82_FR_6209 82 FR 6197 - 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

82 FR 6197 - 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

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range6197-6210
FR Document2017-00857

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 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.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6197-6210]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                                                                                                                                                             6197

                                                  Rules and Regulations                                                                                            Federal Register
                                                                                                                                                                   Vol. 82, No. 12

                                                                                                                                                                   Thursday, January 19, 2017



                                                  This section of the FEDERAL REGISTER                    as an area of application county to the                    DEFINITIONS OF WAGE AREAS AND
                                                  contains regulatory documents having general            Nueces, TX, NAF FWS wage area.                             WAGE AREA SURVEY AREAS—Con-
                                                  applicability and legal effect, most of which             FPRAC, the national labor-
                                                  are keyed to and codified in the Code of                                                                           tinued
                                                                                                          management committee responsible for                      Huron
                                                  Federal Regulations, which is published under           advising OPM on matters concerning                        Iosco
                                                  50 titles pursuant to 44 U.S.C. 1510.
                                                                                                          the pay of FWS employees, reviewed                        Kent
                                                  The Code of Federal Regulations is sold by              and recommended this change by                            Leelanau
                                                  the Superintendent of Documents. Prices of              consensus.                                                Ottawa
                                                  new books are listed in the first FEDERAL                 The proposed rule had a 30-day                          Saginaw
                                                  REGISTER issue of each week.                            comment period, during which OPM                          Washtenaw
                                                                                                                                                                    Wayne
                                                                                                          received no comments.                                    Ohio:
                                                                                                          Regulatory Flexibility Act                                Ottawa
                                                  OFFICE OF PERSONNEL
                                                  MANAGEMENT                                                 I certify that these regulations will not               *          *         *           *            *
                                                                                                          have a significant economic impact on                                         TEXAS
                                                  5 CFR Part 532                                          a substantial number of small entities
                                                  RIN 3206–AN40                                           because they will affect only Federal                      *          *          *          *            *
                                                                                                          agencies and employees.                                                       Nueces
                                                  Prevailing Rate Systems; Definition of                                                                                              Survey Area
                                                                                                          List of Subjects in 5 CFR Part 532                       Texas:
                                                  Kent County, Michigan, and Cameron
                                                  County, Texas, to Nonappropriated                         Administrative practice and                              Nueces
                                                  Fund Federal Wage System Wage                           procedure, Freedom of information,                          Area of Application. Survey area plus:
                                                  Areas                                                   Government employees, Reporting and                      Texas:
                                                                                                          recordkeeping requirements, Wages.                         Bee
                                                  AGENCY:  U.S. Office of Personnel                       U.S. Office of Personnel Management.                       Calhoun
                                                  Management.                                                                                                        Cameron
                                                                                                          Beth F. Cobert,                                            Kleberg
                                                  ACTION: Final rule.
                                                                                                          Acting Director.                                           San Patricio
                                                  SUMMARY:   This rule amends the                           Accordingly, OPM is amending 5 CFR                       Webb
                                                  geographic boundaries of two                            part 532 as follows:
                                                                                                                                                                     *          *           *         *            *
                                                  nonappropriated fund (NAF) Federal
                                                  Wage System (FWS) wage areas. Based                     PART 532—PREVAILING RATE                                 [FR Doc. 2017–00574 Filed 1–18–17; 8:45 a.m.]
                                                  on recommendations of the Federal                       SYSTEMS                                                  BILLING CODE 6325–39–P
                                                  Prevailing Rate Advisory Committee
                                                                                                          ■ 1. The authority citation for part 532
                                                  (FPRAC), the U.S. Office of Personnel
                                                                                                          continues to read as follows:                            DEPARTMENT OF AGRICULTURE
                                                  Management (OPM) is defining Kent
                                                  County, Michigan, as an area of                           Authority: 5 U.S.C. 5343, 5346; § 532.707
                                                  application county to the Macomb, MI,                   also issued under 5 U.S.C. 552.                          Animal and Plant Health Inspection
                                                  NAF FWS wage area and Cameron                           ■  2. The table in appendix D to subpart                 Service
                                                  County, Texas, as an area of application                B is amended by revising the wage area
                                                  county to the Nueces, TX, NAF FWS                       listing for the Macomb, MI, and Nueces,                  7 CFR Part 331
                                                  wage area. These changes are necessary                  TX, wage areas to read as follows:
                                                  due to NAF FWS employees working in                                                                              9 CFR Part 121
                                                  Kent and Cameron Counties, and the                      Appendix D to Subpart B of Part 532—
                                                                                                          Nonappropriated Fund Wage and                            [Docket No. APHIS–2014–0095]
                                                  counties are not currently defined to
                                                  NAF wage areas.                                         Survey Areas                                             RIN 0579–AE08
                                                  DATES: Effective date: This regulation is               *        *      *       *      *                         Agricultural Bioterrorism Protection
                                                  effective on January 19, 2017.                                                                                   Act of 2002; Biennial Review and
                                                     Applicability date: This change                            DEFINITIONS OF WAGE AREAS AND                      Republication of the Select Agent and
                                                  applies on the first day of the first                           WAGE AREA SURVEY AREAS                           Toxin List; Amendments to the Select
                                                  applicable pay period beginning on or                                                                            Agent and Toxin Regulations
                                                  after February 21, 2017.                                    *           *          *           *          *
                                                                                                                                MICHIGAN                           AGENCY:  Animal and Plant Health
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                                                 Macomb                            Inspection Service, USDA.
                                                  Madeline Gonzalez, by telephone at
                                                                                                                                Survey Area                        ACTION: Final rule.
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  (202) 606–2858 or by email at pay-leave-
                                                                                                          Michigan:
                                                  policy@opm.gov.                                          Macomb                                                  SUMMARY:   In accordance with the
                                                  SUPPLEMENTARY INFORMATION: On August                      Area of Application. Survey area plus:                 Agricultural Bioterrorism Protection Act
                                                  24, 2016, OPM issued a proposed rule                    Michigan:                                                of 2002, we are amending and
                                                  (81 FR 57809) to define Kent County,                     Alpena                                                  republishing the list of select agents and
                                                  Michigan, as an area of application                      Calhoun                                                 toxins that have the potential to pose a
                                                  county to the Macomb, MI, NAF FWS                        Crawford                                                severe threat to animal or plant health,
                                                  wage area and Cameron County, Texas,                     Grand Traverse                                          or to animal or plant products. The Act


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                                                  6198             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                  requires the biennial review and                        primary responsibility for implementing                plant products, and amend the
                                                  republication of the list of select agents              the provisions of the Bioterrorism                     regulations in order to add definitions
                                                  and toxins and the revision of the list as              Response Act for the Department of                     and clarify language concerning
                                                  necessary. This action will amend the                   Health and Human Services (HHS).                       security, training, biosafety,
                                                  regulations in several ways, including                     Subtitle B (which is cited as the                   biocontainment, and incident response.
                                                  the addition of provisions to address the               ‘‘Agricultural Bioterrorism Protection                   We solicited comments concerning
                                                  inactivation of select agents, provisions               Act of 2002’’ and referred to below as                 our proposal for 60 days ending March
                                                  addressing biocontainment and                           the Act), section 212(a), provides, in                 21, 2016. We received 24 comments by
                                                  biosafety, and clarification of regulatory              part, that the Secretary of Agriculture                that date. They were from researchers,
                                                  language concerning security, training,                 (the Secretary) must establish by                      scientific organizations, industry
                                                  incident response, and records. These                   regulation a list of each biological agent             groups, laboratories, and universities.
                                                  changes will increase the usability of                  and each toxin that the Secretary                      Eighteen were supportive of the
                                                  the select agent regulations as well as                 determines has the potential to pose a                 proposed action. The remaining six
                                                  providing for enhanced program                          severe threat to animal or plant health,               comments are discussed below by topic.
                                                  oversight. After carefully considering                  or to animal or plant products.
                                                                                                                                                                 Removal of Select Agents and Toxins
                                                  the technical input of subject matter                   Paragraph (a)(2) of section 212 requires
                                                  experts and recommendations from                        the Secretary to review and republish                     We proposed to amend the list of PPQ
                                                  Federal advisory groups, we have                        the list every 2 years and to revise the               select agents and toxins listed in 7 CFR
                                                  decided not to finalize the proposed                    list as necessary. In this document, we                331.3 by removing three PPQ select
                                                  changes to the contents of the list of                  are amending and republishing the list                 agents and toxins from the list:
                                                  select agents and toxins at this time. In               of select agents and toxins based on the               Peronosclerospora philippinensis
                                                  a companion document published in                       findings of our fourth biennial review of              (Peronosclerospora sacchari),
                                                  this issue of the Federal Register, the                 the list.                                              Sclerophthora rayssiae, and Phoma
                                                  Centers for Disease Control and                            In determining whether to include an                glycinicola (formerly Pyrenochaeta
                                                  Prevention has made parallel regulatory                 agent or toxin on the list, the Act                    glycines).
                                                  changes.                                                requires that the following criteria be                   We also proposed to remove three
                                                                                                          considered:                                            overlap select agents and toxins from
                                                  DATES: Effective February 21, 2017.
                                                  FOR FURTHER INFORMATION CONTACT: Dr.
                                                                                                             • The effect of exposure to the agent               the list set out in 9 CFR 121.4(b):
                                                                                                          or the toxin on animal and plant health,               Bacillus anthracis (Pasteur strain),
                                                  Freeda Isaac, National Director,                                                                               Brucella abortus and Brucella suis.
                                                  Agriculture Select Agent Services,                      and on the production and marketability
                                                                                                          of animal or plant products;                              After carefully considering the
                                                  APHIS, 4700 River Road, Unit 2,                                                                                technical input of subject matter experts
                                                  Riverdale, MD 20737–1231; (301) 851–                       • The pathogenicity of the agent or
                                                                                                          the toxin and the methods by which the                 and recommendations from Federal
                                                  3300, Option 3.                                                                                                advisory groups, we have decided not to
                                                                                                          agent or toxin is transferred to animals
                                                  SUPPLEMENTARY INFORMATION:                                                                                     finalize the proposed changes to the list
                                                                                                          or plants;
                                                  Background                                                 • The availability and effectiveness of             of select agents and toxins at this time.
                                                    The Public Health Security and                        pharmacotherapies and prophylaxis to                   Definitions
                                                  Bioterrorism Preparedness and                           treat and prevent any illness caused by
                                                                                                          the agent or toxin; and                                   In 7 CFR 331.1 and 9 CFR 121.1, we
                                                  Response Act of 2002 (referred to below                                                                        proposed to add definitions for
                                                                                                             • Any other criteria that the Secretary
                                                  as the Bioterrorism Response Act)                                                                              inactivation and kill curve to clarify
                                                                                                          considers appropriate to protect animal
                                                  provides for the regulation of certain                                                                         terms contained within the proposed
                                                                                                          or plant health, or animal or plant
                                                  biological agents that have the potential                                                                      inactivation provisions. As detailed
                                                                                                          products.
                                                  to pose a severe threat to both human                                                                          later in this final rule, we have removed
                                                                                                             We use the term ‘‘select agents and
                                                  and animal health, to animal health, to                                                                        the requirement for generation of a kill
                                                                                                          toxins’’ throughout the preamble of this
                                                  plant health, or to animal plant health,                                                                       curve. We are therefore not including
                                                                                                          rule. Unless otherwise specified, the
                                                  or to animal and plant products. The                                                                           the definition in the regulations.
                                                                                                          term ‘‘select agents and toxins’’ will
                                                  Animal and Plant Health Inspection                                                                                One commenter suggested that we
                                                                                                          refer to all agents or toxins listed by
                                                  Service (APHIS) has the primary                                                                                specify that a ‘‘validated method’’ was
                                                                                                          APHIS. When it is necessary to specify
                                                  responsibility for implementing the                                                                            used for inactivation. The commenter
                                                                                                          the type of select agent or toxin, we will
                                                  provisions of the Act within the United                                                                        said that the addition of the word
                                                                                                          use the following terms: ‘‘PPQ select
                                                  States Department of Agriculture                                                                               ‘‘validated’’ would ensure that tested
                                                                                                          agents and toxins’’ (for the plant agents
                                                  (USDA). Veterinary Services (VS) select                                                                        and appropriate methods of inactivation
                                                                                                          and toxins listed in 7 CFR 331.3), ‘‘VS
                                                  agents and toxins are those that have                                                                          would be utilized.
                                                                                                          select agents and toxins’’ (for the animal
                                                  been determined to have the potential to                                                                          We are eliminating the definition for
                                                                                                          agents and toxins listed in 9 CFR 121.3),
                                                  pose a severe threat to animal health or                                                                       inactivation and instead adding a
                                                                                                          or ‘‘overlap select agents and toxins’’
                                                  animal products. Plant Protection and                                                                          definition of validated inactivation
                                                                                                          (for the overlap agents and toxins listed
                                                  Quarantine (PPQ) select agents and                                                                             procedure to the regulations. This
                                                                                                          in both 9 CFR 121.4 and 42 CFR 73.4).
                                                  toxins are those that have the potential                                                                       definition encompasses the prior
                                                                                                             On January 19, 2016, we published in
                                                  to pose a severe threat to plant health                                                                        definition of inactivation as well as
                                                                                                          the Federal Register (81 FR 2762–2774,
                                                  or plant products. Overlap select agents                                                                       providing further detail which we
                                                                                                          Docket No. APHIS–2014–0095) a
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                                                  and toxins are those that have been                                                                            believe will be useful for regulated
                                                                                                          proposal 1 to amend and republish the
                                                  determined to pose a severe threat to                                                                          entities. Validated inactivation
                                                                                                          list of select agents and toxins that have
                                                  both human and animal health or to                                                                             procedure is defined as a procedure,
                                                                                                          the potential to pose a severe threat to
                                                  human health and animal products.                                                                              whose efficacy is confirmed by data
                                                                                                          animal or plant health, or to animal or
                                                  Overlap select agents are subject to                                                                           generated from a viability testing
                                                  regulation by both APHIS and the                          1 To view the proposed rule and the comments         protocol, to render a select agent non-
                                                  Centers for Disease Control and                         we received, go to http://www.regulations.gov/         viable but allows the select agent to
                                                  Prevention (CDC), which has the                         #!docketDetail;D=APHIS-2014-0095.                      retain characteristics of interest for


