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[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Rules and Regulations]
[Pages 61055-61081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24434]

[[Page 61055]]

Vol. 77

Friday,

No. 194

October 5, 2012

Part II

Department of Agriculture

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 Animal and Plant Health Inspection Service

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7 CFR Part 331

9 CFR Part 121

 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; Final Rule

Federal Register / Vol. 77 , No. 194 / Friday, October 5, 2012 / 
Rules and Regulations

[[Page 61056]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2009-0070]
RIN 0579-AD09

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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are amending and republishing the list of select agents 
and toxins that have the potential to pose a severe threat to animal or 
plant health, or to animal or plant products. The Act requires the 
biennial review and republication of the list of select agents and 
toxins and the revision of the list as necessary. This action 
implements the findings of the third biennial review of the list. In 
addition, we are reorganizing the list of select agents and toxins 
based on the relative potential of each select agent or toxin to be 
misused to adversely affect human, plant, or animal health. Such 
tiering of the list allows for the optimization of security measures 
for those select agents or toxins that present the greatest risk of 
deliberate misuse with the most significant potential for mass 
casualties or devastating effects to the economy, critical 
infrastructure, or public confidence. We are also making a number of 
amendments to the regulations, including the addition of definitions 
and clarification of language concerning security, training, biosafety, 
biocontainment, and incident response. These changes will increase the 
usability of the select agent regulations as well as provide for 
enhanced program oversight.

DATES: The amendments to 7 CFR 331.1 through 331.10, 331.13, and 331.16 
through 331.20 and 9 CFR 121.1 through 121.10, 121.13, 121.16, 121.17, 
and 121.20 are effective December 4, 2012. The remaining provisions of 
this final rule are effective April 3, 2013.

FOR FURTHER INFORMATION CONTACT: Mr. Charles L. Divan, Acting Director, 
APHIS Agriculture Select Agent Program, APHIS, 4700 River Road Unit 2, 
Riverdale, MD 20737-1231; (301) 851-3300, option 1.

SUPPLEMENTARY INFORMATION:

Executive Summary

    On July 29, 2010, we published in the Federal Register (75 FR 
44724-44725, Docket No. APHIS-2009-0070) an advance notice of proposed 
rulemaking and request for comments (ANPR)\1\ and On October 3, 2011, 
we published in the Federal Register (76 FR 61228-61244, Docket No. 
APHIS-2009-0070) a proposal\2\ regarding our intent 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, reorganize the list of select agents and toxins based 
on the relative potential of each select agent or toxin to be misused 
to adversely affect human, plant, or animal health, and amend the 
regulations in order to add definitions and clarify language concerning 
security, training, biosafety, biocontainment, and incident response.
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    \1\ To view the ANPR and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
    \2\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
---------------------------------------------------------------------------

    Specifically, the ANPR solicited comments regarding whether there 
are other select agents or toxins that should be added to the Plant 
Protection and Quarantine (PPQ) and Veterinary Services (VS) lists of 
select agents and toxins, whether any of the select agents or toxins on 
the PPQ or VS lists should be removed, whether the PPQ and VS lists of 
select agents and toxins should be tiered based on the relative 
bioterrorism risk presented by each select agent or toxin, and whether 
the security requirements for select agents or toxins in the highest 
tier should be stratified based on type of use or other factors. 
Comments received as a result of the ANPR were used in order to inform 
our discussions on the content of the select agent list and our 
determination regarding reorganization of the list in the proposed 
rule. We solicited comments concerning our proposal for 60 days ending 
December 2, 2011. We reopened and extended the deadline for comments 
until January 17, 2012, in a document published in the Federal Register 
on December 15, 2011 (76 FR 77914, Docket No. APHIS-2009-0070). We 
received 30 comments by that date. They were from researchers, 
scientific organizations, laboratories, and universities.
    Changes to the current regulations detailed in this final rule 
include:
    1. Modification of the select agent and toxin list:
     The following agents would no longer be considered PPQ 
select agents or toxins, or would be excluded from compliance with the 
select agent regulations: Any subspecies of Ralstonia solanacearum 
except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae 
except var. zeae, and Xylella fastidiosa, citrus variegated chlorosis 
(CVC) strain.
     The following agents would no longer be considered VS 
select agents or toxins, or would be excluded from compliance with the 
select agent regulations: Any low pathogenic strains of avian influenza 
virus, any strain of Newcastle disease virus which does not meet the 
criteria for virulent Newcastle disease virus, 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), Akabane virus; Bluetongue virus (exotic), Bovine 
spongiform encephalopathy agent; Camel pox virus; Ehrlichia ruminantium 
(Heartwater); Japanese encephalitis virus; Malignant catarrhal fever 
virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular 
stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
     The following agent would no longer be considered a VS/
Department of Health and Human Services (HHS) overlap select agent: 
Venezuelan Equine Encephalitis Virus (subtypes ID and IE).
    2. Tiering of the select agent and toxin lists:
    Tier 1 select agents and toxins:
     PPQ select agents and toxins: None.
     VS select agents and toxins: Foot-and-mouth disease virus 
and Rinderpest virus.
     VS/HHS overlap select agents and toxins: Bacillus 
anthracis, Burkholderia mallei, and Burkholderia pseudomallei.
    3. Establishing physical security standards for entities possessing 
Tier 1 select agents and toxins, including the requirement to conduct 
pre-access assessments and ongoing monitoring of personnel with access 
to Tier 1 agents and toxins;
    4. Miscellaneous revisions to the regulations to clarify regulatory 
language concerning security, training, biosafety, and incident 
response.
    Costs of the Rule: Entities affected by the rule include research 
and diagnostic facilities; Federal, State, and university laboratories; 
and private commercial and non-profit enterprises. The regulations 
require registering the

[[Page 61057]]

possession, use, and transfer of select agents or toxins. In addition, 
the entity is required to ensure that the facility where the agent or 
toxin is housed has adequate biosafety and containment measures, that 
the physical security of the premises is adequate, that all individuals 
with access to select agents or toxins have the appropriate education, 
training, and/or experience to handle such agents or toxins, and that 
complete records concerning activities related to the select agents or 
toxins are maintained.
    The rule will further reduce or minimize the risk of misuse of 
select 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 and HHS recognize that several of the required measures 
of the regulations may impose certain operational costs upon affected 
entities, particularly entities that have the newly designated Tier 1 
select agents and toxins. In many cases, however, the affected entities 
already employ some or all of the required measures. Compliance costs 
actually incurred will therefore vary from one entity to the next.
    While information on the specific changes that would need to occur 
at individual sites and the associated costs was not readily available 
during proposed rulemaking, some general observations regarding the 
potential costs were presented. These general cost observations can be 
found in Table 2 of the Regulatory Impact Analysis located at: 
www.regulations.gov and at http://www.selectagents.gov.
    Benefits of the Rule: The objectives of the final rule is to create 
a means of ensuring enhanced oversight in the transfer, storage, and 
use of select agents and toxins; define the security procedures and 
suitability assessments for pre-access suitability and continual 
monitoring of individuals with access to Tier 1 select agents and 
toxins; and require that entities in possession of such agents and 
toxins develop and implement effective means of biosafety, information 
security, and physical security. The overall benefit of the amended 
provisions will be a reduced likelihood of the accidental or 
intentional release of a select agent or toxin and the avoidance of 
costs associated with such a release. The goal of the amended 
regulations is to enhance the protection of human, animal, and plant 
health and safety.

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (referred to below as the Bioterrorism Response 
Act) provides for the regulation of certain biological agents that have 
the potential to pose a severe threat to both human and animal health, 
to animal health, to plant health, or to animal and plant products. The 
Animal and Plant Health Inspection Service (APHIS) has the primary 
responsibility for implementing the provisions of the Act within the 
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 human and animal health or 
animal products. Overlap select agents are subject to regulation by 
both APHIS and the Centers for Disease Control and Prevention (CDC), 
which has the primary responsibility for implementing the provisions of 
the Act for the Department of Health and Human Services (HHS).
    Subtitle B (which is cited as the ``Agricultural Bioterrorism 
Protection Act of 2002'' and referred to below as the Act), section 
212(a), provides, in part, that the Secretary of Agriculture (the 
Secretary) must establish by regulation a list of each biological agent 
and each toxin that the Secretary determines has the potential to pose 
a severe threat to animal or plant health, or to animal or plant 
products. Paragraph (a)(2) of section 212 requires the Secretary to 
review and republish the list every 2 years and to revise the list as 
necessary. In this document, we are amending and republishing the list 
of select agents and toxins based on the findings of our third 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 or disease 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 final 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 agents 
and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).
    On October 3, 2011, we published in the Federal Register (76 FR 
61228-61244, Docket No. APHIS-2009-0070) a proposal \3\ 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, reorganize the list of select agents and toxins based 
on the relative potential of each select agent or toxin to be misused 
to adversely affect human, plant, or animal health, and amend the 
regulations in order to add definitions and clarify language concerning 
security, training, biosafety, biocontainment, and incident response.
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    \3\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
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    We solicited comments concerning our proposal for 60 days ending 
December 2, 2011. We reopened and extended the deadline for comments 
until January 17, 2012, in a document published in the Federal Register 
on December 15, 2011 (76 FR 77914, Docket No. APHIS-2009-0070). We 
received 30 comments by that date. They were from researchers, 
scientific organizations, laboratories, and universities. They are 
discussed below by topic.

Guidance Documents

    In the proposed rule, we specifically requested comment from the 
regulated community and any other interested persons on the need for 
and desirability of guidance documents that would serve to assist 
regulated entities in meeting the requirements of regulations. We were 
particularly interested in public comment regarding Web sites, 
articles, or other sources useful in developing such guidance 
documents. We received a number of comments on the issue of guidance, 
which are discussed below.
    Two commenters suggested the use of specific documents in creating 
guidance: The Laboratory Biorisk Management Standard, which was

[[Page 61058]]

developed by the European Committee for Standardization, and the report 
``Guidance for Enhancing Personnel Reliability and Strengthening the 
Culture of Responsibility,'' which was developed by the National 
Science Advisory Board for Biosecurity.
    We agree with the commenters and have utilized both sources in 
developing guidance.
    One commenter stated that the select agent program should develop a 
standardized template that addresses each item required by the 
regulations, both for regulated entities and inspectors. The commenter 
went on to say that the templates should be posted on the select agent 
Web site.
    The National Select Agent Registry at www.selectagents.gov includes 
checklists, guidance documents, and templates that we have developed to 
aid entities in meeting the requirements of the regulations. The select 
agent program also conducts regular inspector training in order to 
standardize inspector understanding of the regulations and inspection 
process. We accept entity feedback regarding the inspection process and 
incorporate it into our training program as appropriate.
    Another commenter stated that the involvement of regulated entities 
in the development of guidance is crucial, as it will ensure that the 
new regulations may be implemented without unsustainable increases in 
cost to those entities.
    The guidance documents developed in conjunction with this rule are, 
in part, a response to the questions and issues raised by the 
commenters regarding various aspects of the proposed rule. We also 
consulted HHS and USDA subject matter experts and other sources 
including National Science Advisory Board for Biosecurity, the National 
Academies, the Department of Defense Security Engineering Facilities 
Planning Manual, and Director of Central Intelligence Directive Number 
6/9. Regarding the commenter's cost concerns, the guidance developed by 
the select agent program does not set out a prescriptive series of 
procedures that must be followed by all regulated entities; rather, it 
establishes examples of ways in which an entity may choose to meet the 
requirements of the regulations. We have purposefully left the 
regulations in their general state in order to allow for the wide 
variety of regulated entities to meet the regulatory standard in a way 
that is most cost-effective for each.

