are identified until they are transferred or 
destroyed. One commenter argued that the safeguarding requirements 
should be the same as those that would apply if they were not subject 
to the exemption provisions. In response, we agree that the entity must 
take measures to safeguard the select agents or toxins. Accordingly, we 
have included a provision in the regulations to require the entity to 
secure the specimens or isolates containing a select agent or toxin 
during the period from identification until transfer or destruction. In 
addition, we added the provisions that the individual or entity must 
also meet the requirements of Sec.  73.19 (Notification of theft, loss, 
or release). We believe that any theft, loss, or release of a select 
agent or toxin must be reported to protect public health and safety.
    Commenters opposed the exemption provisions concerning diagnosis or 
testing that require an entity to transfer or destroy select agents or 
toxins. The commenters opposed the destruction option by asserting that 
by encouraging diagnostic laboratories such as state health facilities 
to destroy all isolates, the ability to deal with future outbreaks and 
terrorist events would be undermined. More specifically, they argued:
     ``Destruction will result in the loss of valuable 
scientific material since much of our knowledge of the ecology and 
epidemiology of emerging and select agents, and our future ability to 
identify the source of a terrorist introduction, depend on having 
collections of reference agents available for genetic and phenotypic 
analyses.
     If an agent is introduced by a terrorist group in a failed 
attempt to cause an outbreak, and the samples are all destroyed, 
retrospective analyses of activities preceding a significant 
bioterrorist event will be hampered by the loss of information.''
    One commenter also asserted that the final rule should require CDC 
to consult with the state public health laboratory director or other 
appropriate contact such as the state health officer before destroying 
a select agent or toxin based on the conclusion that ``There may be 
circumstances in which a state public health laboratory director would 
want such specimens or isolates preserved to support epidemiologic 
investigations in the state * * * such as isolated cases of Yersinia 
pestis infection in the Southwest, but for which state-based infection 
control activities must proceed.'' One commenter suggested that a team 
from the Department of Justice could ``arrive and monitor the 
situation, and safeguard the isolate.''
    The regulations require that a diagnostic or testing entity 
transfer or destroy a select agent or toxin if, and only if, such an 
entity does not want to be registered pursuant to the Select Agent 
regulations. If any entity has a legitimate need to keep possession of 
a select agent or toxin it may do so once it has become registered. We 
have added a provision to allow a diagnostic or testing entity to 
retain possession of a select agent or toxin in situations where it has 
been determined that such action is necessary to protect public health 
and safety.
    Commenters argued that the seven day requirement for transferring 
or destroying select agents or toxins used for diagnosis or testing is 
too short a

[[Page 13301]]

time limit. We made no changes based on these comments. Based on input 
from technical experts and risks posed by select agents and toxins, we 
believe seven calendar days provides a sufficient amount of time for 
the entity to destroy or transfer the select agents or toxins after 
identification. However, as noted above, we have included language for 
special allowance of these provisions when necessary to protect public 
health and safety.
    One commenter asserted that the final rule should not require an 
entity to submit to CDC a record of destruction of select agents or 
toxins or as an alternative should require ``entities to maintain a 
record of destruction, which would be subject to inspection by CDC and/
or APHIS.'' The commenter argued that ``This action would reduce the 
associated paperwork burden and maintain consistency with the intent of 
the regulations.'' The commenter further stated that ``Unlike transfers 
from other regulated entities, a transfer record does not precede 
isolation through diagnostic procedures.'' We made no changes based on 
this comment. The Act requires a report of the identification of select 
agents or toxins (42 U.S.C. 262a(g)(1)(a)). We need to be advised of 
the disposition to ensure compliance with the requirements of the 
regulations and to ensure the protection of public health and safety.
Exempted Products
    The amended interim final rule provides for exemption from the 
regulations under certain circumstances for products that are, bear, or 
contain listed select agents or toxins that are cleared, approved, 
licensed, or registered under any of the specified laws, insofar as 
their use is only for the approved purpose and meets the requirements 
of such laws. Commenters asserted that the requirement that the use be 
limited to approved purposes be deleted because of the allowance of 
off-label use. In response, we agree and have deleted the ``approved 
purpose'' language. We see no reason to distinguish between products 
that are used for off-label, but in a manner that doesn't violate the 
law, and products that are used in accordance with the approved 
labeling.
    One commenter recommended that the regulations list the exempted 
products. We made no changes based on this comment. The regulations 
provide the criteria for determining which products are exempt and it 
would be impracticable for the maintenance of such a list.
    The amended interim final rule provided that the HHS Secretary on a 
case-by-case basis may exempt from the requirements of the part 73 
regulations an investigational product that is, bears, or contains a 
select agent or toxin, when such product is being used in an 
investigation authorized under any of four specified Federal acts and 
additional regulation is not necessary to protect public health and 
safety. The final rule allows such an exemption under any Federal act 
since the statutory authority allows exemptions for investigational 
products under any Federal act.

