[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6197-6210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00857]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2014-0095]
RIN 0579-AE08


Agricultural Bioterrorism Protection Act of 2002; Biennial Review 
and Republication of the Select Agent and Toxin List; Amendments to the 
Select Agent and Toxin Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are amending and republishing 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. The Act

[[Page 6198]]

requires the biennial review and republication of the list of select 
agents and toxins and the revision of the list as necessary. This 
action will amend the regulations in several ways, including the 
addition of provisions to address the inactivation of select agents, 
provisions addressing biocontainment and biosafety, and clarification 
of regulatory language concerning security, training, incident 
response, and records. These changes will increase the usability of the 
select agent regulations as well as providing for enhanced program 
oversight. After carefully considering the technical input of subject 
matter experts and recommendations from Federal advisory groups, we 
have decided not to finalize the proposed changes to the contents of 
the list of select agents and toxins at this time. In a companion 
document published in this issue of the Federal Register, the Centers 
for Disease Control and Prevention has made parallel regulatory 
changes.

DATES: Effective February 21, 2017.

FOR FURTHER INFORMATION CONTACT: Dr. Freeda Isaac, National Director, 
Agriculture Select Agent Services, APHIS, 4700 River Road, Unit 2, 
Riverdale, MD 20737-1231; (301) 851-3300, Option 3.

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 that have 
the potential to pose a severe threat to both human and animal health, 
to animal health, to plant health, or to animal plant health, or to 
animal and plant products. The Animal and Plant Health Inspection 
Service (APHIS) has the primary responsibility for implementing the 
provisions of the Act within the United States Department of 
Agriculture (USDA). Veterinary Services (VS) select agents and toxins 
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 are those that have the 
potential to pose a severe threat to plant health or plant products. 
Overlap select agents and toxins are those that have been determined to 
pose a severe threat to both human and animal health or to human health 
and 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 Bioterrorism Response Act for the Department of Health and Human 
Services (HHS).
    Subtitle B (which is cited as the ``Agricultural Bioterrorism 
Protection Act of 2002'' and referred to below as the Act), section 
212(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. Paragraph (a)(2) of section 212 requires the Secretary to 
review and republish the list every 2 years and to revise the list as 
necessary. In this document, we are amending and republishing the list 
of select agents and toxins based on the findings of our fourth 
biennial review of the list.
    In determining whether to include an agent or toxin on the list, 
the Act requires that the following criteria be considered:
     The effect of exposure to the agent or the toxin on animal 
and plant health, and on the production and marketability of animal or 
plant products;
     The pathogenicity of the agent or the toxin and the 
methods by which the agent or toxin is transferred to animals or 
plants;
     The availability and effectiveness of pharmacotherapies 
and prophylaxis to treat and prevent any illness caused by the agent or 
toxin; and
     Any other criteria that the Secretary considers 
appropriate to protect animal or plant health, or animal or plant 
products.
    We use the term ``select agents and toxins'' throughout the 
preamble of this rule. Unless otherwise specified, the term ``select 
agents and toxins'' will refer to all agents or toxins listed by APHIS. 
When it is necessary to specify the type of select agent or toxin, we 
will use the following terms: ``PPQ select agents and toxins'' (for the 
plant agents and toxins listed in 7 CFR 331.3), ``VS select agents and 
toxins'' (for the animal agents and toxins listed in 9 CFR 121.3), or 
``overlap select agents and toxins'' (for the overlap agents and toxins 
listed in both 9 CFR 121.4 and 42 CFR 73.4).
    On January 19, 2016, we published in the Federal Register (81 FR 
2762-2774, Docket No. APHIS-2014-0095) a proposal \1\ 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, and amend the regulations in order to add definitions 
and clarify language concerning security, training, biosafety, 
biocontainment, and incident response.
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    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
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    We solicited comments concerning our proposal for 60 days ending 
March 21, 2016. We received 24 comments by that date. They were from 
researchers, scientific organizations, industry groups, laboratories, 
and universities. Eighteen were supportive of the proposed action. The 
remaining six comments are discussed below by topic.

Removal of Select Agents and Toxins

    We proposed to amend the list of PPQ select agents and toxins 
listed in 7 CFR 331.3 by removing three PPQ select agents and toxins 
from the list: Peronosclerospora philippinensis (Peronosclerospora 
sacchari), Sclerophthora rayssiae, and Phoma glycinicola (formerly 
Pyrenochaeta glycines).
    We also proposed to remove three overlap select agents and toxins 
from the list set out in 9 CFR 121.4(b): Bacillus anthracis (Pasteur 
strain), Brucella abortus and Brucella suis.
    After carefully considering the technical input of subject matter 
experts and recommendations from Federal advisory groups, we have 
decided not to finalize the proposed changes to the list of select 
agents and toxins at this time.

Definitions

    In 7 CFR 331.1 and 9 CFR 121.1, we proposed to add definitions for 
inactivation and kill curve to clarify terms contained within the 
proposed inactivation provisions. As detailed later in this final rule, 
we have removed the requirement for generation of a kill curve. We are 
therefore not including the definition in the regulations.
    One commenter suggested that we specify that a ``validated method'' 
was used for inactivation. The commenter said that the addition of the 
word ``validated'' would ensure that tested and appropriate methods of 
inactivation would be utilized.
    We are eliminating the definition for inactivation and instead 
adding a definition of validated inactivation procedure to the 
regulations. This definition encompasses the prior definition of 
inactivation as well as providing further detail which we believe will 
be useful for regulated entities. Validated inactivation procedure is 
defined 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

[[Page 6199]]

future use; or to render any nucleic acids that can produce infectious 
forms of any select agent virus non-infectious for future use. While 
the commenter suggested we use the term ``method,'' we have decided to 
use the term ``procedure'' in response to comments received on the CDC 
docket.
    The same commenter suggested that we add definitions of validated 
sterility test and safety margin as these terms were both proposed for 
use in the biocontainment and biosafety sections and could prove 
confusing or be subject to misinterpretation.
    Given that we are adding a definition of validated inactivation 
procedure as described previously, we are not adding a definition of 
validated sterility test. We are not adding a definition of safety 
margin since that term will not be in the regulations.
    While we did not receive any further comments regarding 
definitions, in response to comments received by CDC and in the 
interests of maintaining parity between the APHIS and CDC regulations, 
we are adding a definition for viability testing protocol. That term, 
which is now used in Sec. Sec.  331.3, 121.3, and 121.4, is defined as, 
``a protocol to confirm the validated inactivation procedure by 
demonstrating the inability of a select agent to replicate.''

