[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Proposed Rules]
[Pages 61228-61244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25520]



[[Page 61227]]

Vol. 76

Monday,

No. 191

October 3, 2011

Part V





Department of Agriculture





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 Animal and Plant Health Inspection Service





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7 CFR Part 331

9 CFR Part 121





 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and 
Republication of the Select Agent and Toxin List; Amendments to the 
Select Agent and Toxin Regulations; Proposed Rule

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

[[Page 61228]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2009-0070]
RIN 0579-AD09


Agricultural Bioterrorism Protection Act of 2002; Biennial Review 
and Republication of the Select Agent and Toxin List; Amendments to the 
Select Agent and Toxin Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are proposing to amend and republish the list of select 
agents and toxins that have the potential to pose a severe threat to 
animal or plant health, or to animal or plant products. The Act 
requires the biennial review and republication of the list of select 
agents and toxins and the revision of the list as necessary. This 
action would implement the findings of the third biennial review of the 
list. In addition, we are proposing to reorganize the list of select 
agents and toxins based on the relative potential of each select agent 
or toxin to be misused to adversely affect human, plant, or animal 
health. Such tiering of the list would allow for the optimization of 
security measures for those select agents or toxins that 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. We are also proposing a number of 
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 
usability of the select agent regulations as well as provide for 
enhanced program oversight.

DATES: We will consider all comments that we receive on or before 
December 2, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0070-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2009-0070, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2009-
0070 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.

FOR FURTHER INFORMATION CONTACT: Mr. Charles L. Divan, Branch Chief, 
APHIS Agriculture Select Agent Program, APHIS, 4700 River Road Unit 2, 
Riverdale, MD 20737-1231; (301) 734-5960.

SUPPLEMENTARY INFORMATION: 

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (referred to below as the Bioterrorism Response 
Act) provides for the regulation of certain biological agents that have 
the potential to pose a severe threat to both human and animal health, 
to animal health, to plant health, or to animal and plant products. The 
Animal and Plant Health Inspection Service (APHIS) has the primary 
responsibility for implementing the provisions of the Act within the 
Department of Agriculture (USDA). 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. 
Plant Protection and Quarantine (PPQ) select agents and toxins are 
those that have the potential to pose a severe threat to plant health 
or plant products. Overlap select agents and toxins are those that have 
been determined to pose a severe threat to both human and animal health 
or animal products. Overlap select agents are subject to regulation by 
both APHIS and the Centers for Disease Control and Prevention (CDC), 
which has the primary responsibility for implementing the provisions of 
the Act for the Department of Health and Human Services (HHS).
    Subtitle B (which is cited as the ``Agricultural Bioterrorism 
Protection Act of 2002'' and referred to below as the Act), section 
212(a), provides, in part, that the Secretary of Agriculture (the 
Secretary) must establish by regulation a list of each biological agent 
and each toxin that the Secretary determines has the potential to pose 
a severe threat to animal or plant health, or to animal or plant 
products. Paragraph (a)(2) of section 212 requires the Secretary to 
review and republish the list every 2 years and to revise the list as 
necessary. In this document, we are proposing to amend and republish 
the list of select agents and toxins based on the findings of our third 
biennial review of the list.
    In determining whether to include an agent or toxin on the list, 
the Act requires that the following criteria be considered:
     The effect of exposure to the agent or the toxin on animal 
and plant health, and on the production and marketability of animal or 
plant products;
     The pathogenicity of the agent or the toxin and the 
methods by which the agent or toxin is transferred to animals or 
plants;
     The availability and effectiveness of pharmacotherapies 
and prophylaxis to treat and prevent any illness caused by the agent or 
toxin; and
     Any other criteria that the Secretary considers 
appropriate to protect animal or plant health, or animal or plant 
products.
    We use the term ``select agents and toxins'' throughout the 
preamble of this proposed rule. Unless otherwise specified, the term 
``select agents and toxins'' will refer to all agents or toxins listed 
by APHIS. When it is necessary to specify the type of select agent or 
toxin, we will use the following terms: ``PPQ select agents and 
toxins'' (for the plant agents and toxins listed in 7 CFR 331.3), ``VS 
select agents and toxins'' (for the animal agents and toxins listed in 
9 CFR 121.3), or ``overlap select agents and toxins'' (for the agents 
and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).
    On July 29, 2010, we published in the Federal Register (75 FR 
44724-44725, Docket No. APHIS-2009-0070) an advance notice of proposed 
rulemaking and request for comments (ANPR) \1\ in order to announce our 
intention to review and reorganize the select agent list. We solicited 
comments regarding potential additions and deletions from the list of 
select agents and toxins as well as comments on reorganization of the 
list based on the relative potential of each select agent or toxin to 
be misused to adversely affect human, plant, or animal health. We 
requested recommendations as to what criteria should be utilized to 
designate high risk select agents and toxins and incorporated those 
recommendations

[[Page 61229]]

into the interagency working group discussions on the matter. We 
solicited comments for 30 days ending August 30, 2010. We received 30 
comments by that date. They were from scientists, scientific 
organizations, private individuals, and industry groups. Suggestions in 
these comments were used in order to inform our discussions on the 
content of the select agent list and our determination regarding 
reorganization of the list.
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    \1\ To view the ANPR and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
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PPQ Select Agents and Toxins

