Fast Track Action Committee Report:

Recommendations on the Select Agent 

Regulations Based on Broad 

Stakeholder Engagement

October 2015

National Science and Technology Council

Committee on Homeland and National Security

Subcommittee on Biological Defense Research and 

Development

Fast Track Action Committee on the Select Agents 

Regulations 
iii

Executive Summary

Following several biosafety incidents at U.S. Government laboratories in 2014, the 

White House issued a memorandum outlining a series of short- and long-term actions to 

enhance laboratory biosafety and biosecurity practices.

One short-term action was a safety stand-down for all Federal laboratories that 

possess, use, or transfer human, animal, or plant infectious agents or toxins. Senior 

leadership and staff of departments and agencies were urged to review and improve 

biosafety and biosecurity practices, as needed. Departments and agencies were also urged 

to develop and implement plans for a sustainable inventory management and control 

system. Long-term actions included engaging broader stakeholders’ input into how the 

Select Agent Regulations (SAR) have impacted science, technology, and national 

security in the United States.

In order to engage a wide range of stakeholders, the National Science and 

Technology Council (NSTC) established a Fast Track Action Committee (FTAC) on the 

Select Agent Regulations under the Subcommittee on Biological Defense Research and 

Development of its Committee on Homeland and National Security. The FTAC and the 

White House Office of Science and Technology Policy (OSTP) convened two listening 

sessions of SAR stakeholders to provide individual views to inform and support the 

process. Furthermore, the FTAC published a Request for Public Comment in the Federal 

Register to collect additional input from interested individuals and organizations 

throughout the United States and globally. 

This report describes findings and recommendations formulated from the listening 

sessions, the responses to the Federal Register notice, and previous reviews of the SAR. 

Recommendations from stakeholders obtained during the information gathering process 

focused on ways to improve the regulatory process and address perceived gaps in the 

SAR in the future. Based on individual stakeholder input, the FTAC developed

recommendations that it believes can be reasonably implemented. The FTAC also 

identified more complex issues that will require additional analysis before specific 

proposals can be developed and evaluated.

FTAC Recommendations

1. Regulation Interpretations: The FTAC recommends developing a formal 

mechanism for issuing, publicizing, and accepting requests for interpretations 

of the SAR.
iv

2. Public Release of Information: The FTAC recommends that information 

about biological select agents and toxins (BSAT) research, including 

laboratory incidents, be periodically provided to the public, and that Federal 

BSAT laboratories adopt, to the maximum extent feasible, a policy of 

transparency regarding both the agents used and laboratory incidents.

3. Sharing Best Practices: The FTAC recommends members of the regulated 

community establish a mechanism for sharing best practices.

4. Individual-based Security Risk Assessments: The FTAC recommends that in 

the absence of specific information indicating otherwise, individuals who 

have been granted access to select agents or toxins at one BSAT institution 

be able to move to another BSAT institution without having to wait for a new 

Security Risk Assessment.

5. Emergency Situations: The FTAC recommends development of a mechanism 

to expedite approvals or to relax Federal Select Agent Program (FSAP)

requirements in response to time-urgent emergency situations. 

6. Inventory Control Requirements: The FTAC recommends retaining 

requirements to maintain inventories of samples containing biological select 

agents and toxins, while ensuring that BSAT institutions are not requested to 

characterize biological agents quantitatively.

7. Consistency of Inspections: The FTAC recommends development of an 

approach to improve the consistency of the inspection process across 

inspectors, inspecting agencies, and inspected sites.

8. Improve Customer Service in Communicating with Regulated Entities: The 

FTAC recommends improving communication before and after site 

inspections and improving the timeliness of inspection reports.

9. Categorize Inspection Findings: The FTAC recommends developing a 

system to categorize findings on inspection reports.

10. Appeals Process: The FTAC recommends expanding the appeals process for 

institutions to adjudicate disputed findings in inspection reports.

11. Peer Advisory Mechanism: The FTAC recommends creating an expert panel 

or Federal Advisory Committee to serve as an external group that could share 

best practices or make recommendations to the FSAP.

12. International Engagement: The FTAC recommends international engagement 

to explore harmonization of pathogen security standards and ensure 

understanding of the rationale for, and implementation of, the SARequivalent standards by collaborating foreign governments.
v

13. Guidance for Customs Inspectors: The FTAC recommends providing better 

training and guidance for customs inspectors who process BSAT shipments.

Issues for Further Analysis

A. Institutional Scope of Regulation: Consider whether to bring all bioscience 

institutions, or at least all those operating at or above Biosafety Level 3 or 

“high containment”, under Federal biosafety regulation.

B. Possible Exemptions for Quality Assurance: Consider creating exemptions

from certain security regulations for laboratories that retain certain select 

agents only for the purposes of positive control material availability and 

quality-assurance procedures.

C. Security Expenses: Examine mechanisms for funding security-related 

expenses for use of BSAT; determine if those mechanisms are adequate; and 

if not, propose options to ensure that funding is available for necessary 

security measures.

D. Consistent Disclosure Policies: Seek to ensure that institutions regulated 

under the SAR fall under consistent information-disclosure policies, to the 

extent that State and local laws and regulations pertaining to these institutions 

can be reconciled with Federal requirements.

E. Common Chemical, Biological, and Radiological Security Framework: 

Explore the feasibility of establishing a common interface for institutions—

with respect to personnel vetting and personnel reliability—for people with 

access to chemical, biological, and radiological materials of security concern.

F. Risk-based Approach: Explore the feasibility of adopting a “risk-based”

approach to managing the safety and security oversight of biological agents 

and toxins. 

G. Shipping Regulations: Review domestic and international shipping 

regulations and requirements, as well as related guidance, with a view to 

simplifying and clarifying, and to facilitating compliance by other countries.
vi

Contents

A. Introduction .................................................................................................................1

B. Background and Previous Reports on Biosafety and Biosecurity...............................3

C. Stakeholder Comments and Observations...................................................................4

1. Human Resources Costs......................................................................................5

2. Financial Costs....................................................................................................5

3. Challenges with Personnel Suitability Requirements .........................................6

4. Gaps in the Select Agent Regulations.................................................................6

5. Consistency, Clarity, and Responsiveness of the Select Agent Program............6

6. SAR in an International Context .........................................................................7

D. FTAC Recommendations............................................................................................7

1. Regulation Interpretations: The FTAC recommends developing a formal 

mechanism for issuing, publicizing, and accepting requests for interpretations 

of the SAR...........................................................................................................7

2. Public Release of Information: The FTAC recommends that information about 

BSAT research, including laboratory incidents, be periodically provided to the 

public, and that Federal BSAT laboratories adopt, to the maximum extent 

feasible, a policy of transparency regarding both the agents used and laboratory 

incidents...............................................................................................................8

3. Sharing Best Practices: The FTAC recommends members of the regulated 

community establish a mechanism for sharing best practices...........................10

4. Individual-based Security Risk Assessments: The FTAC recommends that in 

the absence of specific information indicating otherwise, individuals who have 

been granted access to select agents or toxins at one BSAT institution be able 

to move to another BSAT institution without having to wait for a new Security 

Risk Assessment................................................................................................10

5. Emergency Situations: The FTAC recommends development of a mechanism 

to expedite approvals or to relax FSAP requirements in response to time-urgent 

emergency situations. ........................................................................................11

6. Inventory Control Requirements: The FTAC recommends retaining 

requirements to maintain inventories of samples containing biological select 

agents and toxins, while ensuring that BSAT institutions are not requested to 

characterize biological agents quantitatively. ...................................................12

7. Consistency of Inspections: The FTAC recommends development of an 

approach to improve the consistency of the inspection process across 

inspectors, inspecting agencies, and inspected sites..........................................12
vii

8. Improve Customer Service in Communicating with Regulated Entities: The 

FTAC recommends improving communication before and after site inspections 

and improving the timeliness of inspection reports...........................................13

9. Categorize Inspection Findings: The FTAC recommends developing a system 

to categorize findings on inspection reports......................................................14

10. Appeals Process: The FTAC recommends expanding the appeals process for 

institutions to adjudicate disputed findings in inspection reports. ....................14

11. Peer Advisory Mechanism: The FTAC recommends creating an expert panel or 

Federal Advisory Committee to serve as an external group that could share best 

practices or make recommendations to the FSAP.............................................14

12. International Engagement: The FTAC recommends international engagement 

to explore harmonization of pathogen security standards and ensure 

understanding of the rationale for, and implementation of, the SAR-equivalent 

standards by collaborating foreign governments...............................................15

13. Guidance for Customs Inspectors: The FTAC recommends providing better 

training and guidance for customs inspectors who process BSAT shipments..15

E. Issues for Further Analysis........................................................................................16

A. Institutional Scope of Regulation: Consider whether to bring all bioscience 

institutions, or at least all those operating at or above Biosafety Level 3 or 

“high containment,” under Federal biosafety regulation...................................16

