61228 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 

1To view the ANPR and the comments we 

received, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2009-0070. 

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. 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 61229 

2Available on the Internet at http://www.phe.gov/ 

Preparedness/legal/boards/biosecurity/Documents/ 

biosecreportfinal102309.pdf. 

3Available on the Internet at http://www.phe.gov/ 

Preparedness/legal/boards/fesap/Documents/fesaprecommendations-101102.pdf. 

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. 

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 welldeveloped 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 § 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. 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS3
61230 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 

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-andmouth 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 


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


srobinson on DSK4SPTVN1PROD with PROPOSALS3
61232 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 

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 


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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 sitespecific 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 


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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 peerreporting 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 sitespecific 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 


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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 wideranging 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.) 

Section Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

9 CFR 121.5 and 6, 7 CFR 331.5, 

43 CFR 73.5 and 6.

Report of Identification of a Select 

Agent or Toxin.

161 3 1 299 

§ 121.7, § 331.7, § 73.7 ..................... Application for Registration .............. 7 1 5 35 

§ 121.7, § 331.7, § 73.7 ..................... Amendment to a Certificate of Registration.380 7 1 1,955 


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61236 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 

Section Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

§ 121.11, § 331.11, § 73.11 ............... Security Plan .................................... 380 1 5 1,900 

§ 121.12, § 331.12, § 73.12 ............... Biosafety/Biocontainment Plan ........ 380 1 8 3,040 

§ 121.13, § 331.13, § 73.13 ............... Request Regarding a Restricted Experiment.160 1 2 320 

§ 121.14, § 331.14, § 73.14 ............... Incident Response Plan ................... 380 1 5 1,900 

§ 121.15, § 331.15, § 73.15 ............... Training ............................................ 380 1 1 380 

§ 121.16, § 331.16, § 73.16 ............... Request to Transfer Select Agents 

and Toxins.

290 1 2 580 

§ 121.17, § 331.17, § 73.17 ............... Records ............................................ 295 1 0.5 148 

§ 121.19, § 331.19, § 73.19 ............... Notification of Theft, Loss, or Release.195 1 2 390 

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: 

§ 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. 

* * * * * 


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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. 

§ 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. 

* * * * * 

§ 331.8 [Amended] 

4. In § 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. 

§ 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: 


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4Technical assistance and guidance may be 

obtained by contacting APHIS. 

5Nothing in this section is meant to supersede or 

preempt incident response requirements imposed 

by other statutes or regulations. 

6Technical assistance and guidance may be 

obtained by contacting APHIS. 

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. 

§ 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. 

§ 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: 

§ 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. 

* * * * * 

§ 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. 

§ 331.14 Incident response.5

(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. * * * 


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(b) The incident response plan must 

fully describe the entity’s response 

procedures for the theft, loss, or release 

of a select agent or toxin; inventory 

discrepancies; security breaches 

(including information systems); severe 

weather and other natural disasters; 

workplace violence; bomb threats and 

suspicious packages; and emergencies 

such as fire, gas leak, explosion, power 

outage, etc. 

(c) The response procedures must 

account for hazards associated with the 

select agent or toxin and appropriate 

actions to contain such select agent or 

toxin, including any animals or plants 

intentionally or accidentally exposed to 

or infected with a select agent. 

* * * * * 

11. Section 331.15 is revised to read 

as follows: 

§ 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. 

§ 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. 

§ 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); 

* * * * * 

§ 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: 

§ 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: 

§ 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS3
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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. 


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1A 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. 

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. 

§ 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

* * * * * 

* * * * * 

(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. 

§ 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. 

* * * * * 

§ 121.5 [Amended] 

20. In § 121.5, paragraph (a)(3)(i) is 

amended by removing the words 

‘‘bovine spongiform encephalopathy 

agent,’’. 

§ 121.6 [Amended] 

21. In § 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. 

§ 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. 

§ 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. 

* * * 


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(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. 

§ 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. 

§ 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 


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9Technical assistance and guidance may be 

obtained by contacting APHIS. 

10Nothing in this section is meant to supersede 

or preempt incident response requirements 

imposed by other statutes or regulations. 

11Technical assistance and guidance may be 

obtained by contacting APHIS. 

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-andmouth 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. 

§ 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. 

* * * * * 

(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. 

* * * * * 

§ 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. 

§ 121.14 Incident response.10

(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. * * * 

(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 


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61244 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 

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: 

§ 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. 

§ 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. 

§ 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: 

§ 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS3