









































The Select Agent Regulations: 
Structure and Stricture

Shreya Kalra, Michael Parker

Volume Two
Edition Two
Spring 2022

 
GEORGETOWN SCIENTIFIC
RESEARCH JOURNAL

60



Georgetown	Scientific	Research	Journal	

The Select Agent Regulations: Structure and Stricture 

Shreya Kalra1, Michael Parker2 

1 School of Foreign Services, Georgetown University, Washington, D.C. 
2Assistant Dean, Georgetown College, Georgetown University, D.C. 
E-mail: skk70@georgetown.edu
https://doi.org/10.48091/gsr.v2i2.46

Abstract 
Since their inception in 1996, the select agent regulations have shaped the direction of research on high-risk 
biological agents in the United States. Implemented in response to an increased concern about nefarious use 
of biological agents, the overarching aim of the regulations is to protect the public health of the United States 
through both security and safety infrastructure. However, while there does exist an evident need for effective 
regulations surrounding certain pathogens and toxins, the bureaucratic and inordinate nature of the existing 
regulations has created significant regulatory and financial burdens in conducting select agent research. 
Specifically, impediments to this research have arisen from complicated bureaucratic procedures, the 
impractical financial burden associated with adhering to facility standards, and confusion about research 
surrounding species-level designation of listed microorganisms. While intended to protect public health, the 
ineffectual and overly stringent nature of these regulatory policies continues to hinder essential scientific 
research and, in turn, may paradoxically lead to safety and security vulnerabilities now and in the future. 

Keywords: Select Agent, Pathogen, Regulation, Policy, Biosecurity, Biowarfare, Bioterrorism 

1. Regulating Access to Agents in Response to
Domestic Threats

The necessity of regulation for certain select 
agents was brought to the forefront of the public’s 
minds in 1995, when microbiologist Larry Wayne 
Harris successfully ordered and received a sample of 
Yersinia pestis, the causative agent of bubonic plague, 
from a laboratory in Rockville, Maryland. The 
laboratory mailed the sample to Harris under the 
impression that it would be delivered to the company 
for which he was working. However, the laboratory, 
growing suspicious after Harris repeatedly pestered 
them about the sample, ultimately alerted 
authorities. Harris, who had, in fact, intended to 
spread the Yersinia pestis in the New York City 
subway,1 was found with three vials of the bacteria in 

his car’s glove compartment.2 However, due to the 
lack of existing laws governing high-risk biological 
agent possession, Harris was only charged with fraud 
for lying about his intended use of the pathogen.2 
This case prompted Congress to pass the 
Antiterrorism and Effective Death Penalty Act of 
1996. The legislation required the Department of 
Health and Human Services (DHHS) to draft 
regulation of biological select agents and toxins 
(BSAT) deemed most capable of posing a severe 
threat to public health and safety.3 In response, 
DHHS published the first version of the select agent 
regulations (SARs), which regulated the possession, 
use, and transfer of 47 pathogens and toxins.4

Public concern surrounding bioterrorism was 
exacerbated further in 2001, when letters containing 

61



Georgetown	Scientific	Research	Journal	

anthrax spores were anonymously mailed to news 
offices and senators just one week after the attack on 
the World Trade Center, killing five and infecting 
seventeen others. Congress was thus compelled to 
move swiftly to strengthen the SARs, developing a 
strict set of laws surrounding these agents.5 The 
USA PATRIOT Act was the first Congressional 
response to this end, restricting access to select 
agents by “restricted persons”. These persons are 
defined as those guilty of a crime punishable by 
imprisonment for over one year, fugitives, illegal 
“aliens”, prior patients of mental institutions, or 
those who received dishonorable discharges from the 
United States Armed Services.6 In accordance with 
the USA PATRIOT Act, institutions are required 
to document and submit the names of employees 
who require access to select agents. These 
individuals must then comply with a security risk 
assessment conducted by the attorney general to 
ensure they meet the criteria to possess, use, or 
transfer agents. Once an individual has passed the 
security risk assessment, they are subjected to 
intensive training provided by the laboratory’s 
designated responsible official (RO) before they are 
granted access to the select agents. Detailed records 
of these trainings must be kept by the RO, including 
the identity of the individuals trained, the date of 
training, and the specific means used to verify that 
the individual understood the training. Even upon 
successful completion of this risk assessment and 
training, approval for an individual to work with 
select agents is only valid for 5 years, after which it 
must be renewed.7 Furthermore, access to select 
agents is only valid at the specific laboratory wherein 
an individual is currently employed.8

