[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Proposed Rules]
[Pages 2762-2774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00681]


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 Proposed Rules
                                                 Federal Register
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 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