81_FR_2773 81 FR 2762 - 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

81 FR 2762 - 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 81, Issue 11 (January 19, 2016)

Page Range2762-2774
FR Document2016-00681

In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. 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 would implement the findings of the fourth biennial review of the list. In addition, we are proposing several amendments to the regulations, 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 would increase the usability of the select agent regulations as well as provide for enhanced program oversight.

Federal Register, Volume 81 Issue 11 (Tuesday, January 19, 2016)
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Proposed Rules]
[Pages 2762-2774]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00681]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / 
Proposed Rules

[[Page 2762]]



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: Proposed rule.

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SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are proposing to amend and republish the list of select 
agents and toxins that have the potential to pose a severe threat to 
animal or plant health, or to animal or plant products. 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 would implement the findings of the fourth biennial review of 
the list. In addition, we are proposing several amendments to the 
regulations, 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 would 
increase the usability of the select agent regulations as well as 
provide for enhanced program oversight.

DATES: We will consider all comments that we receive on or before March 
21, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0095, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-
0095 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

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: 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 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 proposing to amend and republish 
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 proposed 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 February 27, 2015, we published in the Federal Register (80 FR 
10627, Docket No. APHIS-2014-0095) an advance notice of proposed 
rulemaking

[[Page 2763]]

and request for comments (ANPR) \1\ in order to announce our intention 
to review the select agent list. We solicited comments regarding 
potential additions and deletions from the list of select agents and 
toxins for 60 days ending April 28, 2015. We received 20 comments by 
that date. They were from scientists, scientific organizations, a State 
government, private individuals, and industry groups. Suggestions in 
these comments were used in order to inform our discussions on the 
content of the select agent list.
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    \1\ To view the ANPR and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
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PPQ Select Agents and Toxins

    APHIS's PPQ program convened an interagency working group to review 
the list of PPQ select agents and toxins and develop recommendations 
regarding possible changes to that list. Using the four criteria for 
listing found in the Act, economic crop data, current Federal 
quarantine notices, and new scientific information, the working group 
revisited the currently listed PPQ select agents and toxins and 
evaluated a number of new plant pathogens for inclusion on the list. 
Based on this review, APHIS is proposing 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. Specifically, we are proposing 
to remove the following:
     Peronosclerospora philippinensis (Peronosclerospora 
sacchari) and Sclerophthora rayssiae: There are no viable cultures of 
these corn pathogens currently held in U.S. laboratories, they are 
difficult to grow or maintain, difficult to keep viable during 
transport, and would require a large amount of inoculum to infect 
fields by artificial means due to the fact that they must spread via 
infected plant material; and
     Phoma glycinicola (formerly Pyrenochaeta glycines): This 
soybean pathogen's natural distribution is limited to two countries in 
Africa, it does not spread rapidly in the field, soybean importation 
pathways into the United States by which the pathogen might enter are 
limited, and while no U.S. soybean variety is immune to this pathogen, 
Environmental Protection Agency-approved fungicides are available to 
treat any infestation.

VS Select Agents and Toxins

    APHIS' VS program also convened an interagency working group to 
review the list of VS select agents and toxins and the list of overlap 
select agents and toxins in 9 CFR part 121 in order to consider changes 
to the lists. Based on the review, APHIS is proposing to remove three 
overlap select agents and toxins from the list set out in Sec.  
121.4(b):
     Bacillus anthracis (Pasteur strain): Historically, the B. 
anthracis Pasteur strain has been retained as a select agent to allow 
for continued oversight of laboratories in which the accidental (or 
intentional) combination of this strain with the excluded Sterne strain 
could occur to produce the wild type phenotype B. anthracis de novo. 
However, a recent study \2\ indicates that bacterial transformation of 
B. subtilis with plasmid DNA is inefficient; indicating that 
transformation with bacteria such as B. anthracis (e.g., pXO1 into B. 
anthracis Pasteur strain) would also be inefficient. Given that B. 
anthracis Pasteur strain does not encode the plasmid which carries the 
pathogenic toxin genes, analogous to the Sterne strain which was 
excluded from Select Agent oversight in 2003, we believe there is no 
potential for high animal mortality rates or for misuse that might 
result in social or economic disruption. Therefore, we are proposing 
that the Pasteur strain be removed from the overlap select agent list.
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    \2\ C. Johnston, B. Martin, G. Fichant, P. Polard, and J.P. 
Claverys. ``Bacterial transformation: distribution, shared 
mechanisms and divergent control.'' Nature Reviews Microbiology. 
2014. 12: 181-196.
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     Brucella abortus and Brucella suis: While both of these 
organisms have been eradicated from the domestic livestock industry, 
they are currently endemic in wildlife and feral swine populations in 
the United States. However, there is an extensive regulatory control 
program in place for B. abortus in the remaining affected Designated 
Surveillance Area. APHIS has also recently enacted a national program 
to control feral swine that will include surveillance and disease 
monitoring for swine brucellosis. Therefore, we believe the effect of 
exposure to these agents on animal health and on the production and 
marketability of animal products is minimized. We are proposing that 
these two Brucella species be removed from the overlap select agent 
list. However, Brucella melitensis, as a foreign animal disease agent 
not currently found in the United States, would be kept as a VS select 
agent.
    Accordingly, CDC will also be proposing a parallel change to its 
overlap select agent regulations.

Additional Changes

    We are proposing to make several changes to the regulations, 
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, which are described in 
detail below, would increase the usability of the select agent 
regulations as well as provide for enhanced program oversight.

Definitions

    In 7 CFR 331.1 and 9 CFR 121.1, we are proposing to add definitions 
for inactivation and kill curve. We believe these definitions are 
necessary as they are included in the additional biocontainment and 
biosafety language we are proposing to add to the regulations.
    The definition of inactivation would be established as ``a method 
to render a select agent non-viable but retain characteristic 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.'' This definition draws a distinction between inactivation 
for waste treatment and inactivation of regulated material for future 
purposes such as research. The definition of kill curve would be 
established as ``the results of a dose-response experiment where a 
select agent is subjected to increasing amounts of the inactivating 
treatment to determine the minimum conditions required to render it 
non-viable or to render any nucleic acids that can produce infectious 
forms of any select agent virus as non-infectious.''

Exclusions and Inactivation

    We are proposing to amend 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 
9 CFR 121.4(d)(2), which currently 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 method 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.
    We are proposing 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.

[[Page 2764]]

    We are also proposing that the entity develop a site-specific kill 
curve in order to define 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.
    In addition, we are proposing that an entity be required to report 
any viability of a select agent or infectivity of regulated nucleic 
acids that can produce infectious forms of any select agent virus that 
was subjected to a validated inactivation protocol to APHIS or CDC.
    We are also proposing to require that an entity review annually, 
and revise as necessary, the following: (1) The kill curve procedure 
and results; (2) 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 (3) the validated sterility testing protocol used to ensure 
that the inactivation method has rendered a select agent non-viable or 
regulated nucleic acids that can produce infectious forms of any select 
agent viruses non-infectious.
    Finally, we are proposing that written records be kept for any 
select agent that has been rendered nonviable or regulated nucleic 
acids that have been rendered non-infectious. We are particularly 
requesting comments regarding whether there are more specific measures 
available to demonstrate that a select agent has been rendered 
nonviable, or a regulated infectious nucleic acid has been rendered 
non-infectious.
    We are also proposing to add to 7 CFR 331.3(e), 9 CFR 121.3(e), and 
9 CFR 121.4(e) a paragraph stating that an individual or entity may 
make a written request to the Administrator for reconsideration of a 
decision denying an exclusion application. The written request for 
reconsideration would have to state the facts and reasoning upon which 
the individual or entity relies to show the decision was incorrect. The 
Administrator would grant or deny the request for reconsideration as 
promptly as circumstances allow and will state, in writing, the reasons 
for the decision. This language was included in previous versions of 
the regulations and was erroneously removed by an earlier rulemaking.

Exemptions for Select Agents and Toxins

    Sections 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. Paragraph (a) requires that the identification of 
the agent or toxin be reported to APHIS or CDC. Since select agents and 
toxins have the potential to pose a severe threat to both human and 
animal health, to animal health, to plant health, or to animal and 
plant products, clinical and diagnostic laboratories typically have 
their initial results confirmed by a registered or certified reference 
laboratory. We are proposing to require that in addition to notifying 
APHIS or CDC, the reference laboratory inform the specimen provider 
upon confirmation of the identification of a select agent or toxin. 
This change would clarify our expectations regarding communication and 
notification between the reference laboratory and the specimen 
provider.
    We are also proposing to add language to paragraph (a) in sections 
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. 
This language was added to the CDC select agent regulations in a 
previous rulemaking, but not to the APHIS regulations and this change 
is necessary in order to achieve uniformity across all regulations 
associated with the diagnosis and care for individuals infected with a 
select agent or toxin. Specifically, we are proposing 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, these specimens 
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. These requirements would be set out 
in new paragraphs 9 CFR 121.3(d)(4) and 9 CFR 121.4(d)(4).

Registration and Related Security Risk Assessments

    The regulations in 7 CFR 331.7 and 9 CFR 121.7 set out registration 
requirements for those entities that wish to work with select agents 
and toxins and stipulates the individuals within those entities that 
must undergo a security risk assessment by the Attorney General.
    We are proposing to state that an entity registered to possess, 
use, or transfer a select agent or toxin would have to meet the 
requirements of the regulations for those select agents and toxins 
listed on the entity's official registration regardless of whether the 
entity is in possession of those select agents or toxins and without 
regard to the amount of select agents or toxins in the entity's 
possession. This change would serve to codify existing policy and would 
be added as a new paragraph (b).

Responsible Official

    The regulations in 7 CFR 331.9 and 9 CFR 121.9 set out requirements 
for entities requesting to work with select agents and toxins to 
designate a responsible official, who ensures that the entity continues 
to meet the requirements of the regulations.
    Paragraph (a)(6) requires the responsible official to ensure that 
annual inspections are conducted for each location where select agents 
or toxins are stored or used in order to determine compliance with the 
regulations. The responsible official also must document the results of 
each inspection and identify and address any deficiencies.
    We are proposing to require that any corrections of deficiencies 
found must also be documented. This change is necessary to improve 
recordkeeping practices and to provide a more complete account of 
facility containment and security procedures. We are also proposing to 
replace the word ``laboratory'' with the phrase ``registered space.'' 
This terminology is more accurate, as registered spaces are not always 
laboratories.
    We are also proposing to add a new paragraph (a)(7), which would 
require the entity's responsible official to provide contact 
information for the USDA or HHS Office of Inspector General Hotline, so 
that employees and other individuals may anonymously report any 
containment or security concerns they may have. Although the select 
agent program has established a whistleblower portal on its Web site, 
there is currently no requirement for employees at registered entities 
to be

[[Page 2765]]

made aware of its existence or how to use it. Adding this requirement 
would allow for increased worker involvement in biosafety/
biocontainment and security programs at registered entities and may 
also enhance the quality of Federal oversight in this area.

Security Risk Assessments

    We are proposing to amend the regulations in 7 CFR 331.10 and 9 CFR 
121.10. These regulations establish parameters for restricting access 
to select agents and toxins and the process by which individuals may be 
approved for access to select agents and toxins after the completion of 
a security risk assessment by the Attorney General.
    Paragraph (e) states that a person with valid approval from the HHS 
Secretary or Administrator to have access to select agents or toxins 
may request, through his or her responsible official, that the HHS 
Secretary or APHIS Administrator provide their approved access status 
to another registered individual or entity for a specified period of 
time. We are proposing to also require that the responsible official at 
the visiting person's home entity notify the host entity if that 
person's approved access to select agents or toxins has been 
terminated. This would ensure that an individual whose permissions have 
been terminated would not be allowed further access to select agents 
and toxins.

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 are proposing 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 are proposing 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).
    We are also proposing to add a requirement that the biocontainment, 
biosafety, and incident response plans be submitted for initial 
registration, renewal of registration, or when requested. These 
additions would be located in 7 CFR 331.12(a), 331.14(a), 9 CFR 
121.12(a), and 121.14(a). This change is necessary in order to bring 
the requirements for these plans in line with existing requirements for 
the security plan.
    Details of the changes we are proposing to the security, 
biosecurity, and biosafety plans individually may be found below.

Security Plan

    Paragraph (c)(5) of 7 CFR 331.11 and 9 CFR 121.11 requires that the 
security plan describe procedures for addressing loss or compromise of 
keys, passwords, combinations, etc. and protocols for changing access 
numbers or locks following staff changes. We are proposing to add 
keycards to that list as they are commonly used. We are also proposing 
to use the term ``access permissions'' instead of the term ``access 
numbers,'' as it covers a broader range of topics.
    We are also proposing to add a new paragraph (c)(11) to the 
regulations in 7 CFR 331.11 and 9 CFR 121.11. This would require that 
the security plan contain a description of how the entity authorizes 
the means of entry into areas where select agents or toxins are stored 
or used, which would include a description of all centralized access 
control management systems (e.g., keycards) and/or mechanical key 
management. This requirement would allow us to directly ascertain the 
way in which entities allow individuals entry to areas containing 
select agents and toxins and potentially identify any weaknesses in 
that process.
    In the same sections, paragraphs (d)(7)(i) through (d)(7)(v) 
encompass a list of activities that individuals with access approval 
from the Administrator or the HHS Secretary must immediately report to 
the responsible official. We are proposing to add a new paragraph 
(d)(7)(vi) to require that the responsible official must be notified of 
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. Such notification will facilitate notification of the 
Federal Bureau of Investigation if deemed necessary by the responsible 
official as the loss of such equipment may be criminal in nature.

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 are proposing to additionally require that laboratory-
specific biocontainment and/or biosafety manuals must be accessible to 
individuals working in those laboratories. This change would 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.
    In the aftermath of recent biosafety incidents involving an 
unintentional release of potentially viable anthrax within the CDC's 
Roybal Campus, in Atlanta, GA, and the inadvertent cross-contamination 
and shipment of a laboratory specimen of low-pathogenic avian influenza 
virus with the VS select agent highly pathogenic avian influenza virus, 
we believe that the biocontainment and biosafety plans should be 
designed according to a site-specific risk assessment in accordance 
with the risk posed by a select agent or toxin. Therefore, we are 
proposing to

[[Page 2766]]

add specific provisions to the biocontainment and biosafety plans that 
would require completion of a written risk assessment for each 
procedure. This risk assessment would have to include the following 
elements: A description of the safeguards in place to protect entity 
personnel, the public, and the environment from exposure to the select 
agent or toxin; decontamination procedures; waste management 
procedures; and procedures for handling select agents and toxins in the 
same spaces as non-select agents and toxins in order to prevent 
unintentional cross-contamination.
    We are specifically requesting comments regarding any specific 
biocontainment or biosafety measures to prevent laboratory acquired 
infections or accidental or intentional release of the select agents 
and toxins from an entity into the community.
    Finally, paragraph (c)(2) of 9 CFR 121.12 requires that entities 
should consider the guidance found in the Occupational Safety and 
Health Administration regulations in 29 CFR 1910.1200 and 1910.1450. We 
are proposing to remove this reference as the information in those 
regulations is also contained in the CDC/National Institutes of Health 
publication, ``Biosafety in Microbiological and Biomedical 
Laboratories,'' which is referenced in paragraph (c)(1) and a second 
reference is therefore duplicative.

Training

    We are proposing 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 are proposing 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. 
This change is necessary in order to codify our position regarding 
which individuals at registered entities are required to receive 
training.

Transfers

    We are proposing to amend the regulations in 7 CFR 331.16 and 9 CFR 
121.16, which concern the transfer of select agents and toxins to a 
registered entity. Specifically, paragraph (b) states that select 
agents and toxins may need a permit issued in accordance with 7 CFR 
part 330 or 9 CFR part 122. We have determined that a permit for the 
importation or interstate movement of a select agent or toxin listed in 
7 CFR 331.3, 9 CFR 121.3, or 121.4 is not required for such importation 
and/or interstate movement provided that the select agent or toxin is 
authorized for transfer in accordance with 7 CFR 331.16(b) or 9 CFR 
121.16(b).

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 are proposing to add 
this requirement in order to ensure consistency with the toxin 
provisions and ensure proper tracking of select agents from acquisition 
to destruction. These requirements would be added in a new paragraph 
(a)(1)(ix).
    We are also proposing to require that regulated entities maintain 
records concerning those select agents that have been rendered 
nonviable or regulated nucleic acids that have been rendered non-
infectious. These records would specifically capture the activities 
detailed under the heading ``Exclusions and Inactivation'' above. Such 
recordkeeping is necessary in order to confirm that an entity has 
performed the procedures necessary. The select agent program would then 
have the ability to review those records in order to ensure that the 
entity is performing all procedures necessary for nonviability or 
inactivation. The requirements would be added in a new paragraph (a)(8) 
in 7 CFR 331.17 and 9 CFR 121.17.
    We are also proposing 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. This 
requirement would be added to revised paragraph (c). Given the wide 
variety of entities regulated under the Federal Select Agent Program, 
the scope of records readily available for program review will enhance 
the ability of the program to evaluate entity biosafety, 
biocontainment, security, and incident response programs. Paragraph (c) 
in both 7 CFR 331.17 and 9 CFR 121.17 would also be revised 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.
    Finally, paragraph (b) in both 7 CFR 331.17 and 9 CFR 121.17 
requires that regulated entities implement a system to ensure that all 
records and databases created under this part are accurate, have 
controlled access, and that their authenticity may be verified. To 
ensure the accuracy of handwritten records, we are proposing to specify 
that such records must be legible.