2. Refining the Regulations
The form of the SARs as they appear today was 
initiated by the Public Health Security and 
Bioterrorism Preparedness and Response Act of 
2002. This act built upon the infrastructure of the 
Antiterrorism and Effective Death Penalty Act of 
1996, requiring the Department of Health

and Human Services (DHHS) to regulate 
BSAT concerning human health and the U.S. 
Department of Agriculture (USDA) to regulate 
those concerning plant and animal health.6 Under 
the authority of this legislation, the SARs were to 
be updated within one year; DHHS and USDA 
also published their own lists of “overlap agents” 
that pose risks to both human and animal 
health. The resultant SARs9–11 delegated 
authority to regulate select agents dangerous 
to human and agricultural health to the Centers 
for Disease Control and Prevention (CDC) 
Division of Select Agents and Toxins (DSAT) and 
the Animal and Plant Health Inspection Service 
(APHIS), respectively.12 These regulations are 
reviewed biennially, so it is the responsibility of 
institutions and researchers to work in accordance 
with the most up-to-date legislation. Failure to 
comply with these regulations can yield criminal 
penalties including fines and up to ten years of 
imprisonment.8

To ensure and track abidance, entities 
possessing listed select agents must legally register 
by applying to either the CDC or the USDA for 
each select agent it uses, transfers, or 
possesses. This registration requires the 
designation of an RO who must maintain extensive 
records about every activity involving select agents. 
Specifically, these ROs must provide a list of all 
select agents in or intended for laboratory use, 
possession, or transfer, detailing the specific 
location within buildings the select agents will be 
stored. In this inventory, the RO must include 
the characteristics, source, date of 
acquisition, and vial quantity of select agents, as 
well as an explanation for any inventory 
discrepancies.7 Additionally, each laboratory must 
develop a safety plan in accordance with the 
CDC and NIH guidelines for work with 
recombinant DNA.7 To this end, laboratories 
must implement and 

Georgetown	Scientific	Research	Journal	

document a site-specific security plan that addresses: 
inventory control procedures; education and 
experience criteria for those with access to agents; 
rules regarding cleaning, maintenance, and repair; 
provisions for training employees in security 
procedures; provisions for securing select agent 
areas; provisions for loss of means to enter to select 
agent areas (i.e.: keys, passwords, etc.); inspection of 
all packages that enter and exit the area; and protocol 
for select agent transfers between entities. 7 

The RO is responsible for inspecting facilities 
and procedures to ensure compliance with these 
regulations, the results of which must be 
documented, and any deficiencies corrected.7 
Laboratories working with select agents are also 
subjected to outside inspections, with 15% of select 
agent laboratories enduring inspections from 
multiple federal agencies within the same two-year 
period. These federal agencies include the 
Department of Transportation (DOT), the CDC, 
the APHIS, the Department of Homeland Security 
(DHS) and Department of Defense (DOD).13

3. Ramifications of the Regulations
The bureaucratic and uncompromising nature of

the SARs has presented excessive and significant 
challenges for researchers, leading to sample 
destruction, abandoning of research programs on 
select agents, increased facility maintenance costs, 
and ambiguity about species-level designation of 
some agents. Here, we will survey accounts of each 
of these hurdles and review certain challenges 
associated with specific aspects of the SARs. 

After the enactment of the SARs, in response to 
the strict legal and regulatory framework governing 
select agent research, many institutions decided to 
discontinue their research on these agents. While 
some investigators worked to save their collections 
by transferring them to a registered entity, when 
confronted with the complicated and time-

