[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Proposed Rules]
[Pages 5795-5819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01501]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

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Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / 
Proposed Rules

[[Page 5795]]



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.

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SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are proposing to amend and republish the list of select 
agents and toxins that have the potential to pose a severe threat to 
animal or plant health, or to animal or plant products. 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:
    <bullet> 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.
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#4923282a2c22673d2827202c3e3a2220093c3a2d28672e263f"><span class="__cf_email__" data-cfemail="412b2022242a6f35202f282436322a2801343225206f262e37">[email protected]</span></a>.

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:
    <bullet> 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;
    <bullet> 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;

[[Page 5796]]

    <bullet> The availability and effectiveness of pharmacotherapies 
and prophylaxis to treat and prevent any illness caused by the agent or 
toxin;
    <bullet> 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
    <bullet> 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 Ag-ISATTAC 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:
    <bullet> 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.)
    <bullet> 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.)
    <bullet> 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-to-farm transmission risk, and effective 
quarantine procedures. (Center for Food Security and Public Health, 
2009; Moreno, E., 2014; Olsen, S.C., 2011.)
    <bullet> 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.)
    <bullet> 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

[[Page 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 non-registered 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:
    <bullet> A registered individual or entity finds a select agent or 
toxin not accounted for in their inventory; or
    <bullet> 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 Sec.  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 follow-up 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 na[iuml]ve or experimental animal, 
or the introduction of a na[iuml]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 na[iuml]ve or

[[Page 5798]]

experimental animal, does not meet the exclusion criteria. To provide 
an example, avian influenza virus is listed in Sec.  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 na[iuml]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:
    <bullet> In-house validation of the inactivation procedure is 
completed prior to use;
    <bullet> A certificate of inactivation (discussed below) has been 
generated in accordance with the regulations;
    <bullet> 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
    <bullet> 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, paraffin-embedded 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

[[Page 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:
    <bullet> In-house validation of the viable select agent removal 
procedure is completed prior to use;
    <bullet> A certificate of viable select agent removal (discussed 
below) has been generated in accordance with Sec.  121.17(a)(8) or 
Sec.  331.17(a)(8);
    <bullet> 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
    <bullet> 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:
    <bullet> An incident resulting in occupational exposure to a select 
agent or toxin;
    <bullet> An incident resulting in animal/plant exposure to a select 
agent or toxin;
    <bullet> 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;
    <bullet> The failure of or breach in personal protective equipment 
in the presence of a select agent or toxin; or
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> For intra-entity transfers (sender and the recipient are 
covered by the

[[Page 5800]]

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 
real-time 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.

[[Page 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:
    <bullet> 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).
    <bullet> The entity's security plan is being effectively 
implemented as outlined in the regulations (7 CFR 333.11 and 9 CFR 
121.11, respectively).
    <bullet> 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).
    <bullet> 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-and-mouth 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

[[Page 5802]]

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-and-mouth 
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 
LD<INF>50</INF> < 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

[[Page 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 Sec.  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, Sec.  121.11(f) requires pre-access 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-and-mouth 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 cost-benefit 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

[[Page 5804]]

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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> Loss, Release, and Theft: APHIS proposes to add 
definitions for the terms Loss, Release, and Theft.
    <bullet> 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 long-term 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> Annual Internal Inspections: We are proposing to codify 
current policy on what an entity's annual internal inspections must 
address.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 maximum-containment laboratories.
    <bullet> 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 benefit-cost 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

[[Page 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-and-mouth 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

[[Page 5806]]

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.