B. Possible Exemptions for Quality Assurance: Consider creating exemptions 

from certain security regulations for laboratories that retain certain select 

agents only for the purposes of positive control material availability and 

quality-assurance procedures. ...........................................................................17

C. Security Expenses: Examine mechanisms for funding security-related expenses 

for use of BSAT; determine if those mechanisms are adequate; and if not, 

propose options to ensure that funding is available for necessary security 

measures. ...........................................................................................................18

D. Consistent Disclosure Policies: Seek to ensure that institutions regulated under 

the SAR fall under consistent information-disclosure policies, to the extent that 

State and local laws and regulations pertaining to these institutions can be 

reconciled with Federal requirements. ..............................................................18

E. Common Chemical, Biological, and Radiological Security Framework: 

Explore the feasibility of establishing a common interface for institutions—

with respect to personnel vetting and personnel reliability—for people with 

access to chemical, biological, and radiological materials of security 

concern. .............................................................................................................19

F. Risk-based Approach: Explore the feasibility of adopting a “risk-based” 

approach to managing the safety and security oversight of biological agents 

and toxins. .........................................................................................................20

G. Shipping Regulations: Review domestic and international shipping regulations 

and requirements, as well as related guidance, with a view to simplifying and 

clarifying, and to facilitating compliance by other countries............................21

Appendix A Summary of Comments from Listening Sessions...................................... A-1
viii
1

A. Introduction

Life sciences research in the United States is essential to characterize, prevent, detect,

and respond to biological threats of natural, accidental, or deliberate origin. It is the U.S. 

Government’s responsibility to ensure that life sciences research in the United States is 

conducted safely and securely. In the summer of 2014, laboratory biosafety/biosecurity 

incidents in U.S. Government facilities led Lisa O. Monaco, the Assistant to the President 

for Homeland Security and Counterterrorism, and John P. Holdren, the Assistant to the 

President for Science and Technology, to issue a memorandum outlining a series of 

immediate and longer-term steps the U.S. Government would take to identify and address 

the underlying causes of these incidents.1

Issued August 18, 2014, the memorandum urged all U.S. Government departments 

and agencies that operate facilities that possess, use, or transfer any human, animal, or

plant infectious agent or toxin to perform a safety stand-down. The memo also urged 

all such departments and agencies to prepare an immediate full accounting of their 

holdings to (1) identify any biological select agents and toxins and ensure their proper 

registration, safe stewardship, and secure storage or disposal; and (2) have senior 

leaders devote time to review laboratory biosafety and biosecurity best practices and 

protocols and develop a sustainable inventory monitoring plan. The memorandum also 

urged non-federal and international entities that receive Federal Government funds to 

voluntarily take part in similar activities.

The longer-term actions included reconvening the Federal Experts Security 

Advisory Panel (FESAP, established in 2010 by Executive Order 13546) to conduct a 

coordinated Federal review to identify gaps and make recommendations for optimizing 

biosafety, biosecurity, oversight, and inventory management and control of biological 

select agents and toxins.2 They also included the formation of an interagency group to 

comprehensively engage the broader stakeholder community to review the impact that 

the Select Agent Regulations3 (SAR) have had on science, technology, and national 

security. This second action was to ensure that members of the scientific, regulatory, 

and security communities, as well as interested citizens, would have an opportunity to 

provide direct feedback on this important issue. 

 

1 L. Monaco, and J. Holdren, “Ensuring Biosafety and Biosecurity in U.S. 

Laboratories,”https://www.whitehouse.gov/sites/default/files/microsites/ostp/enhancing_biosafety_and_b

iosecurity_19aug2014_final.pdf.

2 Executive Order 13546, “Optimizing the Security of Biological Select Agents and Toxins in the United 

States,” July 2, 2010, https://www.whitehouse.gov/the-press-office/executive-order-optimizing-securitybiological-select-agents-and-toxins-united-stat.

3 42 CFR Part 73, 9 CFR Part 121, 7 CFR Part 331.
2

To ensure that this stakeholder review benefited from diverse perspectives and 

the broadest possible input, the National Science and Technology Council established a 

Fast Track Action Committee (FTAC) on the Select Agent Regulations under the 

Subcommittee on Biological Defense Research and Development of its Committee on 

Homeland and National Security. The FTAC and the White House Office of Science and 

Technology Policy (OSTP) convened two listening sessions of SAR stakeholders 

(February 17, 2015, and March 20, 2015) to inform the process and provide insight into 

how the SAR have affected science, innovation, biosafety, and biosecurity in the United 

States. Approximately 55 individual scientists, research administrators, biosecurity 

experts, and other interested stakeholders attended the two sessions, either in person or by 

teleconference. The specific goals of the listening sessions were to solicit a broader and 

deeper understanding of the impact of the SAR on science and innovation, safety and 

security, and public or agricultural health and response, as well as understand how the SAR 

might be applied now and in the future. Appendix A summarizes the individual comments 

provided at the meetings. 

On March 16, 2015, the FTAC published a Request for Public Comment in the 

Federal Register to collect additional input from interested individuals and organizations 

throughout the United States and globally regarding the impacts of the SAR on science, 

technology, biosafety, and biosecurity.4 During the three-week comment period, 43 

submissions from 63 respondents were received. The perspectives, observations, and 

recommendations gathered from the listening sessions and the Federal Register 

submissions coalesced around a few overall themes. Including the listening sessions, a total 

of 118 stakeholders provided comments on both negative and positive impacts of the SAR, 

on specific challenges related to SAR implementation, and on perceived gaps in the SAR 

as currently conceived and implemented. Recommendations received during the

information-gathering process focused on ways to improve the regulatory process and 

address gaps in the SAR in the future. The FTAC reviewed the recommendations it 

received, grouping them by topic.

Section B of this report provides general background on the SAR. Section C is a

summary of general comments and observations. Section D contains the most salient and 

actionable FTAC recommendations based on stakeholder feedback. Finally, the more 

complex issues, including those that require more analysis than is feasible under the 

FTAC’s timeline, are presented in Section E.

 

4 Impact of the Select Agent Regulations, Federal Register Notice (80 FR 13639), March 16, 2015, 

https://www.federalregister.gov/articles/2015/03/16/2015-05906/impact-of-the-select-agent-regulations.
3

B. Background and Previous Reports on Biosafety and Biosecurity 

The SAR were developed so that the U.S. Government could minimize the risk of 

bioterrorism and ensure the legitimate use of pathogens by regulating the security and 

safety of entities that possess, transfer, or use certain (select) biological pathogens and 

toxins. Title V of Public Law 104-132 (1996) included provisions that required the 

Secretary of Health and Human Services (HHS) to regulate the transfer of select agents 

and toxins from one laboratory to another.

5 This authority was expanded to cover 

possession and utilization of these agents by Public Law 107-188.

6 Public Law 107-188 

authorizes the Secretaries of Health and Human Services and Agriculture to regulate the 

possession, use, or transfer of a “select” list of human, animal or plant infectious agents or 

biological toxins (biological select agents or toxins, or BSAT) that have the potential to 

pose a severe threat to public, animal, or plant health or animal and plant products. Public 

Law 107-188 requires a biennial review of the BSAT list during which BSAT may be 

added or removed based on new information or a better understanding of the risks they 

pose.

The SAR require individuals, private and public organizations, academic institutions,

and government agencies in the United States to register with the Federal Select Agent 

Program (FSAP) before they can lawfully possess and use BSAT. Implementation of these 

regulations is delegated to the Centers for Disease Control and Prevention’s (CDC)

Division of Select Agents and Toxins (DSAT) for HHS and to the Animal and Plant Health 

Inspection Service’s (APHIS) Agriculture Select Agent Services (AgSAS) for the United 

States Department of Agriculture (USDA). DSAT and AgSAS operate as the FSAP to 

coordinate the regulation of BSAT. Between 2004 and 2010, over 300 entities registered 

to possess, use, or transfer BSAT, and more than 13,171 individuals (scientists, technicians, 

and support personnel) were approved for access to select agents.

7 In 2012, the SAR were 

modified to create two tiers of BSAT. Fifteen agents and toxins posing the greatest risk 

were designated as “Tier 1” agents, and additional regulations were imposed upon 

institutions possessing and working with them. These regulations included requirements 

for occupational health and personnel suitability assessments for staff with access to or 

who work with Tier 1 select agents.

 

5 Antiterrorism and Effective Death Penalty Act of 1996, Public Law 104-132, April 24, 1996, 

http://www.gpo.gov/fdsys/pkg/PLAW-104publ132/pdf/PLAW-104publ132.pdf.

6 Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188

Sec. 231, June 12, 2002, http://www.gpo.gov/fdsys/pkg/PLAW-107publ188/pdf/PLAW107publ188.pdf.