Exclusions and Inactivation

    We proposed to amend 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 9 
CFR 121.4(d)(2), which exclude nonviable select agents or nonfunctional 
toxins from the requirements of the regulations, in order to clarify 
our policy that an entity must use a validated procedure to render a 
select agent nonviable or regulated nucleic acids non-infectious for 
future use. This means that the method must be scientifically sound and 
that it will produce consistent results each time it is used.
    One commenter stated that we need to consistently address toxins 
throughout the regulations and suggested adding language specifying 
that required methods would also render a select toxin as 
nonfunctional.
    We did not include language concerning toxins because, unlike 
select agents, toxins do not replicate. An inactivation failure with a 
toxin therefore represents a lower level of risk and thus does not 
justify the potential additional recordkeeping and reporting burden for 
registered entities at this time. We may revisit this issue in the 
future.
    We proposed that inactivation include the use of one of the 
following: The exact conditions of a commonly accepted method that has 
been validated as applied (e.g., autoclaving), a published method with 
adherence to the exact published conditions (i.e., extrapolations or 
deductions are to be avoided), or in-house methods, only if validation 
testing includes the specific conditions used and appropriate controls.
    The same commenter also suggested that we require that the 
inactivation process be repeatable.
    We agree with the commenter that the inactivation process has to be 
validated so that the results are repeatable. The definition of 
validated inactivation procedure states that the procedure must be 
supported by data generated from viability testing. A process that is 
not repeatable would never be validated.
    We also proposed that the entity develop a site-specific kill curve 
in order to define the conditions of inactivation for each select agent 
or regulated nucleic acid. If there are strain-to-strain variations in 
the resistance of a select agent to the inactivation procedure, then a 
specific kill curve would have to be developed for each strain that 
undergoes the inactivation procedure. A new kill curve would have to be 
created upon any change in procedure or inactivation equipment. In 
addition, a validated sterility testing protocol would have to be 
conducted in order to ensure that the inactivation method has rendered 
a select agent nonviable or regulated nucleic acids non-infectious.
    Several commenters raised objections regarding development and use 
of the kill curve. We have considered these comments and determined 
that the kill curve and safety margin requirements are not applicable 
to all inactivation procedures and should therefore not be included in 
the regulations. We are instead requiring that registered entities 
develop a validated inactivation procedure by establishing parameters 
for quantities of starting material and measures of uncertainty for 
repeated successful inactivation. This is a broad performance standard 
that will allow for flexibility given the variety of select agents and 
toxins under regulation.\2\ In addition, for the sake of clarity and 
efficiency, we have removed the requirements specific to extracts of 
select agents, instead including them within the overall performance 
standard for select agents and toxins as a whole.
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    \2\ Additional guidance regarding this performance standard has 
been developed and is available on the Internet at 
www.selectagents.gov.
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    One commenter said that, without more specific direction, the 
subjectivity of individual inspectors would be the principal factor in 
determining acceptable inactivation verification.
    We will not review or approve inactivation protocols. We believe 
this activity should be approved at the entity, which will allow for 
researchers to continue to develop new inactivation procedures. 
However, inspectors will verify that the entity has developed a 
validated inactivation procedure and will review viability testing 
results during the entity's inspection.
    Another commenter asked that we provide minimum requirements for 
the sterility testing protocol and specify whether or not this must be 
site-specific or if validated methods of sterility testing given in 
published journal articles may be followed.
    We recognize that the limits of detection of the viability testing 
procedures and expected variation from run to run, even when following 
an inactivation procedure precisely precludes demonstrating full 
sterility of an inactivated sample. These sources of error must be 
considered when the entity establishes performance parameters for 
inactivation procedures. While complete sterility is not a feasible 
goal for material that is intended for further use, we expect that the 
risk of live agent in materials that are removed from containment and 
are thus no longer subject to select agent requirements will be as low 
as realistically possible from both a safety and security perspective. 
We will be addressing the need for onsite validation of both 
inactivation protocols and viability testing in guidance.
    The same commenter cited the guidance document entitled ``Non-
viable Select Agents and Nonfunctional Select Toxins and Rendering 
Samples Free of Select Agents and Toxins,'' \3\ which states that, 
``this guidance does not apply to inactivation for waste disposal.'' 
The commenter urged us to clearly and accurately describe what is 
intended regarding verification of non-viability in the regulations, 
stating that they had received comments from some inspectors indicating 
confusion between inactivation validation requirements for moving 
materials to a lower containment level and inactivation validation 
requirements for waste disposal.
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    \3\ You may view this guidance document on the Internet at 
http://www.selectagents.gov/guidance-nonviable.html.
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    We have modified the reporting requirements to require the 
responsible official to investigate any viability of material that was 
subjected to a validated inactivation protocol to

[[Page 6200]]

determine the reason of the inactivation failure. If the responsible 
official is unable to determine the reason for this failure, he or she 
must report the inactivation failure to CDC or APHIS. Our intention is 
to require registered entities to create an environment where 
inactivation failures are investigated to determine the root source of 
the errors instead of re-subjecting the material to an inactivation 
method that may be flawed or faulty. The revised language only requires 
reporting of inactivation failures to CDC or APHIS when the responsible 
official cannot determine the reason for the inactivation failure. We 
are also clarifying that these provisions apply only to those select 
agents inactivated for future use as non-select agents and not those 
intended for waste disposal.
    Two commenters asked about the minimum percentage of samples 
required to be tested to constitute a ``representative sample.'' 
Another commenter suggested that inactivated lots be stored with 
documentation that demonstrates that the lot has met the established 
standard, but added that it is impractical to conduct validated 
sterility testing on every sample that is inactivated. The commenter 
claimed that implementing such a requirement would waste specimens 
where limited volumes are available, be costly in terms of technical 
time and resources, and is scientifically unjustified.
    Successful implementation of the required validated inactivation 
procedure and the subsequent data derived from viability testing using 
that procedure will determine the extent of sampling required. We have 
removed the sterility testing requirement to allow entities flexibility 
in establishing and utilizing individualized, validated inactivation 
procedures.
    We also proposed to require that an entity conduct an annual review 
of their site-specific standard operating procedures to ensure that 
select agents or regulated nucleic acids that can produce infectious 
forms of any select agent virus are inactivated by a safety margin and 
revise as necessary.
    Two commenters questioned our use of the term ``safety margin.'' 
The commenters requested that we remove or define the term, as its 
meaning is unclear. The commenters further stated that the need for 
including a safety margin is unclear and appears superfluous if the 
intent of the requirement is to define the conditions that achieve 
conditions that render 100 percent of the select agent non-viable or 
noninfectious.
    We are not defining ``safety margin'' as the proposed regulatory 
text using this term will not be incorporated into the final rule.
    Finally, we proposed that written records be kept for any select 
agent that has been rendered nonviable or regulated nucleic acids that 
have been rendered non-infectious.
    Two commenters asked for clarification of the actions constituting 
review, including description of any documentation that will be 
expected to demonstrate compliance with the requirement. The commenters 
wanted to know if it was our expectation that the kill curve and 
sterility testing be repeated and verified annually, or if this is a 
review of data and written procedures.
    In response, we have modified the language regarding review of 
site-specific standard operating inactivation procedures to clarify 
that the entity should review these procedures to determine if they are 
being adhered to by staff. The annual review requirement does not 
necessarily involve revalidating inactivation procedures. This review 
may simply take the form of an evaluation of the site-specific standard 
operating inactivation procedures to ensure the inactivation conditions 
used and upper agent limits found in validation data are consistent and 
that the entity staff are following the site-specific standard 
operating inactivation procedures. At times an entity may need to 
revalidate inactivation procedures during the annual review. For 
example, review may be needed if the entity finds that staff are not 
adhering to standard operating procedures or if the entity wants to 
deviate from the established, validated inactivation procedure.
    While we did not receive any further comments on this issue, in 
response to comments received by CDC and in the interests of 
maintaining parity between the APHIS and CDC regulations, we have made 
the following changes:
     Establishing that surrogate strains that are known to 
possess properties equivalent to select agents may be used to validate 
the required inactivation procedures under certain conditions;
     Replacing the term ``extract'' with ``material containing 
a select agent'' to clarify that the inactivation requirements apply to 
such materials as serums or liquid cultures from which select agents 
are typically removed via filtration without first undergoing 
inactivation. This is intended to more accurately describe an element 
of a two-step process: An inactivation step to destroy the select agent 
and a second step intended to remove any remaining, viable select 
agent; and
     Clarification of when an entity may submit a waiver 
request to the Administrator as well as the procedure for such 
determinations.
    Finally, in 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 9 CFR 
121.4(d)(2), we are replacing the term ``nonfunctional toxin'' with 
``nontoxic toxin.'' We have determined that the term ``nonfunctional'' 
is overbroad and has caused confusion. Our intent was to exclude toxins 
that can no longer exert their toxic effect and cause disease. For 
example, Botulinum neurotoxin has three functional domains: Binding 
domain, translocation domain, and catalytic domain. Each functional 
domain may be solely manipulated such that the toxin is no longer toxic 
and does not cause disease even though the other two domains may remain 
functional. Note that the example provided is for a CDC toxin due to 
the fact that APHIS does not currently regulate any select toxins.