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 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 are therefore 
soliciting 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 are soliciting 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.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for 
the purposes of Executive Order 12866 and, therefore, has not been 
reviewed by the Office of Management and Budget.

[[Page 2767]]

    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188) provides for the regulation of 
certain biological agents and toxins that have the potential to pose a 
severe threat to human, animal, or plant health, or to animal or plant 
products. APHIS has completed its fourth biennial review of select 
agent regulations and is proposing changes that would increase their 
usability as well as provide for enhanced program oversight. The 
proposed amendments include provisions to address the inactivation of 
select agents, provisions addressing biosafety, and clarification of 
regulatory language concerning security, training, incident response, 
and records.
    The proposed rule would require that entities develop an agent-
specific kill curve in order to define conditions of inactivation for 
each select agent or regulated infectious nucleic acid and maintain 
written records of having done so.\3\ Costs of complying with this 
amendment are therefore expected to be modest.
---------------------------------------------------------------------------

    \3\ The definition of kill curve would be ``the results of a 
dose-response experiment where a select agent is subjected to 
increasing amounts of the inactivating treatment to determine the 
minimum conditions required to render it non-viable or to render any 
nucleic acids that can produce infectious forms of any select agent 
virus as non-infectious.''
---------------------------------------------------------------------------

    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 proposed record keeping and reporting requirements, an additional 10 
to 20 hours per year may be required. At an imputed cost of $33.40 per 
hour (GS-12, step 2), this additional time requirement per entity would 
cost between $334 and $668 per year, or in total for all registered 
entities between $80,000 and $160,000.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), we have determined that there is 
burden associated with this action. We will publish a separate document 
in the Federal Register, announcing our determination of burden and 
soliciting comments on it.

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 proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects

7 CFR Part 331

    Agricultural research, Laboratories, Plant diseases and pests, 
Reporting and recordkeeping requirements.

9 CFR Part 121

    Agricultural research, Animal diseases, Laboratories, Medical 
research, Reporting and recordkeeping requirements.
    Accordingly, we propose to amend 7 CFR part 331 and 9 CFR part 121 
as follows:

TITLE 7--AGRICULTURE

PART 331--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

0
1. The authority citation for part 331 continues to read as follows:


    Authority:  7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.


0
2. Section 331.1 is amended by adding, in alphabetical order, 
definitions of inactivation and kill curve to read as follows:


Sec.  331.1  Definitions.

* * * * *
    Inactivation. A method to render a select agent non-viable but 
retain characteristic 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.
* * * * *
    Kill curve. The results of a dose-response experiment where a 
select agent is subjected to increasing amounts of the inactivating 
treatment to determine the minimum conditions required to render it 
non-viable, or to render any nucleic acids that can produce infectious 
forms of any select agent virus as non-infectious.
* * * * *
0
3. Section 331.3 is amended as follows:
0
a. In paragraph (b), by removing the words ``Peronosclerospora 
philippinensis (Peronosclerospora sacchari);'', ``Phoma glycinicola 
(formerly Pyrenochaeta glycines);'', and ``Sclerophthora rayssiae;''
0
b. By revising paragraph (d)(2).
0
c. By adding paragraph (e)(3).
    The addition and revision read as follows:


Sec.  331.3  PPQ select agents and toxins.

* * * * *
    (d) * * *
    (2) Nonviable select agents or nonfunctional toxins.
    (i) Unless waived by the Administrator, 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 process to 
remove viability or infectious form (i.e., the ability to reproduce or 
produce disease, while maintaining cellular structure) is not excluded 
from the requirements of this part until an individual or entity:
    (A) Develops a site-specific kill curve to define conditions of 
inactivation for each select agent or regulated nucleic acids that can 
produce infectious forms

[[Page 2768]]

of any select agent virus. If there are strain-to-strain variations in 
resistance of a select agent to the inactivation procedure, then a 
specific kill curve must be developed for each strain that undergoes 
the inactivation procedure. A new kill curve must be created upon any 
change in procedure or inactivation equipment.
    (B) Develops site-specific standard operating inactivation 
procedures to ensure that the material is inactivated by a safety 
margin determined by the kill curve.
    (C) Subjects representative samples of inactivated select agents or 
any nucleic acids that can produce infectious forms of any select agent 
viruses to a validated sterility testing protocol to ensure that the 
inactivation method has rendered the select agent non-viable or 
regulated nucleic acids non-infectious.
    (D) Any viability of a select agent or infectivity of regulated 
nucleic acids that can produce infectious forms of any select agent 
virus that was subjected to a validated inactivation protocol is 
reported to APHIS.
    (E) Reviews annually, and revises as necessary, the following:
    (1) The kill curve procedure and results;
    (2) 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
    (3) The validated sterility testing protocol used to ensure that 
the inactivation method has rendered a select agent non-viable or 
regulated nucleic acids that can produce infectious forms of any select 
agent virus sample non-infectious.
    (F) Reviews, and revises as necessary, documents listed in 
paragraph (d)(2)(i)(E) of this section after any change in principal 
investigator, change in protocol, or any reported viability of a select 
agent or infectivity of regulated nucleic acids that can produce 
infectious forms of any select agent viruses previously assessed as 
inactive.
    (ii) Unless waived by the Administrator, an extract from a select 
agent is not excluded from the requirements of this part until an 
individual or entity meets the following requirements:
    (A) Any extract is subjected to a process that removes all viable 
cells, spores, or virus particles.
    (B) Any extract is subjected to a validated sterility testing 
protocol to ensure that the inactivation method has rendered the 
extract free of a select agent.
    (C) Any viability of an extract that was subjected to a validated 
inactivation protocol is reported to the responsible official.
    (D) Any viability of a select agent or infectivity of regulated 
nucleic acids that can produce infectious forms of any select agent 
virus that was previously assessed as inactive by their validated 
sterility testing protocol is reported to APHIS.
* * * * *
    (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. In Sec.  331.5, paragraph (a)(3) is revised to read as follows:


Sec.  331.5  Exemptions.

    (a) * * *
    (3) The identification of the agent or toxin is reported to APHIS, 
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 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. In regard to toxins, 
the entity registered for possession, use, or transfer of toxins must 
be in compliance with the requirements of this part regardless of the 
amounts of toxins currently in possession.
* * * * *
0
6. Section 331.9 is amended as follows:
0
a. 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
b. By adding paragraph (a)(7).
    The addition reads as follows:


Sec.  331.9  Responsible official.

    (a) * * *
    (7) Ensure that individuals are provided the contact information 
for the USDA or HHS Office of Inspector General Hotline so that they 
may anonymously report any biosafety/biocontainment or security 
concerns related to select agents and toxins.
* * * * *
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. By adding paragraph (c)(11).
0
c. In paragraph (d)(7)(iv), by removing the word ``and''.
0
d. By adding paragraph (d)(7)(vi).
0
e. By adding a sentence at the end of paragraph (h).
    The additions read as follows:


Sec.  331.11  Security.

* * * * *
    (c) * * *
    (11) Describe how the entity authorizes the means of entry into 
areas where select agents or toxins are stored or used to include 
centralized access control management systems (e.g., keycards) and/or 
mechanical key management.
    (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.
* * * * *
    (h) * * * Drills or exercises must be documented to include how the 
drill or

[[Page 2769]]

exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and all individuals who 
participated in the drill or exercise.
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 biocontainment procedures specific to 
each registered laboratory must be available to each individual working 
in that laboratory. 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) A written risk assessment for each prescribed procedure 
involving a select agent or toxin.
    (i) The hazardous characteristics of the agent or toxin listed on 
the entity's registration, including probable routes of transmission in 
the laboratory and in the environment, infective dose (if known), 
stability in the environment, host range, contribution of any genetic 
manipulations, and endemicity.
    (ii) Hazards associated with laboratory procedures related to the 
select agent or toxin.
    (2) Safeguards in place with associated containment procedures to 
protect registered entity personnel, the public, and the environment 
from exposure to the select agent or toxin including, but not limited 
to: Safety training requirements for registered entity personnel 
performing the procedure; required personal protective equipment; 
required containment equipment including, but not limited to, 
biological safety cabinets, arthropod caging systems, and centrifuge 
safety containers; and required physical plant engineering controls.
    (3) Written procedures for decontamination, with a validated 
method, of all contaminated or potentially 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 or toxins, personal protective equipment, 
arthropod caging systems and extracted plant and/or arthropod tissues.
    (4) Written procedures for decontamination, with a validated 
method, of laboratory surfaces and equipment using manufacturer's 
specification.
    (5) Effluent decontamination procedures, with a validated method, 
that describe the treatment of effluent material contaminated with 
select agents or toxins.
    (6) Procedures to respond to emergencies such as spills, sharps 
injury, or any other incident involving select agents and toxins.
    (7) Procedures for handling of select agents and toxins in the same 
spaces as non-select agents and toxins in order 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 all individuals who 
participated in the drill or exercise.
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 all individuals who 
participated in the drill or exercise.
0
11. Section 331.15 is amended as follows:
0
a. By revising paragraph (a), introductory text.
0
b. By revising paragraph (a)(1).
    The revisions 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, security 
(including security awareness), incident response, and agent- and 
toxin-specific training to:
    (1) Each individual with access approval from the Administrator, 
within 12 months of that individual's anniversary of receiving such 
approval or prior to his or her entry into an area where select agents 
or toxins are used or stored, whichever occurs first; and
* * * * *
0
12. In Sec.  331.16, paragraph (b), introductory text, is revised 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 adding paragraph (a)(1)(ix).
0
c. In paragraph (a)(3)(v), by adding the words ``or other storage 
container'' after the word ``freezer''.
0
d. By adding paragraph (a)(8).
0
e. By adding a sentence at the end of paragraph (b).
0
f. By revising paragraph (c).
    The additions and revision read as follows:


Sec.  331.17  Records.

    (a) * * *
    (1) * * *
    (ix) If destroyed, the quantity (e.g., containers, vials, tubes, 
etc.) of select agent destroyed, the date of such action, and by whom.
* * * * *
    (8) For a select agent or an extract from a select agent that has 
been rendered nonviable or regulated nucleic acids that have been 
rendered non-infectious:
    (i) A written description of the inactivation process used for 
rendering a select agent or an extract from a select agent nonviable or 
regulated nucleic acids non-infectious;
    (ii) The sterility testing protocol used to verify nonviability of 
a select agent or an extract from a select agent or non-infectivity of 
regulated nucleic acids and the results of the test, including 
investigation, of any inactivation process failures and the corrective 
actions taken;
    (iii) The name of each individual performing the inactivation 
method and sterility testing protocols;
    (iv) The date(s) the inactivation method and sterility testing 
protocols were completed;

[[Page 2770]]

    (v) The location where the inactivated method and sterility testing 
protocols were performed; and
    (vi) An inactivation certificate that includes the date of 
inactivation, method of inactivation, date of final sterility testing 
protocol result, and the name of the person performing the 
inactivation. A copy of the inactivation certificate must accompany any 
transfer of inactivated material.
    (b) * * * All written records created under this part are legible.
    (c) Any records that contain information related to the 
requirements of the regulations. 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. 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 inactivation and kill curve to read as follows:


Sec.  121.1  Definitions.

* * * * *
    Inactivation. A method to render a select agent non-viable but 
retain characteristic 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.
* * * * *
    Kill curve. The results of a dose-response experiment where a 
select agent is subjected to increasing amounts of the inactivating 
treatment to determine the minimum conditions required to render it 
non-viable, or to render any nucleic acids that can produce infectious 
forms of any select agent virus as non-infectious.
* * * * *
0
16. Section 121.3 is amended as follows:
0
a. By revising paragraphs (d)(2) and (d)(3).
0
b. By adding paragraph (d)(4).
0
c. By adding paragraph (e)(3).
    The additions and revisions read as follows:


Sec.  121.3  VS select agents and toxins.

* * * * *
    (d) * * *
    (2) Nonviable VS select agents or nonfunctional 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.
---------------------------------------------------------------------------

    (i) Unless waived by the Administrator, 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 process to 
remove viability or infectious form (i.e., the ability to reproduce or 
produce disease, while maintaining cellular structure) is not excluded 
from the requirements of this part until an entity:
    (A) Develops a site-specific kill curve to define conditions of 
inactivation for each select agent or regulated nucleic acids that can 
produce infectious forms of any select agent virus. If there are 
strain-to-strain variations in resistance of a select agent to the 
inactivation procedure, then a specific kill curve must be developed 
for each strain that undergoes the inactivation procedure. A new kill 
curve must be created upon any change in procedure or inactivation 
equipment.
    (B) Develops site-specific standard operating inactivation 
procedures to ensure that the material is inactivated by a safety 
margin determined by the kill curve.
    (C) Subjects representative samples of inactivated select agents or 
any nucleic acids that can produce infectious forms of any select agent 
viruses to a validated sterility testing protocol to ensure that the 
inactivation method has rendered the select agent non-viable or 
regulated nucleic acids non-infectious.
    (D) Any viability of a select agent or infectivity of regulated 
nucleic acids that can produce infectious forms of any select agent 
virus that was subjected to a validated inactivation protocol is 
reported to APHIS or CDC.
    (E) Reviews annually, and revises as necessary, the following:
    (1) The kill curve procedure and results;
    (2) 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
    (3) The validated sterility testing protocol used to ensure that 
the inactivation method has rendered a select agent non-viable or 
regulated nucleic acids that can produce infectious forms of any select 
agent viruses non-infectious.
    (F) Reviews, and revises as necessary, documents listed in 
paragraph (d)(2)(i)(E) of this section after any change in principal 
investigator, change in protocol, or any reported viability of a select 
agent or infectivity of regulated nucleic acids that can produce 
infectious forms of any select agent viruses previously assessed as 
inactive.
    (ii) Unless waived by the Administrator, an extract from a select 
agent is not excluded from the requirements of this part until an 
individual or entity meets the following requirements:
    (A) Any extract is subjected to a process that removes all viable 
cells, spores, or virus particles.
    (B) Any extract is subjected to a validated sterility testing 
protocol to ensure that the inactivation method has rendered the 
extract free of a select agent.
    (C) Any viability of an extract that was subjected to a validated 
inactivation protocol is reported to the responsible official.
    (D) Any viability of a select agent or infectivity of regulated 
nucleic acids that can produce infectious forms of any select agent 
virus that was previously assessed as inactive by their validated 
sterility testing protocol is reported to APHIS or CDC.
    (E) Reviews annually, and revises as necessary, the following:
    (1) The kill curve procedure and results;
    (2) Site-specific standard operating procedures to ensure that 
select agents or regulated nucleic acids that can produce infectious 
forms of any select agent viruses are inactivated by a safety margin; 
and
    (3) The validated sterility testing protocol used to ensure that 
the inactivation method has rendered a select agent non-viable or 
regulated nucleic acids that can produce infectious forms of any select 
agent viruses non-infectious.
    (F) Reviews, and revises as necessary, documents listed in 
paragraph (d)(2)(ii)(E) of this section after any change in principal 
investigator, change in protocol, or any reported viability of a select 
agent or infectivity of regulated nucleic acids that can produce 
infectious forms of any select agent virus previously assessed as 
inactive.
    (3) Any low pathogenic strains of avian influenza virus, avian 
paramyxovirus serotype-1 (APMV-1) viruses which do not meet the 
criteria

[[Page 2771]]

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.
---------------------------------------------------------------------------

    (4) Waste generated during the delivery of patient care from a 
patient infected with a select agent that is decontaminated with a 
validated method 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
17. Section 121.4 is amended as follows:
0
a. In paragraph (b), by removing the words ``Bacillus anthracis 
(Pasteur strain);'', ``Brucella abortus;'', and ``Brucella suis;''.
0
b. In paragraph (c)(1), by redesignating footnote 4 as footnote 6.
0
c. By revising paragraph (d)(2).
0
d. By adding paragraph (d)(4).
0
e. By adding paragraph (e)(3).
    The additions and revision read as follows:


Sec.  121.4  Overlap select agents and toxins.