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                                                                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations                                                   6199

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



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                                                  6200             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                  determine the reason of the inactivation                this term will not be incorporated into                   • Clarification of when an entity may
                                                  failure. If the responsible official is                 the final rule.                                        submit a waiver request to the
                                                  unable to determine the reason for this                    Finally, we proposed that written                   Administrator as well as the procedure
                                                  failure, he or she must report the                      records be kept for any select agent that              for such determinations.
                                                  inactivation failure to CDC or APHIS.                   has been rendered nonviable or                            Finally, in 7 CFR 331.3(d)(2), 9 CFR
                                                  Our intention is to require registered                  regulated nucleic acids that have been                 121.3(d)(2), and 9 CFR 121.4(d)(2), we
                                                  entities to create an environment where                 rendered non-infectious.                               are replacing the term ‘‘nonfunctional
                                                  inactivation failures are investigated to                  Two commenters asked for                            toxin’’ with ‘‘nontoxic toxin.’’ We have
                                                  determine the root source of the errors                 clarification of the actions constituting              determined that the term
                                                  instead of re-subjecting the material to                review, including description of any                   ‘‘nonfunctional’’ is overbroad and has
                                                  an inactivation method that may be                      documentation that will be expected to                 caused confusion. Our intent was to
                                                  flawed or faulty. The revised language                  demonstrate compliance with the                        exclude toxins that can no longer exert
                                                  only requires reporting of inactivation                 requirement. The commenters wanted to                  their toxic effect and cause disease. For
                                                  failures to CDC or APHIS when the                       know if it was our expectation that the                example, Botulinum neurotoxin has
                                                  responsible official cannot determine                   kill curve and sterility testing be                    three functional domains: Binding
                                                  the reason for the inactivation failure.                repeated and verified annually, or if this             domain, translocation domain, and
                                                  We are also clarifying that these                       is a review of data and written                        catalytic domain. Each functional
                                                  provisions apply only to those select                   procedures.                                            domain may be solely manipulated such
                                                  agents inactivated for future use as non-                  In response, we have modified the                   that the toxin is no longer toxic and
                                                  select agents and not those intended for                language regarding review of site-                     does not cause disease even though the
                                                  waste disposal.                                         specific standard operating inactivation               other two domains may remain
                                                     Two commenters asked about the                       procedures to clarify that the entity                  functional. Note that the example
                                                  minimum percentage of samples                           should review these procedures to                      provided is for a CDC toxin due to the
                                                  required to be tested to constitute a                   determine if they are being adhered to                 fact that APHIS does not currently
                                                  ‘‘representative sample.’’ Another                      by staff. The annual review requirement                regulate any select toxins.
                                                  commenter suggested that inactivated                    does not necessarily involve                           Exemptions for Select Agents and
                                                  lots be stored with documentation that                  revalidating inactivation procedures.                  Toxins
                                                  demonstrates that the lot has met the                   This review may simply take the form
                                                  established standard, but added that it                                                                           The provisions of 7 CFR 331.5, 9 CFR
                                                                                                          of an evaluation of the site-specific                  121.5, and 9 CFR 121.6 concern
                                                  is impractical to conduct validated
                                                                                                          standard operating inactivation                        conditions under which entities may be
                                                  sterility testing on every sample that is
                                                                                                          procedures to ensure the inactivation                  exempted from the requirements of the
                                                  inactivated. The commenter claimed
                                                                                                          conditions used and upper agent limits                 regulations. We proposed to add
                                                  that implementing such a requirement
                                                                                                          found in validation data are consistent                language to paragraph (a) in 7 CFR
                                                  would waste specimens where limited
                                                                                                          and that the entity staff are following                331.5, 9 CFR 121.5, and 9 CFR 121.6
                                                  volumes are available, be costly in terms
                                                                                                          the site-specific standard operating                   that specifies that entities may be
                                                  of technical time and resources, and is
                                                                                                          inactivation procedures. At times an                   required to report identification of
                                                  scientifically unjustified.
                                                     Successful implementation of the                     entity may need to revalidate                          agents or toxins to other appropriate
                                                  required validated inactivation                         inactivation procedures during the                     authorities when required by Federal,
                                                  procedure and the subsequent data                       annual review. For example, review                     State, or local law. Specifically, we
                                                  derived from viability testing using that               may be needed if the entity finds that                 proposed to add provisions that state
                                                  procedure will determine the extent of                  staff are not adhering to standard                     that we do not regulate material
                                                  sampling required. We have removed                      operating procedures or if the entity                  containing select agents or toxins when
                                                  the sterility testing requirement to allow              wants to deviate from the established,                 it is in a patient care setting and is not
                                                  entities flexibility in establishing and                validated inactivation procedure.                      being collected or otherwise tested or
                                                  utilizing individualized, validated                        While we did not receive any further                retained, nor do we regulate waste
                                                  inactivation procedures.                                comments on this issue, in response to                 generated during delivery of patient
                                                     We also proposed to require that an                  comments received by CDC and in the                    care. However, once delivery of patient
                                                  entity conduct an annual review of their                interests of maintaining parity between                care for the select agent or toxin
                                                  site-specific standard operating                        the APHIS and CDC regulations, we                      infection has concluded, waste would
                                                  procedures to ensure that select agents                 have made the following changes:                       become subject to the requirements of
                                                  or regulated nucleic acids that can                        • Establishing that surrogate strains               the regulations. If an entity cannot meet
                                                  produce infectious forms of any select                  that are known to possess properties                   these requirements, then the material
                                                  agent virus are inactivated by a safety                 equivalent to select agents may be used                may be transferred to another entity
                                                  margin and revise as necessary.                         to validate the required inactivation                  according to the select agent regulations
                                                     Two commenters questioned our use                    procedures under certain conditions;                   or destroyed using an approved method.
                                                  of the term ‘‘safety margin.’’ The                         • Replacing the term ‘‘extract’’ with               The decision to retain, transfer, or
                                                  commenters requested that we remove                     ‘‘material containing a select agent’’ to              destroy any specimens must be made
                                                  or define the term, as its meaning is                   clarify that the inactivation                          within 7 calendar days of the
                                                  unclear. The commenters further stated                  requirements apply to such materials as                conclusion of patient care.
                                                  that the need for including a safety                    serums or liquid cultures from which                      One commenter disagreed with
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                                                  margin is unclear and appears                           select agents are typically removed via                adding such a provision to 9 CFR 121.5.
                                                  superfluous if the intent of the                        filtration without first undergoing                    The commenter said that VS should
                                                  requirement is to define the conditions                 inactivation. This is intended to more                 have authority to regulate waste and
                                                  that achieve conditions that render 100                 accurately describe an element of a two-               carcasses from animals (i.e., veterinary
                                                  percent of the select agent non-viable or               step process: An inactivation step to                  patients) naturally infected with select
                                                  noninfectious.                                          destroy the select agent and a second                  agents to ensure that infection does not
                                                     We are not defining ‘‘safety margin’’                step intended to remove any remaining,                 spread to other livestock or poultry. The
                                                  as the proposed regulatory text using                   viable select agent; and                               commenter asked that we alter the


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                                                                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations                                          6201

