[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:
Federal eRulemaking Portal: Go to www.regulations.gov.
Enter APHIS-2019-0018 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2019-0018, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Commenters should not include any information in their
comments or supporting materials that they consider confidential or
inappropriate for public disclosure. APHIS will carefully consider all
comments submitted in preparation of a final rule.
Supporting documents and any comments we receive on this docket may
be viewed at www.regulations.gov or in our reading room, which is
located in Room 1620 of the USDA South Building, 14th Street and
Independence Avenue SW, Washington, DC. Normal reading room hours are 8
a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 7997039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Jacek Taniewski, DVM, Director,
Division of Agricultural Select Agents and Toxins, ERCS, APHIS, 4700
River Road, Riverdale, MD 20737; (301) 851-3352;
[email protected].
SUPPLEMENTARY INFORMATION:
Background
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (referred to below as the Bioterrorism Response
Act) provides for the regulation of certain biological agents and
toxins that have the potential to pose a severe threat to human,
animal, and plant health, or to animal and plant products. The Animal
and Plant Health Inspection Service (APHIS) has the responsibility for
implementing the provisions of the Bioterrorism Response Act within the
U.S. Department of Agriculture (USDA). Veterinary Services (VS) select
agents and toxins, listed in 9 CFR 121.3, are those that have been
determined to have the potential to pose a severe threat to animal
health or animal products. Plant Protection and Quarantine (PPQ) select
agents and toxins, listed in 7 CFR 331.3, are those that have been
determined to have the potential to pose a severe threat to plant
health or plant products. Overlap select agents and toxins, listed in 9
CFR 121.4, are those that have been determined to pose a severe threat
to public health and safety, to animal health, or to animal products.
Overlap select agents are subject to regulation by both APHIS and the
Centers for Disease Control and Prevention (CDC), which has the primary
responsibility for implementing the provisions of the Act for the U.S.
Department of Health and Human Services (HHS). Together, APHIS and CDC
comprise the Federal Select Agent Program (FSAP).
Title II, Subtitle B of the Bioterrorism Response Act (which is
cited as the ``Agricultural Bioterrorism Protection Act of 2002'' and
referred to below as the Act), section 212(a)(1)(A) (7 U.S.C.
8401(a)(1)(A)), provides, in part, that the Secretary of Agriculture
(the Secretary) must establish by regulation a list of each biological
agent and each toxin that the Secretary determines has the potential to
pose a severe threat to animal or plant health, or to animal or plant
products.
In determining whether to include an agent or toxin in the list,
the Act (7 U.S.C. 8401(a)(1)(B)) requires that the following criteria
be considered:
The effect of exposure to the agent or toxin on animal or
plant health, and on the production and marketability of animal or
plant products;
The pathogenicity of the agent or the toxicity of the
toxin and the methods by which the agent or toxin is transferred to
animals or plants;
[[Page 5796]]
The availability and effectiveness of pharmacotherapies
and prophylaxis to treat and prevent any illness caused by the agent or
toxin;
Whether such inclusion would have a substantial negative
impact on the research and development of solutions for the animal and
plant disease caused by the agent or toxin and whether the negative
impact on research and development would substantially outweigh the
risk posed by the agent or toxin to animal or plant health if it is not
included on the list (added by the 2018 Farm Bill); and
Any other criteria that the Secretary considers
appropriate to protect animal or plant health, or animal or plant
products.
Paragraph (a)(2) of section 212 of the Act (7 U.S.C. 8401(a)(2))
requires the Secretary to review and republish the list of select
agents and toxins every 2 years and to otherwise revise the list as
necessary. To fulfill this statutory mandate, APHIS convenes separate
interagency working groups in order to review the lists of PPQ and VS
select agents and toxins, as well as any overlap select agents and
toxins, and develop recommendations regarding possible changes to the
list using the five criteria for listing found in the Act.
Advance Notice of Proposed Rulemaking
Pursuant to this same paragraph of the Act, on March 17, 2020, we
issued an advance notice of proposed rulemaking (ANPR) in the Federal
Register (85 FR 15078-15079, Docket No. APHIS-2019-0018) in which we
solicited public comment on the possible delisting of one PPQ select
agent, Peronosclerospora philippinensis, formerly known as
Peronosclerospora sacchari, one VS select agent, African horse sickness
virus, and five overlap select agents, Bacillus anthracis (Pasteur
strain), Brucella abortus, B. suis, and B. melitensis, and Venezuelan
equine encephalitis virus. We took comment on the ANPR for 60 days,
ending May 18, 2020. We received 224 comments by that time. They were
from private citizens and stakeholders. We discuss the comments on the
ANPR below.