    APHIS's PPQ program convened an interagency working group to review 
the list of PPQ select agents and toxins and develop recommendations 
regarding possible changes to that list. Using the four criteria for 
listing found in the Act, economic crop data, current Federal 
quarantine notices, and new scientific information, the working group 
revisited the currently listed PPQ select agents and toxins and 
evaluated a number of new plant pathogens for inclusion on the list. 
Based on this review, APHIS is proposing to amend the list of PPQ 
select agents and toxins listed in 7 CFR 331.3 by removing Xylella 
fastidiosa, citrus variegated chlorosis (CVC) strain, from the list as 
it no longer meets the criteria for use as an agroterrorism agent. 
Since CVC was first included on the list, extensive research on this 
select agent has been completed. New scientific information has led to 
creation of detection methods that provide for better early response 
and control methods. These new technologies can be applied regardless 
of how the agent might be introduced, including purposeful introduction 
for harmful purposes. Furthermore, the use of geostatistical analysis 
in citrus production areas using geographic information systems is now 
well-developed with relation to monitoring and facilitating a response 
to any purposeful introduction. As a result of this new research, as 
well as the development of new regulatory systems for CVC, the 
likelihood that someone would use CVC as an agent of bioterrorism is 
reduced, and our ability to manage an introduction is increased.

VS Select Agents and Toxins

    APHIS's VS program also convened an interagency working group to 
review the list of VS select agents and toxins and the list of overlap 
select agents and toxins in 9 CFR part 121 in order to update and 
revise the lists as necessary.
    We are proposing to remove nine VS select agents and toxins from 
the list set out in Sec.  121.3(b). Specifically, we are proposing to 
remove the following: Akabane virus; Bluetongue virus (exotic), Bovine 
spongiform encephalopathy agent; Camel pox virus; Ehrlichia ruminantium 
(Heartwater); Japanese encephalitis virus; Malignant catarrhal fever 
virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular 
stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
    The interagency working group considered each of the VS select 
agents and toxins with respect to the four criteria for listing found 
in the Act and based on the group's analysis, APHIS has determined that 
the nine VS select agents and toxins listed above should be removed 
from the list. These agents were judged not to pose a significant 
threat to animal health, either because the disease risk is not 
significant (e.g., low mortality rate in the event of infection), they 
affect only minor (i.e., not economically significant) species, or they 
are not likely to be used as an agroterrorism agent (e.g., difficulty 
of transmission from animal to animal).
    For example, Japanese encephalitis virus primarily affects horses 
and pigs and is transmitted via a mosquito bite. It is not directly 
contagious between animals. Horses represent a dead-end host for the 
disease; mosquitoes biting an infected horse will not pick up virus to 
transmit to any new animals. Pigs represent an amplifying host, but 
modern pig husbandry practices in the U.S. minimize exposure of the 
herd to mosquitoes and make it difficult to establish and sustain a 
natural transmission cycle.
    Likewise, a sustained transmission cycle of malignant catarrhal 
fever virus (Alcelaphine herpesevirus type 1) requires the presence of 
the reservoir host (African wildlife) in close physical association 
with the susceptible domestic species (cattle and bison).
    With respect to the remaining agents:
     Camel pox only affects camels, which are a minor species 
in the US;
     Akabane virus, bluetongue virus (exotic), Ehrlichia 
ruminantium (Heartwater), and vesicular stomatitis virus (exotic): 
Indiana subtypes VSV-IN2, VSV-IN3 all utilize insect vectors as a mode 
of transmission and are not usually spread by direct contact between 
animals;
     Menangle virus transmission is associated with certain 
species of fruit bats, which are native only to Australia and Southeast 
Asia; and
     Bovine spongiform encephalopathy agent is only known to be 
transmitted through the ingestion of infected tissues.
    All of these circumstances make transmission from animal-to-animal 
difficult, which greatly lessens the chance of an outbreak either 
accidental or intentional. Consequently, the extent to which Federal, 
State, and/or local officials need to take special action in planning 
for a major animal health disaster as a result of any of these 
organisms is decreased in light of these factors. Therefore, in 
considering these reasons as well as recommendations provided in 
previous reports such as ``The Report of the Working Group on 
Strengthening the Biosecurity of the United States'' \2\ and the 
``Federal Experts Security Advisory Panel: Recommendations Concerning 
the Select Agent Program'' \3\ as well as comments received on the 
ANPR, APHIS has determined those pathogens listed here are not likely 
to be used as agroterrorism agents and no longer need to be designated 
as VS select agents.
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    \2\ Available on the Internet at http://www.phe.gov/Preparedness/legal/boards/biosecurity/Documents/biosecreportfinal102309.pdf.
    \3\ Available on the Internet at http://www.phe.gov/Preparedness/legal/boards/fesap/Documents/fesap-recommendations-101102.pdf.
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Overlap Select Agents and Toxins

    We are also proposing to modify the listing for one of the overlap 
select agents by removing certain subtypes of Venezuelan equine 
encephalitis virus from the list of overlap select agents and toxins 
set out in 9 CFR 121.4(b), and to clarify that only Venezuelan equine 
encephalitis subtypes IAB and IC would remain on the list. These 
subtypes contain the only recognized strains of Venezuelan equine 
encephalitis that can suddenly affect a large number of animals over a 
large area (i.e., epizootic). The remaining subtypes, ID and IE, are 
strains prevalent among existing animal populations (i.e., enzootic) 
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 list of overlap select 
agents and toxins. Accordingly, CDC will also be proposing a parallel 
change to its overlap select agent regulations.