* * * * *
    (d) * * *
    (2) Nonviable overlap select agents or nonfunctional 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.
---------------------------------------------------------------------------

    (i) Unless waived by the APHIS Administrator or HHS Secretary, 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 process to remove viability or infectious form (i.e., the 
ability to reproduce or produce disease, while maintaining cellular 
structure) is not excluded from the requirements of this part until an 
individual or entity:
    (A) Develops a site-specific kill curve to define conditions of 
inactivation for each select agent or regulated nucleic acids that can 
produce infectious forms of any select agent virus. If there are 
strain-to-strain variations in resistance of a select agent to the 
inactivation procedure, then a specific kill curve must be developed 
for each strain that undergoes the inactivation procedure. A new kill 
curve must be created upon any change in procedure or inactivation 
equipment.
    (B) Develops site-specific standard operating inactivation 
procedures to ensure that the material is inactivated by a safety 
margin determined by the kill curve.
    (C) Subjects representative samples of inactivated select agents or 
any regulated nucleic acids that can produce infectious forms of any 
select agent viruses to a validated sterility testing protocol to 
ensure that the inactivation method has rendered the select agent non-
viable or regulated nucleic acids non-infectious.
    (D) Reports any viability of a select agent or infectivity of 
regulated nucleic acids that can produce infectious forms of any select 
agent virus that was subjected to a validated inactivation protocol to 
the responsible official.
    (E) Reviews annually, and revises as necessary, the following:
    (1) The kill curve procedure and results;
    (2) 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
    (3) The validated sterility testing protocol used to ensure that 
the inactivation method has rendered a select agent non-viable or 
regulated nucleic acids that can produce infectious forms of any select 
agent viruses non-infectious.
    (F) Reviews, and revises as necessary, documents listed in 
paragraph (d)(2)(i)(E) of this section after any change in principal 
investigator, change in protocol, or any reported viability of a select 
agent or infectivity of regulated nucleic acids that can produce 
infectious forms of any select agent virus previously assessed as 
inactive.
    (ii) Unless waived by the APHIS Administrator or HHS Secretary, an 
extract from a select agent is not excluded from the requirements of 
this part until an individual or entity meets the following 
requirements:
    (A) Any extract is subjected to a process that removes all viable 
cells, spores, or virus particles.
    (B) Any extract is subjected to a validated sterility testing 
protocol to ensure that the inactivation method has rendered the 
extract free of a select agent.
    (C) Any viability of an extract that was subjected to a validated 
inactivation protocol is reported to the responsible official.
    (D) Any viability of a select agent or infectivity of regulated 
nucleic acids that can produce infectious forms of any select agent 
virus that was previously assessed as inactive by the validated 
sterility testing protocol is reported to APHIS or CDC.
* * * * *
    (4) Waste generated during the delivery of patient care from a 
patient infected with a select agent that is decontaminated with a 
validated method 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. Section 121.5 is amended as follows:
0
a. By revising paragraphs (a)(2) and (a)(3).
0
b. By adding paragraph (a)(4).
    The addition and revisions read as follows:


Sec.  121.5  Exemptions for VS select agents and toxins.

    (a) * * *

[[Page 2772]]

    (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 directed otherwise 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 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. In paragraph (a)(2), by removing the word ``and'' at the end of the 
paragraph.
0
b. By redesignating paragraph (a)(3) as paragraph (a)(4).
0
c. By adding new paragraph (a)(3).
0
d. By revising newly redesignated paragraph (a)(4).
    The addition and revision read as follows:


Sec.  121.6  Exemptions for overlap select agents and toxins.

    (a) * * *
    (3) Unless directed otherwise 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 has concluded;
    (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 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 paragraph (c)(3), introductory text, by redesignating footnote 6 
as footnote 8.
0
d. In paragraph (h)(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 toxin currently in 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. 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
b. By adding paragraph (a)(7).
    The addition reads as follows:


Sec.  121.9  Responsible official.

    (a) * * *
    (7) Ensure that individuals are provided the contact information 
for the USDA or HHS Office of Inspector General Hotline so that they 
may anonymously report any safety or security concerns related to 
select agents and toxins.
* * * * *
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. By adding paragraph (c)(11).
0
c. In paragraph (d)(7)(iv), by removing the word ``and''.
0
d. By adding paragraph (d)(7)(vi).
0
e. By adding a sentence at the end of paragraph (h).
    The additions read as follows:


Sec.  121.11  Security.

* * * * *
    (c) * * *
    (11) Describe how the entity authorizes the means of entry into 
areas where select agents or toxins are stored or used to include 
centralized access control management systems (e.g., keycards) and/or 
mechanical key management.
    (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.
* * * * *
    (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 all individuals who 
participated in the drill or exercise.
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 removing 
the words ``NIH Guidelines for Research Involving Recombinant DNA 
Molecules'' and replacing them with 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. Biosafety and containment 
procedures specific to

[[Page 2773]]

each registered laboratory must be available to each individual working 
in that laboratory. 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) A written risk assessment for each procedure involving a select 
agent or toxin that addresses the hazards associated with the agent or 
toxin.
    (i) The hazardous characteristics of each agent or toxin listed on 
the entity's registration, including probable routes of transmission in 
the laboratory and in the environment, infective dose (if known), 
stability in the environment, host range, contribution of any genetic 
manipulations, and endemicity.
    (ii) Hazards associated with laboratory procedures related to the 
select agent or toxin.
    (2) Safeguards in place with associated work practices to protect 
registered entity personnel, the public, and the environment from 
exposure to the select agent or toxin including, but not limited to: 
Safety training requirements for registered entity personnel performing 
the procedure; required personal protective equipment and other safety 
equipment; required containment equipment including, but not limited 
to, biological safety cabinets, animal caging systems, and centrifuge 
safety containers; and required engineering controls and other facility 
safeguards.
    (3) Written procedures for decontamination, with a validated 
method, of all contaminated or potentially 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, and animal carcasses or extracted 
tissues.
    (4) Written procedures for decontamination, with a validated 
method, of laboratory surfaces and equipment using manufacturer's 
specification.
    (5) Effluent decontamination procedures, with a validated method, 
that describe the treatment of effluent material contaminated with 
select agents and toxins.
    (6) Procedures to respond to emergencies such as spills, sharps 
injury, or animal bites involving select agents and toxins.
    (7) Procedures for the handling of select agents and toxins in the 
same spaces with non-select agents and toxins in order 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 
identified and corrective action(s) that were taken, and all 
individuals who participated in the drill or exercise.
0
26. Section 121.14 is amended as follows:
0
a. In paragraph (a), by redesignating footnote 11 as footnote 13, and 
by adding a sentence at the end of the paragraph.
0
b. 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 
identified and corrective action(s) that were taken, and all 
individuals who participated in the drill or exercise.
0
27. Section 121.15 is amended as follows:
0
a. By revising paragraphs (a), introductory text, and (a)(1).
0
b. By adding paragraph (e).
    The addition and revisions 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), incident response, and agent- 
and toxin-specific training to:
    (1) Each individual with access approval from the HHS Secretary or 
Administrator, within 12 months of that individual's anniversary of 
receiving such approval or prior to his or her entry into an area where 
select agents or toxins are used or stored, whichever occurs first; and
* * * * *
    (e) The responsible official must ensure and document that 
individuals are provided the contact information of the HHS or USDA 
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 (i.e., 
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 adding paragraph (a)(1)(ix).
0
c. In paragraph (a)(3)(v), by adding the words ``or other storage 
container'' after the word ``freezer''.
0
d. By adding paragraph (a)(8).
0
e. By adding a sentence at the end of paragraph (b).
0
f. By revising paragraph (c).
    The additions and revision read as follows:


Sec.  121.17  Records.

    (a) * * *
    (1) * * *
    (ix) If destroyed, the quantity (e.g., containers, vials, tubes, 
etc.) of select agent destroyed, the date of such action, and by whom.
* * * * *
    (8) For a select agent or an extract from a select agent that has 
been rendered non-viable or regulated nucleic acids that can produce 
infectious forms of any select agent virus that have been rendered non-
infectious through inactivation:
    (i) A written description of the inactivation process used for 
rendering a select agent non-viable or regulated nucleic acids that can 
produce infectious forms of any select agent virus non-infectious;
    (ii) The sterility testing protocol used to verify non-viability of 
a select agent or non-infectivity of regulated nucleic acids that can 
produce infectious forms of any select agent virus and the results of 
the test, including investigation, of

[[Page 2774]]

any inactivation process failures and the corrective actions taken;
    (iii) The name of each individual performing the inactivation 
method and sterility testing protocols;
    (iv) The date(s) the inactivation method and sterility testing 
protocols were completed;
    (v) The location where the inactivated method and sterility testing 
protocols were performed; and
    (vi) An inactivation certificate that includes the date of 
inactivation, method of inactivation, date of final sterility testing 
protocol result, and the Principal Investigator. A copy of the 
inactivation certificate must accompany any transfer of inactivated 
material.
    (b) * * * All written records created under this part are legible.
    (c) Any records that contain information related to the 
requirements of the regulations. Such records may include, but are not 
limited to, 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 8th day of January 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-00681 Filed 1-14-16; 4:15 pm]
 BILLING CODE 3410-34-P



                                                      2762

                                                      Proposed Rules                                                                                                 Federal Register
                                                                                                                                                                     Vol. 81, No. 11

                                                                                                                                                                     Tuesday, January 19, 2016



                                                      This section of the FEDERAL REGISTER                       • Postal Mail/Commercial Delivery:                     Subtitle B (which is cited as the
                                                      contains notices to the public of the proposed          Send your comment to Docket No.                        ‘‘Agricultural Bioterrorism Protection
                                                      issuance of rules and regulations. The                  APHIS–2014–0095, Regulatory Analysis                   Act of 2002’’ and referred to below as
                                                      purpose of these notices is to give interested          and Development, PPD, APHIS, Station                   the Act), section 212(a), provides, in
                                                      persons an opportunity to participate in the            3A–03.8, 4700 River Road Unit 118,
                                                      rule making prior to the adoption of the final
                                                                                                                                                                     part, that the Secretary of Agriculture
                                                                                                              Riverdale, MD 20737–1238.                              (the Secretary) must establish by
                                                      rules.
                                                                                                                 Supporting documents and any                        regulation a list of each biological agent
                                                                                                              comments we receive on this docket                     and each toxin that the Secretary
                                                      DEPARTMENT OF AGRICULTURE                               may be viewed at http://                               determines has the potential to pose a
                                                                                                              www.regulations.gov/#!docketDetail;D                   severe threat to animal or plant health,
                                                      Animal and Plant Health Inspection                      =APHIS-2014-0095 or in our reading                     or to animal or plant products.
                                                      Service                                                 room, which is located in room 1141 of                 Paragraph (a)(2) of section 212 requires
                                                                                                              the USDA South Building, 14th Street                   the Secretary to review and republish
                                                      7 CFR Part 331                                          and Independence Avenue SW.,                           the list every 2 years and to revise the
                                                                                                              Washington, DC. Normal reading room                    list as necessary. In this document, we
                                                      9 CFR Part 121                                          hours are 8 a.m. to 4:30 p.m., Monday                  are proposing to amend and republish
                                                                                                              through Friday, except holidays. To be                 the list of select agents and toxins based
                                                      [Docket No. APHIS–2014–0095]                            sure someone is there to help you,
                                                                                                                                                                     on the findings of our fourth biennial
                                                      RIN 0579–AE08                                           please call (202) 799–7039 before
                                                                                                                                                                     review of the list.
                                                                                                              coming.
                                                      Agricultural Bioterrorism Protection                                                                              In determining whether to include an
                                                                                                              FOR FURTHER INFORMATION CONTACT: Dr.
                                                      Act of 2002; Biennial Review and                                                                               agent or toxin on the list, the Act
                                                                                                              Freeda Isaac, National Director,
                                                      Republication of the Select Agent and                                                                          requires that the following criteria be
                                                                                                              Agriculture Select Agent Services,
                                                      Toxin List; Amendments to the Select                                                                           considered:
                                                                                                              APHIS, 4700 River Road Unit 2,
                                                      Agent and Toxin Regulations                                                                                       • The effect of exposure to the agent
                                                                                                              Riverdale, MD 20737–1231; (301) 851–
                                                      AGENCY:  Animal and Plant Health                        3300, Option 3.                                        or the toxin on animal and plant health,
                                                      Inspection Service, USDA.                               SUPPLEMENTARY INFORMATION: The                         and on the production and marketability
                                                      ACTION: Proposed rule.                                  Public Health Security and Bioterrorism                of animal or plant products;
                                                                                                              Preparedness and Response Act of 2002                     • The pathogenicity of the agent or
                                                      SUMMARY:    In accordance with the                      (referred to below as the Bioterrorism                 the toxin and the methods by which the
                                                      Agricultural Bioterrorism Protection Act                Response Act) provides for the                         agent or toxin is transferred to animals
                                                      of 2002, we are proposing to amend and                  regulation of certain biological agents                or plants;
                                                      republish the list of select agents and                 that have the potential to pose a severe
                                                      toxins that have the potential to pose a                                                                          • The availability and effectiveness of
                                                                                                              threat to both human and animal health,
                                                      severe threat to animal or plant health,                to animal health, to plant health, or to               pharmacotherapies and prophylaxis to
                                                      or to animal or plant products. The Act                 animal and plant products. The Animal                  treat and prevent any illness caused by
                                                      requires the biennial review and                        and Plant Health Inspection Service                    the agent or toxin; and
                                                      republication of the list of select agents              (APHIS) has the primary responsibility                    • Any other criteria that the Secretary
                                                      and toxins and the revision of the list as              for implementing the provisions of the                 considers appropriate to protect animal
                                                      necessary. This action would implement                  Act within the United States                           or plant health, or animal or plant
                                                      the findings of the fourth biennial                     Department of Agriculture (USDA).                      products.
                                                      review of the list. In addition, we are                 Veterinary Services (VS) select agents
                                                      proposing several amendments to the                                                                               We use the term ‘‘select agents and
                                                                                                              and toxins are those that have been                    toxins’’ throughout the preamble of this
                                                      regulations, including the addition of                  determined to have the potential to pose
                                                      provisions to address the inactivation of                                                                      proposed rule. Unless otherwise
                                                                                                              a severe threat to animal health or                    specified, the term ‘‘select agents and
                                                      select agents, provisions addressing                    animal products. Plant Protection and
                                                      biocontainment and biosafety, and                                                                              toxins’’ will refer to all agents or toxins
                                                                                                              Quarantine (PPQ) select agents and                     listed by APHIS. When it is necessary to
                                                      clarification of regulatory language                    toxins are those that have the potential
                                                      concerning security, training, incident                                                                        specify the type of select agent or toxin,
                                                                                                              to pose a severe threat to plant health                we will use the following terms: ‘‘PPQ
                                                      response, and records. These changes                    or plant products. Overlap select agents
                                                      would increase the usability of the                                                                            select agents and toxins’’ (for the plant
                                                                                                              and toxins are those that have been                    agents and toxins listed in 7 CFR 331.3),
                                                      select agent regulations as well as                     determined to pose a severe threat to
                                                      provide for enhanced program                                                                                   ‘‘VS select agents and toxins’’ (for the
                                                                                                              both human and animal health or to
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      oversight.                                                                                                     animal agents and toxins listed in 9 CFR
                                                                                                              human health and animal products.                      121.3), or ‘‘overlap select agents and
                                                      DATES: We will consider all comments                    Overlap select agents are subject to                   toxins’’ (for the overlap agents and
                                                      that we receive on or before March 21,                  regulation by both APHIS and the                       toxins listed in both 9 CFR 121.4 and 42
                                                      2016.                                                   Centers for Disease Control and                        CFR 73.4).
                                                      ADDRESSES: You may submit comments                      Prevention (CDC), which has the
                                                      by either of the following methods:                     primary responsibility for implementing                   On February 27, 2015, we published
                                                        • Federal eRulemaking Portal: Go to                   the provisions of the Bioterrorism                     in the Federal Register (80 FR 10627,
                                                      http://www.regulations.gov/#!docket                     Response Act for the Department of                     Docket No. APHIS–2014–0095) an
                                                      Detail;D=APHIS-2014-0095.                               Health and Human Services (HHS).                       advance notice of proposed rulemaking


                                                 VerDate Sep<11>2014   15:55 Jan 15, 2016   Jkt 238001   PO 00000   Frm 00001   Fmt 4702   Sfmt 4702   E:\FR\FM\19JAP1.SGM   19JAP1


                                                                             Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules                                             2763