consuming transport procedures, many elected to 
simply eliminate the samples rather than comply 
with the extensive process.14 One of the logistical 
aspects that makes transfer especially difficult is that 
non-registered institutions are allotted only a short 
time period to transfer select agents; however, the 
SARs require all BSAT transfers to be approved 
prior to shipment, a time consuming process meant 
to ensure that the receiving entity and principal 
investigator are registered appropriately.12 
Consequently, unregistered institutions which are 
unwilling or unable to transfer agents continue to 
destroy collections of select agent isolates to date. In 
some of the collections destroyed thus far, there were 
unusual samples indicating potential new strains or 
species. Further, given that these are often field 
samples, the libraries of which are made by isolating 
and maintaining specimens from wild animals or 
infected humans, these collections can contain 
unique and unusual isolates -- the analysis of which 
can be invaluable in assessing the genetic diversity in 
a strain. Additionally, the historical isolates of 
certain microbes with rapid genetic variation can 
develop distinct genomics over time, the study of 
which is invaluable in understanding the spread 
and evolution of disease.14 Thus, the potentially 
irretrievable loss of biodiversity from the 
destructions of these unique and invaluable 
collections will undoubtedly have an impact on 
scientific advancement, with the depletion of these 
samples likely hindering future investigations on 
pathogenesis and epidemiology, forensic 
investigations, and therapeutic development. Given 
the critical role of microbial collections in these 
endeavors, the lamentable and avoidable loss of these 
collections represents a potential decline in future 
public health security.14 Furthermore, because of the 
severity of the SARs, talented researchers may be 
more inclined to enter fields where they will not be 

62



Georgetown	Scientific	Research	Journal	

document a site-specific security plan that addresses: 
inventory control procedures; education and 
experience criteria for those with access to agents; 
rules regarding cleaning, maintenance, and repair; 
provisions for training employees in security 
procedures; provisions for securing select agent 
areas; provisions for loss of means to enter to select 
agent areas (i.e.: keys, passwords, etc.); inspection of 
all packages that enter and exit the area; and protocol 
for select agent transfers between entities. 7 

The RO is responsible for inspecting facilities 
and procedures to ensure compliance with these 
regulations, the results of which must be 
documented, and any deficiencies corrected.7 
Laboratories working with select agents are also 
subjected to outside inspections, with 15% of select 
agent laboratories enduring inspections from 
multiple federal agencies within the same two-year 
period. These federal agencies include the 
Department of Transportation (DOT), the CDC, 
the APHIS, the Department of Homeland Security 
(DHS) and Department of Defense (DOD).13

3. Ramifications of the Regulations
The bureaucratic and uncompromising nature of

the SARs has presented excessive and significant 
challenges for researchers, leading to sample 
destruction, abandoning of research programs on 
select agents, increased facility maintenance costs, 
and ambiguity about species-level designation of 
some agents. Here, we will survey accounts of each 
of these hurdles and review certain challenges 
associated with specific aspects of the SARs. 

After the enactment of the SARs, in response to 
the strict legal and regulatory framework governing 
select agent research, many institutions decided to 
discontinue their research on these agents. While 
some investigators worked to save their collections 
by transferring them to a registered entity, when 
confronted with the complicated and time-

consuming transport procedures, many elected to 
simply eliminate the samples rather than comply 
with the extensive process.14 One of the logistical 
aspects that makes transfer especially difficult is that 
non-registered institutions are allotted only a short 
time period to transfer select agents; however, the 
SARs require all BSAT transfers to be approved 
prior to shipment, a time consuming process meant 
to ensure that the receiving entity and principal 
investigator are registered appropriately.12 
Consequently, unregistered institutions which are 
unwilling or unable to transfer agents continue to 
destroy collections of select agent isolates to date. In 
some of the collections destroyed thus far, there were 
unusual samples indicating potential new strains or 
species. Further, given that these are often field 
samples, the libraries of which are made by isolating 
and maintaining specimens from wild animals or 
infected humans, these collections can contain 
unique and unusual isolates -- the analysis of which 
can be invaluable in assessing the genetic diversity in 
a strain. Additionally, the historical isolates of 
certain microbes with rapid genetic variation can 
develop distinct genomics over time, the study of 
which is invaluable in understanding the spread 
and evolution of disease.14 Thus, the potentially 
irretrievable loss of biodiversity from the 
destructions of these unique and invaluable 
collections will undoubtedly have an impact on 
scientific advancement, with the depletion of these 
samples likely hindering future investigations on 
pathogenesis and epidemiology, forensic 
investigations, and therapeutic development. Given 
the critical role of microbial collections in these 
endeavors, the lamentable and avoidable loss of these 
collections represents a potential decline in future 
public health security.14 Furthermore, because of the 
severity of the SARs, talented researchers may be 
more inclined to enter fields where they will not be 