Reorganization of the Current List of Select Agents and Toxins

    We are proposing to establish a number of select agents and toxins 
as ``Tier 1'' select agents and toxins within the lists of VS and 
overlap select agents and toxins. We are not including PPQ select 
agents and toxins in this proposed reorganization because none of the 
proposed Tier 1 select agents and toxins are from the plant list. All 
other select agents and toxins would continue to be subject to the 
current requirements concerning select agents and toxins. All select 
agents and toxins were scored against 20 criteria by over 60 subject

[[Page 61230]]

matter experts representing the Federal life sciences, public health, 
law enforcement, security, and intelligence communities. These criteria 
included:
     The relative ease with which a particular select agent or 
toxin might be disseminated or transmitted from one animal to another 
or into the environment where it could produce a deleterious effect 
upon animal or plant health;
     The potential for high animal or plant mortality rates;
     The potential for a major animal or plant 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 animal or plant health disasters.
    APHIS and CDC determined that two VS select agents and three 
overlap select agents should be given Tier 1 status. Based on the 
criteria listed above, we are proposing to list foot-and-mouth disease 
virus and rinderpest virus as Tier 1 VS select agents and toxins and 
Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei 
as Tier 1 overlap select agents and toxins. We are also proposing to 
amend the list of overlap select agents and toxins whose seizure by any 
Federal law enforcement agency requires reporting to APHIS or CDC 
within 24 hours (located in 9 CFR 121.4(f)(3)(i)) to include only those 
overlap agents designated as Tier 1. The current list, which is 
comprised of Bacillus anthracis, Brucella melitensis, Hendra virus, 
Nipah virus, Rift Valley fever virus, and Venezuelan equine 
encephalitis virus was initially adapted from a different system of 
threat assessment categorization. The proposed changes would bring the 
list in line with the listing of Tier 1 agents, which was developed as 
a result of the experience and expertise of the select agent program. 
These changes, in tandem with the enhanced practices for physical and 
information security detailed below, would serve to further mitigate 
the potential for deliberate misuse of these select agents and toxins 
that could result in devastating effects to the economy, critical 
infrastructure, or public confidence.
    Accordingly, we are also proposing additions to the VS regulations 
that would allow for the optimization of security measures for those 
select agents or toxins that 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, i.e., Tier 1 select agents and toxins. These requirements 
would include:
     Additions regarding the assessment of persons who will 
have access to Tier 1 select agents and toxins that would be made to 
the security plan currently required to be developed by all entities 
seeking approval for the possession, use, and transfer of select agents 
and toxins; ongoing oversight of those persons with access to Tier 1 
select agents and toxins; and the role of the entity's responsible 
official in coordinating and assuring the security of Tier 1 select 
agents and toxins;
     Security enhancements that include provisions for security 
barriers, intrusion detection and monitoring, delay/response force, 
access control, and information security;
     Additions to the biosafety plan currently required to be 
developed by all entities seeking approval for the possession, use, and 
transfer of select agents and toxins that would describe implementation 
of an occupational health program for individuals with access to Tier 1 
select agents and toxins;
     Development of security policies and procedures describing 
the entity's response to a failure of an intrusion detection or alarm 
system and notification procedures for the Federal Bureau of 
Investigation (FBI) in the event of theft or suspicious activity that 
may be criminal in nature involving a Tier 1 select agent or toxin. 
These policies and procedures would be required as part of the entity's 
incident response plan; and
     Required annual insider threat awareness briefings focused 
on how to identify and report suspicious behaviors.
    These changes would serve to further mitigate the potential for 
deliberate misuse of these select agents and toxins that could result 
in devastating effects to the economy, critical infrastructure, or 
public confidence.
    We are also proposing to add required physical security measures in 
addition to the proposed general Tier 1 required security measures for 
those entities working with foot-and-mouth disease virus and rinderpest 
virus due to the particular dangers posed by these two viruses.
    Foot-and-mouth disease is an extremely contagious viral disease of 
domesticated cloven-hoofed animals (e.g., cattle, sheep, goats, and 
pigs) and many wild animals. It is easily transmissible from infected 
animals to susceptible animals through contact with contaminated 
objects, consumption of contaminated meat products or ingestion of 
contaminated milk, artificial insemination, and inhalation of 
infectious aerosols. It is not found in the United States and the U.S. 
domestic animal population is therefore considered highly susceptible. 
Foot-and-mouth disease virus can cause infection and disease in close 
to 100 percent of susceptible animals. The potential exists for severe 
economic impacts through loss of animal production and products and 
trade restrictions. Because of these factors, this select agent is 
considered to have a high potential as a weapon of bioterrorism and we 
are therefore proposing to require that it be handled only in high 
containment facilities which provide enhanced biosafety and biosecurity 
features in order to safeguard its distribution.
    Rinderpest is a contagious viral disease of cattle, buffalo, and 
some wild species of cloven-hoofed animals, such as giraffe and 
wildebeest. Like foot-and-mouth disease virus, it is not native to the 
United States and can cause 100 percent illness if susceptible animals 
come in contact with infected animals or contaminated surfaces. As the 
result of an extensive international campaign consisting of 
vaccinations, clinical disease research, serological surveillance 
sampling, contingency planning, and laboratory support in affected 
regions, the World Organization for Animal Health declared rinderpest 
to be globally eradicated in May 2011. Post-eradication efforts will 
include surveillance of all international laboratories with existing 
stocks of the virus, consensus regarding laboratories authorized to 
retain the agent and the type of laboratory work which will continue, 
and destruction of all other inventoried stocks. Also, conditions for 
laboratory storage will be developed in order to ensure biosafety and 
security of the agent. The proposed enhanced security measures are 
necessary in order to ensure that the United States will be able to 
maintain inventories of rinderpest virus under secure and safe 
conditions.
    All of these proposed changes are based on established Government 
and security industry standards with respect to securing high risk 
material and developed in accordance with the experience and expertise 
of the Select Agent Program. They are necessary in order to further 
ensure the safety and security of those select agents and toxins that 
pose the most potential harm to the animal and human environment. As 
stated previously, the requirements for working with all other select 
agents and toxins would remain unchanged with the exception of certain

[[Page 61231]]

miscellaneous changes, which are detailed below.