                                                      and request for comments (ANPR) 1 in                    consider changes to the lists. Based on                inactivation of select agents, provisions
                                                      order to announce our intention to                      the review, APHIS is proposing to                      addressing biocontainment and
                                                      review the select agent list. We solicited              remove three overlap select agents and                 biosafety, and clarification of regulatory
                                                      comments regarding potential additions                  toxins from the list set out in § 121.4(b):            language concerning security, training,
                                                      and deletions from the list of select                      • Bacillus anthracis (Pasteur strain):              incident response, and records. These
                                                      agents and toxins for 60 days ending                    Historically, the B. anthracis Pasteur                 changes, which are described in detail
                                                      April 28, 2015. We received 20                          strain has been retained as a select agent             below, would increase the usability of
                                                      comments by that date. They were from                   to allow for continued oversight of                    the select agent regulations as well as
                                                      scientists, scientific organizations, a                 laboratories in which the accidental (or               provide for enhanced program
                                                      State government, private individuals,                  intentional) combination of this strain                oversight.
                                                      and industry groups. Suggestions in                     with the excluded Sterne strain could
                                                                                                              occur to produce the wild type                         Definitions
                                                      these comments were used in order to
                                                      inform our discussions on the content of                phenotype B. anthracis de novo.                           In 7 CFR 331.1 and 9 CFR 121.1, we
                                                      the select agent list.                                  However, a recent study 2 indicates that               are proposing to add definitions for
                                                                                                              bacterial transformation of B. subtilis                inactivation and kill curve. We believe
                                                      PPQ Select Agents and Toxins                            with plasmid DNA is inefficient;                       these definitions are necessary as they
                                                         APHIS’s PPQ program convened an                      indicating that transformation with                    are included in the additional
                                                      interagency working group to review the                 bacteria such as B. anthracis (e.g., pXO1              biocontainment and biosafety language
                                                      list of PPQ select agents and toxins and                into B. anthracis Pasteur strain) would                we are proposing to add to the
                                                      develop recommendations regarding                       also be inefficient. Given that B.                     regulations.
                                                      possible changes to that list. Using the                anthracis Pasteur strain does not encode                  The definition of inactivation would
                                                      four criteria for listing found in the Act,             the plasmid which carries the                          be established as ‘‘a method to render a
                                                      economic crop data, current Federal                     pathogenic toxin genes, analogous to the               select agent non-viable but retain
                                                      quarantine notices, and new scientific                  Sterne strain which was excluded from                  characteristic of interest for future use,
                                                      information, the working group                          Select Agent oversight in 2003, we                     or to render any nucleic acids that can
                                                      revisited the currently listed PPQ select               believe there is no potential for high                 produce infectious forms of any select
                                                      agents and toxins and evaluated a                       animal mortality rates or for misuse that              agent virus non-infectious for future
                                                      number of new plant pathogens for                       might result in social or economic                     use.’’ This definition draws a distinction
                                                      inclusion on the list. Based on this                    disruption. Therefore, we are proposing                between inactivation for waste
                                                      review, APHIS is proposing to amend                     that the Pasteur strain be removed from                treatment and inactivation of regulated
                                                      the list of PPQ select agents and toxins                the overlap select agent list.                         material for future purposes such as
                                                      listed in 7 CFR 331.3 by removing three                    • Brucella abortus and Brucella suis:               research. The definition of kill curve
                                                      PPQ select agents and toxins from the                   While both of these organisms have                     would be established as ‘‘the results of
                                                      list. Specifically, we are proposing to                 been eradicated from the domestic                      a dose-response experiment where a
                                                      remove the following:                                   livestock industry, they are currently                 select agent is subjected to increasing
                                                         • Peronosclerospora philippinensis                   endemic in wildlife and feral swine                    amounts of the inactivating treatment to
                                                      (Peronosclerospora sacchari) and                        populations in the United States.                      determine the minimum conditions
                                                      Sclerophthora rayssiae: There are no                    However, there is an extensive                         required to render it non-viable or to
                                                      viable cultures of these corn pathogens                 regulatory control program in place for                render any nucleic acids that can
                                                      currently held in U.S. laboratories, they               B. abortus in the remaining affected                   produce infectious forms of any select
                                                      are difficult to grow or maintain,                      Designated Surveillance Area. APHIS                    agent virus as non-infectious.’’
                                                      difficult to keep viable during transport,              has also recently enacted a national
                                                                                                                                                                     Exclusions and Inactivation
                                                      and would require a large amount of                     program to control feral swine that will
                                                                                                              include surveillance and disease                          We are proposing to amend 7 CFR
                                                      inoculum to infect fields by artificial
                                                                                                              monitoring for swine brucellosis.                      331.3(d)(2), 9 CFR 121.3(d)(2), and 9
                                                      means due to the fact that they must
                                                                                                              Therefore, we believe the effect of                    CFR 121.4(d)(2), which currently
                                                      spread via infected plant material; and
                                                                                                              exposure to these agents on animal                     exclude nonviable select agents or
                                                         • Phoma glycinicola (formerly
                                                                                                              health and on the production and                       nonfunctional toxins from the
                                                      Pyrenochaeta glycines): This soybean
                                                                                                              marketability of animal products is                    requirements of the regulations, in order
                                                      pathogen’s natural distribution is
                                                                                                              minimized. We are proposing that these                 to clarify our policy that an entity must
                                                      limited to two countries in Africa, it
                                                                                                              two Brucella species be removed from                   use a validated method to render a
                                                      does not spread rapidly in the field,
                                                                                                              the overlap select agent list. However,                select agent nonviable or regulated
                                                      soybean importation pathways into the
                                                                                                              Brucella melitensis, as a foreign animal               nucleic acids non-infectious for future
                                                      United States by which the pathogen
                                                                                                              disease agent not currently found in the               use. This means that the method must
                                                      might enter are limited, and while no
                                                                                                              United States, would be kept as a VS                   be scientifically sound and that it will
                                                      U.S. soybean variety is immune to this
                                                                                                              select agent.                                          produce consistent results each time it
                                                      pathogen, Environmental Protection
                                                                                                                 Accordingly, CDC will also be                       is used.
                                                      Agency-approved fungicides are                                                                                    We are proposing that inactivation
                                                                                                              proposing a parallel change to its
                                                      available to treat any infestation.                                                                            include the use of one of the following:
                                                                                                              overlap select agent regulations.
                                                      VS Select Agents and Toxins                                                                                    The exact conditions of a commonly
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                                                                              Additional Changes
                                                         APHIS’ VS program also convened an                                                                          accepted method that has been
                                                                                                                We are proposing to make several                     validated as applied (e.g., autoclaving),
                                                      interagency working group to review the                 changes to the regulations, including the
                                                      list of VS select agents and toxins and                                                                        a published method with adherence to
                                                                                                              addition of provisions to address the                  the exact published conditions (i.e.,
                                                      the list of overlap select agents and
                                                      toxins in 9 CFR part 121 in order to                                                                           extrapolations or deductions are to be
                                                                                                                2 C. Johnston, B. Martin, G. Fichant, P. Polard,
                                                                                                                                                                     avoided), or in-house methods, only if
                                                                                                              and J.P. Claverys. ‘‘Bacterial transformation:
                                                        1 To view the ANPR and the comments we                distribution, shared mechanisms and divergent
                                                                                                                                                                     validation testing includes the specific
                                                      received, go to http://www.regulations.gov/             control.’’ Nature Reviews Microbiology. 2014. 12:      conditions used and appropriate
                                                      #!docketDetail;D=APHIS-2014-0095.                       181–196.                                               controls.


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                                                      2764                   Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules

                                                         We are also proposing that the entity                This language was included in previous                 Registration and Related Security Risk
                                                      develop a site-specific kill curve in                   versions of the regulations and was                    Assessments
                                                      order to define conditions of                           erroneously removed by an earlier                         The regulations in 7 CFR 331.7 and 9
                                                      inactivation for each select agent or                   rulemaking.                                            CFR 121.7 set out registration
                                                      regulated nucleic acid. If there are                                                                           requirements for those entities that wish
                                                                                                              Exemptions for Select Agents and
                                                      strain-to-strain variations in the                                                                             to work with select agents and toxins
                                                                                                              Toxins
                                                      resistance of a select agent to the                                                                            and stipulates the individuals within
                                                      inactivation procedure, then a specific                   Sections 7 CFR 331.5, 9 CFR 121.5,
                                                                                                              and 9 CFR 121.6 concern conditions                     those entities that must undergo a
                                                      kill curve would have to be developed
                                                                                                              under which entities may be exempted                   security risk assessment by the Attorney
                                                      for each strain that undergoes the
                                                                                                              from the requirements of the                           General.
                                                      inactivation procedure. A new kill curve
                                                                                                              regulations. Paragraph (a) requires that                  We are proposing to state that an
                                                      would have to be created upon any
                                                                                                              the identification of the agent or toxin               entity registered to possess, use, or
                                                      change in procedure or inactivation
                                                                                                              be reported to APHIS or CDC. Since                     transfer a select agent or toxin would
                                                      equipment. In addition, a validated
                                                                                                              select agents and toxins have the                      have to meet the requirements of the
                                                      sterility testing protocol would have to
                                                                                                              potential to pose a severe threat to both              regulations for those select agents and
                                                      be conducted in order to ensure that the
                                                                                                              human and animal health, to animal                     toxins listed on the entity’s official
                                                      inactivation method has rendered a
                                                                                                              health, to plant health, or to animal and              registration regardless of whether the
                                                      select agent nonviable or regulated
                                                                                                              plant products, clinical and diagnostic                entity is in possession of those select
                                                      nucleic acids non-infectious.
                                                         In addition, we are proposing that an                laboratories typically have their initial              agents or toxins and without regard to
                                                      entity be required to report any viability              results confirmed by a registered or                   the amount of select agents or toxins in
                                                      of a select agent or infectivity of                     certified reference laboratory. We are                 the entity’s possession. This change
                                                      regulated nucleic acids that can produce                proposing to require that in addition to               would serve to codify existing policy
                                                      infectious forms of any select agent                    notifying APHIS or CDC, the reference                  and would be added as a new paragraph
                                                      virus that was subjected to a validated                 laboratory inform the specimen provider                (b).
                                                      inactivation protocol to APHIS or CDC.                  upon confirmation of the identification                Responsible Official
                                                         We are also proposing to require that                of a select agent or toxin. This change
                                                      an entity review annually, and revise as                would clarify our expectations regarding                  The regulations in 7 CFR 331.9 and 9
                                                      necessary, the following: (1) The kill                  communication and notification                         CFR 121.9 set out requirements for
                                                      curve procedure and results; (2) site-                  between the reference laboratory and                   entities requesting to work with select
                                                      specific standard operating procedures                  the specimen provider.                                 agents and toxins to designate a
                                                      to ensure that select agents or regulated                 We are also proposing to add language                responsible official, who ensures that
                                                      nucleic acids that can produce                          to paragraph (a) in sections 7 CFR 331.5,              the entity continues to meet the
                                                      infectious forms of any select agent                    9 CFR 121.5, and 9 CFR 121.6 that                      requirements of the regulations.
                                                      virus are inactivated by a safety margin;               specifies that entities may be required to                Paragraph (a)(6) requires the
                                                      and (3) the validated sterility testing                 report identification of agents or toxins              responsible official to ensure that
                                                      protocol used to ensure that the                        to other appropriate authorities when                  annual inspections are conducted for
                                                      inactivation method has rendered a                      required by Federal, State, or local law.              each location where select agents or
                                                      select agent non-viable or regulated                    This language was added to the CDC                     toxins are stored or used in order to
                                                      nucleic acids that can produce                          select agent regulations in a previous                 determine compliance with the
                                                      infectious forms of any select agent                    rulemaking, but not to the APHIS                       regulations. The responsible official also
                                                      viruses non-infectious.                                 regulations and this change is necessary               must document the results of each
                                                         Finally, we are proposing that written               in order to achieve uniformity across all              inspection and identify and address any
                                                      records be kept for any select agent that               regulations associated with the                        deficiencies.
                                                      has been rendered nonviable or                          diagnosis and care for individuals                        We are proposing to require that any
                                                      regulated nucleic acids that have been                  infected with a select agent or toxin.                 corrections of deficiencies found must
                                                      rendered non-infectious. We are                         Specifically, we are proposing to add                  also be documented. This change is
                                                      particularly requesting comments                        provisions that state that we do not                   necessary to improve recordkeeping
                                                      regarding whether there are more                        regulate material containing select                    practices and to provide a more
                                                      specific measures available to                          agents or toxins when it is in a patient               complete account of facility
                                                      demonstrate that a select agent has been                care setting and is not being collected or             containment and security procedures.
                                                      rendered nonviable, or a regulated                      otherwise tested or retained, nor do we                We are also proposing to replace the
                                                      infectious nucleic acid has been                        regulate waste generated during delivery               word ‘‘laboratory’’ with the phrase
                                                      rendered non-infectious.                                of patient care. However, once delivery                ‘‘registered space.’’ This terminology is
                                                         We are also proposing to add to 7 CFR                of patient care for the select agent or                more accurate, as registered spaces are
                                                      331.3(e), 9 CFR 121.3(e), and 9 CFR                     toxin infection has concluded, these                   not always laboratories.
                                                      121.4(e) a paragraph stating that an                    specimens would become subject to the                     We are also proposing to add a new
                                                      individual or entity may make a written                 requirements of the regulations. If an                 paragraph (a)(7), which would require
                                                      request to the Administrator for                        entity cannot meet these requirements,                 the entity’s responsible official to
                                                      reconsideration of a decision denying an                then the material may be transferred to                provide contact information for the
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                                                      exclusion application. The written                      another entity according to the select                 USDA or HHS Office of Inspector
                                                      request for reconsideration would have                  agent regulations or destroyed using an                General Hotline, so that employees and
                                                      to state the facts and reasoning upon                   approved method. The decision to                       other individuals may anonymously
                                                      which the individual or entity relies to                retain, transfer, or destroy any                       report any containment or security
                                                      show the decision was incorrect. The                    specimens must be made within 7                        concerns they may have. Although the
                                                      Administrator would grant or deny the                   calendar days of the conclusion of                     select agent program has established a
                                                      request for reconsideration as promptly                 patient care. These requirements would                 whistleblower portal on its Web site,
                                                      as circumstances allow and will state, in               be set out in new paragraphs 9 CFR                     there is currently no requirement for
                                                      writing, the reasons for the decision.                  121.3(d)(4) and 9 CFR 121.4(d)(4).                     employees at registered entities to be


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                                                                             Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules                                             2765

                                                      made aware of its existence or how to                   systems); severe weather and other                     or used, which would include a
                                                      use it. Adding this requirement would                   natural disasters; workplace violence;                 description of all centralized access
                                                      allow for increased worker involvement                  bomb threats and suspicious packages;                  control management systems (e.g.,
                                                      in biosafety/biocontainment and                         and emergencies such as fire, gas leak,                keycards) and/or mechanical key
                                                      security programs at registered entities                explosion, power outage, etc. The                      management. This requirement would
                                                      and may also enhance the quality of                     response procedures must account for                   allow us to directly ascertain the way in
                                                      Federal oversight in this area.                         hazards associated with the select agent               which entities allow individuals entry
                                                                                                              or toxin and appropriate actions to                    to areas containing select agents and
                                                      Security Risk Assessments
                                                                                                              contain such agent or toxin.                           toxins and potentially identify any
                                                         We are proposing to amend the                           All of these plans require annual                   weaknesses in that process.
                                                      regulations in 7 CFR 331.10 and 9 CFR                   review and revision as necessary. Drills                  In the same sections, paragraphs
                                                      121.10. These regulations establish                     or exercises must also be conducted at                 (d)(7)(i) through (d)(7)(v) encompass a
                                                      parameters for restricting access to                    least annually to test and evaluate the                list of activities that individuals with
                                                      select agents and toxins and the process                effectiveness of the plans. The plans                  access approval from the Administrator
                                                      by which individuals may be approved                    must be reviewed and revised, as                       or the HHS Secretary must immediately
                                                      for access to select agents and toxins                  necessary, after any drill or exercise and             report to the responsible official. We are
                                                      after the completion of a security risk                 after any incident. We are proposing to                proposing to add a new paragraph
                                                      assessment by the Attorney General.                     require that these drills or exercises be              (d)(7)(vi) to require that the responsible
                                                         Paragraph (e) states that a person with              documented to include how the drill or                 official must be notified of any loss of
                                                      valid approval from the HHS Secretary                   exercise tested and evaluated the plan,                computer, hard drive, or other data
                                                      or Administrator to have access to select               any problems identified, any corrective                storage device containing information
                                                      agents or toxins may request, through                   action taken, and the names of the                     that can be used to gain access to select
                                                      his or her responsible official, that the               individuals who participated in the drill              agents or toxins. Such notification will
                                                      HHS Secretary or APHIS Administrator                    or exercise. This will provide a more                  facilitate notification of the Federal
                                                      provide their approved access status to                 thorough accounting of required                        Bureau of Investigation if deemed
                                                      another registered individual or entity                 activities as well as increasing the                   necessary by the responsible official as
                                                      for a specified period of time. We are                  efficacy of the plans via testing and                  the loss of such equipment may be
                                                      proposing to also require that the                      entity-directed improvements. We are                   criminal in nature.
                                                      responsible official at the visiting                    proposing to add these requirements to
                                                                                                                                                                     Biocontainment/Biosafety Plan
                                                      person’s home entity notify the host                    7 CFR 331.11(h), 331.12(e), 331.14(f), 9
                                                      entity if that person’s approved access                 CFR 121.11(h), 121.12(e), and 121.14(f).                 Paragraph (a) of 7 CFR 331.12 and 9
                                                      to select agents or toxins has been                        We are also proposing to add a                      CFR 121.12 requires that the
                                                      terminated. This would ensure that an                   requirement that the biocontainment,                   biocontainment or biosafety plan
                                                      individual whose permissions have                       biosafety, and incident response plans                 contain sufficient information and
                                                      been terminated would not be allowed                    be submitted for initial registration,                 documentation to describe the biosafety
                                                      further access to select agents and                     renewal of registration, or when                       and containment procedures for each
                                                      toxins.                                                 requested. These additions would be                    select agent or toxin that the registered
                                                                                                              located in 7 CFR 331.12(a), 331.14(a), 9               entity will possess. The plan must also
                                                      Security, Biocontainment/Biosafety,                     CFR 121.12(a), and 121.14(a). This                     include a description of the biosafety
                                                      and Incident Response Plans                             change is necessary in order to bring the              and containment procedures for any
                                                        The regulations require registered                    requirements for these plans in line                   animals (including arthropods) or plants
                                                      entities to develop and implement a                     with existing requirements for the                     intentionally or accidentally exposed to
                                                      number of plans in order to ensure the                  security plan.                                         or infected with a select agent. We are
                                                      safety and security of the select agents                   Details of the changes we are                       proposing to additionally require that
                                                      they handle. These are:                                 proposing to the security, biosecurity,                laboratory-specific biocontainment and/
                                                        • A security plan, as described by the                and biosafety plans individually may be                or biosafety manuals must be accessible
                                                      regulations in 7 CFR 331.11 and 9 CFR                   found below.                                           to individuals working in those
                                                      121.11, that provides for measures                                                                             laboratories. This change would help to
                                                      sufficient to safeguard the select agent                Security Plan                                          foster an enhanced culture of
                                                      or toxin against unauthorized access,                      Paragraph (c)(5) of 7 CFR 331.11 and                responsibility by ensuring that
                                                      theft, loss, or release;                                9 CFR 121.11 requires that the security                appropriate biocontainment and/or
                                                        • A biocontainment plan, in the case                  plan describe procedures for addressing                biosafety resources are available to all
                                                      of PPQ select agents, or a biosafety plan,              loss or compromise of keys, passwords,                 staff with access to select agents and
                                                      in the case of VS and overlap select                    combinations, etc. and protocols for                   toxins within a select agent laboratory.
                                                      agents, as described in the regulations in              changing access numbers or locks                         In the aftermath of recent biosafety
                                                      7 CFR 331.12 and 9 CFR 121.12, that                     following staff changes. We are                        incidents involving an unintentional
                                                      provides for measures sufficient to                     proposing to add keycards to that list as              release of potentially viable anthrax
                                                      contain the select agent or toxin (e.g.,                they are commonly used. We are also                    within the CDC’s Roybal Campus, in
                                                      physical structure and features of the                  proposing to use the term ‘‘access                     Atlanta, GA, and the inadvertent cross-
                                                      entity, and operational and procedural                  permissions’’ instead of the term                      contamination and shipment of a
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                                                      safeguards); and                                        ‘‘access numbers,’’ as it covers a broader             laboratory specimen of low-pathogenic
                                                        • An incident response plan, as                       range of topics.                                       avian influenza virus with the VS select
                                                      described in the regulations in 7 CFR                      We are also proposing to add a new                  agent highly pathogenic avian influenza
                                                      331.14 and 9 CFR 121.14, that provides                  paragraph (c)(11) to the regulations in 7              virus, we believe that the
                                                      for measures that the registered entity                 CFR 331.11 and 9 CFR 121.11. This                      biocontainment and biosafety plans
                                                      will implement in the event of theft,                   would require that the security plan                   should be designed according to a site-
                                                      loss, or release of a select agent or toxin;            contain a description of how the entity                specific risk assessment in accordance
                                                      inventory discrepancies; security                       authorizes the means of entry into areas               with the risk posed by a select agent or
                                                      breaches (including information                         where select agents or toxins are stored               toxin. Therefore, we are proposing to