[[Page 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   <1,000 Employees    1,000+ Employees    <1,000 Employees    1,000+ Employees
 on Employment.                    small entities.     large entities.     small entities.     large entities.
541714 R&D in Biotechnology       438...............  2,671.............  $20.6 m...........  $24.5b.
 (commercial and non-profit)
 3,109 firms.
541715 R&D in the Life Sciences   0.................  8,019.............  $0................  $96.8.
 (commercial and non-profit)
 8,019 firms.
                                  <1,250 Employees..  1,250+ Employees..  <1,250 Employees..  1,250+ Employees.
325412 Pharmaceutical             494...............  513...............  $1.9b.............  $152.7b.
 Preparation.
325413 In-vitro Diagnostic        153...............  35................  $1b...............  $12.6b.
 Substance.
325414 Biological Product         197...............  67................  $1.4b.............  $29.2b.
 (except Diagnostic).
----------------------------------------------------------------------------------------------------------------
SBA Small-entity Standard based   <$8 million in      $8 million+ in      <$8 million in      $8 million+ in
 on Annual Receipts.               Receipts            Receipts            Receipts.           Receipts.
                                   employees.          employees.
541940 Veterinary Services 42 b   0.................  28,291............  $0................  $42.1 b.
 receipts.
----------------------------------------------------------------------------------------------------------------
SBA Small-entity Standard based   <$35 million in     $35 million+ in     <$35 million in     $35 million+ in
 on Annual Receipts.               Receipts            Receipts            Receipts.           Receipts.
                                   employees.          employees.
621511 Medical Laboratories       438...............  2,927.............  $22.m.............  $35.6b.
 35.6b.
----------------------------------------------------------------------------------------------------------------
SBA Small-entity Standard based   <$30 million in     $30 million+ in     <$30 million in     $30 million+ in
 on Annual Receipts.               Receipts            Receipts            Receipts.           Receipts.
                                   employees.          employees.
611310 Colleges, Universities,    168...............  2,265.............  7.9 m.............  255.6 b.
 and Professional Schools.
----------------------------------------------------------------------------------------------------------------
SBA Small-entity Standard based   <$41.5 million in   $41.5 million+ in   <$41.5 million in   $41.5 million+ in
 on Annual Receipts.               Receipts            Receipts            Receipts.           Receipts.
                                   employees.          employees.
622110 General Medical and        65................  2,495.............  $35.5 m...........  $997.3 b.
 Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------

    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

[[Page 5808]]

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 government-
to-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 self-inspection, 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.
---------------------------------------------------------------------------

    \1\ Go to www.regulations.gov and enter CDC-2020-0024 in the 
Search field.
_____________________________________-

    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 ICR-related 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

[[Page 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.planthealthaustralia.com.au/wp-content/uploads/2013/03/Downy-mildew-of-maize-and-sorghum-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/CornDownyMildewsRecoveryPlanRevised2013.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/terrestrial-code/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

0
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.

0
2. Amend Sec.  331.1 by:
0
a. Adding in alphabetical order definitions for ``Discovery'' and 
``Loss'';
0
b. Removing the definition for ``Permit'';
0
c. Adding in alphabetical order definitions for ``Release'' and 
``Theft'';
0
d. Revising the definition for ``Validated inactivation procedure'';
0
e. Adding in alphabetical order definitions for ``Validated removal 
procedure'' and ``Verification viability testing protocol''; and
0
f. Revising the definition for ``Viability testing protocol''.
    The additions and revisions read as follows:


Sec.  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 in-house viability testing 
protocol, to render a select agent non-viable but allows the select 
agent to retain characteristics of interest for future use;

[[Page 5810]]

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.
0
3. Revise Sec.  331.2 to read as follows:


Sec.  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.
0
4. Amend Sec.  331.3 by:
0
a. Revising paragraphs (b) and (d)(4) through (6);
0
b. Redesignating paragraphs (d)(7) through (9) as paragraphs as (d)(8) 
through (10) and adding a new paragraph (d)(7);
0
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;
0
d. Revising newly redesignated paragraph (d)(10);
0
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
0
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:


Sec.  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 Sec.  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 Sec.  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.
* * * * *
0
5. Amend Sec.  331.5 by:
0
a. Revising paragraphs (a) introductory text and (a)(1); and
0
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.