Commenters overwhelmingly supported delisting of B. abortus, B.
suis, and B. melitensis. We did not receive any comments relative to
delisting P. philippinensis or African horse sickness virus.
Additionally, we did receive adverse comments regarding our proposed
possible removal of Venezuelan equine encephalitis virus (VEEV) and
Bacillus anthracis (Pasteur strain).
Finally, we received two comments suggesting the delisting of
Ralstonia solanacearum Race 3 biovar 2 and several comments suggesting
delisting of other agents from the list of select agents and toxins. We
acknowledge these requests but before we propose to delist or list an
agent, it is reviewed by the Agricultural Interagency Select Agents and
Toxins Technical Advisory Committee, or Ag-ISATTAC. In that regard, it
is beneficial to clarify how those reviews take place. On a biannual
basis, the Ag-ISATTAC, a Federal interagency committee of subject
matter experts in domestic and transboundary animal diseases and
toxins, reviews existing USDA select agents and toxins and makes
recommendations regarding their continued listing, possible delisting,
or addition of new agents/toxins, according to several risk categories.
Until such time as the 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:
Peronosclerospora philippinensis: This agent is only able
to survive and reproduce in the host plant and requires specific
environmental conditions to become infectious, for which mitigations
exist. (Food and Agriculture Organization of the United Nations, cited
October 19, 2017; Murray, G.M. 2009; Purdue University Extension, cited
October 20, 2017; USDA, 2013.)
African horse sickness virus: This virus is difficult to
successfully disseminate and effectively transmit. An effective vaccine
exists. (Alberca, B, et al., 2014; Braverman, Y, 1996; Lulla, V., et
al., 2017; Sanchez-Vizcaino, J.M., 2004; Spickler, 2015.)
Brucella abortus: This agent presents little economic or
animal health risk as it is unlikely to result in large-scale
population introduction due to the high concentration of the agent
necessary to produce disease as well as modern cattle production
processes that limit animal-to-animal transmission routes. There is an
efficacious vaccine, moderate immunity status within vulnerable
populations, limited farm-to-farm transmission risk, and effective
quarantine procedures. (Center for Food Security and Public Health,
2009; Moreno, E., 2014; Olsen, S.C., 2011.)
Brucella melitensis: This agent, which primarily affects
goats and sheep, is of lesser concern because the low farm-to-farm
transmission risk due to modern production practices limits the chance
of introduction on a scale large enough to impact domestic production.
(The Center for Food Security and Public Health, 2009; Moreno, E.,
2014; Olsen, S.C., 2011.)
Brucella suis: This agent presents a low to moderate
animal health risk due to limited farm-to-farm transmission risk as a
result of modern production practices which reduce the risk of a large-
scale introduction. (The Center for Food Security and Public Health,
2009; Stoffregen, W.C., 2006; World Organizsation for Animal Health
(OIE), 2017; Zhu, L., et al., 2016.)
In addition, we are proposing to retain Venezuelan equine
encephalitis virus and Bacillus anthracis (Pasteur strain) as select
agents.
We appreciate all comments received from the ANPR and will consider
these comments in future deliberations.
We are also proposing additional changes to the regulations beyond
those discussed in the ANPR. Certain of these would be codifications of
existing operational policy. These include provisions related to:
Discovery of a select agent or toxin, disposal of select agent waste
after conclusion of patient care, the exclusion of animals naturally
infected with select agents from the requirements of the regulations,
allowing individuals other than the responsible official (e.g.,
principal investigators) to revise inactivation procedure
documentation, removal procedures, and the content of annual internal
inspections.
Many of the proposed revisions are intended to clarify existing
provisions of the regulations. These include proposed definitions of
loss, release, and theft; clarifying reporting requirements for
``discovered'' select agents or toxins, a clarification regarding what
constitutes an acceptable ``validated inactivation procedure,''
clarifications related to the existing reporting requirements,
clarifying that certificates must accompany transfers of a select agent
or toxin, including intra-entity transfers, clarifying that the
documentation in the IT system for the FSAP program serves as official
records required by the regulations, clarifying the documentation that
may be needed for the issuance of a certificate of
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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:
A registered individual or entity finds a select agent or
toxin not accounted for in their inventory; or
A non-registered individual or entity finds a select agent
or toxin.