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                                                      2766                   Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules

                                                      add specific provisions to the                          a permit issued in accordance with 7                   certifications, laboratory notebooks,
                                                      biocontainment and biosafety plans that                 CFR part 330 or 9 CFR part 122. We                     institutional biosafety and/or animal use
                                                      would require completion of a written                   have determined that a permit for the                  committee minutes and approved
                                                      risk assessment for each procedure. This                importation or interstate movement of a                protocols, and records associated with
                                                      risk assessment would have to include                   select agent or toxin listed in 7 CFR                  occupational health and suitability
                                                      the following elements: A description of                331.3, 9 CFR 121.3, or 121.4 is not                    programs.
                                                      the safeguards in place to protect entity               required for such importation and/or                     Finally, paragraph (b) in both 7 CFR
                                                      personnel, the public, and the                          interstate movement provided that the                  331.17 and 9 CFR 121.17 requires that
                                                      environment from exposure to the select                 select agent or toxin is authorized for                regulated entities implement a system to
                                                      agent or toxin; decontamination                         transfer in accordance with 7 CFR                      ensure that all records and databases
                                                      procedures; waste management                            331.16(b) or 9 CFR 121.16(b).                          created under this part are accurate,
                                                      procedures; and procedures for                                                                                 have controlled access, and that their
                                                                                                              Records
                                                      handling select agents and toxins in the                                                                       authenticity may be verified. To ensure
                                                      same spaces as non-select agents and                       The regulations in 7 CFR 331.17 and                 the accuracy of handwritten records, we
                                                      toxins in order to prevent unintentional                9 CFR 121.17 concern required                          are proposing to specify that such
                                                      cross-contamination.                                    recordkeeping procedures for regulated                 records must be legible.
                                                         We are specifically requesting                       entities as those records relate to select
                                                      comments regarding any specific                         agents and toxins. Paragraph (a)(3)(x)                 Records for Select Agents in Long-Term
                                                      biocontainment or biosafety measures to                 requires that registered entities record               Storage
                                                      prevent laboratory acquired infections                  the destruction of any toxins by
                                                                                                                                                                        Paragraph (a)(1) in both 7 CFR 331.17
                                                      or accidental or intentional release of                 specifically noting the quantity of toxin
                                                                                                                                                                     and 9 CFR 121.17 requires entities to
                                                      the select agents and toxins from an                    destroyed, the date of such action, and
                                                                                                                                                                     maintain an accurate, current inventory
                                                      entity into the community.                              by whom. However, there is not an
                                                                                                                                                                     for each select agent (including viral
                                                         Finally, paragraph (c)(2) of 9 CFR                   equivalent requirement regarding the
                                                                                                                                                                     genetic elements, recombinant and/or
                                                      121.12 requires that entities should                    destruction of select agents. We are
                                                                                                                                                                     synthetic nucleic acids, and organisms
                                                      consider the guidance found in the                      proposing to add this requirement in
                                                                                                                                                                     containing recombinant and/or
                                                      Occupational Safety and Health                          order to ensure consistency with the
                                                                                                                                                                     synthetic nucleic acids) held in long-
                                                      Administration regulations in 29 CFR                    toxin provisions and ensure proper
                                                                                                                                                                     term storage. We continue to receive
                                                      1910.1200 and 1910.1450. We are                         tracking of select agents from
                                                                                                              acquisition to destruction. These                      comments critical of that portion of the
                                                      proposing to remove this reference as
                                                                                                              requirements would be added in a new                   regulations. Criticism is typically
                                                      the information in those regulations is
                                                                                                              paragraph (a)(1)(ix).                                  focused on the belief that a container-
                                                      also contained in the CDC/National
                                                                                                                 We are also proposing to require that               based inventory requirement is not a
                                                      Institutes of Health publication,
                                                                                                              regulated entities maintain records                    useful mechanism to track inventory of
                                                      ‘‘Biosafety in Microbiological and
                                                                                                              concerning those select agents that have               biological agents, since small amounts
                                                      Biomedical Laboratories,’’ which is
                                                                                                              been rendered nonviable or regulated                   could be stolen without detection and
                                                      referenced in paragraph (c)(1) and a
                                                                                                              nucleic acids that have been rendered                  used to grow larger quantities.
                                                      second reference is therefore
                                                      duplicative.                                            non-infectious. These records would                       However, the Public Health Security
                                                                                                              specifically capture the activities                    and Bioterrorism Preparedness and
                                                      Training                                                detailed under the heading ‘‘Exclusions                Response Act of 2002 obliges APHIS
                                                        We are proposing to amend the                         and Inactivation’’ above. Such                         and CDC to include a requirement for
                                                      regulations in 7 CFR 331.15 and 9 CFR                   recordkeeping is necessary in order to                 ‘‘the prompt notification of the
                                                      121.15, which concern provision of                      confirm that an entity has performed the               Secretary, and appropriate Federal,
                                                      mandatory training for staff and visitors               procedures necessary. The select agent                 State, and local law enforcement
                                                      who work in or visit areas where select                 program would then have the ability to                 agencies, of the theft or loss of listed
                                                      agents or toxins are handled or stored.                 review those records in order to ensure                agents and toxins’’ in the regulations.
                                                      We are proposing to require that all                    that the entity is performing all                      We are therefore soliciting comment
                                                      individuals who have received approval                  procedures necessary for nonviability or               regarding what regulatory requirement
                                                      to have access to select agents and                     inactivation. The requirements would                   or requirements should be implemented
                                                      toxins must undergo training regardless                 be added in a new paragraph (a)(8) in 7                such that a registered entity could
                                                      of whether they have access to those                    CFR 331.17 and 9 CFR 121.17.                           quickly determine whether a select
                                                      select agents or toxins. The training                      We are also proposing to state that                 agent had been lost or stolen from long-
                                                      would have to be completed within a                     any records created that contain                       term storage without that registered
                                                      year of that individual’s approval or                   information related to an entity’s                     entity first having an accurate, current
                                                      prior to entry into an area where select                registration or its select agents and                  inventory for each select agent held in
                                                      agents and toxins are used or stored,                   toxins must be provided promptly upon                  long-term storage. Additionally, we are
                                                      whichever occurs first. This change is                  request. This requirement would be                     soliciting ideas concerning ways in
                                                      necessary in order to codify our position               added to revised paragraph (c). Given                  which the current regulations could be
                                                      regarding which individuals at                          the wide variety of entities regulated                 amended to address the possibility of
                                                      registered entities are required to                     under the Federal Select Agent Program,                theft of a select agent from a container
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                                                      receive training.                                       the scope of records readily available for             held in long-term storage.
                                                                                                              program review will enhance the ability
                                                      Transfers                                                                                                      Executive Order 12866 and Regulatory
                                                                                                              of the program to evaluate entity
                                                                                                                                                                     Flexibility Act
                                                        We are proposing to amend the                         biosafety, biocontainment, security, and
                                                      regulations in 7 CFR 331.16 and 9 CFR                   incident response programs. Paragraph                    This proposed rule has been
                                                      121.16, which concern the transfer of                   (c) in both 7 CFR 331.17 and 9 CFR                     determined to be not significant for the
                                                      select agents and toxins to a registered                121.17 would also be revised to specify                purposes of Executive Order 12866 and,
                                                      entity. Specifically, paragraph (b) states              that such records may include, but are                 therefore, has not been reviewed by the
                                                      that select agents and toxins may need                  not limited to, biocontainment                         Office of Management and Budget.


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                                                                             Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules                                                2767

                                                        In accordance with the Regulatory                     have a significant economic impact on                  TITLE 7—AGRICULTURE
                                                      Flexibility Act, we have analyzed the                   a substantial number of small entities.
                                                      potential economic effects of this action                                                                      PART 331—POSSESSION, USE, AND
                                                      on small entities. The analysis is                      Executive Order 12372                                  TRANSFER OF SELECT AGENTS AND
                                                      summarized below. Copies of the full                                                                           TOXINS
                                                                                                                This program/activity is listed in the
                                                      analysis are available by contacting the                Catalog of Federal Domestic Assistance
                                                      person listed under FOR FURTHER                                                                                ■ 1. The authority citation for part 331
                                                                                                              under No. 10.025 and is subject to                     continues to read as follows:
                                                      INFORMATION CONTACT or on the
                                                                                                              Executive Order 12372, which requires
                                                      Regulations.gov Web site (see                           intergovernmental consultation with                      Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
                                                      ADDRESSES above for instructions for                                                                           and 371.3.
                                                                                                              State and local officials. (See 2 CFR
                                                      accessing Regulations.gov).
                                                                                                              chapter IV.)                                           ■ 2. Section 331.1 is amended by
                                                        The Public Health Security and
                                                      Bioterrorism Preparedness and                           Executive Order 12988                                  adding, in alphabetical order,
                                                      Response Act of 2002 (Pub. L. 107–188)                                                                         definitions of inactivation and kill curve
                                                      provides for the regulation of certain                     This proposed rule has been reviewed                to read as follows:
                                                      biological agents and toxins that have                  under Executive Order 12988, Civil
                                                                                                                                                                     § 331.1   Definitions.
                                                      the potential to pose a severe threat to                Justice Reform. If this proposed rule is
                                                      human, animal, or plant health, or to                   adopted: (1) All State and local laws and              *      *    *     *     *
                                                      animal or plant products. APHIS has                     regulations that are inconsistent with                    Inactivation. A method to render a
                                                      completed its fourth biennial review of                 this rule will be preempted; (2) no                    select agent non-viable but retain
                                                      select agent regulations and is proposing               retroactive effect will be given to this               characteristic of interest for future use,
                                                      changes that would increase their                       rule; and (3) administrative proceedings               or to render any nucleic acids that can
                                                      usability as well as provide for                        will not be required before parties may                produce infectious forms of any select
                                                      enhanced program oversight. The                         file suit in court challenging this rule.              agent virus non-infectious for future
                                                      proposed amendments include                                                                                    use.
                                                                                                              Paperwork Reduction Act                                *      *    *     *     *
                                                      provisions to address the inactivation of
                                                      select agents, provisions addressing                                                                              Kill curve. The results of a dose-
                                                                                                                In accordance with section 3507(d) of
                                                      biosafety, and clarification of regulatory                                                                     response experiment where a select
                                                                                                              the Paperwork Reduction Act of 1995
                                                      language concerning security, training,                                                                        agent is subjected to increasing amounts
                                                                                                              (44 U.S.C. 3501 et seq.), we have
                                                      incident response, and records.                                                                                of the inactivating treatment to
                                                                                                              determined that there is burden
                                                        The proposed rule would require that                                                                         determine the minimum conditions
                                                                                                              associated with this action. We will                   required to render it non-viable, or to
                                                      entities develop an agent-specific kill                 publish a separate document in the
                                                      curve in order to define conditions of                                                                         render any nucleic acids that can
                                                                                                              Federal Register, announcing our                       produce infectious forms of any select
                                                      inactivation for each select agent or                   determination of burden and soliciting
                                                      regulated infectious nucleic acid and                                                                          agent virus as non-infectious.
                                                                                                              comments on it.
                                                      maintain written records of having done                                                                        *      *    *     *     *
                                                      so.3 Costs of complying with this                       E-Government Act Compliance                            ■ 3. Section 331.3 is amended as
                                                      amendment are therefore expected to be                                                                         follows:
                                                      modest.                                                    The Animal and Plant Health                         ■ a. In paragraph (b), by removing the
                                                        Currently, there are 291 entities                     Inspection Service is committed to                     words ‘‘Peronosclerospora
                                                      registered with APHIS and CDC. Of                       compliance with the E-Government Act                   philippinensis (Peronosclerospora
                                                      these entities, there are 240 registered to             to promote the use of the Internet and                 sacchari);’’, ‘‘Phoma glycinicola
                                                      possess Tier 1 select agents and toxins,                other information technologies, to                     (formerly Pyrenochaeta glycines);’’, and
                                                      including 78 academic, 29 commercial,                   provide increased opportunities for                    ‘‘Sclerophthora rayssiae;’’
                                                      80 State government, 37 Federal                         citizen access to Government                           ■ b. By revising paragraph (d)(2).
                                                      government, and 16 private (non-profit)                 information and services, and for other                ■ c. By adding paragraph (e)(3).
                                                      institutions, most of which are                         purposes. For information pertinent to                    The addition and revision read as
                                                      considered to be small entities. Based                  E-Government Act compliance related                    follows:
                                                      on proposed record keeping and                          to this proposed rule, please contact Ms.
                                                                                                                                                                     § 331.3   PPQ select agents and toxins.
                                                      reporting requirements, an additional 10                Kimberly Hardy, APHIS’ Information
                                                      to 20 hours per year may be required.                   Collection Coordinator, at (301) 851–                  *     *      *    *     *
                                                      At an imputed cost of $33.40 per hour                   2727.                                                    (d) * * *
                                                      (GS–12, step 2), this additional time                                                                            (2) Nonviable select agents or
                                                                                                              List of Subjects                                       nonfunctional toxins.
                                                      requirement per entity would cost
                                                                                                                                                                       (i) Unless waived by the
                                                      between $334 and $668 per year, or in                   7 CFR Part 331
                                                                                                                                                                     Administrator, a select agent or
                                                      total for all registered entities between
                                                                                                                Agricultural research, Laboratories,                 regulated nucleic acids that can produce
                                                      $80,000 and $160,000.
                                                        Under these circumstances, the                        Plant diseases and pests, Reporting and                infectious forms of any select agent
                                                      Administrator of the Animal and Plant                   recordkeeping requirements.                            virus that has been subjected to a
                                                                                                                                                                     validated inactivation process to remove
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      Health Inspection Service has
                                                                                                              9 CFR Part 121                                         viability or infectious form (i.e., the
                                                      determined that this action would not
                                                                                                                                                                     ability to reproduce or produce disease,
                                                                                                                Agricultural research, Animal                        while maintaining cellular structure) is
                                                        3 The  definition of kill curve would be ‘‘the        diseases, Laboratories, Medical research,              not excluded from the requirements of
                                                      results of a dose-response experiment where a
                                                      select agent is subjected to increasing amounts of      Reporting and recordkeeping                            this part until an individual or entity:
                                                      the inactivating treatment to determine the             requirements.                                            (A) Develops a site-specific kill curve
                                                      minimum conditions required to render it non-
                                                      viable or to render any nucleic acids that can
                                                                                                                Accordingly, we propose to amend 7                   to define conditions of inactivation for
                                                      produce infectious forms of any select agent virus      CFR part 331 and 9 CFR part 121 as                     each select agent or regulated nucleic
                                                      as non-infectious.’’                                    follows:                                               acids that can produce infectious forms