                                                  wording of the proposed section in                      natural disasters; workplace violence;                 laboratory-specific biocontainment and/
                                                  order to specify that the requirement                   bomb threats and suspicious packages;                  or biosafety manuals must be accessible
                                                  refers to human patients only.                          and emergencies such as fire, gas leak,                to individuals working in those
                                                     The provisions the commenter refers                  explosion, power outage, etc. The                      laboratories. This change will help to
                                                  to relate to the care of human patients                 response procedures must account for                   foster an enhanced culture of
                                                  only. However, it should be noted that                  hazards associated with the select agent               responsibility by ensuring that
                                                  any waste or carcasses from animals                     or toxin and appropriate actions to                    appropriate biocontainment and/or
                                                  infected with a select agent, provided                  contain such agent or toxin.                           biosafety resources are available to all
                                                  the select agent or toxin has not been                     All of these plans require annual                   staff with access to select agents and
                                                  intentionally introduced, cultivated,                   review and revision as necessary. Drills               toxins within a select agent laboratory.
                                                  collected, or otherwise extracted from                  or exercises must also be conducted at                    One commenter suggested that the
                                                  its natural source, are already listed as               least annually to test and evaluate the                specific practice of making manuals
                                                  excluded in §§ 121.3(d)(1) and                          effectiveness of the plans. The plans                  accessible is already employed by
                                                  121.4(d)(1) of the regulations.                         must be reviewed and revised, as                       registered entities. The commenter
                                                     While we did not receive any further                 necessary, after any drill or exercise and             therefore questioned the need for a
                                                  comments on this issue, in response to                  after any incident. We proposed to                     separate requirement.
                                                  comments received by CDC and in the                     require that these drills or exercises be                 We agree with the commenter and
                                                  interests of maintaining parity between                 documented to include how the drill or                 have removed the requirement.
                                                  the APHIS and CDC regulations, we are                   exercise tested and evaluated the plan,                   Two commenters urged that, ‘‘a
                                                  amending the text to clarify the                        any problems identified, any corrective                description of the biosafety and
                                                  following:                                              action taken, and the names of the                     containment procedures for any animals
                                                     • That patient care refers to actions                individuals who participated in the drill              (including arthropods) or plants
                                                  by health care professionals;                           or exercise. This will provide a more                  intentionally or accidentally exposed to
                                                     • To clarify that destruction and                    thorough accounting of required                        or infected with a select agent’’ should
                                                  transfer requirements apply solely to                   activities as well as increasing the                   clearly refer not only to animals within
                                                  waste generated in the course of patient                efficacy of the plans via testing and                  the laboratory but also wildlife,
                                                  care and not specimens or samples                       entity-directed improvements. We                       domestic, and stray animals outside of
                                                  taken from the patient; and                             proposed to add these requirements to                  the buildings if they are potentially
                                                     • That specimens taken from a                        7 CFR 331.11(h), 331.12(e), 331.14(f), 9               exposed via accidental release. The
                                                  patient are not subject to the regulations              CFR 121.11(h), 121.12(e), and 121.14(f).               commenter added that there should be
                                                  during the period in which they are                        One commenter stated that the                       a system in place to detect such
                                                  directly associated with the diagnosis,                 requirement to record the names of the                 incidents if they occur.
                                                  but all specimens taken and kept more                   individuals who participated in a given                   The term ‘‘any animals’’ includes both
                                                  than 7 days after the conclusion of                     drill or exercise should be limited to                 laboratory animals as well as the wild,
                                                  patient care are subject to the                         registered entity personnel and not                    domestic, and stray animals described
                                                  regulations.                                            include first responders or others who                 by the commenters. We will, however,
                                                                                                          participate. The commenter suggested                   add specific clarification to the
                                                  Security, Biocontainment/Biosafety,                                                                            guidance documents associated with the
                                                                                                          that a list of the participating external
                                                  and Incident Response Plans                                                                                    biocontainment and biosafety plans.
                                                                                                          agencies (e.g., emergency management,
                                                    The regulations require registered                    emergency medical services, fire                          One commenter requested
                                                  entities to develop and implement a                     department, etc.) could be included.                   clarification regarding the term
                                                  number of plans in order to ensure the                     We agree with the commenter’s                       ‘‘laboratory.’’ The commenter wanted to
                                                  safety and security of the select agents                suggestion and have updated the                        know whether the term refers to a single
                                                  they handle. These are:                                 regulations in order to clarify that only              room, a building, or to a group of rooms
                                                    • A security plan, as described by the                the names of individuals at the                        (e.g., laboratory, animal room, and
                                                  regulations in 7 CFR 331.11 and 9 CFR                   registered entity are required to be                   necropsy) used by a principal
                                                  121.11, that provides for measures                      listed. The entity may choose to list the              investigator for a research project. The
                                                  sufficient to safeguard the select agent                names of external agencies (e.g., fire                 commenter also requested clarification
                                                  or toxin against unauthorized access,                   department, police department, etc.)                   regarding the phrase, ‘‘must be available
                                                  theft, loss, or release;                                that participated in the drill or exercise.            to each individual working in the
                                                    • A biocontainment plan, in the case                     Comments on more specific proposed                  laboratory,’’ asking if this would require
                                                  of PPQ select agents, or a biosafety plan,              changes to these plans may be found                    creation of a specific biocontainment or
                                                  in the case of VS and overlap select                    below.                                                 biosafety manual for each room.
                                                  agents, as described in the regulations in                                                                        We have clarified the language to state
                                                  7 CFR 331.12 and 9 CFR 121.12, that                     Biocontainment/Biosafety Plan                          that ‘‘biosafety and containment
                                                  provides for measures sufficient to                       Paragraph (a) of 7 CFR 331.12 and 9                  procedures specific to use of the select
                                                  contain the select agent or toxin (e.g.,                CFR 121.12 requires that the                           agent or toxin by the principal
                                                  physical structure and features of the                  biocontainment or biosafety plan                       investigator must be available to each
                                                  entity, and operational and procedural                  contain sufficient information and                     individual involved with that project.’’
                                                  safeguards); and                                        documentation to describe the biosafety                This more appropriately ties the
                                                    • An incident response plan, as                       and containment procedures for each                    creation and distribution of
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                                                  described in the regulations in 7 CFR                   select agent or toxin that the registered              biocontainment and biosafety manuals
                                                  331.14 and 9 CFR 121.14, that provides                  entity will possess. The plan must also                to specific projects, select agents, and
                                                  for measures that the registered entity                 include a description of the biosafety                 people.
                                                  will implement in the event of theft,                   and containment procedures for any                        We also proposed to add specific
                                                  loss, or release of a select agent or toxin;            animals (including arthropods) or plants               provisions to the biocontainment and
                                                  inventory discrepancies; security                       intentionally or accidentally exposed to               biosafety plans that would require
                                                  breaches (including information                         or infected with a select agent. We                    completion of a written risk assessment
                                                  systems); severe weather and other                      proposed to additionally require that                  for each procedure.


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                                                  6202             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                     Two commenters stated that these                     person’s role and level of access to                   provided promptly upon request. We
                                                  requirements are unnecessary and                        select agents.                                         proposed to specify that such records
                                                  would prove excessively burdensome to                      We agree with the commenters’ point                 may include, but are not limited to,
                                                  researchers and the responsible official                and have altered the required training                 biocontainment certifications,
                                                  and should be removed. The                              language to clearly delineate the types                laboratory notebooks, institutional
                                                  commenters said that the new                            of training required for individuals with              biosafety and/or animal use committee
                                                  requirements regarding validation of                    varying access levels.                                 minutes and approved protocols, and
                                                  inactivation procedures would serve the                    One commenter asked that we clearly                 records associated with occupational
                                                  same security function. The commenters                  specify the requirements for both initial              health and suitability programs.
                                                  added that APHIS already has                            and annual training. The commenter                        One commenter expressed concern
                                                  opportunity to review and require                       also asked that we consider making                     regarding the requirement to keep
                                                  amendment of an entity’s                                training a prerequisite for access to                  laboratory notebooks for inspection
                                                  biocontainment or biosafety plan as a                   select agents and toxins.                              purposes. The commenter stated that
                                                  condition of registration or as a result of                While we made no changes to our                     items may include proprietary
                                                  inspection.                                             regulatory language based on this                      intellectual property and requested
                                                     We agree with the commenter that                     comment, the document entitled,                        clarification regarding the information
                                                  this level of detail would prove                        ‘‘Guidance for Meeting the Training                    needed from the notebooks. The
                                                  unnecessarily burdensome. We have                       Requirements of the Select Agent                       commenter asked that we amend the
                                                  instead added language to 7 CFR                         Regulations’’ 4 will be updated to                     regulatory language in order to protect
                                                  331.12(a)(1) and 9 CFR 331.12(a)(1) to                  provide further detail and assistance                  intellectual property interests and
                                                  explicitly require that the                             regarding the content of initial and                   specify if any information would be
                                                  biocontainment and biosafety plans                      annual training. The regulations in 7                  required from laboratory notebooks
                                                  include a description of the hazardous                  CFR 331.15(a)(1) and 9 CFR 121.15(a)(1)                apart from that collected for inventory
                                                  characteristics of each agent or toxin                  already require that each approved                     purposes.
                                                  listed on the entity’s registration and the             individual receive information and                        We agree with the commenter and we
                                                  biosecurity or biosafety risk associated                training on biosecurity/biosafety,                     have clarified that only information
                                                  with laboratory procedures related to                   security (including security awareness),               related to the requirements of the
                                                  the select agent or toxin.                              and incident response before that                      regulations must be produced upon
                                                     One commenter asked that we define                   individual has access to any select                    request. Such information may be found
                                                  ‘‘risk assessment,’’ given that it is a very            agents and toxins.                                     in biocontainment certifications,
                                                  broad term and therefore open to                                                                               laboratory notebooks, institutional
                                                  interpretation. This commenter and                      Records                                                biosecurity/biosafety and/or animal use
                                                  another requested that we provide basic                    The regulations in 7 CFR 331.17 and                 committee minutes and approved
                                                  templates for these new required                        9 CFR 121.17 concern required                          protocols, and records associated with
                                                  sections and indicate where registered                  recordkeeping procedures for regulated                 occupational health and suitability
                                                  entities and entities seeking registration              entities as those records relate to select             programs. Accordingly, we will only be
                                                  may find these templates.                               agents and toxins. Paragraph (a)(3)(x)                 reviewing relevant portions of any
                                                     We have revised and condensed the                    requires that registered entities record               laboratory notebooks or documents and
                                                  proposed language as a result of this and               the destruction of any toxins by                       only if they contain information related
                                                  other comments. It no longer includes                   specifically noting the quantity of toxin              to any requirements of the regulations.
                                                  the term ‘‘risk assessment.’’                           destroyed, the date of such action, and                   To ensure the accuracy of
                                                  Training                                                by whom. However, there is not an                      handwritten records, we also proposed
                                                                                                          equivalent requirement regarding the                   to specify that such records must be
                                                     We proposed to amend the                             destruction of select agents. We                       legible.
                                                  regulations in 7 CFR 331.15 and 9 CFR                   proposed to add this requirement in                       Another commenter suggested that we
                                                  121.15, which concern provision of                      order to ensure consistency with the                   require that records be written in ink
                                                  mandatory training for staff and visitors               toxin provisions and ensure proper                     and not pencil and should be signed
                                                  who work in or visit areas where select                 tracking of select agents from                         and dated when appropriate.
                                                  agents or toxins are handled or stored.                 acquisition to destruction.                               We acknowledge this suggestion as
                                                  We proposed to require that all                            While we did not receive any                        good practice. However, in the interests
                                                  individuals who have received approval                  comments on this issue, in response to                 of not being overly prescriptive, we are
                                                  to have access to select agents and                     comments received by CDC and in the                    leaving the interpretation of ‘‘legible’’
                                                  toxins must undergo training regardless                 interests of maintaining parity between                up to individual registered entities.
                                                  of whether they have access to those                    the APHIS and CDC regulations, we are
                                                  select agents or toxins. The training                                                                          Records for Select Agents in Long-Term
                                                                                                          amending the text to stipulate that                    Storage
                                                  would have to be completed within a                     registered entities must maintain a
                                                  year of that individual’s approval or                                                                            Paragraph (a)(1) in both 7 CFR 331.17
                                                                                                          record of the select agent used, purpose
                                                  prior to entry into an area where select                                                                       and 9 CFR 121.17 requires entities to
                                                                                                          of use, and, when applicable, final
                                                  agents and toxins are used or stored,                                                                          maintain an accurate, current inventory
                                                                                                          disposition (including destruction) for
                                                  whichever occurs first.                                                                                        for each select agent (including viral
                                                                                                          each select agent held in long-term
                                                     Two commenters objected to the                                                                              genetic elements, recombinant and/or
                                                                                                          storage.
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                                                  proposed addition, stating that we                                                                             synthetic nucleic acids, and organisms
                                                                                                             We also proposed to state that any
                                                  should include a description of the level                                                                      containing recombinant and/or
                                                                                                          records created that contain information
                                                  of training necessary for personnel in                                                                         synthetic nucleic acids) held in long-
                                                                                                          related to an entity’s registration or its
                                                  varying positions with highly disparate                                                                        term storage. We continue to receive
                                                                                                          select agents and toxins must be
                                                  job duties and responsibilities. The                                                                           comments critical of that portion of the
                                                  commenters requested that we clarify                      4 You may view this document on the Internet at      regulations. Criticism is typically
                                                  that required training will be conducted                http://www.selectagents.gov/guidance-                  focused on the belief that a container-
                                                  at a level appropriate to the registered                training.html.                                         based inventory requirement is not a