Miscellaneous Changes

    We are proposing to make several smaller-scale changes to the 
regulations, including the addition of definitions and clarification of 
language concerning security, training, biosafety, biocontainment, and 
incident response. These changes, which are described in detail below, 
would increase the usability of the select agent regulations as well as 
provide for enhanced program oversight.
    In 7 CFR 331.1 and 9 CFR 121.1, we are proposing to add definitions 
for adjudicated as a mental defective, alien, committed to any mental 
institution, controlled substance, crime punishable by imprisonment for 
a term exceeding 1 year, indictment, lawfully admitted for permanent 
residence, mental institution, restricted person, and unlawful user of 
any controlled substance. We believe that these definitions would 
assist regulated entities 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.
    The definition of crime punishable by imprisonment for a term 
exceeding 1 year would be established 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 which 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 US 385 (2005) in which the court, interpreting the provisions of 18 
U.S.C. 922(g)(1), held that the 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 language included foreign 
convictions. In the case of the Bioterrorism 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 those crimes were committed. 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 the 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 only 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 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 select agents and toxins, but 
still allow access to an individual convicted in a foreign court of a 
similar offense. We also believe that the instances of regulation can 
be distinguished in that with regard to the Gun Control Act 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 which the government has recognized as 
having the potential to be used in the wrong hands as weapons of mass 
destruction.
    We are specifically requesting 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.
    We are also proposing to add a definition for information security 
to the

[[Page 61232]]

regulations in 7 CFR 331.1 and 9 CFR 121.1 as it is used but not 
defined. This definition would be identical to that used in the 
``Information Security'' subchapter of the U.S. Code (44 U.S.C. 3542).
    We are also proposing to add a definition for occupational exposure 
to the VS regulations in 9 CFR 121.1 as it is used in the regulations 
but not defined. This definition is based on that used in the 
Occupational Safety and Health Administration regulations in 29 CFR 
1910.1030. We are not proposing to add a corresponding definition to 
the PPQ regulations in 7 CFR 331.1 since PPQ select agents and toxins 
do not pose a severe threat to human health and, therefore, it is 
unnecessary to address personnel safety and health.
    Finally, we are proposing to add a definition for recombinant and 
synthetic nucleic acids. This addition is necessary, as the term 
``synthetic nucleic acids'' is employed in the proposed changes to the 
select agent regulations. We are proposing to include synthetic nucleic 
acids in the regulations because, while synthetic nucleic acids have 
the same potential for harm as recombinant nucleic acids, the process 
of production is different.
    We are proposing to amend 7 CFR 331.3(e), 9 CFR 121.3(e) and 9 CFR 
121.4(e). These paragraphs specify that attenuated strains of select 
agents or toxins may be excluded from the requirements of the select 
agent regulations subject to an official request and supporting 
scientific information. We are proposing to state that the ``inactive 
form of a select toxin'' may be excluded from regulation under each 
respective part subject to the application procedure. This change is 
necessary because 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. ``Inactive form 
of a select toxin'' is a more accurate term and we are therefore 
proposing to amend the regulations to include the correct terminology. 
We are also proposing to update the Web site address in paragraph 
(e)(1) of each section as all information concerning the Select Agent 
Program is now centralized on the National Select Agent Registry Web 
site at http://www.selectagents.gov/. Finally, 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. We are therefore proposing to update the regulations to 
accurately reflect the way in which we handle the listing of 
exclusions.
    The regulations in 7 CFR 331.9 and 9 CFR 121.9 set out requirements 
for entities requesting to work with select agents and toxins to 
designate a responsible official, who ensures that the entity continues 
to meet the requirements of the regulations. We are proposing to 
explicitly require that all designated responsible officials possess 
the appropriate training or expertise to execute their required duties. 
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. Finally, we are proposing 
to add a requirement that the responsible official's principal duty 
station be the physical location of the registered entity. These 
changes would clarify the requirements that a person must meet in order 
to serve as a responsible official or alternate responsible official.
    We are proposing to amend the regulations in 7 CFR 331.10 and 9 CFR 
121.10. These regulations establish parameters for restricting access 
to select agents and toxins and the process by which individuals may be 
approved 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 at entities other than the individual's 
``home'' entity. We are also proposing to decrease the maximum length 
of time for which a security risk assessment will be valid from 5 years 
to 3 years in order to more expeditiously identify individuals who may 
have fallen into one of the prohibited or restricted categories.
    The regulations require registered entities to develop and 
implement a number of plans in order to ensure the safety and security 
of the select agents they handle. These are:
     A security plan, as described by the regulations in 7 CFR 
331.11 and 9 CFR 121.11, that provides for measures sufficient to 
safeguard the select agent or toxin against unauthorized access, theft, 
loss, or release;
     A biocontainment plan, in the case of PPQ select agents, 
or a biosafety plan, in the case of VS select agents, as described in 
the regulations in 7 CFR 331.12 and 9 CFR 121.12, that provides for 
measures sufficient to contain the select agent or toxin (e.g., 
physical structure and features of the entity, and operational and 
procedural safeguards); and
     An incident response plan, as described in the regulations 
in 7 CFR 331.14 and 9 CFR 121.14, that provides for measures that the 
registered entity will implement in the event of 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. The response procedures must account for hazards 
associated with the select agent or toxin and appropriate actions to 
contain such agent or toxin.
    Details of the changes we are proposing to each plan individually 
may be found below. Generally, we are proposing to require that the 
security plan, biocontainment/biosafety plan, and incident response 
plan include provisions to address the safeguarding of animals or 
plants that have been intentionally or accidentally exposed to or 
infected with select agents against unauthorized access, theft, loss or 
release. This would enhance the comprehensiveness of the regulations as 
well as provide necessary guidance regarding handling of animals and 
plants inoculated with select agents. We would not require the plan to 
address animals and plants exposed to select toxins, however. 
Recovering the toxin from within an animal or plant subject is highly 
difficult and such removal does not produce a reasonable yield of 
recovery. In addition, there is uncertainty as to whether or not the 
toxin would remain active when recovered from the animal or plant. For 
these reasons it is highly unlikely that once introduced into an animal 
or plant, a sufficient amount of toxin could be recovered to pose a 
significant hazard to public health, agriculture or agriculture 
products.
    Currently, the security plan described in 7 CFR 331.11 and 9 CFR 
121.11 must be developed by all regulated entities and submitted for 
review only upon request. We are now proposing to require that the 
security plan be submitted for initial registration and renewals of 
registration as well as at any other time upon request. We are also 
proposing to add a requirement that the security plan include 
procedures that require the responsible official to immediately notify 
the FBI in order to initiate a threat assessment process in the event 
that he or she becomes aware