7 R. D. Henkel, T. Miller, and R. S. Weyant, “Monitoring Select Agent Theft, Loss and Release Reports in 

the United States—2004–2010,” Appl. Biosafety 17 (2012), 171–180.
4

There have been multiple, complementary, and sometimes overlapping efforts, both 

Federal and non-federal, to scrutinize and evaluate the issues related to BSAT, personnel 

and cyber security, FSAP administration, and the benefits and costs of SAR 

implementation.8 These previous efforts include reports from a number of Federal task 

forces and panels that can be found on the Legal Authorities, Policies and Committees page 

of the Public Health Emergency, Department of Health and Human Services website: the 

Executive Order 13486 Working Group on Strengthening the Biosecurity of the United 

States (2009) report, the Trans-Federal Task Force on Optimizing Biosafety and 

Biocontainment Oversight (TFTF) report (2009), and the report of the Federal Experts 

Security Advisory Panel (2010).

9

The FTAC’s review of these reports was not exhaustive, but rather weaves together 

the many threads and recommendations of previous efforts pertinent to the purpose of this 

FTAC. The FTAC also drew upon a number of non-federal reviews that echoed many of 

the issues identified and reiterated in this FTAC report. For example, while greater 

transparency is a continuous theme in these reports, it also stands out as a continuous 

challenge for all parties. Greater transparency was a key recommendation from the TFTF

and FESAP reports, as well as reports from the National Science Advisory Board on 

Biosecurity (NSABB),

10 the National Science Foundation, Institute of Medicine advisory 

groups, professional societies and the broader community. These reports highlight the 

important role that communication and information sharing with communities that 

surround high-level containment laboratories play in good-neighbor relationships and in 

fostering a culture of transparency. Also highlighted were the cost of effective biosecurity, 

personnel suitability requirements, standardized and harmonized approaches to site 

inspections, inventory systems, and collaborative problem-solving.

C. Stakeholder Comments and Observations

This broad stakeholder engagement on the review of the impact of SAR on science, 

technology, and national security draws on an extensive background of previous studies of 

the SAR regulations and FSAP program. The FTAC has arrived at a number of 

recommendations that it believes can be reasonably implemented. It also highlighted more 

 

8 S. A. Morse, “Pathogen Security—Help or Hindrance?” Frontiers in Bioengineering and Biotechnology

2 (2015), 1–12.

9 Public Health Emergency, Science Safety Security, Strategies and Reports, 

http://www.phe.gov/s3/strategies/Pages/default.aspx.

10 National Science Advisory Board for Biosecurity, “Enhancing Personnel Reliability among Individuals 

with Access to Select Agents,” May 2009, 

http://osp.od.nih.gov/sites/default/files/resources/NSABB%20Final%20Report%20on%20PR%205-29-

09.pdf; National Science Advisory Board on Biosecurity, “Guidance for Enhancing Personnel Reliability 

and Strengthening the Culture of Responsibility,” September 2011, 

http://osp.od.nih.gov/sites/default/files/resources/CRWG_Report_final.pdf.
5

complex, which will require additional analysis before specific proposals can be developed 

and evaluated.

The predominant sentiment of stakeholders is best captured in the statement by more 

than one individual that there is a “love-hate” relationship between the select agentregulated community and the SAR as currently designed and implemented. Several 

stakeholders expressed the view that there were positive benefits to having oversight and 

inspections, particularly with respect to biosafety, that would not otherwise occur in the 

absence of the SAR. Since the SAR emphasize laboratory safety and require inspections, 

stakeholders expressed their belief that the SAR provide an extra impetus for laboratory 

personnel to be more diligent in working with select agents. Stakeholders also recognize 

that the SAR have helped prevent the unauthorized release of select agents and enhanced 

a culture of safety.

Stakeholders offered mixed perspectives on BSAT inventory accountability 

requirements; most of them viewed overall accountability requirements to be valuable and 

appropriate at the strategic level. There were also several specific and ardent concerns 

about the negative effects of the SAR, however, notably in terms of their impact on the 

willingness of researchers to work on BSAT, the financial costs of compliance, and the

destruction of potentially valuable material as a result of inventory requirements.

1. Human Resources Costs

Many stakeholders said that the requirements of the SAR, particularly for Tier 1 

agents, have become so financially and administratively burdensome that students, 

postdoctoral researchers, and well-established researchers are leaving research with BSAT 

in favor of research with non-select agents, although no data were provided. The majority 

of stakeholders who spoke on this issue implied that the overall strength of scientific 

advancement in select agent research in the United States is directly tied to the number of 

facilities and researchers working in the field. They also noted that researchers may in some 

cases be driven to perform research in countries that do not have the same regulatory

requirements. 

2. Financial Costs

Stakeholders suggested that the financial cost of physical security requirements and 

personnel suitability regulations around Tier 1 agents is a substantial burden to many 

institutions. Some said that several manufacturers have decided to stop producing 

veterinary vaccines or diagnostics due to a combination of rising SAR compliance costs 

and small profit margins for those products, which could affect the availability of products 

for agricultural health and emergency response. Following the establishment of the Tier 1 

designation for 15 select agents and toxins, and the associated regulations, some 

institutions decided to abandon research with Tier 1 select agents because the financial 
6

costs associated with compliance were too high. Stakeholders noted that implementing the 

SAR requires committing much time and money, especially for inventory control and staff 

to handle paperwork and ensure compliance. Several stakeholders said that they had at least 

one full-time equivalent employee devoted to SAR compliance, with many other 

individuals involved secondarily.

Additional topics discussed during the listening sessions included the negative 

impacts of the SAR on the food safety/manufacturing/processing industry, particularly 

with respect to botulinum neurotoxin’s designation as a Tier 1 toxin. According to 

stakeholders, the cost of implementing Tier 1 regulations has led at least some food 

processors and manufacturers to cease their work with Tier 1 agents, which could have 

negative consequences for a public health emergency response involving the food supply.

3. Challenges with Personnel Suitability Requirements

Difficulties in implementing personnel suitability requirements for Tier 1 agents were 

noted, and some stakeholders said these requirements negatively affect their ability to 

engage highly qualified scientists. Several stakeholders noted that implementation of the 

SAR created particular burdens on public health laboratories, and in some cases, the lack 

of available security risk assessment “cleared” personnel could have a negative impact on 

responsive patient care by delaying testing of clinical samples. Multiple stakeholders in the 

listening session and in the Federal Register notice submissions suggested the need for 

better guidance or a mechanism for sharing and harmonizing best practices on the 

implementation of personnel suitability programs.

4. Gaps in the Select Agent Regulations

Some respondents believed that the potential risks posed by novel organisms and new 

techniques are significant and inadequately addressed by existing regulatory approaches.

The rapid pace of advances in genetic engineering and molecular biology has lowered 

barriers to the ability of researchers to use recombinant technologies to potentially increase 

an organism’s virulence or synthesize a biological select agent de novo. The ability to 

translate biological data into digital form and back again raises questions about regulatory 

oversight measures, such as the SAR, that rely on the physical presence of a pathogen. It 

was argued that additional consideration should therefore be given to regulatory

approaches that anticipate technological challenges and are flexible enough to keep pace 

with them.

5. Consistency, Clarity, and Responsiveness of the Select Agent Program

Many stakeholders said a number of improvements were needed in how the SAR was 

implemented with regard to coordination between Federal regulatory agencies and the 

regulated community. One key comment was that the perceived lack of consistency in 
7

interpretations of the SAR between regulatory agencies led to variations in application 

during rounds of inspections and even differences in interpretation between inspectors

when conducting an inspection. Respondents also noted that a lack of communication about

the scope and process of an inspection beforehand and delays in receiving responses from 

regulatory agencies about inquiries regarding inspection findings prevented SAR facilities 

from implementing compliance actions in time for the next inspection. Also, delays in 

approvals for specific research projects caused researchers to miss funding deadlines. 

Finally, protracted communications and ambiguities in the inspection process have resulted 

in more time spent in inspection preparation and compliance, an additional resource burden 

that is placed on SAR researchers. The FTAC recognized these concerns as “customer 

service” issues on the part of the FSAP and has offered recommendations to address them.

6. SAR in an International Context

A set of comments centered on considerations of the SAR and its impact on

international engagement. Many stakeholders were concerned that restrictions placed on 

BSAT researchers in the United States would lead them to join foreign laboratories with 

more lenient requirements, in turn creating an unequal playing field. Moreover, 

stakeholders commented that a lack of clarity and understanding of the rationale and 

processes of the SAR by foreign researchers hinders international research relationships. 

Finally, stakeholders said they needed additional guidance on how the SAR affects their 

international research collaborations, as well as additional training for customs officials in 

handling international shipments of BSAT materials. 