[[Page 5811]]

    The revisions read as follows:


Sec.  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 Sec.  331.16 or 
destroyed on-site by a recognized sterilization process or inactivated 
for future use in accordance with Sec.  331.3(d)(4).
* * * * *
0
6. Amend Sec.  331.7 by:
0
a. In paragraph (f), removing the words ``the relevant page(s) of'' and 
adding the words ``information related to'' in their place;
0
b. Revising paragraph (g);
0
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;
0
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:


Sec.  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.
* * * * *


Sec.  331.8  [Amended]

0
7. Amend Sec.  331.8, in paragraph (a)(3), by redesignating footnote 3 
as footnote 1.
0
8. Amend Sec.  331.9 by:
0
a. Redesignating paragraphs (a)(5) through (9) as paragraphs (a)(6) 
through (10) and adding a new paragraph (a)(5);
0
b. Revising newly redesignated paragraphs (a)(7), (9), and (10);
0
c. Adding a new second sentence to paragraph (b); and
0
d. Revising paragraph (c)(1).
    The addition and revisions read as follows:


Sec.  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 Sec.  331.12.
    (B) The entity's security plan is being effectively implemented as 
outlined in Sec.  331.11.
    (C) The entity's incident response plan is implemented to ensure 
whether the entity is able to respond, as outlined in Sec.  331.14.
    (D) Each individual with access approval from the Administrator or 
HHS Secretary has received the appropriate training as outlined in 
Sec.  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.
* * * * *


Sec.  331.10  [Amended]

0
9. Amend Sec.  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.
0
10. Amend Sec.  331.11 by:
0
a. Redesignating paragraphs (c)(9) and (10) as (c)(10) and (11) and 
adding a new paragraph (c)(9);
0
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
0
c. Removing paragraph (g) and redesignating paragraph (h) as paragraph 
(g).
    The addition reads as follows:


Sec.  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.
* * * * *
0
11. Amend Sec.  331.12 by:
0
a. In paragraph (a) introductory text, redesignating footnote 4 as 
footnote 1.
0
b. Removing paragraph (c)(1) and redesignating paragraph (c)(2) as 
paragraph (c)(1);
0
c. Adding a new reserved paragraph (c)(2); and
0
d. Adding paragraphs (f), (g), and (h).
    The additions read as follows:


Sec.  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

[[Page 5812]]

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.


Sec.  331.13  [Amended]

0
12. Amend Sec.  331.13, in paragraph (a) introductory text, by adding 
the words ``or transfer'' after the word ``possess''.
0
13. Amend Sec.  331.14 by:
0
a. In the section heading, redesignating footnote 5 as footnote 1;
0
b. In paragraph (a), redesignating footnote 6 as footnote 2;
0
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
0
d. Revising paragraph (c).
    The revision reads as follows:


Sec.  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.
* * * * *
    \1\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.

0
14. Amend Sec.  331.15 by:
0
a. In paragraph (d), revising the last sentence; and
0
b. In paragraph (e), removing the words ``and document.''
    The addition reads as follows:


Sec.  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.
* * * * *


Sec.  331.16  [Amended]

0
15. Amend Sec.  331.16, in paragraph (a), by redesignating footnote 7 
as footnote 1.
0
16. Amend Sec.  331.17 by:
0
a. Revising paragraphs (a)(1), (3), and (8);
0
b. Removing the last sentence in paragraph (c); and
0
c. Adding paragraph (d).
    The revisions and addition read as follows:


Sec.  331.17  Records.

    (a) * * *
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
organisms containing recombinant and/or synthetic nucleic acids) held 
in long-term storage (placement in a system designed to ensure 
viability for future use, such as in a freezer or lyophilized 
materials), including:
    (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 Sec.  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 Sec.  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);

[[Page 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 Sec.  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 Sec.  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.


Sec.  331.19  [Amended]

0
17. Amend Sec.  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

0
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.