PPQ Select Agents and Toxins

    We proposed to amend the list of PPQ select agents and toxins 
listed in 7 CFR 331.3 by removing Xylella fastidiosa, citrus variegated 
chlorosis (CVC) strain, from the list as it no longer meets the 
criteria for use as an agroterrorism agent.
    One commenter stated that the scientific basis for the removal of 
Xylella fastidiosa from the list was unclear and requested 
clarification concerning our decision. The commenter additionally 
stated that if the review process for such removal were to be 
transparent, with expert opinion from the public and private sector, 
including a sound scientific analysis and an assessment of the 
biosecurity risk of each agent, other plant pathogens on the list of 
select agents and toxins could potentially be removed.
    We are making no changes as a result of this comment. Each agent on 
the select agent and toxin list was considered for retention or removal 
based on a variety of factors, including, but not limited to, the 
scientific concerns cited by the commenter. Further, the select agent 
program did employ subject-matter experts as part of the decision-
making process as recommended by the commenter in addition to 
soliciting public comment. Experts in the biology of these agents and 
toxins evaluated their ``potential for mass casualties or devastating 
effects to the economy, critical infrastructure, or public 
confidence.'' This evaluation included assessments of morbidity and 
mortality, communicability, low infectious dose, availability of 
countermeasures, and economic impact of a potential attack. Each agent 
and toxin was then assessed for its ``risk of deliberate misuse,'' 
including its history of weaponization and/or known interest by State 
or non-State adversaries. These evaluations, combined with input 
received as a result of the publication of an advance notice of 
proposed rulemaking and request for comments (ANPR) \4\ in the Federal 
Register on July 29, 2010, and relevant findings in recent government 
and non-government reports, formed the basis for deliberations 
concerning which agents should constitute the list. It is important to 
note that removal of pathogens from the list of select agents and 
toxins does not mean that they are not of potential concern, but rather 
that the risk they represent has been reevaluated using the above 
criteria. Reduction of the list is meant to decrease the burden on 
researchers and focus attention on agents and toxins judged to be of 
greatest biosecurity concern.
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    \4\ To view the ANPR and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
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    The list of PPQ select agents and toxins includes an entry for 
Xanthomonas oryzae. While we did not propose any changes to the entry 
for Xanthomonas oryzae, one commenter stated that it should be removed 
from the list of select agents and toxins and offered a number of 
arguments, which are discussed below.
    The commenter proposed the removal of Xanthomonas oryzae based on 
the assertion that Xanthomonas oryzae populations are adapted only to 
local conditions and do not persist upon introduction to new 
environments. Given that the major natural host for Xanthomonas oryzae 
is rice, the commenter also compared cultivation practices utilized in 
domestic commercial rice production with those utilized in Asian 
commercial rice production. The commenter argued that domestic 
commercial cultivation practices eliminate transmission of the pathogen 
since rice seeds are directly planted whereas in Asia rice seedlings 
are cultivated elsewhere and then transplanted, and wounds created 
during such handling and transplant are important modes of transmission 
for the pathogen to healthy seedlings. In addition, the commenter said 
that domestic weather patterns are not conducive to dissemination and 
that quarantines can prevent seed-borne disease. The commenter claimed 
that field-to-field spread of Xanthomonas oryzae in Asia is largely 
dependent on the strong winds and driving rains that occur frequently 
during typhoon season.
    We are making no changes to the regulations as a result of this 
comment. Natural spread or persistence of the pathogen in a particular 
location is not at issue; it is the risk of deliberate misuse leading 
to the most significant potential for mass casualties or devastating 
effects to the economy, critical infrastructure, or public confidence. 
The issue of standard commercial planting practices for rice in a 
domestic versus Asian setting is not relevant to the discussion of 
Xanthomonas oryzae's potential for use as a biological weapon. APHIS 
analyzed and assessed this pathogen using the criteria discussed 
earlier in this document. Based on that analysis and assessment and the 
knowledge that Xanthomonas oryzae has been modified for use as a 
biological weapon in the past, it has been retained on the list of PPQ 
select agents and toxins.
    The commenter also stated that Xanthomonas oryzae should be

[[Page 61059]]

removed from the list of select agents and toxins because it is endemic 
in the United States and any foreign strains introduced in the future 
would prove unlikely to establish and spread.
    While we disagree with the commenter's assertion regarding 
Xanthomonas oryzae's pathogenicity, these arguments are unrelated to 
the work of the select agent program as a whole as the select agent 
regulations do not allow for the environmental release of listed agents 
and toxins. Whether or not a given select agent or toxin is endemic in 
the United States is not the only determining factor in the select 
agent or toxin's inclusion on the list. The regulations govern use of 
listed select agents and toxins in laboratory settings only. In this 
regard, the case for maintaining Xanthomonas oryzae on the list of 
those select agents and toxins whose deliberate misuse represents the 
most significant potential for mass casualties or devastating effects 
to the economy, critical infrastructure, or public confidence, is 
compelling as work was done on Xanthomonas oryzae in the 1970s which 
led to its classification as a bioterrorism agent by the security 
community.
    The list of PPQ select agents and toxins includes an entry for 
Ralstonia solanacearum, race 3, biovar 2. While we did not propose any 
changes to the entry for Ralstonia solanacearum, race 3, biovar 2, five 
commenters stated that it should be removed from the list of select 
agents and toxins.
    The commenters argued that, based on the biological and historical 
climate data for North America, Ralstonia solanacearum, race 3, biovar 
2 does not have the potential to pose a severe threat to plant health 
or plant products in the context of U.S. agriculture. The commenters 
stated that Ralstonia solanacearum, race 3, biovar 2 is only a serious 
problem in the developing world in those areas of cool highland tropics 
where annual temperature profiles differ significantly from those found 
in the major potato growing regions in the United States (i.e., 
Colorado, Idaho, Maine, Minnesota, North Dakota, and Wisconsin). The 
commenters argued that, unlike the northern States, the cool highland 
tropics experience few hard freezes and no long winters. Since, the 
commenters claimed, epidemiological and laboratory research data show 
that Ralstonia solanacearum, race 3, biovar 2 is intolerant of freezing 
and freeze-thaw cycles and does not generally survive winters in 
regions with sustained low temperatures, the bacterium is unlikely to 
become established in the northern U.S. where potatoes are commercially 
grown.
    We disagree with the commenters' claim that Ralstonia solanacearum, 
race 3, biovar 2 is only a serious pathogen in the developing world as 
the bacterium has been shown to establish itself in northern Europe by 
over-wintering in weeds, thereby posing a severe threat to Solanaceae 
species (e.g., potato, eggplant, and tomato) in cool climates such as 
those found both in northern Europe and North America. In addition, as 
discussed earlier in this document, the evaluation process for select 
agents includes broad criteria that not only focus on the biological 
characteristics of a given pathogen, but also that pathogen's ability 
to produce a devastating effect on the economy and the threat that 
pathogen represents if it were to be used as a biological weapon. We 
are making no changes as a result of these comments.
    The commenters also stated that retaining Ralstonia solanacearum, 
race 3, biovar 2 on the list of select agents and toxins would further 
constrain research in the field of Ralstonia research. The commenters 
attributed such listing with registration time for use, transfer, or 
possession of select agents and toxins in excess of 18 months prior to 
the initiation of research and difficulty in meeting the registration 
requirements.
    We are making no changes in response to these comments. While there 
are added requirements concerning physical security, personnel 
authorization, recordkeeping, biocontainment, and site inspections, we 
do not believe these requirements will impede research as, in many 
cases these regulations serve to codify systems and procedures already 
in use by a majority of regulated entities. Further, entity 
registration for use, transfer, or possession of select agents and 
toxins does not take, nor has ever taken, 18 months. On average, new 
entity registration takes 6 months from the date the request is 
received by the select agent program and the issuance of the 
registration certificate. The security risk assessment (SRA) takes less 
than 45 days and runs parallel to the entity registration process. 
These timeframes are all based on the assumption that the entity 
registration submission and the SRA submission are complete and 
accurate for select agent program review prior to the required on-site 
inspection.
    Commenters additionally stated that Ralstonia solanacearum, race 3, 
biovar 2 should be removed from the list for the same reasons that were 
cited for the proposed removal of Xylella fastidiosa, CVC strain.
    We are making no changes as a result of these comments. The 
decision to remove the CVC strain from the list of select agents and 
toxins was based on the completion of extensive review and analysis of 
the criteria for inclusion on the list. In particular, the creation of 
detection methods and the use of geostatistical analysis with relation 
to monitoring in order to facilitate a response to any purposeful 
introduction are both key components in our decision to delist CVC. As 
discussed earlier in this document, the evaluation process for select 
agents includes a broad number of criteria that not only focus on the 
biological characteristics of a given pathogen but also that pathogen's 
ability to produce a devastating effect on the economy and the threat 
that pathogen represents if it were to be used as a biological weapon. 
Based on that analysis and assessment Ralstonia solanacearum, race 3, 
biovar 2 will remain on the list of select agents and toxins.
    Commenters said that eradicating Ralstonia solanacearum, race 3, 
biovar 2 introduced into the United States through infected geraniums 
cost commercial greenhouses and importers millions of dollars as a 
direct result of its presence on the list of select agents and toxins.
    We are making no changes as a result of these comments. The 
presence of Ralstonia solanacearum, race 3, biovar 2 on the list of 
select agents and toxins had no bearing on the eradication program 
instituted by APHIS. The cost of this eradication program to commercial 
greenhouses and importers was the same as the cost of eradicating any 
other quarantine plant pathogen not known to be present in the United 
States.

Identification of Strains

    The list of VS select agents and toxins includes an entry for 
virulent Newcastle disease virus. While we did not propose any changes 
to the entry for virulent Newcastle disease virus, one commenter stated 
that, by not considering all forms of Newcastle disease virus as select 
agents, APHIS has created a period of uncertainty prior to the 
completion of the sequencing necessary to identify whether a form of 
Newcastle disease virus is virulent or not. The commenter requested 
clarification as to whether laboratories would be required to treat 
uncharacterized Newcastle disease virus as a select agent given this 
uncertainty.
    We agree with the commenter's point. We have therefore revised the 
list of VS only select agents and toxins in order to list certain 
select agents and toxins not by specific strains but by the generic