Disposal of Select Agent Waste After Conclusion of Patient Care
In 7 CFR 331.3(d)(8), 9 CFR 121.3(d)(8) and 9 CFR 121.4(d)(8), the
regulations provide that waste generated during the delivery of patient
care by health care professionals from a patient diagnosed with an
illness or condition associated with a select agent is excluded from
the requirements of the regulations, provided that the waste is
decontaminated or transferred for destruction by complying with State
and Federal regulations within 7 calendar days of the conclusion of
patient care. Additionally, 9 CFR 121.5(a)(3) and 9 CFR 121.6(a)(3)
exempt from the regulations diagnostic laboratories and other entities
that collect clinical or diagnostic specimens from a patient infected
with a select agent provided that, among other requirements, the
specimens are transferred in accordance with 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
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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:
In-house validation of the inactivation procedure is
completed prior to use;
A certificate of inactivation (discussed below) has been
generated in accordance with the regulations;
For use of a select agent surrogate to validate an
inactivation procedure, the select agent surrogate chosen is known to
possess equivalent properties with respect to inactivation, and, if
there are known variations in the resistance of a select agent to an
inactivation procedure, including strain to strain, then the
inactivation procedure must also be validated using the most resistant
select agent surrogate; and
For use of a whole tissue or homogenized tissue surrogate
to validate a chemical inactivation procedure for other tissues,
including those in other animal or plant models, all standardized
conditions must be held constant such as the select agent used, the
tissue volume, and the ratio of tissue to volume of inactivating
material; a safety margin must be incorporated into the final
inactivation procedure to ensure the effective inactivation of the
select agent; and the tissue surrogate is either expected to have the
highest concentration of the specific select agent to be inactivated,
or the concentration of the select agent in the tissue is determined
and this select agent concentration is not exceeded when applying the
validated inactivation procedure on subsequent tissue samples.
The purpose of these revisions is to indicate that the inactivation
procedure must have been validated in-house and must have been
validated in a manner that provides assurances regarding its general
suitability and use within that facility. The regulations in 9 CFR
121.5(a) and 9 CFR 121.6(a) currently also exempt diagnostic
laboratories and other entities that possess, use, or transfer a select
agent or toxin that is contained in a specimen presented for diagnosis
or verification from the requirements of the regulations, if, among
other requirements, the select agent or toxin is destroyed on-site
within 7 calendar days using an approved inactivation process. We are
proposing to revise this exemption so that if an inactivation process
is used, it meets the parameters in the above exclusion, as revised. We
are also clarifying that such an inactivation process may not
necessarily entail physical destruction of the select agent or toxin.
We are also proposing a new exclusion related to inactivation in 7
CFR 331.3(d), 9 CFR 121.3(d), and 9 CFR 121.4(d). Specifically, we
propose to exclude from the requirements of the regulations any select
agent or regulated nucleic acid that can produce infectious forms of
any select agent virus if the material is contained in a formalin-fixed
paraffin-embedded tissue that has been effectively inactivated by a
recognized method for that particular agent or regulated nucleic acid.
This would exclude from the requirements of the regulations, as an
example, appropriately prepared histopathology samples that have
undergone satisfactory formalin fixation and further paraffin embedding
processes that result in a quality sample. In this example, such
properly prepared samples that will yield a usable histopathology
sample provide assurances that the additional processing steps required
to prepare an acceptable formalin-fixed, 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:
In-house validation of the viable select agent removal
procedure is completed prior to use;
A certificate of viable select agent removal (discussed
below) has been generated in accordance with Sec. 121.17(a)(8) or
Sec. 331.17(a)(8);
For use of a surrogate to validate a viable select agent
removal procedure, only surrogates known to possess equivalent
properties with respect to removal are used; and
A portion of each subsequent sample has been subjected to
a verification viability testing protocol to ensure that the validated
viable select agent removal procedure has rendered the material free of
all viable select agent.