Exemptions for Select Agents and Toxins

    The provisions of 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 concern 
conditions under which entities may be exempted from the requirements 
of the regulations. We proposed to add language to paragraph (a) in 7 
CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 that specifies that entities 
may be required to report identification of agents or toxins to other 
appropriate authorities when required by Federal, State, or local law. 
Specifically, we proposed to add provisions that state that we do not 
regulate material containing select agents or toxins when it is in a 
patient care setting and is not being collected or otherwise tested or 
retained, nor do we regulate waste generated during delivery of patient 
care. However, once delivery of patient care for the select agent or 
toxin infection has concluded, waste would become subject to the 
requirements of the regulations. If an entity cannot meet these 
requirements, then the material may be transferred to another entity 
according to the select agent regulations or destroyed using an 
approved method. The decision to retain, transfer, or destroy any 
specimens must be made within 7 calendar days of the conclusion of 
patient care.
    One commenter disagreed with adding such a provision to 9 CFR 
121.5. The commenter said that VS should have authority to regulate 
waste and carcasses from animals (i.e., veterinary patients) naturally 
infected with select agents to ensure that infection does not spread to 
other livestock or poultry. The commenter asked that we alter the

[[Page 6201]]

wording of the proposed section in order to specify that the 
requirement refers to human patients only.
    The provisions the commenter refers to relate to the care of human 
patients only. However, it should be noted that any waste or carcasses 
from animals infected with a select agent, provided the select agent or 
toxin has not been intentionally introduced, cultivated, collected, or 
otherwise extracted from its natural source, are already listed as 
excluded in Sec. Sec.  121.3(d)(1) and 121.4(d)(1) of the regulations.
    While we did not receive any further comments on this issue, in 
response to comments received by CDC and in the interests of 
maintaining parity between the APHIS and CDC regulations, we are 
amending the text to clarify the following:
     That patient care refers to actions by health care 
professionals;
     To clarify that destruction and transfer requirements 
apply solely to waste generated in the course of patient care and not 
specimens or samples taken from the patient; and
     That specimens taken from a patient are not subject to the 
regulations during the period in which they are directly associated 
with the diagnosis, but all specimens taken and kept more than 7 days 
after the conclusion of patient care are subject to the regulations.

Security, Biocontainment/Biosafety, and Incident Response Plans

    The regulations require registered entities to develop and 
implement a number of plans in order to ensure the safety and security 
of the select agents they handle. These are:
     A security plan, as described by the regulations in 7 CFR 
331.11 and 9 CFR 121.11, that provides for measures sufficient to 
safeguard the select agent or toxin against unauthorized access, theft, 
loss, or release;
     A biocontainment plan, in the case of PPQ select agents, 
or a biosafety plan, in the case of VS and overlap select agents, as 
described in the regulations in 7 CFR 331.12 and 9 CFR 121.12, that 
provides for measures sufficient to contain the select agent or toxin 
(e.g., physical structure and features of the entity, and operational 
and procedural safeguards); and
     An incident response plan, as described in the regulations 
in 7 CFR 331.14 and 9 CFR 121.14, that provides for measures that the 
registered entity will implement in the event of theft, loss, or 
release of a select agent or toxin; inventory discrepancies; security 
breaches (including information systems); severe weather and other 
natural disasters; workplace violence; bomb threats and suspicious 
packages; and emergencies such as fire, gas leak, explosion, power 
outage, etc. The response procedures must account for hazards 
associated with the select agent or toxin and appropriate actions to 
contain such agent or toxin.
    All of these plans require annual review and revision as necessary. 
Drills or exercises must also be conducted at least annually to test 
and evaluate the effectiveness of the plans. The plans must be reviewed 
and revised, as necessary, after any drill or exercise and after any 
incident. We proposed to require that these drills or exercises be 
documented to include how the drill or exercise tested and evaluated 
the plan, any problems identified, any corrective action taken, and the 
names of the individuals who participated in the drill or exercise. 
This will provide a more thorough accounting of required activities as 
well as increasing the efficacy of the plans via testing and entity-
directed improvements. We proposed to add these requirements to 7 CFR 
331.11(h), 331.12(e), 331.14(f), 9 CFR 121.11(h), 121.12(e), and 
121.14(f).
    One commenter stated that the requirement to record the names of 
the individuals who participated in a given drill or exercise should be 
limited to registered entity personnel and not include first responders 
or others who participate. The commenter suggested that a list of the 
participating external agencies (e.g., emergency management, emergency 
medical services, fire department, etc.) could be included.
    We agree with the commenter's suggestion and have updated the 
regulations in order to clarify that only the names of individuals at 
the registered entity are required to be listed. The entity may choose 
to list the names of external agencies (e.g., fire department, police 
department, etc.) that participated in the drill or exercise.
    Comments on more specific proposed changes to these plans may be 
found below.

Biocontainment/Biosafety Plan

    Paragraph (a) of 7 CFR 331.12 and 9 CFR 121.12 requires that the 
biocontainment or biosafety plan contain sufficient information and 
documentation to describe the biosafety and containment procedures for 
each select agent or toxin that the registered entity will possess. The 
plan must also include a description of the biosafety and containment 
procedures for any animals (including arthropods) or plants 
intentionally or accidentally exposed to or infected with a select 
agent. We proposed to additionally require that laboratory-specific 
biocontainment and/or biosafety manuals must be accessible to 
individuals working in those laboratories. This change will help to 
foster an enhanced culture of responsibility by ensuring that 
appropriate biocontainment and/or biosafety resources are available to 
all staff with access to select agents and toxins within a select agent 
laboratory.
    One commenter suggested that the specific practice of making 
manuals accessible is already employed by registered entities. The 
commenter therefore questioned the need for a separate requirement.
    We agree with the commenter and have removed the requirement.
    Two commenters urged that, ``a description of the biosafety and 
containment procedures for any animals (including arthropods) or plants 
intentionally or accidentally exposed to or infected with a select 
agent'' should clearly refer not only to animals within the laboratory 
but also wildlife, domestic, and stray animals outside of the buildings 
if they are potentially exposed via accidental release. The commenter 
added that there should be a system in place to detect such incidents 
if they occur.
    The term ``any animals'' includes both laboratory animals as well 
as the wild, domestic, and stray animals described by the commenters. 
We will, however, add specific clarification to the guidance documents 
associated with the biocontainment and biosafety plans.
    One commenter requested clarification regarding the term 
``laboratory.'' The commenter wanted to know whether the term refers to 
a single room, a building, or to a group of rooms (e.g., laboratory, 
animal room, and necropsy) used by a principal investigator for a 
research project. The commenter also requested clarification regarding 
the phrase, ``must be available to each individual working in the 
laboratory,'' asking if this would require creation of a specific 
biocontainment or biosafety manual for each room.
    We have clarified the language to state that ``biosafety and 
containment procedures specific to use of the select agent or toxin by 
the principal investigator must be available to each individual 
involved with that project.'' This more appropriately ties the creation 
and distribution of biocontainment and biosafety manuals to specific 
projects, select agents, and people.
    We also proposed to add specific provisions to the biocontainment 
and biosafety plans that would require completion of a written risk 
assessment for each procedure.

[[Page 6202]]

    Two commenters stated that these requirements are unnecessary and 
would prove excessively burdensome to researchers and the responsible 
official and should be removed. The commenters said that the new 
requirements regarding validation of inactivation procedures would 
serve the same security function. The commenters added that APHIS 
already has opportunity to review and require amendment of an entity's 
biocontainment or biosafety plan as a condition of registration or as a 
result of inspection.
    We agree with the commenter that this level of detail would prove 
unnecessarily burdensome. We have instead added language to 7 CFR 
331.12(a)(1) and 9 CFR 331.12(a)(1) to explicitly require that the 
biocontainment and biosafety plans include a description of the 
hazardous characteristics of each agent or toxin listed on the entity's 
registration and the biosecurity or biosafety risk associated with 
laboratory procedures related to the select agent or toxin.
    One commenter asked that we define ``risk assessment,'' given that 
it is a very broad term and therefore open to interpretation. This 
commenter and another requested that we provide basic templates for 
these new required sections and indicate where registered entities and 
entities seeking registration may find these templates.
    We have revised and condensed the proposed language as a result of 
this and other comments. It no longer includes the term ``risk 
assessment.''

