This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

5795 

Vol. 89, No. 20 

Tuesday, January 30, 2024 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 331 

9 CFR Part 121 

[Docket No. APHIS–2019–0018] 

RIN 0579–AE52 

Agricultural Bioterrorism Protection 

Act of 2002; Biennial Review and 

Republication of the Select Agent and 

Toxin List 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: In accordance with the 

Agricultural Bioterrorism Protection Act 

of 2002, we are proposing to amend and 

republish the list of select agents and 

toxins that have the potential to pose a 

severe threat to animal or plant health, 

or to animal or plant products. This Act 

requires the biennial review and 

republication of the list of select agents 

and toxins and the revision of the list as 

necessary. This action would implement 

findings from the biennial review for the 

list. The biennial review was initiated 

within 2 years of the completion of the 

previous biennial review. In addition, 

we are proposing to add definitions for 

several terms; codify policies regarding 

the role of responsible officials and 

alternate responsible officials, 

conclusion of patient care, and annual 

internal inspections; and revise or 

clarify provisions related to validated 

inactivation procedures and viable 

select agent removal methods, 

recordkeeping, non-possession of select 

agents and toxins, electronic Federal 

Select Agent Programs, registration, Tier 

1 enhancements, and exclusion of 

naturally infected animals. We are also 

proposing to add requirements for 

reporting discoveries of select agents 

and toxins, provisions regarding effluent 

decontamination system, biosafety 

provisions for facility verification 

requirements for registered biosafety 

level 3 and animal biosafety level 3 

laboratories, a new requirement related 

to restricted experiments, and to correct 

editorial errors. These proposed changes 

would economically benefit producers, 

research and reference laboratories, and 

State and Federal oversight agencies, 

while also maintaining adequate 

program oversight of select agents and 

toxins. 

DATES: We will consider all comments 

that we receive on or before April 1, 

2024. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

www.regulations.gov. Enter APHIS– 

2019–0018 in the Search field. Select 

the Documents tab, then select the 

Comment button in the list of 

documents. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2019–0018, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. 

Commenters should not include any 

information in their comments or 

supporting materials that they consider 

confidential or inappropriate for public 

disclosure. APHIS will carefully 

consider all comments submitted in 

preparation of a final rule. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at www.regulations.gov 

or in our reading room, which is located 

in Room 1620 of the USDA South 

Building, 14th Street and Independence 

Avenue SW, Washington, DC. Normal 

reading room hours are 8 a.m. to 4:30 

p.m., Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 7997039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Jacek Taniewski, DVM, Director, 

Division of Agricultural Select Agents 

and Toxins, ERCS, APHIS, 4700 River 

Road, Riverdale, MD 20737; (301) 851– 

3352; jacek.taniewski@usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (referred to below 

as the Bioterrorism Response Act) 

provides for the regulation of certain 

biological agents and toxins that have 

the potential to pose a severe threat to 

human, animal, and plant health, or to 

animal and plant products. The Animal 

and Plant Health Inspection Service 

(APHIS) has the responsibility for 

implementing the provisions of the 

Bioterrorism Response Act within the 

U.S. Department of Agriculture (USDA). 

Veterinary Services (VS) select agents 

and toxins, listed in 9 CFR 121.3, are 

those that have been determined to have 

the potential to pose a severe threat to 

animal health or animal products. Plant 

Protection and Quarantine (PPQ) select 

agents and toxins, listed in 7 CFR 331.3, 

are those that have been determined to 

have the potential to pose a severe 

threat to plant health or plant products. 

Overlap select agents and toxins, listed 

in 9 CFR 121.4, are those that have been 

determined to pose a severe threat to 

public health and safety, to animal 

health, or to animal products. Overlap 

select agents are subject to regulation by 

both APHIS and the Centers for Disease 

Control and Prevention (CDC), which 

has the primary responsibility for 

implementing the provisions of the Act 

for the U.S. Department of Health and 

Human Services (HHS). Together, 

APHIS and CDC comprise the Federal 

Select Agent Program (FSAP). 

Title II, Subtitle B of the Bioterrorism 

Response Act (which is cited as the 

‘‘Agricultural Bioterrorism Protection 

Act of 2002’’ and referred to below as 

the Act), section 212(a)(1)(A) (7 U.S.C. 

8401(a)(1)(A)), provides, in part, that the 

Secretary of Agriculture (the Secretary) 

must establish by regulation a list of 

each biological agent and each toxin 

that the Secretary determines has the 

potential to pose a severe threat to 

animal or plant health, or to animal or 

plant products. 

In determining whether to include an 

agent or toxin in the list, the Act (7 

U.S.C. 8401(a)(1)(B)) requires that the 

following criteria be considered: 

• The effect of exposure to the agent 

or toxin on animal or plant health, and 

on the production and marketability of 

animal or plant products; 

• The pathogenicity of the agent or 

the toxicity of the toxin and the 

methods by which the agent or toxin is 

transferred to animals or plants; 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5796 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

• The availability and effectiveness of 

pharmacotherapies and prophylaxis to 

treat and prevent any illness caused by 

the agent or toxin; 

• Whether such inclusion would have 

a substantial negative impact on the 

research and development of solutions 

for the animal and plant disease caused 

by the agent or toxin and whether the 

negative impact on research and 

development would substantially 

outweigh the risk posed by the agent or 

toxin to animal or plant health if it is 

not included on the list (added by the 

2018 Farm Bill); and 

• Any other criteria that the Secretary 

considers appropriate to protect animal 

or plant health, or animal or plant 

products. 

Paragraph (a)(2) of section 212 of the 

Act (7 U.S.C. 8401(a)(2)) requires the 

Secretary to review and republish the 

list of select agents and toxins every 2 

years and to otherwise revise the list as 

necessary. To fulfill this statutory 

mandate, APHIS convenes separate 

interagency working groups in order to 

review the lists of PPQ and VS select 

agents and toxins, as well as any overlap 

select agents and toxins, and develop 

recommendations regarding possible 

changes to the list using the five criteria 

for listing found in the Act. 

Advance Notice of Proposed 

Rulemaking 

Pursuant to this same paragraph of the 

Act, on March 17, 2020, we issued an 

advance notice of proposed rulemaking 

(ANPR) in the Federal Register (85 FR 

15078–15079, Docket No. APHIS–2019– 

0018) in which we solicited public 

comment on the possible delisting of 

one PPQ select agent, Peronosclerospora 

philippinensis, formerly known as 

Peronosclerospora sacchari, one VS 

select agent, African horse sickness 

virus, and five overlap select agents, 

Bacillus anthracis (Pasteur strain), 

Brucella abortus, B. suis, and B. 

melitensis, and Venezuelan equine 

encephalitis virus. We took comment on 

the ANPR for 60 days, ending May 18, 

2020. We received 224 comments by 

that time. They were from private 

citizens and stakeholders. We discuss 

the comments on the ANPR below. 

Commenters overwhelmingly 

supported delisting of B. abortus, B. 

suis, and B. melitensis. We did not 

receive any comments relative to 

delisting P. philippinensis or African 

horse sickness virus. Additionally, we 

did receive adverse comments regarding 

our proposed possible removal of 

Venezuelan equine encephalitis virus 

(VEEV) and Bacillus anthracis (Pasteur 

strain). 

Finally, we received two comments 

suggesting the delisting of Ralstonia 

solanacearum Race 3 biovar 2 and 

several comments suggesting delisting 

of other agents from the list of select 

agents and toxins. We acknowledge 

these requests but before we propose to 

delist or list an agent, it is reviewed by 

the Agricultural Interagency Select 

Agents and Toxins Technical Advisory 

Committee, or Ag-ISATTAC. In that 

regard, it is beneficial to clarify how 

those reviews take place. On a biannual 

basis, the Ag-ISATTAC, a Federal 

interagency committee of subject matter 

experts in domestic and transboundary 

animal diseases and toxins, reviews 

existing USDA select agents and toxins 

and makes recommendations regarding 

their continued listing, possible 

delisting, or addition of new agents/ 

toxins, according to several risk 

categories. Until such time as the AgISATTAC has recommended listing or 

delisting, we do not propose to do so. 

In the case of the additional changes to 

the list recommended by commenters, 

we have not received recommendations 

from the Ag-ISATTAC in support of the 

changes. 

Based upon the subject matter expert 

scientific assessment conducted during 

the biennial review, the conclusions of 

which were referenced in the ANPR, 

along with consideration of the 

accompanying public comments 

received on the ANPR, we are proposing 

to delist P. philippinensis, African horse 

sickness virus, B. abortus, B. suis, and 

B. melitensis as select agents. As we 

discussed in the ANPR, the technical 

justification for the agents we are 

proposing to delist is the following: 

• Peronosclerospora philippinensis: 

This agent is only able to survive and 

reproduce in the host plant and requires 

specific environmental conditions to 

become infectious, for which 

mitigations exist. (Food and Agriculture 

Organization of the United Nations, 

cited October 19, 2017; Murray, G.M. 

2009; Purdue University Extension, 

cited October 20, 2017; USDA, 2013.) 

• African horse sickness virus: This 

virus is difficult to successfully 

disseminate and effectively transmit. An 

effective vaccine exists. (Alberca, B, et 

al., 2014; Braverman, Y, 1996; Lulla, V., 

et al., 2017; Sanchez-Vizcaino, J.M., 

2004; Spickler, 2015.) 

• Brucella abortus: This agent 

presents little economic or animal 

health risk as it is unlikely to result in 

large-scale population introduction due 

to the high concentration of the agent 

necessary to produce disease as well as 

modern cattle production processes that 

limit animal-to-animal transmission 

routes. There is an efficacious vaccine, 

moderate immunity status within 

vulnerable populations, limited farm-tofarm transmission risk, and effective 

quarantine procedures. (Center for Food 

Security and Public Health, 2009; 

Moreno, E., 2014; Olsen, S.C., 2011.) 

• Brucella melitensis: This agent, 

which primarily affects goats and sheep, 

is of lesser concern because the low 

farm-to-farm transmission risk due to 

modern production practices limits the 

chance of introduction on a scale large 

enough to impact domestic production. 

(The Center for Food Security and 

Public Health, 2009; Moreno, E., 2014; 

Olsen, S.C., 2011.) 

• Brucella suis: This agent presents a 

low to moderate animal health risk due 

to limited farm-to-farm transmission 

risk as a result of modern production 

practices which reduce the risk of a 

large-scale introduction. (The Center for 

Food Security and Public Health, 2009; 

Stoffregen, W.C., 2006; World 

Organizsation for Animal Health (OIE), 

2017; Zhu, L., et al., 2016.) 

In addition, we are proposing to retain 

Venezuelan equine encephalitis virus 

and Bacillus anthracis (Pasteur strain) 

as select agents. 

We appreciate all comments received 

from the ANPR and will consider these 

comments in future deliberations. 

We are also proposing additional 

changes to the regulations beyond those 

discussed in the ANPR. Certain of these 

would be codifications of existing 

operational policy. These include 

provisions related to: Discovery of a 

select agent or toxin, disposal of select 

agent waste after conclusion of patient 

care, the exclusion of animals naturally 

infected with select agents from the 

requirements of the regulations, 

allowing individuals other than the 

responsible official (e.g., principal 

investigators) to revise inactivation 

procedure documentation, removal 

procedures, and the content of annual 

internal inspections. 

Many of the proposed revisions are 

intended to clarify existing provisions of 

the regulations. These include proposed 

definitions of loss, release, and theft; 

clarifying reporting requirements for 

‘‘discovered’’ select agents or toxins, a 

clarification regarding what constitutes 

an acceptable ‘‘validated inactivation 

procedure,’’ clarifications related to the 

existing reporting requirements, 

clarifying that certificates must 

accompany transfers of a select agent or 

toxin, including intra-entity transfers, 

clarifying that the documentation in the 

IT system for the FSAP program serves 

as official records required by the 

regulations, clarifying the 

documentation that may be needed for 

the issuance of a certificate of 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5797 

registration, clarifying that a responsible 

official cannot be approved as the 

responsible official at more than one 

registered entity and cannot be the sole 

alternate responsible official at another 

registered entity, clarifying 

requirements related to restricted 

experiments, clarifying the notification 

requirements for changes to the 

application for registration, and 

clarifying the scope of pre-access 

suitability assessments. 

Lastly, there are certain provisions 

that would be new. They include: 

Provisions regarding effluent 

decontamination system, biosafety 

provisions for facility verification 

requirements for registered biosafety 

level 3 and animal biosafety level 3 

laboratories, and a new requirement 

related to restricted experiments. 

We discuss the codifications of 

existing policy, the proposed 

clarifications, and the new provisions 

immediately below, by topic. 

Discovery of Select Agents or Toxins 

Since 2003, the FSAP has received at 

least 100 instances of reports from 

entities that ‘‘discovered’’ a select agent 

or toxin in their possession for which 

the entity was not registered to possess 

and neither an exemption nor an 

exclusion to compliance with the select 

agent and toxins regulations applied. 

Many of the select agents and toxins 

‘‘discovered’’ were from studies 

associated with personnel who had left 

their entity, such as a research 

institution, and the custodianship of 

samples was not reassigned. Some of the 

materials were labeled with obsolete 

pathogen names, where other 

‘‘discovered’’ materials were found in 

laboratories where their active use had 

ceased, in some cases, decades prior to 

the establishment of the select agent and 

toxin regulations. Discovery of a select 

agent in situations when there is an 

unexpected finding of the select agent as 

described above, is mutually exclusive 

from regulatory applications when 

instances of a theft, loss, or release of a 

select agent occur. 

Since 2003, unless an exemption 

applied or the select agent was excluded 

from the requirements of the select 

agent and toxin regulations, 

unregistered possession of a select agent 

or toxin on the HHS or USDA select 

agent and toxin list is a regulatory 

violation that could subject an 

individual or entity to civil and/or 

criminal penalties. 

APHIS continues to receive reports 

from registered and non-registered 

entities who find themselves in 

possession of select agents and toxins 

that they are not registered to possess 

and to which neither an exemption nor 

exclusion applies. We are proposing to 

revise 9 CFR 121.2 and 7 CFR 331.2 of 

the regulations to codify this 

longstanding operational policy by 

clarifying that any individual or entity 

in possession of a select agent or toxin, 

for which an exclusion or exemption 

listed in 9 CFR part 121 or 7 CFR part 

331 does not apply, and that is not 

included on a certificate of registration 

issued by the HHS Secretary or APHIS 

Administrator for that individual or 

entity, must immediately report such 

possession to either the APHIS 

Administrator or the HHS Secretary. 

To date, when registered and nonregistered entities have reported such 

‘‘discoveries,’’ they have often done so 

on an APHIS/CDC Form 3. However, the 

APHIS/CDC Form 3 is for reporting of 

thefts, losses, and releases, and not for 

discoveries. To facilitate such reporting 

for discoveries, HHS and USDA plan to 

create, in compliance with the 

Paperwork Reduction Act, a new 

APHIS/CDC Form 6 that will require 

submission of information regarding the 

discovery of a select agent or toxin. 

Establishing a standard form for 

reporting will enable HHS and USDA to 

better understand the circumstances and 

assess regulatory violations related to 

the possession of a ‘‘discovered’’ select 

agent and/or toxin. We would also add 

reference to this form in the regulations. 

We are also proposing to add a 

definition for the term Discovery to 7 

CFR 331.1 and 9 CFR 121.1 of the 

regulations to distinguish a ‘‘discovery’’ 

from a ‘‘theft,’’ ‘‘loss,’’ and ‘‘release’’ 

and to clarify the scope of the reporting 

requirement for discoveries. We would 

define Discovery to mean the finding of 

a select agent or toxin by an individual 

or entity that is not aware of the select 

agent or toxin’s existence. Examples 

would include, but would not be 

limited to, the following: 

• A registered individual or entity 

finds a select agent or toxin not 

accounted for in their inventory; or 

• A non-registered individual or 

entity finds a select agent or toxin. 

Disposal of Select Agent Waste After 

Conclusion of Patient Care 

In 7 CFR 331.3(d)(8), 9 CFR 

121.3(d)(8) and 9 CFR 121.4(d)(8), the 

regulations provide that waste generated 

during the delivery of patient care by 

health care professionals from a patient 

diagnosed with an illness or condition 

associated with a select agent is 

excluded from the requirements of the 

regulations, provided that the waste is 

decontaminated or transferred for 

destruction by complying with State 

and Federal regulations within 7 

calendar days of the conclusion of 

patient care. Additionally, 9 CFR 

121.5(a)(3) and 9 CFR 121.6(a)(3) 

exempt from the regulations diagnostic 

laboratories and other entities that 

collect clinical or diagnostic specimens 

from a patient infected with a select 

agent provided that, among other 

requirements, the specimens are 

transferred in accordance with § 121.16 

or destroyed on-site within 7 calendar 

days after delivery of patient care by 

health care professionals has concluded. 

In this rulemaking, APHIS is 

proposing to codify in regulation a 

current operational policy that, for an 

individual who has been admitted to a 

medical facility, that individual’s 

‘‘conclusion of patient care,’’ and the 

point when ‘‘delivery of patient care by 

health care professionals has 

concluded,’’ is when an individual is 

released from the medical facility where 

treatment was being provided by the 

medical facility or physician. If the 

patient is seen by the physician or 

medical facility for follow-up care (e.g., 

6 month follow-up visit), such followup care would be considered a new 

delivery of patient care. The policy that 

we are codifying further clarifies that 

the exclusion is intended for select 

agent waste generated during the 

treatment of humans and is not 

intended to apply to animals receiving 

veterinary care, or plants or plant 

products submitted for diagnostic 

purposes. 

Exclusion of Animals Naturally Infected 

With Select Agents 

In this rulemaking, we are proposing 

to codify in regulation the current 

policy regarding when animals naturally 

infected with select agents are excluded 

from the requirements of the 

regulations. Sections 121.3(d)(1) and 

121.4(d)(1) in 9 CFR of the regulations 

provide for exclusion of select agents 

occurring in their natural environment. 

Mere possession of an animal that is 

naturally infected with a select agent, 

either within its natural environment or 

having been transported to an 

artificially established environment, 

meets the criteria of this exclusion. 

However, the removal of an animal that 

is infected with a select agent from its 

natural environment to an artificially 

established environment for the purpose 

of the intentional exposure or 

introduction of a select agent to a naı ̈ve 

or experimental animal, or the 

introduction of a naı ̈ve animal to a 

natural environment where there is an 

animal that is naturally infected with a 

select agent for the purpose of the 

intentional exposure or introduction of 

a select agent to the naı ̈ve or 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5798 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

experimental animal, does not meet the 

exclusion criteria. To provide an 

example, avian influenza virus is listed 

in § 121.3(b) as a VS select agent. When 

animals within a poultry flock are 

confirmed to be naturally infected with 

highly pathogenic avian influenza, the 

individual infected animals are not 

subject to the select agent requirements 

based on possession of the animals. 

However, if animals from the same flock 

were sold to a research facility for the 

purpose of intentionally exposing naı ̈ve 

animals to these naturally infected 

animals during a disease 

transmissibility study, that study and 

the associated animals would be subject 

to the select agent requirements. 

We are proposing to revise the two 

sections to clarify the scope of the 

exclusion. 

Finally, please note that when such 

infected animals are involved there may 

be existing USDA disease control 

programs and requirements regarding 

the management, movement, and 

disposition of infected animals. 

Additionally, even if an animal is 

confirmed to be naturally infected with 

a select agent and is excluded from the 

select agent and toxin regulations, there 

may still be transfer and/or transport 

restrictions placed upon its movement 

based upon specific Federal and/or 

State requirements. 