D. FTAC Recommendations

The FTAC recommendations are based on input gathered from two listening sessions 

and responses to a solicitation published in the Federal Register asking for comment on 

how the SAR have affected science, innovation, biosafety, and biosecurity in the United 

States. 

1. Regulation Interpretations: The FTAC recommends developing a formal 

mechanism for issuing, publicizing, and accepting requests for interpretations 

of the SAR.

No regulations can be detailed enough to specify how they should be applied in every 

situation, particularly when—like the SAR—they are applied to a diverse set of institutions 

(e.g., clinical laboratories, academic research laboratories, public health laboratories, food 

manufacturing facilities, and animal facilities). The necessary provision of flexibility for 

case-by-case application introduces the possibility that the regulations may be interpreted 

in different ways by different institutions and by the officials who inspect them.
8

To minimize inconsistent interpretations of the regulations, several respondents have 

asked that a mechanism be established by which they can request a formal interpretation 

of the SAR as they apply to that institution’s particular circumstance. Public issuance of an

interpretation would provide predictability for the institution, minimize inconsistent 

interpretations by different inspectors, and allow other institutions in similar circumstances 

to adopt a consistent approach. The FTAC recommends the development of a formal 

mechanism for accepting requests for, issuing, publicizing, and holding consistently to 

interpretations of its regulations. However, given that application of the regulations can be 

site-specific and can depend on factors that would be difficult to capture in a statement of 

interpretation, there may be limitations on how effectively an archive of regulatory 

interpretations could serve to promote consistency in inspections across different 

institutions.

2. Public Release of Information: The FTAC recommends that information about 

BSAT research, including laboratory incidents, be periodically provided to the 

public, and that Federal BSAT laboratories adopt, to the maximum extent 

feasible, a policy of transparency regarding both the agents used and 

laboratory incidents.

Maintenance of the public trust is essential for conducting high- or maximumcontainment biological research. This trust is enhanced when communities surrounding 

containment laboratories are confident that they are being kept aware of activities within 

the laboratories, including, but not limited to, the occurrence of incidents that might affect 

them. At the same time, the willingness of laboratories to provide such information is 

enhanced when there is confidence that such transparency will not prove harmful to them—

for example, when the press and public clearly understand that multiple layers of protection 

stand between potentially hazardous pathogens and the public. Administrative 

irregularities or incidents involving a single one of these protective measures do need to be 

addressed, but by themselves do not necessarily put the public at risk.

News reports on incidents at biocontainment laboratories, as well as congressional 

testimony from interested parties and reports from the Government Accountability Office, 

have stressed the perceived opaqueness of the program. For example, one recent article

asserted, “select agent oversight is cloaked in secrecy, making it difficult to assess 

regulators’ effectiveness in ensuring safety.” The article also quoted a member of a citizen 

advisory panel as saying, “the more people in the community [surrounding a select agent 
9

research laboratory] feel that there’s secrecy, the more they’re distrustful, whether their 

distrust is warranted or not.”11

The FTAC recommends that information about BSAT research or incidents in BSAT

laboratories be shared with the public, to the maximum extent possible. In most cases, 

withholding this information has negligible security value, since the research, researchers, 

institutions, and agents involved with BSAT research are often published in scientific 

journals or can readily be inferred from public materials. However, the FTAC also 

recognizes that in many cases, certain work with BSAT, including work on the 

characterization of biological threats or the evaluation of their use in bioterror and biocrime 

events, cannot be fully released for security reasons, lest that information be used to 

facilitate the efforts of those who would seek to inflict harm with BSAT. 

Specific statutory restrictions12 preventing the Federal government from releasing 

certain select agent information in response to requests under the Freedom of Information 

Act do not preclude research institutions or government laboratories from voluntarily 

disclosing such information. Indeed, the biocontainment laboratories at Fort Detrick, 

Maryland, and Galveston, Texas, have started posting information about all their laboratory 

incidents on public websites. For example, Galveston National Laboratory provides the 

public with a history of possible exposures from 2002 to the present, including the name 

of the agent or toxin and a description of the incident.

Over time, providing biosafety data to the public will facilitate long-term risk 

assessments, provide the public with greater context for high-profile or novel events, and 

allow for assessment of the overall risk associated with biocontainment laboratories. 

Dissemination of this information, perhaps through a third-party professional organization, 

could mitigate concerns or direct needed resources, as appropriate. The FTAC recommends 

that institutions conducting BSAT research periodically, to the maximum extent possible,

release information regarding their BSAT research programs and that the FSAP release 

aggregated information on laboratory incidents on an annual basis. The FTAC further 

recommends that the Federal Government lead by example and that Federal BSAT

laboratories adopt, to the maximum extent feasible, a policy of transparency regarding both 

the agents used and laboratory incidents.

 

11 See Alison Young and Nick Penzenstadler, “Inside America’s Secretive Biolabs,” USA Today, May 28, 

2015, http://www.usatoday.com/story/news/2015/05/28/biolabs-pathogens-locationincidents/26587505/.

12 See 42 USC 262a(h)(1).
10

3. Sharing Best Practices: The FTAC recommends members of the regulated 

community establish a mechanism for sharing best practices.

Listening session participants said that they would appreciate the opportunity to 

improve their safety and security practices by learning from their peers. Mechanisms to 

accomplish sharing best practices, such as a website, would be well received and would 

enhance safety and security among many institutions. The FTAC recommends establishing 

such an information-sharing mechanism, while recognizing that the FSAP might not be the 

best party to establish it. This need might best be met if the regulated institutions 

themselves, or a non-governmental entity such a professional society, were to establish a 

mechanism to do so and update the information in a timely manner.

FSAP sponsorship of such an information-sharing mechanism might put the program 

in the position of appearing to endorse a particular practice described there, which some 

institutions may find valuable, but which would not necessarily be researched or vetted by 

the FSAP. Moreover, government sponsorship may make it difficult to maintain a robust 

and frank dialogue among the participants in such an exchange, if that privacy were sought.

4. Individual-based Security Risk Assessments: The FTAC recommends that in 

the absence of specific information indicating otherwise, individuals who have 

been granted access to select agents or toxins at one BSAT institution be able 

to move to another BSAT institution without having to wait for a new Security 

Risk Assessment.

Once an individual undergoes a Security Risk Assessment and is permitted to work 

with select agents, any change to the list of agents he or she is working with, or a transfer 

to a different institution, should continue to require notification to FSAP. However, an 

individual transferring from one registered entity to another registered entity should not 

have to wait for the completion of a new Security Risk Assessment. This continued 

approval would be dependent on both the original institution and the receiving institution

(1) formally exercising their responsibilities to report to the FSAP if an individual becomes 

a “restricted person,” (2) being held accountable for their own personnel suitability 

assessments (meaning that the receiving institution needs to do its own if the individual 

will be working with Tier 1 agents), and (3) reporting suspicious behavior as required by 

the regulations. The FSAP would be able to update or redo the Security Risk Assessment

at its discretion, and it always has the responsibility to deny access of the individual to 

select agents and toxins should disqualifying information be uncovered. However, the

individual’s access to select agents should be maintained without break, pending any such 

reevaluation. Notification of the change to FSAP would enable FSAP to conduct a new 

Security Risk Assessment if necessary, and maintain a current list of personnel who have 

access to select agents (including which agents they have access to and at which 

institutions), while minimizing unnecessary delays or duplicative investigations.
11

5. Emergency Situations: The FTAC recommends development of a mechanism 

to expedite approvals or to relax FSAP requirements in response to timeurgent emergency situations.

Some respondents noted that the development of a vaccine to an emerging pandemic 

strain of influenza would be impeded by the requirement to treat potential vaccine strains

as select agents until the extensive process needed to show that they were attenuated. These 

respondents argued that highly pathogenic H5N1 avian influenza can be predictably 

attenuated by standard genetic methods used in vaccine development, making extensive 

testing unnecessary. If subject-matter experts are able to provide evidence of the efficacy 

of such attenuation methods through scientific documentation and peer-reviewed 

publications, the FSAP should evaluate whether employing such attenuation is sufficient 

to consider H5N1 influenza vaccine strains, or other influenza strains, as exempt from 

select agent controls. FSAP should also consider whether the exigencies of an emerging 

pandemic might warrant such a determination even if it might not be considered 

appropriate under normal circumstances.

Other FSAP requirements, such as the security provisions that prevent unauthorized 

individuals from gaining access to or working with select agents, would have less relevance 

during a widespread outbreak—during which patients, clinical samples, health-care 

environments, and other settings may be rife with the organism responsible—than they 

would have if the organism was strictly confined to approved laboratories. The FSAP 

program should be able to allow appropriate officials to expedite approvals or relax FSAP 

requirements in time-urgent emergency situations if those requirements are judged to 

confer negligible security value during an outbreak but would impede the response. (Note 

that relaxing or waiving safety requirements may not be appropriate, unless safety can be 

assured in the absence of experimental validation.) Any waived provisions could be 

reinstituted once the outbreak has been controlled.