Training

    We proposed to amend the regulations in 7 CFR 331.15 and 9 CFR 
121.15, which concern provision of mandatory training for staff and 
visitors who work in or visit areas where select agents or toxins are 
handled or stored. We proposed to require that all individuals who have 
received approval to have access to select agents and toxins must 
undergo training regardless of whether they have access to those select 
agents or toxins. The training would have to be completed within a year 
of that individual's approval or prior to entry into an area where 
select agents and toxins are used or stored, whichever occurs first.
    Two commenters objected to the proposed addition, stating that we 
should include a description of the level of training necessary for 
personnel in varying positions with highly disparate job duties and 
responsibilities. The commenters requested that we clarify that 
required training will be conducted at a level appropriate to the 
registered person's role and level of access to select agents.
    We agree with the commenters' point and have altered the required 
training language to clearly delineate the types of training required 
for individuals with varying access levels.
    One commenter asked that we clearly specify the requirements for 
both initial and annual training. The commenter also asked that we 
consider making training a prerequisite for access to select agents and 
toxins.
    While we made no changes to our regulatory language based on this 
comment, the document entitled, ``Guidance for Meeting the Training 
Requirements of the Select Agent Regulations'' \4\ will be updated to 
provide further detail and assistance regarding the content of initial 
and annual training. The regulations in 7 CFR 331.15(a)(1) and 9 CFR 
121.15(a)(1) already require that each approved individual receive 
information and training on biosecurity/biosafety, security (including 
security awareness), and incident response before that individual has 
access to any select agents and toxins.
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    \4\ You may view this document on the Internet at http://www.selectagents.gov/guidance-training.html.
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Records

    The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required 
recordkeeping procedures for regulated entities as those records relate 
to select agents and toxins. Paragraph (a)(3)(x) requires that 
registered entities record the destruction of any toxins by 
specifically noting the quantity of toxin destroyed, the date of such 
action, and by whom. However, there is not an equivalent requirement 
regarding the destruction of select agents. We proposed to add this 
requirement in order to ensure consistency with the toxin provisions 
and ensure proper tracking of select agents from acquisition to 
destruction.
    While we did not receive any comments on this issue, in response to 
comments received by CDC and in the interests of maintaining parity 
between the APHIS and CDC regulations, we are amending the text to 
stipulate that registered entities must maintain a record of the select 
agent used, purpose of use, and, when applicable, final disposition 
(including destruction) for each select agent held in long-term 
storage.
    We also proposed to state that any records created that contain 
information related to an entity's registration or its select agents 
and toxins must be provided promptly upon request. We proposed to 
specify that such records may include, but are not limited to, 
biocontainment certifications, laboratory notebooks, institutional 
biosafety and/or animal use committee minutes and approved protocols, 
and records associated with occupational health and suitability 
programs.
    One commenter expressed concern regarding the requirement to keep 
laboratory notebooks for inspection purposes. The commenter stated that 
items may include proprietary intellectual property and requested 
clarification regarding the information needed from the notebooks. The 
commenter asked that we amend the regulatory language in order to 
protect intellectual property interests and specify if any information 
would be required from laboratory notebooks apart from that collected 
for inventory purposes.
    We agree with the commenter and we have clarified that only 
information related to the requirements of the regulations must be 
produced upon request. Such information may be found in biocontainment 
certifications, laboratory notebooks, institutional biosecurity/
biosafety and/or animal use committee minutes and approved protocols, 
and records associated with occupational health and suitability 
programs. Accordingly, we will only be reviewing relevant portions of 
any laboratory notebooks or documents and only if they contain 
information related to any requirements of the regulations.
    To ensure the accuracy of handwritten records, we also proposed to 
specify that such records must be legible.
    Another commenter suggested that we require that records be written 
in ink and not pencil and should be signed and dated when appropriate.
    We acknowledge this suggestion as good practice. However, in the 
interests of not being overly prescriptive, we are leaving the 
interpretation of ``legible'' up to individual registered entities.

Records for Select Agents in Long-Term Storage

    Paragraph (a)(1) in both 7 CFR 331.17 and 9 CFR 121.17 requires 
entities to maintain 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. We continue to receive 
comments critical of that portion of the regulations. Criticism is 
typically focused on the belief that a container-based inventory 
requirement is not a

[[Page 6203]]

useful mechanism to track inventory of biological agents, since small 
amounts could be stolen without detection and used to grow larger 
quantities.
    However, the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 obliges APHIS and CDC to include a requirement 
for ``the prompt notification of the Secretary, and appropriate 
Federal, State, and local law enforcement agencies, of the theft or 
loss of listed agents and toxins'' in the regulations. We therefore 
solicited comment regarding what regulatory requirement or requirements 
should be implemented such that a registered entity could quickly 
determine whether a select agent had been lost or stolen from long-term 
storage without that registered entity first having an accurate, 
current inventory for each select agent held in long-term storage. 
Additionally, we solicited ideas concerning ways in which the current 
regulations could be amended to address the possibility of theft of a 
select agent from a container held in long-term storage.
    One commenter stated that, while they understand the need for such 
inventory and notification requirements, an enormous amount of time and 
effort is spent during inspections validating that inventories are 
accurate. The commenter said that this has resulted in the loss of 
valuable virus isolates due to unintentional thawing, failure of 
ultralow temperature freezers due to repeated opening and the resulting 
loss of ultralow temperature, and inefficient use of employee time. The 
commenter said that measuring the volumes of stored vials of bacteria 
and viruses in the manner that toxins or other non-replicative select 
agents are inventoried is illogical. The commenter acknowledged that it 
is important to indicate the nature of the pathogens stored and the 
numbers of vials in freezer stocks, but even the most fastidious 
recordkeeping could not demonstrate that vials of replicative organisms 
had not been accessed. The commenter stated that current select agent 
practices allow for these stocks to be maintained in tamper-evident 
stocks (e.g., security ties on freezer boxes) so that vials are not 
individually removed, thawed, and measured. The commenter concluded 
that requiring the use of tools of this nature in the case of 
replicative organisms is a logical step that would not eliminate the 
need to inventory, but which also would not degrade samples and allow 
for detection of samples that may have disappeared.
    We appreciate this comment and will continue to consider how the 
recognition of theft and loss might be addressed through alternative 
approaches.