Inactivation 

The regulations in 7 CFR 331.3(d)(4), 

9 CFR 121.3(d)(4), and 9 CFR 121.4(d)(4) 

provide an exclusion from the 

requirements of the regulations for a 

select agent or regulated nucleic acids 

that can produce infectious forms of any 

select agent virus that has been 

subjected to a validated inactivation 

procedure that is confirmed through a 

viability testing protocol. The exclusion 

further specifies that surrogate strains 

that are known to possess equivalent 

properties with respect to inactivation 

can be used to validate an inactivation 

procedure; however, if there are known 

strain-to-strain variations in the 

resistance of a select agent to an 

inactivation procedure, then an 

inactivation procedure validated on a 

lesser resistant strain must also be 

validated on the more resistant strains. 

We are proposing several revisions 

(discussed in detail below) related to the 

inactivation exclusion discussed above. 

We are clarifying what constitutes an 

acceptable ‘‘validated inactivation 

procedure.’’ Specifically, we are 

proposing to revise the exclusion 

discussed above so that a select agent or 

regulated nucleic acids that can produce 

infectious forms of any select agent 

virus would be excluded from the 

requirements of the regulations if 

subjected to a validated inactivation 

procedure, provided that: 

• In-house validation of the 

inactivation procedure is completed 

prior to use; 

• A certificate of inactivation 

(discussed below) has been generated in 

accordance with the regulations; 

• For use of a select agent surrogate 

to validate an inactivation procedure, 

the select agent surrogate chosen is 

known to possess equivalent properties 

with respect to inactivation, and, if 

there are known variations in the 

resistance of a select agent to an 

inactivation procedure, including strain 

to strain, then the inactivation 

procedure must also be validated using 

the most resistant select agent surrogate; 

and 

• For use of a whole tissue or 

homogenized tissue surrogate to 

validate a chemical inactivation 

procedure for other tissues, including 

those in other animal or plant models, 

all standardized conditions must be 

held constant such as the select agent 

used, the tissue volume, and the ratio of 

tissue to volume of inactivating 

material; a safety margin must be 

incorporated into the final inactivation 

procedure to ensure the effective 

inactivation of the select agent; and the 

tissue surrogate is either expected to 

have the highest concentration of the 

specific select agent to be inactivated, or 

the concentration of the select agent in 

the tissue is determined and this select 

agent concentration is not exceeded 

when applying the validated 

inactivation procedure on subsequent 

tissue samples. 

The purpose of these revisions is to 

indicate that the inactivation procedure 

must have been validated in-house and 

must have been validated in a manner 

that provides assurances regarding its 

general suitability and use within that 

facility. The regulations in 9 CFR 

121.5(a) and 9 CFR 121.6(a) currently 

also exempt diagnostic laboratories and 

other entities that possess, use, or 

transfer a select agent or toxin that is 

contained in a specimen presented for 

diagnosis or verification from the 

requirements of the regulations, if, 

among other requirements, the select 

agent or toxin is destroyed on-site 

within 7 calendar days using an 

approved inactivation process. We are 

proposing to revise this exemption so 

that if an inactivation process is used, 

it meets the parameters in the above 

exclusion, as revised. We are also 

clarifying that such an inactivation 

process may not necessarily entail 

physical destruction of the select agent 

or toxin. 

We are also proposing a new 

exclusion related to inactivation in 7 

CFR 331.3(d), 9 CFR 121.3(d), and 9 

CFR 121.4(d). Specifically, we propose 

to exclude from the requirements of the 

regulations any select agent or regulated 

nucleic acid that can produce infectious 

forms of any select agent virus if the 

material is contained in a formalin-fixed 

paraffin-embedded tissue that has been 

effectively inactivated by a recognized 

method for that particular agent or 

regulated nucleic acid. This would 

exclude from the requirements of the 

regulations, as an example, 

appropriately prepared histopathology 

samples that have undergone 

satisfactory formalin fixation and 

further paraffin embedding processes 

that result in a quality sample. In this 

example, such properly prepared 

samples that will yield a usable 

histopathology sample provide 

assurances that the additional 

processing steps required to prepare an 

acceptable formalin-fixed, paraffinembedded tissue sample will result in 

agent inactivation. 

The regulations in 7 CFR 331.9(a) and 

9 CFR 121.9(a) require individuals or 

entities required to register under the 

regulations to designate an individual to 

be the responsible official for the 

individual or entity. One of the current 

responsibilities of the responsible 

official is to review, and revise as 

necessary, each of the entity’s validated 

inactivation procedures or viable select 

agent removal methods (7 CFR 

331.9(a)(9); 9 CFR 121.9(a)(9)). 

We are proposing to codify a policy 

that allows individuals besides the 

responsible official (e.g., principal 

investigators) to revise the inactivation 

procedures, if necessary. Responsible 

officials would still be responsible for 

ensuring the revision occurs but would 

not necessarily have to revise the 

procedure themselves. This revision is 

being proposed because, often, the 

principal investigators are the subject 

matter experts when it comes to the 

procedures and are the most qualified to 

enact revisions to the inactivation 

procedures. 

Finally, we are proposing to revise the 

existing definition of validated 

inactivation procedure in 7 CFR 331.1 

and 9 CFR 121.1. Currently, we define 

the term as ‘‘[a] procedure, whose 

efficacy is confirmed by data generated 

from a viability testing protocol, to 

render a select agent non-viable but 

allows the select agent to retain 

characteristics of interest for future use; 

or to render any nucleic acids that can 

produce infectious forms of any select 

agent virus non-infectious for future 

use.’’ As revised, to be consistent with 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5799 

its use in our proposed revisions to the 

exclusion and exemption noted above, 

we would specify that the validated 

inactivation procedure must be 

conducted in-house and must have its 

efficacy confirmed by an in-house 

viability test, and would clarify that, if 

used on nucleic acids of a select agent 

virus, it must render the nucleic acids 

incapable of producing infectious virus. 

Removal 

In addition to inactivation, the 

regulations in 7 CFR 331.3(d)(5), 9 CFR 

121.3(d)(5), and 9 CFR 121.4(d)(5) also 

provide for an exclusion from the 

requirements of the regulations for 

material containing a select agent that is 

subjected to a procedure that removes 

all viable select agent cells, spores, or 

virus particles if the material is 

subjected to a viability testing protocol 

to ensure that the removal method has 

rendered the material free of all viable 

select agent. We are proposing to revise 

this exclusion to reflect current 

operational practices and policies. As 

revised, it would exclude from the 

requirements of the regulations material 

containing a select agent that is 

subjected to a validated viable select 

agent removal procedure, provided that 

all of the following conditions are met: 

• In-house validation of the viable 

select agent removal procedure is 

completed prior to use; 

• A certificate of viable select agent 

removal (discussed below) has been 

generated in accordance with 

§ 121.17(a)(8) or § 331.17(a)(8); 

• For use of a surrogate to validate a 

viable select agent removal procedure, 

only surrogates known to possess 

equivalent properties with respect to 

removal are used; and 

• A portion of each subsequent 

sample has been subjected to a 

verification viability testing protocol to 

ensure that the validated viable select 

agent removal procedure has rendered 

the material free of all viable select 

agent. 

In a similar manner to our proposed 

revisions to the exclusion based on 

inactivation in 7 CFR 331.3(d)(4), 9 CFR 

121.3(d)(4), and 9 CFR 121.4(d)(4), the 

intent of these revisions is to indicate 

that the removal procedure must be 

validated in-house as appropriate and 

effective for the facility’s particular 

circumstances. We are also proposing to 

add to the definitions in 7 CFR 331.1 

and 9 CFR 121.1 the term Validated 

removal procedure, which we propose 

to define as ‘‘a procedure, whose 

efficacy has been confirmed by data 

generated in-house from a viability 

testing protocol, to confirm removal of 

all viable select agent, or nucleic acids 

of any select agent virus capable of 

producing infectious virus.’’ 

Currently, the definition of Viability 

testing protocol in 7 CFR 331.1 and 9 

CFR 121.1 does not include reference to 

removal procedures. However, given 

that we are proposing to include 

viability testing protocols in our 

proposed revision to the removal 

procedures, it is correspondingly 

necessary to revise the definition of 

Viability testing protocol to include 

such reference. We would also specify 

that it must be conducted in-house. We 

would also add to the definitions in 7 

CFR 331.1 and 9 CFR 121.1 a definition 

of the term Verification viability testing 

protocol. We would define this term as 

‘‘a protocol, used on samples that have 

been subjected to a validated 

inactivation or removal procedure, to 

confirm the material is free of all viable 

select agent, or nucleic acids of any 

select agent virus capable of producing 

infectious virus.’’ 

Finally, wherever the exclusion 

related to removal is currently discussed 

in other provisions of the regulations, 

we are proposing harmonizing changes 

to ensure the terminology remains 

consistent with our proposed revisions 

to that exclusion. 

Loss, Release, and Theft 

The terms loss, release, and theft are 

used in several instances in the existing 

regulations. For example, 7 CFR 331.19 

and 9 CFR 121.19 discuss the 

notification requirements for loss, 

release, and theft. Additionally, 7 CFR 

331.3(f) and 9 CFR 121.3(f) also contain 

an exclusion from the requirements of 

the regulations for any select agent or 

toxin seized by a Federal law 

enforcement agency during the period 

between seizure of the agent or toxin 

and the transfer or destruction of such 

agent or toxin provided that, among 

other requirements, the Federal law 

enforcement agency safeguards and 

secures the seized agent or toxin against 

theft, loss, or release, and reports any 

theft, loss, or release of such agent or 

toxin. However, the terms loss, release, 

and theft are not currently defined 

within the regulations. We are 

proposing definitions for each of these 

terms in 7 CFR 331.1 and 9 CFR 121.1 

to clarify their meaning. 

We are proposing to define loss as 

‘‘the inability to account for a select 

agent or toxin known to be in the 

individual or entity’s possession.’’ 

We are proposing to define release as 

any of the following: 

• An incident resulting in 

occupational exposure to a select agent 

or toxin; 

• An incident resulting in animal/ 

plant exposure to a select agent or toxin; 

• The failure of equipment used to 

contain a select agent or toxin such that 

it is reasonably anticipated that a select 

agent or toxin was released; 

• The failure of or breach in personal 

protective equipment in the presence of 

a select agent or toxin; or 

• The failure of biosafety procedures 

such that it is reasonably anticipated 

that a select agent or toxin was outside 

of containment. 

Finally, we are proposing to define 

theft as the unauthorized taking and 

removing of a select agent or toxin from 

the possession of an entity or 

individual. 

Recordkeeping 

The regulations in 7 CFR 331.17 and 

9 CFR 121.17 contain recordkeeping 

requirements for individuals and 

entities required to register pursuant to 

the regulations. We are proposing 

amendments to these sections to ensure 

an accurate, current inventory is 

maintained for all select agents and 

toxins held in long-term storage. 

Specifically, the section is being 

modified to add more specific language 

regarding from whom material is 

acquired and the date the agent was 

removed and returned from the storage 

locations to more specifically define 

required recordkeeping information. 

We are proposing to require that 

records contain: 

• The quantity acquired and the name 

of the individual by whom it was 

acquired. The quantity acquired is 

currently one of the recordkeeping 

requirements; the name of the 

individual by whom it was acquired 

would be new. 

• The location where the select agent 

or toxin is stored (e.g., building, room 

number or name, and freezer 

identification or other storage 

container). This is an existing 

requirement, but we are clarifying that 

the salient information is not the 

manner in which it is stored (e.g., 

freezer versus non-refrigerated unit) but 

where in the facility it is stored. 

• The date the agent was removed 

and returned, the purpose for using the 

agent, the name of the individual who 

removed and returned the agent, and 

when applicable, date of final 

disposition of the agent and by whom. 

This would clarify the existing 

recordkeeping requirement to keep 

records of when an agent is removed or 

returned; we require a record of the 

calendar date, but not specific times 

within that day. 

• For intra-entity transfers (sender 

and the recipient are covered by the 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5800 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

same certificate of registration), name of 

the select agent or toxin, the date of the 

transfer, the number of items transferred 

or number of vials or quantity of toxin 

transferred, the name of the sender, and 

the name of the recipient. The current 

recordkeeping requirement is 

substantially similar but only 

specifically refers to select agents, 

whereas the intent is that it applies both 

to select agents and toxins. 

The regulations in 7 CFR 

331.17(a)(8)(vii) and 9 CFR 

121.17(a)(8)(vii) also currently require 

individuals and entities to maintain, for 

select agents or material containing 

select agents or regulated nucleic acids 

that can produce infectious forms of any 

select agent virus that have been 

subjected to a validated inactivation 

procedure or a procedure for removal of 

viable select agent, a certificate, signed 

by the principal investigator, that 

includes the date of inactivation or 

viable select agent removal, the 

validated inactivation or viable select 

agent removal method used, and the 

name of the principal investigator. The 

regulations further specify that a copy of 

the certificate must accompany any 

transfer of inactivated or select agent 

removed material. 

We are proposing several revisions to 

the records needed for inactivated or 

select agent-free material created by an 

entity. We are proposing to allow a 

designee to sign the certificate of 

inactivation on behalf of a principal 

investigator, so that certificates may be 

signed during the principal 

investigator’s absence. We are further 

proposing that certificates must be 

signed within 7 days after completion of 

the validated inactivation or validated 

viable select agent removal, so that a 

significant amount of time does not 

elapse between when the inactivation or 

removal occurs and when the certificate 

is issued. We are also proposing that 

records must be maintained for as long 

as the material is in the possession of 

the registered individual or entity plus 

an additional 3 years, and clarifying the 

requirement that certificates must 

accompany any transfers, and that such 

transfers include intra-entity transfers. 

Principal investigator is defined in the 

regulations as the one individual who is 

designated by the entity to direct a 

project or program and who is 

responsible to the entity for the 

scientific and technical direction of that 

project or program. When a principal 

investigator is unavailable (such as out 

of the office) to review the results of a 

select agent that has been subjected to 

a validated inactivation or removal 

procedure, a temporary designee 

(appointed by the principal investigator 

and approved of by the responsible 

official) may sign the inactivation 

certificate to allow for work to continue. 

The temporary designee must be listed 

on the entity’s registration and have the 

knowledge and expertise to provide 

scientific and technical direction 

regarding the validated inactivation 

procedure or the procedure for removal 

of viable select agent to which the 

certificate refers. The appointment of a 

designee to sign certificates is not for 

regular substitution of the principal 

investigator, such as the principal 

investigator relinquishing this 

requirement to other individuals in the 

laboratory due to normal work demands 

or general unavailability. 

Non-Possession of Select Agent or 

Toxin 

When an individual or entity registers 

to possess a select agent or toxin, they 

agree to comply with the standards in 

the regulations regardless of whether 

they currently possess or plan on 

possessing the agent or toxin. 

Registration is a choice, and indicates 

readiness to possess, use, or transfer 

select agents or toxins; the specific 

select agents or toxins for which the 

facility is registered are listed on its 

registration certificate. Although an 

entity does not need to have intent to 

possess a select agent or toxin to be 

registered, in most cases, registered 

entities for a select agent or toxin 

possess or are in the process of 

acquiring the select agent or toxin. 

Should these plans change, prior to 

registration, an individual or entity may 

ask FSAP to hold review and processing 

of their registration application at any 

point. They may, also, choose to 

terminate their registration certificate at 

any time, if they no longer possess a 

select agent or toxin and no longer wish 

to be registered. Lastly, prior to required 

annual inspections and triannual 

renewal of registration, FSAP will ask a 

non-possessing entity if they desire to 

continue to be registered since there are 

agency and entity-related regulatory 

compliance costs associated with 

maintaining registration. 

Despite the foregoing considerations, 

there are a few registered entities, 

primarily academic institutions, who 

have never possessed the select agent or 

toxin for which they are registered and 

have no current plans to obtain it, yet 

still wish to remain registered. We 

propose to revise the regulations in 

order to clarify that these entities must 

meet all regulatory requirements for 

registered entities should they continue 

to desire to maintain registration. 

Electronic Federal Select Agent Program 

(eFSAP) Information System 

As discussed previously in this 

document, the regulations sometimes 

require individuals and entities to 

submit reports and maintain records 

pursuant to the terms of the regulations. 

The regulations currently do not 

provide, however, how such reports 

may be submitted or how such records 

are to be maintained. 

APHIS currently utilizes a highly 

secure information system, the eFSAP 

information system, to conduct all select 

agent program activities. The eFSAP 

information system is a two-way 

communication portal, which is 

accessible by both CDC and APHIS staff 

and the regulated community. For users 

at registered entities, benefits of the 

system include reduced paperwork, 

increased ease of validating and 

submitting information, and reduced 

processing time for requests (as realtime information exchange allows for 

increased responsiveness). Based on the 

implementation of the eFSAP 

information system, APHIS is proposing 

to update the regulations to indicate that 

reports (e.g., APHIS/CDC Forms 2, 3, 

and 4) and requests (e.g., amendments 

to registration) can be submitted via the 

eFSAP information system (or successor 

IT system as specified by APHIS in 

guidance). In addition, APHIS is 

proposing to update the regulations to 

clarify that the electronic 

documentation in the eFSAP 

information system serves as official 

records required by the select agent and 

toxin regulations, and once submitted in 

the eFSAP information system, there is 

no requirement for entities to retain a 

separate copy. 

Registration 

Unless exempted by the regulations, 

individuals and entities are required to 

have a certificate of registration issued 

by the APHIS Administrator to possess, 

use, or transfer select agents or toxins (7 

CFR 331.7(a); 9 CFR 121.7(a)). This 

certificate of registration denotes 

approval for the select agents and/or 

toxins that an individual or entity is 

authorized to possess, use, and/or 

transfer; the specific activities the 

individual or entity is approved to 

conduct related to the registered select 

agents and/or toxins; the persons 

authorized to access the select agents 

and/or toxins; and the locations 

(buildings, rooms, suites of rooms, 

storage facilities, etc.) where select 

agents and/or toxins are authorized to 

be present as described in the entity’s 

APHIS/CDC Form 1. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5801 

The regulations currently indicate 

that issuance of a certificate of 

registration may be contingent upon 

inspection or submission of additional 

information, such as the security plan, 

biosafety plan, incident response plan, 

or any other documents required to be 

prepared to meet the requirements of 

the select agent and toxin regulations (7 

CFR 331.7(g) and 9 CFR 121.7(g)). This 

provision could be construed to suggest 

that the security plan, biosafety plan, 

and incident response plan are each 

mutually exclusive, illustrative 

examples of additional information that 

APHIS may request, but that we would 

not request more than one of the 

examples. This is, however, not the 

case. Depending on the circumstances of 

the facility, we may request any or all 

of the documents listed in this 

provision. We are proposing to clarify 

that this may be the case. 

Additionally, currently, the 

regulations in 7 CFR 331.7(i) and 9 CFR 

121.7(i) state that a certificate of 

registration may be amended to reflect 

changes in circumstances (e.g., 

replacement of the responsible official 

or other personnel changes, changes in 

ownership or control of the entity, 

changes in the activities involving any 

select agents or toxins, or the addition 

or removal of select agents or toxins). 

However, this amendment is not 

discretionary. Each of the illustrative 

examples currently provided in the 

regulations could have a direct, material 

adverse impact on the possession and 

use of the select agents and toxins at the 

entity, and the entity’s certificate of 

registration must be amended to reflect 

those changes. We are proposing to 

clarify that such an amendment is not 

discretionary. 

Responsible Official and Alternate 

Responsible Official 

As we mentioned previously in this 

document, the regulations in 7 CFR 

331.9(a) and 9 CFR 121.9(a) require 

individuals or entities required to 

register under the regulations to 

designate an individual to be the 

responsible official for the individual or 

entity. The regulations require the 

responsible official to have a physical, 

and not merely telephonic or audio/ 

visual, presence at the registered entity 

to ensure compliance with the 

regulations and respond in a timely 

manner to onsite incidents (7 CFR 

331.9(a)(5); 9 CFR 121.9(a)(5)). This 

requirement effectively precludes a 

responsible official from serving as the 

primary responsible official for two 

separate registered entities, because the 

responsible official cannot be physically 

present at both entities simultaneously. 