63



Georgetown	Scientific	Research	Journal	

faced with such cumbersome regulatory 
requirements, causing institutions to in turn 
continue to abstain from select agent research.15 
Thus, it is plausible that the SARs could potentially 
drive select agent research out of US academia, 
making US citizens vulnerable to these agents and 
posing a risk to public health.6  

Institutions that have chosen to proceed with 
select agent research continue to endure significant 
regulatory burdens. The strict regulations 
surrounding those who can work with select agents 
also make it difficult for foreign nationals to work 
with these agents.8 Restricting access to this 
demographic is intended to protect public health 
security. However, given that, as of a 2010 report, 
foreign nationals constituted 60% of postdocs 
employed in US federally funded research and 
development centers, restricting access of these 
agents to such a substantial proportion of researchers 
significantly limits the breadth of skill set and 
qualifications in this field.16

Additionally, to meet the requirements of the 
SARs, many laboratories must increase 
administrative and laboratory staffing. The costs of 
the security and safety installments necessary for a 
lab to be authorized to conduct select agent research 
often exceed the federal funding received by 
institutions to cover facility, maintenance, and 
operational costs.5 As an example, two laboratories 
have stated that the cost to employ armed guards in 
accordance with the SARs is over 3 million dollars 
per year, a cost that composes over 10% of the 
operating budget for one lab, and around 25% for 
the other.17 Ultimately, as a direct result of SARs, 
there has been an estimated 2 to 5-fold increase in 
the cost of researching select agents.15 Provided 
regulations were less fiscally demanding, laboratories 
could instead use a fraction of the funds currently 
required for SAR compliance to advance their 
research.5 Furthermore, there exists significant 
criticism regarding the extent to which these 

expensive administrative security and safety 
requirements actually provide genuine security. The 
requirement to track individual vials is particularly 
problematic, given that select agents are living and 
reproducing organisms and thus can easily be 
removed from a vial without a noticeable change. 
Consequently, this documentation does not 
necessarily prevent the removal of material for 
malicious purposes.18 It is also more likely that a 
knowledgeable insider would simply take a sample 
from intrinsically unaccountable sources for 
infectious materials, such as discarded pipette tips.17 
Thus, the meticulous documentation required to 
account for select agent vials, while putting 
significant stressors on time and laboratory 
efficiency (one lab reports hiring 2 full-time 
employees solely to account for the vials), provides 
only “the illusion of security.” 17 Additionally, the 
multiplicity of agencies conducting laboratory SAR 
compliance inspections can often lead to 
discrepancies in standards. The varied 
interpretations of inspection results make it difficult 
for laboratories to be compliant with these 
conflicting standards. Further, this abundance of 
inspections requires copious amounts of time, effort, 
and funds, detracting from what could otherwise be 
spent on research.18 Thus, the overly administrative 
and counterproductive oversight surrounding 
BSATs is at the preventable expense of essential 
scientific progress. 

Taxonomic semantics have also proven 
challenging for researchers, as there are instances of 
significant confusion surrounding what constitutes a 
select agent. Microorganisms that are added to the 
select agents list are codified by standards of 
taxonomy, which is a problematic approach given 
the uncertainty surrounding what constitutes a 
microbial species.19 Consequently, the boundaries 
between a select agent pathogen and a similar 
sequence from a related species are often equivocal 
and unclear. For instance, criminal penalties apply to 
unlawful possession of biological matter “that 

64



Georgetown	Scientific	Research	Journal	

contains more than 85 percent of the gene sequence 
of the variola…virus,” 6 defining the agent on the 
sole basis of genome sequence similarity. However, 
there does not yet exist a clear and objective 
definition of an agent based on sequence homology. 
Thus, the sequence homology stipulation is 
subjective, failing to account for differences in 
virulence and allowing for multiple interpretations of 
what is covered within this 85%. For example, many 
regions of the variola major and minor virus 
genomes are over 85% similar to sequences found in 
harmless naturally occurring viruses, such as the 
vaccinia virus. Given that the vaccinia virus is vital 
for research surrounding the development and 
production of smallpox vaccine, the problematic and 
arbitrary definition surrounding the variola virus 
could inadvertently restrict and criminalize this 
essential vaccine research.20 In one case, because 
researchers were unsure if samples qualified as select 
agents, an entire collection of Newcastle disease 
virus was destroyed. In another, stocks of attenuated 
acapsular strains of Bacillus anthracis were lost to the 
ambiguity surrounding whether or not they qualified 
as select agents. In fact, there have been thirteen 
documented cases (almost undoubtedly an 
underestimate) wherein microbial collections were 
destroyed due to confusion about whether they fell 
within the regulatory scope of the SARs, impeding 
scientific advances meant to promote public health.14 