0
19. Amend Sec.  121.1 by:
0
a. Adding in alphabetical order definitions for ``Discovery'', 
``Loss'', ``Release'', and ``Theft'';
0
b. Revising the definition of ``Validated inactivation procedure'';
0
c. Adding in alphabetical order definitions for ``Validated removal 
procedure'' and ``Verification viability testing protocol''; and
0
d. Revising the definition of ``Viability testing protocol''.
    The additions and revisions read as follows:


Sec.  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 in-house 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.
* * * * *

[[Page 5814]]

0
20. Revise Sec.  121.2 to read as follows:


Sec.  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.
0
21. Amend Sec.  121.3 by:
0
a. Revising paragraphs (b) and (d)(1), (4), (5), and (6);
0
b. Redesignating paragraphs (d)(7) through (9) as paragraphs as (d)(8) 
through (10) and adding a new paragraph (d)(7);
0
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;
0
d. In newly redesignated paragraph (d)(10), revising footnotes 4 and 5;
0
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
0
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:


Sec.  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 na[iuml]ve or experimental animal; or
    (ii) the introduction of a na[iuml]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 na[iuml]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 Sec.  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 Sec.  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.
* * * * *
    \1\ A 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.
* * * * *
    \4\ An avian paramyxovirus type 1 virus (APMV-1) isolated from 
poultry which 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

[[Page 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.
    \5\ Pigeon 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.

0
22. Amend Sec.  121.4 by:
0
a. Revising paragraph (b);
0
b. In paragraph (c)(1), redesignating footnote 6 as footnote 1;
0
c. Revising paragraph (d)(1);
0
d. In paragraph (d)(2), redesignating footnote 7 as footnote 2;
0
e. Revising paragraphs (d)(4) through (6);
0
f. Redesignating paragraphs (d)(7) through (9) as paragraphs as (d)(8) 
through (10) and adding a new paragraph (d)(7);
0
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;
0
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;
0
i. Revising paragraph (f)(3)(i);
0
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
0
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:


Sec.  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 na[iuml]ve or experimental animal; or
    (ii) The introduction of a na[iuml]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 na[iuml]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 Sec.  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 Sec.  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.
* * * * *
0
23. Amend Sec.  121.5 by:
0
a. Revising paragraphs (a) introductory text and (a)(1);
0
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;
0
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;

[[Page 5816]]

0
d. Adding paragraphs (a)(4)(i) and (ii);
0
e. Revising paragraph (b)(1); and
0
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:


Sec.  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 Sec.  121.16 or 
destroyed on-site by a recognized sterilization process or inactivated 
for future use in accordance with Sec.  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 Sec.  121.16 or destroyed on-site by a recognized 
sterilization process or inactivated for future use in accordance with 
Sec.  121.3(d)(4).
* * * * *
0
24. Amend Sec.  121.6 by:
0
a. Revising paragraph (a)(1);
0
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;
0
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;
0
d. Adding paragraphs (a)(4)(i) through (iv);
0
e. Revising paragraph (b)(1); and
0
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:


Sec.  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 Sec.  121.16 or 42 CFR 
73.16 or destroyed on-site by a recognized sterilization process, or 
inactivated for future use in accordance with Sec.  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 Sec.  121.16 or 42 CFR 73.16 or 
destroyed on-site by a recognized sterilization process or inactivated 
for future use in accordance with Sec.  121.4(d)(4);
* * * * *
0
25. Amend Sec.  121.7 by:
0
a. In paragraph (d)(3) introductory text, redesignating footnote 8 as 
footnote 1;
0
b. In paragraph (f), removing the words ``the relevant page(s) of'' and 
adding the words ``information related to'' in their place;
0
c. Revising paragraph (g);
0
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
0
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:


Sec.  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.
* * * * *


Sec.  121.8   [Amended]