Likewise, although the regulations allow 

the responsible official for one 

registered entity to serve as an alternate 

responsible official for another 

registered entity, the regulations do not 

currently provide that the official 

cannot be the sole alternate responsible 

official at the other entity; such an 

allowance would, again, run the risk of 

requiring the official to be physically 

present at two entities simultaneously. 

Accordingly, we are proposing to amend 

the regulations to clarify that a 

responsible official cannot be approved 

as the responsible official at more than 

one registered entity and cannot be the 

sole alternate responsible official at 

another registered entity. We are, 

however, proposing to allow an 

individual who has been approved as an 

alternate responsible official at one 

entity to also be able to be approved to 

be an alternate responsible official at 

another registered entity. 

Annual Internal Inspections 

The regulations at 7 CFR 331.9(a)(6) 

and 9 CFR 121.9(a)(6) currently require 

responsible officials to ensure that 

annual inspections are conducted of 

each registered space where select 

agents or toxins are stored or used to 

ensure compliance with the 

requirements of the regulations. The 

results of each inspection must be 

documented, and any deficiencies 

identified during an inspection must be 

corrected and the corrections 

documented. However, the content of 

the inspections themselves is not 

specified. We are therefore proposing to 

codify the current policy that an entity’s 

annual internal inspections must 

address whether: 

• The entity’s biosafety/ 

biocontainment plan is being effectively 

implemented as outlined in the 

regulations (7 CFR 331.12 and 9 CFR 

121.12, respectively). 

• The entity’s security plan is being 

effectively implemented as outlined in 

the regulations (7 CFR 333.11 and 9 CFR 

121.11, respectively). 

• The entity’s incident response plan 

is implemented to ensure whether the 

entity is able to respond, as outlined in 

the regulations (7 CFR 331.14 and 9 CFR 

121.14, respectively). 

• Each individual with access 

approval from the Administrator or HHS 

Secretary has received the appropriate 

training as outlined in the regulations (7 

CFR 331.15 and 9 CFR 121.15, 

respectively). 

Tier 1 Security Enhancements 

Currently, the regulations in 9 CFR 

121.3 specify that certain VS select 

agents and toxins are Tier 1; the current 

VS Tier 1 select agents are foot-andmouth disease virus and rinderpest 

virus. The regulations further specify 

that Tier 1 select agents are subject to 

additional requirements relative to other 

VS select agents and toxins. Currently, 

among these additional requirements is 

a requirement that registered entities 

with Tier 1 select agents must have 

procedures for screening visitors, 

including their property, and vehicles, 

at the entry and exit points to the 

registered space or at other designated 

points of entry to the building, facility, 

or compound that are based on the 

entity’s site-specific risk assessment (9 

CFR 121.11(f)(4)(iii)). 

This requirement could be construed 

to suggest that the facility must 

authorize visitors to enter the facility, 

whereas the intent is to specify that, if 

the facility does allow visitors, they 

must be screened at an appropriate 

checkpoint. Accordingly, we propose to 

revise the provision to require 

procedures for screening any visitors, 

their property, and, where appropriate, 

vehicles at entry points to registered 

space based on the entity’s site-specific 

risk assessment. 

Biosafety—Facility Verification 

The CDC has established guidelines 

for four biosafety levels for laboratories 

engaged in microbiological and 

biomedical laboratories (Biosafety in 

Microbiological & Biomedical 

Laboratories (BMBL), current edition). 

Biosafety level 3 facilities are facilities 

that possess an agent with a known 

potential for aerosol transmission and 

that may cause serious or potentially 

lethal disease in humans. The CDC has 

also established parallel animal 

biosafety level 3 biosafety guidelines for 

facilities that possess an agent with a 

known potential for aerosol 

transmission and that may cause lethal 

disease in animals. 

Because of the unique and significant 

biosafety risks at such facilities, we are 

proposing to amend 7 CFR 331.12 and 

9 CFR 121.12 to require facility 

verification every 12 months for 

registered entities that maintain 

biosafety level 3 and animal biosafety 

level 3 laboratories. The verifications 

would also have to be documented to 

confirm that systems are in place to 

monitor, maintain, and validate 

performance of the facility’s 

containment functions, such as inward 

directional airflow, decontamination 

systems, as well as preventative 

maintenance conducted to ensure all 

systems are functioning appropriately to 

maintain containment during normal 

operations. Therefore, we also are 

proposing to amend 7 CFR 331.12 and 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5802 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

9 CFR 121.12 to require the entity to 

document facility verification and 

require the entity to verify the facility’s 

containment functions. 

APHIS does not believe that the new 

provisions will create an additional 

burden to entities that maintain 

biosafety level 3 and animal biosafety 

level 3 laboratories because we believe 

these entities are already performing 

such annual facility verifications. 

However, if a registered entity has not 

been performing annual facility 

verifications for biosafety level 3 and 

animal biosafety level 3 laboratories, we 

would be interested in comments 

concerning the cost and burden of 

annual facility verifications, especially 

if the entity is considered a small 

business. 

Biosafety—Effluent Decontamination 

Systems 

Biosafety level 3 and biosafety level 4 

facilities are highly sophisticated 

facilities built to contain biological 

agents and toxins with the highest 

potential to threaten agricultural, plant, 

and public health and safety. Any 

defect, such as a crack or leaky pipe, 

could have severe consequences. For 

example, in August 2007, foot-andmouth disease virus was discovered at 

farms in the United Kingdom. The 

source of the contamination was 

determined to be long-term damage and 

leakage of a drainage system used by a 

high-containment laboratory working 

with the foot-and-mouth disease virus. 

As such, APHIS is proposing to amend 

the security (7 CFR 331.11 and 9 CFR 

121.11), biosafety (7 CFR 331.12 and 9 

CFR 121.12), and incident response (7 

CFR 331.14 and 9 CFR 121.14) sections 

of the select agent and toxin regulations 

to address risks posed by the effluent 

decontamination systems used by 

biosafety level 3 and biosafety level 4 

facilities. 

If an effluent decontamination system 

is used by an entity possessing and 

using select agents and toxins, to 

comply with the regulations, the entity 

would have to include in its plans how 

it will address security, biosafety, and 

incident response as it relates to the 

system. Specifically, the biosafety plan, 

to ensure it contains adequate biosafety 

and containment procedures, would 

have to provide for verification that the 

liquid waste generated from registered 

space is sufficiently treated to prevent 

the release of a select agent or toxin 

prior to discharge of the waste from the 

facility. The security plan, to ensure it 

contains adequate safeguards for select 

agents and toxins for any space not 

listed on the entity’s registration that 

contains a portion of an effluent 

decontamination system, would have to 

describe procedures to prevent the theft, 

loss, release, or unauthorized access to 

a select agent or toxin. The incident 

response plan, to ensure it contains 

adequate response procedures, would 

have to fully describe the entity’s 

response procedures for the theft, loss, 

or release of a select agent or toxin; the 

failure of an effluent decontamination 

system resulting in a release of a select 

agent or toxin; and how personnel will 

access an area potentially containing a 

select agent or toxin due to the failure 

of an effluent decontamination system. 

Restricted Experiments 

The regulations in 7 CFR 331.13 and 

9 CFR 121.13 place restrictions on the 

experiments that registered entities or 

individuals may conduct and on their 

possession of products resulting from 

such experiments. Under the 

regulations, restricted experiments are 

experiments that involve the deliberate 

transfer of, or selection for, a drug or 

chemical resistance trait to select agents 

that are not known to acquire the trait 

naturally, if such acquisition could 

compromise the control of disease 

agents in humans, veterinary medicine, 

or agriculture, and experiments that 

involve the deliberate formation of 

synthetic or recombinant nucleic acids 

containing genes for the biosynthesis of 

select toxins lethal for vertebrates at an 

LD50 < 100 ng/kg body weight. 

Due to heightened biosafety concerns 

of research involving potential 

pandemic pathogens and emerging 

diseases, increased emphasis on 

oversight of products of restricted 

experiments is being proposed. To 

ensure that an entity has the appropriate 

safeguards to work with the product of 

a select agent or toxin resulting from a 

restricted experiment, APHIS is 

proposing to clarify the provision that 

the receiving entity of a transfer must 

amend their certificate of registration 

and receive approval by CDC or APHIS 

to possess the products of a restricted 

experiment. Entities are currently 

required to obtain approval to conduct 

restricted experiments and possess the 

product of a select agent or toxin 

resulting from a restricted experiment. 

Training 

The regulations in 9 CFR 121.15 

require individuals or entities registered 

to possess, use or transfer select agents 

or toxins to provide information and 

training on biocontainement, biosafety, 

security, and incident response to 

individuals with access to select agents 

or toxins. APHIS is proposing revisions 

to the training requirements in 

accordance with the new mandate in the 

Prepare for and Respond to Existing 

Viruses, Emerging New Threats, and 

Pandemics Act (42 U.S.C. 262a(k)(1); 

Pub. L. 117–328) amendment of 

subsection (b)(1). These revisions have 

been made in an effort to comply with 

the statutory amendment that states 

training requirements for (1) 

unapproved individuals whose 

responsibilities routinely place them in 

close proximity to laboratory facilities 

and (2) those individuals who perform 

administrative or oversight functions. 

Trainings must be completed within 6 

months after publication of a final rule 

for this proposed rulemaking. 

Miscellaneous 

We are proposing to remove the 

definition of the term permit from 7 CFR 

331.1. We currently define the term as 

‘‘a written authorization by the 

Administrator to import or move 

interstate select agents or toxins, under 

conditions prescribed by the 

Administrator.’’ However, the term is 

only used once in 7 CFR part 331, 

specifically in 7 CFR 331.11(c)(9)(i) and 

is used as a verb. Additionally, it is used 

in that one instance with the dictionary 

definition of allowing or authorizing an 

action to occur. For these reasons, the 

definition of the term permit serves no 

function and its removal is appropriate. 

In 7 CFR 331.3(b), Ralstonia 

solanacearum is listed as a select agent. 

However, only Ralstonia solanacearum 

Race 3 biovar 2 poses a severe threat to 

plant health or plant products and 

merits inclusion on the list of select 

agents; other races and biovars are less 

pathogenic. We propose to amend this 

section accordingly. 

The regulations in 7 CFR 331.3(e)(1), 

9 CFR 121.3(e)(1), and 9 CFR 121.4(e)(1) 

currently refer to exclusions being 

posted to ‘‘the National Select Agent 

Registry website.’’ However, the name of 

the website has changed to ‘‘the Federal 

Select Agent Program website.’’ We 

propose to update the regulations 

accordingly. 

Multiple regulations currently 

indicate that APHIS can receive reports 

received via facsimile. Due to the 

implementation of the eFSAP 

information system for official 

recordkeeping, this is no longer the 

case. We are proposing to amend the 

regulations accordingly. 

Prior to issuance of a certificate of 

registration, we currently require that 

the responsible official must provide 

notification of any changes to the 

application for registration by 

submitting the relevant pages of the 

registration application (7 CFR 331.7(f); 

9 CFR 121.7(f)). We propose to clarify 

that the submission should be the 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5803 

relevant information that needs to be 

updated, rather than a particular page 

citation. 

The regulations in 7 CFR 331.11(d)(4) 

and 9 CFR 121(d)(4) currently require 

registered individuals and entities to 

inspect all suspicious packages before 

they are brought into or removed from 

an area where select agents or toxins are 

used or stored. However, the presence of 

a suspicious package in any registered 

space, and not just the area where the 

select agents or toxins are used or 

stored, could represent a significant 

biosecurity and personal safety risk, and 

therefore, the presence of a suspicious 

package in any registered space should 

be inspected. We propose to amend the 

regulations accordingly. 

In § 121.3, we are proposing revisions 

to footnotes 1, 4, and 5 to reflect the 

current understanding of the genomic 

structure and advancements in 

molecular characterization of infectious 

Newcastle disease virus and pigeon 

paramyxovirus in columbid birds. 

Currently, § 121.11(f) requires preaccess suitability assessments and 

ongoing assessments of suitability for 

persons who will have access to a Tier 

1 select agent or toxin at a registered 

entity. We are proposing to clarify that 

such assessments are needed for all 

employees authorized to have access to 

the Tier 1 select agent or toxin, whether 

or not they ever actually access the 

select agent or toxin. The current 

language can be interpreted that an 

ongoing assessment is only required for 

those who do access a Tier 1 select 

agent or toxin and not necessarily 

applicable to those individuals 

authorized for access but not currently 

accessing the Tier 1 agent space. This 

updated language will ensure all those 

authorized to have access will have 

ongoing assessments. The section is also 

updated to more clearly define 

requirements for visitor screening for 

security enhancements. 

In that same section of the regulations 

(9 CFR 121.11(f)(5)(iii)), we currently 

require entities that possess foot-andmouth disease virus and rinderpest 

virus to have closed circuit television, 

or CCTV. We are proposing to revise 

this to video surveillance, which may or 

may not be by CCTV. With the advances 

in video surveillance and options 

available, a broader video surveillance 

provision is being proposed. 

Although we previously updated 

paragraph (b) of 9 CFR 121.3 to list 

avian influenza virus as a select agent, 

without reference to particular strains or 

pathogenicity, two references later in 

the regulations, in paragraph (f)(3)(i) of 

that same section and paragraph (c)(1) of 

9 CFR 121.9, were not updated at that 

time to conform with that revised 

listing. We are proposing to update 

them accordingly. 

Finally, although Newcastle disease 

virus is listed as a select agent 

regardless of virulence, in certain 

instances within part 121, requirements 

are stated to pertain to ‘‘virulent’’ 

Newcastle disease virus. To clarify that 

the requirements pertain to Newcastle 

disease virus in the broad sense, we are 

proposing to delete the word ‘‘virulent’’ 

in those instances. 

Executive Orders 12866 and 13563 and 

Regulatory Flexibility Act 

This proposed rule has been 

determined to be significant for the 

purposes of Executive Order 12866 as 

amended by Executive Order 14094, 

‘‘Modernizing Regulatory Review,’’ and, 

therefore, has been reviewed by the 

Office of Management and Budget. 

We have prepared an economic 

analysis for this proposed rule. The 

economic analysis provides a costbenefit analysis, as required by 

Executive Orders 12866 and 13563, 

which direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and equity). Executive Order 

13563 emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. The 

economic analysis also examines the 

potential economic effects of this 

rulemaking on small entities, as 

required by the Regulatory Flexibility 

Act. 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Pub. L. 107–188) 

provides for the regulation of certain 

biological agents and toxins that have 

the potential to pose a severe threat to 

human, animal, or plant health, or to 

animal or plant products. The Animal 

and Plant Health Inspection Service 

(APHIS), Division of Agricultural Select 

Agents and Toxins (DASAT) has the 

primary responsibility for implementing 

the provisions of the Act with the 

United States Department of Agriculture 

(USDA). Within APHIS, Veterinary 

Services (VS) select agents and toxins, 

listed in 9 CFR 121.3, are those that 

have been determined to have the 

potential to pose a severe threat to 

animal health or animal products, and 

Plant Protection and Quarantine (PPQ) 

select agents and toxins, listed in 7 CFR 

331.3, are those that have been 

determined to have the potential to pose 

a severe threat to plant health or plant 

products. Overlap select agents and 

toxins, listed in 9 CFR 121.4, are those 

that have been determined to pose a 

severe threat to public health and safety, 

to animal health, or to animal products. 

Overlap select agents and toxins are 

subject to regulation by both APHIS 

DASAT and the Centers for Disease 

Control and Prevention (CDC), Division 

of Regulatory Science and Compliance 

(DRSC), which has the primary 

responsibility for implementing the 

provisions of the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 for the 

Department of Health and Human 

Services (HHS). Together, APHIS’ 

DASAT and CDC’s DRSC comprise the 

Federal Select Agent Program (FSAP). 

Title II, Subtitle B of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (which is 

cited as the ‘‘Agricultural Bioterrorism 

Protection Act of 2002’’ and referred to 

below as the Act), section 212(a) (7 

U.S.C. 8401(a)(1)), provides, in part, that 

the Secretary of Agriculture (the 

Secretary) must establish by regulation 

a list of each biological agent and each 

toxin that the Secretary determines has 

the potential to pose a severe threat to 

animal or plant health, or to animal or 

plant products. Paragraph (a)(2) of 

section 212 of the Act (7 U.S.C. 

8401(a)(2)) requires the Secretary to 

review and republish the list of select 

agents and toxins every two years and 

to otherwise revise the list as necessary. 

To fulfill this statutory mandate, APHIS 

convenes separate interagency working 

groups to review the list of PPQ and VS 

select agents and toxins, as well as any 

overlap select agents and toxins, and 

develop recommendations regarding 

possible changes to the list using the 

five criteria for listing found in the Act. 

APHIS and CDC coordinate on the 

biennial review for overlap select agents 

and toxins that have been determined to 

pose a severe threat to human and 

animal health or animal products. 

Description of Proposed Rule 

Pursuant to the Agricultural 

Bioterrorism Protection Act of 2002 (7 

U.S.C. 8401(a)(2)), APHIS has 

completed its required biennial review 

of the current list of select agents and 

toxins in 7 CFR 331.3 (PPQ select 

agents), 9 CFR 121.3 (VS select agents), 

and 9 CFR 121.4 (overlap select agents 

overseen jointly with CDC). This 

proposed rule would implement the 

recommendations of the interagency 

working groups with respect to the list 

of select agents and toxins. APHIS, in 

conjunction with CDC, proposes 

removing the following overlap select 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5804 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

agents: Brucella abortus, Brucella suis, 

and Brucella melitensis. APHIS 

proposes removing one VS select agent, 

African horse sickness virus. APHIS 

also proposes removing one PPQ select 

agent, Peronosclerospora philippinensis, 

also known as Peronosclerospora 

sacchari. 

Public response showed 

overwhelming support for the proposed 

delisting, particularly for the Brucella 

agents. Therefore, for reasons set forth 

in the ANPR and further articulated in 

the proposed rule that this economic 

analysis accompanies, we consider it 

appropriate to propose to delist the 

agents. 

In addition to the delisting of some 

select agents, APHIS is also proposing 

several amendments to the select agent 

and toxin regulations and several 

corrections to fix editorial errors. The 

amendments are summarized as follows: 

• Discovery of Select Agents and 

Toxins: We are proposing a definition 

for the term Discovery, clarifying that an 

individual or entity in possession of a 

select agent or toxin for which an 

exclusion or exemption listed in 9 CFR 

part 121 or 7 CFR part 331 does not 

apply, and that is not included on a 

certificate of registration, must 

immediately report such possession to 

either the APHIS Administrator or HHS 

Secretary, and creating a new APHIS/ 

CDC Form 6 to facilitate reporting of 

discoveries. 

• Disposal of Select Agent Waste 

After Conclusion of Patient Care: This 

proposes to codify a current operational 

policy that, for an individual who has 

been admitted to a medical facility, that 

individual’s ‘‘conclusion of patient 

care’’ and the point when ‘‘delivery of 

patient care by health care professionals 

has concluded’’ is when an individual 

is released from the medical facility 

where treatment was being provided by 

the medical facility or physician. 

• Exclusion of Animals Naturally 

Infected with Select Agents: We are 

proposing to codify the current 

operational policy regarding when 

animals naturally infected with select 

agents are excluded from the 

requirements of the regulations. 