[[Page 61233]]

of suspicious activity which is criminal in nature, related to the 
facility, its personnel, or select agents. This addition would provide 
for added security and establish a framework for communication between 
regulated entities and the FBI. We are also proposing to add provisions 
for information security, including the need for backup measures if the 
entity relies on information systems for security. These 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, 
and configuration management including regular patching and system and 
software updates. We believe these additions are necessary in order to 
establish requirements for a more comprehensive security plan. We are 
also proposing to codify current practices 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 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. 
Finally, we are proposing to amend paragraph (e) in 7 CFR 331.11 and 9 
CFR 121.11, which currently directs individuals creating a security 
plan to guidance for developing such documents contained in the 
``Morbidity and Mortality Weekly Report'' from December 2002. 
Applicants would instead be directed to the ``Security Information 
Document'' and the ``Security Plan Template'' on the select agents Web 
site.
    We are proposing to update the specific Web site address references 
to various CDC and National Institutes of Health guidance publications 
found in 9 CFR 331.12(c)(1) and (c)(3). The regulations in 7 CFR 331.13 
and 9 CFR 121.13 concern restricted experiments, which are those 
experiments that may not be performed by regulated entities without the 
approval of the Administrator. We are proposing to state that, in 
addition to the existing prohibition on conducting restricted 
experiments, entities may not possess the products of restricted 
experiments without the approval of the Administrator. We are also 
proposing to remove recombinant technology as a determining factor for 
a restricted experiment. This is because the 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 or 
other methods (e.g., 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 
synthetic DNA. Finally, we are proposing to add language in order to 
clarify the requirement that all experiments involving the creation of 
drug resistant select agents must be submitted to the Select Agent 
Program for approval.
    Additionally, we are proposing to specify in 7 CFR 331.14 and 9 CFR 
121.14 that each entity's incident response plan be based upon a site-
specific risk assessment. This change would further ensure the 
specificity and quality of the plan. In addition, we are proposing that 
the incident response procedures contain stipulations concerning 
animals and plants accidentally or intentionally exposed to or infected 
with a select agent. This change would provide specific guidance and 
further elaborate our requirements for incident response plans.
    We are proposing to amend the regulations in 7 CFR 331.15 and 9 CFR 
121.15, which concern provision of mandatory training for staff and 
visitors who work in or visit areas where select agents or toxins are 
handled or stored. We are proposing to require all registered entities 
to provide security awareness and incident response training. This is 
in addition to the existing training requirements, which are concerned 
with biocontainment and security practices in the case of PPQ select 
agents, and biosafety and security practices in the case of VS select 
agents. We are also proposing to establish that training for escorted 
personnel would be 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, biosafety, or 
biocontainment 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. The above changes are necessary in order to provide 
clarity and ease of use to the regulations.
    We are proposing to amend the regulations in 7 CFR 331.16 and 9 CFR 
121.16, which concern the transfer of select agents and toxins from one 
registered entity to another. The proposed additions would serve to 
codify practices for shipping, receiving, and storage of select agents 
and toxins and ensure that all registered entities have 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.
    The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required 
recordkeeping procedures for regulated entities as those records relate 
to select agents and toxins. We are proposing to add language to 
address synthetic select agent organisms and animals and plants 
inoculated with select agents. This change would improve oversight of 
the select agent program as it relates to synthetic select agent 
organisms. We are also proposing to add recordkeeping requirements 
whereby regulated entities maintain 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). As previously stated, we are not 
proposing to require regulated entities to keep records regarding 
animals or plants exposed to select toxins.
    We are proposing to amend the regulations in 7 CFR 331.19, which 
concern requirements for notification of theft, loss, or release of 
select agents. Specifically, we are proposing to remove paragraph 
(b)(1)(vi), which states that an individual entity must report certain 
information to APHIS or CDC immediately upon discovery of a release of 
a select agent or toxin outside of the primary barriers of the 
biocontainment area. Currently we require that the number of 
individuals potentially exposed at the entity be reported. We are 
proposing to remove this requirement as PPQ select agents and toxins do 
not pose a severe threat to human health and, therefore, it is 
unnecessary to address personnel safety and health in the same manner 
as they are addressed in the VS regulations. The notification 
requirements in 9 CFR 121.19 would remain unchanged.
    The regulations in 7 CFR 331.20 and 9 CFR 121.20 concern the 
guidelines for administrative review of an individual's or entity's 
denial, revocation, or suspension of registration and access approval. 
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