4. Review of Recommendations Made by the
Scientific Community

Ultimately, while scientists recognize the 
incumbent role of the SARs in addressing United 
States biosecurity and bioterrorism concerns, there 
exists an evident need to significantly reform the 
current regulations so that they do not unnecessarily 
hinder laboratory efficiency and scientific progress. 
We will review recommendations made by others, 
based on both general and specific observations from 
the regulations and the literature. To this end, we 
will focus on five topics: sample accounting, 

inspection standardization, transport requirements, 
dedicated central funding for select agent research, 
and nomenclature concerns. 

4.1 Sample Accounting 
As discussed, there are a myriad of ways that 

select agents can be stolen, given that only trace 
amounts of these replicating agents are required to 
grow and establish new stocks. Thus, the current 
time-intensive and bureaucratic procedure of “vial 
counting” fails to functionally inhibit this nefarious 
activity, instead providing only an outward 
appearance of security. To address the ineffective 
procedure of vial counting, it is the recommendation 
of the National Center for Biotechnology 
Information (NCBI) that the Federal Select Agents 
Program (FSAP) implements a more rational 
inventory system that accounts for the living and 
self-replicating nature of BSAT.18 Suggestions from 
the scientific community in this vein include an 
accountability system, which rather than attempting 
to count the amount of select agents in a laboratory, 
would instead account for those who have access to 
the agents–documenting when and which 
individuals access agents, as well as their intended 
use with these BSATs. Accountability of the 
individuals working with select agents would 
effectively combat and reduce nefarious 
opportunity.21 Although this solution still requires 
documentation, the implementation of this method 
would ensure that the valuable laboratory time 
dedicated towards security measures is being used 
efficiently and efficaciously. 

4.2 Inspection Standardization 
Substantial laboratory time, effort, and money is 

also spent reconciling the inconsistent inspection 
results that arise from being subjected to multiple 
laboratory inspections by varying agencies. This 
bureaucratic burden could be significantly alleviated 
by converging the standards and interpretations of 
the SARs, centralizing control and responsibility for 

65



Georgetown	Scientific	Research	Journal	

select agent laboratory inspections to a single 
agency.18 In ensuring consistent regulations, this 
solution could preserve laboratory resources and 
efficiency without compromising the protection 
offered by the SARs.   

4.3 Transport Requirements 
Provided the implementation of effective policy 

promoting feasible transport of select agents, it is 
likely that many microbial collections destroyed 
because they contained (or might have contained) 
select agents could have been saved. Specifically, 
lengthening the grace period allotted to store and 
secure recently regulated BSATs outside of SAR 
approved labs would ensure that there is sufficient 
time for these laboratories to transfer the 
collections.14 As a result of this increased time and 
flexibility laboratories would have in the transfer of 
select agents, a longer grace period would necessarily 
promote the likelihood of successful transfer. 
Laboratories could still take measures to further 
secure select agents on-site until a time they could 
transfer them, necessarily ensuring the agents 
remain safe from theft or tampering during this 
grace period. It would also be beneficial to catalogue 
microbial collections of agents being considered for 
inclusion within the SARs prior to listing, as this 
would allow government agencies to preemptively 
work to ensure the preservation of these 
collections.14 These solutions, all of which could be 
implemented with relative ease, would be invaluable 
in ensuring the preservation of irreplaceable and 
indispensable microbial collections. 

4.4 Dedicated Central Funding for Select Agent 
Research 

The copious cost required to meet the safety and 
security requirements of the regulations is arguably 
one of the most consequential barriers to select agent 
research. To ensure that laboratories do not have to 
use their research funding to meet these regulatory 
demands, it is the recommendation of the National 

Research Council that entities conducting select 
agent research are granted a separate and stable 
federal fund to finance the security subsidization, 
facility upgrades, and other administrative demands 
of the SAR. Given the important role of central 
infrastructure in conducting select agent research, 
this added and distinct form of financial support 
would be imperative in ensuring that operational 
costs do not compete directly with scientific 
funding.21 With this funding addressing the added 
financial burden of select agent research, which has 
disincentivized countless laboratories, it is likely that 
many more institutions would be willing to engage 
in this research, creating unprecedented 
opportunities for scientific advancement in this field.  