• Inactivation: We are proposing to 

clarify what constitutes an acceptable 

‘‘validated inactivation procedure,’’ 

including revising the existing 

definition of the term; add a new 

exclusion 7 CFR 331.3(d), 9 CFR 

121.3(d), and 9 CFR 121.4(d) that would 

exclude any select agent or regulated 

nucleic acid that can produce infectious 

forms of any select agent virus if the 

material is contained in a formalin-fixed 

paraffin-embedded tissue or fixed to 

slides (e.g., Gram stain) that has been 

effectively inactivated by a recognized 

method; and codify a policy that allows 

individuals besides the responsible 

official to revise the inactivation 

procedures. 

• Removal: We are proposing to 

codify an operational exclusion in 7 

CFR 331.3(d)(5), 9 CFR 121.3(d)(5), and 

9 CFR 121.4(d)(5) regarding material 

containing a select agent that is 

subjected to a validated viable select 

agent removal procedure, revise the 

definition of Viability testing protocol, 

and add a definition for the term 

Verification viability testing protocol. 

• Loss, Release, and Theft: APHIS 

proposes to add definitions for the terms 

Loss, Release, and Theft. 

• Recordkeeping: We are proposing 

amendments to the recordkeeping 

requirements in 7 CFR 331.17 and 9 

CFR 121.17 to ensure an accurate, 

current inventory is maintained for all 

select agents and toxins held in longterm storage and address intra-agency 

transfer. APHIS is also proposing 

several revisions to the records needed 

for inactivated or select agent-free 

material created by an entity and to 

clarify throughout the regulations that 

whenever an entity is registered to 

possess, use, or transfer a select agent or 

toxin, the entity is required to meet all 

of the regulatory requirements for those 

select agents and toxins listed on the 

entity’s certificate of registration 

regardless of whether the select agent or 

toxin is in the actual possession of the 

entity and without regard to the amount 

of toxin in possession. 

• Electronic Federal Select Agent 

Program (eFSAP) Information System: 

We are proposing to add references to 

eFSAP’s electronic data submission and 

management procedures throughout the 

regulations. 

• Registration: We are clarifying the 

conditions under which issuance of a 

certificate of registration may be 

contingent and that amendment of a 

certification of registration to reflect 

changes in circumstances is mandatory. 

• Responsible Official and Alternate 

Responsible Official: We are proposing 

to clarify that a responsible official is 

precluded from serving as the primary 

responsible official for two separate 

registered entities. We are also clarifying 

that a responsible official cannot be the 

sole alternate responsible official at 

another registered entity, but that an 

alternate responsible official at one 

entity may be approved to be an 

alternate responsible official at another 

registered entity. 

• Annual Internal Inspections: We are 

proposing to codify current policy on 

what an entity’s annual internal 

inspections must address. 

• Tier 1 Security Enhancements: We 

are proposing to clarify that registered 

entities that possess Tier 1 select agents 

must have procedures for screening any 

visitors, their property, and, where 

appropriate, vehicles at entry points to 

registered space based on the entity’s 

site-specific risk assessment. 

• Biosafety—Facility Verification: We 

are proposing to amend 7 CFR 331.12 

and 9 CFR 121.12 to require facility 

verification every 12 months for 

registered entities that maintain 

biosafety level 3 and animal biosafety 

level 3 laboratories. 

• Biosafety—Effluent 

Decontamination System: We are 

proposing to amend the security (7 CFR 

331.11 and 9 CFR 121.11), biosafety (7 

CFR 331.12 and 9 CFR 121.12), and 

incident response (7 CFR 331.14 and 9 

CFR 121.14) sections of the select agent 

and toxin regulations to address risks 

posed by the effluent decontamination 

systems used by high and maximumcontainment laboratories. 

• Restricted Experiments: We are 

proposing to add a provision that an 

individual or entity must submit a 

written request to CDC or APHIS prior 

to the transfer or possession of the 

products of restricted experiments. 

Overview of the Action and Affected 

Entities 

There are 236 entities registered with 

APHIS and CDC. Of these entities, there 

are 13 Private entities, 30 Federal 

entities, 42 Commercial entities, 84 

Academic entities, and 67 State entities. 

Of these, less than 4 percent of all 

entities within these NAICS categories 

are considered to be small entities. The 

delisting of several select agents and the 

proposed amendments to the select 

agent and toxins regulations are 

anticipated to economically benefit 

producers, research and reference 

laboratories, and State and Federal 

oversight agencies, while also 

maintaining adequate program oversight 

of select agents and toxins, while 

minimizing additional costs to 

adherence. Below we provide a benefitcost analysis, as required by Executive 

Orders 12866, 13563, and 14094, to 

examine the potential economic effects 

of the rule on small entities. 

Expected Benefits and Costs of the 

Proposed Rule 

Costs for regulated entities to 

implement the changes contemplated in 

this proposed rule are expected to be 

very modest. For example, APHIS is 

proposing to add a provision that an 

individual or entity must submit a 

written request to CDC or APHIS prior 

to the transfer or possession of the 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5805 

products of restricted experiments. 

(Restricted experiments are experiments 

that involve the deliberate transfer of, or 

selection for, a drug or chemical 

resistance trait to select agents that are 

not known to acquire the trait naturally, 

if such acquisition could compromise 

the control of disease agents in humans, 

veterinary medicine, or agriculture, and 

experiments that involve the deliberate 

formation of synthetic or recombinant 

nucleic acids containing genes for the 

biosynthesis of select toxins lethal for 

vertebrates at an LD[50] < 100 ng/kg 

body weight.) 

This request is likely to take minimal 

time, less than a few minutes per 

request for these entities to provide, but 

could inform and result in a rapid 

mitigation if the products are accidently 

exposed to the natural environment. 

The written request is simply checking 

a box on a form that has already been 

readily available to them. 

Additionally, there are benefits of 

reducing the risks of the unintended 

release of select of select agents and 

toxins. For example, Kaufman et. al., 

1997 estimated the economic impacts of 

a bioterrorist attack at approximately 

$26.2 billion per 100,000 people 

exposed to the release of the anthrax 

select agent. Additionally, many 

regulated entities have been requesting 

some of the amendments, particularly 

the delisting of Brucella species. State 

Veterinarians have expressed concern 

regarding the limitation on brucellosis 

research because of the designation of 

Brucella as a select agent. 

Livestock producer organizations and 

the United States Animal Health 

Association (USAHA) have emphasized 

the need for continued research on an 

improved B. abortus vaccine and 

development of a B. suis vaccine, as 

well as improved diagnostics for both 

agents. Regulatory restrictions prohibit 

vaccine trials using natural transmission 

models, limit the opportunity for large 

animal studies, inhibit available 

surveillance, and prohibit studies that 

would evaluate vaccine or diagnostic 

product efficacy through comingling 

vaccinated and naturally infected 

animals. These limitations increase 

disease management costs for State and 

Federal governments as well as 

livestock producers. 

One previous example of the public 

requesting delisting of a select agent for 

research purposes was Valley Fever or 

Coccidiodes spp. Until October 2012, 

Valley Fever or Coccidiodes spp. had 

been listed as a select agent by both 

USDA and HHS as a level 3 pathogen, 

but due to financial difficulties for 

researchers to provide a biosafety three 

laboratory to conduct desperately 

needed clinical and environmental 

research, research was limited. Now 

research is taking place, and doctors and 

medical personnel are more familiar 

with it and understand that climate 

change is contributing to this disease in 

California, and research is ongoing 

along with outreach to inform potential 

infected citizens. Again, due to the high 

cost of laboratory requirements for 

select agents as mentioned above for 

Valley fever and other select agents, the 

appropriate research and field studies 

could not take place, thus hampering 

new information and research to limit or 

stop the spread of the disease or at least 

inform the public of its method of 

infection. Very few laboratories have the 

resources or ability to do research on 

select agents due to costs of 

containment and facility needs required 

by the regulations. 

There is currently limited courier 

availability for these five select agent 

shipments, which has resulted in 

prohibitive shipment costs for many 

laboratories. The increased shipment 

costs have inhibited isolate sharing 

between reference and research 

laboratories, thus leading to decreased 

advancements from researchers and 

laboratories involved in diagnostic 

improvements and disease eradication 

efforts. Removing the three Brucella 

agents (B. abortus, B. suis, and B. 

melitensis), as overlap select agents and 

one VS agent, African horse sickness 

virus, along with one plant agent, 

Peronosclerospora philippinensis, from 

the list of select agents and toxins 

would thus economically benefit 

producers, research and reference 

laboratories, and State and Federal 

oversight agencies. We welcome 

comments from the public if there are 

any reasons we should not be delisting 

these select agents. 

APHIS’ proposed amendment to 

require facility verification every 12 

months for registered entities that 

maintain biosafety level 3 and animal 

biosafety level 3 laboratories is not 

anticipated to create an additional 

burden to entities that maintain 

biosafety level 3 and animal biosafety 

level 3 laboratories. APHIS reached this 

conclusion as we understand that these 

entities are already performing such 

annual facility verifications. Level 3 

facilities are a highly regulated industry 

(at the Federal, State, and local level) 

with significant start-up and 

maintenance costs. It is highly likely 

that these are being monitored multiple 

times a week, if only for safety reasons. 

Also, many of the facilities operate, at 

least in part, on grants that are 

conditioned on demonstrating routine 

maintenance checks. However, APHIS 

has specifically requested comments 

concerning the cost and burden of 

annual facility verifications, especially 

if the entity is considered a small 

business, and will reevaluate as 

appropriate. 

APHIS has proposed several 

amendments to the select agent and 

toxin regulations related to security, 

biosafety, and incident response to 

address risks posed by the effluent 

decontamination systems used by Level 

3 and level 4-containment laboratories. 

Level 3 and level 4-containment 

laboratories are highly sophisticated 

facilities built to contain biological 

agents and toxins with the highest 

potential to threaten agricultural, plant, 

and public health and safety. Any 

defect, such as a crack or leaky pipe, 

could have severe consequences. For 

example, in August 2007, foot-andmouth disease virus was discovered at 

farms in the United Kingdom. The 

source of the contamination was 

determined to be long-term damage and 

leakage of a drainage system used by a 

high-containment laboratory working 

with the foot-and-mouth disease virus. 

APHIS does not believe this proposal 

will cause an undue burden to regulated 

entities. The regulations already require 

that entities prepare a security plan that 

is sufficient to safeguard the select agent 

or toxin against theft, loss, or release 

and unauthorized access, a 

biocontainment plan that is 

commensurate with the risk of the select 

agent or toxin, given its intended use, 

and an incident response plan based 

upon a site-specific risk assessment. 

These facilities are well versed in the 

security, biocontainment, and incident 

response measures that are necessary. 

Therefore, making changes to their 

current security, biocontainment, and 

incident response plans, as applicable, 

is not expected to cause a burden to 

these facilities other than the time it 

takes to develop the plans—if not 

previously done—and clearly describe 

the procedures to address the risks 

posed by the effluent decontamination 

systems. We have estimated that 

adherence to future security, 

biocontainment, and incident response 

plans could take as little as a few hours 

to no longer than a day. Additionally, 

the procedures needed are, in most 

cases, well-known and currently being 

implemented by entities with these 

effluent decontamination systems 

because lack of such procedures could 

potentially result in millions/billions of 

dollars in damages if a select agent or 

toxin was accidentally released into the 

natural environment. Once again, 

APHIS would be interested in 

comments concerning the cost and 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5806 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

burden of annual security plans, 

especially if the entity is considered a 

small business. 

APHIS is also proposing that an entity 

must submit a written request to APHIS 

or CDC prior to the transfer or 

possession of products of restricted 

experiments. Restricted experiments are 

experiments that involve the deliberate 

transfer of, or selection for, a drug or 

chemical resistance trait to select agents 

that are not known to acquire the trait 

naturally, if such acquisition could 

compromise the control of disease 

agents in humans, veterinary medicine, 

or agriculture, and experiments that 

involve the deliberate formation of 

synthetic or recombinant nucleic acids 

containing genes for the biosynthesis of 

select toxins lethal for vertebrates at an 

LD[50] < 100 ng/kg body weight. Again, 

we do not believe this proposed 

requirement will negatively impact 

these highly sophisticated entities other 

than the time requirement it takes to 

send a written request for the transfer or 

possession of products of restricted 

experiments. APHIS would once again 

welcome feedback regarding the burden 

of providing written requests prior to 

the transfer of restricted items, 

especially if the entity is considered a 

small business. 

Lastly, as described above, this 

proposed rule will codify several 

current policies that entities have 

already implemented, specifically, 

policies related to the disposal of select 

agent waste after conclusion of patient 

care, the exclusion appliable to animals 

naturally infected with a select agent, 

who can revise inactivation procedures, 

and matters that an entity’s annual 

internal inspection must address. 

APHIS has no reason to believe that 

continued adherence to these polices 

would negatively impact regulated 

entities going forward. In contrast, 

APHIS believes codification of the 

current policies adds clarity and 

consistency across facilities, which 

benefits the security of select agents and 

toxins. 

As described, any impacts of the 

proposed changes to the list of select 

agents and toxins are expected to be 

beneficial for the affected industries. 

Small-Entity Prevalence 

Entities that possess, use, or transfer 

certain plant, animal, or human select 

agents or toxins would either benefit or 

be unaffected by this rulemaking. 

Potentially affected entities include 

laboratories, other research institutions, 

and related entities in possession of 

select agents or toxins. Affected entities 

(other than Federal and State 

governmental entities) are likely found 

within the following North American 

Industry Classification System (NAICS) 

categories: 

541714, Research and Development in 

Biotechnology. 

541715, Research and Development in the 

Physical, Engineering, and Life Sciences 

(except Biotechnology); 

325412, Pharmaceutical Preparation 

Manufacturing; 

325413, In-Vitro Diagnostic Substance 

Manufacturing; 

325414, Biological Product (except 

Diagnostic) Manufacturing; 

541940, Veterinary Services; 

611310, Colleges, Universities and 

Professional Schools; 

621511, Medical Laboratories; 

622110, General Medical and Surgical 

Hospitals. 

The Small Business Administration 

(SBA) has established small-entity size 

standards based on the NAICS 

categories. An entity classified within 

NAICS 541714 or NAICS 541715 is 

considered small with 1,000 or fewer 

employees, and one within NAICS 

325412, 325413, or 325414 is 

considered small with 1,250 or fewer 

employees. An entity in NAICS 541940 

is considered small with annual receipts 

of $8 million or less, and an entity in 

NAICS 611310 is considered small with 

annual receipts of not more than $30 

million. Entities classified within 

NAICS 621511 are considered to be 

small if they have annual receipts of not 

more than $35 million. An entity 

classified within NAICS 622110 is 

considered to be small with annual 

receipts of not more than $41.5 million. 

While the breakdown of the size of 

the establishments, as reported by the 

2017 Economic Census, does not 

precisely fit the SBA guidelines, the 

data indicate that the vast majority of 

the entities in industries potentially 

affected by this proposed rule, other 

than post-secondary institutions, can be 

considered large entities. In other 

words, over 96 percent of all firms 

included in the above mentioned NAICS 

codes are large entities meaning only 

approximately 4 percent of these firms 

are small entities. According to the 2017 

Economic Census, the most recent 

census data available for all entities, 96 

percent of entities in NAICS 541714 and 

541715, 49 percent of entities in NAICS 

325412, 19 percent of entities in NAICS 

325413, 25 percent of entities in NAICS 

325414, 100 percent of entities in 

NAICS 541940, 87 percent of entities in 

NAICS 621511, 93 percent of entities in 

NAICS 611310, and 97 percent of 

entities in NAICS 622110 and can be 

classified as large. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5807 

TABLE 1—PREVALENCE OF SMALL/LARGE ENTITIES WITHIN AFFECTED INDUSTRIES

NAICS code Number of firms Annual revenue, receipts, or value of shipments 

SBA Small-entity Standard based on 

Employment.

<1,000 Employees small entities.1,000+ Employees large entities.<1,000 Employees small entities.1,000+ Employees large entities. 

541714 R&D in Biotechnology 

(commercial and non-profit) 3,109 

firms.

438 ........................................ 2,671 ..................................... $20.6 m ................................. $24.5b. 

541715 R&D in the Life Sciences 

(commercial and non-profit) 8,019 

firms.

0 ............................................ 8,019 ..................................... $0 .......................................... $96.8. 

<1,250 Employees ................ 1,250+ Employees ................ <1,250 Employees ................ 1,250+ Employees. 

325412 Pharmaceutical Preparation 494 ........................................ 513 ........................................ $1.9b ..................................... $152.7b. 

325413 In-vitro Diagnostic Substance.153 ........................................ 35 .......................................... $1b ........................................ $12.6b. 

325414 Biological Product (except 

Diagnostic).

197 ........................................ 67 .......................................... $1.4b ..................................... $29.2b. 

SBA Small-entity Standard based on 

Annual Receipts.

<$8 million in Receipts employees.$8 million+ in Receipts employees.<$8 million in Receipts .......... $8 million+ in Receipts. 

541940 Veterinary Services 42 b receipts.0 ............................................ 28,291 ................................... $0 .......................................... $42.1 b. 

SBA Small-entity Standard based on 

Annual Receipts.

<$35 million in Receipts employees.$35 million+ in Receipts employees.<$35 million in Receipts ........ $35 million+ in Receipts. 

621511 Medical Laboratories 35.6b 438 ........................................ 2,927 ..................................... $22.m .................................... $35.6b. 

SBA Small-entity Standard based on 

Annual Receipts.

<$30 million in Receipts employees.$30 million+ in Receipts employees.<$30 million in Receipts ........ $30 million+ in Receipts. 

611310 Colleges, Universities, and 

Professional Schools.

168 ........................................ 2,265 ..................................... 7.9 m ..................................... 255.6 b. 

SBA Small-entity Standard based on 

Annual Receipts.

<$41.5 million in Receipts 

employees.

$41.5 million+ in Receipts 

employees.

<$41.5 million in Receipts ..... $41.5 million+ in Receipts. 

622110 General Medical and Surgical Hospitals.65 .......................................... 2,495 ..................................... $35.5 m ................................. $997.3 b. 

The analysis above shows the 

potential costs of the proposed rule to 

be slight. The benefits will of the 

proposed rule will accrue to all firms, 

most of which (96 percent) included in 

the above mentioned NAICS codes are 

large entities meaning only 

approximately 4 percent of these firms 

are small entities. Very few entities 

registered for select agents and toxins 

are considered small and because there 

are so few small entities, the proposed 

rule is not expected to have a significant 

economic impact on small entities. 

Alternatives to the Rule 

Status Quo—Not Delisting 

APHIS convenes separate interagency 

working groups in order to review the 

list of PPQ and VS select agents and 

toxins, as well as any overlap select 

agents and toxins, and develop 

recommendations regarding possible 

changes to the list using the five criteria 

for listing found in the Act. APHIS and 

CDC coordinate on the biennial review 

for overlap select agents and toxins that 

have been determined to pose a severe 

threat to human and animal health or 

animal products. The proposed changes 

are based on the recommendations of 

the interagency working groups. 

Maintaining the status quo would 

mean foregoing continued research on 

an improved B. abortus vaccine and 

development of a B. suis vaccine, as 

well as improved diagnostics for both 

agents. Regulatory restrictions prohibit 

vaccine trials using natural transmission 

models, limit the opportunity for large 

animal studies, inhibit available 

surveillance, and prohibit studies that 

would evaluate vaccine or diagnostic 

product efficacy through comingling 

vaccinated and naturally infected 

animals. These limitations increase 

disease management costs for State and 

Federal governments as well as 

livestock producers. 

Not Codifying Policies 

One alternative to the proposed rule 

considered by APHIS was not to 

propose to codify the current 

operational policies listed above and 

just delist the proposed select agents. 