[[Page 61234]]

revocation of access approval. Currently, this process must be 
completed in 30 calendar days. We are proposing to extend the deadline 
to 180 calendar days. This change is necessary because, thus far, all 
appeal requests from individuals regarding their access approval have 
been received after the 30-day deadline has passed. Because of specific 
program procedures, these individuals receive no advance notice of a 
denial, limitation, or revocation of their access approval. Given this 
situation and the requirements for submitting a formal appeal, we 
believe it is appropriate to extend the deadline in order to allow 
individuals to gather the necessary background data for their appeals. 
We are not proposing to grant a similar extension for entities which 
have had their registration denied, revoked, or suspended, as these 
entities typically have had advance notice of such a determination and 
are thus able to document and prepare their appeals within the existing 
30-day timeframe.
    Given that we are reorganizing 7 CFR 331.20 and 9 CFR 121.20 in 
order to more clearly spell out the way in which an individual or an 
entity may appeal the denial, revocation, or suspension of registration 
and access approval, we are also proposing to remove footnote 9 from 
the regulations in 7 CFR 331.20 and corresponding footnote 15 in 9 CFR 
121.20. This proposed change is necessary because these footnotes would 
offer redundant information concerning the appeals process in light of 
both sections' reorganization. Finally, we are proposing to remove the 
provision stating that a request for review of a denial, limitation, or 
revocation of access approval will be forwarded to the Attorney General 
by the Administrator for further review. Forwarding a request for 
review to the Attorney General describes an internal process. This 
proposed change is necessary because the current language implies a 
level of decisionmaking on the part of the Attorney General that does 
not exist and the change would more clearly establish that the decision 
to grant access approval rests solely with the Administrator.

Guidance Documents

    We are specifically requesting comment from the regulated community 
and any other interested persons on the need for and desirability of 
guidance documents that would serve to assist regulated entities in 
preparation of the elements that comprise various aspects of the select 
agent regulations.
    The areas where such guidance documents may be useful include, but 
are not limited to:
    1. Aspects of the required security plan. These may include, but 
are not limited to:
     Provisions for information security;
     Development of suitability or personnel reliability 
practices, including pre-access and ongoing assessment 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;
     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 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 Web sites, articles, or other sources 
that may be used to develop such guidance 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.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, and an initial regulatory flexibility analysis 
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 Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    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

[[Page 61235]]

generally recognized industry standards. Costs actually incurred would 
depend upon the extent to which current facility 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.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 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.

Paperwork Reduction Act

    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.)

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
            Section                 Form name       respondents    responses per   response  (in       hours
                                                                    respondent        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.

[[Page 61236]]

 
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.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects

7 CFR Part 331

    Agricultural research, Laboratories, Plant diseases and pests, 
Reporting and recordkeeping requirements.

9 CFR Part 121

    Agricultural research, Animal diseases, Laboratories, Medical 
research, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 7 CFR part 331 and 9 CFR part 121 
as follows:

TITLE 7--[AMENDED]

PART 331--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

    1. The authority citation for part 331 continues to read as 
follows:

    Authority:  7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.

    2. Section 331.1 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, recombinant and synthetic nucleic acids, restricted 
person, and unlawful user of any controlled substance to read as 
follows:


Sec.  331.1  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 ``controlled substance'' is 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 which 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 the 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 an ``information,'' which 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.
* * * * *

[[Page 61237]]

    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.
* * * * *
    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 paragraph (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. 2780(d)), 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 
regulation, 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 331.3 is amended as follows:
    a. By revising paragraph (b) to read as set forth below.
    b. In paragraph (c) introductory text, by adding the words ``and/or 
synthetic'' after the word ``recombinant'' each time it appears.
    c. In paragraph (c)(2) introductory text, by adding the words 
``and/or synthetic'' after the word ``Recombinant''.
    d. By revising paragraph (e) to read as set forth below.


Sec.  331.3  PPQ select agents and toxins.

* * * * *
    (b) PPQ select agents and toxins:

Peronosclerospora philippinensis (Peronosclerospora sacchari);
Phoma glycinicola (formerly Pyrenochaeta glycines);
Ralstonia solanacearum, race 3, biovar 2;
Rathayibacter toxicus;
Sclerophthora rayssiae var. zeae;
Synchytrium endobioticum;
Xanthomonas oryzae.
* * * * *
    (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 that the attenuated strain or inactivated toxin 
does not pose a severe threat to plant health or plant 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.  331.8  [Amended]

    4. In Sec.  331.8, paragraph (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.
    5. Section 331.9 is amended as follows:
    a. By redesignating paragraphs (a)(3) through (a)(5) as paragraphs 
(a)(4), (a)(5), and (a)(7) 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 adding a new paragraph (a)(6) to read as set forth below.
    e. By revising the first sentence of paragraph (b) to read as set 
forth below.


Sec.  331.9  Responsible official.

    (a) * * *
    (3) Have the appropriate training or 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. * * *
* * * * *

    6. Section 331.10 is amended as follows:

[[Page 61238]]

    a. By redesignating paragraphs (e) through (i) as paragraphs (f) 
through (j) respectively.
    b. By adding a new paragraph (e) to read as set forth below.
    c. In newly redesignated paragraph (g)(1), 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 (i), by removing the number 
``5'' and adding the number ``3'' in its place.


Sec.  331.10  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.
* * * * *

    7. Section 331.11 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. In paragraph (c)(6), by removing the word ``and''.
    d. In paragraph (c)(7), by removing the period and adding a 
semicolon in its place.
    e. By adding new paragraphs (c)(8), (c)(9), and (c)(10) to read as 
set forth below.
    f. By revising paragraph (e) to read as set forth below.


Sec.  331.11  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 viruses, 
worms, and 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 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/.
* * * * *

    8. Section 331.12 is amended by revising paragraph (a) to read as 
follows:


Sec.  331.12  Biocontainment.