0
26. Amend Sec.  121.8, in paragraph (a)(3), by redesignating footnote 
10 as footnote 1.
0
27. Amend Sec.  121.9 by:
0
a. Redesignating paragraphs (a)(5) through (9) as paragraphs (a)(6) 
through (10) and adding a new paragraph (a)(5);
0
b. Revising newly redesignated paragraphs (a)(7), (9), and (10);
0
c. Adding a new second sentence to paragraph (b);
0
d. Revising paragraph (c)(1); and
0
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:


Sec.  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 Sec.  121.12.
    (B) The entity's security plan is being effectively implemented as 
outlined in Sec.  121.11.
    (C) The entity's incident response plan is implemented to ensure 
whether the entity is able to respond, as outlined in Sec.  121.14.
    (D) Each individual with access approval from the Administrator or 
HHS Secretary has received the appropriate training as outlined in 
Sec.  121.15.
* * * * *

[[Page 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.
* * * * *


Sec.  121.10   [Amended]

0
28. Amend Sec.  121.10 by:
0
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
0
b. In paragraph (h), removing the text ``(f)(2) through (f)(3)'' and 
adding the text ``(g)(2) through (3)'' in its place.
0
29. Amend Sec.  121.11 by:
0
a. Redesignating paragraphs (c)(9) and (10) as paragraphs (c)(11) and 
(12) and adding new paragraphs (c)(9) and (10);
0
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;
0
c. In paragraph (f) introductory text, removing the word ``possessing'' 
and adding the words ``registered for'' in their place;
0
d. Revising paragraph (f)(4)(iii);
0
e. In paragraph (f)(5)(iii), removing the ``CCTV'' and adding the word 
``Video'' in its place; and
0
f. Removing paragraph (g) and redesignating paragraph (h) as paragraph 
(g).
    The additions and revision read as follows:


Sec.  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;
* * * * *
0
30. Amend Sec.  121.12 by:
0
a. In paragraph (a) introductory text, redesignating footnote 11 as 
footnote 1;
0
b. In paragraph (c)(1), removing the words ``National Select Agent 
Registry'' and adding the words ``Federal Select Agent Program 
website'' in their place;
0
c. In paragraph (c)(2), removing the words ``the internet'' and adding 
the words ``the Federal Select Agent Program website'';
0
d. Revising paragraph (d); and
0
e. Adding paragraphs (f), (g), and (h).
    The revision and additions read as follows:


Sec.  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

[[Page 5818]]

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.


Sec.  121.13  [Amended]

0
31. Amend Sec.  121.13, in paragraph (a) introductory text, by adding 
the words ``or transfer'' after the word ``possess''.
0
32. Amend Sec.  121.14 by:
0
a. In the section heading, redesignating footnote 12 as footnote 1;
0
b. In paragraph (a), redesignating footnote 13 as footnote 2;
0
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;'';
0
d. Revising paragraph (c); and
0
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:


Sec.  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.
* * * * *
    \1\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.

0
33. Amend Sec.  121.15 by:
0
a. Adding paragraphs (a)(3) and (4);
0
b. In paragraph (b), removing the words ``Entities with'' and adding 
the words ``An individual or entity registered for'' in their place;
0
c. Revising paragraph (d); and
0
d. In paragraph (e), by removing words ``and document''.
    The additions and revision read as follows:


Sec.  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.
* * * * *


Sec.  121.16  [Amended]

0
34. Amend Sec.  121.16, in paragraph (a), by redesignating footnote 14 
as footnote 1.
0
35. Amend Sec.  121.17 by:
0
a. Revising paragraphs (a)(1), (3), and (8);
0
b. Removing the last sentence in paragraph (c); and
0
c. Adding paragraph (d).
    The revisions and addition read as follows:


Sec.  121.17  Records.

    (a) * * *
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
organisms containing recombinant and/or synthetic nucleic acids) held 
in long-term storage (placement in a system designed to ensure 
viability for future use, such as in a freezer or lyophilized 
materials), including:
    (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 Sec.  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 Sec.  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

[[Page 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 Sec.  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 Sec.  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.


Sec.  121.19   [Amended]

0
36. Amend Sec.  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


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