In a similar manner to our proposed revisions to the exclusion
based on inactivation in 7 CFR 331.3(d)(4), 9 CFR 121.3(d)(4), and 9
CFR 121.4(d)(4), the intent of these revisions is to indicate that the
removal procedure must be validated in-house as appropriate and
effective for the facility's particular circumstances. We are also
proposing to add to the definitions in 7 CFR 331.1 and 9 CFR 121.1 the
term Validated removal procedure, which we propose to define as ``a
procedure, whose efficacy has been confirmed by data generated in-house
from a viability testing protocol, to confirm removal of all viable
select agent, or nucleic acids of any select agent virus capable of
producing infectious virus.''
Currently, the definition of Viability testing protocol in 7 CFR
331.1 and 9 CFR 121.1 does not include reference to removal procedures.
However, given that we are proposing to include viability testing
protocols in our proposed revision to the removal procedures, it is
correspondingly necessary to revise the definition of Viability testing
protocol to include such reference. We would also specify that it must
be conducted in-house. We would also add to the definitions in 7 CFR
331.1 and 9 CFR 121.1 a definition of the term Verification viability
testing protocol. We would define this term as ``a protocol, used on
samples that have been subjected to a validated inactivation or removal
procedure, to confirm the material is free of all viable select agent,
or nucleic acids of any select agent virus capable of producing
infectious virus.''
Finally, wherever the exclusion related to removal is currently
discussed in other provisions of the regulations, we are proposing
harmonizing changes to ensure the terminology remains consistent with
our proposed revisions to that exclusion.
Loss, Release, and Theft
The terms loss, release, and theft are used in several instances in
the existing regulations. For example, 7 CFR 331.19 and 9 CFR 121.19
discuss the notification requirements for loss, release, and theft.
Additionally, 7 CFR 331.3(f) and 9 CFR 121.3(f) also contain an
exclusion from the requirements of the regulations for any select agent
or toxin seized by a Federal law enforcement agency during the period
between seizure of the agent or toxin and the transfer or destruction
of such agent or toxin provided that, among other requirements, the
Federal law enforcement agency safeguards and secures the seized agent
or toxin against theft, loss, or release, and reports any theft, loss,
or release of such agent or toxin. However, the terms loss, release,
and theft are not currently defined within the regulations. We are
proposing definitions for each of these terms in 7 CFR 331.1 and 9 CFR
121.1 to clarify their meaning.
We are proposing to define loss as ``the inability to account for a
select agent or toxin known to be in the individual or entity's
possession.''
We are proposing to define release as any of the following:
An incident resulting in occupational exposure to a select
agent or toxin;
An incident resulting in animal/plant exposure to a select
agent or toxin;
The failure of equipment used to contain a select agent or
toxin such that it is reasonably anticipated that a select agent or
toxin was released;
The failure of or breach in personal protective equipment
in the presence of a select agent or toxin; or
The failure of biosafety procedures such that it is
reasonably anticipated that a select agent or toxin was outside of
containment.
Finally, we are proposing to define theft as the unauthorized
taking and removing of a select agent or toxin from the possession of
an entity or individual.
Recordkeeping
The regulations in 7 CFR 331.17 and 9 CFR 121.17 contain
recordkeeping requirements for individuals and entities required to
register pursuant to the regulations. We are proposing amendments to
these sections to ensure an accurate, current inventory is maintained
for all select agents and toxins held in long-term storage.
Specifically, the section is being modified to add more specific
language regarding from whom material is acquired and the date the
agent was removed and returned from the storage locations to more
specifically define required recordkeeping information.
We are proposing to require that records contain:
The quantity acquired and the name of the individual by
whom it was acquired. The quantity acquired is currently one of the
recordkeeping requirements; the name of the individual by whom it was
acquired would be new.
The location where the select agent or toxin is stored
(e.g., building, room number or name, and freezer identification or
other storage container). This is an existing requirement, but we are
clarifying that the salient information is not the manner in which it
is stored (e.g., freezer versus non-refrigerated unit) but where in the
facility it is stored.
The date the agent was removed and returned, the purpose
for using the agent, the name of the individual who removed and
returned the agent, and when applicable, date of final disposition of
the agent and by whom. This would clarify the existing recordkeeping
requirement to keep records of when an agent is removed or returned; we
require a record of the calendar date, but not specific times within
that day.
For intra-entity transfers (sender and the recipient are
covered by the
[[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:
The entity's biosafety/biocontainment plan is being
effectively implemented as outlined in the regulations (7 CFR 331.12
and 9 CFR 121.12, respectively).