The Secretaries of Health and Human Services and Agriculture already have authority 

to temporarily exempt individuals from the requirements of the SAR for the purpose of 

responding to domestic or foreign public health emergencies that involve select agents or 

toxins.

13 The FTAC recommends that the need for any additional waivers or waiver 

processes be examined, such as whether waivers are needed that are defined in terms of 

regulated actions, rather than actors; whether officials other than the Cabinet Secretaries 

should be able to issue them, and whether the emergencies that might prompt such waivers 

are sufficiently anticipated and defined in advance. If needed, these waivers should be 

provided for a defined time period, or for as long as some pre-defined set of conditions are 

satisfied, with the option to review for an extension.

 

13 See 42 USC 262a(g)(3) and (4); 7 USC 8401(g)(1)(D) and (E); and 7 USC 8401(g)(2).
12

6. Inventory Control Requirements: The FTAC recommends retaining

requirements to maintain inventories of samples containing biological select 

agents and toxins, while ensuring that BSAT institutions are not requested to 

characterize biological agents quantitatively.

Many responders objected to the detailed vial-by-vial inventory requirements of the 

SAR on the grounds that this type of inventory is not appropriate for replicating organisms.

These responders argued that a microscopic amount of a sample can be imperceptibly 

removed from any select agent sample and used to grow an arbitrarily large, and 

undocumented, culture. They also argued that discrepancies between actual inventories and 

their corresponding databases are far more likely to result from bookkeeping errors than 

from the theft or diversion of actual samples. Therefore, these responders questioned the 

value of detailed inventories on the grounds that correlation of databases with physical 

samples can neither confirm that a diversion has taken place nor assure that it has not.

The FTAC agrees with this analysis. However, it also believes that institutions 

possessing BSAT are obligated to know and document what is stored in their laboratories

and where those agents and toxins are located. It is therefore appropriate to require 

institutions to maintain inventories of their select agent stocks and be able to show not only 

that all their samples are documented, but that all entries in an inventory database 

correspond to physical samples. Maintaining and validating select agent inventories are 

essential elements of responsible conduct, even if they cannot be used to rule in or rule out 

a theft or diversion.

Correlation of database and physical stocks is therefore an indicator of quality 

management, and entities should practice accountability. The SAR do not require 

quantitative inventory controls for select biological agents, only for select toxins. The 

FTAC therefore recommends that accountability in the SAR be maintained at the level of 

identifiable physical items, such as vials or plates, and not extended to quantitative 

measurements of the size, volume, mass, or concentration of biological agents (other than 

as needed to describe them qualitatively). Currently, record keeping and inventory 

validation do not require accounting for and verifying biological agent concentrations or 

volumes. The FSAP should ensure that inventory validation through quantitative sample

characterization (such as by thawing a frozen sample to measure its volume) is not 

occurring during inspections, except with toxins where appropriate. Quantitative sample 

characterization could otherwise needlessly degrade or destroy samples.

7. Consistency of Inspections: The FTAC recommends development of an 

approach to improve the consistency of the inspection process across 

inspectors, inspecting agencies, and inspected sites.

Respondents cited the loss of significant time, effort, and financial investment to 

reconcile inconsistent inspection results and inconsistent interpretation of regulations 
13

among inspectors. Many larger laboratories and facilities undergo multiple inspections 

annually by various agencies. Inspectors from different Federal agencies, or inspectors 

from the same agency arriving at different times, often have differing standards and 

interpretations of the SAR, which lead the laboratory to engage in compliance actions that 

may not meet another inspector’s compliance standards during future inspections. In 

addition, respondents outlined other factors that create inconsistency in inspections: a lack 

of pre-inspection communication by lead inspectors regarding changes to the scope and 

process of the inspection, as well as new regulatory interpretations when there is a change 

among case managers at regulatory institutions. Although there have been significant 

improvements over the past several years in coordinating inspections across agencies, 

stakeholders consistently identify this as a major issue. The FTAC recommends that the 

FSAP gather concrete examples of the inconsistencies and issues identified by stakeholders 

and develop an approach to improving the consistency of inspections and resolving these 

persistent issues, recognizing that solutions proposed in Recommendation 1 may help 

address these concerns.

8. Improve Customer Service in Communicating with Regulated Entities: The 

FTAC recommends improving communication before and after site 

inspections and improving the timeliness of inspection reports.

Respondents said that communication between inspectors and regulated institutions 

needs significant improvement. Many respondents believe the speed and method of 

communication would be greatly improved if paperwork and other written communication 

could be transmitted through a protected electronic mechanism rather than using paper and 

fax submissions. The FTAC strongly recommends that CDC and APHIS implement an 

electronic communication mechanism within one year of the release of this report to 

improve the efficiency and speed of communication.

Other examples of deficient communication include (1) delays in issuing inspection 

reports such that facilities cannot address compliance issues before subsequent inspections 

and (2) delays in receiving approval for new experiments, causing investigators to miss 

grant application deadlines. Moreover, while CDC requires responses from institutions 

within 30 days of inspection, the agency might take much longer to respond to laboratories 

on their proposed changes, amendments, and inspection reports, delaying research that

cannot be done without approval. The FTAC strongly recommends inspection reports be 

communicated to registered facilities within 30 days of the inspection and that customer 

service performance metrics be established, monitored, and publicly reported.
14

9. Categorize Inspection Findings: The FTAC recommends developing a system 

to categorize findings on inspection reports.

Respondents noted that recorded violations received equal treatment, whether they 

were minor administrative errors or egregious safety or security violations. In addition, the 

lack of discrimination between a minor and a serious violation presents a communications 

challenge when a facility choses to share information regarding its regulatory compliance 

with the community or other members of the public. 

The FTAC recommends categorizing observed SAR violations into one of three 

groups: administrative, important, or critical. Although more detailed definitions would 

have to be developed, critical violations would be those that have the potential to create a 

serious security or safety problem; important violations would be those having the potential 

to compromise the safety or security of the laboratory and staff, possibly in conjunction 

with other errors; and administrative violations might involve paperwork or documentation 

errors. The FTAC recommends the FSAP develop rigorous definitions for each category 

within 120 days of this report’s release.

Finally, some stakeholders also suggested that, in addition to the focus on identified 

violations, facilities receive feedback on those aspects of regulatory compliance where they

are doing well. The FTAC recognizes that this would be difficult to accommodate within 

a regulatory framework; other than attesting to regulatory compliance, inspectors are not 

in a position to opine on if, or by how much, the regulatory institutions exceed expectations. 

10. Appeals Process: The FTAC recommends expanding the appeals process for 

institutions to adjudicate disputed findings in inspection reports.

Respondents expressed concern that there is no formal mechanism for engaging with 

the FSAP regarding disagreements, misunderstandings, or disputes with respect to 

inspection findings. The FTAC recommends that a timely and formal process be 

established for laboratories to resolve differences over inspection outcomes.

11. Peer Advisory Mechanism: The FTAC recommends creating an expert panel 

or Federal Advisory Committee to serve as an external group that could share 

best practices or make recommendations to the FSAP.

Respondents expressed a desire for greater peer-to-peer involvement with the FSAP.

Respondents wished for a process by which they would be able to interact with the FSAP 

to provide subject-matter expertise on the SAR on a regular basis. To provide broader 

scientific and security viewpoints and advice, the FTAC recommends that HHS and USDA

establish a framework of external scientific and security experts drawn from regulated 

communities, those having regulatory experience, and other relevant communities. This 

framework could be formed as a Network of Experts, as used by FDA, which provides 

opportunities for individual consultation. Alternatively, the framework could be a formal
15

Federal Advisory Committee, reporting to the FSAP, which provides consensus 

recommendations. Forming the latter would likely entail budgetary actions, but could be 

beneficial in building trust with regulated entities.

12. International Engagement: The FTAC recommends international engagement 

to explore harmonization of pathogen security standards and ensure 

understanding of the rationale for, and implementation of, the SAR-equivalent 

standards by collaborating foreign governments.

Respondents emphasized that rigorous pathogen security measures applied to select 

agents in the United States, if not complemented by the adoption of analogous measures 

internationally, would have only partial safety and security benefits and at the same time 

potentially harm U.S. research, since international competitors would not face an 

equivalent regulatory burden. One respondent also expressed concern that if the SAR were

not adequately explained to foreign audiences, they could be misconstrued in ways that 

would be counterproductive to international dialogue on a range of issues, including access 

to, and sharing of, the benefits of research activities. The FTAC notes that the U.S. 

Government has been actively promoting the development of systems of biosecurity 

oversight both bilaterally and in appropriate multilateral forums for a number of years, and 

although the details vary, national oversight systems for biosafety or biosecurity are 

increasingly common among countries with significant life science research enterprises. 