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                                                                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations                                             6203

                                                  useful mechanism to track inventory of                  addressed through alternative                          these entities, there are 240 registered to
                                                  biological agents, since small amounts                  approaches.                                            possess Tier 1 select agents and toxins,
                                                  could be stolen without detection and                                                                          including 78 academic, 29 commercial,
                                                                                                          Miscellaneous Changes
                                                  used to grow larger quantities.                                                                                80 State government, 37 Federal
                                                     However, the Public Health Security                     We are also adding a definition of                  government, and 16 private (non-profit)
                                                  and Bioterrorism Preparedness and                       principal investigator to the regulations              institutions, most of which are
                                                  Response Act of 2002 obliges APHIS                      in 7 CFR 331.1 and 9 CFR 121.1 as it                   considered to be small entities. Based
                                                  and CDC to include a requirement for                    is used but not defined in the APHIS                   on current recordkeeping and reporting
                                                  ‘‘the prompt notification of the                        regulations. The addition also serves to               requirements, an additional 10 to 20
                                                  Secretary, and appropriate Federal,                     maintain parity with the CDC                           hours per year may be required for
                                                  State, and local law enforcement                        regulations. Our definition is identical               maintaining records associated with
                                                  agencies, of the theft or loss of listed                to that used by CDC.                                   select agents or material containing
                                                  agents and toxins’’ in the regulations.                    Therefore, for the reasons given in the             select agents or regulated nucleic acids
                                                  We therefore solicited comment                          proposed rule and in this document, we                 that can produce infectious forms of any
                                                  regarding what regulatory requirement                   are adopting the proposed rule as a final              select agent virus that have been
                                                  or requirements should be implemented                   rule with the changes discussed in this                subjected to a validated inactivation
                                                  such that a registered entity could                     document.                                              procedure or a procedure for removal of
                                                  quickly determine whether a select                      Executive Order 12866 and Regulatory                   viable select agents. At an imputed cost
                                                  agent had been lost or stolen from long-                Flexibility Act                                        of $33.40 per hour (GS–12, step 2), this
                                                  term storage without that registered                                                                           additional time requirement per entity
                                                  entity first having an accurate, current                   This final rule has been determined to              will cost between $334 and $668 per
                                                  inventory for each select agent held in                 be significant for the purposes of                     year, or in total for all registered entities
                                                  long-term storage. Additionally, we                     Executive Order 12866 and, therefore,                  between $80,000 and $160,000.
                                                  solicited ideas concerning ways in                      has been reviewed by the Office of                     Assuming that costs of the rule could be
                                                  which the current regulations could be                  Management and Budget.                                 considered to be significant if they
                                                  amended to address the possibility of                      In accordance with 5 U.S.C. 604, we                 exceeded 1 percent of revenue earned
                                                  theft of a select agent from a container                have performed a final regulatory                      by the affected entities, revenues would
                                                  held in long-term storage.                              flexibility analysis, which is                         need to average less than $33,400 to
                                                     One commenter stated that, while                     summarized below, regarding the                        $66,800 for this to be the case. While the
                                                  they understand the need for such                       economic effects of this rule on small                 vast majority of the entities in industries
                                                  inventory and notification requirements,                entities. Copies of the full analysis are              potentially affected by this rule, other
                                                  an enormous amount of time and effort                   available on the Regulations.gov Web                   than post-secondary institutions, can be
                                                  is spent during inspections validating                  site (see footnote 1 in this document for              considered small, average annual
                                                  that inventories are accurate. The                      a link to Regulations.gov) or by                       revenues are well above this range.
                                                  commenter said that this has resulted in                contacting the person listed under FOR                   Due to the reasons summarized here
                                                  the loss of valuable virus isolates due to              FURTHER INFORMATION CONTACT.                           and explained in the analysis
                                                  unintentional thawing, failure of                          Sections 201 and 212(a)(2) of the Act               accompanying this rule, the
                                                  ultralow temperature freezers due to                    require a biennial review and                          Administrator certifies that this action
                                                  repeated opening and the resulting loss                 republication of the select agent and                  will not have a significant economic
                                                  of ultralow temperature, and inefficient                toxin list, with revisions as appropriate              impact on a substantial number of small
                                                  use of employee time. The commenter                     in accordance with this law. This final                entities.
                                                  said that measuring the volumes of                      rule will implement the
                                                  stored vials of bacteria and viruses in                 recommendations of the fourth biennial                 Executive Order 12988
                                                  the manner that toxins or other non-                    review of select agent regulations and                    This final rule has been reviewed
                                                  replicative select agents are inventoried               has finalized changes that will increase               under Executive Order 12988, Civil
                                                  is illogical. The commenter                             their usability as well as provide for                 Justice Reform. This rule: (1) Preempts
                                                  acknowledged that it is important to                    enhanced program oversight. These                      all State and local laws and regulations
                                                  indicate the nature of the pathogens                    amendments include new provisions                      that are inconsistent with this rule; (2)
                                                  stored and the numbers of vials in                      regarding the inactivation of select                   has no retroactive effect; and (3) does
                                                  freezer stocks, but even the most                       agents, specific biosafety and toxin                   not require administrative proceedings
                                                  fastidious recordkeeping could not                      requirements and clarification of                      before parties may file suit in court
                                                  demonstrate that vials of replicative                   regulatory language concerning security,               challenging this rule.
                                                  organisms had not been accessed. The                    training, and records. The final rule will
                                                                                                          require that entities develop a validated              Executive Order 13175
                                                  commenter stated that current select
                                                  agent practices allow for these stocks to               inactivation procedure by establishing                   This rule has been reviewed in
                                                  be maintained in tamper-evident stocks                  parameters for quantities of starting                  accordance with the requirements of
                                                  (e.g., security ties on freezer boxes) so               material and measures of uncertainty for               Executive Order 13175, Consultation
                                                  that vials are not individually removed,                repeated successful inactivation. This is              and Coordination with Indian Tribal
                                                  thawed, and measured. The commenter                     a broad performance standard that will                 Governments. Executive Order 13175
                                                  concluded that requiring the use of tools               allow for flexibility given the variety of             requires Federal agencies to consult and
                                                  of this nature in the case of replicative               select agents and toxins under                         coordinate with tribes on a government-
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                                                  organisms is a logical step that would                  regulation to define conditions of                     to-government basis on policies that
                                                  not eliminate the need to inventory, but                inactivation for each select agent or                  have tribal implications, including
                                                  which also would not degrade samples                    regulated infectious nucleic acid and                  regulations, legislative comments or
                                                  and allow for detection of samples that                 maintain written records of having done                proposed legislation, and other policy
                                                  may have disappeared.                                   so. Costs of complying with this                       statements or actions that have
                                                     We appreciate this comment and will                  amendment are expected to be modest.                   substantial direct effects on one or more
                                                  continue to consider how the                               Currently, there are 291 entities                   Indian tribes, on the relationship
                                                  recognition of theft and loss might be                  registered with APHIS and CDC. Of                      between the Federal Government and


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                                                  6204             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                  Indian tribes or on the distribution of                 definitions of principal investigator,                 is subjected to a viability testing
                                                  power and responsibilities between the                  validated inactivation procedure, and                  protocol to ensure that the removal
                                                  Federal Government and Indian tribes.                   viability testing protocol to read as                  method has rendered the material free of
                                                    The Animal and Plant Health                           follows:                                               all viable select agent.
                                                  Inspection Service has assessed the                                                                               (6) A select agent or regulated nucleic
                                                  impact of this rule on Indian tribes and                § 331.1    Definitions.                                acids that can produce infectious forms
                                                  determined that this rule does not, to                  *     *     *     *      *                             of any select agent virus not subjected
                                                  our knowledge, have tribal implications                   Principal investigator. The one                      to a validated inactivation procedure or
                                                  that require tribal consultation under                  individual who is designated by the                    material containing a select agent not
                                                  E.O. 13175. If a Tribe requests                         entity to direct a project or program and              subjected to a procedure that removes
                                                  consultation, the Animal and Plant                      who is responsible to the entity for the               all viable select agent cells, spores, or
                                                  Health Inspection Service will work                     scientific and technical direction of that             virus particles if the material is
                                                  with the Office of Tribal Relations to                  project or program.                                    determined by the Administrator to be
                                                  ensure meaningful consultation is                       *     *     *     *      *                             effectively inactivated or effectively
                                                  provided where changes, additions and                     Validated inactivation procedure. A                  removed. To apply for a determination
                                                  modifications identified herein are not                 procedure, whose efficacy is confirmed                 an individual or entity must submit a
                                                  expressly mandated by Congress.                         by data generated from a viability                     written request and supporting
                                                                                                          testing protocol, to render a select agent             scientific information to APHIS. A
                                                  Paperwork Reduction Act
                                                                                                          non-viable but allows the select agent to              written decision granting or denying the
                                                    In accordance with section 3507(d) of                 retain characteristics of interest for                 request will be issued.
                                                  the Paperwork Reduction Act of 1995                     future use; or to render any nucleic                      (7) A PPQ select toxin identified in an
                                                  (44 U.S.C. 3501 et seq.), the reporting,                acids that can produce infectious forms                original food sample or clinical sample.
                                                  recordkeeping, and third-party                          of any select agent virus non-infectious                  (8) Waste generated during the
                                                  disclosure requirements included this                   for future use.                                        delivery of patient care by health care
                                                  rule are in the process of being                                                                               professionals from a patient diagnosed
                                                                                                          *     *     *     *      *
                                                  reinstated by the Office of Management                                                                         with an illness or condition associated
                                                                                                            Viability testing protocol. A protocol
                                                  and Budget under 0579–0213.                                                                                    with a select agent, where that waste is
                                                                                                          to confirm the validated inactivation
                                                  E-Government Act Compliance                             procedure by demonstrating the                         decontaminated or transferred for
                                                                                                          material is free of all viable select agent.           destruction by complying with State
                                                     The Animal and Plant Health                                                                                 and Federal regulations within 7
                                                  Inspection Service is committed to                      ■ 3. Section 331.3 is amended as
                                                                                                                                                                 calendar days of the conclusion of
                                                  compliance with the E-Government Act                    follows:
                                                                                                                                                                 patient care.
                                                  to promote the use of the Internet and                  ■ a. By revising paragraph (d)(2).
                                                                                                          ■ b. By redesignating paragraph (d)(3) as              *      *     *    *      *
                                                  other information technologies, to
                                                                                                          paragraph (d)(9)                                          (e) * * *
                                                  provide increased opportunities for                                                                               (3) An individual or entity may make
                                                  citizen access to Government                            ■ c. By adding paragraphs (d)(3) through
                                                                                                          (8) and (e)(3).                                        a written request to the Administrator
                                                  information and services, and for other                                                                        for reconsideration of a decision
                                                  purposes. For information pertinent to                    The additions and revision read as
                                                                                                          follows:                                               denying an application for the exclusion
                                                  E-Government Act compliance related                                                                            of an attenuated strain of a select agent
                                                  to this rule, please contact Ms. Kimberly               § 331.3    PPQ select agents and toxins.               or a select toxin modified to be less
                                                  Hardy, APHIS’ Information Collection                                                                           potent or toxic. The written request for
                                                  Coordinator, at 301–851–2483.                           *      *    *     *      *
                                                                                                             (d) * * *                                           reconsideration must state the facts and
                                                  List of Subjects                                           (2) Nonviable select agents or                      reasoning upon which the individual or
                                                                                                          nontoxic toxins.                                       entity relies to show the decision was
                                                  7 CFR Part 331                                                                                                 incorrect. The Administrator will grant
                                                                                                             (3) A select agent or toxin that has
                                                    Agricultural research, Laboratories,                  been subjected to decontamination or a                 or deny the request for reconsideration
                                                  Plant diseases and pests, Reporting and                 destruction procedure when intended                    as promptly as circumstances allow and
                                                  recordkeeping requirements.                             for waste disposal.                                    will state, in writing, the reasons for the
                                                  9 CFR Part 121                                             (4) A select agent or regulated nucleic             decision.
                                                                                                          acids that can produce infectious forms                *      *     *    *      *
                                                    Agricultural research, Animal
                                                                                                          of any select agent virus that has been                ■ 4. Section 331.5 is amended as
                                                  diseases, Laboratories, Medical research,
                                                                                                          subjected to a validated inactivation                  follows:
                                                  Reporting and recordkeeping
                                                                                                          procedure that is confirmed through a                  ■ a. By revising paragraph (a)(1).
                                                  requirements.
                                                                                                          viability testing protocol. Surrogate                  ■ b. In paragraph (a)(2), by removing ‘‘;
                                                    Accordingly, 7 CFR part 331 and 9                     strains that are known to possess                      and’’ and adding a period in its place.
                                                  CFR part 121 are amended as follows:                    equivalent properties with respect to                  ■ c. By revising paragraph (a)(3).
                                                  Title 7—Agriculture                                     inactivation can be used to validate an                   The revisions read as follows:
                                                                                                          inactivation procedure; however, if
                                                  PART 331—POSSESSION, USE, AND                           there are known strain-to-strain                       § 331.5   Exemptions.
                                                  TRANSFER OF SELECT AGENTS AND                           variations in the resistance of a select                  (a) * * *
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                                                  TOXINS                                                  agent to an inactivation procedure, then                  (1) Unless directed otherwise by the
                                                                                                          an inactivation procedure validated on                 Administrator, within 7 calendar days
                                                  ■ 1. The authority citation for part 331                a lesser resistant strain must also be                 after identification of the select agent or
                                                  continues to read as follows:                           validated on the more resistant strains.               toxin, the select agent or toxin is
                                                    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,              (5) Material containing a select agent              transferred in accordance with § 331.16
                                                  and 371.3.                                              that is subjected to a procedure that                  or destroyed on-site by a recognized
                                                  ■ 2. Section 331.1 is amended by                        removes all viable select agent cells,                 sterilization or inactivation process.
                                                  adding, in alphabetical order,                          spores, or virus particles if the material             *      *    *     *     *