[[Page 61060]]

taxonomic classifications for those select agents. The specific VS only 
select agents and toxins affected are: Avian influenza virus (highly 
pathogenic), mycoplasma capricolum subspecies capripneumoniae 
(contagious caprine pleuropneumonia), mycoplasma mycoides subspecies 
mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), and 
virulent Newcastle disease virus, which we have altered to read avian 
influenza virus, mycoplasma capricolum, mycoplasma mycoides, and 
Newcastle disease virus, respectively. In order to capture the 
applicable strains, subtypes, or pathogenicity levels we have also 
added exemptions for those strains, subtypes, or pathogenicity levels 
of certain select agents and toxins which are not considered to have 
the potential to pose a severe threat to animal health or animal 
products.
    The list of overlap select agents and toxins contains an entry for 
Venezuelan equine encephalitis. One commenter stated that, by not 
considering all subtypes of Venezuelan equine encephalitis as select 
agents, APHIS has created a period of uncertainty prior to the 
completion of the typing necessary to identify whether a form of 
Venezuelan equine encephalitis is among the subtypes classified by 
APHIS as select agents. The commenter requested clarification as to 
whether laboratories would be required to treat untyped Venezuelan 
equine encephalitis as a select agent given this uncertainty.
    We agree with the commenter's point. As stated previously, we have 
therefore revised the list of overlap select agents and toxins in order 
to list certain select agents and toxins not by specific strains but by 
the generic taxonomic classifications for those select agents. The 
specific overlap select agent is Venezuelan equine encephalitis virus: 
Epizootic Subtypes IAB, IC, which we have altered to read Venezuelan 
equine encephalitis virus. In order to capture the applicable strains, 
subtypes, or pathogenicity levels we have also added exemptions for 
those strains, subtypes, or pathogenicity levels of certain select 
agents and toxins which are not considered to have the potential to 
pose a severe threat to animal or human health or animal products. We 
do note that we have specifically included Bacillus anthracis (Pasteur 
strain) in the list of overlap select agents and toxins. This is 
necessary in order to distinguish this strain, which we do not consider 
to be a Tier 1 select agent, from all other strains of Bacillus 
anthracis, which are classified as Tier 1 select agents.
    Although we did not receive any comments on this issue as it 
concerns PPQ only select agents and toxins, in order to strengthen the 
regulations as discussed previously as well as to maintain parity 
between the VS and PPQ regulations, we are revising the list of PPQ 
only select agents and toxins in order to list certain select agents 
and toxins not by specific strains but by the generic taxonomic 
classifications for those select agents. The specific PPQ only select 
agents and toxins affected are: Ralstonia solanacearum, race 3, biovar 
2 and Sclerophthora rayssiae var. zeae which we have altered to read 
Ralstonia solanacearum and Sclerophthora rayssiae, respectively. In 
order to capture the applicable strains, subtypes, or pathogenicity 
levels we have also added exemptions for those strains, subtypes, or 
pathogenicity levels of certain select agents and toxins which are not 
considered to have the potential to pose a severe threat to plant 
health or plant products.
    With the changes described above, we clearly establish that when an 
agent or toxin is initially identified to a taxonomic level, in the 
case of an agent, or by its toxicological properties, in the case of a 
toxin, it is regulated under the select agent regulations until further 
testing is accomplished to exclude the particular agent by strain, 
subtype, pathogenicity levels, or a particular toxin by properties. We 
believe it is important that laboratories treat these agents as select 
agents until further testing can be conducted to verify whether the 
agent is of a strain, subtype, or pathogenicity level that presents a 
higher level of danger to animal health and safety. These changes will 
not have any impact on the exemption for diagnostic laboratories or 
alter the process of receiving diagnostic samples and forwarding any 
potentially identified select agents for further testing. They also do 
not change the reporting criteria for those agents confirmed to be 
select agents. Finally, they do not change the current lists of select 
agents and toxins but alters the fashion in which select agents and 
toxins are listed with specific exemptions included to ensure that 
appropriate verification of the agents by strains, subtypes, or 
pathogenicity level occurs.

VS Select Agents and Toxins

    We proposed to remove nine VS select agents and toxins from the 
list set out in Sec.  121.3(b). Specifically, we proposed to remove the 
following: Akabane virus; Bluetongue virus (exotic), Bovine spongiform 
encephalopathy agent; Camel pox virus; Ehrlichia ruminantium 
(Heartwater); Japanese encephalitis virus; Malignant catarrhal fever 
virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular 
stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
    One commenter recommended that we exclude the Texas GB strain of 
Newcastle disease virus from select agent status. The commenter stated 
that the exclusion is warranted since, although Newcastle disease virus 
is widespread in the environment, there is little illness if a flock is 
exposed because nearly all commercial poultry is vaccinated against the 
disease. The commenter observed that the Texas GB strain of Newcastle 
disease virus is used by vaccine manufacturers as the challenge 
organism to verify the potency of Newcastle disease virus vaccines and 
this fact gives poultry producers a high degree of assurance that their 
flocks are protected against the Texas GB strain. Given these factors, 
the commenter concluded that the Texas GB strain is not a biosecurity 
threat to the domestic poultry industry, and the strain should be 
excluded from APHIS's definition of virulent Newcastle disease virus.
    We are making no change in this final rule as a result of this 
comment. Texas GB strain of Newcastle disease virus is a highly 
virulent form of Newcastle disease virus and, as such, is appropriately 
included in the general category of ``virulent Newcastle disease 
virus.'' While vaccine manufacturers do use the Texas GB strain of 
Newcastle disease virus as a challenge organism for Newcastle disease 
virus vaccines, this is on account of its high level of virulence. A 
vaccine effective against the Texas GB strain of Newcastle disease 
virus can therefore be assumed to be effective against less virulent 
forms of Newcastle disease virus.
    The list of VS select agents and toxins includes an entry for avian 
influenza virus (highly pathogenic) (HPAI). While we did not propose 
any changes to the entry for HPAI, one commenter proposed that we 
change the guidance by which influenza strains are categorized as HPAI. 
The commenter argued that extensive evidence has been obtained to 
support the conclusion that, while the HA polybasic cleavage site is 
the primary determinant for HPAI strains, strains with removed HA 
polybasic cleavage sites have been created, tested, and ultimately 
excluded from select agent status. The commenter stated that, as a 
result of these experiments and history, APHIS should specify that 
avian influenza strains without the HA polybasic cleavage site are not 
HPAI viruses and, therefore, not subject to the select agent 
regulations.

[[Page 61061]]

    The commenter further argued that continuing to consider strains of 
avian influenza with removed HA polybasic cleavage sites as select 
agents until such time as an exclusion is granted would impede vaccine 
availability in the event of an HPAI pandemic in either the human or 
avian population. The commenter stated that the lead candidates for the 
seed viruses that would be used to make vaccines against HPAI viruses 
during such an event will likely be attenuated strains with mutated 
polybasic cleavage sites. The commenter stated that the current process 
by which avian influenza strains that lack the polybasic cleavage site 
are granted exclusions takes weeks or months, an untenable timeline in 
the event of an HPAI pandemic.
    We are making no changes in response to this comment. APHIS 
standards are based on existing internationally recognized requirements 
established by the World Animal Health Organization (OIE). In the event 
of a future HPAI pandemic such as the one described by the commenter, 
APHIS would work in conjunction with HHS to address any vaccine 
availability issues. Finally, attenuated strains of select agents 
officially approved for human vaccination purposes by the Food and Drug 
Administration (FDA) or other recognized national or international 
organizations continue to be exempt from the select agent regulations 
as specified by the regulations in Sec.  121.5(c) and (d).

Overlap Select Agents and Toxins

    We proposed to modify the list of overlap select agents and toxins 
by removing certain subtypes of Venezuelan equine encephalitis virus 
from the list of overlap select agents and toxins set out in 9 CFR 
121.4(b), and to clarify that only Venezuelan equine encephalitis 
subtypes IAB and IC would remain on the list. These subtypes contain 
the only recognized strains of Venezuelan equine encephalitis that can 
suddenly affect a large number of animals over a large area (i.e., 
epizootic). The remaining subtypes, ID and IE, are strains prevalent 
among existing animal populations (i.e., enzootic) and do not represent 
the same type of risk. Other viruses within the Venezuelan equine 
encephalitis complex (subtypes IF and II through IV) are separate 
viruses and are not included in the list of overlap select agents and 
toxins.
    Another commenter recommended that we remove Venezuelan equine 
encephalitis strain 3014 from the list of select agents and toxins. The 
commenter argued that, although strain 3014 was derived from a 1AB 
isolate, this molecularly cloned strain has properties that render it 
incapable of causing epizootic or epidemic transmission. The commenter 
stated that mutations selected after only a handful of passages make 
the virus avirulent in adult mice and dramatically increases its 
clearance from the bloodstream of mice following intravenous 
inoculation. Further, the vanishingly low titers of strain 3014 consist 
of envelope glycoprotein gene mutations, which allow the strain to bind 
heparin sulfate; such binding is also associated with the attenuated 
phenotype of Venezuelan equine encephalitis strain TC-83, which is also 
derived from the 1AB Trinidad donkey strain by passage in culture that 
has already been excluded from select agent status.
    We are making no changes as a result of this comment. Since 
Venezuelan equine encephalitis strain 3014 is derived from a listed 
overlap select agent, the commenter's proposal for its removal is more 
appropriately addressed via the exclusion process for overlap select 
agents and toxins as detailed in 9 CFR 121.6. We have contacted the 
commenter and provided guidance regarding how they may initiate this 
process.
    We proposed to designate Bacillus anthracis as a Tier 1 select 
agent. A number of commenters objected to such a blanket designation, 
arguing instead that the Bacillus anthracis Pasteur strain should be 
exempted from consideration both as a Tier 1 select agent and as a 
select agent in general.
    One commenter argued that given the fact that Laboratory Response 
Network (LRN) laboratories maintain live cultures of non-pathogenic 
Bacillus anthracis Pasteur strain for use in quality control testing, 
designation of Bacillus anthracis as a Tier 1 select agent therefore 
has the potential to impact the willingness or ability of LRN 
laboratories to maintain inventories of Bacillus anthracis Pasteur 
strain due to the regulatory and financial burdens associated with 
possession of Tier 1 select agents and toxins. The commenter went on to 
state that this situation could potentially impact national health and 
safety given that the potential use of Bacillus anthracis spores as a 
bioweapon remains a viable threat and increased burdens, particularly 
on small laboratories, could lead to the overall decrease in the number 
of laboratories that would otherwise serve to ensure that the LRN has 
sufficient capacity to detect and respond to a deliberate release of 
Bacillus anthracis.
    Three commenters stated that the Bacillus anthracis Pasteur strain 
is analogous to the Bacillus anthracis Sterne strain, which is excluded 
since it was determined not to pose a severe threat to public health 
and safety, animal health, or animal products. The commenter argued 
that Bacillus anthracis Pasteur strain should not be considered as a 
select agent given that the only way to create an agent that poses a 
severe threat would be via combination of the Pasteur strain with a 
non-regulated strain. The commenter pointed out that other agents that 
pose little harm individually, but could be modified genetically to 
become harmful are not included on the select agent list because of 
this potential threat.
    Another commenter claimed that the designation of Bacillus 
anthracis Pasteur strain as a select agent would not serve to prevent 
an authorized person from intentionally or accidentally facilitating 
the combination of plasmids from Sterne and Pasteur types of strains to 
create a wild type phenotype. The commenter stated that combination of 
these two strains can be accomplished no matter what sort of physical 
security may be employed to prevent access, theft, loss, or release of 
the agent. The commenter concluded that more effective preventive 
measures can be achieved through training and educating microbiologists 
on how to avoid accidentally combining these two strains and by 
penalizing any individuals who intentionally try to combine them.
    We agree with the commenters that Bacillus anthracis Pasteur strain 
is attenuated and poses a significantly lower risk than wild type 
Bacillus anthracis strains. We also agree that the Pasteur strain is 
not likely to have the potential for mass casualties or devastating 
effects to the economy, critical infrastructure, or public confidence 
and therefore does not meet the criteria used to apply the Tier 1 
designation. In addition, we note that the Pasteur strain has been used 
successfully as a veterinary and human vaccine, which further 
demonstrates the attenuation of this strain. Therefore we have 
determined that the Bacillus anthracis Pasteur strain should not be 
designated as a Tier 1 select agent.
    While we agree that the Bacillus anthracis Pasteur strain does not 
meet the criteria for inclusion as a Tier 1 select agent, we do not 
agree with the argument that regulating the Bacillus anthracis Pasteur 
strain would not serve to prevent the accidental (or intentional) 
generation of a wild type Bacillus anthracis strain by the combination 
of the Bacillus anthracis Pasteur strain with the Bacillus anthracis 
pXO1+/pXO2- Sterne strain. Retaining the