    (a) An individual or entity required to register under this part 
must develop and implement a written biocontainment plan that is 
commensurate with the risk of the select agent or toxin, given its 
intended use.\4\ The biocontainment plan must contain sufficient 
information and documentation to describe the containment procedures 
for the select agent or toxin, including any animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent.
---------------------------------------------------------------------------

    \4\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

* * * * *


Sec.  331.13  [Amended]

    9. Section 331.13 is amended as follows:
    a. By removing footnote 5.
    b. In paragraph (a) introductory text, by adding the words ``, 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''.
    c. In paragraph (a)(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,''.
    d. In paragraph (a)(2), by adding the words ``synthetic or'' before 
the word ``recombinant''.

    10. Section 331.14 is amended as follows:
    a. By redesignating footnote 6 as footnote 5.
    b. By revising the first sentence in paragraph (a) to read as set 
forth below.
    c. By redesignating footnote 7 as footnote 6.
    d. By revising paragraph (b) to read as set forth below.
    e. By redesignating paragraphs (c) and (d) as paragraphs (d) and 
(e), respectively.
    f. By adding a new paragraph (c) to read as set forth below.


Sec.  331.14  Incident response.\5\
---------------------------------------------------------------------------

    \5\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.
---------------------------------------------------------------------------

    (a) An individual or entity required to register under this part 
must develop and implement a written incident response plan \6\ based 
upon a site specific risk assessment. * * *
---------------------------------------------------------------------------

    \6\ Technical assistance and guidance may be obtained by 
contacting APHIS.

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

[[Page 61239]]

    (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.
* * * * *
    11. Section 331.15 is revised to read as follows:


Sec.  331.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biocontainment, security 
(including security awareness), and incident response to:
    (1) 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 
individuals, the work they will do, and the risks posed by the select 
agents or toxins; and
    (2) 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) Refresher training must be provided annually or at such time as 
the registered individual or entity significantly amends its security, 
incident response, or biocontainment plans.
    (c) 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.

    12. Section 331.16 is amended as follows:
    a. By redesignating footnote 8 as footnote 7.
    b. By redesignating paragraphs (e) through (h) as paragraphs (h), 
(i), (j), and (f) respectively.
    c. By adding a new paragraph (e) to read as set forth below.
    d. In newly redesignated paragraph (f), by removing the words 
``packaging and''.
    e. By adding a new paragraph (g) to read as set forth below.


Sec.  331.16  Transfers.

* * * * *
    (e) After authorization is provided by APHIS or CDC, the select 
agent(s) or 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.
* * * * *
    (g) 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.
* * * * *

    13. Section 331.17 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.  331.17  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);
* * * * *


Sec.  331.19  [Amended]

    14. Section 331.19 is amended as follows:
    a. By removing paragraph (b)(1)(iv).
    b. By redesignating paragraphs (b)(1)(v) through (b)(1)(viii) as 
paragraphs (b)(1)(iv) through (b)(1)(vii), respectively.

    15. Section 331.20 is revised to read as follows:


Sec.  331.20  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 Administrator 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 Administrator 
within 180 calendar days of the decision.
    (c) The Administrator's decision constitutes final agency action.

TITLE 9--[AMENDED]

PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

    16. The authority citation for part 121 continues to read as 
follows:

    Authority:  7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

    17. Section 121.1 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 follows:


Sec.  121.1  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

[[Page 61240]]

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 which 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 the 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 an ``information,'' which 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.
    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 paragraph (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 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. 2780(d)), 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 
regulation, 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.
* * * * *

    18. Section 121.3 is amended as follows:
    a. By adding a new sentence at the end of paragraph (a) to read as 
set forth below.
    b. By revising paragraph (b) to read as set forth below.

[[Page 61241]]

    c. In paragraph (c) introductory text, by adding the words ``and/or 
synthetic'' after the word ``recombinant'' each time it appears.
    d. In paragraph (c)(2), by adding the words ``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 ``Newcastle 
disease virus (velogenic)'' and adding the words ``virulent Newcastle 
disease virus'' in their place.


Sec.  121.3  VS 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) VS select agents and toxins:

African horse sickness virus;
African swine fever virus;
Avian influenza virus (highly pathogenic);
Classical swine fever virus;
* Foot-and-mouth disease virus;
Goat pox virus;
Lumpy skin disease virus;
Mycoplasma capricolum subspecies capripneumoniae (contagious caprine 
pleuropneumonia);
Mycoplasma mycoides subspecies mycoides small colony (Mmm SC) 
(contagious bovine pleuropneumonia);
Peste des petits ruminants virus;
* Rinderpest virus;
Sheep pox virus;
Swine vesicular disease virus;
Virulent Newcastle disease virus.\1\
* * * * *
---------------------------------------------------------------------------

    \1\ A virulent Newcastle disease virus (avian paramyxovirus 
serotype 1) has an intracerebral pathogenicity index in day-old 
chicks (Gallus gallus) of 0.7 or greater or has an amino acid 
sequence at the fusion (F) protein cleavage site that is consistent 
with virulent strains of Newcastle disease virus. A failure to 
detect a cleavage site that is consistent with virulent strains does 
not confirm the absence of a virulent virus.
---------------------------------------------------------------------------

* * * * *
    (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 Administrator that the attenuated strain or 
inactivated toxin does not pose a severe threat 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.
* * * * *
    19. Section 121.4 is amended as follows:
    a. By adding a new sentence at 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) introductory text, by adding the words ``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 (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.  121.4  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.  121.5  [Amended]

    20. In Sec.  121.5, paragraph (a)(3)(i) is amended by removing the 
words ``bovine spongiform encephalopathy agent,''.


Sec.  121.6  [Amended]

    21. In Sec.  121.6, paragraph (a)(3)(i) is amended by removing the 
words ``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.  121.8  [Amended]

    22. In section 121.8, paragraph (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.

    23. Section 121.9 is amended as follows:
    a. By redesignating paragraphs (a)(3) through (a)(5) as paragraphs 
(a)(4), (a)(5), and (a)(7) 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 adding a new paragraph (a)(6) to read as set forth below.
    e. By revising the first sentence of paragraph (b) to read as set 
forth below.
    f. By revising the first sentence of paragraph (c)(1) to read as 
set forth below.