4.5 Nomenclature Concerns 
Grouping microbial strains by species in the 

designation of select agents can also unnecessarily 
hinder essential scientific research, as this method 
fails to consider differences in virulence within the 
specific strains of a species. As recommended by the 
NCBI, excluding strains with a lower virulence 
when designating select agents would facilitate 
innocuous research and allow investigators to carry 
out critical work on low-virulence strains outside of 
the confines of the SARs.18 In ensuring that 
harmless strains are not subject to these restricting 
regulations, this solution would address needless 
administrative burdens endured by researchers while 
preserving the intent of the SARs.  

5. Conclusion
The SARs, while intended to protect public

safety against bioterrorism and biowarfare threats, 
have created significant barriers to scientific research 
conducted in the best interest of public health. 
Specifically, the time consuming and costly 
requirements have deterred countless researchers 
and laboratory entities from working with select 
agents, hindering scientific advancements in a 
crucial field. In working to reform administrative 

Georgetown	Scientific	Research	Journal	

regulations that do little to provide safety or security, 
we can ensure that scientific research meant to 
protect public health is necessarily robust and 
streamlined. Balancing the obligation for oversight 
surrounding BSATs while recognizing the necessity 
of facilitating scientific progress and freedom, 
reformed regulations can promote the 
complementary goals of scientific research and 
federal aims, ensuring the best outcome for the 
public health of our nation now and for generations 
to come.  

Acknowledgments  
I would like to acknowledge and give my 

immense thanks to my research supervisor, Dr. 
Michael Parker, who has made this work possible. 
He provided me with the opportunity to do this 
research, offering invaluable counseling every step of 
the way. His continued guidance and advice carried 
me through every stage of the subsequent writing 
process, and his meticulous and profound comments 
and suggestions have shaped this manuscript. I am 
extremely grateful for the time and immeasurable 
support that he has offered me throughout my 
involvement in this research, and it has been a 
privilege to work under his mentorship. This project 
was supported by a grant from the Center for 
Effective Altruism’s Long-Term Future Fund. 

References 
1. Birch, D., & Shane, S. (1998, February 20). FBI

foils anthrax plot in U.S. White supremacist, lab 
owner arrested by FBI in Nevada; Vials, car taken 
for testing; Bacillus to be used as terror weapon, say 
federal charges. The Baltimore Sun. 
https://www.baltimoresun.com/news/bs-xpm-1998-
02-20-1998051082-story.html

2. Vick, K. (1997, April 23). Ohio man gets probation
in bubonic plague case. The Washington Post. 
https://www.washingtonpost.com/archive/local/199 
7/04/23/ohio-man-gets-probation-in-bubonic-
plague-case/e098f691-6fea-4452-9c84-6d9e3f83be7d/  

3. Center for Disease Control & U.S. Department of 
Agriculture. (2020, September 23). Bioterrorism: A 
brief history. Federal Select Agent Program.
https://www.selectagents.gov/overview/history.htm

4. Richmond, J. Y. (2005). 42 CFR Part 72: Additional 
requirements for facilities transferring or receiving 
select agents. Center for Disease Control and 
Prevention.
http://www.cdc.gov/od/ohs/lrsat/42cfr72.htm

5. Wurtz, N., Grobusch, M. P., & Raoult, D. (2014). 
Negative impact of laws regarding biosecurity and 
bioterrorism on real diseases. Clinical Microbiology 
and Infection, 20(6), 507–515. Blackwell Publishing 
Ltd. https://doi.org/10.1111/1469-0691.12709

6. National Research Council (U.S.) Committee on 
Scientific Milestones for the Development of a Gene 
Sequence-Based Classification System for the 
Oversight of Select Agents. (2010). Sequence-based 
classification of select agents : a brighter line. National 
Academies Press.
https://pubmed.ncbi.nlm.nih.gov/21210555/