Miscellaneous Changes

    We are also adding a definition of principal investigator to the 
regulations in 7 CFR 331.1 and 9 CFR 121.1 as it is used but not 
defined in the APHIS regulations. The addition also serves to maintain 
parity with the CDC regulations. Our definition is identical to that 
used by CDC.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    In accordance with 5 U.S.C. 604, we have performed a final 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this rule on small entities. Copies of the full 
analysis are available on the Regulations.gov Web site (see footnote 1 
in this document for a link to Regulations.gov) or by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT.
    Sections 201 and 212(a)(2) of the Act require a biennial review and 
republication of the select agent and toxin list, with revisions as 
appropriate in accordance with this law. This final rule will implement 
the recommendations of the fourth biennial review of select agent 
regulations and has finalized changes that will increase their 
usability as well as provide for enhanced program oversight. These 
amendments include new provisions regarding the inactivation of select 
agents, specific biosafety and toxin requirements and clarification of 
regulatory language concerning security, training, and records. The 
final rule will require that entities develop a validated inactivation 
procedure by establishing parameters for quantities of starting 
material and measures of uncertainty for repeated successful 
inactivation. This is a broad performance standard that will allow for 
flexibility given the variety of select agents and toxins under 
regulation to define conditions of inactivation for each select agent 
or regulated infectious nucleic acid and maintain written records of 
having done so. Costs of complying with this amendment are expected to 
be modest.
    Currently, there are 291 entities registered with APHIS and CDC. Of 
these entities, there are 240 registered to possess Tier 1 select 
agents and toxins, including 78 academic, 29 commercial, 80 State 
government, 37 Federal government, and 16 private (non-profit) 
institutions, most of which are considered to be small entities. Based 
on current recordkeeping and reporting requirements, an additional 10 
to 20 hours per year may be required for maintaining records associated 
with 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 agents. At an imputed cost of 
$33.40 per hour (GS-12, step 2), this additional time requirement per 
entity will cost between $334 and $668 per year, or in total for all 
registered entities between $80,000 and $160,000. Assuming that costs 
of the rule could be considered to be significant if they exceeded 1 
percent of revenue earned by the affected entities, revenues would need 
to average less than $33,400 to $66,800 for this to be the case. While 
the vast majority of the entities in industries potentially affected by 
this rule, other than post-secondary institutions, can be considered 
small, average annual revenues are well above this range.
    Due to the reasons summarized here and explained in the analysis 
accompanying this rule, the Administrator certifies that this action 
will not have a significant economic impact on a substantial number of 
small entities.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent 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.

Executive Order 13175

    This 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

[[Page 6204]]

Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    The Animal and Plant Health Inspection Service has assessed the 
impact of this rule on Indian tribes and determined that this rule does 
not, to our knowledge, have tribal implications that require tribal 
consultation under E.O. 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.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and 
third-party disclosure requirements included this rule are in the 
process of being reinstated by the Office of Management and Budget 
under 0579-0213.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service 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. For information pertinent to E-Government Act 
compliance related to this rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at 301-851-2483.

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, 7 CFR part 331 and 9 CFR part 121 are amended 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. Section 331.1 is amended by adding, in alphabetical order, 
definitions of principal investigator, validated inactivation 
procedure, and viability testing protocol to read as follows:


Sec.  331.1   Definitions.

* * * * *
    Principal investigator. 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.
* * * * *
    Validated inactivation procedure. 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.
* * * * *
    Viability testing protocol. A protocol to confirm the validated 
inactivation procedure by demonstrating the material is free of all 
viable select agent.

0
3. Section 331.3 is amended as follows:
0
a. By revising paragraph (d)(2).
0
b. By redesignating paragraph (d)(3) as paragraph (d)(9)
0
c. By adding paragraphs (d)(3) through (8) and (e)(3).
    The additions and revision read as follows:


Sec.  331.3  PPQ select agents and toxins.

* * * * *
    (d) * * *
    (2) Nonviable select agents or nontoxic toxins.
    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.
    (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 that is confirmed through a viability 
testing protocol. 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.
    (5) 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.
    (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 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 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) A PPQ select toxin identified in an original food sample or 
clinical sample.
    (8) 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, where that waste is 
decontaminated or transferred for destruction by complying with State 
and Federal regulations within 7 calendar days of the conclusion of 
patient care.
* * * * *
    (e) * * *
    (3) An individual or entity may make a written request to the 
Administrator for reconsideration of a decision denying an application 
for the exclusion of an attenuated strain of a select agent or a select 
toxin modified to be less potent or toxic. The written request for 
reconsideration must state the facts and reasoning upon which the 
individual or entity relies to show the decision was incorrect. The 
Administrator will grant or deny the request for reconsideration as 
promptly as circumstances allow and will state, in writing, the reasons 
for the decision.
* * * * *

0
4. Section 331.5 is amended as follows:
0
a. By revising paragraph (a)(1).
0
b. In paragraph (a)(2), by removing ``; and'' and adding a period in 
its place.
0
c. By revising paragraph (a)(3).
    The revisions read as follows:


Sec.  331.5  Exemptions.

    (a) * * *
    (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 or inactivation 
process.
* * * * *

[[Page 6205]]

    (3) The identification of the agent or toxin is reported to APHIS 
or CDC, the specimen provider, and to other appropriate authorities 
when required by Federal, State, or local law by telephone, facsimile, 
or email. This report must be followed by submission of APHIS/CDC Form 
4 to APHIS or CDC within 7 calendar days after identification.
* * * * *

0
5. Section 331.7 is amended as follows:
0
a. By redesignating paragraphs (b) through (k) as paragraphs (c) 
through (l), respectively.
0
b. By adding a new paragraph (b).
    The addition reads as follows:


Sec.  331.7  Registration and related security risk assessments.

* * * * *
    (b) As a condition of registration, each entity is required to be 
in compliance with the requirements of this part for select agents and 
toxins listed on the registration regardless of whether the entity is 
in actual possession of the select agent or toxin. With regard to 
toxins, the entity registered for possession, use, or transfer of a 
toxin must be in compliance with the requirements of this part 
regardless of the amount of toxins currently in its possession.
* * * * *

0
6. Section 331.9 is amended as follows:
0
a. By removing the semicolons at the ends of paragraphs (a)(1) through 
(4) and ``; and'' at the end of paragraph (a)(5) and adding periods in 
their place.
0
b. In paragraph (a)(6), by removing the word ``laboratory'' and adding 
the words ``registered space'' in its place and by adding the words 
``and the corrections documented'' at the end of the second sentence 
after the words ``must be corrected''.
0
c. By adding paragraphs (a)(7), (8), and (9).
    The additions read as follows:


Sec.  331.9  Responsible official.

    (a) * * *
    (7) Ensure that individuals are provided the contact information 
for the USDA Office of Inspector General Hotline and the HHS Office of 
Inspector General Hotline so that they may anonymously report any 
biosafety/biocontainment or security concerns related to select agents 
and toxins.
    (8) Investigate to determine the reason for any failure of a 
validated inactivation procedure or any failure to remove viable select 
agent from material. If the responsible official is unable to determine 
the cause of a deviation from a validated inactivation procedure or a 
viable select agent removal method; or receives any report of any 
inactivation failure after the movement of material to another 
location, the responsible official must report immediately by telephone 
or email the inactivation or viable agent removal method failure to 
APHIS or CDC.
    (9) Review, and revise as necessary, each of the entity's validated 
inactivation procedures or viable select agent removal methods. The 
review must be conducted annually or after any change in principal 
investigator, change in the validated inactivation procedure or viable 
select agent removal method, or failure of the validated inactivation 
procedure or viable select agent removal method. The review must be 
documented and training must be conducted if there are any changes to 
the validated inactivation procedure, viable select agent removal 
method, or viability testing protocol.
* * * * *

0
7. In Sec.  331.10, paragraph (e) is amended by adding a sentence at 
the end of the paragraph to read as follows:


Sec.  331.10  Restricting access to select agents and toxins; security 
risk assessments.

* * * * *
    (e) * * * A responsible official must immediately notify the 
responsible official of the visiting entity if the person's access to 
select agents or toxins has been terminated.
* * * * *

0
8. Section 331.11 is amended as follows:
0
a. In paragraph (c)(5), by adding the word ``keycards,'' after the word 
``keys,'' and by removing the word ``numbers'' and adding the word 
``permissions'' in its place.
0
b. In paragraph (d)(7)(iv), by removing the word ``and''.
0
c. By adding paragraph (d)(7)(vi).
0
d. By adding a sentence at the end of paragraph (h).
    The additions read as follows:


Sec.  331.11   Security.

* * * * *
    (d) * * *
    (7) * * *
    (vi) Any loss of computer, hard drive or other data storage device 
containing information that can be used to gain access to select agents 
or toxins; and
* * * * *
    (h) * * * Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

0
9. Section 331.12 is amended as follows:
0
a. By revising paragraph (a).
0
b. By adding a sentence at the end of paragraph (e).
    The addition and revision read as follows:


Sec.  331.12  Biocontainment.