Section 73.7 Registration and Related Security Risk Assessments, Sec.  
73.8 Denial, Revocation, or Suspension of Registration, and Sec.  73.10 
Restricting Access to Select Agents and Toxins; Security Risk 
Assessments

[These Subjects Are in Sec. Sec.  73.7 and 73.8 in the Amended Interim 
Final Rule]
General
    We have revised the provisions regarding registration and security 
risk assessments and, as noted above, have placed these provisions in 
three sections: Sec.  73.7 (Registration and related security risk 
assessments), Sec.  73.8 (Denial, revocation, or suspension of 
registration), and Sec.  73.10 (Restricting access to select agents and 
toxins; security risk assessments). To conduct certain activities 
regulated under part 73, the revised provisions, consistent with the 
provisions of the amended interim final rule, require that the 
individual or entity obtain a certificate of registration and that the 
following must have an approval from the HHS Secretary or Administrator 
following a security risk assessment by the Attorney General: the 
individual or entity, any individual who owns or controls the entity, 
the Responsible Official of the entity, and any individual who is to 
access select agents or toxins under the entity's certificate of 
registration.
    One commenter, a private, non-profit organization that provides 
medical research personnel to work at government entities for the 
purpose of performing work covered by the regulations, requested that 
the regulations be changed to state that such a private non-profit 
organization would not be subject to any requirements imposed by the 
regulations. We made no changes based on this comment. The entity 
conducting regulated activities must obtain a certificate of 
registration and otherwise comply with the Part 73 regulation. Also, 
any individuals having access to select agents or toxins on behalf of 
an entity must meet the requirements for such activities, regardless of 
the type of entity.
    One commenter asserted that the regulations should specifically 
``prohibit HHS, USDA or other federal agencies from using the 
information collected through the registration process to evaluate the 
merit of proposals involving research on select agents or toxins.'' We 
made no changes based on this comment. The regulations contain 
provisions to implement the intent of the Act which is to provide 
protection against the effects of misuse of select agents and toxins 
whether inadvertent or the result of terrorist acts against the United 
States homeland or other criminal acts. The part 73 regulations contain 
no provisions for evaluating the merits of research proposals and are 
not intended to cover such activities.
    One commenter asserted that the approval process for security risk 
assessments should include requirements for credit checks and random 
drug screening. We made no changes based on this comment. With respect 
to security risk assessments, the Act provides that the Attorney 
General shall use criminal, immigration, national security, and other 
electronic databases available to the Federal Government, as 
appropriate for the purpose of identifying restricted persons and for 
identifying those reasonably suspected of committing certain crimes, 
being involved with an organization that engages in domestic or 
international terrorism, or being an agent of a foreign power. The Act 
does not provide for credit checks or random drug screening.
    Commenters asserted that the regulations should explicitly provide 
that the clearance process is confidential. We made no changes based on 
these comments. Information obtained as a result of the security risk 
assessment process will be protected in accordance with the provisions 
of the Privacy Act.
Individual Who Owns or Controls the Entity
    Commenters asserted that provisions requiring a security risk 
assessment approval for an individual who ``owns or controls the 
entity'' should not apply to educational institutions. One commenter 
asserted that ``under most state laws governing the organization of 
nonprofit entities such as a university, there are no owners of the 
entity, i.e., no stockholders or partners, because the entity is 
organized for the good of the public, not for the good of the 
`stockholders' or `investors.' '' They expressed concern regarding 
possible delays if these provisions were broadly interpreted to include 
members of the board of trustees or other similar officials. One 
commenter asserted that