7. Gonder, J. C. (2005). Select agent regulations. ILAR 
Journal, 46(1), 4–7.
https://doi.org/10.1093/ilar.46.1.4

8. Jaax, J. (2005). Administrative issues related to 
infectious disease research in the age of bioterrorism. 
ILAR Journal, 46(1), 8–14.
https://doi.org/10.1093/ilar.46.1.8

9. Department of Health and Human Services. (2005). 
Possession, use, and transfer of select agents and 
toxins; Final rule. Federal Register, 13294 - 13325. 
https://www.govinfo.gov/content/pkg/FR-2005-
03-18/pdf/05-5216.pdf#page=2

10. U.S. Department of Agriculture. (2002). 
Possession, use and transfer of biological agents and 
toxins; Interim final rule. Animal and Plant Health 
Inspection Service. www.aphis.usda.gov/ppd/rad/

11. Animal and Plant Health Inspection Service, 
USDA. (2002). Agricultural Bioterrorism 
Protection Act of 2002; Listing of biological agents 
and toxins and requirements and procedures for 
notification of possession. Federal Register, 52383–
52389.
https://www.federalregister.gov/documents/2002/08

66



Georgetown	Scientific	Research	Journal	

regulations that do little to provide safety or security, 
we can ensure that scientific research meant to 
protect public health is necessarily robust and 
streamlined. Balancing the obligation for oversight 
surrounding BSATs while recognizing the necessity 
of facilitating scientific progress and freedom, 
reformed regulations can promote the 
complementary goals of scientific research and 
federal aims, ensuring the best outcome for the 
public health of our nation now and for generations 
to come.  

Acknowledgments  
I would like to acknowledge and give my 

immense thanks to my research supervisor, Dr. 
Michael Parker, who has made this work possible. 
He provided me with the opportunity to do this 
research, offering invaluable counseling every step of 
the way. His continued guidance and advice carried 
me through every stage of the subsequent writing 
process, and his meticulous and profound comments 
and suggestions have shaped this manuscript. I am 
extremely grateful for the time and immeasurable 
support that he has offered me throughout my 
involvement in this research, and it has been a 
privilege to work under his mentorship. This project 
was supported by a grant from the Center for 
Effective Altruism’s Long-Term Future Fund. 

References 
1. Birch, D., & Shane, S. (1998, February 20). FBI

foils anthrax plot in U.S. White supremacist, lab 
owner arrested by FBI in Nevada; Vials, car taken 
for testing; Bacillus to be used as terror weapon, say 
federal charges. The Baltimore Sun. 
https://www.baltimoresun.com/news/bs-xpm-1998-
02-20-1998051082-story.html

2. Vick, K. (1997, April 23). Ohio man gets probation
in bubonic plague case. The Washington Post. 
https://www.washingtonpost.com/archive/local/199 
7/04/23/ohio-man-gets-probation-in-bubonic-
plague-case/e098f691-6fea-4452-9c84-6d9e3f83be7d/  

3. Center for Disease Control & U.S. Department of 
Agriculture. (2020, September 23). Bioterrorism: A 
brief history. Federal Select Agent Program.
https://www.selectagents.gov/overview/history.htm

4. Richmond, J. Y. (2005). 42 CFR Part 72: Additional 
requirements for facilities transferring or receiving 
select agents. Center for Disease Control and 
Prevention.
http://www.cdc.gov/od/ohs/lrsat/42cfr72.htm

5. Wurtz, N., Grobusch, M. P., & Raoult, D. (2014). 
Negative impact of laws regarding biosecurity and 
bioterrorism on real diseases. Clinical Microbiology 
and Infection, 20(6), 507–515. Blackwell Publishing 
Ltd. https://doi.org/10.1111/1469-0691.12709

6. National Research Council (U.S.) Committee on 
Scientific Milestones for the Development of a Gene 
Sequence-Based Classification System for the 
Oversight of Select Agents. (2010). Sequence-based 
classification of select agents : a brighter line. National 
Academies Press.
https://pubmed.ncbi.nlm.nih.gov/21210555/

7. Gonder, J. C. (2005). Select agent regulations. ILAR 
Journal, 46(1), 4–7.
https://doi.org/10.1093/ilar.46.1.4

8. Jaax, J. (2005). Administrative issues related to 
infectious disease research in the age of bioterrorism. 
ILAR Journal, 46(1), 8–14.
https://doi.org/10.1093/ilar.46.1.8