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                                                                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations                                                 6205

                                                     (3) The identification of the agent or               unable to determine the cause of a                     any problems that were identified and
                                                  toxin is reported to APHIS or CDC, the                  deviation from a validated inactivation                corrective action(s) taken, and the
                                                  specimen provider, and to other                         procedure or a viable select agent                     names of registered entity personnel
                                                  appropriate authorities when required                   removal method; or receives any report                 participants.
                                                  by Federal, State, or local law by                      of any inactivation failure after the                  ■ 9. Section 331.12 is amended as
                                                  telephone, facsimile, or email. This                    movement of material to another                        follows:
                                                  report must be followed by submission                   location, the responsible official must                ■ a. By revising paragraph (a).
                                                  of APHIS/CDC Form 4 to APHIS or CDC                     report immediately by telephone or                     ■ b. By adding a sentence at the end of
                                                  within 7 calendar days after                            email the inactivation or viable agent                 paragraph (e).
                                                  identification.                                         removal method failure to APHIS or                       The addition and revision read as
                                                  *      *    *     *     *                               CDC.                                                   follows:
                                                  ■ 5. Section 331.7 is amended as
                                                                                                            (9) Review, and revise as necessary,
                                                                                                                                                                 § 331.12   Biocontainment.
                                                  follows:                                                each of the entity’s validated
                                                                                                          inactivation procedures or viable select                  (a) An individual or entity required to
                                                  ■ a. By redesignating paragraphs (b)                                                                           register under this part must develop
                                                  through (k) as paragraphs (c) through (l),              agent removal methods. The review
                                                                                                          must be conducted annually or after any                and implement a written
                                                  respectively.                                                                                                  biocontainment plan that is
                                                  ■ b. By adding a new paragraph (b).
                                                                                                          change in principal investigator, change
                                                                                                          in the validated inactivation procedure                commensurate with the risk of the select
                                                     The addition reads as follows:                                                                              agent or toxin, given its intended use.4
                                                                                                          or viable select agent removal method,
                                                  § 331.7 Registration and related security               or failure of the validated inactivation               The biocontainment plan must contain
                                                  risk assessments.                                       procedure or viable select agent removal               sufficient information and
                                                  *      *     *     *    *                               method. The review must be                             documentation to describe the
                                                     (b) As a condition of registration, each             documented and training must be                        biocontainment procedures for the
                                                  entity is required to be in compliance                  conducted if there are any changes to                  select agent or toxin, including any
                                                  with the requirements of this part for                  the validated inactivation procedure,                  animals (including arthropods) or plants
                                                  select agents and toxins listed on the                  viable select agent removal method, or                 intentionally or accidentally exposed to
                                                  registration regardless of whether the                  viability testing protocol.                            or infected with a select agent. The
                                                  entity is in actual possession of the                                                                          current biocontainment plan must be
                                                                                                          *     *     *     *     *
                                                  select agent or toxin. With regard to                                                                          submitted for initial registration,
                                                                                                          ■ 7. In § 331.10, paragraph (e) is                     renewal of registration, or when
                                                  toxins, the entity registered for                       amended by adding a sentence at the
                                                  possession, use, or transfer of a toxin                                                                        requested. The biocontainment plan
                                                                                                          end of the paragraph to read as follows:               must include the following provisions:
                                                  must be in compliance with the
                                                  requirements of this part regardless of                 § 331.10 Restricting access to select                     (1) The hazardous characteristics of
                                                  the amount of toxins currently in its                   agents and toxins; security risk                       each agent or toxin listed on the entity’s
                                                  possession.                                             assessments.                                           registration and the biocontainment risk
                                                                                                          *      *     *     *     *                             associated with laboratory procedures
                                                  *      *     *     *    *                                                                                      related to the select agent or toxin;
                                                                                                             (e) * * * A responsible official must
                                                  ■ 6. Section 331.9 is amended as                                                                                  (2) Safeguards in place with
                                                                                                          immediately notify the responsible
                                                  follows:                                                                                                       associated work practices to protect
                                                                                                          official of the visiting entity if the
                                                  ■ a. By removing the semicolons at the                                                                         entity personnel, the public, and the
                                                                                                          person’s access to select agents or toxins
                                                  ends of paragraphs (a)(1) through (4)                                                                          environment from exposure to the select
                                                                                                          has been terminated.
                                                  and ‘‘; and’’ at the end of paragraph                                                                          agent or toxin including, but not limited
                                                  (a)(5) and adding periods in their place.               *      *     *     *     *                             to: Personal protective equipment and
                                                  ■ b. In paragraph (a)(6), by removing the               ■ 8. Section 331.11 is amended as                      other safety equipment; containment
                                                  word ‘‘laboratory’’ and adding the                      follows:                                               equipment including, but not limited to,
                                                  words ‘‘registered space’’ in its place                 ■ a. In paragraph (c)(5), by adding the                biological safety cabinets, animal caging
                                                  and by adding the words ‘‘and the                       word ‘‘keycards,’’ after the word ‘‘keys,’’            systems, and centrifuge safety
                                                  corrections documented’’ at the end of                  and by removing the word ‘‘numbers’’                   containers; and engineering controls
                                                  the second sentence after the words                     and adding the word ‘‘permissions’’ in                 and other facility safeguards;
                                                  ‘‘must be corrected’’.                                  its place.                                                (3) Written procedures for each
                                                  ■ c. By adding paragraphs (a)(7), (8), and              ■ b. In paragraph (d)(7)(iv), by removing              validated method used for disinfection,
                                                  (9).                                                    the word ‘‘and’’.                                      decontamination, or destruction, as
                                                     The additions read as follows:                       ■ c. By adding paragraph (d)(7)(vi).                   appropriate, of all contaminated or
                                                                                                          ■ d. By adding a sentence at the end of                presumptively contaminated materials
                                                  § 331.9   Responsible official.                         paragraph (h).                                         including, but not limited to: Cultures
                                                    (a) * * *                                                The additions read as follows:                      and other materials related to the
                                                    (7) Ensure that individuals are                                                                              propagation of select agents or toxins,
                                                  provided the contact information for the                § 331.11    Security.
                                                                                                                                                                 items related to the analysis of select
                                                  USDA Office of Inspector General                        *     *     *     *    *
                                                                                                                                                                 agents and toxins, personal protective
                                                  Hotline and the HHS Office of Inspector                   (d) * * *
                                                                                                                                                                 equipment, arthropod containment
                                                  General Hotline so that they may                          (7) * * *
                                                                                                                                                                 systems, extracted plant and/or
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                                                  anonymously report any biosafety/                         (vi) Any loss of computer, hard drive
                                                                                                                                                                 arthropod tissues, laboratory surfaces
                                                  biocontainment or security concerns                     or other data storage device containing
                                                                                                                                                                 and equipment, and effluent material;
                                                  related to select agents and toxins.                    information that can be used to gain
                                                                                                                                                                 and
                                                    (8) Investigate to determine the reason               access to select agents or toxins; and                    (4) Procedures for the handling of
                                                  for any failure of a validated                          *     *     *     *    *                               select agents and toxins in the same
                                                  inactivation procedure or any failure to                  (h) * * * Drills or exercises must be
                                                  remove viable select agent from                         documented to include how the drill or                   4 Technical assistance and guidance may be

                                                  material. If the responsible official is                exercise tested and evaluated the plan,                obtained by contacting APHIS.