However, we decided to propose 

codification for the sake of consistency 

with CDC and transparency with our 

stakeholders. The proposed changes are 

currently operationalized, and 

codification of the policies has been 

recommended by various governmental 

entities. 

Without codification we would not 

have transparency and consistency 

throughout agencies which is important 

when requiring strict adherence to our 

proposed regulatory policies for select 

agents; thus we have rejected the 

alternative to not codify our operational 

policies that are closely coordinated 

between APHIS and CDC. 

APHIS convenes separate interagency 

working groups in order to review the 

list of PPQ and VS select agents and 

toxins, as well as any overlap select 

agents and toxins, and develop 

recommendations regarding possible 

changes to the list using the five criteria 

for listing found in the Act. APHIS and 

CDC coordinate on the biennial review 

for overlap select agents and toxins that 

have been determined to pose a severe 

threat to human and animal health or 

animal products. The proposed changes 

are based on the recommendations of 

the interagency working groups. 

Maintaining the status quo would 

mean foregoing continued research on 

an improved B. abortus vaccine and 

development of a B. suis vaccine, as 

well as improved diagnostics for both 

agents. Regulatory restrictions prohibit 

vaccine trials using natural transmission 

models, limit the opportunity for large 

animal studies, inhibit available 

surveillance, and prohibit studies that 

would evaluate vaccine or diagnostic 

product efficacy through comingling 

vaccinated and naturally infected 

animals. These limitations increase 

disease management costs for State and 

Federal governments as well as 

livestock producers. 

The analysis above shows the 

potential costs of the proposed rule to 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5808 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

1 Go to www.regulations.gov and enter CDC– 

2020–0024 in the Search field. 

be slight. The benefits of the proposed 

rule will accrue to all firms, most of 

which (96 percent) included in the 

above mentioned NAICS codes are large 

entities, meaning only approximately 4 

percent of these firms are small entities. 

Very few entities registered for select 

agents and toxins are considered small 

and because there are so few small 

entities, the proposed rule is not 

expected to have a significant economic 

impact on small entities. 

Objectives of and Legal Basis for the 

Rule 

Pursuant to the Agricultural 

Bioterrorism Protection Act of 2002 (7 

U.S.C. 8401(a)(2)), APHIS has 

completed its required biennial review 

of the current list of select agents and 

toxins in 7 CFR 331.3 (PPQ select 

agents), 9 CFR 121.3 (VS select agents), 

and 9 CFR 121.4 (overlap select agents 

overseen jointly with CDC). This 

proposed rule will implement the 

recommendations of the interagency 

working groups with respect to the list 

of select agents and toxins. APHIS, in 

conjunction with CDC, proposes 

removing the following overlap select 

agents: Brucella abortus, Brucella suis, 

and Brucella melitensis. APHIS 

proposes removing one VS select agent, 

African horse sickness virus. APHIS 

also proposes removing one PPQ select 

agent, Peronosclerospora philippinensis, 

also known as Peronosclerospora 

sacchari. 

Projected Reporting, Recordkeeping, 

and Other Compliance Requirements 

New regulatory compliance, reporting 

and recordkeeping requirements 

associated with the information 

collection in this proposed rule are 

discussed above in the section on 

expected benefits and costs of the 

proposed rule. Those requirements are 

also discussed in the rule under the 

heading ‘‘Paperwork Reduction Act.’’ 

Executive Order 13175 

This proposed rule has been reviewed 

in accordance with the requirements of 

Executive Order 13175, ‘‘Consultation 

and Coordination with Indian Tribal 

Governments.’’ Executive Order 13175 

requires Federal agencies to consult and 

coordinate with tribes on a governmentto-government basis on policies that 

have tribal implications, including 

regulations, legislative comments or 

proposed legislation, and other policy 

statements or actions that have 

substantial direct effects on one or more 

Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

What follows is a summary of such 

coordination to date. 

The Animal and Plant Health 

Inspection Service (APHIS) has assessed 

the impact of this proposed rule on 

Indian Tribes by soliciting tribal 

feedback on its provisions. On April 8, 

2022, APHIS sent tribal nations a letter 

outlining the provisions of the proposed 

rule and soliciting their feedback. On 

May 5, 2022, the Sac and Fox Tribe of 

the Mississippi in Iowa submitted a 

response expressing concerns regarding 

whether possible Brucella abortus 

delisting would materially adversely 

impact APHIS’ domestic quarantine 

program for the control and eradication 

of brucellosis in cattle and bison. In 

response, APHIS clarified that the two 

issues were distinct, and no adverse 

operational impacts were anticipated. 

On June 6, 2022, the Tribe indicated 

that they have no further comments or 

concerns. To date, no other Tribes have 

expressed concerns regarding the 

proposed rule. Therefore, the Agency 

has determined that this proposed rule 

does not, to our knowledge, have Tribal 

implications that require formal Tribal 

consultation under Executive Order 

13175. If a Tribe requests consultation, 

the Animal and Plant Health Inspection 

Service will work with the Office of 

Tribal Relations to ensure meaningful 

consultation is provided where changes, 

additions and modifications identified 

herein are not expressly mandated by 

Congress. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 2 CFR 

Chapter IV.) 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule (1) preempts 

all State and local laws and regulations 

that are in conflict with this rule; (2) has 

no retroactive effect; and (3) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

FSAP is the collaboration of the CDC’s 

Division of Regulatory Science and 

Compliance (DRSC) and the APHIS 

Division of Agricultural Select Agents 

and Toxins (DASAT) to administer the 

select agent and toxin regulations in a 

manner to minimize the administrative 

burden on persons subject to the select 

agent and toxin regulations. The Federal 

select agent activities managed by 

APHIS are described in 7 CFR part 331 

and 9 CFR part 121; otherwise, they are 

managed by the CDC in 42 CFR part 73. 

Both agencies are concurrently 

publishing proposed rules in this issue 

of the Federal Register 1 with changes to 

the select agent and toxin regulations, 

and the changes are uniform, as 

applicable, across all three sets of 

regulations. In accordance with section 

3507(d) of the Paperwork Reduction Act 

of 1995 (44 U.S.C. 3501 et seq.), the CDC 

is reporting, as the sponsoring agency, 

information collection requirements to 

the Office of Management and Budget 

under OMB control number 0920–0576, 

Possession, Use, and Transfer of Select 

Agents and Toxins. Reportable activities 

include requests for exclusions, reports 

of identification of a select agent or 

toxin, requests of exemption, 

applications for registration, 

amendments to a certificate of 

registration, documentation of selfinspection, requests for expedited 

review, security plans, biosafety plans, 

requests regarding restricted 

experiments, incident response plans, 

training, requests to transfer select 

agents and toxins, recordkeeping, 

notifications of theft, loss, or release; 

and administrative reviews. There are 

no new activities in this proposed rule. 

There are an estimated 3,656 hours of 

burden associated with this program. 

Information about information 

collection 0920–0576 may be obtained 

from the www.reginfo.gov website or 

from Ms. Lori Bane, Deputy Director, 

Division of Select Agents and Toxins, 

Center for Preparedness and Response, 

Centers for Disease Control and 

Prevention, at (404) 718–2006. APHIS 

and CDC will respond to any ICRrelated comments in the final rule. All 

comments will also become a matter of 

public record. 

E-Government Act Compliance 

APHIS is committed to compliance 

with the E-Government Act to promote 

the use of the internet and other 

information technologies, to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. FSAP 

utilizes a highly secure eFSAP 

information system to conduct select 

agent and toxin program activities and 

the information system is a two-way 

communication portal accessible by 

both CDC and APHIS staff and the 

regulated community. APHIS estimates 

100 percent of the total responses can be 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5809 

processed electronically. For users at 

registered entities, benefits of the system 

include reduced paperwork, increased 

ease of validating and submitting 

information, and reduced processing 

time for requests (as real-time 

information exchange allows for 

increased responsiveness). Both APHIS 

and CDC collect information from 

reports (e.g., APHIS/CDC Forms 2, 3, 

and 4) and requests (e.g., amendments 

to registration) submitted via the eFSAP 

information system. 

For assistance with E-Government Act 

compliance related to this proposed 

rule, please contact Mr. Joseph Moxey, 

APHIS’ Paperwork Reduction Act 

Coordinator, at (301) 851–2483, or the 

individual listed under FOR FURTHER

INFORMATION CONTACT. 

References 

Alberca, B., et al. Vaccination of horses with 

a recombinant modified vaccinia Ankara 

virus (MVA) expressing African horse 

sickness (AHS) virus major capsid 

protein VP2 provides complete clinical 

protection against challenge. Vaccine, 

2014. 32(29): p. 3670–3674. 

Braverman, Y. and A. Chizov-Ginzburg. Role 

of dogs (Canis domesticus) as hosts for 

African horse sickness virus. Vet 

Microbiol, 1996. 51(1–2): p. 19–25. 

Center for Food Security and Public Health. 

Brucellosis fact sheet. July 19, 2009. 

Available from: http://www.cfsph.iastate.

edu/Factsheets/pdfs/brucellosis.pdf. 

Center for Food Security and Public Health. 

Porcine and Rangiferine Brucellosis: 

Brucella suis Fact Sheet. July 2009. 

Available from: http://www.cfsph.iastate.

edu/Factsheets/pdfs/brucellosis_

suis.pdf. 

Food and Agriculture Organization of the 

United Nations. List of Regulated Pests. 

International Plant Protection 

Convention. Cited October 19, 2017. 

Available from: https://www.ippc.int/en/ 

countries/all/regulatedpests/. 

Kajon, A.E., et al. Molecular epidemiology 

and brief history of emerging adenovirus 

14-associated respiratory disease in the 

United States. J Infect Dis, 2010. 202(1): 

p. 93–103. 

Lulla, V., et al. Protective efficacy of 

multivalent replication-abortive vaccine 

strains in horses against African horse 

sickness virus challenge. Vaccine, 2017. 

35(33): p. 4262–4269. 

Moreno, E. Retrospective and prospective 

perspectives on zoonotic brucellosis. 

Frontiers in Microbiology, 2014. 5. 

Available from: https://pubmed.ncbi.

nlm.nih.gov/24860561/. 

Murray, G.M. Industry Biosecurity Plan for 

the Grains Industry: Threat Specific 

Contingency Plan Philippine downy 

mildew of maize (Perenosclerospora 

philippensis) and Downy mildew of 

sorghum (P. sorghi). Plant Health 

Australia 2009 [cited 2017 Oct 20]; 

Available from: http://www.planthealth

australia.com.au/wp-content/uploads/ 

2013/03/Downy-mildew-of-maize-andsorghum-CP-2009.pdf. 

Olsen, S.C. and C. Johnson. Comparison of 

Abortion and Infection after 

Experimental Challenge of Pregnant 

Bison and Cattle with Brucella abortus 

Strain 2308. Clinical and Vaccine 

Immunology, 2011. 18(12): p. 2075– 

2078. Available from: https://pubmed.

ncbi.nlm.nih.gov/21976222/. 

Purdue University Extension. 

Peronosclerospora philippinensis Fact 

Sheet. Cited Oct 20, 2017. Available 

from: http://download.ceris.purdue.edu/ 

file/3117. 

Sanchez-Vizcaino, J.M., Control and 

eradication of African horse sickness 

with vaccine. Dev Biol (Basel), 2004. 119: 

p. 255–8. 

Spickler, A.R. African Horse Sickness. Center 

for Food Security and Public Health 

Technical Factsheets February 2015. 

Available from: http://www.cfsph.iastate.

edu/Factsheets/pdfs/african_horse_

sickness.pdf. 

Stoffregen, W.C. Brucella infection and 

vaccine studies in feral and domestic 

swine. 2006. 

The Center for Food Security and Public 

Health. Ovine and Caprine Breucellosis: 

Brucella melitensis. 2009, Iowa State 

University: Ames, Iowa. 

USDA. Recovery Plan for Philippine Downy 

Mildew and Brown Stripe Downy Mildew 

of Corn. Cited Oct 20, 2017. Available 

from: https://www.ars.usda.gov/ 

ARSUserFiles/opmp/CornDownyMildews

RecoveryPlanRevised2013.pdf. 

World Organizsation for Animal Health 

(OIE). Terrestrial Animal Health Code 

(2017). [cited 2017 Oct 11]; Available 

from: http://www.oie.int/en/ 

international-standard-setting/terrestrialcode/access-online/. 

Zhu, L., et al., Brucella suis strain 2 vaccine 

is safe and protective against 

heterologous Brucella spp. infections. 

Vaccine, 2016. 34(3): p. 395–400. 

Available at: https://pubmed.ncbi.nlm.

nih.gov/26626213/. 

List of Subjects 

7 CFR Part 331 

Agricultural research, Laboratories, 

Plant diseases and pests, Reporting and 

recordkeeping requirements. 

9 CFR Part 121 

Agricultural research, Animal 

diseases, Laboratories, Medical research, 

Reporting and recordkeeping 

requirements. 

Accordingly, we propose to amend 7 

CFR part 331 and 9 CFR part 121 as 

follows: 

TITLE 7—AGRICULTURE 

PART 331—POSSESSION, USE, AND 

TRANSFER OF SELECT AGENTS AND 

TOXINS 

■ 1. The authority citation for part 331 

continues to read as follows: 

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

and 371.3. 

■ 2. Amend § 331.1 by: 

■ a. Adding in alphabetical order 

definitions for ‘‘Discovery’’ and ‘‘Loss’’; 

■ b. Removing the definition for 

‘‘Permit’’; 

■ c. Adding in alphabetical order 

definitions for ‘‘Release’’ and ‘‘Theft’’; 

■ d. Revising the definition for 

‘‘Validated inactivation procedure’’; 

■ e. Adding in alphabetical order 

definitions for ‘‘Validated removal 

procedure’’ and ‘‘Verification viability 

testing protocol’’; and 

■ f. Revising the definition for 

‘‘Viability testing protocol’’. 

The additions and revisions read as 

follows: 

§ 331.1 Definitions. 

* * * * * 

Discovery. The finding of a select 

agent or toxin by an individual or entity 

that is not aware of the select agent or 

toxin’s existence. Examples include, but 

are not limited to the following: 

(1) A registered individual or entity 

finds a select agent or toxin not 

accounted for in their purpose 

inventory; or 

(2) A non-registered individual or 

entity finds a select agent or toxin. 

* * * * * 

Loss. The inability to account for a 

select agent or toxin known to be in the 

individual or entity’s possession. 

* * * * * 

Release means any of the following: 

(1) An incident resulting in 

occupational exposure to a select agent 

or toxin; 

(2) An incident resulting in animal/ 

plant exposure to a select agent or toxin; 

(3) The failure of equipment used to 

contain a select agent or toxin such that 

it is reasonably anticipated that a select 

agent of toxin was released; 

(4) The failure of or breach in 

personal protective equipment in the 

presence of a select agent or toxin; or 

(5) The failure of biosafety procedures 

such that it is reasonably anticipated 

that a select agent or toxin was outside 

of containment. 

* * * * * 

Theft. The unauthorized taking and 

removing of a select agent or toxin from 

the possession of an entity or 

individual. 

* * * * * 

Validated inactivation procedure. A 

procedure, whose efficacy has been 

confirmed by data generated from an inhouse viability testing protocol, to 

render a select agent non-viable but 

allows the select agent to retain 

characteristics of interest for future use; 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5810 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

or to render any nucleic acids that can 

produce infectious forms of any select 

agent virus non-infectious for future 

use. 

Validated removal procedure. A 

procedure, whose efficacy has been 

confirmed by data generated in-house 

from a viability testing protocol, to 

confirm removal of all viable select 

agent, or nucleic acids of any select 

agent virus capable of producing 

infectious virus. 

* * * * * 

Verification viability testing protocol. 

A protocol, used on samples that have 

been subjected to a validated 

inactivation or removal procedure, to 

confirm the material is free of all viable 

select agent, or nucleic acids of any 

select agent virus capable of producing 

infectious virus. 

Viability testing protocol. A protocol, 

used on samples that have been 

subjected to a validated inactivation or 

removal procedure, to confirm the 

material is free of all viable select agent, 

or nucleic acids of any select agent virus 

capable of producing infectious virus. 

■ 3. Revise § 331.2 to read as follows: 

§ 331.2 Purpose and scope. 

(a) This part implements the 

provisions of the Agricultural 

Bioterrorism Protection Act of 2002 

setting forth the requirements for 

possession, use, and transfer of select 

agents and toxins. The biological agents 

and toxins listed in this part have the 

potential to pose a severe threat to plant 

health or plant products. 

(b) Any individual or entity in 

possession of a select agent or toxin, for 

which an exclusion or exemption listed 

in this part does not apply, and that is 

not included on a certificate of 

registration issued by the Administrator 

for that individual or entity, must 

immediately report such possession to 

the Administrator by the submission of 

an APHIS/CDC Form 6. 

■ 4. Amend § 331.3 by: 

■ a. Revising paragraphs (b) and (d)(4) 

through (6); 

■ b. Redesignating paragraphs (d)(7) 

through (9) as paragraphs as (d)(8) 

through (10) and adding a new 

paragraph (d)(7); 

■ c. In newly redesignated paragraph 

(d)(9), removing the words ‘‘of the 

conclusion of patient care’’ and adding 

the words ‘‘from when the individual 

has been released from the medical 

facility where treatment was being 

provided’’ in their place; 

■ d. Revising newly redesignated 

paragraph (d)(10); 

■ e. In paragraph (e)(1), removing the 

words ‘‘National Select Agent Registry 

website’’ and adding the words ‘‘Federal 

Select Agent Program website’’ in their 

place; and 

■ f. In paragraph (f)(3), removing the 

words ‘‘telephone, facsimile, or email’’ 

and adding the words ‘‘eFSAP 

information system, telephone, or 

email’’ in their place in the second 

sentence. 

The revisions and addition read as 

follows: 

§ 331.3 PPQ select agents and toxins. 

* * * * * 

(b) PPQ select agents and toxins: 

Coniothyrium glycines, (formerly 

Phoma glycinicola, Pyrenochaeta 

glycines); 

Ralstonia solanacearum Race 3 biovar 

2; 

Rathayibacter toxicus; 

Sclerophthora rayssiae; 

Synchytrium endobioticum; and 

Xanthomonas oryzae. 

* * * * * 

(d) * * * 

(4) A select agent or regulated nucleic 

acids that can produce infectious forms 

of any select agent virus that has been 

subjected to a validated inactivation 

procedure, provided that: 

(i) In-house validation of the 

inactivation procedure is completed 

prior to use; 

(ii) A certificate of inactivation has 

been generated in accordance with 

§ 331.17(a)(8); 

(iii) For use of a select agent surrogate 

is used to validate an inactivation 

procedure: 

(A) Select agent surrogates must be 

known to possess equivalent properties 

with respect to inactivation; 

(B) If there are known variations in 

the resistance of a select agent to an 

inactivation procedure, including strain 

to strain, then an inactivation procedure 

must also be validated using the most 

resistant select agent surrogate; 

(iv) For use of whole plant tissue or 

homogenized plant tissue surrogate to 

validate a chemical inactivation 

procedure for other tissues including 

those in other plant models: 

(A) All standardized conditions must 

be held constant such as the select agent 

used, plant tissue volume, and ratio of 

plant tissue to volume of inactivating 

chemical; 

(B) A safety margin must be 

incorporated into the final chemical 

inactivation procedure to ensure the 

effective inactivation of the select agent; 

(C) The tissue surrogate must meet the 

following criteria: 

(1) The plant tissue is expected to 

have the highest concentration of the 

specific select agent to be inactivated; or 

(2) The concentration of the select 

agent in the plant tissue must be 

determined and this select agent 

concentration must not be exceeded 

when applying the validated 

inactivation procedure on subsequent 

plant tissue samples. 