The entity's security plan is being effectively
implemented as outlined in the regulations (7 CFR 333.11 and 9 CFR
121.11, respectively).
The entity's incident response plan is implemented to
ensure whether the entity is able to respond, as outlined in the
regulations (7 CFR 331.14 and 9 CFR 121.14, respectively).
Each individual with access approval from the
Administrator or HHS Secretary has received the appropriate training as
outlined in the regulations (7 CFR 331.15 and 9 CFR 121.15,
respectively).
Tier 1 Security Enhancements
Currently, the regulations in 9 CFR 121.3 specify that certain VS
select agents and toxins are Tier 1; the current VS Tier 1 select
agents are foot-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
LD50 < 100 ng/kg body weight.
Due to heightened biosafety concerns of research involving
potential pandemic pathogens and emerging diseases, increased emphasis
on oversight of products of restricted experiments is being proposed.
To ensure that an entity has the appropriate safeguards to work with
the product of a select agent or toxin resulting from a restricted
experiment, APHIS is proposing to clarify the provision that the
receiving entity of a transfer must amend their certificate of
registration and receive approval by CDC or APHIS to possess the
products of a restricted experiment. Entities are currently required to
obtain approval to conduct restricted experiments and possess the
product of a select agent or toxin resulting from a restricted
experiment.
Training
The regulations in 9 CFR 121.15 require individuals or entities
registered to possess, use or transfer select agents or toxins to
provide information and training on biocontainement, biosafety,
security, and incident response to individuals with access to select
agents or toxins. APHIS is proposing revisions to the training
requirements in accordance with the new mandate in the Prepare for and
Respond to Existing Viruses, Emerging New Threats, and Pandemics Act
(42 U.S.C. 262a(k)(1); Pub. L. 117-328) amendment of subsection (b)(1).
These revisions have been made in an effort to comply with the
statutory amendment that states training requirements for (1)
unapproved individuals whose responsibilities routinely place them in
close proximity to laboratory facilities and (2) those individuals who
perform administrative or oversight functions. Trainings must be
completed within 6 months after publication of a final rule for this
proposed rulemaking.
Miscellaneous
We are proposing to remove the definition of the term permit from 7
CFR 331.1. We currently define the term as ``a written authorization by
the Administrator to import or move interstate select agents or toxins,
under conditions prescribed by the Administrator.'' However, the term
is only used once in 7 CFR part 331, specifically in 7 CFR
331.11(c)(9)(i) and is used as a verb. Additionally, it is used in that
one instance with the dictionary definition of allowing or authorizing
an action to occur. For these reasons, the definition of the term
permit serves no function and its removal is appropriate.
In 7 CFR 331.3(b), Ralstonia solanacearum is listed as a select
agent. However, only Ralstonia solanacearum Race 3 biovar 2 poses a
severe threat to plant health or plant products and merits inclusion on
the list of select agents; other races and biovars are less pathogenic.
We propose to amend this section accordingly.
The regulations in 7 CFR 331.3(e)(1), 9 CFR 121.3(e)(1), and 9 CFR
121.4(e)(1) currently refer to exclusions being posted to ``the
National Select Agent Registry website.'' However, the name of the
website has changed to ``the Federal Select Agent Program website.'' We
propose to update the regulations accordingly.
Multiple regulations currently indicate that APHIS can receive
reports received via facsimile. Due to the implementation of the eFSAP
information system for official recordkeeping, this is no longer the
case. We are proposing to amend the regulations accordingly.
Prior to issuance of a certificate of registration, we currently
require that the responsible official must provide notification of any
changes to the application for registration by submitting the relevant
pages of the registration application (7 CFR 331.7(f); 9 CFR 121.7(f)).
We propose to clarify that the submission should be the
[[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:
Discovery of Select Agents and Toxins: We are proposing a
definition for the term Discovery, clarifying that an individual or
entity in possession of a select agent or toxin for which an exclusion
or exemption listed in 9 CFR part 121 or 7 CFR part 331 does not apply,
and that is not included on a certificate of registration, must
immediately report such possession to either the APHIS Administrator or
HHS Secretary, and creating a new APHIS/CDC Form 6 to facilitate
reporting of discoveries.