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                                                  6206              Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                  spaces with non-select agents and toxins                greenhouses, storage areas, shipping/                    (ii) A written description of the
                                                  to prevent unintentional contamination.                 receiving areas, production facilities,                viability testing protocol used;
                                                  *     *     *    *     *                                etc.). Training for escorted personnel                   (iii) A written description of the
                                                    (e) * * * Drills or exercises must be                 must be based on the risk associated                   investigation conducted by the entity
                                                  documented to include how the drill or                  with accessing areas where select agents               responsible official involving an
                                                  exercise tested and evaluated the plan,                 and toxins are used and/or stored. The                 inactivation or viable select agent
                                                  any problems that were identified and                   training must be accomplished prior to                 removal failure and the corrective
                                                  corrective action(s) taken, and the                     the individual’s entry into where select               actions taken;
                                                  names of registered entity personnel                    agents or toxins are handled or stored                   (iv) The name of each individual
                                                  participants.                                           (e.g., laboratories, growth chambers,                  performing the validated inactivation or
                                                  ■ 10. Section 331.14 is amended as                      animal rooms, greenhouses, storage                     viable select agent removal method;
                                                  follows:                                                areas, shipping/receiving areas,                         (v) The date(s) the validated
                                                  ■ a. By adding a sentence at the end of                 production facilities, etc.).                          inactivation or viable select agent
                                                  paragraph (a).                                          *      *     *     *    *                              removal method was completed;
                                                  ■ b. By adding a sentence at the end of                    (e) The responsible official must                     (vi) The location where the validated
                                                  paragraph (f).                                          ensure and document that individuals                   inactivation or viable select agent
                                                    The additions read as follows:                        are provided the contact information of                removal method was performed; and
                                                                                                          the USDA Office of Inspector General                     (vii) A certificate, signed by the
                                                  § 331.14    Incident response.5                                                                                principal investigator, that includes the
                                                                                                          Hotline and the HHS Office of Inspector
                                                    (a) * * * The current incident                        General Hotline so that they may                       date of inactivation or viable select
                                                  response plan must be submitted for                     anonymously report any safety or                       agent removal, the validated
                                                  initial registration, renewal of                        security concerns related to select                    inactivation or viable select agent
                                                  registration, or when requested.                        agents and toxins.                                     removal method used, and the name of
                                                  *     *      *     *     *                                                                                     the principal investigator. A copy of the
                                                                                                          ■ 12. In § 331.16, paragraph (b)
                                                    (f) * * * Drills or exercises must be                                                                        certificate must accompany any transfer
                                                                                                          introductory text is revised to read as
                                                  documented to include how the drill or                                                                         of inactivated or select agent removed
                                                                                                          follows:
                                                  exercise tested and evaluated the plan,                                                                        material.
                                                  any problems that were identified and                   § 331.16    Transfers.                                   (b) The individual or entity must
                                                  corrective action(s) taken, and the                     *      *    *     *     *                              implement a system to ensure that all
                                                  names of registered entity personnel                       (b) A transfer may be authorized if:                records and databases created under this
                                                  participants.                                                                                                  part are accurate and legible, have
                                                                                                          *      *    *     *     *
                                                  ■ 11. Section 331.15 is amended as
                                                                                                                                                                 controlled access, and that their
                                                                                                          ■ 13. Section 331.17 is amended as                     authenticity may be verified.
                                                  follows:                                                follows:
                                                  ■ a. By revising paragraph (a).                                                                                  (c) The individual or entity must
                                                                                                          ■ a. In paragraph (a)(1)(iii), by adding               promptly produce upon request any
                                                  ■ b. By adding paragraph (e).
                                                                                                          the words ‘‘or other storage container’’               information that is related to the
                                                    The addition and revision read as                     after the word ‘‘freezer’’.
                                                  follows:                                                                                                       requirements of this part but is not
                                                                                                          ■ b. By revising paragraph (a)(1)(v).                  otherwise contained in a record
                                                  § 331.15    Training.                                   ■ c. In paragraph (a)(3)(v), by adding the
                                                                                                                                                                 required to be kept by this section. The
                                                     (a) An individual or entity required to              words ‘‘or other storage container’’ after             location of such information may
                                                  register under this part must provide                   the word ‘‘freezer’’.                                  include, but is not limited to,
                                                                                                          ■ d. By removing the word ‘‘and’’ at the
                                                  information and training on                                                                                    biocontainment certifications,
                                                  biocontainment, biosafety, security                     end of paragraph (a)(6) and removing                   laboratory notebooks, institutional
                                                  (including security awareness), and                     the period at the end of paragraph (a)(7)              biosafety and/or animal use committee
                                                  incident response to:                                   and adding ‘‘; and’’ in its place.                     minutes and approved protocols, and
                                                                                                          ■ e. By adding paragraph (a)(8).
                                                     (1) Each individual with access                                                                             records associated with occupational
                                                                                                          ■ f. By revising paragraphs (b) and (c).
                                                  approval from the Administrator or HHS                                                                         health and suitability programs. All
                                                  Secretary. The training must address the                   The addition and revisions read as
                                                                                                                                                                 records created under this part must be
                                                  particular needs of the individual, the                 follows:
                                                                                                                                                                 maintained for 3 years.
                                                  work they will do, and the risks posed                  § 331.17    Records.
                                                  by the select agents or toxins. The                                                                            Title 9—Animals and Animal Products
                                                                                                            (a) * * *
                                                  training must be accomplished prior to                    (1) * * *                                            PART 121—POSSESSION, USE, AND
                                                  the individual’s entry into an area                       (v) The select agent used, purpose of                TRANSFER OF SELECT AGENTS AND
                                                  where a select agent is handled or                      use, and, when applicable, final                       TOXINS
                                                  stored, or within 12 months of the date                 disposition;
                                                  the individual was approved by the                                                                             ■ 14. The authority citation for part 121
                                                                                                          *     *     *     *    *
                                                  Administrator or the HHS Secretary for                                                                         continues to read as follows:
                                                                                                            (8) For select agents or material
                                                  access, whichever is earlier.                                                                                    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
                                                     (2) Each individual not approved for                 containing select agents or regulated
                                                                                                          nucleic acids that can produce                         and 371.4.
                                                  access to select agents and toxins by the
                                                  Administrator or HHS Secretary before                   infectious forms of any select agent                   ■ 15. Section 121.1 is amended by
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                                                  that individual enters areas under escort               virus that have been subjected to a                    adding, in alphabetical order,
                                                  where select agents or toxins are                       validated inactivation procedure or a                  definitions of principal investigator,
                                                  handled or stored (e.g., laboratories,                  procedure for removal of viable select                 validated inactivation procedure, and
                                                  growth chambers, animal rooms,                          agent:                                                 viability testing protocol to read as
                                                                                                            (i) A written description of the                     follows:
                                                    5 Nothing in this section is meant to supersede or    validated inactivation procedure or
                                                  preempt incident response requirements imposed          viable select agent removal method                     § 121.1     Definitions.
                                                  by other statutes or regulations.                       used, including validation data;                       *       *      *     *     *


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                                                                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations                                                    6207

                                                    Principal investigator. The one                       spores, or virus particles if the material               of an attenuated strain of a select agent
                                                  individual who is designated by the                     is subjected to a viability testing                      or a select toxin modified to be less
                                                  entity to direct a project or program and               protocol to ensure that the removal                      potent or toxic. The written request for
                                                  who is responsible to the entity for the                method has rendered the material free of                 reconsideration must state the facts and
                                                  scientific and technical direction of that              all viable select agent.                                 reasoning upon which the individual or
                                                  project or program.                                        (6) A select agent or regulated nucleic               entity relies to show the decision was
                                                  *     *     *     *      *                              acids that can produce infectious forms                  incorrect. The Administrator will grant
                                                    Validated inactivation procedure. A                   of any select agent virus not subjected                  or deny the request for reconsideration
                                                  procedure, whose efficacy is confirmed                  to a validated inactivation procedure or                 as promptly as circumstances allow and
                                                  by data generated from a viability                      material containing a select agent not                   will state, in writing, the reasons for the
                                                  testing protocol, to render a select agent              subjected to a procedure that removes                    decision.
                                                  non-viable but allows the select agent to               all viable select agent cells, spores, or                *     *      *    *      *
                                                  retain characteristics of interest for                  virus particles if the material is                       ■ 17. Section 121.4 is amended as
                                                  future use; or to render any nucleic                    determined by the Administrator to be                    follows:
                                                  acids that can produce infectious forms                 effectively inactivated or effectively                   ■ a. In paragraph (c)(1), by redesignating
                                                  of any select agent virus non-infectious                removed. To apply for a determination                    footnote 4 as footnote 6.
                                                  for future use.                                         an individual or entity must submit a                    ■ b. In paragraph (c)(2) introductory
                                                  *     *     *     *      *                              written request and supporting                           text, by removing the word ‘‘functional’’
                                                    Viability testing protocol. A protocol                scientific information to APHIS. A                       and adding in its place the word
                                                  to confirm the validated inactivation                   written decision granting or denying the                 ‘‘toxic’’.
                                                  procedure by demonstrating the                          request will be issued.                                  ■ c. By revising paragraph (d)(2).
                                                  material is free of all viable select agent.               (7) A VS select toxin identified in an                ■ d. By redesignating paragraph (d)(3) as
                                                                                                          original food sample or clinical sample.                 paragraph (d)(9).
                                                  *     *     *     *      *                                 (8) Waste generated during the                        ■ e. By adding paragraphs (d)(3) through
                                                  ■ 16. Section 121.3 is amended as                       delivery of patient care by health care
                                                  follows:                                                                                                         (8) and (e)(3).
                                                                                                          professionals from a patient diagnosed                      The additions and revision read as
                                                  ■ a. By revising paragraph (d)(2).                      with an illness or condition associated
                                                  ■ b. By redesignating paragraph (d)(3) as                                                                        follows:
                                                                                                          with a select agent, where that waste is
                                                  paragraph (d)(4).                                       decontaminated or transferred for                        § 121.4   Overlap select agents and toxins.
                                                  ■ c. By adding a new paragraph (d)(3).
                                                                                                          destruction by complying with State                      *      *    *     *      *
                                                  ■ d. By revising newly redesignated
                                                                                                          and Federal regulations within 7                            (d) * * *
                                                  paragraph (d)(4).
                                                                                                          calendar days of the conclusion of                          (2) Nonviable overlap select agents or
                                                  ■ e. By adding paragraphs (d)(5) through
                                                                                                          patient care.                                            nontoxic overlap toxins.7
                                                  (9) and (e)(3).
                                                                                                             (9) Any low pathogenic strains of                        (3) A select agent or toxin that has
                                                    The additions and revisions read as
                                                                                                          avian influenza virus, avian                             been subjected to decontamination or a
                                                  follows:
                                                                                                          paramyxovirus serotype-1 (APMV–1)                        destruction procedure when intended
                                                  § 121.3   VS select agents and toxins.                  viruses which do not meet the criteria                   for waste disposal.
                                                  *      *    *     *      *                              for Newcastle disease virus,4 including                     (4) A select agent or regulated nucleic
                                                     (d) * * *                                            those identified as pigeon                               acids that can produce infectious forms
                                                     (2) Nonviable VS select agents or                    paramyxovirus-12 5 isolated from a non-                  of any select agent virus that has been
                                                  nontoxic VS toxins.3                                    poultry species, all subspecies                          subjected to a validated inactivation
                                                     (3) A select agent or toxin that has                 Mycoplasma capricolum except                             procedure that is confirmed through a
                                                  been subjected to decontamination or a                  subspecies capripneumoniae                               viability testing protocol. Surrogate
                                                  destruction procedure when intended                     (contagious caprine pleuropneumonia),                    strains that are known to possess
                                                  for waste disposal.                                     and all subspecies Mycoplasma                            equivalent properties with respect to
                                                     (4) A select agent or regulated nucleic              mycoides except subspecies mycoides                      inactivation can be used to validate an
                                                  acids that can produce infectious forms                 small colony (Mmm SC) (contagious                        inactivation procedure; however, if
                                                  of any select agent virus that has been                 bovine pleuropneumonia), provided                        there are known strain-to-strain
                                                  subjected to a validated inactivation                   that the individual or entity can identify               variations in the resistance of a select
                                                  procedure that is confirmed through a                   that the agent is within the exclusion                   agent to an inactivation procedure, then
                                                  viability testing protocol. Surrogate                   category.                                                an inactivation procedure validated on
                                                  strains that are known to possess                          (e) * * *                                             a lesser resistant strain must also be
                                                  equivalent properties with respect to                      (3) An individual or entity may make                  validated on the more resistant strains.
                                                  inactivation can be used to validate an                 a written request to the Administrator                      (5) Material containing a select agent
                                                  inactivation procedure; however, if                     for reconsideration of a decision                        that is subjected to a procedure that
                                                  there are known strain-to-strain                        denying an application for the exclusion                 removes all viable select agent cells,
                                                  variations in the resistance of a select                                                                         spores, or virus particles if the material
                                                                                                            4 An APMV–1 virus isolated from poultry which
                                                  agent to an inactivation procedure, then                                                                         is subjected to a viability testing
                                                                                                          has an intracerebral pathogenicity index in day-old
                                                  an inactivation procedure validated on                  chicks (Gallus gallus) of 0.7 or greater or has an
                                                                                                                                                                   protocol to ensure that the removal
                                                  a lesser resistant strain must also be                  amino acid sequence at the fusion (F) protein            method has rendered the material free of
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                                                  validated on the more resistant strains.                cleavage site that is consistent with virulent strains   all viable select agent.
                                                     (5) Material containing a select agent               of Newcastle disease virus. A failure to detect a           (6) A select agent or regulated nucleic
                                                                                                          cleavage site that is consistent with virulent strains
                                                  that is subjected to a procedure that                   does not confirm the absence of a virulent virus.
                                                                                                                                                                   acids that can produce infectious forms
                                                  removes all viable select agent cells,                    5 Pigeon paramyxovirus (PPMV–1) is a species-          of any select agent virus not subjected
                                                                                                          adapted APMV–1 virus which is endemic in
                                                    3 However, the importation and interstate             pigeons and doves in the United States and can be          7 However, the importation and interstate

                                                  movement of these nonviable select agents may be        identified through monoclonal antibody testing and       movement of these nonviable overlap select agents
                                                  subject to the permit requirements under part 122       demonstration of their characteristic amino acid         may be subject to the permit requirements under
                                                  of this subchapter.                                     signature at the fusion gene cleavage site.              part 122 of this subchapter.