    (a) An individual or entity required to register under this part 
must develop and implement a written biocontainment plan that is 
commensurate with the risk of the select agent or toxin, given its 
intended use.\4\ The biocontainment plan must contain sufficient 
information and documentation to describe the biocontainment procedures 
for the select agent or toxin, including any animals (including 
arthropods) or plants intentionally or accidentally exposed to or 
infected with a select agent. The current biocontainment plan must be 
submitted for initial registration, renewal of registration, or when 
requested. The biocontainment plan must include the following 
provisions:
---------------------------------------------------------------------------

    \4\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

    (1) The hazardous characteristics of each agent or toxin listed on 
the entity's registration and the biocontainment risk associated with 
laboratory procedures related to the select agent or toxin;
    (2) Safeguards in place with associated work practices to protect 
entity personnel, the public, and the environment from exposure to the 
select agent or toxin including, but not limited to: Personal 
protective equipment and other safety equipment; containment equipment 
including, but not limited to, biological safety cabinets, animal 
caging systems, and centrifuge safety containers; and engineering 
controls and other facility safeguards;
    (3) Written procedures for each validated method used for 
disinfection, decontamination, or destruction, as appropriate, of all 
contaminated or presumptively contaminated materials including, but not 
limited to: Cultures and other materials related to the propagation of 
select agents or toxins, items related to the analysis of select agents 
and toxins, personal protective equipment, arthropod containment 
systems, extracted plant and/or arthropod tissues, laboratory surfaces 
and equipment, and effluent material; and
    (4) Procedures for the handling of select agents and toxins in the 
same

[[Page 6206]]

spaces with non-select agents and toxins to prevent unintentional 
contamination.
* * * * *
    (e) * * * Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

0
10. Section 331.14 is amended as follows:
0
a. By adding a sentence at the end of paragraph (a).
0
b. By adding a sentence at the end of paragraph (f).
    The additions read as follows:


Sec.  331.14  Incident response.5
---------------------------------------------------------------------------

    \5\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.
---------------------------------------------------------------------------

    (a) * * * The current incident response plan must be submitted for 
initial registration, renewal of registration, or when requested.
* * * * *
    (f) * * * Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

0
11. Section 331.15 is amended as follows:
0
a. By revising paragraph (a).
0
b. By adding paragraph (e).
    The addition and revision read as follows:


Sec.  331.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biocontainment, biosafety, 
security (including security awareness), and incident response to:
    (1) Each individual with access approval from the Administrator or 
HHS Secretary. The training must address the particular needs of the 
individual, the work they will do, and the risks posed by the select 
agents or toxins. The training must be accomplished prior to the 
individual's entry into an area where a select agent is handled or 
stored, or within 12 months of the date the individual was approved by 
the Administrator or the HHS Secretary for access, whichever is 
earlier.
    (2) Each individual not approved for access to select agents and 
toxins by the Administrator or HHS Secretary before that individual 
enters areas under escort where select agents or toxins are handled or 
stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, 
storage areas, shipping/receiving areas, production facilities, etc.). 
Training for escorted personnel must be based on the risk associated 
with accessing areas where select agents and toxins are used and/or 
stored. The training must be accomplished prior to the individual's 
entry into where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage 
areas, shipping/receiving areas, production facilities, etc.).
* * * * *
    (e) The responsible official must ensure and document that 
individuals are provided the contact information of the USDA Office of 
Inspector General Hotline and the HHS Office of Inspector General 
Hotline so that they may anonymously report any safety or security 
concerns related to select agents and toxins.

0
12. In Sec.  331.16, paragraph (b) introductory text is revised to read 
as follows:


Sec.  331.16   Transfers.

* * * * *
    (b) A transfer may be authorized if:
* * * * *

0
13. Section 331.17 is amended as follows:
0
a. In paragraph (a)(1)(iii), by adding the words ``or other storage 
container'' after the word ``freezer''.
0
b. By revising paragraph (a)(1)(v).
0
c. In paragraph (a)(3)(v), by adding the words ``or other storage 
container'' after the word ``freezer''.
0
d. By removing the word ``and'' at the end of paragraph (a)(6) and 
removing the period at the end of paragraph (a)(7) and adding ``; and'' 
in its place.
0
e. By adding paragraph (a)(8).
0
f. By revising paragraphs (b) and (c).
    The addition and revisions read as follows:


Sec.  331.17  Records.

    (a) * * *
    (1) * * *
    (v) The select agent used, purpose of use, and, when applicable, 
final disposition;
* * * * *
    (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 procedure for removal of viable select agent:
    (i) A written description of the validated inactivation procedure 
or viable select agent removal method 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 responsible official involving an inactivation or viable select 
agent removal failure and the corrective actions taken;
    (iv) The name of each individual performing the validated 
inactivation or viable select agent removal method;
    (v) The date(s) the validated inactivation or viable select agent 
removal method was completed;
    (vi) The location where the validated inactivation or viable select 
agent removal method was performed; and
    (vii) 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. A copy of the certificate must 
accompany any transfer of inactivated or select agent removed material.
    (b) The individual or entity must implement a system to ensure that 
all records and databases created under this part are accurate and 
legible, have controlled access, and that their authenticity may be 
verified.
    (c) The individual or entity must promptly produce upon request any 
information that is related to the requirements of this part but is not 
otherwise contained in a record required to be kept by this section. 
The location of such information may include, but is not limited to, 
biocontainment certifications, laboratory notebooks, institutional 
biosafety and/or animal use committee minutes and approved protocols, 
and records associated with occupational health and suitability 
programs. All records created under this part must be maintained for 3 
years.

Title 9--Animals and Animal Products

PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

0
14. 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
15. Section 121.1 is amended by adding, in alphabetical order, 
definitions of principal investigator, validated inactivation 
procedure, and viability testing protocol to read as follows:


Sec.  121.1  Definitions.

* * * * *

[[Page 6207]]

    Principal investigator. 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.
* * * * *
    Validated inactivation procedure. 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.
* * * * *
    Viability testing protocol. A protocol to confirm the validated 
inactivation procedure by demonstrating the material is free of all 
viable select agent.
* * * * *

0
16. Section 121.3 is amended as follows:
0
a. By revising paragraph (d)(2).
0
b. By redesignating paragraph (d)(3) as paragraph (d)(4).
0
c. By adding a new paragraph (d)(3).
0
d. By revising newly redesignated paragraph (d)(4).
0
e. By adding paragraphs (d)(5) through (9) and (e)(3).
    The additions and revisions read as follows:


Sec.  121.3  VS select agents and toxins.

* * * * *
    (d) * * *
    (2) Nonviable VS select agents or nontoxic VS toxins.\3\
---------------------------------------------------------------------------

    \3\ However, the importation and interstate movement of these 
nonviable select agents may be subject to the permit requirements 
under part 122 of this subchapter.
---------------------------------------------------------------------------

    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.
    (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 that is confirmed through a viability 
testing protocol. 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.
    (5) 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.
    (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 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 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) A VS select toxin identified in an original food sample or 
clinical sample.
    (8) 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, where that waste is 
decontaminated or transferred for destruction by complying with State 
and Federal regulations within 7 calendar days of the conclusion of 
patient care.
    (9) Any low pathogenic strains of avian influenza virus, avian 
paramyxovirus serotype-1 (APMV-1) viruses which do not meet the 
criteria for Newcastle disease virus,\4\ including those identified as 
pigeon paramyxovirus-12 \5\ isolated from a non-poultry species, all 
subspecies Mycoplasma capricolum except subspecies capripneumoniae 
(contagious caprine pleuropneumonia), and all subspecies Mycoplasma 
mycoides except subspecies mycoides small colony (Mmm SC) (contagious 
bovine pleuropneumonia), provided that the individual or entity can 
identify that the agent is within the exclusion category.
---------------------------------------------------------------------------