Disposal of Select Agent Waste After Conclusion of Patient
Care: This proposes to codify a current operational policy that, for an
individual who has been admitted to a medical facility, that
individual's ``conclusion of patient care'' and the point when
``delivery of patient care by health care professionals has concluded''
is when an individual is released from the medical facility where
treatment was being provided by the medical facility or physician.
Exclusion of Animals Naturally Infected with Select
Agents: We are proposing to codify the current operational policy
regarding when animals naturally infected with select agents are
excluded from the requirements of the regulations.
Inactivation: We are proposing to clarify what constitutes
an acceptable ``validated inactivation procedure,'' including revising
the existing definition of the term; add a new exclusion 7 CFR
331.3(d), 9 CFR 121.3(d), and 9 CFR 121.4(d) that would exclude any
select agent or regulated nucleic acid that can produce infectious
forms of any select agent virus if the material is contained in a
formalin-fixed paraffin-embedded tissue or fixed to slides (e.g., Gram
stain) that has been effectively inactivated by a recognized method;
and codify a policy that allows individuals besides the responsible
official to revise the inactivation procedures.
Removal: We are proposing to codify an operational
exclusion in 7 CFR 331.3(d)(5), 9 CFR 121.3(d)(5), and 9 CFR
121.4(d)(5) regarding material containing a select agent that is
subjected to a validated viable select agent removal procedure, revise
the definition of Viability testing protocol, and add a definition for
the term Verification viability testing protocol.
Loss, Release, and Theft: APHIS proposes to add
definitions for the terms Loss, Release, and Theft.
Recordkeeping: We are proposing amendments to the
recordkeeping requirements in 7 CFR 331.17 and 9 CFR 121.17 to ensure
an accurate, current inventory is maintained for all select agents and
toxins held in 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.
Electronic Federal Select Agent Program (eFSAP)
Information System: We are proposing to add references to eFSAP's
electronic data submission and management procedures throughout the
regulations.
Registration: We are clarifying the conditions under which
issuance of a certificate of registration may be contingent and that
amendment of a certification of registration to reflect changes in
circumstances is mandatory.
Responsible Official and Alternate Responsible Official:
We are proposing to clarify that a responsible official is precluded
from serving as the primary responsible official for two separate
registered entities. We are also clarifying that a responsible official
cannot be the sole alternate responsible official at another registered
entity, but that an alternate responsible official at one entity may be
approved to be an alternate responsible official at another registered
entity.
Annual Internal Inspections: We are proposing to codify
current policy on what an entity's annual internal inspections must
address.
Tier 1 Security Enhancements: We are proposing to clarify
that registered entities that possess Tier 1 select agents must have
procedures for screening any visitors, their property, and, where
appropriate, vehicles at entry points to registered space based on the
entity's site-specific risk assessment.
Biosafety--Facility Verification: We are proposing to
amend 7 CFR 331.12 and 9 CFR 121.12 to require facility verification
every 12 months for registered entities that maintain biosafety level 3
and animal biosafety level 3 laboratories.
Biosafety--Effluent Decontamination System: We are
proposing to amend the security (7 CFR 331.11 and 9 CFR 121.11),
biosafety (7 CFR 331.12 and 9 CFR 121.12), and incident response (7 CFR
331.14 and 9 CFR 121.14) sections of the select agent and toxin
regulations to address risks posed by the effluent decontamination
systems used by high and maximum-containment laboratories.
Restricted Experiments: We are proposing to add a
provision that an individual or entity must submit a written request to
CDC or APHIS prior to the transfer or possession of the products of
restricted experiments.
Overview of the Action and Affected Entities
There are 236 entities registered with APHIS and CDC. Of these
entities, there are 13 Private entities, 30 Federal entities, 42
Commercial entities, 84 Academic entities, and 67 State entities. Of
these, less than 4 percent of all entities within these NAICS
categories are considered to be small entities. The delisting of
several select agents and the proposed amendments to the select agent
and toxins regulations are anticipated to economically benefit
producers, research and reference laboratories, and State and Federal
oversight agencies, while also maintaining adequate program oversight
of select agents and toxins, while minimizing additional costs to
adherence. Below we provide a 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
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modified vaccinia Ankara virus (MVA) expressing African horse
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Braverman, Y. and A. Chizov-Ginzburg. Role of dogs (Canis
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protective against heterologous Brucella spp. infections. Vaccine,
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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