(5) Material containing a select agent 

that is subjected to a validated viable 

select agent removal procedure that has 

rendered the material free of all viable 

select agent provided that: 

(i) In-house validation of the viable 

select agent removal procedure is 

completed prior to use; 

(ii) A certificate of viable select agent 

removal has been generated in 

accordance with § 331.17(a)(8); 

(iii) For use of a surrogate to validate 

a viable select agent removal procedure, 

only surrogates known to possess 

equivalent properties with respect to 

removal are used; 

(iv) A portion of each subsequent 

sample has been subjected to a 

verification viability testing protocol to 

ensure that the validated viable select 

agent removal procedure has rendered 

the material free of all viable select 

agent. 

(6) A select agent or regulated nucleic 

acids that can produce infectious forms 

of any select agent virus not subjected 

to a validated inactivation procedure or 

material containing a select agent not 

subjected to a validated viable select 

agent removal procedure that removes 

all viable select agent cells, spores, or 

virus particles if the material is 

determined by the Administrator or 

HHS Secretary to be effectively 

inactivated or effectively removed. To 

apply for a determination, an individual 

or entity must submit a written request 

and supporting scientific information to 

APHIS. A written decision granting or 

denying the request will be issued. 

(7) Any select agent or regulated 

nucleic acids that can produce 

infectious forms of any select agent 

virus contained in a formalin-fixed 

paraffin-embedded (FFPE) tissue if the 

FFPE process used is a recognized 

procedure for that particular select agent 

or regulated nucleic acids. 

* * * * * 

(10) All subspecies of Sclerophthora 

rayssiae except var. zeae, provided that 

the individual or entity can identify that 

the agent is within the exclusion 

category. 

* * * * * 

■ 5. Amend § 331.5 by: 

■ a. Revising paragraphs (a) 

introductory text and (a)(1); and 

■ b. In paragraph (a)(3), removing the 

words ‘‘by telephone, facsimile, or 

email’’ and adding the words ‘‘through 

the eFSAP information system, 

telephone, or email’’ in their place in 

the first sentence. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5811 

The revisions read as follows: 

§ 331.5 Exemptions. 

(a) Clinical or diagnostic laboratories 

and other entities that possess, use, or 

transfer a PPQ select agent or toxin that 

is contained in a specimen presented for 

diagnosis or verification will be exempt 

from the requirements of this part for 

such agent or toxin contained in the 

specimen, provided that: 

(1) Unless directed otherwise by the 

Administrator, within 7 calendar days 

after identification of the select agent or 

toxin, the select agent or toxin is 

transferred in accordance with § 331.16 

or destroyed on-site by a recognized 

sterilization process or inactivated for 

future use in accordance with 

§ 331.3(d)(4). 

* * * * * 

■ 6. Amend § 331.7 by: 

■ a. In paragraph (f), removing the 

words ‘‘the relevant page(s) of’’ and 

adding the words ‘‘information related 

to’’ in their place; 

■ b. Revising paragraph (g); 

■ c. In paragraph (i) introductory text, 

removing the word ‘‘may’’ and adding 

the word ‘‘must’’ in its place, and 

removing the word ‘‘circumstances’’ and 

adding the words ‘‘the possession and 

use of the select agents and toxins’’ in 

its place; 

■ d. In paragraph (i)(1), removing the 

words ‘‘the relevant page(s) of’’ and 

adding the words ‘‘information related 

to’’ in their place and removing footnote 

2. 

The revision reads as follows: 

§ 331.7 Registration and related security 

risk assessments. 

* * * * * 

(g) The issuance of a certificate of 

registration may be contingent upon 

inspection and submission of additional 

information to include any or all of the 

following: The security plan, biosafety 

plan, incident response plan, or any 

other documents related to the 

requirements of this part. 

* * * * * 

§ 331.8 [Amended] 

■ 7. Amend § 331.8, in paragraph (a)(3), 

by redesignating footnote 3 as footnote 

1. 

■ 8. Amend § 331.9 by: 

■ a. Redesignating paragraphs (a)(5) 

through (9) as paragraphs (a)(6) through 

(10) and adding a new paragraph (a)(5); 

■ b. Revising newly redesignated 

paragraphs (a)(7), (9), and (10); 

■ c. Adding a new second sentence to 

paragraph (b); and 

■ d. Revising paragraph (c)(1). 

The addition and revisions read as 

follows: 

§ 331.9 Responsible official. 

(a) * * * 

(5) Not be approved as Responsible 

Official or alternate Responsible Official 

at another registered entity. 

* * * * * 

(7) Ensure that annual inspections are 

conducted for each registered space to 

determine compliance with the 

requirements in accordance with the 

regulations of this part. The results of 

each inspection must be documented, 

and any deficiencies identified during 

an inspection must be corrected and the 

corrections documented. The annual 

inspection must address whether: 

(A) The entity’s biosafety/ 

biocontainment plan is being effectively 

implemented as outlined in § 331.12. 

(B) The entity’s security plan is being 

effectively implemented as outlined in 

§ 331.11. 

(C) The entity’s incident response 

plan is implemented to ensure whether 

the entity is able to respond, as outlined 

in § 331.14. 

(D) Each individual with access 

approval from the Administrator or HHS 

Secretary has received the appropriate 

training as outlined in § 331.15. 

* * * * * 

(9) Investigate to determine the reason 

for any failure of a validated 

inactivation or validated viable select 

agent removal procedure to render 

material free from viable select agent. If 

the responsible official is unable to 

determine the cause of the failure from 

a validated inactivation or validated 

viable select agent removal procedure or 

receives a report of any inactivation 

failure after the movement of material to 

another location, the responsible official 

must report immediately through the 

eFSAP information system, telephone, 

or email the inactivation or viable select 

agent removal procedure failure to 

APHIS or CDC. 

(10) Review each of the entity’s 

validated select agent inactivation 

procedure or validated viable select 

agent removal procedure and ensure 

they are revised as necessary. The 

review must be conducted annually or 

after any change in principal 

investigator, change in the validated 

inactivation or validated viable select 

agent removal procedure, or failure of 

the validated inactivation or validated 

viable select agent removal procedure. 

The review must be documented, and 

training must be conducted if there are 

any changes to the validated select agent 

inactivation or validated viable select 

agent removal procedure, or viability 

testing protocol. 

(b) * * * An alternate responsible 

official can serve at multiple registered 

entities. * * * 

* * * * * 

(c) * * * 

(1) The identification of the select 

agent or toxin must be immediately 

reported through the eFSAP information 

system, telephone, or email. The final 

disposition of the agent or toxin must be 

reported by submission of APHIS/CDC 

Form 4 within 7 calendar days after 

identification. A copy of the completed 

form not submitted through eFSAP 

information system must be maintained 

for 3 years. 

* * * * * 

§ 331.10 [Amended] 

■ 9. Amend § 331.10, in paragraph (c), 

by removing the words ‘‘access to select 

agents or toxins’’ and adding the words 

‘‘approval from the Administrator or 

HHS Secretary’’ in their place. 

■ 10. Amend § 331.11 by: 

■ a. Redesignating paragraphs (c)(9) and 

(10) as (c)(10) and (11) and adding a 

new paragraph (c)(9); 

■ b. In paragraph (d)(4), removing the 

words ‘‘an area where select agents or 

toxins are used or stored’’ and adding 

the words ‘‘registered space’’ in their 

place; and 

■ c. Removing paragraph (g) and 

redesignating paragraph (h) as 

paragraph (g). 

The addition reads as follows: 

§ 331.11 Security. 

* * * * * 

(c) * * * 

(9) Describe procedures to prevent the 

theft, loss, release, or unauthorized 

access to a select agent or toxin from an 

effluent decontamination system 

originating from a registered laboratory. 

* * * * * 

■ 11. Amend § 331.12 by: 

■ a. In paragraph (a) introductory text, 

redesignating footnote 4 as footnote 1. 

■ b. Removing paragraph (c)(1) and 

redesignating paragraph (c)(2) as 

paragraph (c)(1); 

■ c. Adding a new reserved paragraph 

(c)(2); and 

■ d. Adding paragraphs (f), (g), and (h). 

The additions read as follows: 

§ 331.12 Biocontainment. 

* * * * * 

(c) * * * 

(2) [Reserved] 

* * * * * 

(f) When an effluent decontamination 

system is used, the plan must provide 

for verification that the liquid waste 

generated from registered space is 

sufficiently treated to prevent the 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5812 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

release of a select agent or toxin prior 

to discharge of the waste from the 

facility. 

(1) For a new effluent 

decontamination system, verification is 

required before initial use. 

(2) For an effluent decontamination 

system in place, verification is required 

at least once every 12 months and 

following any major change to the 

effluent decontamination system. 

(3) The verification must be 

documented. 

(g) When an effluent decontamination 

system is used, the plan must provide 

that monthly routine maintenance is 

conducted of the effluent 

decontamination system, including at a 

minimum verification that: 

(1) Alarms are functioning according 

to established specifications; 

(2) Piping, pumps, valves, and tanks 

are not leaking; and 

(3) Methods used to monitor and 

record performance measurements are 

functioning according to established 

specifications. 

(h) An individual or entity must 

document every 12 months the 

following facility verification 

requirements for registered biosafety 

level 3 and animal biosafety level 3 

laboratories. 

(1) Accuracy of devices that monitor 

directional air-flow; 

(2) Confirmation that 

decontamination systems (e.g., 

autoclave, room decontamination 

systems, digesters, liquid effluent 

decontamination systems) are operating 

to ensure the containment of the select 

agent and toxin; 

(3) Confirmation that systems are in 

place to monitor, maintain, and validate 

performance of mechanical systems to 

ensure that airflows and differential 

pressures are appropriate to maintain 

containment during normal/operational 

conditions; 

(4) Verification that the facility 

mechanical, electrical, and drain waste 

and ventilation systems responsible for 

containment are inspected, maintained, 

and function as designed by the 

manufacturer specifications; 

(5) Verification that the facility 

systems perform as intended in 

response to failure conditions as defined 

and tested during commissioning to 

prevent the release of a select agent or 

toxin and verification of secondary 

containment: 

(i) Evaluate using work objectives, use 

of space, and facility infrastructure 

systems against the verified original 

design and standards (e.g., Biosafety in 

Microbiological and Biomedical 

Laboratories, NIH Design Requirements 

Manual). 

(ii) Implement controls and alarms to 

identify and alert personnel when 

systems fail, malfunction, or are unable 

to maintain containment during such an 

event. 

(6) Certification of laboratory 

ventilation system HEPA filters, if 

present; 

(7) Confirmation that room integrity 

has been evaluated and repairs are 

addressed (e.g., sealed penetrations); 

(8) Primary containment equipment is 

certified based on manufacturer’s 

specifications (or recommendations) 

(e.g., biological safety cabinets, flexible 

film isolators, animal caging); 

(9) Seals on centrifuges not used in 

primary containment have been checked 

and replaced if needed; and 

(10) Showers, eye wash stations, and 

hands-free sinks are operating properly. 

§ 331.13 [Amended] 

■ 12. Amend § 331.13, in paragraph (a) 

introductory text, by adding the words 

‘‘or transfer’’ after the word ‘‘possess’’. 

■ 13. Amend § 331.14 by: 

■ a. In the section heading, 

redesignating footnote 5 as footnote 1; 

■ b. In paragraph (a), redesignating 

footnote 6 as footnote 2; 

■ c. In paragraph (b), adding the words 

‘‘the failure of an effluent 

decontamination system resulting in a 

release of a select agent or toxin;’’ after 

the words ‘‘a select agent or toxin;’’; and 

■ d. Revising paragraph (c). 

The revision reads as follows: 

§ 331.14 Incident response 1. 

* * * * * 

(c) The response procedures must 

account for hazards associated with the 

select agent or toxin and appropriate 

actions to contain such select agent or 

toxin in registered space including any 

animals (including arthropods) or plants 

intentionally or accidentally exposed to 

or infected with a select agent, or an 

effluent decontamination system 

originating from registered space. 

* * * * * 1Nothing in this section is meant to 

supersede or preempt incident response 

requirements imposed by other statutes or 

regulations. 

■ 14. Amend § 331.15 by: 

■ a. In paragraph (d), revising the last 

sentence; and 

■ b. In paragraph (e), removing the 

words ‘‘and document.’’ 

The addition reads as follows: 

§ 331.15 Training. 

* * * * * 

(d) * * * The record must include the 

name of the individual who received the 

training, the date of the training, a 

description of the training provided, 

and the means used to verify that the 

individual understood the training. 

* * * * * 

§ 331.16 [Amended] 

■ 15. Amend § 331.16, in paragraph (a), 

by redesignating footnote 7 as footnote 

1. 

■ 16. Amend § 331.17 by: 

■ a. Revising paragraphs (a)(1), (3), and 

(8); 

■ b. Removing the last sentence in 

paragraph (c); and 

■ c. Adding paragraph (d). 

The revisions and addition read as 

follows: 

§ 331.17 Records. 

(a) * * * 

(1) An accurate, current inventory for 

each select agent (including viral 

genetic elements, recombinant and/or 

synthetic nucleic acids, and organisms 

containing recombinant and/or 

synthetic nucleic acids) held in longterm storage (placement in a system 

designed to ensure viability for future 

use, such as in a freezer or lyophilized 

materials), including: 

(i) The name and characteristics (e.g., 

strain designation, GenBank Accession 

number); 

(ii) The quantity acquired from 

another individual or entity (e.g., 

containers, vials, tubes), date of 

acquisition, by whom, and the source; 

(iii) Location where it is stored (e.g., 

building, room number or name, and 

freezer identification or other storage 

container); 

(iv) The date the agent was removed 

and returned, the purpose for using the 

agent, the name of the individual who 

removed and returned the agent, and 

when applicable, date of final 

disposition of the agent and by whom; 

(v) Records created under § 331.16; 

(vi) For intra-entity transfers (sender 

and the recipient are covered by the 

same certificate of registration), name of 

the select agent, the date of the transfer, 

the number of items transferred, the 

name of the sender, and the name of the 

recipient; and 

(vii) Records created under § 331.19. 

* * * * * 

(3) Accurate, current inventory for 

each toxin held, including: 

(i) The name and characteristics; 

(ii) The quantity acquired from 

another individual or entity (e.g., 

containers, vials, tubes, volume 

including concentration), date of 

acquisition, by whom, and the source; 

(iii) The initial and current amount 

(e.g., milligrams, milliliters, grams); 

(iv) Location where the toxin is stored 

(e.g., building, room number or name, 

and freezer identification or other 

storage container); 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5813 

(v) When the toxin was accessed, the 

name of the toxin, the location where 

the toxin was accessed, the date the 

toxin was accessed, the purpose for 

accessing the toxin, the name of the 

individual accessing the toxin, the date 

the toxin was returned back to storage, 

the name of the individual returning the 

toxin back to storage, and date of final 

disposition of the toxin and by whom; 

(vi) Records created under § 331.16; 

(vii) For intra-entity transfers (sender 

and the recipient are covered by the 

same certificate of registration), name of 

the toxin, the date of the transfer, the 

number of vials or quantity of toxin 

transferred, the name of the sender, and 

the name of the recipient; and 

(viii) Records created under § 331.19. 

* * * * * 

(8) For select agents or material 

containing select agents or regulated 

nucleic acids that can produce 

infectious forms of any select agent 

virus that have been subjected to a 

validated inactivation procedure or a 

validated viable select agent removal 

procedure: 

(i) A written description of the 

validated inactivation procedure or 

validated viable select agent removal 

procedure used, including validation 

data; 

(ii) A written description of the 

viability testing protocol used; 

(iii) A written description of the 

investigation conducted by the entity’s 

responsible official involving a 

validated inactivation or validated 

viable select agent removal failure and 

the corrective actions taken; 

(iv) The name of each individual 

performing the validated select agent 

inactivation or validated viable select 

agent removal; 

(v) The date(s) the validated 

inactivation or validated viable select 

agent removal was completed; 

(vi) The location where the validated 

inactivation or validated viable select 

agent removal was performed; and 

(vii) A signed certificate that must: 

(A) Include the date(s) the validated 

inactivation or validated viable select 

agent removal was completed. 

(B) Include the validated inactivation 

procedure or validated viable select 

agent removal procedure used. 

(C) Include the name of the principal 

investigator. 

(D) Include an attestation statement 

certifying that the information on the 

certificate is true, complete, and 

accurate, and that the validated 

inactivation or validated viable select 

agent removal was performed as 

described in paragraph (a)(8)(i) of this 

section. 

(E) Be signed by the principal 

investigator or designee within 7 days 

after completion of the validated 

inactivation or validated viable select 

agent removal. Such designee must be 

listed on the entity’s registration and 

have the knowledge and expertise to 

provide scientific and technical 

direction regarding the validated 

inactivation procedure or the validated 

viable select agent removal procedure to 

which the certificate refers. 

(F) Be maintained for as long as the 

material is in the possession of the 

registered individual or entity plus an 

additional 3 years. 

(G) A copy of the certificate must 

accompany all transfers of inactivated or 

select agent removed material including 

intra-entity transfers. 

* * * * * 

(d) All records created in accordance 

with the regulations of this part must be 

maintained for 3 years unless otherwise 

stated. 

§ 331.19 [Amended] 

■ 17. Amend § 331.19, in paragraphs 

(a)(1) introductory text and (b)(1) 

introductory text, by removing the 

words ‘‘telephone, facsimile, or e-email’’ 

and adding the words ‘‘eFSAP 

information system, telephone, or 

email’’ in their place. 

TITLE 9—ANIMALS AND ANIMAL 

PRODUCTS 

PART 121—POSSESSION, USE, AND 

TRANSFER OF SELECT AGENTS AND 

TOXINS 

■ 18. The authority citation for part 121 

continues to read as follows: 

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

and 371.4. 

■ 19. Amend § 121.1 by: 

■ a. Adding in alphabetical order 

definitions for ‘‘Discovery’’, ‘‘Loss’’, 

‘‘Release’’, and ‘‘Theft’’; 

■ b. Revising the definition of 

‘‘Validated inactivation procedure’’; 

■ c. Adding in alphabetical order 

definitions for ‘‘Validated removal 

procedure’’ and ‘‘Verification viability 

testing protocol’’; and 

■ d. Revising the definition of ‘‘Viability 

testing protocol’’. 

The additions and revisions read as 

follows: 

§ 121.1 Definitions. 

* * * * * 

Discovery. The finding of a select 

agent or toxin by an individual or entity 

that is not aware of the select agent or 

toxin’s existence. Examples include, but 

are not limited to the following: 

(1) A registered individual or entity 

finds a select agent or toxin not 

accounted for in their inventory; or 

(2) A non-registered individual or 

entity finds a select agent or toxin. 

* * * * * 

Loss. The inability to account for a 

select agent or toxin known to be in the 

individual or entity’s possession. 

* * * * * 

Release means any of the following: 

(1) An incident resulting in 

occupational exposure to a select agent 

or toxin; 

(2) An incident resulting in animal/ 

plant exposure to a select agent or toxin; 

(3) The failure of equipment used to 

contain a select agent or toxin such that 

it is reasonably anticipated that a select 

agent of toxin was released; 

(4) The failure of or breach in 

personal protective equipment in the 

presence of a select agent or toxin; or 

(5) The failure of biosafety procedures 

such that it is reasonably anticipated 

that a select agent or toxin was outside 

of containment. 

* * * * * 

Theft. The unauthorized taking and 

removing of a select agent or toxin from 

the possession of an entity or 

individual. 

* * * * * 

Validated inactivation procedure. A 

procedure, whose efficacy has been 

confirmed by data generated from an inhouse viability testing protocol, to 

render a select agent non-viable but 

allows the select agent to retain 

characteristics of interest for future use; 

or to render any nucleic acids that can 

produce infectious forms of any select 

agent virus non-infectious for future 

use. 