    \4\ An APMV-1 virus isolated from poultry which has an 
intracerebral pathogenicity index in day[hyphen]old chicks (Gallus 
gallus) of 0.7 or greater or has an amino acid sequence at the 
fusion (F) protein cleavage site that is consistent with virulent 
strains of Newcastle disease virus. A failure to detect a cleavage 
site that is consistent with virulent strains does not confirm the 
absence of a virulent virus.
    \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 monoclonal antibody testing and 
demonstration of their characteristic amino acid signature at the 
fusion gene cleavage site.
---------------------------------------------------------------------------

    (e) * * *
    (3) An individual or entity may make a written request to the 
Administrator for reconsideration of a decision denying an application 
for the exclusion of an attenuated strain of a select agent or a select 
toxin modified to be less potent or toxic. The written request for 
reconsideration must state the facts and reasoning upon which the 
individual or entity relies to show the decision was incorrect. The 
Administrator will grant or deny the request for reconsideration as 
promptly as circumstances allow and will state, in writing, the reasons 
for the decision.
* * * * *

0
17. Section 121.4 is amended as follows:
0
a. In paragraph (c)(1), by redesignating footnote 4 as footnote 6.
0
b. In paragraph (c)(2) introductory text, by removing the word 
``functional'' and adding in its place the word ``toxic''.
0
c. By revising paragraph (d)(2).
0
d. By redesignating paragraph (d)(3) as paragraph (d)(9).
0
e. By adding paragraphs (d)(3) through (8) and (e)(3).
    The additions and revision read as follows:


Sec.  121.4  Overlap select agents and toxins.

* * * * *
    (d) * * *
    (2) Nonviable overlap select agents or nontoxic overlap toxins.\7\
---------------------------------------------------------------------------

    \7\ However, the importation and interstate movement of these 
nonviable overlap select agents may be subject to the permit 
requirements under part 122 of this subchapter.
---------------------------------------------------------------------------

    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.
    (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 that is confirmed through a viability 
testing protocol. 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.
    (5) 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.
    (6) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus not subjected

[[Page 6208]]

to a validated inactivation procedure or material containing a select 
agent not subjected to a 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) An overlap select toxin identified in an original food sample 
or clinical sample.
    (8) 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, where that waste is 
decontaminated or transferred for destruction by complying with State 
and Federal regulations within 7 calendar days of the conclusion of 
patient care.
* * * * *
    (e) * * *
    (3) An individual or entity may make a written request to the 
Administrator or HHS Secretary for reconsideration of a decision 
denying an application for the exclusion of an attenuated strain of a 
select agent or a select toxin modified to be less potent or toxic. The 
written request for reconsideration must state the facts and reasoning 
upon which the individual or entity relies to show the decision was 
incorrect. The Administrator or HHS Secretary will grant or deny the 
request for reconsideration as promptly as circumstances allow and will 
state, in writing, the reasons for the decision.
* * * * *

0
18. In Sec.  121.5, paragraph (a) is revised as follows:


Sec.  121.5  Exemptions for VS select agents and toxins.

    (a) 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 or inactivation 
process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported;
    (3) Unless otherwise directed by the Administrator, the clinical or 
diagnostic specimens collected from a patient infected with a select 
agent are transferred in accordance with Sec.  121.16 or destroyed on-
site by a recognized sterilization or inactivation process within 7 
calendar days after delivery of patient care by heath care 
professionals has concluded; and
    (4) The identification of the agent or toxin is reported to APHIS 
or CDC, the specimen provider, and to other appropriate authorities 
when required by Federal, State, or local law by telephone, facsimile, 
or email. This report must be followed by submission of APHIS/CDC Form 
4 to APHIS or CDC within 7 calendar days after identification.
* * * * *

0
19. Section 121.6 is amended as follows:
0
a. By revising paragraph (a)(1).
0
b. In paragraph (a)(2), by removing the word ``and'' at the end of the 
paragraph.
0
c. By redesignating paragraph (a)(3) as paragraph (a)(4).
0
d. By adding new paragraph (a)(3).
0
e. By revising newly redesignated paragraph (a)(4).
    The addition and revisions read as follows:


Sec.  121.6   Exemptions for overlap select agents and toxins.

    (a) * * *
    (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 or inactivation 
process;
* * * * *
    (3) Unless otherwise directed by the Administrator or HHS 
Secretary, the clinical or diagnostic specimens collected from a 
patient infected with a select agent are transferred in accordance with 
Sec.  121.16 or destroyed on-site by a recognized sterilization or 
inactivation process within 7 calendar days after delivery of patient 
care by heath care professionals has concluded; and
    (4) The identification of the agent or toxin is reported to APHIS 
or CDC, the specimen provider, and to other appropriate authorities 
when required by Federal, State, or local law by telephone, facsimile, 
or email. This report must be followed by submission of APHIS/CDC Form 
4 to APHIS or CDC within 7 calendar days after identification.
* * * * *

0
20. Section 121.7 is amended as follows:
0
a. By redesignating paragraphs (b) through (k) as paragraphs (c) 
through (l), respectively.
0
b. By adding a new paragraph (b).
0
c. In newly redesignated paragraph (d)(3) introductory text, by 
redesignating footnote 6 as footnote 8.
0
d. In newly redesignated paragraph (i)(1), by redesignating footnote 7 
as footnote 9.
    The addition reads as follows:


Sec.  121.7  Registration and related security risk assessments.

* * * * *
    (b) As a condition of registration, each entity is required to be 
in compliance with the requirements of this part for select agents and 
toxins listed on the registration regardless of whether the entity is 
in actual possession of the select agent or toxin. With regard to 
toxins, the entity registered for possession, use, or transfer of a 
toxin must be in compliance with the requirements of this part 
regardless of the amount of toxins currently in its possession.
* * * * *


Sec.  121.8  [Amended]

0
21. In Sec.  121.8, footnote 8 is redesignated as footnote 10.

0
22. Section 121.9 is amended as follows:
0
a. By removing the semicolons at the ends of paragraphs (a)(1) through 
(4) and ``; and'' at the end of paragraph (a)(5) an adding periods in 
their place.
0
b. In paragraph (a)(6), by removing the word ``laboratory'' and adding 
the words ``registered space'' in its place and by adding the words 
``and the corrections documented'' at the end of the second sentence 
after the words ``must be corrected''.
0
c. By adding paragraphs (a)(7), (8), and (9).
    The additions read as follows:


Sec.  121.9  Responsible official.

    (a) * * *
    (7) Ensure that individuals are provided the contact information 
for the USDA Office of Inspector General Hotline and the HHS Office of 
Inspector General Hotline so that they may anonymously report any 
biosafety/biocontainment or security concerns related to select agents 
and toxins.
    (8) Investigate to determine the reason for any failure of a 
validated

[[Page 6209]]

inactivation procedure or any failure to remove viable select agent 
from material. If the responsible official is unable to determine the 
cause of a deviation from a validated inactivation procedure or a 
viable select agent removal method; or receives any report of any 
inactivation failure after the movement of material to another 
location, the responsible official must report immediately by telephone 
or email the inactivation or viable agent removal method failure to 
APHIS or CDC.
    (9) Review, and revise as necessary, each of the entity's validated 
inactivation procedures or viable select agent removal methods. The 
review must be conducted annually or after any change in principal 
investigator, change in the validated inactivation procedure or viable 
select agent removal method, or failure of the validated inactivation 
procedure or viable select agent removal method. The review must be 
documented and training must be conducted if there are any changes to 
the validated inactivation procedure, viable select agent removal 
method, or viability testing protocol.
* * * * *

0
23. In Sec.  121.10, paragraph (e) is amended by adding a sentence at 
the end of the paragraph to read as follows:


Sec.  121.10   Restricting access to select agents and toxins; security 
risk assessments.