Nevertheless, the FTAC agrees with the importance of such international engagement and 

recommends sustained and increased efforts by the Federal Government to both promote 

such oversight and to explore opportunities to harmonize regulatory approaches to the 

extent feasible.

13. Guidance for Customs Inspectors: The FTAC recommends providing better 

training and guidance for customs inspectors who process BSAT shipments.

Several respondents referred to incidents in which shipments of select agent materials 

had been delayed because customs officials were unfamiliar with the SAR, including cases 

where samples were degraded due to the delay and being stored at room temperature.

Customs inspectors have also requested better connectivity to relevant sources of technical 

expertise—available at any time—for guidance on what to do with packages that arrive 

damaged and how to address associated exposure risks. Although the frequency of such 

events is unclear, the FTAC recommends that the Department of Homeland Security work

with the FSAP to develop clear guidance and familiarization training for customs 

inspectors.
16

E. Issues for Further Analysis

The FTAC has identified several additional proposals for improving the SAR that

could not be analyzed and assessed during FTAC’s charter, including some issues that 

would require far-ranging change. The FTAC recommends continued analysis of these 

proposals to determine whether they would be advisable and, if so, to develop concrete 

approaches for implementing them. It is recognized that for some of the proposals, 

significant changes to the statute authorizing the SAR would be required.

A. Institutional Scope of Regulation: Consider whether to bring all bioscience 

institutions, or at least all those operating at or above Biosafety Level 3 or “high 

containment”, under Federal biosafety regulation.

In the time available, the FTAC was not able to recommend one or the other of these 

proposed approaches or to develop an alternative. Instead, it recommends that a task force 

be charged with making proposals on whether and how the Federal Government should 

regulate biosafety of non-select agents, particularly those requiring containment at or above 

Biosafety Level 3. The FTAC does, however, caution against the inappropriate application 

of the SAR’s security requirements to agents that pose primarily safety concerns.

Legislation initiating controls over the transfer of BSAT (the Antiterrorism and 

Effective Death Penalty Act of 1996; Public Law 104-132) and their possession, use, and 

transfer (the Public Health Security and Bioterrorism Preparedness and Response Act of 

2002, Public Law 107-188) was enacted in the wake of security incidents involving 

hazardous pathogens; the original motivation for these laws was not to regulate safety.

However, the current SAR serve both security and biosafety objectives. Specifically, the 

SAR require that registered individuals or entities “develop and implement a written 

biosafety plan that is commensurate with the risk of the select agent or toxin, given its 

intended use.”14 The regulations go on to specify a number of biosafety guidance 

documents that should be considered in the development of this plan. But these guidance

documents, such as the CDC/National Institutes of Health publication “Biosafety in 

Microbiological and Biomedical Laboratories (BMBL),” are not written in the form of 

prescriptive regulations, and they do not themselves have the force and effect of law.

The FTAC received a wide range of views with respect to broadening the way in 

which biosafety should be regulated. Several respondents appreciated that in addition to its 

security rationale, the FSAP provides Federal oversight, inspection, and control of 

biosafety for work done with BSAT, and some argued that biosafety for all biological 

agents requiring high-containment or above facilities (e.g., Biosafety Level 3 or above) be 

similarly regulated. At present, agents such as multi-drug resistant Mycobacterium 

tuberculosis, Japanese encephalitis virus, St. Louis encephalitis virus, rabies virus, or 

 

14 See 42 USC 73.12(a), 7 USC 331.12(a), 9 USC 121.12(a)
17

Middle East Respiratory Syndrome-Coronavirus (MERS-CoV) require the use of 

Biosafety Level 3 facilities, but they are not deemed to pose the security concerns that

would warrant their designation as select agents.

Since the security requirements of the FSAP are unnecessary for these agents and 

would significantly impede research and other activities with them if applied, placing them 

under biosafety regulation would either require creating a biosafety-only regulatory 

regime, or it would require splitting the security requirements of the SAR from the safety 

requirements and generalizing the latter. These approaches likely would require statutory 

changes. They would also require defining “containment laboratory” or biosafety levels 

concretely enough to make clear which laboratories would be regulated, but generically

enough to accommodate the wide range of objectives for which containment laboratories 

are constructed and the wide range of technical activities that are performed within them.

.

B. Possible Exemptions for Quality Assurance: Consider creating exemptions 

from certain security regulations for laboratories that retain certain select agents 

only for the purposes of positive control material availability and quality-assurance 

procedures.

The FTAC recommends that a future task force examine whether provisions can be 

made to ease the burden of SAR compliance for diagnostic, clinical, or food industry 

laboratories that work with BSAT without impairing the security benefits for controlling 

BSAT at other facilities.

Respondents from many clinical or diagnostic laboratories, or who worked in the food 

industry, reported that the SAR imposed undue burdens on those who, like themselves, 

retained select agents only for the purpose of validating their laboratory procedures, or for 

use as reference standards or positive controls to ensure that analytical tests were correctly 

identifying or characterizing the presence of select agents. They proposed that they not be 

burdened with the full panoply of SAR compliance, particularly with respect to the need 

for the FBI to conduct a Security Risk Assessment on each person with actual or potential 

access to BSAT and the need to keep detailed inventories.

The FTAC appreciates these concerns and recognizes that many organizations have 

robust hiring procedures to help ensure the honesty and integrity of the employees that they 

hire. But it also recognizes that the security value of controlling access to BSAT in any 

given facility has little to do with the purpose or the extent to which those agents are used 

in that facility. Therefore, the FTAC suggests that a task force, with appropriate input from 

the regulated and the security communities, examine the possibility of alternative 

approaches to achieving the overarching security goals for select agents in these types of 

dedicated-purpose laboratories. The alternative approaches would need to balance the risk 
18

of misuse specific to this set of activities and institutions with the risk that if nothing is 

done, these laboratories may find it impossible to continue using BSAT for quality 

assurance.

C. Security Expenses: Examine mechanisms for funding security-related expenses 

for use of BSAT; determine if those mechanisms are adequate; and if not, propose 

options to ensure that funding is available for necessary security measures.

The FTAC recommends that the appropriate Departments and Agencies in the 

Federal government, as well as Office of Management and Budget (OMB) and OSTP, 

explore the costs associated with conducting work with Tier 1 BSAT as compared to 

other infectious agents and toxins requiring the same biocontainment levels; identify 

mechanisms for funding security-related expenses; determine if those mechanisms are 

adequate; and if not, propose options to ensure that funding is available for necessary 

security measures.

Many institutions registered to possess and use Tier 1 select agents noted that the 

costs of the security requirements associated with these agents are substantially higher 

than those corresponding to research with non-select agents, or with non-Tier 1 select 

agents. Funding agencies and funded institutions should work together to understand 

what the actual costs are, compared to work with other infectious agents and toxins at the 

same biocontainment levels, and whether current funding mechanisms, including the 

negotiated indirect expense reimbursement rates that federally funded research 

institutions are allowed to charge, are sufficient to cover these security expenses. Note 

that some institutions using BSAT, such as public health laboratories, may not be 

conducting federally funded research or collecting federal reimbursement for indirect 

expenses, and options that rely on federal research funding mechanisms would not 

address those institutions.

D. Consistent Disclosure Policies: Seek to ensure that institutions regulated under 

the SAR fall under consistent information-disclosure policies, to the extent that 

State and local laws and regulations pertaining to these institutions can be 

reconciled with Federal requirements.

The U.S. Government should explore ways to reconcile any contradictory Federal, 

State, and local regulations and policies, either by relaxing Federal protections or by 

enacting Federal statutes to extend to the State and local level the current protections 

against releasing certain security-relevant information under Federal Freedom of

Information Act (5 USC § 552) requests.

Notwithstanding Recommendation 2 above, which promotes the disclosure of 

information relevant to the operation of laboratories regulated by the SAR, there will 

continue to be a need to withhold some security-related information concerning BSAT
19

research from public release. This need may extend to vulnerability analyses addressing 

the possible environmental release of certain organisms or the publication of Dual Use 

Research of Concern (i.e., research that has legitimate applications, but that generates 

materials or information that could be misused to cause harm), lest these vulnerability 

analyses become available to potential adversaries intent on exploiting those

vulnerabilities.

The legislation establishing the FSAP required the program to protect certain SARrelated information from release under the Freedom of Information Act. However, BSAT

laboratories operated by State universities or other State Governmental offices are subject 

to State open records or freedom of information acts, against which the Federal statutory 

language provides no protection. The FTAC recommends that this discrepancy be 

addressed to the extent possible, recognizing that the 10th Amendment to the U.S. 

Constitution restricts the Federal Government’s ability to direct actions of State or local 

government.