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                                                      2768                   Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules

                                                      of any select agent virus. If there are                   (C) Any viability of an extract that                 ■ 6. Section 331.9 is amended as
                                                      strain-to-strain variations in resistance               was subjected to a validated inactivation              follows:
                                                      of a select agent to the inactivation                   protocol is reported to the responsible                ■ a. In paragraph (a)(6), by removing the
                                                      procedure, then a specific kill curve                   official.                                              word ‘‘laboratory’’ and adding the
                                                      must be developed for each strain that                    (D) Any viability of a select agent or               words ‘‘registered space’’ in its place
                                                      undergoes the inactivation procedure. A                 infectivity of regulated nucleic acids                 and by adding the words ‘‘and the
                                                      new kill curve must be created upon                     that can produce infectious forms of any               corrections documented’’ at the end of
                                                      any change in procedure or inactivation                 select agent virus that was previously                 the second sentence after the words
                                                      equipment.                                              assessed as inactive by their validated                ‘‘must be corrected’’.
                                                         (B) Develops site-specific standard                  sterility testing protocol is reported to              ■ b. By adding paragraph (a)(7).
                                                      operating inactivation procedures to                    APHIS.                                                   The addition reads as follows:
                                                      ensure that the material is inactivated                 *      *     *     *     *                             § 331.9    Responsible official.
                                                      by a safety margin determined by the                      (e) * * *                                              (a) * * *
                                                      kill curve.                                               (3) An individual or entity may make                   (7) Ensure that individuals are
                                                         (C) Subjects representative samples of               a written request to the Administrator                 provided the contact information for the
                                                      inactivated select agents or any nucleic                for reconsideration of a decision                      USDA or HHS Office of Inspector
                                                      acids that can produce infectious forms                 denying an application for the exclusion               General Hotline so that they may
                                                      of any select agent viruses to a validated              of an attenuated strain of a select agent              anonymously report any biosafety/
                                                      sterility testing protocol to ensure that               or a select toxin modified to be less                  biocontainment or security concerns
                                                      the inactivation method has rendered                    potent or toxic. The written request for               related to select agents and toxins.
                                                      the select agent non-viable or regulated                reconsideration must state the facts and
                                                      nucleic acids non-infectious.                                                                                  *     *     *     *     *
                                                                                                              reasoning upon which the individual or                 ■ 7. In § 331.10, paragraph (e) is
                                                         (D) Any viability of a select agent or               entity relies to show the decision was                 amended by adding a sentence at the
                                                      infectivity of regulated nucleic acids                  incorrect. The Administrator will grant                end of the paragraph to read as follows:
                                                      that can produce infectious forms of any                or deny the request for reconsideration
                                                      select agent virus that was subjected to                as promptly as circumstances allow and                 § 331.10 Restricting access to select
                                                      a validated inactivation protocol is                    will state, in writing, the reasons for the            agents and toxins; security risk
                                                      reported to APHIS.                                      decision.                                              assessments.
                                                         (E) Reviews annually, and revises as                 *      *     *     *     *                             *      *     *     *     *
                                                      necessary, the following:                               ■ 4. In § 331.5, paragraph (a)(3) is                      (e) * * * A responsible official must
                                                         (1) The kill curve procedure and                     revised to read as follows:                            immediately notify the responsible
                                                      results;                                                                                                       official of the visiting entity if the
                                                         (2) Site-specific standard operating                 § 331.5    Exemptions.                                 person’s access to select agents or toxins
                                                      procedures to ensure that select agents                    (a) * * *                                           has been terminated.
                                                      or regulated nucleic acids that can                        (3) The identification of the agent or              *      *     *     *     *
                                                      produce infectious forms of any select                  toxin is reported to APHIS, the                        ■ 8. Section 331.11 is amended as
                                                      agent virus are inactivated by a safety                 specimen provider, and to other                        follows:
                                                      margin; and                                             appropriate authorities when required                  ■ a. In paragraph (c)(5), by adding the
                                                         (3) The validated sterility testing                  by Federal, State, or local law by                     word ‘‘keycards,’’ after the word ‘‘keys,’’
                                                      protocol used to ensure that the                        telephone, facsimile, or email. This                   and by removing the word ‘‘numbers’’
                                                      inactivation method has rendered a                      report must be followed by submission                  and adding the word ‘‘permissions’’ in
                                                      select agent non-viable or regulated                    of APHIS/CDC Form 4 to APHIS within                    its place.
                                                      nucleic acids that can produce                          7 calendar days after identification.                  ■ b. By adding paragraph (c)(11).
                                                      infectious forms of any select agent                                                                           ■ c. In paragraph (d)(7)(iv), by removing
                                                                                                              *      *    *     *     *
                                                      virus sample non-infectious.                            ■ 5. Section 331.7 is amended as
                                                                                                                                                                     the word ‘‘and’’.
                                                         (F) Reviews, and revises as necessary,                                                                      ■ d. By adding paragraph (d)(7)(vi).
                                                                                                              follows:                                               ■ e. By adding a sentence at the end of
                                                      documents listed in paragraph                           ■ a. By redesignating paragraphs (b)
                                                      (d)(2)(i)(E) of this section after any                                                                         paragraph (h).
                                                                                                              through (k) as paragraphs (c) through (l),                The additions read as follows:
                                                      change in principal investigator, change                respectively.
                                                      in protocol, or any reported viability of               ■ b. By adding a new paragraph (b).                    § 331.11    Security.
                                                      a select agent or infectivity of regulated                 The addition reads as follows:                      *     *     *     *    *
                                                      nucleic acids that can produce                                                                                   (c) * * *
                                                      infectious forms of any select agent                    § 331.7 Registration and related security
                                                                                                                                                                       (11) Describe how the entity
                                                      viruses previously assessed as inactive.                risk assessments.
                                                                                                                                                                     authorizes the means of entry into areas
                                                         (ii) Unless waived by the                            *     *      *    *     *                              where select agents or toxins are stored
                                                      Administrator, an extract from a select                   (b) As a condition of registration, each             or used to include centralized access
                                                      agent is not excluded from the                          entity is required to be in compliance                 control management systems (e.g.,
                                                      requirements of this part until an                      with the requirements of this part for                 keycards) and/or mechanical key
                                                      individual or entity meets the following                select agents and toxins listed on the                 management.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      requirements:                                           registration regardless of whether the                   (d) * * *
                                                         (A) Any extract is subjected to a                    entity is in actual possession of the                    (7) * * *
                                                      process that removes all viable cells,                  select agent or toxin. In regard to toxins,              (vi) Any loss of computer, hard drive
                                                      spores, or virus particles.                             the entity registered for possession, use,             or other data storage device containing
                                                         (B) Any extract is subjected to a                    or transfer of toxins must be in                       information that can be used to gain
                                                      validated sterility testing protocol to                 compliance with the requirements of                    access to select agents or toxins.
                                                      ensure that the inactivation method has                 this part regardless of the amounts of                 *     *     *     *    *
                                                      rendered the extract free of a select                   toxins currently in possession.                          (h) * * * Drills or exercises must be
                                                      agent.                                                  *     *      *    *     *                              documented to include how the drill or


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                                                                             Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules                                              2769

                                                      exercise tested and evaluated the plan,                    (3) Written procedures for                          § 331.15   Training.
                                                      any problems that were identified and                   decontamination, with a validated                        (a) An individual or entity required to
                                                      corrective action(s) taken, and all                     method, of all contaminated or                         register under this part must provide
                                                      individuals who participated in the drill               potentially contaminated materials                     information and training on
                                                      or exercise.                                            including, but not limited to: Cultures                biocontainment, security (including
                                                      ■ 9. Section 331.12 is amended as                       and other materials related to the                     security awareness), incident response,
                                                      follows:                                                propagation of select agents or toxins,                and agent- and toxin-specific training to:
                                                      ■ a. By revising paragraph (a).                         items related to the analysis of select                  (1) Each individual with access
                                                      ■ b. By adding a sentence at the end of                 agents or toxins, personal protective                  approval from the Administrator, within
                                                      paragraph (e).                                          equipment, arthropod caging systems                    12 months of that individual’s
                                                        The addition and revision read as                     and extracted plant and/or arthropod                   anniversary of receiving such approval
                                                      follows:                                                tissues.                                               or prior to his or her entry into an area
                                                                                                                 (4) Written procedures for                          where select agents or toxins are used or
                                                      § 331.12   Biocontainment.                                                                                     stored, whichever occurs first; and
                                                                                                              decontamination, with a validated
                                                         (a) An individual or entity required to              method, of laboratory surfaces and                     *     *     *     *     *
                                                      register under this part must develop                   equipment using manufacturer’s                         ■ 12. In § 331.16, paragraph (b),
                                                      and implement a written                                 specification.                                         introductory text, is revised as follows:
                                                      biocontainment plan that is                                (5) Effluent decontamination
                                                      commensurate with the risk of the select                                                                       § 331.16   Transfers.
                                                                                                              procedures, with a validated method,
                                                      agent or toxin, given its intended use.4                that describe the treatment of effluent                *      *    *     *     *
                                                      The biocontainment plan must contain                    material contaminated with select                         (b) A transfer may be authorized if:
                                                      sufficient information and                              agents or toxins.                                      *      *    *     *     *
                                                      documentation to describe the                              (6) Procedures to respond to                        ■ 13. Section 331.17 is amended as
                                                      biocontainment procedures for the                       emergencies such as spills, sharps                     follows:
                                                      select agent or toxin, including any                    injury, or any other incident involving                ■ a. In paragraph (a)(1)(iii), by adding
                                                      animals (including arthropods) or plants                select agents and toxins.                              the words ‘‘or other storage container’’
                                                      intentionally or accidentally exposed to                   (7) Procedures for handling of select               after the word ‘‘freezer’’.
                                                      or infected with a select agent. The                    agents and toxins in the same spaces as                ■ b. By adding paragraph (a)(1)(ix).
                                                      biocontainment procedures specific to                                                                          ■ c. In paragraph (a)(3)(v), by adding the
                                                                                                              non-select agents and toxins in order to
                                                      each registered laboratory must be                      prevent unintentional contamination.                   words ‘‘or other storage container’’ after
                                                      available to each individual working in                                                                        the word ‘‘freezer’’.
                                                                                                              *      *     *    *     *                              ■ d. By adding paragraph (a)(8).
                                                      that laboratory. The current                               (e) * * * Drills or exercises must be
                                                      biocontainment plan must be submitted                                                                          ■ e. By adding a sentence at the end of
                                                                                                              documented to include how the drill or                 paragraph (b).
                                                      for initial registration, renewal of                    exercise tested and evaluated the plan,                ■ f. By revising paragraph (c).
                                                      registration, or when requested. The                    any problems that were identified and                     The additions and revision read as
                                                      biocontainment plan must include the                    corrective action(s) taken, and all                    follows:
                                                      following provisions:                                   individuals who participated in the drill
                                                         (1) A written risk assessment for each               or exercise.                                           § 331.17   Records.
                                                      prescribed procedure involving a select                 ■ 10. Section 331.14 is amended as                        (a) * * *
                                                      agent or toxin.                                         follows:                                                  (1) * * *
                                                         (i) The hazardous characteristics of                 ■ a. By adding a sentence at the end of                   (ix) If destroyed, the quantity (e.g.,
                                                      the agent or toxin listed on the entity’s               paragraph (a).                                         containers, vials, tubes, etc.) of select
                                                      registration, including probable routes                 ■ b. By adding a sentence at the end of                agent destroyed, the date of such action,
                                                      of transmission in the laboratory and in                paragraph (f).                                         and by whom.
                                                      the environment, infective dose (if                        The additions read as follows:                      *       *    *      *     *
                                                      known), stability in the environment,                                                                             (8) For a select agent or an extract
                                                      host range, contribution of any genetic                 § 331.14    Incident response.5                        from a select agent that has been
                                                      manipulations, and endemicity.                            (a) * * * The current incident                       rendered nonviable or regulated nucleic
                                                         (ii) Hazards associated with laboratory              response plan must be submitted for                    acids that have been rendered non-
                                                      procedures related to the select agent or               initial registration, renewal of                       infectious:
                                                      toxin.                                                  registration, or when requested.                          (i) A written description of the
                                                         (2) Safeguards in place with                         *     *      *     *     *                             inactivation process used for rendering
                                                      associated containment procedures to                      (f) * * * Drills or exercises must be                a select agent or an extract from a select
                                                      protect registered entity personnel, the                documented to include how the drill or                 agent nonviable or regulated nucleic
                                                      public, and the environment from                        exercise tested and evaluated the plan,                acids non-infectious;
                                                      exposure to the select agent or toxin                   any problems that were identified and                     (ii) The sterility testing protocol used
                                                      including, but not limited to: Safety                   corrective action(s) taken, and all                    to verify nonviability of a select agent or
                                                      training requirements for registered                    individuals who participated in the drill              an extract from a select agent or non-
                                                      entity personnel performing the                         or exercise.                                           infectivity of regulated nucleic acids
                                                                                                                                                                     and the results of the test, including
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      procedure; required personal protective                 ■ 11. Section 331.15 is amended as
                                                      equipment; required containment                         follows:                                               investigation, of any inactivation
                                                      equipment including, but not limited to,                ■ a. By revising paragraph (a),                        process failures and the corrective
                                                      biological safety cabinets, arthropod                   introductory text.                                     actions taken;
                                                      caging systems, and centrifuge safety                   ■ b. By revising paragraph (a)(1).
                                                                                                                                                                        (iii) The name of each individual
                                                      containers; and required physical plant                   The revisions read as follows:                       performing the inactivation method and
                                                      engineering controls.                                                                                          sterility testing protocols;
                                                                                                                5 Nothing in this section is meant to supersede or      (iv) The date(s) the inactivation
                                                        4 Technicalassistance and guidance may be             preempt incident response requirements imposed         method and sterility testing protocols
                                                      obtained by contacting APHIS.                           by other statutes or regulations.                      were completed;


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                                                      2770                   Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules

                                                        (v) The location where the inactivated                  The additions and revisions read as                  nucleic acids that can produce
                                                      method and sterility testing protocols                  follows:                                               infectious forms of any select agent
                                                      were performed; and                                                                                            viruses non-infectious.
                                                                                                              § 121.3    VS select agents and toxins.
                                                        (vi) An inactivation certificate that                                                                           (F) Reviews, and revises as necessary,
                                                      includes the date of inactivation,                      *      *     *     *     *                             documents listed in paragraph
                                                      method of inactivation, date of final                      (d) * * *                                           (d)(2)(i)(E) of this section after any
                                                      sterility testing protocol result, and the                 (2) Nonviable VS select agents or
                                                                                                                                                                     change in principal investigator, change
                                                      name of the person performing the                       nonfunctional VS toxins.3
                                                                                                                 (i) Unless waived by the                            in protocol, or any reported viability of
                                                      inactivation. A copy of the inactivation                                                                       a select agent or infectivity of regulated
                                                                                                              Administrator, a select agent or
                                                      certificate must accompany any transfer                                                                        nucleic acids that can produce
                                                                                                              regulated nucleic acids that can produce
                                                      of inactivated material.                                                                                       infectious forms of any select agent
                                                                                                              infectious forms of any select agent
                                                        (b) * * * All written records created                                                                        viruses previously assessed as inactive.
                                                                                                              virus that has been subjected to a
                                                      under this part are legible.                                                                                      (ii) Unless waived by the
                                                                                                              validated inactivation process to remove
                                                        (c) Any records that contain                                                                                 Administrator, an extract from a select
                                                                                                              viability or infectious form (i.e., the
                                                      information related to the requirements                                                                        agent is not excluded from the
                                                                                                              ability to reproduce or produce disease,
                                                      of the regulations. Such records may                                                                           requirements of this part until an
                                                                                                              while maintaining cellular structure) is
                                                      include, but are not limited to,                                                                               individual or entity meets the following
                                                                                                              not excluded from the requirements of
                                                      biocontainment certifications,                                                                                 requirements:
                                                                                                              this part until an entity:
                                                      laboratory notebooks, institutional                        (A) Develops a site-specific kill curve                (A) Any extract is subjected to a
                                                      biosafety and/or animal use committee                   to define conditions of inactivation for               process that removes all viable cells,
                                                      minutes and approved protocols, and                     each select agent or regulated nucleic                 spores, or virus particles.
                                                      records associated with occupational                    acids that can produce infectious forms                   (B) Any extract is subjected to a
                                                      health and suitability programs. All                    of any select agent virus. If there are                validated sterility testing protocol to
                                                      records created under this part must be                 strain-to-strain variations in resistance              ensure that the inactivation method has
                                                      maintained for 3 years.                                 of a select agent to the inactivation                  rendered the extract free of a select
                                                      TITLE 9—ANIMALS AND ANIMAL                              procedure, then a specific kill curve                  agent.
                                                      PRODUCTS                                                must be developed for each strain that                    (C) Any viability of an extract that
                                                                                                              undergoes the inactivation procedure. A                was subjected to a validated inactivation
                                                      PART 121—POSSESSION, USE, AND                           new kill curve must be created upon                    protocol is reported to the responsible
                                                      TRANSFER OF SELECT AGENTS AND                           any change in procedure or inactivation                official.
                                                      TOXINS                                                  equipment.                                                (D) Any viability of a select agent or
                                                                                                                 (B) Develops site-specific standard                 infectivity of regulated nucleic acids
                                                      ■ 14. The authority citation for part 121               operating inactivation procedures to
                                                      continues to read as follows:                                                                                  that can produce infectious forms of any
                                                                                                              ensure that the material is inactivated                select agent virus that was previously
                                                        Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,           by a safety margin determined by the                   assessed as inactive by their validated
                                                      and 371.4.                                              kill curve.                                            sterility testing protocol is reported to
                                                                                                                 (C) Subjects representative samples of              APHIS or CDC.
                                                      ■ 15. Section 121.1 is amended by                       inactivated select agents or any nucleic
                                                      adding, in alphabetical order,                                                                                    (E) Reviews annually, and revises as
                                                                                                              acids that can produce infectious forms                necessary, the following:
                                                      definitions of inactivation and kill curve              of any select agent viruses to a validated
                                                      to read as follows:                                                                                               (1) The kill curve procedure and
                                                                                                              sterility testing protocol to ensure that              results;
                                                      § 121.1   Definitions.                                  the inactivation method has rendered
                                                                                                                                                                        (2) Site-specific standard operating
                                                                                                              the select agent non-viable or regulated
                                                      *     *     *     *     *                                                                                      procedures to ensure that select agents
                                                                                                              nucleic acids non-infectious.
                                                        Inactivation. A method to render a                       (D) Any viability of a select agent or              or regulated nucleic acids that can
                                                      select agent non-viable but retain                      infectivity of regulated nucleic acids                 produce infectious forms of any select
                                                      characteristic of interest for future use,              that can produce infectious forms of any               agent viruses are inactivated by a safety
                                                      or to render any nucleic acids that can                 select agent virus that was subjected to               margin; and
                                                      produce infectious forms of any select                  a validated inactivation protocol is                      (3) The validated sterility testing
                                                      agent virus non-infectious for future                   reported to APHIS or CDC.                              protocol used to ensure that the
                                                      use.                                                       (E) Reviews annually, and revises as                inactivation method has rendered a
                                                      *     *     *     *     *                               necessary, the following:                              select agent non-viable or regulated
                                                        Kill curve. The results of a dose-                       (1) The kill curve procedure and                    nucleic acids that can produce
                                                      response experiment where a select                      results;                                               infectious forms of any select agent
                                                      agent is subjected to increasing amounts                   (2) Site-specific standard operating                viruses non-infectious.
                                                      of the inactivating treatment to                        procedures to ensure that select agents                   (F) Reviews, and revises as necessary,
                                                      determine the minimum conditions                        or regulated nucleic acids that can                    documents listed in paragraph
                                                      required to render it non-viable, or to                 produce infectious forms of any select                 (d)(2)(ii)(E) of this section after any
                                                      render any nucleic acids that can                       agent virus are inactivated by a safety                change in principal investigator, change
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      produce infectious forms of any select                  margin; and                                            in protocol, or any reported viability of
                                                      agent virus as non-infectious.                             (3) The validated sterility testing                 a select agent or infectivity of regulated
                                                      *     *     *     *     *                               protocol used to ensure that the                       nucleic acids that can produce
                                                      ■ 16. Section 121.3 is amended as                       inactivation method has rendered a                     infectious forms of any select agent
                                                      follows:                                                select agent non-viable or regulated                   virus previously assessed as inactive.
                                                      ■ a. By revising paragraphs (d)(2) and                                                                            (3) Any low pathogenic strains of
                                                                                                                3 However, the importation and interstate
                                                      (d)(3).                                                                                                        avian influenza virus, avian
                                                                                                              movement of these nonviable select agents may be
                                                      ■ b. By adding paragraph (d)(4).                        subject to the permit requirements under part 122
                                                                                                                                                                     paramyxovirus serotype-1 (APMV–1)
                                                      ■ c. By adding paragraph (e)(3).                        of this subchapter.                                    viruses which do not meet the criteria


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                                                                                Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules                                         2771

                                                      for Newcastle disease virus,4 including                     (2) Nonviable overlap select agents or             (d)(2)(i)(E) of this section after any
                                                      those identified as pigeon                               nonfunctional overlap toxins.7                        change in principal investigator, change
                                                      paramyxovirus-12 5 isolated from a non-                     (i) Unless waived by the APHIS                     in protocol, or any reported viability of
                                                      poultry species, all subspecies                          Administrator or HHS Secretary, a select              a select agent or infectivity of regulated
                                                      Mycoplasma capricolum except                             agent or regulated nucleic acids that can             nucleic acids that can produce
                                                      subspecies capripneumoniae                               produce infectious forms of any select                infectious forms of any select agent
                                                      (contagious caprine pleuropneumonia),                    agent virus that has been subjected to a              virus previously assessed as inactive.
                                                      and all subspecies Mycoplasma                            validated inactivation process to remove                 (ii) Unless waived by the APHIS
                                                      mycoides except subspecies mycoides                      viability or infectious form (i.e., the               Administrator or HHS Secretary, an
                                                      small colony (Mmm SC) (contagious                        ability to reproduce or produce disease,              extract from a select agent is not
                                                      bovine pleuropneumonia), provided                        while maintaining cellular structure) is              excluded from the requirements of this
                                                      that the individual or entity can identify               not excluded from the requirements of                 part until an individual or entity meets
                                                      that the agent is within the exclusion                   this part until an individual or entity:              the following requirements:
                                                      category.                                                   (A) Develops a site-specific kill curve               (A) Any extract is subjected to a
                                                         (4) Waste generated during the                        to define conditions of inactivation for              process that removes all viable cells,
                                                      delivery of patient care from a patient                  each select agent or regulated nucleic                spores, or virus particles.
                                                      infected with a select agent that is                     acids that can produce infectious forms                  (B) Any extract is subjected to a
                                                                                                               of any select agent virus. If there are               validated sterility testing protocol to
                                                      decontaminated with a validated
                                                                                                               strain-to-strain variations in resistance             ensure that the inactivation method has
                                                      method within 7 calendar days of the
                                                                                                               of a select agent to the inactivation                 rendered the extract free of a select
                                                      conclusion of patient care.
                                                                                                               procedure, then a specific kill curve                 agent.
                                                         (e) * * *                                             must be developed for each strain that
                                                         (3) An individual or entity may make                                                                           (C) Any viability of an extract that
                                                                                                               undergoes the inactivation procedure. A               was subjected to a validated inactivation
                                                      a written request to the Administrator                   new kill curve must be created upon
                                                      for reconsideration of a decision                                                                              protocol is reported to the responsible
                                                                                                               any change in procedure or inactivation               official.
                                                      denying an application for the exclusion                 equipment.
                                                      of an attenuated strain of a select agent                                                                         (D) Any viability of a select agent or
                                                                                                                  (B) Develops site-specific standard
                                                      or a select toxin modified to be less                                                                          infectivity of regulated nucleic acids
                                                                                                               operating inactivation procedures to
                                                      potent or toxic. The written request for                                                                       that can produce infectious forms of any
                                                                                                               ensure that the material is inactivated
                                                      reconsideration must state the facts and                                                                       select agent virus that was previously
                                                                                                               by a safety margin determined by the
                                                      reasoning upon which the individual or                   kill curve.                                           assessed as inactive by the validated
                                                      entity relies to show the decision was                      (C) Subjects representative samples of             sterility testing protocol is reported to
                                                      incorrect. The Administrator will grant                  inactivated select agents or any                      APHIS or CDC.
                                                      or deny the request for reconsideration                  regulated nucleic acids that can produce              *       *    *     *     *
                                                      as promptly as circumstances allow and                   infectious forms of any select agent                     (4) Waste generated during the
                                                      will state, in writing, the reasons for the              viruses to a validated sterility testing              delivery of patient care from a patient
                                                      decision.                                                protocol to ensure that the inactivation              infected with a select agent that is
                                                      *      *      *     *    *                               method has rendered the select agent                  decontaminated with a validated
                                                                                                               non-viable or regulated nucleic acids                 method within 7 calendar days of the
                                                      ■ 17. Section 121.4 is amended as
                                                                                                               non-infectious.                                       conclusion of patient care.
                                                      follows:                                                    (D) Reports any viability of a select                 (e) * * *
                                                      ■ a. In paragraph (b), by removing the                   agent or infectivity of regulated nucleic                (3) An individual or entity may make
                                                      words ‘‘Bacillus anthracis (Pasteur                      acids that can produce infectious forms               a written request to the Administrator or
                                                      strain);’’, ‘‘Brucella abortus;’’, and                   of any select agent virus that was                    HHS Secretary for reconsideration of a
                                                      ‘‘Brucella suis;’’.                                      subjected to a validated inactivation                 decision denying an application for the
                                                      ■ b. In paragraph (c)(1), by redesignating               protocol to the responsible official.                 exclusion of an attenuated strain of a
                                                      footnote 4 as footnote 6.                                   (E) Reviews annually, and revises as               select agent or a select toxin modified to
                                                      ■ c. By revising paragraph (d)(2).                       necessary, the following:                             be less potent or toxic. The written
                                                      ■ d. By adding paragraph (d)(4).                            (1) The kill curve procedure and                   request for reconsideration must state
                                                      ■ e. By adding paragraph (e)(3).
                                                                                                               results;                                              the facts and reasoning upon which the
                                                                                                                  (2) Site-specific standard operating               individual or entity relies to show the
                                                         The additions and revision read as                    procedures to ensure that select agents
                                                      follows:                                                                                                       decision was incorrect. The
                                                                                                               or regulated nucleic acids that can                   Administrator or HHS Secretary will
                                                      § 121.4   Overlap select agents and toxins.              produce infectious forms of any select                grant or deny the request for
                                                                                                               agent virus are inactivated by a safety               reconsideration as promptly as
                                                      *       *    *        *      *
                                                                                                               margin; and                                           circumstances allow and will state, in
                                                          (d) * * *                                               (3) The validated sterility testing                writing, the reasons for the decision.
                                                                                                               protocol used to ensure that the
                                                        4 An APMV–1 virus isolated from poultry which                                                                *       *    *     *     *
                                                                                                               inactivation method has rendered a
                                                      has an intracerebral pathogenicity index in day-old                                                            ■ 18. Section 121.5 is amended as
                                                                                                               select agent non-viable or regulated
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      chicks (Gallus gallus) of 0.7 or greater or has an                                                             follows:
                                                      amino acid sequence at the fusion (F) protein            nucleic acids that can produce
                                                                                                                                                                     ■ a. By revising paragraphs (a)(2) and
                                                      cleavage site that is consistent with virulent strains   infectious forms of any select agent
                                                      of Newcastle disease virus. A failure to detect a        viruses non-infectious.                               (a)(3).
                                                      cleavage site that is consistent with virulent strains
                                                                                                                  (F) Reviews, and revises as necessary,             ■ b. By adding paragraph (a)(4).
                                                      does not confirm the absence of a virulent virus.                                                                 The addition and revisions read as
                                                        5 Pigeon paramyxovirus (PPMV–1) is a species-          documents listed in paragraph
                                                                                                                                                                     follows:
                                                      adapted APMV–1 virus which is endemic in
                                                      pigeons and doves in the United States and can be          7 However, the importation and interstate
                                                                                                                                                                     § 121.5 Exemptions for VS select agents
                                                      identified through monoclonal antibody testing and       movement of these nonviable overlap select agents
                                                      demonstration of their characteristic amino acid         may be subject to the permit requirements under
                                                                                                                                                                     and toxins.
                                                      signature at the fusion gene cleavage site.              part 122 of this subchapter.                            (a) * * *


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                                                      2772                   Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules

                                                         (2) The agent or toxin is secured                    ■ c. In paragraph (c)(3), introductory                 and adding the word ‘‘permissions’’ in
                                                      against theft, loss, or release during the              text, by redesignating footnote 6 as                   its place.
                                                      period between identification of the                    footnote 8.                                            ■ b. By adding paragraph (c)(11).
                                                      agent or toxin and transfer or                          ■ d. In paragraph (h)(1), by                           ■ c. In paragraph (d)(7)(iv), by removing
                                                      destruction of such agent or toxin, and                 redesignating footnote 7 as footnote 9.                the word ‘‘and’’.
                                                      any theft, loss, or release of such agent                 The addition reads as follows:                       ■ d. By adding paragraph (d)(7)(vi).
                                                      or toxin is reported;                                                                                          ■ e. By adding a sentence at the end of
                                                                                                              § 121.7 Registration and related security              paragraph (h).
                                                         (3) Unless directed otherwise by the                 risk assessments.
                                                      Administrator, the clinical or diagnostic                                                                         The additions read as follows:
                                                      specimens collected from a patient                      *     *      *    *     *
                                                                                                                (b) As a condition of registration, each             § 121.11   Security.
                                                      infected with a select agent are
                                                      transferred in accordance with § 121.16                 entity is required to be in compliance                 *     *     *     *    *
                                                      or destroyed on-site by a recognized                    with the requirements of this part for                   (c) * * *
                                                      sterilization or inactivation process                   select agents and toxins listed on the                   (11) Describe how the entity
                                                      within 7 calendar days after delivery of                registration regardless of whether the                 authorizes the means of entry into areas
                                                      patient care has concluded; and                         entity is in actual possession of the                  where select agents or toxins are stored
                                                         (4) The identification of the agent or               select agent or toxin. With regard to                  or used to include centralized access
                                                      toxin is reported to APHIS or CDC, the                  toxins, the entity registered for                      control management systems (e.g.,
                                                      specimen provider, and to other                         possession, use, or transfer of a toxin                keycards) and/or mechanical key
                                                      appropriate authorities when required                   must be in compliance with the                         management.
                                                      by Federal, State, or local law by                      requirements of this part regardless of                  (d) * * *
                                                      telephone, facsimile, or email. This                    the amount of toxin currently in                         (7) * * *
                                                      report must be followed by submission                   possession.                                              (vi) Any loss of computer, hard drive
                                                      of APHIS/CDC Form 4 to APHIS or CDC                     *     *      *    *     *                              or other data storage device containing
                                                      within 7 calendar days after                                                                                   information that could be used to gain
                                                                                                              § 121.8    [Amended]                                   access to select agents or toxins.
                                                      identification.
                                                                                                              ■ 21. In § 121.8, footnote 8 is                        *     *     *     *    *
                                                      *      *    *     *      *                              redesignated as footnote 10.                             (h) * * * Drills or exercises must be
                                                      ■ 19. Section 121.6 is amended as
                                                                                                              ■ 22. Section 121.9 is amended as                      documented to include how the drill or
                                                      follows:                                                follows:                                               exercise tested and evaluated the plan,
                                                      ■ a. In paragraph (a)(2), by removing the               ■ a. In paragraph (a)(6), by removing the              any problems that were identified and
                                                      word ‘‘and’’ at the end of the paragraph.               word ‘‘laboratory’’ and adding the                     corrective action(s) taken, and all
                                                      ■ b. By redesignating paragraph (a)(3) as               words ‘‘registered space’’ in its place                individuals who participated in the drill
                                                      paragraph (a)(4).                                       and by adding the words ‘‘and the                      or exercise.
                                                      ■ c. By adding new paragraph (a)(3).                    corrections documented’’ at the end of                 ■ 25. Section 121.12 is amended as
                                                      ■ d. By revising newly redesignated                     the second sentence after the words                    follows:
                                                      paragraph (a)(4).                                       ‘‘must be corrected’’.                                 ■ a. By revising paragraph (a).
                                                         The addition and revision read as                    ■ b. By adding paragraph (a)(7).                       ■ b. By removing paragraph (c)(2).
                                                      follows:                                                  The addition reads as follows:                       ■ c. By redesignating paragraph (c)(3) as
                                                      § 121.6 Exemptions for overlap select                   § 121.9    Responsible official.
                                                                                                                                                                     paragraph (c)(2), and removing the
                                                      agents and toxins.                                                                                             words ‘‘NIH Guidelines for Research
                                                                                                                (a) * * *                                            Involving Recombinant DNA
                                                         (a) * * *                                              (7) Ensure that individuals are
                                                         (3) Unless directed otherwise by the                                                                        Molecules’’ and replacing them with the
                                                                                                              provided the contact information for the               words ‘‘NIH Guidelines for Research
                                                      Administrator or HHS Secretary, the                     USDA or HHS Office of Inspector
                                                      clinical or diagnostic specimens                                                                               Involving Recombinant or Synthetic
                                                                                                              General Hotline so that they may                       Nucleic Acid Molecules’’.
                                                      collected from a patient infected with a                anonymously report any safety or
                                                      select agent are transferred in                                                                                ■ d. By adding a sentence at the end of
                                                                                                              security concerns related to select                    paragraph (e).
                                                      accordance with § 121.16, or destroyed                  agents and toxins.
                                                      on-site by a recognized sterilization or                                                                         The addition and revision read as
                                                                                                              *     *     *     *    *                               follows:
                                                      inactivation process within 7 calendar
                                                                                                              ■ 23. In § 121.10, paragraph (e) is
                                                      days after delivery of patient care has                                                                        § 121.12   Biosafety.
                                                                                                              amended by adding a sentence at the
                                                      concluded;
                                                                                                              end of the paragraph to read as follows:                 (a) An individual or entity required to
                                                         (4) The identification of the agent or
                                                                                                                                                                     register under this part must develop
                                                      toxin is reported to APHIS or CDC, the                  § 121.10 Restricting access to select                  and implement a written biosafety plan
                                                      specimen provider, and to other                         agents and toxins; security risk
                                                                                                              assessments.
                                                                                                                                                                     that is commensurate with the risk of
                                                      appropriate authorities when required
                                                                                                                                                                     the select agent or toxin, given its
                                                      by Federal, State, or local law by                      *     *      *     *     *                             intended use.11 The biosafety plan must
                                                      telephone, facsimile, or email. This                      (e) * * * A responsible official must                contain sufficient information and
                                                      report must be followed by submission                   immediately notify the responsible
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                                                                                                                                     documentation to describe the biosafety
                                                      of APHIS/CDC Form 4 to APHIS within                     official of the visited entity if the                  and containment procedures for the
                                                      7 calendar days after identification.                   person’s access to select agents and                   select agent or toxin, including any
                                                      *      *    *     *     *                               toxins has been terminated.                            animals (including arthropods) or plants
                                                      ■ 20. Section 121.7 is amended as                       *     *      *     *     *                             intentionally or accidentally exposed to
                                                      follows:                                                ■ 24. Section 121.11 is amended as                     or infected with a select agent. Biosafety
                                                      ■ a. By redesignating paragraphs (b)                    follows:                                               and containment procedures specific to
                                                      through (k) as paragraphs (c) through (l),              ■ a. In paragraph (c)(5), by adding the
                                                      respectively.                                           word ‘‘keycards,’’ after the word ‘‘keys,’’              11 Technical assistance and guidance may be

                                                      ■ b. By adding a new paragraph (b).                     and by removing the word ‘‘numbers’’                   obtained by contacting APHIS.