[[Page 61062]]

Bacillus anthracis Pasteur strain as a select agent will allow for 
continued oversight of laboratories in which the accidental (or 
intentional) combination of this strain with the Bacillus anthracis 
Sterne strain could occur to produce the wild type phenotype of 
Bacillus anthracis de novo. Failure to retain the Bacillus anthracis 
Pasteur strain as a select agent could result in an environment in 
which the probability of creation of virulent wild type Bacillus 
anthracis strains by the combination of non-regulated strains would be 
enhanced. Therefore, we have chosen not to exclude the Bacillus 
anthracis Pasteur strain from the list of select agents in this 
rulemaking. We will continue to evaluate exclusion requests as 
additional information becomes available in this area.
    As explained above under the heading ``VS Select Agents and 
Toxins,'' avian influenza virus (highly pathogenic) is currently on the 
list of VS only select agents and toxins. One commenter recommended 
that, in light of recent studies whereby researchers have generated 
derivatives of influenza virus A (H5N1) capable of efficient aerosol 
transmission, we add ``Replication competent forms of influenza virus A 
(H5N1) capable of efficient aerosol transmission in ferrets or primates 
containing any portion of the coding regions of all eight gene segments 
[influenza virus A (H5N1) capable of efficient aerosol transmission in 
ferrets or primates]'' to the list of overlap select agents and toxins. 
The commenter also recommended that this type of avian influenza virus 
be classified as a Tier 1 agent given the historical 50 percent case-
fatality rate of avian influenza virus A (H5N1) in humans.
    The select agent program is currently in discussions regarding this 
issue and may address it in future rulemaking. Given the stage these 
discussions are in, however, we are not making any changes in this 
final rule based on this comment.

Reorganization of the Current List of Select Agents and Toxins

    We proposed to establish a number of select agents and toxins as 
``Tier 1'' select agents and toxins within the lists of VS and overlap 
select agents and toxins. Specifically, we proposed to list foot-and-
mouth disease (FMD) virus and rinderpest virus as Tier 1 VS select 
agents and toxins and Bacillus anthracis, Burkholderia mallei, and 
Burkholderia pseudomallei as Tier 1 overlap select agents and toxins. 
We did not include PPQ select agents and toxins in this proposed 
reorganization because none of the PPQ select agents and toxins met the 
minimum criteria for inclusion on the proposed Tier 1 select agents and 
toxins list. All other select agents and toxins would continue to be 
subject to the current requirements concerning select agents and 
toxins.
    One commenter argued that Burkholderia mallei and Burkholderia 
pseudomallei should not be classified as Tier 1 select agents. The 
commenter stated that these two select agents do not represent the same 
level of concern as the other select agents proposed for inclusion in 
Tier 1 and should therefore be assigned non-Tier 1 status.
    Another commenter observed that Bacillus anthracis is less virulent 
than either Yersinia pestis or Francisella tularensis, which are on the 
list of HHS only select agents and toxins. The commenter additionally 
stated that the virulence of all three is far less than that of the 
hemorrhagic fever viruses and the encephalitis viruses that were not 
proposed for inclusion on the list of Tier 1 select agents and toxins. 
The commenter stated that significant advances have been made in the 
development of products for environmental decontamination and 
prophylaxis against inhalation of Bacillus anthracis.
    We are making no changes to the regulations as a result of these 
comments. The process by which we determined which select agents and 
toxins should be designated as Tier 1 was multi-faceted and we are 
confident in the results of that process. Our determinations were not 
based on one aspect of each of the proposed select agents or toxins 
only. In order to determine which select agents and toxins should be 
given Tier 1 status, a two-part risk analysis was conducted on each. 
First, experts in the biology of these agents and toxins evaluated 
their potential for mass casualties or devastating effects to the 
economy, critical infrastructure, or public confidence. This process 
included assessments of morbidity and mortality, communicability, low 
infectious dose, availability of countermeasures, and economic impact 
of a potential attack. Second, each select agent and toxin was assessed 
for its risk of deliberate misuse, including its history of 
weaponization and/or known interest by State or non-State adversaries. 
These evaluations, combined with input from public comments received on 
our July 2010 ANPR and relevant findings in recent government and non-
government reports, formed the basis for deliberations on which agents 
should constitute the Tier list. Agents that scored highly on both the 
public health and biothreat sets of criteria were judged to be those 
that were appropriately given a Tier 1 designation.
    Two commenters pointed out that the categorization of select agents 
and toxins has already been carefully stratified into four biological 
safety levels (BSL) as specified by the CDC, with each BSL based on 
infectivity, virulence, and ease of transmission of the material in 
question. The commenters further observed that the Tier 1 designation 
implies the existence of a Tier 2 category which would require less 
attention to security. The commenters concluded that the process of 
tiering will only add confusion and administrative and financial burden 
to the current BSL grouping of select agents and toxins.
    Two additional commenters stated that the proposed rule did not do 
enough to reduce the regulatory burden associated with non-Tier 1 
agents. The commenters said that reduced levels of security 
requirements for personnel and facilities should be considered for non-
Tier 1 agents.
    In designating certain select agents and toxins as ``Tier 1,'' the 
select agent program considered and rejected the idea of designating 
the remaining select agents and toxins as ``Tier 2.'' The aim of 
establishing the Tier 1 category is to account for and respond to the 
particular risks associated with the agents and toxins in this category 
by increasing their handling and security requirements accordingly. The 
establishment of the Tier 1 category is in no way intended to imply 
that the non-Tier 1 select agents and toxins pose a lesser risk to 
public health and safety than they have previously. In accordance with 
that fact, we have not decreased the handling and security requirements 
for those non-Tier 1 agents. Biosafety levels describe the required 
combination of lab practices and techniques, safety equipment, and lab 
facilities appropriate for the operations being performed using 
potentially harmful materials such as select agents and toxins while 
the Tier 1 designation institutes security measures applicable to the 
agents and toxins themselves. For this reason there is no conflict that 
exists between BSL classifications and Tier 1 select agents and toxins.
    Two commenters expressed concern regarding the proposal to list 
rinderpest virus as a Tier 1 agent, given that there are already 
special conditions in place as contained in Sec. Sec.  121.3(f)(3)(i), 
121.5(a)(3)(i), and 121.9(c)(1) concerning its handling and tracking. 
The commenters suggested that an alternative approach would be for 
APHIS to designate rinderpest virus as

[[Page 61063]]

a pathogen with very special handling requirements that is not 
considered to be part of either category of select agents. The 
commenters argued that this approach is justified due to the fact that 
rinderpest has now been officially eradicated worldwide.
    We disagree with the commenters' suggestion to classify rinderpest 
virus as a separate type of agent apart from either of the select agent 
categories of designation. While it is true that rinderpest was 
declared to be officially eradicated by the OIE on May 25, 2011, this 
development does not render the disease any less of a concern as a 
select agent with potential for misuse. Enacting the suggestion that 
rinderpest virus be treated as a pathogen with ``very special handling 
requirements'' and not as either a Tier 1 or non-Tier 1 select agent 
would only serve to create a further level of required administrative 
oversight for regulated entities.
    One commenter stated that the proposed tiering system poses 
significant questions as to the nature of the risk assessment process. 
Specifically, the commenter questioned listing as Tier 1 agents 
bacterial diseases that are treated with licensed antibiotics, that are 
not commonly spread person to person, and that are present in the 
environment of the United States, while viruses that have no known 
therapy and that pose extreme risk to Western populations are absent. 
The commenter further stated that the 20 criteria used for evaluation 
of each select agent and toxin should be made available to the 
regulated community for review and assessment.
    We are making no changes as a result of this comment. The relative 
ease by which exposure to a select agent or toxin may be treated is 
only one aspect considered by the select agent program when determining 
the tier status of each. The 20 criteria referenced by the commenter 
are those employed by the Federal Experts Security Advisory Panel 
(FESAP) in providing recommendations to the select agent program. The 
criteria that the FESAP used in its risk assessment process are:
    1. The relative ease with which a select agent or toxin might be 
acquired from a laboratory or commercial source;
    2. The relative ease of production of a select agent or toxin;
    3. The relative ease by which a select agent or toxin might be 
modified in order to enhance its pathogenicity, transmissibility, or 
ability to evade medical and non-medical countermeasures;
    4. The potential for easy deliberate dissemination;
    5. The potential for creating disease or illness;
    6. The relative environmental stability of a select agent or toxin 
by itself and how well it survives in the environment in which it is 
formulated or disseminated;
    7. The amount of select agent or toxin necessary to induce illness;
    8. The relative ease with which a particular select agent or toxin 
might be disseminated or transmitted from one animal or person to 
another or into the environment where it could produce a deleterious 
effect upon animal, plant, or human health;
    9. Whether the target population has innate immunity to the select 
agent or toxin or whether immunity has been acquired from a source such 
as vaccines;
    10. The potential for the select agent or toxin to create morbidity 
(i.e., any non-fatal illness that renders partial dysfunction to an 
animal or human lasting weeks or months that will eventually resolve 
with medical, veterinary, and/or supportive care);
    11. The burden placed on the human, veterinary, or plant health 
system by the deliberate release of the select agent or toxin;
    12. The ability to detect a release of the select agent or toxin 
into the environment, food, water, or soil;
    13. The ability of the human and agricultural health authorities to 
accurately and rapidly diagnose and treat the disease presented by a 
release of the select agent or toxin;
    14. The existence of countermeasures to prevent, treat, or mitigate 
the symptoms of a disease caused by the release of a select agent or 
toxin and/or its spread through a population;
    15. The potential for high animal, plant, or human mortality rates 
with delivery of medical countermeasures;
    16. The potential for high animal, plant, or human mortality rates 
without delivery of medical countermeasures;
    17. The short-term economic impact of a single outbreak of a 
disease or release of a toxin;
    18. The human, monetary, and other resource costs of making an 
area, building, industrial plant, farm, or field safe for humans, 
animals or plants to inhabit following the release of the select agent 
or toxin;
    19. The pathogen's ability to persist in the environment or to find 
a reservoir that makes its recurrence more likely; and
    20. The long-term health or economic consequences caused by a 
single release of the select agent or toxin.
    We believe that the process by which determinations were made 
regarding the Tier 1 or non-Tier 1 status of the select agents and 
toxins was responsive to regulated community concerns received during 
the comment period for the advance notice of proposed rulemaking as 
well as for the proposed rule.
    One commenter asked why the requirements for working with plant 
pathogens had not been lessened. The commenter stated that a 
transparent process does not exist that is inclusive of expert opinion 
from both the private and public sectors to determine which agents 
should be removed or added to the list of select agents and toxins.
    We are making no changes as a result of this comment. In creating 
the Tier 1 class of agents, the Select Agent Program considered and 
rejected the idea of designating the remaining agents as ``Tier 2.'' 
The aim of establishing the Tier 1 category is to account for and 
respond to the particular risks associated with the agents and toxins 
in this category by increasing their handling and security requirements 
accordingly. The establishment of the Tier 1 category is in no way 
intended to imply that the non-Tier 1 agents pose a lesser risk to 
public health and safety than they have previously. In accordance with 
that fact, we have not decreased the handling and security requirements 
for those non-Tier 1 agents. Further, we determined that the 
establishment of more varying levels of risk would serve to create the 
need for increased administrative oversight and complication for 
regulated entities. We believe that the process by which these 
determinations were made was sensitive to public and expert opinion via 
the comment period on the initial advance notice of proposed rulemaking 
as well as on the proposed rule.
Security Measures for Tier 1 Select Agents or Toxins
    We also proposed additions to the VS regulations that would allow 
for the optimization of security measures for those select agents or 
toxins that are designated as Tier 1. These requirements included:
     Additions regarding the assessment of persons prior to 
their access to Tier 1 select agents and toxins that would be made to 
the security plan currently required to be developed by all entities 
seeking approval for the possession, use, and transfer of select agents 
and toxins; ongoing oversight of those persons with access to Tier 1 
select agents and toxins; and the role of the entity's responsible 
official in coordinating and assuring the security of Tier 1 select 
agents and toxins;
     Security enhancements that include provisions for security 
barriers, intrusion detection and monitoring,

[[Page 61064]]

delay/response force, access control, and information security;
     Additions to the biosafety plan currently required to be 
developed by all entities seeking approval for the possession, use, and 
transfer of select agents and toxins that would describe implementation 
of an occupational health program for individuals with access to Tier 1 
select agents and toxins;
     Development of security policies and procedures describing 
the entity's response to a failure of an intrusion detection or alarm 
system and notification procedures for the Federal Bureau of 
Investigation (FBI) in the event of theft or suspicious activity that 
may be criminal in nature involving a Tier 1 select agent or toxin. 
These policies and procedures would be required as part of the entity's 
incident response plan; and
     Required annual insider threat awareness briefings focused 
on how to identify and report suspicious behaviors.
    We have made changes to some of these proposed requirements, which 
are discussed in detail below.
    Many commenters had questions or concerns regarding the additions 
to the security plan for those entities possessing a Tier 1 select 
agent or toxin as proposed in 9 CFR 121.11(e). Specific issues 
addressed by the commenters included: Conduct of pre-access suitability 
assessments, ongoing suitability assessments, and self- and peer-
reporting of incidents or conditions that could affect an individual's 
ability to safely have access to or work with select agents and toxins. 
Commenters generally fell into two categories in their responses to the 
proposed additions: Some felt that the requirements were too vague to 
prove useful, creating administrative burden without improving the 
overall security of Tier 1 select agents and toxins, while others felt 
that the requirements could or would require entities to behave in a 
manner contrary to local laws, privacy laws, or union contracts.
    For the most part, we anticipate that these requirements are 
already being met and that these regulations will merely require those 
entities possessing a Tier 1 select agent or toxin to codify and 
document the systems and processes currently in place. It should be 
noted that many of the specific concerns raised by commenters regarding 
potential violation of laws or union contracts arose as a result of the 
commenters' examination of those recommendations given to the select 
agent program by the FESAP. As a matter of clarification, the select 
agent program considered the FESAP recommendations, as well as 
recommendations from other sources (e.g., National Science Advisory 
Board for Biosecurity), in developing the proposed rule and suitability 
assessment guidance documents; however, we are not adopting all of the 
specific recommendations found in these studies. While we have created 
specific guidance to aid in compliance with this section of the revised 
regulations, we are deliberately leaving the regulatory text in its 
broadly-written state in order to allow entities a measure of 
flexibility in how they meet the requirements. Given our experience 
with the select agent and toxin regulations and the wide variety of 
regulated entities the regulations cover, we have found this to be the 
most effective approach. The guidance document developed in conjunction 
with this rule is, in part, a response to the questions and issues 
raised by the commenters. Issues addressed in this document include, 
but are not limited to:
     Understanding the risks and reasons for suitability 
assessments;
     Delineating the roles and responsibilities of individuals 
to ensure optimal security;
     Requesting information about individuals in a standardized 
manner and assessing individuals in the context of safety and security;
     Responding to reports in a consistent, prompt, and 
confidential manner; and
     Providing training for recognizing and reporting 
suspicious behavior.

Full guidance on this and other issues may be found on the National 
Select Agent Registry at www.selectagents.gov.
    In 9 CFR 121.11(e)(4)(i), we proposed that regulated entities with 
Tier 1 select agents and toxins prescribe and/or implement ``procedures 
that limit access to registered space only to those approved by the HHS 
Secretary or the Administrator and meet the criteria of the entity's 
program that will ensure individuals with access approval to select 
agents and toxins are trustworthy and behaving in a manner that upholds 
public health and safety, the protection of animal or plant health and 
animal or plant products, security, and the integrity of the scientific 
enterprise.'' We are making a minor change to the proposed language in 
9 CFR 121.11(e)(4) in order to stipulate that entities must implement 
these security enhancements, not merely prescribe and/or implement 
them. The proposed rule stated that ``Entities with Tier 1 select 
agents and toxins must prescribe and/or implement the following 
security enhancements.'' We are removing the words ``prescribe and/or'' 
for the purposes of clarity. Our original intent in creating that 
provision was to require the use of the security enhancements in 
question by those entities with Tier 1 select agents or toxins. By 
removing the words ``prescribe and/or'' we are eliminating a potential 
loophole by which entities may have been able to establish but not 
fulfill these requirements while remaining in compliance with the 
regulations.
    Regarding the proposed language in 9 CFR 121.11(e)(4)(i), one 
commenter stated that the use of the phrase ``trustworthy and behaving 
in a manner that upholds public health and safety, the protection of 
animal or plant health and animal or plant products, security, and the 
integrity of the scientific enterprise'' would establish a regulatory 
standard that would prove difficult or impossible to enforce due to its 
subjective nature.
    We agree with the commenter's observation and have changed the 
language to require that entities possessing Tier 1 select agents or 
toxins prescribe and implement ``procedures that will limit access to a 
Tier 1 select agent or toxin to only those individuals who are approved 
by the HHS Secretary or Administrator, following a security risk 
assessment by the Attorney General, have had an entity-conducted pre-
access suitability assessment, and are subject to the entity's 
procedures for ongoing suitability assessment.'' We believe that this 
establishes a more specific set of requirements for regulated entities.
    In 9 CFR 121.11(e)(4)(iv) we proposed that regulated entities with 
Tier 1 select agents and toxins establish a minimum of three barriers 
where each subsequent barrier is different and adds to the delay in 
reaching secured areas where select agents and toxins are used or 
stored. Barriers would be required to be monitored in such a way as to 
detect and assess intentional and unintentional circumventing of 
established access control measures under all conditions (day/night, 
severe weather, etc.) Two commenters requested clarification regarding 
what was meant by the term ``barrier'' and asked for examples of what 
constitutes a barrier. The commenters suggested that a definition for 
``barrier'' be added to the definitions sections in 7 CFR 331.1 and 9 
CFR 121.1.
    We agree with the commenters and we have added a definition for 
security barrier to read as follows: ``A physical structure that is 
designed to prevent entry by unauthorized persons, animals, or 
materials.'' In addition, we have altered the language concerning 
security

[[Page 61065]]

barriers in 9 CFR 121.11(f)(4)(iv) in order to clearly indicate that 
the final security barrier must limit access to the select agent or 
toxin to personnel approved by the HHS Secretary or Administrator and 
following a security risk assessment by the Attorney General.
    In 9 CFR 121.11(e)(4)(v), we proposed that all registered space and 
areas that reasonably afford access to the registered space must be 
protected by an intrusion detection system (IDS) unless physically 
occupied. One commenter stated that the proposed requirement contained 
a potential loophole by which an entity could argue that the presence 
of a janitor or similar personnel in registered space outside of normal 
working hours would allow that entity to avoid installation of an IDS. 
The commenter suggested that such a situation could be avoided by 
adding a stipulation that an IDS would need to be used when the entity 
was not ``physically occupied by the routine contingent of working, 
approved employees.''
    We disagree with the commenter's observation as it is unlikely that 
the entity would be occupied at all hours, thus creating the loophole 
that would allow an entity to fail to install an IDS. We are also not 
adopting the commenter's suggestion to add language regarding the 
presence of approved employees as we believe that would create 
confusion concerning the number of employees that could be described as 
``the routine contingent.'' Further, the IDS is one aspect of the 
security measures required for regulated entities. In the scenario 
proposed by the commenter, the IDS would not be engaged if a janitor or 
other personnel were present in the entity outside of normal working 
hours; however, the other required physical security measures would 
serve to protect the entity at that time. Finally, the training and 
employee suitability assessments required for those employees with 
access to select agents and toxins would also serve to ensure that 
those employees who work in registered areas understand and can employ 
the necessary security and safeguarding measures to maintain the 
physical security of the entity.
    In 9 CFR 121.11(e)(4)(vii), we proposed to require that entities 
provide backup power and energy sources to ensure that information 
security networks and integrated access controls and related systems 
will maintain power during emergencies. While we did not receive any 
comments on this issue, in response to comments received by CDC and in 
the interests of maintaining parity between the APHIS and HHS 
regulations, we are amending the text to stipulate that only those 
entities with powered access control systems will need to fulfill this 
requirement. We have also reworded the requirement to clarify that the 
aim is maintenance of physical security standards in the case of a 
power disruption and that this maintenance may, among the alternatives, 
take the form of backup power.
    In 9 CFR 121.11(e)(4)(viii) we proposed that response time for 
security forces or local police must not exceed 15 minutes from the 
time of an intrusion alarm or report of a security incident for any 
entity with Tier 1 select agents and toxins. One commenter stated that 
such a requirement would be burdensome, unattainable, and cost-
prohibitive depending upon the number and nature of the alarms. The 
commenter went on to state that the security system at their entity 
sounds an alarm when a door is held open longer than a preset length of 
time and that most alarms occur during working hours, primarily as the 
result of staff holding the door open too long. The commenter explained 
that requiring security respond to all these alarms is unwarranted, 
excessive, and costly. The commenter suggested that a better 
alternative would be for a laboratory supervisor or manager to be 
notified of and investigate these incidents, therefore allowing 
entities to respond in a manner commensurate with the severity of the 
incident that triggered the alarm.
    Our selection of the 15 minute response time is based on Department 
of Defense (DOD) and DHS standards for high value assets and also on 
our analysis of incident response plans provided by the regulated 
community since 2003. However, based on this comment and others 
received by CDC, we have modified the language in this section. We have 
retained the 15 minute response time goal for security forces or local 
police, but we have also provided additional flexibility for entities 
to develop systems in line with the optimal achievable response time in 
their area. Entities may either incorporate the 15 minute response time 
into their security plans or determine an alternate response time 
calculated in conjunction with security forces or local police. 
Response time can be determined many ways. For example, an entity can:
     Enter into a formal agreement with local law enforcement.
     Discuss with local law enforcement.
     Discuss with the IDS service provider.
     Conduct an exercise with the guard force.

The issue of multiple false alarms and the potential costs associated 
with such a situation as raised by the commenter is more appropriately 
addressed at the entity level.
    In 9 CFR 121.11(e)(4)(ix) we proposed to require that entities 
conduct complete inventory audits of all Tier 1 select agents and 
toxins in long-term storage upon the physical relocation of a 
collection or inventory of select agents or toxins for those Tier 1 
select agents or toxins in the collection or inventory, upon the 
departure or arrival of a principal investigator for those Tier 1 
select agents or toxins under the control of that principal 
investigator, or in the event of a theft or loss of a Tier 1 select 
agent or toxin.
    We have reevaluated this provision in light of comments received on 
the CDC rule and, based on our experience with the select agent 
program, we believe that this requirement needs to be applied to all 
select agents and toxins, and not only Tier 1 select agents and toxins. 
This change serves to codify our current policy concerning inventory 
audits. We have therefore revised the language to address inventory 
verification for all select agents and toxins.
    In the case of those entities which possess FMD and rinderpest 
virus, we proposed to require four barriers, including one barrier that 
is a perimeter security fence or equivalent. These requirements were 
listed in proposed 9 CFR 121.11(e)(5)(i). One commenter inquired as to 
what the equivalent to a perimeter security fence would be. The 
commenter also wished to know if an IDS would be considered a barrier.
    One equivalent to a perimeter security fence would be a perimeter 
wall surrounding a specific building, complex, compound, or campus, 
with 24 hour a day, 7 days a week monitoring. Such a wall would serve a 
purpose identical to a perimeter security fence. We have developed 
guidance to assist entities with the security barrier requirement, 
which covers the issue of perimeter fencing. Guidance documents may be 
found on National Select Agent Registry at www.selectagents.gov. As to 
the commenter's question regarding the IDS: As stated above, a security 
barrier would include only natural or man-made obstacles preventing or 
delaying the movement of persons, animals, or materials. While an IDS 
may alert security or other personnel to potential incidents, the IDS 
itself would not be considered to be a security barrier since it does 
not actively create an obstacle or delay.
    Another commenter asked whether the proposed requirements would 
make it illegal for U.S. veterinary diagnostic

[[Page 61066]]

laboratories to perform diagnostic and/or surveillance testing 
following an FMD outbreak on U.S. soil if the laboratories in question 
did not have a fourth security barrier. The commenter recommended that 
we revise the paragraph in order to clarify our intent.
    We are making no changes as a result of this comment. The select 
agent program recognizes the critical role of diagnostic laboratories 
in the early detection of and response to outbreaks of select agent and 
toxin-related disease in humans and agriculture. While all of the Tier 
1 regulatory requirements will apply to entities that maintain 
permanent stocks of Tier 1 select agents and toxins, in the case of a 
public health or agricultural emergency, a diagnostic laboratory may 
request to retain the select agent or toxin under the provisions 
contained in 9 CFR 121.6(e).
    Two commenters recommended that the select agent program consult 
with administrators and laboratory managers from public and private 
research institutions prior to the development of any framework of 
suitability that can be used to address security concerns.
    We will engage subject matter experts as necessary in the 
development of guidance documents which may be found on the National 
Select Agent Registry at www.selectagents.gov. The select agent program 
welcomes feedback on the usability and usefulness of existing guidance 
documents at any time.
    One commenter suggested that the minimum security provisions for 
Tier 1 select agents and toxins should include video monitoring of all 
select agents and toxins work and storage areas, a two-person rule for 
entry into select agents and toxins work and storage areas, and 
psychological assessment and monitoring of those employees working with 
select agents and toxins.
    We are making no changes as a result of this comment. The specific 
measures the commenter suggested were considered and rejected in favor 
of the more general requirements listed. The select agent program is 
highly conscious of the need to balance biosecurity and biocontainment 
concerns with allowing entities the necessary flexibility so as to not 
impede their research unduly. Since there is variety in the type and 
size of entities covered under the regulations, we believe this 
approach is warranted. We would note that the regulations do not 
preclude any given entity from adopting the approach suggested by the 
commenter, among others.
    One commenter stated that, while many of the proposed security 
changes are already in place, some are not and it was unclear that 
additional costly or impractical security measures would provide any 
additional benefit since existing measures have proven adequate to 
protect the security of these agents.
    We are making no changes as a result of this comment. It was our 
determination, based on the information available to us, that the 
additional security requirements would not constitute an economic 
burden on the regulated entities. In many cases these regulations serve 
to codify systems and procedures already in use in these regulated 
entities.
    The regulations in 9 CFR 121.12 concern the development of a 
biosafety plan that establishes measures sufficient to contain the 
select agent or toxin (e.g., physical structure and features of the 
entity, and operational and procedural safeguards). We proposed to add 
a paragraph that would stipulate that entities registered to possess 
Tier 1 select agents or toxins establish an occupational health program 
for individuals with access to Tier 1 select agents and toxins. One 
commenter recommended that the occupational health program requirements 
be instituted for all select agents and toxins, regardless of their 
categorization.
    We are making no changes in response to this comment. Due to the 
greater level of concern associated with Tier 1 select agents and 
toxins the select agent program needs to ensure that entity safety 
protocols are in place. Further, after considering the issue and in 
light of the fact that it caused confusion amongst some commenters on 
the CDC proposed rule, we are eliminating the sentence that reads, 
``The occupational health program may also be made available to 
individuals without access to Tier 1 select agents and toxins.'' While 
we believe that regulated entities should use their discretion and 
judgment in considering whether the creation of an occupational health 
program applicable to those employees working with non-Tier 1 select 
agents and toxins is needed, such a suggestion is not appropriately 
contained in the regulations. Guidance on the development of an 
occupational health program may be found on the National Select Agent 
Registry at www.selectagents.gov.
    The regulations in 9 CFR 121.15 concern required mandatory training 
for staff and visitors who work in or visit areas where select agents 
or toxins are handled or stored. In 9 CFR 121.15(b), we proposed to add 
a requirement that entities with Tier 1 select agents and toxins must 
conduct annual insider threat awareness briefings on how to identify 
and report suspicious behaviors. One commenter stated that this 
training should be required for all registered entities possessing, 
storing, or transferring select agents, not just those with Tier 1 
select agents or toxins.
    We are making no changes in response to this comment. Due to the 
greater level of concern associated with Tier 1 select agents and 
toxins the select agent program needs to ensure that entity safety 
protocols are in place. Regulated entities should use their discretion 
and judgment in considering whether the creation of an annual insider 
threat awareness training program applicable to those employees working 
with non-Tier 1 select agents and toxins is needed. Guidance on the 
development of annual insider threat awareness training may be found on 
the National Select Agent Registry at www.selectagents.gov.
    Another commenter asked for clarification and guidance regarding 
the requirement for annual insider threat awareness briefings. The 
commenter asked that the content of these threat awareness briefings be 
made available to public health laboratories so that it could then be 
specifically customized for various regions of the country.
    While we have created specific guidance regarding this section of 
the revised regulations, that guidance does not take the form of a 
prescriptive program with content that may then be adapted and 
distributed as the commenter requests. Given our experience with the 
select agent and toxin regulations and the wide variety of regulated 
entities those regulations cover, we have found a broader approach to 
be most effective. The guidance documents developed in conjunction with 
this rule are, in part, a response to the questions and issues raised 
by the commenters. The documents will contain specific examples of best 
practices that we believe entities would be well served in adopting 
including, but not limited to, a designated person to manage the 
assessment of laboratory personnel, laboratorian involvement in threat 
migration, and those behaviors of concern which may indicate a possible 
insider threat. Full guidance on this and other issues may be found on 
the National Select Agent Registry at www.selectagents.gov.

Miscellaneous Changes

    We proposed to make several smaller-scale changes to the 
regulations, including the addition of definitions and clarification of 
language concerning security, training, biosafety, biocontainment, and 
incident response. These changes are intended to increase the usability 
of the select agent

[[Page 61067]]

regulations as well as provide for enhanced program oversight.
    In 7 CFR 331.1 and 9 CFR 121.1, we proposed to add definitions for 
adjudicated as a mental defective, alien, committed to any mental 
institution, controlled substance, crime punishable by imprisonment for 
a term exceeding 1 year, indictment, lawfully admitted for permanent 
residence, mental institution, and unlawful user of any controlled 
substance. These definitions, which described specific aspects of the 
proposed definition of restricted person, were intended to assist 
regulated entities as well as those seeking approval to access select 
agents and toxins to better understand what status or activities, past 
or present, might prohibit such access.
    Four commenters stated that these definitions needed to be further 
clarified. The commenters generally characterized the proposed 
definitions as either overly restrictive or vague. After careful 
consideration we have agreed with the commenters and have decided not 
to include these definitions or a definition for restricted person in 
the final rule. We will look to develop additional guidance in this 
area.
    We proposed to add a definition for recombinant and synthetic 
nucleic acids. This addition was deemed necessary, as the term 
``synthetic nucleic acids'' is employed in the proposed changes to the 
select agent regulations. We proposed to include synthetic nucleic 
acids in the regulations because, while synthetic nucleic acids have 
the same potential for harm as recombinant nucleic acids, the process 
of production is different.
    One commenter stated that the proposed definition has implications 
in all areas currently impacted by synthetic biology technology, such 
as industrial enzymes, renewable chemicals for pharmaceutical and 
industrial applications, bio-based products, personal care products, 
renewable specialty chemicals, biofuels, and healthcare products. The 
commenter argued that consequences of adopting the proposed definition 
could impede the growth of sustainable products from emerging fields 
such as synthetic biology technology. The commenter therefore 
recommended that we not adopt the new definition of recombinant and 
synthetic nucleic acids as stated in the proposed rule, arguing that 
the existing language of the regulation is sufficient to cover the 
current uses of synthetic nucleic acids. The commenter further stated 
that the proposed definition utilizes language that was proposed to, 
but rejected by, the National Institutes of Health Recombinant DNA 
Advisory Committee (NIH-RAC). The commenter suggested that if the 
select agent program finds it necessary to introduce a new definition 
for recombinant and synthetic nucleic acids, that we follow the 
leadership of the NIH-RAC and establish a simpler definition that is 
not focused on the underlying mechanism of production of the nucleic 
acids.
    We disagree with the commenter's assertion regarding the broad 
impact of the definitions used by the select agent program. Our scope 
of oversight is limited to the list of select agents and toxins and 
therefore does not extend to all synthetic biology. However, we do 
agree that any definition adopted for use in the regulations should be 
based on the most current information available from subject matter 
experts. Following extensive consultation with the NIH, we have updated 
the definition of recombinant and synthetic nucleic acids to reflect 
the most current thinking on the subject. In addition, we have 
separated the definition of recombinant nucleic acids from the 
definition of synthetic nucleic acids for purposes of clarity.
    We proposed to add a definition for occupational exposure to the VS 
regulations in 9 CFR 121.1 as it is used in the regulations but not 
defined. This definition was based on that used in the Occupational 
Safety and Health Administration regulations in 29 CFR 1910.1030. We 
did not propose to add a corresponding definition to the PPQ 
regulations in 7 CFR 331.1 since PPQ select agents and toxins do not 
pose a severe threat to human health and, therefore, it is unnecessary 
to address personnel safety and health. One commenter suggested that we 
expand the definition to specify that, due to aerosol transmission, 
such exposure incidents may impact other employees working in the same 
area.
    We agree with the commenter that the proposed definition did not 
adequately address the possibility of aerosol transmission and have 
amended the language accordingly.
    Additionally, we are also removing references to rickettsiae in the 
definitions for biological agent and toxin. This change is necessary 
because there are no rickettsiae select agents or toxins regulated by 
APHIS on the list of select agents and toxins.
    We proposed to amend 7 CFR 331.3(e), 9 CFR 121.3(e) and 9 CFR 
121.4(e). These paragraphs specify that attenuated strains of select 
agents or toxins may be excluded from the requirements of the select 
agent regulations subject to an official request and supporting 
scientific information. We proposed to state that the ``inactive form 
of a select toxin'' may be excluded from regulation under each 
respective part subject to the application procedure. We also proposed 
to update the Web site address in paragraph (e)(1) of each section as 
all information concerning the Select Agent Program is now centralized 
on the National Select Agent Registry at http://www.selectagents.gov/. 
Finally, we proposed to remove the language stating that exclusions 
will be published in the Federal Register. At the time the regulations 
were initially created we anticipated publication of exclusions both in 
the Federal Register and on the Internet; however, we have found that 
publication on the National Select Agent Registry Web site only has 
served to provide the most up-to-date information to the regulated 
community.
    One commenter suggested that, in addition to publication of 
exclusions on the National Select Agent Registry Web site we should 
also develop and maintain an email distribution list so that registered 
facilities could be notified when updates are added to the Web site.
    We currently engage in the type of email updates that the commenter 
suggests. Emails are sent to responsible officials and alternate 
responsible officials at all registered entities. Dissemination of that 
information is at the discretion of the responsible officials and 
alternate responsible officials. We plan on issuing guidance and 
suggestions regarding information dissemination, which we believe will 
enable further information sharing within regulated entities.
    Another commenter asked that we add a timeline to the regulations 
indicating when the person requesting the exclusion should expect to 
receive a written response. The commenter stated that, in the case of 
grant applications, it may be difficult to meet deadlines if the 
applicant has no idea how long a response from the select agent program 
will take.
    We are making no changes as a result of this comment. Due to the 
wide variety of material submitted for consideration for exclusions, 
establishment of a timeline as the commenter recommends is impractical. 
The select agent program necessarily examines each application on a 
case-by-case basis. We strive to make the process as efficient as 
possible.
    The regulations in 9 CFR 121.6 set out guidelines for those 
instances where overlap select agents and toxins may be considered 
exempt from the regulations. Specifically, Sec.  121.6(e) concerns