Validated removal procedure. A 

procedure, whose efficacy has been 

confirmed by data generated in-house 

from a viability testing protocol, to 

confirm removal of all viable select 

agent, or nucleic acids of any select 

agent virus capable of producing 

infectious virus. 

* * * * * 

Verification viability testing protocol. 

A protocol, used on samples that have 

been subjected to a validated 

inactivation or removal procedure, to 

confirm the material is free of all viable 

select agent, or nucleic acids of any 

select agent virus capable of producing 

infectious virus. 

Viability testing protocol. A protocol 

to confirm the efficacy of the 

inactivation or removal procedure by 

demonstrating the material is free of all 

viable select agent. 

* * * * * 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5814 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

■ 20. Revise § 121.2 to read as follows: 

§ 121.2 Purpose and scope. 

(a) This part implements the 

provisions of the Agricultural 

Bioterrorism Protection Act of 2002 

setting forth the requirements for 

possession, use, and transfer of select 

agents and toxins. The biological agents 

and toxins listed in this part have the 

potential to pose a severe threat to 

public health and safety, to animal 

health, or to animal products. Overlap 

select agents and toxins are subject to 

regulation by both APHIS and CDC. 

(b) Any individual or entity in 

possession of a select agent or toxin, for 

which an exclusion or exemption listed 

in this part does not apply, and that is 

not included on a certificate of 

registration issued by the Administrator 

or HHS Secretary for that individual or 

entity, must immediately report such 

possession to the either the 

Administrator or HHS Secretary by the 

submission of an APHIS/CDC Form 6. 

■ 21. Amend § 121.3 by: 

■ a. Revising paragraphs (b) and (d)(1), 

(4), (5), and (6); 

■ b. Redesignating paragraphs (d)(7) 

through (9) as paragraphs as (d)(8) 

through (10) and adding a new 

paragraph (d)(7); 

■ c. In newly redesignated paragraph 

(d)(9), removing the words ‘‘of the 

conclusion of patient care’’ and adding 

the words ‘‘from when the individual 

has been released from the medical 

facility where treatment was being 

provided’’ in their place; 

■ d. In newly redesignated paragraph 

(d)(10), revising footnotes 4 and 5; 

■ e. In paragraph (e)(1), removing the 

words ‘‘National Select Agent Registry 

website’’ and adding the words ‘‘Federal 

Select Agent Program website’’ in their 

place; and 

■ f. In paragraph (f)(3)(i), removing the 

words ‘‘telephone, facsimile, or email’’ 

and adding the words ‘‘eFSAP 

information system, telephone, or 

email’’ in their place, and removing the 

words ‘‘(highly pathogenic)’’ and 

‘‘virulent’’. 

The revisions and addition read as 

follows: 

§ 121.3 VS select agents and toxins. 

* * * * * 

(b) VS select agents and toxins: 

African swine fever virus; Avian 

influenza virus; Classical swine fever 

virus; * Foot-and-mouth disease virus; 

Goat pox virus; Lumpy skin disease 

virus; Mycoplasma capricolum; 

Mycoplasma mycoides; Newcastle 

disease virus; 1 Peste des petits 

ruminants virus; * Rinderpest virus; 

Sheep pox virus; Swine vesicular 

disease virus. 

* * * * * 

(d) * * * 

(1) Any VS select agent or toxin that 

is in its naturally occurring 

environment, provided that the agent or 

toxin has not been intentionally 

introduced, cultivated, collected, or 

otherwise extracted from its natural 

source. Except for, 

(i) Removal of an animal which is 

naturally infected with a select agent 

from its natural environment to an 

artificially established environment for 

the purpose of the intentional exposure 

or introduction of a select agent to a 

naı ̈ve or experimental animal; or 

(ii) the introduction of a naı ̈ve animal 

to a natural environment where there is 

an animal which is naturally infected 

with a select agent for the purpose of the 

intentional exposure or introduction of 

a select agent to the naı ̈ve or 

experimental animal. 

* * * * * 

(4) A select agent or regulated nucleic 

acids that can produce infectious forms 

of any select agent virus that has been 

subjected to a validated inactivation 

procedure, provided that: 

(i) In-house validation of the 

inactivation procedure is completed 

prior to use; 

(ii) A certificate of inactivation has 

been generated in accordance with 

§ 121.17(a)(8). 

(iii) For use of a select agent surrogate 

to validate an inactivation procedure: 

(A) Select agent surrogates must be 

known to possess equivalent properties 

with respect to inactivation; 

(B) If there are known variations in 

the resistance of a select agent to an 

inactivation procedure, including strain 

to strain, then an inactivation procedure 

must also be validated using the most 

resistant select agent surrogate. 

(iv) For use of whole tissue or 

homogenized tissue surrogate to 

validate a chemical inactivation 

procedure for other tissues including 

those in other animal models: 

(A) All standardized conditions must 

be held constant such as the select agent 

used, tissue volume, and ratio of tissue 

to volume of inactivating chemical; 

(B) A safety margin must be 

incorporated into the final chemical 

inactivation procedure to ensure the 

effective inactivation of the select agent; 

(C) The tissue surrogate must meet 

one of the following criteria: 

(1) The tissue is expected to have the 

highest concentration of the specific 

select agent to be inactivated; or 

(2) The concentration of the select 

agent in the tissue must be determined 

and this select agent concentration must 

not be exceeded when applying the 

validated inactivation procedure on 

subsequent tissue samples. 

(5) Material containing a select agent 

that is subjected to a validated viable 

select agent removal procedure that has 

rendered the material free of all viable 

select agent provided that: 

(i) In-house validation of the viable 

select agent removal procedure is 

completed prior to use; 

(ii) A certificate of viable select agent 

removal has been generated in 

accordance with § 121.17(a)(8); 

(iii) For use of a surrogate to validate 

a viable select agent removal procedure, 

only surrogates known to possess 

equivalent properties with respect to 

removal are used; 

(iv) A portion of each subsequent 

sample has been subjected to a 

verification viability testing protocol to 

ensure that the validated viable select 

agent removal procedure has rendered 

the material free of all viable select 

agent. 

(6) A select agent or regulated nucleic 

acids that can produce infectious forms 

of any select agent virus not subjected 

to a validated inactivation procedure or 

material containing a select agent not 

subjected to a validated viable select 

agent removal procedure that removes 

all viable select agent cells, spores, or 

virus particles if the material is 

determined by the Administrator to be 

effectively inactivated or effectively free 

of select agents. To apply for a 

determination, an individual or entity 

must submit a written request and 

supporting scientific information to 

APHIS. A written decision granting or 

denying the request will be issued. 

(7) Any select agent or regulated 

nucleic acids that can produce 

infectious forms of any select agent 

virus contained in a formalin-fixed 

paraffin-embedded (FFPE) tissue if the 

FFPE process used is a recognized 

procedure for that particular select agent 

or regulated nucleic acids. 

* * * * * 1A virulent Newcastle disease virus (avian 

paramyxovirus type 1) has an intracerebral 

pathogenicity index in day-old chicks (Gallus 

gallus) of 0.7 or greater, or has an amino acid 

sequence at the fusion (F) protein cleavage 

that is consistent with virulent strains of 

Newcastle disease virus and phenylalanine at 

residue 117 of the F1 protein N-terminus, 

except for genotype VI viruses from columbid 

birds. 

* * * * * 4An avian paramyxovirus type 1 virus 

(APMV–1) isolated from poultry which has 

an intracerebral pathogenicity index in dayold chicks (Gallus gallus) of 0.7 or greater or 

has an amino acid sequence at the fusion (F) 

protein cleavage that is consistent with 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5815 

virulent strains of Newcastle disease virus 

and phenylalanine at residue 117 of the F1 

protein N-terminus, except for genotype VI 

viruses from columbid birds. 5Pigeon paramyxovirus (PPMV–1) is a 

species-adapted APMV–1 virus which is 

endemic in pigeons and doves in the United 

States and can be identified through 

demonstration of the characteristic amino 

acid signature at the fusion gene cleavage site 

along with accompanying phylogenetic 

analysis confirming classification as a 

PPMV–1. 

■ 22. Amend § 121.4 by: 

■ a. Revising paragraph (b); 

■ b. In paragraph (c)(1), redesignating 

footnote 6 as footnote 1; 

■ c. Revising paragraph (d)(1); 

■ d. In paragraph (d)(2), redesignating 

footnote 7 as footnote 2; 

■ e. Revising paragraphs (d)(4) through 

(6); 

■ f. Redesignating paragraphs (d)(7) 

through (9) as paragraphs as (d)(8) 

through (10) and adding a new 

paragraph (d)(7); 

■ g. In newly redesignated paragraph 

(d)(9), removing the words ‘‘of the 

conclusion of patient care’’ and adding 

the words ‘‘from when the individual 

has been released from the medical 

facility where treatment was being 

provided’’ in their place; 

■ h. In paragraph (e)(1), removing the 

words ‘‘National Select Agent Registry 

website’’ and adding the words ‘‘Federal 

Select Agent Program website’’ in their 

place in the last sentence; 

■ i. Revising paragraph (f)(3)(i); 

■ j. In paragraph (f)(3)(iii), adding the 

words ‘‘not submitted through eFSAP 

Information System’’ between the words 

‘‘APHIS/CDC Form 4’’ and ‘‘must’’; and 

■ k. In paragraph (f)(4), adding the 

words ‘‘not submitted through eFSAP 

information system’’ between the words 

‘‘form’’ and ‘‘must’’ in the last sentence. 

The revisions and addition read as 

follows: 

§ 121.4 Overlap select agents and toxins. 

* * * * * 

(b) Overlap select agents and toxins: 

* Bacillus anthracis; Bacillus anthracis 

(Pasteur strain); * Burkholderia mallei; 

* Burkholderia pseudomallei; Hendra 

virus; * Nipah virus; and Rift Valley 

fever virus; and Venezuelan equine 

encephalitis virus. 

* * * * * 

(d) * * * 

(1) Any overlap select agent or toxin 

that is in its naturally occurring 

environment, provided that the agent or 

toxin has not been intentionally 

introduced, cultivated, collected, or 

otherwise extracted from its natural 

source. Except for, 

(i) Removal of an animal which is 

naturally infected with a select agent 

from its natural environment to an 

artificially established environment for 

the purpose of the intentional exposure 

or introduction of a select agent to a 

naı ̈ve or experimental animal; or 

(ii) The introduction of a naı ̈ve animal 

to a natural environment where there is 

an animal which is naturally infected 

with a select agent for the purpose of the 

intentional exposure or introduction of 

a select agent to the naı ̈ve or 

experimental animal. 

* * * * * 

(4) A select agent or regulated nucleic 

acids that can produce infectious forms 

of any select agent virus that has been 

subjected to a validated inactivation 

procedure, provided that: 

(i) In-house validation of the 

inactivation procedure is completed 

prior to use; 

(ii) A certificate of inactivation has 

been generated in accordance with 

§ 121.17(a)(8); 

(iii) For use of a select agent surrogate 

to validate an inactivation procedure: 

(A) Select agent surrogates must be 

known to possess equivalent properties 

with respect to inactivation; 

(B) If there are known variations in 

the resistance of a select agent to an 

inactivation procedure, including strain 

to strain, then an inactivation procedure 

must also be validated using the most 

resistant select agent surrogate. 

(iv) For use of a whole tissue or 

homogenized tissue surrogate to 

validate a chemical inactivation 

procedure for other tissues, including 

those in other animal models: 

(A) All standardized conditions must 

be held constant, such as the select 

agent used, tissue volume, and ratio of 

tissue to volume of inactivating 

chemical; 

(B) A safety margin must be 

incorporated into the final chemical 

inactivation procedure to ensure the 

effective inactivation of the select agent; 

(C) The tissue surrogate must meet the 

following criteria: 

(1) The tissue is expected to have the 

highest concentration of the specific 

select agent to be inactivated; or 

(2) The concentration of the select 

agent in the tissue must be determined 

and this select agent concentration must 

not be exceeded when applying the 

validated inactivation procedure on 

subsequent tissue samples. 

(5) Material containing a select agent 

that is subjected to a validated viable 

select agent removal procedure that has 

rendered the material free of all viable 

select agent provided that: 

(i) In-house validation of the viable 

select agent removal procedure is 

completed prior to use; 

(ii) A certificate of viable select agent 

removal has been generated in 

accordance with § 121.17(a)(8); 

(iii) For use of a surrogate to validate 

a viable select agent removal procedure, 

only surrogates known to possess 

equivalent properties with respect to 

removal are used; 

(iv) A portion of each subsequent 

sample has been subjected to a 

verification viability testing protocol to 

ensure that the validated viable select 

agent removal procedure has rendered 

the material free of all viable select 

agent. 

(6) A select agent or regulated nucleic 

acids that can produce infectious forms 

of any select agent virus not subjected 

to a validated inactivation procedure or 

material containing a select agent not 

subjected to a validated viable select 

agent removal procedure that removes 

all viable select agent cells, spores, or 

virus particles if the material is 

determined by the Administrator or 

HHS Secretary to be effectively 

inactivated or effectively removed. To 

apply for a determination, an individual 

or entity must submit a written request 

and supporting scientific information to 

APHIS or CDC. A written decision 

granting or denying the request will be 

issued. 

(7) Any select agent or regulated 

nucleic acids that can produce 

infectious forms of any select agent 

virus contained in a formalin-fixed 

paraffin-embedded (FFPE) tissue if the 

FFPE process used is a recognized 

procedure for that particular select agent 

or regulated nucleic acids. 

* * * * * 

(f) * * * 

(3) * * * 

(i) The seizure of any Tier 1 overlap 

select agents and toxins must be 

reported within 24 hours by eFSAP 

information system, telephone, or email, 

or email. This report must be followed 

by submission of APHIS/CDC Form 4 

within 7 calendar days after seizure of 

the overlap select agent or toxin. 

* * * * * 

■ 23. Amend § 121.5 by: 

■ a. Revising paragraphs (a) 

introductory text and (a)(1); 

■ b. In paragraph (a)(3), removing the 

words ‘‘delivery of patient care by 

health care professionals has 

concluded’’ and adding the words ‘‘the 

individual has been released from the 

medical facility where treatment was 

being provided’’ in their place; 

■ c. In paragraph (a)(4), removing the 

words ‘‘by telephone, facsimile, or 

email’’ and adding the words ‘‘through 

the eFSAP information system, 

telephone, or email’’ in their place in 

the first sentence; 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5816 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

■ d. Adding paragraphs (a)(4)(i) and (ii); 

■ e. Revising paragraph (b)(1); and 

■ f. In paragraph (b)(3), adding the 

words ‘‘not submitted through eFSAP 

information system’’ between the words 

‘‘form’’ and ‘‘must’’ in the last sentence. 

The revisions and additions read as 

follows: 

§ 121.5 Exemptions for VS select agents 

and toxins. 

(a) Clinical or diagnostic laboratories 

and other entities that possess, use, or 

transfer a VS select agent or toxin that 

is contained in a specimen presented for 

diagnosis or verification will be exempt 

from the requirements of this part for 

such agent or toxin contained in the 

specimen, provided that: 

(1) Unless directed otherwise by the 

Administrator, within 7 calendar days 

after identification of the select agent or 

toxin, the select agent or toxin is 

transferred in accordance with § 121.16 

or destroyed on-site by a recognized 

sterilization process or inactivated for 

future use in accordance with 

§ 121.3(d)(4). 

* * * * * 

(4) * * * 

(i) The identification of VS Tier 1 

select agents or toxins must be 

immediately reported through the 

eFSAP information system, telephone, 

or email. This report must be followed 

by submission of APHIS/CDC Form 4 

within 7 calendar days after 

identification. 

(ii) [Reserved] 

(b) * * * 

(1) Unless directed otherwise by the 

Administrator, within 90 calendar days 

of receipt, the select agent or toxin is 

transferred in accordance with § 121.16 

or destroyed on-site by a recognized 

sterilization process or inactivated for 

future use in accordance with 

§ 121.3(d)(4). 

* * * * * 

■ 24. Amend § 121.6 by: 

■ a. Revising paragraph (a)(1); 

■ b. In paragraph (a)(3), removing the 

words ‘‘delivery of patient care by 

health care professionals has 

concluded’’ and adding the words ‘‘the 

individual has been released from the 

medical facility where treatment was 

being provided’’ in their place; 

■ c. In paragraph (a)(4), removing the 

words ‘‘by telephone, facsimile, or 

email’’ and adding the words ‘‘through 

the eFSAP information system, 

telephone, or email’’ in their place in 

the first sentence; 

■ d. Adding paragraphs (a)(4)(i) through 

(iv); 

■ e. Revising paragraph (b)(1); and 

■ f. In paragraph (b)(3), adding the 

words ‘‘not submitted through eFSAP 

information system’’ between the words 

‘‘form’’ and ‘‘must’’ in the last sentence. 

The revisions and additions read as 

follows: 

§ 121.6 Exemptions for overlap select 

agents and toxins. 

(a) * * * 

(1) Unless directed otherwise by the 

Administrator or HHS Secretary, within 

7 calendar days after identification, the 

select agent or toxin is transferred in 

accordance with § 121.16 or 42 CFR 

73.16 or destroyed on-site by a 

recognized sterilization process, or 

inactivated for future use in accordance 

with § 121.4(d)(4); 

* * * * * 

(4) * * * 

(i) The identification of any of the 

following overlap select agents or toxins 

must be immediately reported by 

telephone or email: Bacillus anthracis, 

Burkholderia mallei and Burkholderia 

pseudomallei. This report must be 

followed by submission of APHIS/CDC 

Form 4 within 7 calendar days after 

identification. 

(ii) For all other overlap select agents 

or toxins, APHIS/CDC Form 4 must be 

submitted within 7 calendar days after 

identification. 

(iii) Less stringent reporting may be 

required during agricultural 

emergencies or outbreaks, or in endemic 

areas. 

(iv) A copy of APHIS/CDC Form 4 

must be maintained for 3 years. 

(b) * * * 

(1) Unless directed otherwise by the 

Administrator or HHS Secretary, within 

90 calendar days of receipt, the select 

agent or toxin is transferred in 

accordance with § 121.16 or 42 CFR 

73.16 or destroyed on-site by a 

recognized sterilization process or 

inactivated for future use in accordance 

with § 121.4(d)(4); 

* * * * * 

■ 25. Amend § 121.7 by: 

■ a. In paragraph (d)(3) introductory 

text, redesignating footnote 8 as footnote 

1; 

■ b. In paragraph (f), removing the 

words ‘‘the relevant page(s) of’’ and 

adding the words ‘‘information related 

to’’ in their place; 

■ c. Revising paragraph (g); 

■ d. In paragraph (i) introductory text, 

removing the word ‘‘may’’ and adding 

the word ‘‘must’’ in its place, and 

removing the word ‘‘circumstances’’ and 

adding the words ‘‘the possession and 

use of the select agents and toxins’’ in 

its place; and 

■ e. In paragraph (i)(1), removing the 

words ‘‘the relevant page(s) of’’ and 

adding the words ‘‘information related 

to’’ in their place and removing footnote 

9. 

The revision reads as follows: 

§ 121.7 Registration and related security 

risk assessments. 

* * * * * 

(g) The issuance of a certificate of 

registration may be contingent upon 

inspection and submission of additional 

information to include any or all of the 

following: the security plan, biosafety 

plan, incident response plan, or any 

other documents related to the 

requirements of this part. 

* * * * * 

§ 121.8 [Amended] 

■ 26. Amend § 121.8, in paragraph 

(a)(3), by redesignating footnote 10 as 

footnote 1. 