Sec.  121.9  Responsible official.

    (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 61242]]

    (c) * * *
    (1) The identification of any of the following select agents or 
toxins must be immediately reported by telephone, facsimile, or e-mail: 
African horse sickness virus, African swine fever virus, avian 
influenza virus (highly pathogenic), Bacillus anthracis, Brucella 
melitensis, Burkholderia mallei, Burkholderia pseudomallei, classical 
swine fever virus, foot-and-mouth disease virus, virulent Newcastle 
disease virus, rinderpest virus, and swine vesicular disease virus. * * 
*
* * * * *

    24. Section 121.10 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)(1), 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 number 
``5'' and adding the number ``3'' in its place.


Sec.  121.10  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.
* * * * *

    25. Section 121.11 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. In paragraph (c)(6), by removing the word ``and''.
    d. By adding new paragraphs (c)(8), (c)(9), and (c)(10) to read as 
set forth below.
    e. By redesignating paragraphs (e) and (f) as paragraphs (f) and 
(g), respectively.
    f. By adding a new paragraph (e) to read as set forth below.
    g. By revising newly redesignated paragraph (f) to read as set 
forth below.


Sec.  121.11  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 viruses, 
worms, and spyware) from compromising the confidentiality, integrity, 
or availability of critical 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 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, the 
protection of animal or plant health and animal or plant products, 
security, and the integrity of the scientific enterprise. In developing 
these procedures, an individual or entity may consider the guidance 
documents available on the Internet at http://www.selectagents.gov/.;
    (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

[[Page 61243]]

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 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 or 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 foot-and-mouth disease virus and 
rinderpest virus must have the following additional security 
requirements:
    (i) A minimum of four barriers, one of which must be a perimeter 
security fence or equivalent which is monitored 24 hours a day, 7 days 
a week (24/7) to detect the presence of unauthorized persons, vehicles, 
materials, or unauthorized activities;
    (ii) Onsite 24/7 armed security response force with roving patrol. 
Response time must not exceed 5 minutes from the time of an intrusion 
alarm or report of a security incident;
    (iii) CCTV surveillance with 24/7 monitoring and recording; and
    (iv) Transport vehicle with GPS tracking designed to serve as a 
containment vehicle.
    (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/.
* * * * *

    26. Section 121.12 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 address ``http://www.aphis.usda.gov./programs/ag_selectagent/index.html'' and replacing 
it with the address ``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.  121.12  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.\9\ 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.
---------------------------------------------------------------------------

    \9\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

* * * * *
    (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.  121.13  [Amended]

    27. Section 121.13 is amended as follows:
    a. In the section heading, by removing footnote 10.
    b. In paragraph (a), by adding the words ``, 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.
    c. In paragraph (b)(1), by removing the words ``Experiments 
utilizing recombinant DNA that involve the deliberate transfer of'' and 
adding the words ``Experiments that involve the deliberate transfer of, 
or selection for,'' in their place.
    d. In paragraph (b)(2), by adding the words ``synthetic or'' before 
the word ``recombinant''.
    28. Section 121.14 is amended as follows:
    a. In the section heading, by redesignating footnote 11 as footnote 
10.
    b. In paragraph (a), by redesignating footnote 12 as footnote 11 
and revising the first sentence to read as set forth below.
    c. By revising paragraph (b) to read as set forth below.
    d. By redesignating paragraphs (c) and (d) as paragraphs (d) and 
(f), respectively.
    e. By adding a new paragraph (c) to read as set forth below.
    f. By adding a new paragraph (e) to read as set forth below.


Sec.  121.14   Incident response.\10\
---------------------------------------------------------------------------

    \10\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.
---------------------------------------------------------------------------

    (a) An individual or entity required to register under this part 
must develop and implement a written incident response plan \11\ based 
upon a site specific risk assessment. * * *
---------------------------------------------------------------------------

    \11\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

    (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

[[Page 61244]]

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.
* * * * *

    29. Section 121.15 is revised to read as follows:


Sec.  121.15  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 to:
    (1) 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 
individuals, the work they will do, and the risks posed by the select 
agents or toxins; and
    (2) Each individual not approved for access to select agents and 
toxins by the HHS Secretary or Administrator before that individual 
works in or otherwise 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.

    30. Section 121.16 is amended as follows:
    a. By redesignating footnote 14 as footnote 12.
    b. By redesignating paragraphs (f) through (i) as paragraphs (i), 
(k), and (g), respectively.
    c. By adding a new paragraph (f) to read as set forth below.
    d. In newly redesignated paragraph (g), by removing the words 
``packaging and''.
    e. By adding a new paragraph (h) to read as set forth below.


Sec.  121.16  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.
* * * * *

    31. Section 121.17 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.  121.17  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);
* * * * *

    32. Section 121.20 is revised to read as follows:


Sec.  121.20  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 Administrator 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 Administrator 
within 180 calendar days of the decision.
    (c) The Administrator's decision constitutes final agency action.

    Done in Washington, DC, this 29th day of September 2011.
Gregory L. Parham,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-25520 Filed 9-30-11; 8:45 am]
BILLING CODE 3410-34-P