[[Page 61068]]

procedures by which an individual or entity may be exempted from the 
requirements of the regulations if necessary in order to respond to a 
domestic or foreign agricultural emergency involving an overlap select 
agent or toxin. Upon further consideration, in order to eliminate an 
unnecessary burden on such an individual or entity, we have removed the 
provision stating that the individual or entity must complete APHIS/CDC 
Form 5 in order to request such an exemption. Guidance on requesting an 
exemption for an individual or entity in the case of a domestic or 
foreign agricultural emergency involving an overlap select agent or 
toxin may be found on the National Select Agent Registry at 
www.selectagents.gov.
    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. We proposed to explicitly 
require that all designated responsible officials possess the 
appropriate training or expertise to execute their required duties. We 
also proposed to clarify the role of alternate responsible official in 
order to definitively establish that the alternate responsible official 
must have the knowledge and authority to act for the responsible 
official in his/her absence. Finally, we proposed to add a requirement 
that the responsible official's principal duty station be the physical 
location of the registered entity.
    One commenter stated that the language concerning responsible 
officials is not clear and may cause institutions to unnecessarily 
create new administrative structures and positions to meet this 
requirement. The commenter urged the select agent program to work with 
research institutions in order to identify the most appropriate level 
of administration for the responsible official.
    We are making no change in response to this comment. The 
responsible official should be an individual who can perform all of the 
duties required for that position. The regulations were designed to 
place the responsibility for ensuring entity compliance with the 
regulations in one position. Given the wide variety of entities covered 
by the regulations, establishing more prescriptive guidelines would 
decrease the flexibility and usefulness of the regulations to those 
entities. We neither require nor prohibit the establishment of a 
separate administrative position for the responsible official as we 
leave it to the entity to decide how best to designate a responsible 
official who meets the requirements of the regulations.
    Another commenter said that the absence of specific requirements 
regarding responsible official qualifications will establish an 
inspection process that is subjective and ineffectual. The commenter 
asked that we add a section that explains and/or defines what we 
consider the ``appropriate training or expertise'' necessary for an 
entity's responsible official.
    We have established the regulations regarding the training and 
expertise of the responsible official in order that they provide 
maximum flexibility to regulated entities. The reasons for this are 
twofold: First, given the quickly developing and changing fields of 
biosafety and biosecurity, any attempt on our part to strictly define 
required training and expertise within the regulations would likely 
become obsolete as the parameters continue to evolve; second, given the 
wide variety of entities covered by the regulations, there is a need to 
maintain flexibility so that they may remain applicable to all of those 
entities. We have removed the reference to ``appropriate training or 
expertise'' and will continue to assess the performance of the 
responsible official based on his or her efficacy in implementing the 
regulatory requirements at his or her entity. With an eye to the non-
specificity of the regulations, we have developed guidance documents 
regarding this and other aspects of entity compliance. They are 
available on the National Select Agent Registry at 
www.selectagents.gov.
    Five commenters requested further clarification regarding the 
proposed requirement that the responsible official's principal duty 
station be the physical location of the registered entity. The 
commenters inquired whether this requirement would mean that the 
principal duty station should be in the same building or only at the 
same institution.
    In response to these comments and others received by the CDC, we 
are modifying the language in 7 CFR 331.9 and 9 CFR 121.9 to stipulate 
that the responsible official must have a physical (as opposed to a 
telephonic or audio-visual link) presence at the registered entity to 
ensure that the entity is in compliance with the regulations. The 
responsible official will also be more quickly able to respond to any 
on-site incidents involving select agents and toxins if he or she is 
on-site.
    Three commenters asked that the definition of ``entity'' be 
clarified in relation to the requirement that the responsible 
official's principal duty station be the physical location of the 
registered entity and the impact of the requirement assessed. The 
commenters' request was based on their understanding that an entity has 
to be contiguous and that laboratories separated on a campus constitute 
separate entities. The commenters concluded that having separate 
responsible officials in this case would be burdensome.
    We realize that many entities are located on a campus with several 
registered laboratories in different buildings. The intent of this 
requirement is not to ensure that a responsible official is assigned to 
each physical laboratory but to ensure that the responsible official is 
physically located on the campus.
    We proposed 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. Specifically, we 
proposed to add new provisions by which individuals may have access to 
select agents at entities other than the individual's ``home'' entity. 
We also proposed to decrease the maximum length of time for which a 
security risk assessment will be valid from 5 years to 3 years in order 
to more expeditiously identify individuals who may have fallen into one 
of the prohibited or restricted categories.
    One commenter asked whether, during the time period in which an 
individual has access to select agents at entities other than the 
individual's ``home'' entity, that individual would have access to 
select agents at both facilities, or if the access approval would be 
transferred so that the individual would only have access to the select 
agents and toxins at the new entity for the time specified. The 
commenter stated that, from a biosafety and biosecurity perspective, 
limiting access to only one entity at the time would be appropriate.
    During this timeframe, the individual will maintain access to 
select agents at both facilities. We believe that such an arrangement 
will serve to facilitate collaboration between registered entities as 
well as enabling various entities to use their time and funds most 
efficiently in order to continue ongoing research. We do not agree with 
the commenter's assertion that this procedure would threaten 
biosecurity or biosafety in any way since all registered entities are

[[Page 61069]]

required to undergo the same security screening process as established 
by the regulations.
    Two commenters stated that decreasing the maximum length of time 
for which a security risk assessment will be valid from 5 years to 3 
years would represent an undue burden on registered entities. One 
commenter cited the generally low rate of turnover at these entities, 
while the other stated that the existing policy, with renewal every 5 
years, has proven to be both sufficient and cost effective since the 
establishment of the select agent regulations. The first commenter 
suggested that we allow for less frequent risk assessments in the case 
of those individuals working with non-Tier 1 select agents and toxins 
only. The second commenter recommended making no changes to the 5-year 
interval.
    The decision to begin processing security risk assessments at 3-
year rather than 5-year intervals was made as a result of the 
recommendations from a working group comprised, in part, of 
representatives from the DOD and the HHS as well as various subject 
matter experts. Based on input from the working group as well as the 
FBI, we have determined that conducting security risk assessment 
approvals every 3 years is an effective method for increasing the 
security of our entities. Furthermore, the select agent program has 
been processing security risk assessments on a 3-year basis since June 
1, 2011. Since that date, we have not received any comments from the 
regulated community regarding additional financial or administrative 
burden associated with the changed practice. Regarding the first 
commenter's suggestion to process security risk assessments differently 
for those individuals working with non-Tier 1 select agents and toxins 
only, the establishment of the Tier 1 category is in no way intended to 
imply that the non-Tier 1 agents pose a lesser risk to public health 
and safety than they have previously. In accordance with that fact, we 
have not decreased the handling and security requirements for those 
non-Tier 1 agents.
    We proposed to require that the security plan described in 7 CFR 
331.11 and 9 CFR 121.11 that must be developed by all registered 
entities be submitted for initial registration, renewals of 
registration, and at any other time upon request to replace the 
existing requirement that they be provided upon request only. We also 
proposed that the security plan contain provisions for the control of 
access to select agents and toxins, including the safeguarding of 
animals or plants intentionally or accidentally exposed to or infected 
with a select agent, against unauthorized access, theft, loss or 
release. We also proposed to add a requirement that the security plan 
include procedures that require the responsible official to immediately 
notify the FBI in order to initiate a threat assessment process in the 
event that he or she becomes aware of suspicious activity which is 
criminal in nature, related to the facility, its personnel, or select 
agents. We also proposed to add provisions for information security, 
including the need for backup measures if the entity relies on 
information systems for security. We also proposed to codify current 
practices for shipping, receiving, and storage of select agents and 
toxins to ensure that the entity has documented processes for securing 
and monitoring the shipment, receipt, and storage of these items. 
Finally, we proposed to amend paragraph (e) in 7 CFR 331.11 and 9 CFR 
121.11, which previously directed individuals creating a security plan 
to guidance for developing such documents contained in the ``Morbidity 
and Mortality Weekly Report'' from December 2002. We proposed that 
applicants would instead be directed to the ``Security Information 
Document'' and the ``Security Plan Template'' on the National Select 
Agent Registry Web site.
    Two commenters requested clarification concerning the proposed 
requirement that entities address procedures concerning animals or 
plants accidentally or intentionally exposed to or infected with a 
select agent. Specifically, the commenters requested clarification as 
to whether the requirement would be limited to experimental plants and 
animals that are possessed and controlled by the registered entity. One 
commenter suggested two additions to the requirements: One stipulating 
that the incident response plan only cover those animals or plants 
possessed and controlled by the entity and the second a certifying 
statement confirming that the State animal health official (or plant-
associated equivalent) has an incident response plan in place to 
address intentional or accidental exposure to select agents for animals 
or plants throughout the State, including those plants or animals that 
are not possessed or controlled by the entity but may be located on the 
premises (e.g., wild animals).
    We are making no changes based on these comments. It was always our 
intent that the entity's incident response plan be limited to those 
exposed plants and animals that are possessed by and controlled by the 
registered entity.
    One commenter suggested that we alter the wording from a 
requirement to safeguard animals or plants ``intentionally or 
accidentally exposed to or infected with a select agent'' to a 
requirement to safeguard animals or plants ``intentionally exposed to, 
or infected with, select agents.'' The commenter stated that the 
suggested language would be clearer.
    We are making no changes based on this comment. We believe that 
animals or plants accidentally exposed to or infected with a select 
agent should be handled as select agents and safeguarded in the same 
manner as an animal or plant intentionally exposed to a select agent.
    In the preamble to the proposed rule, we stated that we were not 
proposing to require the security plan to address animals and plants 
exposed to select toxins. This is because recovering the toxin from 
within an animal or plant subject is highly difficult and such removal 
does not produce a reasonable yield of recovery. In addition, there is 
uncertainty as to whether or not the toxin would remain active when 
recovered from the animal or plant. For these reasons it is highly 
unlikely that once introduced into an animal or plant, a sufficient 
amount of toxin could be recovered to pose a significant hazard to 
public health, agriculture, or agriculture products. One commenter 
questioned that rationale, stating that while toxins are unlikely to be 
amplified or move into multiple hosts outside a given facility, there 
is still concern that amplification of toxins could occur in animals or 
insects during the course of an experiment.
    We disagree with the commenter's assertion. Select toxins do not 
amplify the way select agents do. Toxins in an animal or insect would 
prove deadly to that organism before it could reach a level at which 
extraction would become possible.
    One commenter stated that our proposal to add a requirement that 
the security plan include procedures for the responsible official to 
notify the FBI of suspicious activity that may be criminal in nature 
and related to the entity, its personnel, or its select agents or 
toxins contradicts guidance contained in the Nationwide Suspicious 
Activity Reporting (SAR) Initiative (NSI) established by the Department 
of Justice, creates a conflict within those entities that have their 
own recognized law enforcement agencies, and unnecessarily adds 
confusion due to the potential for concurrent jurisdiction. Two other 
commenters questioned the