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                                                  6208             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                  to a validated inactivation procedure or                period between identification of the                   of APHIS/CDC Form 4 to APHIS or CDC
                                                  material containing a select agent not                  agent or toxin and transfer or                         within 7 calendar days after
                                                  subjected to a procedure that removes                   destruction of such agent or toxin, and                identification.
                                                  all viable select agent cells, spores, or               any theft, loss, or release of such agent              *      *     *    *     *
                                                  virus particles if the material is                      or toxin is reported;                                  ■ 20. Section 121.7 is amended as
                                                  determined by the Administrator or                         (3) Unless otherwise directed by the                follows:
                                                  HHS Secretary to be effectively                         Administrator, the clinical or diagnostic              ■ a. By redesignating paragraphs (b)
                                                  inactivated or effectively removed. To                  specimens collected from a patient                     through (k) as paragraphs (c) through (l),
                                                  apply for a determination an individual                 infected with a select agent are                       respectively.
                                                  or entity must submit a written request                 transferred in accordance with § 121.16                ■ b. By adding a new paragraph (b).
                                                  and supporting scientific information to                or destroyed on-site by a recognized                   ■ c. In newly redesignated paragraph
                                                  APHIS or CDC. A written decision                        sterilization or inactivation process                  (d)(3) introductory text, by redesignating
                                                  granting or denying the request will be                 within 7 calendar days after delivery of               footnote 6 as footnote 8.
                                                  issued.                                                 patient care by heath care professionals               ■ d. In newly redesignated paragraph
                                                     (7) An overlap select toxin identified               has concluded; and                                     (i)(1), by redesignating footnote 7 as
                                                  in an original food sample or clinical                     (4) The identification of the agent or              footnote 9.
                                                  sample.                                                 toxin is reported to APHIS or CDC, the                    The addition reads as follows:
                                                     (8) Waste generated during the                       specimen provider, and to other
                                                  delivery of patient care by health care                 appropriate authorities when required                  § 121.7 Registration and related security
                                                  professionals from a patient diagnosed                  by Federal, State, or local law by                     risk assessments.
                                                  with an illness or condition associated                 telephone, facsimile, or email. This                   *     *      *    *     *
                                                  with a select agent, where that waste is                report must be followed by submission                    (b) As a condition of registration, each
                                                  decontaminated or transferred for                       of APHIS/CDC Form 4 to APHIS or CDC                    entity is required to be in compliance
                                                  destruction by complying with State                     within 7 calendar days after                           with the requirements of this part for
                                                  and Federal regulations within 7                        identification.                                        select agents and toxins listed on the
                                                  calendar days of the conclusion of                      *      *    *     *      *                             registration regardless of whether the
                                                  patient care.                                           ■ 19. Section 121.6 is amended as                      entity is in actual possession of the
                                                  *      *    *     *     *                               follows:                                               select agent or toxin. With regard to
                                                     (e) * * *                                            ■ a. By revising paragraph (a)(1).                     toxins, the entity registered for
                                                     (3) An individual or entity may make                 ■ b. In paragraph (a)(2), by removing the              possession, use, or transfer of a toxin
                                                  a written request to the Administrator or               word ‘‘and’’ at the end of the paragraph.              must be in compliance with the
                                                  HHS Secretary for reconsideration of a                  ■ c. By redesignating paragraph (a)(3) as              requirements of this part regardless of
                                                  decision denying an application for the                 paragraph (a)(4).                                      the amount of toxins currently in its
                                                  exclusion of an attenuated strain of a                  ■ d. By adding new paragraph (a)(3).                   possession.
                                                  select agent or a select toxin modified to              ■ e. By revising newly redesignated                    *     *      *    *     *
                                                  be less potent or toxic. The written                    paragraph (a)(4).
                                                  request for reconsideration must state                                                                         § 121.8   [Amended]
                                                                                                             The addition and revisions read as
                                                  the facts and reasoning upon which the                  follows:                                               ■ 21. In § 121.8, footnote 8 is
                                                  individual or entity relies to show the                                                                        redesignated as footnote 10.
                                                  decision was incorrect. The                             § 121.6 Exemptions for overlap select
                                                                                                                                                                 ■ 22. Section 121.9 is amended as
                                                  Administrator or HHS Secretary will                     agents and toxins.
                                                                                                                                                                 follows:
                                                  grant or deny the request for                              (a) * * *                                           ■ a. By removing the semicolons at the
                                                  reconsideration as promptly as                             (1) Unless directed otherwise by the                ends of paragraphs (a)(1) through (4)
                                                  circumstances allow and will state, in                  Administrator, within 7 calendar days                  and ‘‘; and’’ at the end of paragraph
                                                  writing, the reasons for the decision.                  after identification of the select agent or            (a)(5) an adding periods in their place.
                                                  *      *    *     *     *                               toxin, the select agent or toxin is                    ■ b. In paragraph (a)(6), by removing the
                                                                                                          transferred in accordance with § 121.16                word ‘‘laboratory’’ and adding the
                                                  ■ 18. In § 121.5, paragraph (a) is revised
                                                                                                          or destroyed on-site by a recognized                   words ‘‘registered space’’ in its place
                                                  as follows:
                                                                                                          sterilization or inactivation process;                 and by adding the words ‘‘and the
                                                  § 121.5 Exemptions for VS select agents                 *      *    *     *     *                              corrections documented’’ at the end of
                                                  and toxins.                                                (3) Unless otherwise directed by the                the second sentence after the words
                                                     (a) Diagnostic laboratories and other                Administrator or HHS Secretary, the                    ‘‘must be corrected’’.
                                                  entities that possess, use, or transfer a               clinical or diagnostic specimens                       ■ c. By adding paragraphs (a)(7), (8), and
                                                  VS select agent or toxin that is                        collected from a patient infected with a               (9).
                                                  contained in a specimen presented for                   select agent are transferred in                           The additions read as follows:
                                                  diagnosis or verification will be exempt                accordance with § 121.16 or destroyed
                                                  from the requirements of this part for                  on-site by a recognized sterilization or               § 121.9   Responsible official.
                                                  such agent or toxin contained in the                    inactivation process within 7 calendar                   (a) * * *
                                                  specimen, provided that:                                days after delivery of patient care by                   (7) Ensure that individuals are
                                                     (1) Unless directed otherwise by the                 heath care professionals has concluded;                provided the contact information for the
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  Administrator, within 7 calendar days                   and                                                    USDA Office of Inspector General
                                                  after identification of the select agent or                (4) The identification of the agent or              Hotline and the HHS Office of Inspector
                                                  toxin, the select agent or toxin is                     toxin is reported to APHIS or CDC, the                 General Hotline so that they may
                                                  transferred in accordance with § 121.16                 specimen provider, and to other                        anonymously report any biosafety/
                                                  or destroyed on-site by a recognized                    appropriate authorities when required                  biocontainment or security concerns
                                                  sterilization or inactivation process;                  by Federal, State, or local law by                     related to select agents and toxins.
                                                     (2) The agent or toxin is secured                    telephone, facsimile, or email. This                     (8) Investigate to determine the reason
                                                  against theft, loss, or release during the              report must be followed by submission                  for any failure of a validated


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                                                                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations                                                    6209