E. Common Chemical, Biological, and Radiological Security Framework: Explore 

the feasibility of establishing a common interface for institutions—with respect to 

personnel vetting and personnel reliability—for people with access to chemical, 

biological, and radiological materials of security concern.

The FTAC recommends a Federal task force study the feasibility, cost, and benefit of 

integrating chemical, biological, and radiological personnel vetting, particularly for 

personnel suitability, to identify opportunities to make the vetting more thorough and 

efficient. If necessary, specific recommendations for changes in the relevant statutory and 

regulatory regimes should be developed.

Respondents pointed out that institutions that possess BSAT often also possess 

radioactive materials regulated by the Nuclear Regulatory Commission or chemical 

materials regulated by the Controlled Substances Act and other statutes or regulations.

Although regulated in separate regimes, these materials can pose threats to public health 

and safety. Respondents recommended that there be an exploration of the potential for the 

regulatory regimes for these materials to be harmonized, recognizing that biological 

organisms naturally occur in the environment and replicate, as contrasted with nuclear and 

chemical materials.

The FTAC is supportive of the aspiration behind this recommendation, but recognizes 

that while the various regulatory regimes involved share some common elements, the 

various requirements are designed to reflect the unique nature of each material/agent. For 

example, nuclear-related vetting of personnel is concerned with proliferation of knowledge 

to non-nuclear regimes, whereas international collaboration in BSAT research is 

encouraged. As a result, the analytic approach to vet and register people who use or possess 

these materials, as well as the nature of the hazard they pose, the means to protect public 
20

safety, and the executive branch departments or agencies with regulatory authority, are 

quite different. It is worth exploring whether there are areas for the institutions to better 

communicate with the U.S. Government to more seamlessly and efficiently vet individuals.

Note, however, that any changes may require amendment not only of the statutes and 

regulations governing the FSAP, but the other statutory and regulatory regimes as well.

The FTAC believes that further study is required to understand whether it would be feasible 

and desirable to merge aspects of the personnel-vetting process governed by uniquely 

tailored CBRN (chemical, biological, radiological, and nuclear) regulatory regimes. 

Therefore, a Federal task force should be charged to study this issue further and develop 

specific recommendations.

F. Risk-based Approach: Explore the feasibility of adopting a “risk-based” 

approach to managing the safety and security oversight of biological agents and 

toxins.

The FTAC recommends that the National Science and Technology Council charter a 

working group to examine the feasibility of developing a more holistic risk-based approach 

to biosafety and biosecurity. The FTAC notes that the SAR only address agents and toxins 

that are determined to be BSAT. Second, the SAR only address those security risks that 

result from physical access to a listed pathogen. Security risks from the information 

generated while working with pathogens (whether listed or not), or from physical access 

to unlisted organisms that have been genetically modified to confer pathogenic properties, 

cannot be accommodated through the SAR in their current form. Some, but not all, of these 

risks are currently addressed through other instruments, including Federal policies 

concerning the funding of “dual-use research of concern” (DURC) and an ongoing review 

of Federal policy in relation to so-called gain-of-function research; however, these policies 

lack full legal force and effect and are limited in scope.

Given that emerging infectious diseases and the ability to manipulate virulence or 

toxicity factors at the molecular level present potential risks and challenges, a riskmanagement tool or algorithm may provide a more appropriate means than a list-based 

approach to managing risks to laboratory workers and the environment. At the same time, 

developing a purely risk-based approach that can be applied for security purposes (e.g., to 

require suitability vetting of personnel) may prove challenging.

In 1997, the SAR framed a list of dangerous pathogens to control the distribution and 

access to agents based on the following criteria, as stated in the Antiterrorism and Effective 

Death Penalty Act of 1996:

the effect on human health of exposure to the agent; the degree of 

contagiousness of the agent and the methods by which the agent is 

transferred to humans; the availability and effectiveness of immunizations 
21

to prevent and treatments for any illness resulting from infection by the 

agent; and any other criteria that the Secretary considers appropriate.15

The FTAC recognizes that the select agent list is not static. Although there is an 

established process for its biennial review and modification, it is still a list. With the 

creation of the Tier 1 designation (Executive Order 13546), several registered entities 

decided to forego working with the Tier 1 BSAT to avoid increased compliance costs. In 

other cases, those entities that decided to continue working with Tier 1 BSAT used this 

change in the SAR as an opportunity to segregate this work from other activities that would 

not need to meet Tier 1 requirements.

Throughout the multiple Federal and nongovernmental reviews and public comments 

in the past, including this current effort, it is clear that there is tension and discomfort with 

the select agent list. On the one hand, the list allows the imposition of regulatory 

requirements. On the other hand, other pathogens of concern to public health do not meet 

the criteria for consideration as a select agent and are therefore would be inappropriate to

add to this list. Moreover, new technologies and DNA manipulation techniques may not be

addressable in the context of a list-based approach at all.

Stakeholders are part of a community that wants to employ the best practices available 

to enhance laboratory safety and security, and their inputs show that the field is at a 

significant enough crossroads to consider a more robust risk-based management approach 

with an eye to both a list (requiring safety and security measures to be applied to certain 

organisms) and a method of assessing risk management and mitigation. This Issue differs 

from Issue A (above), which would extend the safety aspects of the current regulatory 

regime to a broader set of pathogens. The analysis performed under this Issue would 

address a new regime that replaces many of the specified safety and security requirements 

with a more integrated, risk-based approach that is better able to address the full spectrum 

of biological risks, particularly those resulting from the evolution of biotechnology and 

research techniques. 

G. Shipping Regulations: Review domestic and international shipping regulations 

and requirements, as well as related guidance, with a view to simplifying and 

clarifying, and to facilitating compliance by other countries.

A number of respondents raised concerns with Federal shipping regulations for 

BSAT. Some noted that compliance with these regulations is costly, but others commented 

that relatively few shipping companies were willing to handle select agents and toxins and 

that shippers and customs officials did not in all cases appear to understand the regulations.

One respondent noted that the complexity of regulations posed particular challenges for 

other countries and was harming scientific collaboration. The FTAC recommends that the 

 

15 See Pub. L. No. 104-132, 110 Stat. 1284.
22

Department of Transportation, in consultation with FSAP, review the relevant regulations 

and the availability of clear, readily accessible guidance materials to facilitate

communication and compliance.
A-1

Appendix A

Summary of Comments from Listening Sessions

This appendix includes the summary notes from two non-attribution listening sessions 

of stakeholders convened by the Office of the Science and Technology Policy and the 

FTAC to share individual views and comments on the effect of the SAR on science, 

technology, and national security. The first meeting took place on February 17, 2015; the 

second meeting on March 20, 2015. This appendix highlights representative comments and 

perspectives expressed during the sessions. Table A-1 lists the number of stakeholders, by 

affiliation category, in attendance.

A-1. Listening Session Attendees by Affiliation Category

Affiliation Category # of Attendees

Accounting and Law 2

Other 4

Professional Societies 3

Public Policy Institutions 6

Research Institutions 2

State Public Health Laboratory 5

Universities 11

U.S. Government (Non-FTAC) 22

Grand Total 55

Stakeholder Input from the Meeting of February 17, 2015

Comments on the Overarching SAR Approach (system of reporting, safety, and 

security rules tied to a specific list of pathogens and toxins)

• The current list of select agents is sound and could even be augmented to include 

MERS-CoV. Some consideration should be given to address synthetic and gainof-function organisms in a mechanism similar to the current SAR approach.

• SAR have improved laboratory safety and security across the country.

• There should be equal emphasis on biosafety and biosecurity. Inspection is too 

focused on checklist approach. Inspectors must assess overall safety and security 

in a local context.
A-2

Costs and Benefits of the Current SAR Process (inspections, administrative 

processes, regulatory transparency and communication)

• There have been significant delays in paperwork processing, including receiving 

inspection reports after an inspection (6+ months) and paperwork requests for 

non-substantive amendments (4+ months), and closeout reports after inspection 

report correspondence. These delays have impeded the ability of scientists to 

conduct research. 

• Inventory stocks of potential scientific value have been destroyed because 

regulatory verification standards proved to be too challenging. 

• Following the establishment of the Tier 1 list of select agents and associated 

regulations, some institutions decided to abandon research with Tier 1 select 

agents because the financial costs associated with compliance were too high. 

• The financial costs of physical security regulations and personnel suitability 

regulations, particularly around Tier 1 agents, are placing substantial burdens on 

many institutions. 

• A majority of participants reported the current supply of investigators and 

trainees is shrinking because of burdensome regulation. Others, however,

believed that might be the result of a natural contraction of personnel working 

on select agent research after a 15-year period of overexpansion. 

• Administrative requirements have caused delays in the time needed to transfer a 

select agent. In some instances these delays have exceeded the acceptable time 

requirements, resulting in the destruction of cultures and the loss of valuable 

research material. 