■ 27. Amend § 121.9 by: 

■ a. Redesignating paragraphs (a)(5) 

through (9) as paragraphs (a)(6) through 

(10) and adding a new paragraph (a)(5); 

■ b. Revising newly redesignated 

paragraphs (a)(7), (9), and (10); 

■ c. Adding a new second sentence to 

paragraph (b); 

■ d. Revising paragraph (c)(1); and 

■ e. In paragraphs (c)(2) and (d), adding 

the words ‘‘not submitted through 

eFSAP information system’’ between the 

words ‘‘form’’ and ‘‘must’’ in the last 

sentence. 

The addition and revisions read as 

follows: 

§ 121.9 Responsible official. 

(a) * * * 

(5) Not be approved as responsible 

official or alternate responsible official 

at another registered entity. 

* * * * * 

(7) Ensure that annual inspections are 

conducted for each registered space to 

determine compliance with the 

requirements in accordance with the 

regulations of this part. The results of 

each inspection must be documented, 

and any deficiencies identified during 

an inspection must be corrected and the 

corrections documented. The annual 

inspection must address whether: 

(A) The entity’s biosafety/ 

biocontainment plan is being effectively 

implemented as outlined in § 121.12. 

(B) The entity’s security plan is being 

effectively implemented as outlined in 

§ 121.11. 

(C) The entity’s incident response 

plan is implemented to ensure whether 

the entity is able to respond, as outlined 

in § 121.14. 

(D) Each individual with access 

approval from the Administrator or HHS 

Secretary has received the appropriate 

training as outlined in § 121.15. 

* * * * * 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5817 

(9) Investigate to determine the reason 

for any failure of a validated 

inactivation or validated viable select 

agent removal procedure to render 

material free from viable select agent. If 

the responsible official is unable to 

determine the cause of the failure from 

a validated inactivation or validated 

viable select agent removal procedure or 

receives a report of any inactivation 

failure after the movement of material to 

another location, the responsible official 

must report immediately through the 

eFSAP information system, telephone, 

or email the inactivation or viable select 

agent removal procedure failure to 

APHIS or CDC. 

(10) Review each of the entity’s 

validated select agent inactivation 

procedure or validated viable select 

agent removal procedure and ensure 

they are revised as necessary. The 

review must be conducted annually or 

after any change in principal 

investigator, change in the validated 

inactivation or validated viable select 

agent removal procedure, or failure of 

the validated inactivation or validated 

viable select agent removal procedure. 

The review must be documented, and 

training must be conducted if there are 

any changes to the validated select agent 

inactivation or validated viable select 

agent removal procedure, or viability 

testing protocol. 

(b) * * * An alternate responsible 

official can serve at multiple registered 

entities. * * * 

* * * * * 

(c) * * * 

(1) The identification of any of the 

following select agents or toxins must be 

immediately reported through the 

eFSAP information system, telephone, 

or email: African swine fever virus, 

avian influenza virus, Bacillus 

anthracis, Burkholderia mallei, 

Burkholderia pseudomallei, classical 

swine fever virus, foot-and-mouth 

disease virus, Newcastle disease virus, 

rinderpest virus, or swine vesicular 

disease virus. The final disposition of 

the agent or toxin must be reported by 

submission of APHIS/CDC Form 4 

within 7 calendar days after 

identification. A copy of the completed 

form must be maintained for 3 years. 

* * * * * 

§ 121.10 [Amended] 

■ 28. Amend § 121.10 by: 

■ a. In paragraph (c), removing the 

words ‘‘to select agents or toxins’’ and 

adding the words ‘‘approval from the 

Administrator or HHS Secretary’’ in 

their place; and 

■ b. In paragraph (h), removing the text 

‘‘(f)(2) through (f)(3)’’ and adding the 

text ‘‘(g)(2) through (3)’’ in its place. 

■ 29. Amend § 121.11 by: 

■ a. Redesignating paragraphs (c)(9) and 

(10) as paragraphs (c)(11) and (12) and 

adding new paragraphs (c)(9) and (10); 

■ b. In paragraph (d)(4), removing the 

words ‘‘an area where select agents or 

toxins are used or stored’’ and adding 

the words ‘‘registered space’’ in their 

place; 

■ c. In paragraph (f) introductory text, 

removing the word ‘‘possessing’’ and 

adding the words ‘‘registered for’’ in 

their place; 

■ d. Revising paragraph (f)(4)(iii); 

■ e. In paragraph (f)(5)(iii), removing the 

‘‘CCTV’’ and adding the word ‘‘Video’’ 

in its place; and 

■ f. Removing paragraph (g) and 

redesignating paragraph (h) as 

paragraph (g). 

The additions and revision read as 

follows: 

§ 121.11 Security. 

* * * * * 

(c) * * * 

(9) Describe procedures for 

conducting a pre-access suitability 

assessment of persons prior to seeking 

access approval for a Tier 1 select agent 

or toxin; 

(10) Describe procedures to prevent 

the theft, loss, release, or unauthorized 

access to a select agent or toxin from an 

effluent decontamination system 

originating from a registered laboratory. 

* * * * * 

(f) * * * 

(4) * * * 

(iii) Procedures for screening any 

visitors, their property, and, where 

appropriate, vehicles at entry points to 

registered space based on the entity’s 

site-specific risk assessment; 

* * * * * 

■ 30. Amend § 121.12 by: 

■ a. In paragraph (a) introductory text, 

redesignating footnote 11 as footnote 1; 

■ b. In paragraph (c)(1), removing the 

words ‘‘National Select Agent Registry’’ 

and adding the words ‘‘Federal Select 

Agent Program website’’ in their place; 

■ c. In paragraph (c)(2), removing the 

words ‘‘the internet’’ and adding the 

words ‘‘the Federal Select Agent 

Program website’’; 

■ d. Revising paragraph (d); and 

■ e. Adding paragraphs (f), (g), and (h). 

The revision and additions read as 

follows: 

§ 121.12 Biosafety. 

* * * * * 

(d) The biosafety plan must include 

an occupational health plan for 

individuals listed on the entity’s 

registration for access to Tier 1 select 

agents and toxins, and those individuals 

must be enrolled in the occupational 

health plan. 

* * * * * 

(f) When an effluent decontamination 

system is used, the plan must provide 

for verification that the liquid waste 

generated from registered space is 

sufficiently treated to prevent the 

release of a select agent or toxin prior 

to discharge of the waste from the 

facility. 

(1) For a new effluent 

decontamination system, verification is 

required before initial use. 

(2) For an effluent decontamination 

system in place, verification is required 

at least once every 12 months and 

following any major change to the 

effluent decontamination system. 

(3) The verification must be 

documented. 

(g) When an effluent decontamination 

system is used, the plan must provide 

that monthly routine maintenance is 

conducted of the effluent 

decontamination system, including at a 

minimum verification that: 

(1) Alarms are functioning according 

to established specifications; 

(2) Piping, pumps, valves, and tanks 

are not leaking; and 

(3) Methods used to monitor and 

record performance measurements are 

functioning according to established 

specifications. 

(h) An individual or entity must 

document every 12 months the 

following facility verification 

requirements for registered biosafety 

level 3 and animal biosafety level 3 

laboratories. 

(1) Accuracy of devices that monitor 

directional air-flow; 

(2) Confirmation that 

decontamination systems (e.g., 

autoclave, room decontamination 

systems, digesters, liquid effluent 

decontamination systems) are operating 

to ensure the containment of the select 

agent and toxin; 

(3) Confirmation that systems are in 

place to monitor, maintain, and validate 

performance of mechanical systems to 

ensure that airflows and differential 

pressures are appropriate to maintain 

containment during normal/operational 

conditions; 

(4) Verification that the facility 

mechanical, electrical, and drain waste 

and ventilation systems responsible for 

containment are inspected, maintained, 

and function as designed by the 

manufacturer specifications; 

(5) Verification that the facility 

systems perform as intended in 

response to failure conditions as defined 

and tested during commissioning to 

prevent the release of a select agent or 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5818 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

toxin and verification of secondary 

containment: 

(i) Evaluate using work objectives, use 

of space, and facility infrastructure 

systems against the verified original 

design and standards (e.g., Biosafety in 

Microbiological and Biomedical 

Laboratories, NIH Design Requirements 

Manual). 

(ii) Implement controls and alarms to 

identify and alert personnel when 

systems fail, malfunction, or are unable 

to maintain containment during such an 

event. 

(6) Certification of laboratory 

ventilation system HEPA filters, if 

present; 

(7) Confirmation that room integrity 

has been evaluated and repairs are 

addressed (e.g., sealed penetrations); 

(8) Primary containment equipment is 

certified based on manufacturer’s 

specifications (or recommendations) 

(e.g., biological safety cabinets, flexible 

film isolators, animal caging); 

(9) Seals on centrifuges not used in 

primary containment have been checked 

and replaced if needed; and 

(10) Showers, eye wash stations, and 

hands-free sinks are operating properly. 

§ 121.13 [Amended] 

■ 31. Amend § 121.13, in paragraph (a) 

introductory text, by adding the words 

‘‘or transfer’’ after the word ‘‘possess’’. 

■ 32. Amend § 121.14 by: 

■ a. In the section heading, 

redesignating footnote 12 as footnote 1; 

■ b. In paragraph (a), redesignating 

footnote 13 as footnote 2; 

■ c. In paragraph (b), adding the words 

‘‘the failure of an effluent 

decontamination system resulting in a 

release of a select agent or toxin;’’ after 

the words ‘‘a select agent or toxin;’’; 

■ d. Revising paragraph (c); and 

■ e. In paragraph (e) introductory text, 

removing the words ‘‘Entities with’’ and 

adding the words ‘‘An individual or 

entity registered for’’ in their place. 

The revision reads as follows: 

§ 121.14 Incident response 1. 

* * * * * 

(c) The response procedures must 

account for hazards associated with the 

select agent or toxin and appropriate 

actions to contain such select agent or 

toxin in registered space including any 

animals (including arthropods) or plants 

intentionally or accidentally exposed to 

or infected with a select agent, or an 

effluent decontamination system 

originating from registered space. 

* * * * * 1Nothing in this section is meant to 

supersede or preempt incident response 

requirements imposed by other statutes or 

regulations. 

■ 33. Amend § 121.15 by: 

■ a. Adding paragraphs (a)(3) and (4); 

■ b. In paragraph (b), removing the 

words ‘‘Entities with’’ and adding the 

words ‘‘An individual or entity 

registered for’’ in their place; 

■ c. Revising paragraph (d); and 

■ d. In paragraph (e), by removing 

words ‘‘and document’’. 

The additions and revision read as 

follows: 

§ 121.15 Training. 

(a) * * * 

(3) Each individual not approved for 

access to HHS and overlap select agents 

and toxins by the HHS Secretary or 

APHIS Administrator whose 

responsibilities routinely place them in 

close proximity (e.g., shared laboratory 

space) to areas where select agents or 

toxins are transferred, possessed, or 

used. The training must be based on the 

particular needs of the individual and 

risks associated with working near areas 

where select agents and toxins are 

handled or stored. The training must 

also instruct each individual on the 

notification requirements related to 

select agents and toxins. Training must 

be accomplished prior to the 

individual’s close proximity to areas 

where select agents or toxins are 

handled or stored and refresher training 

must be provided annually. 

(4) Each individual not approved for 

access to HHS and overlap select agents 

and toxins by the HHS Secretary or 

APHIS Administrator who performs 

administrative or oversight functions of 

the facility related to the transfer, 

possession or use of such agents or 

toxins on behalf of the entity (e.g., 

administrative professionals, facility 

managers, etc.). The training must 

instruct each individual on the 

regulatory requirements relevant to their 

administrative or oversight functions. 

The training must also instruct each 

individual on the notification 

requirements related to select agents 

and toxins. Training must be 

accomplished prior to the individual 

performing these functions and 

refresher training must be provided 

annually. 

* * * * * 

(d) The Responsible Official must 

ensure a record of the training provided 

for each individual listed in paragraph 

(a) of this section is maintained. The 

record must include the name of the 

individual who received the training, 

the date of the training, a description of 

the training provided, and the means 

used to verify that the individual 

understood the training. 

* * * * * 

§ 121.16 [Amended] 

■ 34. Amend § 121.16, in paragraph (a), 

by redesignating footnote 14 as footnote 

1. 

■ 35. Amend § 121.17 by: 

■ a. Revising paragraphs (a)(1), (3), and 

(8); 

■ b. Removing the last sentence in 

paragraph (c); and 

■ c. Adding paragraph (d). 

The revisions and addition read as 

follows: 

§ 121.17 Records. 

(a) * * * 

(1) An accurate, current inventory for 

each select agent (including viral 

genetic elements, recombinant and/or 

synthetic nucleic acids, and organisms 

containing recombinant and/or 

synthetic nucleic acids) held in longterm storage (placement in a system 

designed to ensure viability for future 

use, such as in a freezer or lyophilized 

materials), including: 

(i) The name and characteristics (e.g., 

strain designation, GenBank Accession 

number); 

(ii) The quantity acquired from 

another individual or entity (e.g., 

containers, vials, tubes), date of 

acquisition, by whom, and the source; 

(iii) Location where it is stored (e.g., 

building, room number or name, and 

freezer identification or other storage 

container); 

(iv) The date the agent was removed 

and returned, the purpose for using the 

agent, the name of the individual who 

removed and returned the agent, and 

when applicable, date of final 

disposition of the agent and by whom; 

(v) Records created under § 121.16; 

(vi) For intra-entity transfers (sender 

and the recipient are covered by the 

same certificate of registration), name of 

the select agent, the date of the transfer, 

the number of items transferred, the 

name of the sender, and the name of the 

recipient; and 

(vii) Records created under § 121.19. 

* * * * * 

(3) Accurate, current inventory for 

each toxin held, including: 

(i) The name and characteristics; 

(ii) The quantity acquired from 

another individual or entity (e.g., 

containers, vials, tubes, volume 

including concentration), date of 

acquisition, by whom, and the source; 

(iii) The initial and current amount 

(e.g., milligrams, milliliters, grams); 

(iv) Location where the toxin is stored 

(e.g., building, room number or name, 

and freezer identification or other 

storage container); 

(v) When the toxin was accessed, the 

name of the toxin, the location where 

the toxin was accessed, the date the 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5819 

toxin was accessed, the purpose for 

accessing the toxin, the name of the 

individual accessing the toxin, the date 

the toxin was returned back to storage, 

the name of the individual returning the 

toxin back to storage, and date of final 

disposition of the toxin and by whom; 

(vi) Records created under § 121.16; 

(vii) For intra-entity transfers (sender 

and the recipient are covered by the 

same certificate of registration), name of 

the toxin, the date of the transfer, the 

number of vials or quantity of the toxin 

transferred, the name of the sender, and 

the name of the recipient; and 

(viii) Records created under § 121.19. 

* * * * * 

(8) For select agents or material 

containing select agents or regulated 

nucleic acids that can produce 

infectious forms of any select agent 

virus that have been subjected to a 

validated inactivation procedure or a 

validated viable select agent removal 

procedure: 

(i) A written description of the 

validated inactivation procedure or 

validated viable select agent removal 

procedure used, including validation 

data; 

(ii) A written description of the 

viability testing protocol used; 

(iii) A written description of the 

investigation conducted by the entity’s 

responsible official involving a 

validated inactivation or validated 

viable select agent removal failure and 

the corrective actions taken; 

(iv) The name of each individual 

performing the validated select agent 

inactivation or validated viable select 

agent removal; 

(v) The date(s) the validated 

inactivation or validated viable select 

agent removal was completed; 

(vi) The location where the validated 

inactivation or validated viable select 

agent removal was performed; and 

(vii) A signed certificate that must: 

(A) Include the date(s) the validated 

inactivation or validated viable select 

agent removal was completed. 

(B) Include the validated inactivation 

procedure or validated viable select 

agent removal procedure used. 

(C) Include the name of the principal 

investigator. 

(D) Include an attestation statement 

certifying that the information on the 

certificate is true, complete, and 

accurate, and that the validated 

inactivation or validated viable select 

agent removal was performed as 

described in paragraph (a)(8)(i) of this 

section. 

(E) Be signed by the principal 

investigator or designee within 7 days 

after completion of the validated 

inactivation or validated viable select 

agent removal. Such designee must be 

listed on the entity’s registration and 

have the knowledge and expertise to 

provide scientific and technical 

direction regarding the validated 

inactivation procedure or the validated 

viable select agent removal procedure to 

which the certificate refers. 

(F) Be maintained for as long as the 

material is in the possession of the 

registered individual or entity plus an 

additional 3 years. 

(G) A copy of the certificate must 

accompany all transfers of inactivated or 

select agent removed material including 

intra-entity transfers. 

* * * * * 

(d) All records created in accordance 

with the regulations of this part must be 

maintained for 3 years unless otherwise 

stated. 

§ 121.19 [Amended] 

■ 36. Amend § 121.19, in paragraphs 

(a)(1) introductory text and (b)(1) 

introductory text, by removing the 

words ‘‘telephone, facsimile, or email’’ 

and adding the words ‘‘eFSAP 

information system, telephone, or 

email’’ in their place. 

Done in Washington, DC, this 19th day of 

January 2024. 

Jennifer Moffitt, 

Undersecretary, Marketing and Regulatory 

Programs, USDA. 

[FR Doc. 2024–01501 Filed 1–26–24; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Highway Administration 

23 CFR Part 172 

[FHWA Docket No. FHWA–2023–0046] 

RIN 2125–AG12 

Procurement, Management, and 

Administration of Engineering and 

Design Related Services 

AGENCY: Federal Highway 

Administration (FHWA), U.S. 

Department of Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM); request for comments. 

SUMMARY: This proposed rule would 

update the regulations governing the 

procurement, management, and 

administration of engineering and 

design related services directly related 

to a highway construction project that is 

funded through a discretionary grant 

administered by FHWA. The intent of 

the proposed rule is to clarify how the 

regulations apply to recipients other 

than State transportation agencies 

(STA). This proposed rulemaking would 

also make technical changes and 

corrections to improve the 

administration of these regulations. 

DATES: Comments must be received on 

or before April 1, 2024. Late comments 

will be considered to the extent 

practicable. 

ADDRESSES: You may submit comments 

by any of the following methods: 

• Fax: (202) 493–2251; 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590; 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m. ET, Monday through Friday, 

except Federal holidays; or 

• Electronically through the Federal 

eRulemaking Portal: 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

FOR FURTHER INFORMATION CONTACT: Mr. 

John McAvoy, Consultant Services 

Program Manager, FHWA Office of 

Preconstruction, Construction, and 

Pavements, (202) 853–5593, or via email 

at john.mcavoy@dot.gov, or Mr. Lev 

Gabrilovich, Senior Attorney Advisor, 

FHWA Office of the Chief Counsel, 

(202) 366–3813, or via email at 

lev.gabrilovich@dot.gov. Office hours for 

the FHWA are from 8 a.m. to 4:30 p.m., 

ET, Monday through Friday, except 

Federal holidays. 

SUPPLEMENTARY INFORMATION: 

Electronic Access and Filing 

This document and all comments 

received may be viewed online through 

the Federal eRulemaking portal at 

www.regulations.gov. The website is 

available 24 hours each day, 366 days 

this year. Please follow the instructions. 

Electronic submission and retrieval help 

and guidelines are available under the 

help section of the website. 

An electronic copy of this document 

may also be downloaded by accessing 

the Office of the Federal Register’s home 

page at www.FederalRegister.gov, or the 

Government Printing Office’s website at 

www.GovInfo.gov. 

All comments received before the 

close of business on the comment 

closing date indicated above will be 

considered and will be available for 

examination in the docket at the above 

address. Comments received after the 

comment closing date will be filed in 

the docket and will be considered to the 

extent practicable. In addition to late 


khammond on DSKJM1Z7X2PROD with PROPOSALS