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                                                                             Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules                                              2773

                                                      each registered laboratory must be                      in order to prevent unintentional                      ■ 28. Section § 121.16 is amended as
                                                      available to each individual working in                 contamination.                                         follows:
                                                      that laboratory. The current biosafety                  *     *     *    *      *                              ■ a. In paragraph (a), by redesignating
                                                      plan must be submitted for initial                        (e) * * * Drills or exercises must be                footnote 12 as footnote 14.
                                                      registration, renewal of registration, or               documented to include how the drill or                 ■ b. By revising paragraph (b),
                                                      when requested. The biosafety plan                      exercise tested and evaluated the plan,                introductory text.
                                                      must include the following provisions:                  any problems identified and corrective                 ■ c. By adding paragraph (l).
                                                         (1) A written risk assessment for each               action(s) that were taken, and all                       The addition and revision read as
                                                      procedure involving a select agent or                   individuals who participated in the drill              follows:
                                                      toxin that addresses the hazards                        or exercise.                                           § 121.16   Transfers.
                                                      associated with the agent or toxin.                     ■ 26. Section 121.14 is amended as
                                                                                                              follows:                                               *      *     *     *    *
                                                         (i) The hazardous characteristics of                                                                           (b) A transfer may be authorized if:
                                                                                                              ■ a. In paragraph (a), by redesignating
                                                      each agent or toxin listed on the entity’s
                                                                                                              footnote 11 as footnote 13, and by                     *      *     *     *    *
                                                      registration, including probable routes
                                                                                                              adding a sentence at the end of the                       (l) Transfer the amounts only after the
                                                      of transmission in the laboratory and in
                                                                                                              paragraph.                                             transferor uses due diligence and
                                                      the environment, infective dose (if
                                                                                                              ■ b. In paragraph (f), by adding a                     documents that the recipient has a
                                                      known), stability in the environment,
                                                                                                              sentence at the end of the paragraph.                  legitimate need (i.e., prophylactic,
                                                      host range, contribution of any genetic                   The additions read as follows:                       protective, bona fide research, or other
                                                      manipulations, and endemicity.
                                                                                                                                                                     peaceful purpose) to handle or use such
                                                         (ii) Hazards associated with laboratory              § 121.14    Incident response.12
                                                                                                                                                                     toxins. Information to be documented
                                                      procedures related to the select agent or                 (a) * * * The current incident                       includes, but is not limited, to the
                                                      toxin.                                                  response plan must be submitted for                    recipient information, toxin and amount
                                                         (2) Safeguards in place with                         initial registration, renewal of                       transferred, and declaration that the
                                                      associated work practices to protect                    registration, or when requested.                       recipient has legitimate purpose to store
                                                      registered entity personnel, the public,                *     *      *     *     *                             and use such toxins.
                                                      and the environment from exposure to                      (f) * * * Drills or exercises must be                ■ 29. Section 121.17 is amended as
                                                      the select agent or toxin including, but                documented to include how the drill or                 follows:
                                                      not limited to: Safety training                         exercise tested and evaluated the plan,                ■ a. In paragraph (a)(1)(iii), by adding
                                                      requirements for registered entity                      any problems identified and corrective                 the words ‘‘or other storage container’’
                                                      personnel performing the procedure;                     action(s) that were taken, and all                     after the word ‘‘freezer’’.
                                                      required personal protective equipment                  individuals who participated in the drill              ■ b. By adding paragraph (a)(1)(ix).
                                                      and other safety equipment; required                    or exercise.                                           ■ c. In paragraph (a)(3)(v), by adding the
                                                      containment equipment including, but                    ■ 27. Section 121.15 is amended as                     words ‘‘or other storage container’’ after
                                                      not limited to, biological safety cabinets,             follows:                                               the word ‘‘freezer’’.
                                                      animal caging systems, and centrifuge                   ■ a. By revising paragraphs (a),
                                                                                                                                                                     ■ d. By adding paragraph (a)(8).
                                                      safety containers; and required                         introductory text, and (a)(1).                         ■ e. By adding a sentence at the end of
                                                                                                              ■ b. By adding paragraph (e).
                                                      engineering controls and other facility                                                                        paragraph (b).
                                                                                                                The addition and revisions read as
                                                      safeguards.                                                                                                    ■ f. By revising paragraph (c).
                                                                                                              follows:                                                  The additions and revision read as
                                                         (3) Written procedures for
                                                      decontamination, with a validated                       § 121.15    Training.                                  follows:
                                                      method, of all contaminated or                             (a) An individual or entity required to             § 121.17   Records.
                                                      potentially contaminated materials                      register under this part must provide
                                                                                                                                                                        (a) * * *
                                                      including, but not limited to: Cultures                 information and training on
                                                                                                                                                                        (1) * * *
                                                      and other materials related to the                      biocontainment, biosafety, security                       (ix) If destroyed, the quantity (e.g.,
                                                      propagation of select agents or toxins,                 (including security awareness), incident               containers, vials, tubes, etc.) of select
                                                      items related to the analysis of select                 response, and agent- and toxin-specific
                                                                                                                                                                     agent destroyed, the date of such action,
                                                      agents and toxins, personal protective                  training to:
                                                                                                                                                                     and by whom.
                                                      equipment, animal caging systems and                       (1) Each individual with access
                                                      bedding, and animal carcasses or                        approval from the HHS Secretary or                     *       *    *      *     *
                                                      extracted tissues.                                      Administrator, within 12 months of that                   (8) For a select agent or an extract
                                                                                                              individual’s anniversary of receiving                  from a select agent that has been
                                                         (4) Written procedures for
                                                                                                              such approval or prior to his or her                   rendered non-viable or regulated
                                                      decontamination, with a validated
                                                                                                              entry into an area where select agents or              nucleic acids that can produce
                                                      method, of laboratory surfaces and
                                                                                                              toxins are used or stored, whichever                   infectious forms of any select agent
                                                      equipment using manufacturer’s
                                                                                                              occurs first; and                                      virus that have been rendered non-
                                                      specification.
                                                                                                              *      *     *    *    *                               infectious through inactivation:
                                                         (5) Effluent decontamination                                                                                   (i) A written description of the
                                                      procedures, with a validated method,                       (e) The responsible official must
                                                                                                              ensure and document that individuals                   inactivation process used for rendering
                                                      that describe the treatment of effluent                                                                        a select agent non-viable or regulated
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      material contaminated with select                       are provided the contact information of
                                                                                                              the HHS or USDA Office of Inspector                    nucleic acids that can produce
                                                      agents and toxins.                                                                                             infectious forms of any select agent
                                                         (6) Procedures to respond to                         General Hotline so that they may
                                                                                                              anonymously report any safety or                       virus non-infectious;
                                                      emergencies such as spills, sharps                                                                                (ii) The sterility testing protocol used
                                                      injury, or animal bites involving select                security concerns related to select
                                                                                                              agents and toxins.                                     to verify non-viability of a select agent
                                                      agents and toxins.                                                                                             or non-infectivity of regulated nucleic
                                                         (7) Procedures for the handling of                     12 Nothing in this section is meant to supersede     acids that can produce infectious forms
                                                      select agents and toxins in the same                    or preempt incident response requirements              of any select agent virus and the results
                                                      spaces with non-select agents and toxins                imposed by other statutes or regulations.              of the test, including investigation, of


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                                                      2774                   Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Proposed Rules

                                                      any inactivation process failures and the               DATES:   We will consider comments we                  SUPPLEMENTARY INFORMATION:       Under the
                                                      corrective actions taken;                               receive by April 18, 2016.                             authority of the USGSA (7 U.S.C. 76),
                                                        (iii) The name of each individual                     ADDRESSES: You may submit written or                   GIPSA establishes standards for
                                                      performing the inactivation method and                  electronic comments on this proposed                   sunflower seed and other grains
                                                      sterility testing protocols;                            rule to:                                               regarding kind, class, quality and
                                                        (iv) The date(s) the inactivation                        • Mail: Irene Omade, GIPSA, USDA,                   condition. The sunflower seed
                                                      method and sterility testing protocols                  STOP 3642, 1400 Independence Avenue                    standards, established by USDA on
                                                      were completed;                                         SW., Room 2530–B, Washington, DC                       September 1, 1984, were last revised in
                                                        (v) The location where the inactivated                20250–3604.                                            1988 and appear in the USGSA
                                                      method and sterility testing protocols                     • Fax: (202) 690–2173                               regulations at 7 CFR 810.1801 through
                                                      were performed; and                                        • Internet: Go to http://                           810.1804. The standards facilitate
                                                        (vi) An inactivation certificate that                 www.regulations.gov and follow the on-                 sunflower seed marketing and define
                                                      includes the date of inactivation,                      line instruction for submitting                        U.S. sunflower seed quality in the
                                                      method of inactivation, date of final                   comments.                                              domestic and global marketplace. The
                                                      sterility testing protocol result, and the                 All comments will become a matter of
                                                                                                                                                                     standards define commonly used
                                                      Principal Investigator. A copy of the                   public record and should be identified
                                                                                                                                                                     industry terms; contain basic principles
                                                      inactivation certificate must accompany                 as ‘‘U.S. Standards for Sunflower Seed
                                                                                                              request for information comments,’’                    governing the application of standards,
                                                      any transfer of inactivated material.                                                                          such as the type of sample used for a
                                                        (b) * * * All written records created                 making reference to the date and page
                                                                                                              number of this issue of the Federal                    particular quality analysis; the basis of
                                                      under this part are legible.                                                                                   determination; and specify grades and
                                                        (c) Any records that contain                          Register. All comments received
                                                                                                              become the property of the Federal                     grade requirements. Official procedures
                                                      information related to the requirements                                                                        for determining grading factors are
                                                      of the regulations. Such records may                    government, are a part of the public
                                                                                                              record, and will generally be posted to                provided in GIPSA’s Grain Inspection
                                                      include, but are not limited to,                                                                               Handbook, Book II, Chapter 11,
                                                      certifications, laboratory notebooks,                   www.regulations.gov without change. If
                                                                                                              you send an email comment directly to                  ‘‘Sunflower Seed’’ which also includes
                                                      institutional biosafety and/or animal use
                                                                                                              GIPSA without going through                            standardized procedures for additional
                                                      committee minutes and approved
                                                      protocols, and records associated with                  www.regulations.gov, or you submit a                   quality attributes not used to determine
                                                      occupational health and suitability                     comment to GIPSA via fax, the                          grade, such as moisture content and
                                                      programs. All records created under this                originating email address or telephone                 official criteria. Together, the grading
                                                      part must be maintained for 3 years.                    number will be automatically captured                  standards and testing procedures allow
                                                                                                              and included as part of the comment                    buyers and sellers to communicate
                                                        Done in Washington, DC, this 8th day of               that is placed in the public docket and
                                                      January 2016.
                                                                                                                                                                     quality requirements, compare
                                                                                                              made available on the Internet. Also, all              sunflower seed quality using equivalent
                                                      Kevin Shea,                                             personal identifying information (for                  forms of measurement and assist in
                                                      Administrator, Animal and Plant Health                  example, name, address, etc.)
                                                      Inspection Service.
                                                                                                                                                                     price discovery.
                                                                                                              voluntarily submitted by the commenter
                                                      [FR Doc. 2016–00681 Filed 1–14–16; 4:15 pm]             may be publicly accessible. Do not                        GIPSA’s grading and inspection
                                                      BILLING CODE 3410–34–P                                  submit confidential business                           services are provided through a network
                                                                                                              information or otherwise sensitive or                  of federal, state, and private laboratories
                                                                                                              protected information.                                 that conduct tests to determine the
                                                      DEPARTMENT OF AGRICULTURE                                  Electronic submissions should avoid                 quality and condition of sunflower seed.
                                                                                                              the use of special characters, avoid any               These tests are conducted in accordance
                                                      Grain Inspection, Packers and                           form of encryption, and be free of any                 with applicable standards using
                                                      Stockyards Administration                               defects or viruses, since these may                    approved methodologies and can be
                                                                                                              prevent GIPSA from being able to read                  applied at any point in the marketing
                                                      7 CFR Part 810                                          and understand, and thus consider your                 chain. Furthermore, the tests yield
                                                      United States Standards for Sunflower                   comment.                                               rapid, reliable and consistent results. In
                                                      Seed                                                       GIPSA will post a transcript or report              addition, GIPSA-issued certificates
                                                                                                              summarizing each substantive oral                      describing the quality and condition of
                                                      AGENCY:  Grain Inspection, Packers and                  comment that we receive. This would                    graded sunflower seed are accepted as
                                                      Stockyards Administration, USDA.                        include comments made at any public                    prima facie evidence in all Federal
                                                      ACTION: Request for information.                        meetings hosted by GIPSA during the                    courts. U.S. Standards for Sunflower
                                                                                                              comment period, unless GIPSA                           Seed and the affiliated grading and
                                                      SUMMARY:   The United States Department                 publically announces otherwise.                        testing services offered by GIPSA verify
                                                      of Agriculture’s (USDA) Grain                              All comments will also be available                 that a seller’s sunflower seed meets
                                                      Inspection, Packers, and Stockyards                     for public inspection at the above                     specified requirements, and ensure that
                                                      Administration (GIPSA) is seeking                       address during regular business hours (7
                                                                                                                                                                     customers receive the quality of
                                                      comment from the public regarding the                   CFR 1.27(b)). Please call the GIPSA
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                                                                                                                                     sunflower seed they purchased.
                                                      United States (U.S.) Standards for                      Management and Budget Services
                                                      Sunflower Seed under the United States                  support staff (202) 720–8479 for an                       In order for U.S. standards and
                                                      Grain Standards Act (USGSA). To                         appointment to view the comments.                      grading procedures for sunflower seed
                                                      ensure that standards and official                      FOR FURTHER INFORMATION CONTACT:                       to remain relevant, GIPSA is issuing this
                                                      grading practices remain relevant,                      Andrew Greenfield at GIPSA, USDA,                      request for information to invite
                                                      GIPSA invites interested parties to                     1400 Independence Avenue SW.,                          interested parties to submit comments,
                                                      comment on whether the current                          Washington. DC 20250; Telephone (202)                  ideas, and suggestions on all aspects of
                                                      sunflower seed standards and grading                    720–0277; Fax Number (202) 720–1015;                   the U.S. Standards for Sunflower Seed
                                                      practices need to be changed.                           email Andrew.S.Greenfield@usda.gov..                   and inspection procedures.


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Document Created: 2016-01-16 01:09:18
Document Modified: 2016-01-16 01:09:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesWe will consider all comments that we receive on or before March 21, 2016.
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 Citation81 FR 2762 
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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