[[Page 13302]]

``the interpretation of ``control'' should be limited to those 
individuals who will have actual access to the select agents.'' One 
commenter recommended that we define ``ownership or control'' to mean 
the right to exercise control of an entity ``regardless whether such 
right results from a substantial economic interest or contractual or 
other right to manage an entity.''
    In response, we have added the following language:
    (2) Federal, State, or local governmental agencies, including 
public institutions of higher education, are exempt from the security 
risk assessments for the entity and the individual who owns or controls 
such entity.
    (3) An individual will be deemed to own or control an entity under 
the following conditions: \1\
---------------------------------------------------------------------------

    \1\ These conditions may apply to more than one individual.
---------------------------------------------------------------------------

    (i) For a private institution of higher education, an individual 
will be deemed to own or control the entity if the individual is in a 
managerial or executive capacity with regard to the entity's select 
agents or toxins or with regard to the individuals with access to the 
select agents or toxins possessed, used, or transferred by the entity.
    (ii) For entities other than institutions of higher education, an 
individual will be deemed to own or control the entity if the 
individual:
    (A) Owns 50 percent or more of the entity, or is a holder or owner 
of 50 percent or more of its voting stock, or
    (B) Is in a managerial or executive capacity with regard to the 
entity's select agents or toxins or with regard to the individuals with 
access to the select agents or toxins possessed, used, or transferred 
by the entity.
    (4) An entity will be considered to be an institution of higher 
education if it is an institution of higher education as defined in 
section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), 
or is an organization described in 501(c)(3) of the Internal Revenue 
Code of 1986, as amended (26 U.S.C. 501(c)(3)).''
    We believe the language is consistent with the statutory language 
in section 351 A(e)(6)(B) from the Act which exempts Federal, State, or 
local governmental agencies including public institutions of higher 
education from the security risk assessments for the entity and the 
individual who owns or controls such entity. However, the Act does not 
exempt other individuals or entities even those nonprofit entities from 
the security risk assessment provisions. In addition, we believe those 
individuals that own or control the entity relevant to the entity's 
possession, use, or transfer of select agents or toxins should be 
required to undergo a security risk assessment. However, we determined 
that not all owners or controllers of an entity were relevant to an 
entity's possession, use, or transfer of a select agent and added 
language to identify those individuals who were in a ``managerial or 
executive capacity with regard to the entity's select agents or 
toxins'' such as laboratory directors.
    One commenter asserted that the security risk assessment provisions 
should apply to entities that own or control entities possessing or 
transferring select agents. We made no changes based on this comment. 
The Act requires a security risk assessment for an entity (at any 
level) that conducts regulated activities and for individuals who own 
or control such entity.
Coordination of Activities
    Commenters recommended that CDC and APHIS coordinate their 
activities regarding select agents and toxins through a single office. 
The commenters argued that such coordination through one office would 
decrease regulatory burdens, ensure consistency in agency decision 
making, and ultimately promote compliance. They also argued that 
without a single office, entities conducting activities regulated 
solely by USDA and solely by HHS would be required to submit dual 
registrations, obtain dual security risk assessments, and prepare other 
dual packages, such as safety plans and security plans. One commenter 
argued that such duplication is contrary to the statutory requirements.
    In order to minimize the burden to the public required to register 
to possess, use or transfer select agents and toxins, a single point of 
contact has been developed. This single point of contact is responsible 
for coordinating all activities and communications with respect to the 
entity's registration, including coordination with both the non-lead 
agency and with Federal Bureau of Investigations, Criminal Justice 
Information Services Division. This single point of contact will retain 
responsibility for the application for the life of the registration 
certificate (2-3 years). In addition, a single shared web-based system 
is under development that will allow the regulated community to conduct 
transactions electronically via a single web portal. We envision that 
this system will enable the entity to dynamically communicate in a 
digitally secured environment using a single web portal. The web portal 
will provide a platform for electronic exchange of information. It will 
allow entities to access data related to their own registration data 
and allow them to create, amend,