* * * * *
    (e) * * * A responsible official must immediately notify the 
responsible official of the visited entity if the person's access to 
select agents and toxins has been terminated.
* * * * *

0
24. Section 121.11 is amended as follows:
0
a. In paragraph (c)(5), by adding the word ``keycards,'' after the word 
``keys,'' and by removing the word ``numbers'' and adding the word 
``permissions'' in its place.
0
b. In paragraph (d)(7)(iv), by removing the word ``and''.
0
c. By adding paragraph (d)(7)(vi).
0
d. By adding a sentence at the end of paragraph (h).
    The additions read as follows:


Sec.  121.11  Security.

* * * * *
    (d) * * *
    (7) * * *
    (vi) Any loss of computer, hard drive or other data storage device 
containing information that could be used to gain access to select 
agents or toxins; and
* * * * *
    (h) * * * Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

0
25. Section 121.12 is amended as follows:
0
a. By revising paragraph (a).
0
b. By removing paragraph (c)(2).
0
c. By redesignating paragraph (c)(3) as paragraph (c)(2), and in newly 
redesignated paragraph (c)(2), removing the words ``NIH Guidelines for 
Research Involving Recombinant DNA Molecules'' and adding in their 
place the words ``NIH Guidelines for Research Involving Recombinant or 
Synthetic Nucleic Acid Molecules''.
0
d. By adding a sentence at the end of paragraph (e).
    The addition and revision read as follows:


Sec.  121.12   Biosafety.

    (a) An individual or entity required to register under this part 
must develop and implement a written biosafety plan that is 
commensurate with the risk of the select agent or toxin, given its 
intended use.\11\ The biosafety plan must contain sufficient 
information and documentation to describe the biosafety and containment 
procedures for the select agent or toxin, including any animals 
(including arthropods) or plants intentionally or accidentally exposed 
to or infected with a select agent. The current biosafety plan must be 
submitted for initial registration, renewal of registration, or when 
requested. The biosafety plan must include the following provisions:
---------------------------------------------------------------------------

    \11\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

    (1) The hazardous characteristics of each agent or toxin listed on 
the entity's registration and the biosafety risk associated with 
laboratory procedures related to the select agent or toxin;
    (2) Safeguards in place with associated work practices to protect 
entity personnel, the public, and the environment from exposure to the 
select agent or toxin including, but not limited to: Personal 
protective equipment and other safety equipment; containment equipment 
including, but not limited to, biological safety cabinets, animal 
caging systems, and centrifuge safety containers; and engineering 
controls and other facility safeguards;
    (3) Written procedures for each validated method used for 
disinfection, decontamination, or destruction, as appropriate, of all 
contaminated or presumptively contaminated materials including, but not 
limited to: Cultures and other materials related to the propagation of 
select agents or toxins, items related to the analysis of select agents 
and toxins, personal protective equipment, animal caging systems and 
bedding (if applicable), animal carcasses or extracted tissues and 
fluids (if applicable), laboratory surfaces and equipment, and effluent 
material; and
    (4) Procedures for the handling of select agents and toxins in the 
same spaces with non-select agents and toxins to prevent unintentional 
contamination.
* * * * *
    (e) * * * Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

0
26. Section 121.14 is amended as follows:
0
a. In the section heading, by redesignating footnote 10 as footnote 12.
0
b. In paragraph (a), by redesignating footnote 11 as footnote 13, and 
by adding a sentence at the end of the paragraph.
0
c. In paragraph (f), by adding a sentence at the end of the paragraph.
    The additions read as follows:


Sec.  121.14  Incident response.\12\
---------------------------------------------------------------------------

    \12\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.
---------------------------------------------------------------------------

    (a) * * * The current incident response plan must be submitted for 
initial registration, renewal of registration, or when requested.
* * * * *
    (f) * * * Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

0
27. Section 121.15 is amended as follows:
0
a. By revising paragraph (a).
0
e. By adding paragraph (e).
    The addition and revision read as follows:


Sec.  121.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biocontainment, biosafety, 
security (including security awareness), and incident response to:
    (1) Each individual with access approval from the Administrator or 
HHS Secretary. The training must address the particular needs of the 
individual, the

[[Page 6210]]

work they will do, and the risks posed by the select agents or toxins. 
The training must be accomplished prior to the individual's entry into 
an area where a select agent is handled or stored, or within 12 months 
of the date the individual was approved by the Administrator or the HHS 
Secretary for access, whichever is earlier.
    (2) Each individual not approved for access to select agents and 
toxins by the Administrator or HHS Secretary before that individual 
enters areas under escort where select agents or toxins are handled or 
stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, 
storage areas, shipping/receiving areas, production facilities, etc.). 
Training for escorted personnel must be based on the risk associated 
with accessing areas where select agents and toxins are used and/or 
stored. The training must be accomplished prior to the individual's 
entry into where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage 
areas, shipping/receiving areas, production facilities, etc.).
* * * * *
    (e) The responsible official must ensure and document that 
individuals are provided the contact information of the USDA Office of 
Inspector General Hotline and the HHS Office of Inspector General 
Hotline so that they may anonymously report any safety or security 
concerns related to select agents and toxins.

0
28. Section Sec.  121.16 is amended as follows:
0
a. In paragraph (a), by redesignating footnote 12 as footnote 14.
0
b. By revising paragraph (b) introductory text.
0
c. By adding paragraph (l).
    The addition and revision read as follows:


Sec.  121.16   Transfers.

* * * * *
    (b) A transfer may be authorized if:
* * * * *
    (l) Transfer the amounts only after the transferor uses due 
diligence and documents that the recipient has a legitimate need (e.g., 
prophylactic, protective, bona fide research, or other peaceful 
purpose) to handle or use such toxins. Information to be documented 
includes, but is not limited, to the recipient information, toxin and 
amount transferred, and declaration that the recipient has legitimate 
purpose to store and use such toxins.

0
29. Section 121.17 is amended as follows:
0
a. In paragraph (a)(1)(iii), by adding the words ``or other storage 
container'' after the word ``freezer''.
0
b. By revising paragraph (a)(1)(v).
0
c. In paragraph (a)(3)(v), by adding the words ``or other storage 
container'' after the word ``freezer''.
0
d. By removing the word ``and'' at the end of paragraph (a)(6) and 
removing the period at the end of paragraph (a)(7) and adding the word 
``; and'' in its place.
0
e. By adding paragraph (a)(8).
0
f. By revising paragraphs (b) and (c).
    The addition and revisions read as follows:


Sec.  121.17   Records.

    (a) * * *
    (1) * * *
    (v) The select agent used, purpose of use, and, when applicable, 
final disposition;
* * * * *
    (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 procedure for removal of viable select agent:
    (i) A written description of the validated inactivation procedure 
or viable select agent removal method 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 responsible official involving an inactivation or viable select 
agent removal failure and the corrective actions taken;
    (iv) The name of each individual performing the validated 
inactivation or viable select agent removal method;
    (v) The date(s) the validated inactivation or viable select agent 
removal method was completed;
    (vi) The location where the validated inactivation or viable select 
agent removal method was performed; and
    (vii) 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. A copy of the certificate must 
accompany any transfer of inactivated or select agent removed material.
    (b) The individual or entity must implement a system to ensure that 
all records and databases created under this part are accurate and 
legible, have controlled access, and that their authenticity may be 
verified.
    (c) The individual or entity must promptly produce upon request any 
information that is related to the requirements of this part but is not 
otherwise contained in a record required to be kept by this section. 
The location of such information may include, but is not limited to, 
biocontainment certifications, laboratory notebooks, institutional 
biosafety and/or animal use committee minutes and approved protocols, 
and records associated with occupational health and suitability 
programs. All records created under this part must be maintained for 3 
years.

    Done in Washington, DC, this 10th day of January 2017.
Elvis S. Cordova,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2017-00857 Filed 1-18-17; 8:45 am]
 BILLING CODE 3410-34-P