• Participants cited inconsistent interpretation of vague regulatory language 

regarding inventory management requirements and physical security 

specifications.

• Budgetary constraints associated with SAR at public health laboratories result in 

scarce resources that are inadequate to address laboratory acquired infections 

and deliberate release events.

• Several manufacturers have decided to stop producing veterinary vaccines or 

diagnostics due to a combination of rising SAR compliance costs and small 

profit margins for those products. For example, it costs twice as much to 

develop a vaccine for EEE as for WEE.

• The cost of Tier 1 SAR has led many Food Safety Inspection Service 

laboratories to cease their work with Tier 1 agents, possibly weakening a public 

health emergency response involving the food supply.
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• Inconsistent regulations and standards for biohazard waste management 

discourage hospitals from taking patients infected with select agents, hindering 

the public health response.

Recommendations to Improve SAR Process

• Suggestions for redesigning the inspection process included reformatting the 

inspection reports such that “observations” could be categorized into distinct tiers 

of security and safety concern. Currently, the observed violations carry the same 

weight whether they are typographical errors in a report or egregious security 

violations.

• Many participants reported the need to improve communication between 

regulators and regulated community. Recommendations include creating an active 

and systematic feedback mechanism to allow regulated community to provide 

constructive comments and cite-specific risk assessments.

• A need exists for greater flexibility to incorporate agents on the select agent list.

• There is a need for an online system to facilitate the amendment process, using 

electronic submission technology rather than fax. The forms themselves need to 

be more streamlined.

• Current guidance on personnel security and suitability expectations is insufficient, 

and more guidance is requested.

• Participants suggested lengthening the select agent transfer time period to account 

for administrative delays.

• Excluding physical security features, there should be more disclosure of 

information regarding select agents and stronger engagement with the public. 

Suggestions include creating a website to highlight lessons learned about 

laboratory incidents and provide fact-based information for the public. 

• Public health laboratories are underfunded, work with very limited amounts of 

select agents, and do limited types of manipulations. One suggested approach is to 

stratify Tier 1 agents based on type of agent to provide a tailored riskmanagement approach.

• Clear SAR are needed to guide the interface of select agent diagnostic laboratories 

with medical facilities that treat select agent patients. 

Gaps in the Overarching SAR Approach or Process

• Currently, it is difficult to conduct international select agent research 

collaborations. Many international laboratories are not as well funded as entities 
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in the United States, and it remains unclear how to SAR will affect the global 

engagement of U.S. entities that have international collaborators.

• Gain-of-function experiments and synthetic organisms that are created to be 

nearly identical to select agents represent a daunting challenge that may require an 

approach beyond the current SAR approach. 

• There is a dearth of best practices and benchmarking data on the financial costs 

associated with optimal implementation of regulations associated with various 

select agent research activities.

• Inspectors have difficulty putting SAR in the context of activities conducted in a 

state public health laboratory.

Comments on Additional Approaches

• As suggested by the Defense Science Board and the National Science Advisory 

Board for Biosecurity, SAR are not sufficient by themselves. An improved 

leadership role from the Federal Government and a stronger culture of personal 

responsibility are also important components of biosecurity and biosafety. 

Stakeholder Input from the Meeting of March 20, 2015

Comments on the Overarching SAR Approach (system of reporting, safety, and 

security rules tied to a specific list of pathogens and toxins)

• The SAR is the only regulation that addresses laboratory safety and requires 

inspections, which provide an extra impetus for laboratory personnel to be more 

diligent in working with select agents. 

• While some participants favored a list-centered approach to classifying select 

agents, many suggested revising groupings on the select agent list to discern 

between agents that pose biosecurity risks and food pathogens that affect food 

safety. There was interest in amending the list to include additional agents (such 

as Ebola and meningitis), while removing agents used in food challenge studies. 

• Some participants suggested a move away from an agent-centered approach to 

general approaches and systems for improving safety and security with all 

pathogens, not just select agents. 
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Costs and Benefits of the Current SAR Process (inspections, administrative 

processes, regulatory transparency and communication)

• Participants indicated a general “love-hate relationship” with respect to the SAR 

in that it provides many benefits to the laboratories, but comes at a cost in terms 

of time and money.

• SAR allows laboratories to have better understanding of protocols in processing 

of human samples, provides guidance in whether a sample needs to be inactivated, 

helps ensure there are no unauthorized releases from laboratories, ensures 

decontamination of instruments, etc. 

• While there are areas for improvement, inspections have been positive, have 

provided good models to deal with inventory of all organisms and agents, and 

have provided a system of security checks so that more focus is on the science. 

• Implementing SAR requires much time and money, especially with regard to time 

spent in inventory controls and cost of hiring additional staff to handle paperwork 

and adhere to regulations. 

• The high cost of maintaining Tier 1 facilities has resulted in numerous institutions 

opting out of Tier 1 research. Food safety laboratories in particular are now using 

surrogate agents, which pose a risk to public health. 

• In general, researchers have begun to move away from select agent research due 

to burden of adhering to SAR.

• Personnel approval is an issue, as there is a long timeline for approval, and the 

limited number of SAR-approved staff can cause delays when one or more are 

unable to work. In addition, approved personnel should have the necessary 

scientific background to contribute to the science. 

• Personnel suitability and background checks provide peace of mind for bigger 

laboratories and allow research organizations to focus on science.

Recommendations to Improve SAR Process

• Additional guidance is needed in determining personnel suitability. Suggestions 

included sharing personnel reliability across institutions and looking at the 

Department of Defense’s personnel reliability program, which includes 

certification of officials, and involving supervisors and occupational health 

doctors. 

• Respondents recommended changing the inspections process to foster mutual 

respect and greater collaboration between institutions and regulators. Inspectors 

could do more outreach to the community by giving talks, utilizing individuals 

from other institutions as part of the inspection team, and providing positive 
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feedback (in addition to noting areas for improvement). One recommendation was 

to look at ALAC accreditation process.

• Communication between institutions and inspectors should also be improved, 

especially in terms of receiving more timely feedback, amendments, and 

inspection reports from regulators. 

• Trust is important in personnel reliability program. One suggestion was to add a 

code of conduct to regulations. 

• In the event of an exposure, participants said that there is no clear guidance from 

the CDC on how to respond.

• To increase efficiency in implementation of SAR, respondents suggested a move 

toward having paperwork associated with select agents in an electronic or online 

format.

• Participants suggested that the focus of inspections should be on larger errors that 

post biosecurity risks, moving the focus away from small details that are singular 

person errors (vs. large, systemic errors). In addition, there are problems in 

interpretation of regulation by different inspectors. 

• For larger institutions that have appropriate safety and security measures in place, 

special consideration should be given to making decisions on restricted 

experiments while keeping CDC informed, because approval processes often do

not allow for short timelines.

• For institutions that are already registered as select agent institutions, one 

recommendation was to simplify the process for registration of additional agents 

if the institution is already registered for the same or lesser level to avoid going 

through entire process again.

• Many laboratories also work with radioactive materials and have security 

measures in place. One recommendation was to streamline guidelines for select 

agents and radioactive materials.

Gaps in the Overarching SAR Approach or Process

• In addition to providing laboratories feedback on improvements, regulators should 

also provide feedback on things that are done well, and these could be shared as 

best practices across institutions. There is interest in creating a centralized 

database of best practices, specifically creating a database for inactivation 

protocols. 
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• A suggestion was made to include minimum standards in the SAR, especially for 

distinguishing Tier 1 from non-Tier 1 security standards, video surveillance of 

storage, archiving, information security, and psychological monitoring. 

• Participants emphasized the importance of conducting risk assessments, with one 

recommendation for principal investigators to submit risk assessments at the start 

of each new project. 

• There is a need to for studies on the impact of use of select agents on 

instrumentation, and an evaluation process needs to be developed for safety and 

security when using mass spectrometry instruments. 

• To build a better culture of safety at all staff levels, training programs and 

continuing education should be offered to all staff. 

• The Global Threat Reduction Initiative (GTRI) provides a model for 

improvements to SAR implementation and uptake in institutions. The GTRI 

provides recommendations to laboratories, incentivizes them to make 

improvements, and provides training. 

Comments on Additional Approaches

• To improve consistency and communication of the SAR, a recommendation was 

made to change the management and oversight of the SAR from Federal to an 

independent agency that neither funds nor conducts select agent research. 

• One challenge in applying regulations is having different settings—industry, 

university, government, all of which have different cultures. How regulations are 

taken up and implemented is affected by these cultures.

• The culture of biosafety at institutions should be encouraged by top management 

to all staff levels so that there is less emphasis on regulations and more on 

individuals promoting safety and security. 

• There is an issue of unbalanced perspectives as SAR laboratory personnel think 

SAR is an undue burden but the community thinks not enough is being done. 

Improvements in inspections and community outreach can improve the balance.