9. Department of Health and Human Services. (2005). 
Possession, use, and transfer of select agents and 
toxins; Final rule. Federal Register, 13294 - 13325. 
https://www.govinfo.gov/content/pkg/FR-2005-
03-18/pdf/05-5216.pdf#page=2

10. U.S. Department of Agriculture. (2002). 
Possession, use and transfer of biological agents and 
toxins; Interim final rule. Animal and Plant Health 
Inspection Service. www.aphis.usda.gov/ppd/rad/

11. Animal and Plant Health Inspection Service, 
USDA. (2002). Agricultural Bioterrorism 
Protection Act of 2002; Listing of biological agents 
and toxins and requirements and procedures for 
notification of possession. Federal Register, 52383–
52389.
https://www.federalregister.gov/documents/2002/08

67



Georgetown	Scientific	Research	Journal	

/12/02-20354/agricultural-bioterrorism-protection-
act-of-2002-listing-of-biological-agents-and-
toxins-and  

12. Shelby, B. D., Cartagena, D., McClee, V., 
Gangadharan, D., & Weyant, R. (2015). Transfer of 
select agents and toxins: 2003-2013. Health Security, 
13(4), 256–266. Mary Ann Liebert Inc. https://
doi.org/10.1089/hs.2015.0009

13. U.S. Government Accountability Office. (2013). 
Overlap and duplication: Federal inspections of 
entities registered with the select agent program. 
GAO. https://www.gao.gov/products/gao-13-154

14. Casadevall, A., & Imperiale, M. J. (2010). 
Destruction of microbial collections in response to 
select agent and toxin list regulations. Biosecurity and 
Bioterrorism : Biodefense Strategy, Practice, and Science, 
8(2), 151–154.
https://doi.org/10.1089/bsp.2010.0012

15. Lim, Y.-B., Gillum, D., & Vogel, K. (2021, October 
25). Twenty years after the patriot act, what is the 
future of biosecurity? Issues in Science and Technology. 
https://issues.org/biosecurity-20-years-after-patriot-
act-lim-gillum-
vogel/#:~:text=Twenty%20Years%20After%20the%
20Patriot,Is%20the%20Future%20of%20Biosecurity
%3F&text=To%20deal%20with%20tomorrow’s%20 
biological,and%20lists%20of%20suspicious%20germ 
s

16. National Science Foundation. (2013). Federally 
funded research and development centers 
employed more than 3,000 postdoctoral 
researchers in 2010. NSF.
https://www.nsf.gov/news/news_summ.jsp?cntn_id 
=127756

17. Franz, D. R. (2015). Implementing the select agent 
legislation: Perfect record or wrong metric? Health 
Security, 13(4), 290–294.
https://doi.org/10.1089/hs.2015.0029

18. The National Academies of Science, Engineering, 
and Medicine. (2016). Optimizing the nation’s 
investment in academic research: A new regulatory 
framework for the 21st century. National Academies 
Press. https://doi.org/10.17226/21824

19. Casadevall, A., & Relman, D. A. (2010). Microbial 
threat lists: obstacles in the quest for biosecurity?
Nature Reviews Microbiology, 8(2), 149–154. https://
doi.org/10.1038/nrmicro2299

17.

18.

19.

20. National Science Advisory Board for Biosecurity.
(2006). Addressing biosecurity concerns related to 
the synthesis of select agents. Center for Disease 
Control and Prevention.
http://www.cdc.gov/od/sap/docs/salist.pdf

21. House, M. (2013). The select agent program and dual 
use research of concern: their effects on the regulatory 
environment of pandemic influenza studies. [Master’s 
thesis, Iowa State University].
https://dr.lib.iastate.edu/entities/publication/f7a321 
e9-8e96-44a0-ad47-8eb6b3d8ebbe

68



69




	Table of Contents
	Letter From the Editors
	Increasing COVID-19 Vaccine Uptake in the United States: Addressing Reasons for Vaccine Hesitancy th
	An Analysis of the Effects of Frequency and Type of Physical Activity on Self-Esteem in Adolescent M
	Addressing American Obesity: A Policy Proposal
	The Select Agent Regulations: Structure and Stricture
	An Evaluation of the Human Impact of Climatic Factors in Cook County, Illinois
	An Evaluation of Food Insecurity in the D.C. Community
	About the Authors
	Meet the Staff
	Acknowledgements