                                                  inactivation procedure or any failure to                  (h) * * * Drills or exercises must be                including, but not limited to: Cultures
                                                  remove viable select agent from                         documented to include how the drill or                 and other materials related to the
                                                  material. If the responsible official is                exercise tested and evaluated the plan,                propagation of select agents or toxins,
                                                  unable to determine the cause of a                      any problems that were identified and                  items related to the analysis of select
                                                  deviation from a validated inactivation                 corrective action(s) taken, and the                    agents and toxins, personal protective
                                                  procedure or a viable select agent                      names of registered entity personnel                   equipment, animal caging systems and
                                                  removal method; or receives any report                  participants.                                          bedding (if applicable), animal carcasses
                                                  of any inactivation failure after the                   ■ 25. Section 121.12 is amended as                     or extracted tissues and fluids (if
                                                  movement of material to another                         follows:                                               applicable), laboratory surfaces and
                                                  location, the responsible official must                 ■ a. By revising paragraph (a).                        equipment, and effluent material; and
                                                  report immediately by telephone or                      ■ b. By removing paragraph (c)(2).                        (4) Procedures for the handling of
                                                  email the inactivation or viable agent                  ■ c. By redesignating paragraph (c)(3) as              select agents and toxins in the same
                                                  removal method failure to APHIS or                      paragraph (c)(2), and in newly                         spaces with non-select agents and toxins
                                                  CDC.                                                    redesignated paragraph (c)(2), removing                to prevent unintentional contamination.
                                                    (9) Review, and revise as necessary,                  the words ‘‘NIH Guidelines for Research                *      *     *    *     *
                                                  each of the entity’s validated                          Involving Recombinant DNA                                 (e) * * * Drills or exercises must be
                                                  inactivation procedures or viable select                Molecules’’ and adding in their place                  documented to include how the drill or
                                                  agent removal methods. The review                       the words ‘‘NIH Guidelines for Research                exercise tested and evaluated the plan,
                                                  must be conducted annually or after any                 Involving Recombinant or Synthetic                     any problems that were identified and
                                                  change in principal investigator, change                Nucleic Acid Molecules’’.                              corrective action(s) taken, and the
                                                  in the validated inactivation procedure                 ■ d. By adding a sentence at the end of                names of registered entity personnel
                                                  or viable select agent removal method,                  paragraph (e).                                         participants.
                                                  or failure of the validated inactivation                  The addition and revision read as                    ■ 26. Section 121.14 is amended as
                                                  procedure or viable select agent removal                follows:                                               follows:
                                                  method. The review must be                                                                                     ■ a. In the section heading, by
                                                                                                          § 121.12    Biosafety.
                                                  documented and training must be                                                                                redesignating footnote 10 as footnote 12.
                                                  conducted if there are any changes to                     (a) An individual or entity required to
                                                                                                                                                                 ■ b. In paragraph (a), by redesignating
                                                  the validated inactivation procedure,                   register under this part must develop
                                                                                                          and implement a written biosafety plan                 footnote 11 as footnote 13, and by
                                                  viable select agent removal method, or                                                                         adding a sentence at the end of the
                                                  viability testing protocol.                             that is commensurate with the risk of
                                                                                                          the select agent or toxin, given its                   paragraph.
                                                  *     *     *     *     *                                                                                      ■ c. In paragraph (f), by adding a
                                                                                                          intended use.11 The biosafety plan must
                                                  ■ 23. In § 121.10, paragraph (e) is                                                                            sentence at the end of the paragraph.
                                                                                                          contain sufficient information and
                                                  amended by adding a sentence at the                                                                               The additions read as follows:
                                                                                                          documentation to describe the biosafety
                                                  end of the paragraph to read as follows:                and containment procedures for the                     § 121.14    Incident response.12
                                                  § 121.10 Restricting access to select                   select agent or toxin, including any                     (a) * * * The current incident
                                                  agents and toxins; security risk                        animals (including arthropods) or plants               response plan must be submitted for
                                                  assessments.                                            intentionally or accidentally exposed to               initial registration, renewal of
                                                  *      *     *     *     *                              or infected with a select agent. The                   registration, or when requested.
                                                     (e) * * * A responsible official must                current biosafety plan must be                         *     *      *     *     *
                                                  immediately notify the responsible                      submitted for initial registration,                      (f) * * * Drills or exercises must be
                                                  official of the visited entity if the                   renewal of registration, or when                       documented to include how the drill or
                                                  person’s access to select agents and                    requested. The biosafety plan must                     exercise tested and evaluated the plan,
                                                  toxins has been terminated.                             include the following provisions:                      any problems that were identified and
                                                                                                            (1) The hazardous characteristics of                 corrective action(s) taken, and the
                                                  *      *     *     *     *                              each agent or toxin listed on the entity’s
                                                  ■ 24. Section 121.11 is amended as
                                                                                                                                                                 names of registered entity personnel
                                                                                                          registration and the biosafety risk                    participants.
                                                  follows:                                                associated with laboratory procedures
                                                  ■ a. In paragraph (c)(5), by adding the                                                                        ■ 27. Section 121.15 is amended as
                                                                                                          related to the select agent or toxin;
                                                  word ‘‘keycards,’’ after the word ‘‘keys,’’               (2) Safeguards in place with                         follows:
                                                  and by removing the word ‘‘numbers’’                                                                           ■ a. By revising paragraph (a).
                                                                                                          associated work practices to protect
                                                  and adding the word ‘‘permissions’’ in                                                                         ■ e. By adding paragraph (e).
                                                                                                          entity personnel, the public, and the
                                                  its place.                                                                                                       The addition and revision read as
                                                                                                          environment from exposure to the select
                                                  ■ b. In paragraph (d)(7)(iv), by removing                                                                      follows:
                                                                                                          agent or toxin including, but not limited
                                                  the word ‘‘and’’.                                       to: Personal protective equipment and                  § 121.15    Training.
                                                  ■ c. By adding paragraph (d)(7)(vi).                    other safety equipment; containment                       (a) An individual or entity required to
                                                  ■ d. By adding a sentence at the end of                 equipment including, but not limited to,               register under this part must provide
                                                  paragraph (h).                                          biological safety cabinets, animal caging              information and training on
                                                     The additions read as follows:                       systems, and centrifuge safety                         biocontainment, biosafety, security
                                                  § 121.11   Security.                                    containers; and engineering controls                   (including security awareness), and
                                                                                                          and other facility safeguards;                         incident response to:
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                                                  *     *     *     *    *                                  (3) Written procedures for each
                                                    (d) * * *                                                                                                       (1) Each individual with access
                                                                                                          validated method used for disinfection,                approval from the Administrator or HHS
                                                    (7) * * *                                             decontamination, or destruction, as
                                                    (vi) Any loss of computer, hard drive                                                                        Secretary. The training must address the
                                                                                                          appropriate, of all contaminated or                    particular needs of the individual, the
                                                  or other data storage device containing                 presumptively contaminated materials
                                                  information that could be used to gain                                                                           12 Nothing in this section is meant to supersede
                                                  access to select agents or toxins; and                    11 Technicalassistance and guidance may be           or preempt incident response requirements
                                                  *     *     *     *    *                                obtained by contacting APHIS.                          imposed by other statutes or regulations.



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                                                  6210             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

                                                  work they will do, and the risks posed                  ■ a. In paragraph (a)(1)(iii), by adding                 (c) The individual or entity must
                                                  by the select agents or toxins. The                     the words ‘‘or other storage container’’               promptly produce upon request any
                                                  training must be accomplished prior to                  after the word ‘‘freezer’’.                            information that is related to the
                                                  the individual’s entry into an area                     ■ b. By revising paragraph (a)(1)(v).                  requirements of this part but is not
                                                  where a select agent is handled or                      ■ c. In paragraph (a)(3)(v), by adding the             otherwise contained in a record
                                                  stored, or within 12 months of the date                 words ‘‘or other storage container’’ after             required to be kept by this section. The
                                                  the individual was approved by the                      the word ‘‘freezer’’.                                  location of such information may
                                                  Administrator or the HHS Secretary for                  ■ d. By removing the word ‘‘and’’ at the               include, but is not limited to,
                                                  access, whichever is earlier.                           end of paragraph (a)(6) and removing                   biocontainment certifications,
                                                     (2) Each individual not approved for                 the period at the end of paragraph (a)(7)              laboratory notebooks, institutional
                                                  access to select agents and toxins by the               and adding the word ‘‘; and’’ in its                   biosafety and/or animal use committee
                                                  Administrator or HHS Secretary before                   place.                                                 minutes and approved protocols, and
                                                  that individual enters areas under escort               ■ e. By adding paragraph (a)(8).                       records associated with occupational
                                                  where select agents or toxins are                       ■ f. By revising paragraphs (b) and (c).               health and suitability programs. All
                                                  handled or stored (e.g., laboratories,                     The addition and revisions read as                  records created under this part must be
                                                  growth chambers, animal rooms,                          follows:                                               maintained for 3 years.
                                                  greenhouses, storage areas, shipping/                   § 121.17    Records.                                     Done in Washington, DC, this 10th day of
                                                  receiving areas, production facilities,                   (a) * * *                                            January 2017.
                                                  etc.). Training for escorted personnel                    (1) * * *                                            Elvis S. Cordova,
                                                  must be based on the risk associated                      (v) The select agent used, purpose of                Acting Under Secretary for Marketing and
                                                  with accessing areas where select agents                use, and, when applicable, final                       Regulatory Programs.
                                                  and toxins are used and/or stored. The                  disposition;                                           [FR Doc. 2017–00857 Filed 1–18–17; 8:45 am]
                                                  training must be accomplished prior to
                                                                                                          *      *    *     *      *                             BILLING CODE 3410–34–P
                                                  the individual’s entry into where select
                                                                                                            (8) For select agents or material
                                                  agents or toxins are handled or stored
                                                                                                          containing select agents or regulated
                                                  (e.g., laboratories, growth chambers,                                                                          DEPARTMENT OF AGRICULTURE
                                                                                                          nucleic acids that can produce
                                                  animal rooms, greenhouses, storage
                                                                                                          infectious forms of any select agent
                                                  areas, shipping/receiving areas,                                                                               Agricultural Marketing Service
                                                                                                          virus that have been subjected to a
                                                  production facilities, etc.).
                                                                                                          validated inactivation procedure or a
                                                  *      *     *     *    *                               procedure for removal of viable select                 7 CFR Part 981
                                                     (e) The responsible official must                    agent:                                                 [Doc. No. AMS–SC–16–0047; SC16–981–3
                                                  ensure and document that individuals                      (i) A written description of the                     FIR]
                                                  are provided the contact information of                 validated inactivation procedure or
                                                  the USDA Office of Inspector General                    viable select agent removal method                     Almonds Grown in California; Change
                                                  Hotline and the HHS Office of Inspector                 used, including validation data;                       in Quality Control Requirements
                                                  General Hotline so that they may                          (ii) A written description of the
                                                  anonymously report any safety or                                                                               AGENCY:   Agricultural Marketing Service,
                                                                                                          viability testing protocol used;                       USDA.
                                                  security concerns related to select                       (iii) A written description of the
                                                  agents and toxins.                                      investigation conducted by the entity                  ACTION: Affirmation of interim rule as
                                                                                                          responsible official involving an                      final rule.
                                                  ■ 28. Section § 121.16 is amended as
                                                  follows:                                                inactivation or viable select agent                    SUMMARY:    The Department of
                                                  ■ a. In paragraph (a), by redesignating                 removal failure and the corrective                     Agriculture (USDA) is adopting, as a
                                                  footnote 12 as footnote 14.                             actions taken;                                         final rule, without change, an interim
                                                  ■ b. By revising paragraph (b)                            (iv) The name of each individual                     rule implementing a recommendation
                                                  introductory text.                                      performing the validated inactivation or               from the Almond Board of California
                                                  ■ c. By adding paragraph (l).
                                                                                                          viable select agent removal method;                    (Board) that relaxed the quality control
                                                                                                            (v) The date(s) the validated
                                                     The addition and revision read as                                                                           requirements prescribed under the
                                                                                                          inactivation or viable select agent
                                                  follows:                                                                                                       California almond marketing order
                                                                                                          removal method was completed;
                                                                                                                                                                 (order). The Board locally administers
                                                  § 121.16   Transfers.                                     (vi) The location where the validated
                                                                                                                                                                 the order and is comprised of growers
                                                  *      *     *     *    *                               inactivation or viable select agent
                                                                                                                                                                 and handlers operating within
                                                     (b) A transfer may be authorized if:                 removal method was performed; and
                                                                                                            (vii) A certificate, signed by the                   California. The interim rule relaxed
                                                  *      *     *     *    *                               principal investigator, that includes the              incoming quality requirements by
                                                     (l) Transfer the amounts only after the              date of inactivation or viable select                  increasing the inedible kernel tolerance
                                                  transferor uses due diligence and                       agent removal, the validated                           from 0.50 percent to 2 percent. This
                                                  documents that the recipient has a                      inactivation or viable select agent                    relaxation decreases California almond
                                                  legitimate need (e.g., prophylactic,                    removal method used, and the name of                   handlers’ disposition obligation. This
                                                  protective, bona fide research, or other                the principal investigator. A copy of the              change also allows handlers more
                                                  peaceful purpose) to handle or use such                 certificate must accompany any transfer                flexibility in their operations while
                                                                                                                                                                 continuing to maintain quality control
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                                                  toxins. Information to be documented                    of inactivated or select agent removed
                                                  includes, but is not limited, to the                    material.                                              and ensuring compliance with the
                                                  recipient information, toxin and amount                   (b) The individual or entity must                    order’s requirements.
                                                  transferred, and declaration that the                   implement a system to ensure that all                  DATES: Effective January 20, 2017.
                                                  recipient has legitimate purpose to store               records and databases created under this               FOR FURTHER INFORMATION CONTACT:
                                                  and use such toxins.                                    part are accurate and legible, have                    Andrea Ricci, Marketing Specialist or
                                                  ■ 29. Section 121.17 is amended as                      controlled access, and that their                      Jeffrey Smutny, Regional Director,
                                                  follows:                                                authenticity may be verified.                          California Marketing Field Office,


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Document Created: 2018-02-01 15:15:59
Document Modified: 2018-02-01 15:15:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesEffective February 21, 2017.
ContactDr. Freeda Isaac, National Director, Agriculture Select Agent Services, APHIS, 4700 River Road, Unit 2, Riverdale, MD 20737-1231; (301) 851-3300, Option 3.
FR Citation82 FR 6197 
RIN Number0579-AE08
CFR Citation7 CFR 331
9 CFR 121
CFR AssociatedAgricultural Research; Laboratories; Plant Diseases and Pests; Reporting and Recordkeeping Requirements; Animal Diseases and Medical Research

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