[[Page 61070]]

rationale for requiring FBI reporting given that the select agent 
program is jointly administered by APHIS and CDC and, in the past, 
security concerns were directed to those agencies.
    We do not believe that there exists any conflict between the 
security requirements in 7 CFR 331.11 and 9 CFR 121.11 and the guidance 
offered by the NSI. The intent of this requirement is to facilitate the 
involvement of antiterrorism resources which will increase the security 
of select agents and toxins. FBI field offices, which are centrally 
located in major metropolitan areas across the United States, can 
assist entities by working closely with them on crime threats. However, 
we agree with the commenters that it may be appropriate that 
notification of suspicious activity first be given to local law 
enforcement. We have therefore changed the language in 7 CFR 
331.11(c)(8) and 9 CFR 121.11(c)(8) to read: ``Describe procedures for 
how the Responsible Official will be informed of suspicious activity 
that may be criminal in nature and related to the entity, its 
personnel, or its select agents or toxins; and describe procedures for 
how the entity will notify the appropriate Federal, State, or local law 
enforcement agencies of such activity.''
    Another commenter suggested that we require FBI notification for 
any suspicious activity involving select agents or toxins and not just 
activity that may be criminal in nature. The commenter argued that it 
is more appropriate for the FBI to determine whether or not the 
activity in question is criminal in nature.
    We are making no changes in response to this comment. The intent of 
this section of the regulations is to avoid excessive reporting to the 
FBI. It is our belief that a reasonable person would be able to 
determine if the behavior in question constitutes a potential criminal 
act, which would therefore necessitate FBI reporting.
    One commenter requested that we provide further details concerning 
the proposed requirements for additions to the security plan, 
specifically as it relates to information security.
    The purpose of the requirement in question is to clarify the 
language in 7 CFR 331.11(c)(9)(i) and 9 CFR 121.11(c)(9)(i) of the 
regulations that requires the entity to have procedures in place for 
information systems control. This is an overarching requirement that 
covers electronic and non-electronic information oversight by the 
regulated community. Our intent is not to regulate experimental data or 
the results of studies involving select agents and toxins but to 
regulate the select agents and toxins themselves. Therefore, we have 
revised the language in order to clearly indicate that the information 
security provisions in question should only be for access to the 
entity's registered space and records pertaining to select agents and 
toxins, as identified in sections 7 CFR 331.11, 9 CFR 121.11, 7 CFR 
331.17, and 9 CFR 121.17.
    Another commenter stated that the information security requirement 
represents an added regulatory burden, and the impact of this 
requirement should be evaluated.
    For the most part, we anticipate that these requirements are 
already being met and will merely require entities to codify and 
document the systems and processes currently in place. The guidance 
documents developed in conjunction with this rule are, in part, a 
response to the questions and issues raised by the commenter. Issues 
addressed in this document include, but are not limited to: Information 
technology security, network security, computer security, peripheral 
devices and data storage, physical security and its application to 
information security, risk management, and training. Full guidance on 
information security may be found on the National Select Agent Registry 
at www.selectagents.gov.
    Another commenter said that the proposed requirement that 
authorized and authenticated users only be granted access to select 
agent and toxin related information, files, equipment (e.g., servers or 
mass storage devices), and applications as necessary to fulfill their 
roles and responsibilities, and that their access be modified when the 
user's roles and responsibilities change or when their access to select 
agents and toxins is suspended or revoked, would require registration 
and security risk assessments for all staff managing records pertaining 
to select agent work. The commenter argued that this requirement would 
increase the burden on manufacturers and institutions who utilize 
administrative or information technology staff for such document 
management.
    The security requirements referenced by the commenter refer only to 
those persons who have either physical access to select agents and 
toxins or who have the capability to alter security access to select 
agents and toxins. Guidelines concerning security requirements such as 
these may be found on the National Select Agent Registry at 
www.selectagents.gov.
    Another commenter stated that the meaning of the phrases ``network 
connectivity monitoring'' and ``backup security measures in the event 
that access control systems and/or surveillance devices are rendered 
inoperable'' should be clarified.
    Again, we note that, further details regarding these and other 
aspects of the information security requirements may be found in the 
guidance documents mentioned above, which may be found on the National 
Select Agent Registry at www.selectagents.gov.
    We proposed to require that an entity's security plan contain 
provisions and policies for shipping, receiving, and storage of select 
agents and toxins, including documented procedures for receiving, 
monitoring, and shipping of all select agents and toxins. These 
provisions would provide that an entity must properly secure containers 
on site and have a written contingency plan for unexpected shipments. 
One commenter requested clarification regarding the meaning of the term 
``unexpected shipments.''
    We believe that the term ``unexpected shipments'' is self-
explanatory and believe that the security plan should contain 
procedures for these handling unexpected shipments (e.g., when an 
entity receives a shipment of a select agent that it had neither 
requested nor coordinated for, and therefore was not expecting).
    The regulations in 7 CFR 331.13 and 9 CFR 121.13 concern restricted 
experiments, which are those experiments that may not be performed by 
regulated entities without the approval of the Administrator. In 
addition to the existing prohibition on conducting restricted 
experiments, we proposed to state that entities would not be authorized 
to possess the products of restricted experiments without the approval 
of the Administrator.
    We also proposed to expand the restricted experiment approval 
requirement to include all experiments involving the creation of drug 
resistant select agents that are not known to acquire that resistance 
naturally, if such acquisition could compromise the use of the drug to 
control disease agents in humans, veterinary medicine, or agriculture, 
regardless of the method or technology used to create the resistance. 
Previously, the restricted experiment language concerned only those 
experiments involving recombinant DNA. We proposed this change because, 
while the introduction of a drug resistance trait would normally 
eliminate that drug as a therapeutic option to control the disease, 
there may be alternative drugs available to control the disease.
    In addition, we are adding a reference to ``chemical resistance 
traits,'' to the PPQ regulations in 7 CFR 331.13 in order to capture 
the potential transfer of,

[[Page 61071]]

or selection for, such traits that could adversely affect plant and 
agricultural health. Chemical resistant traits include, but are not 
limited to herbicide resistance, fungicide resistance, and pesticide 
resistance. We did not propose to add a corresponding definition to the 
VS regulations in 9 CFR 121.13 since chemical resistance traits are 
exclusive to plant biology. It should be noted that restricted 
experiments are not prohibited experiments; an entity must seek 
permission prior to the initiation of a restricted experiment and 
receive approval from the Administrator or HHS Secretary. Approval for 
the performance of a restricted experiment or the possession of a 
product of a restricted experiment may involve meeting additional 
safety and/or security requirements as prescribed by the select agent 
program. Many experiments that involve the deliberate transfer of a 
drug resistant trait do not meet the definition of a restricted 
experiment because the drug is not used to control disease in humans, 
veterinary medicine, or agriculture. The select agent program 
encourages anyone who intends to conduct a select agent experiment 
utilizing drug resistance markers to submit that experiment for review 
so that they may be advised regarding whether the experiment would be 
considered a restricted experiment and therefore require approval prior 
to its initiation.
    Two commenters were concerned about the proposed revisions 
classifying those experiments that introduce drug resistance to a 
select agent as restricted. The commenters suggested aligning the 
language concerning restricted experiments with the recombinant DNA 
guidelines issued by the NIH, which restrict and require approval only 
for those experiments with pathogens involving drug resistance for 
therapeutically useful agents against that pathogen. The commenters 
stated that the proposed language was too broad.
    We made no changes as a result of these comments. Contrary to the 
commenters' assertion, we have not expanded the definition of a 
restricted experiment to include all experiments utilizing select 
agents or toxins with drug resistant traits, but only to those 
utilizing select agents or toxins with resistance to those drugs used 
to control disease in humans, veterinary medicine, or agriculture. The 
definition of a restricted experiment contained in the regulations is 
already aligned with the NIH recombinant DNA guidelines.
    One commenter argued that antibiotic resistance not previously 
present could emerge in one or more select agents at any time. The 
commenter wished to know if the possession of such a previously unknown 
antibiotic resistant select agent would mean that all such organisms 
would be required to be destroyed. The commenter expressed concern that 
such a requirement might inadvertently prevent research in the case of 
a select agent that suddenly developed new antibiotic resistance 
traits.
    We are making no changes to the regulations as a result of this 
comment. Regardless of whether the select agent develops a new trait, 
it is still considered and treated as a select agent from a biosafety 
or biocontainment perspective. The aspect of the process that makes a 
select agent the subject of a restricted experiment is the purposeful 
generation of antibiotic resistant properties. If a select agent 
developed new antibiotic resistance spontaneously, then it would be 
included in the category of select agents considered ``known to acquire 
the resistance naturally'' as specified in 7 CFR 331.13(a)(1) and 9 CFR 
121.13(b)(1).
    Another commenter wanted to know whether the use of the terms ``the 
select agent program'' and ``the Administrator,'' which refer to two 
different entities, indicates that restricted experiments would require 
the approval of both the select agent program and the Administrator.
    Terms in this context are interchangeable, as the APHIS 
Administrator has delegated authority for establishing and enforcing 
the regulations to the select agent program. Approval is therefore only 
needed from the select agent program.
    Another commenter stated that an ombudsman, in the form of 
additional working groups, should be included in the approval process 
for restricted experiments. The commenter said that involvement of such 
groups in this capacity would serve to engage those regulated 
scientists while furthering their understanding of the select agent 
program.
    We are making no changes as a result of this comment. In reviewing 
applications to conduct restricted experiments, the select agent 
program utilizes the expertise of the Intragovernmental Select Agents 
and Toxins Technical Advisory Committee (ISATTAC), which is composed of 
Federal scientists from the CDC, NIH, FDA, APHIS, the Agricultural 
Research Service (ARS), APHIS' Center for Veterinary Biologics (CVB), 
and DOD, and its USDA counterpart, the Agricultural ISATTAC, which is 
composed of Federal scientists from ARS, APHIS, and CVB. In the past, 
when appropriate, we have engaged the advice of subject matter experts 
from outside the government.
    The regulations in 7 CFR 331.14 and 9 CFR 121.14 concern 
development of an entity's incident response plan. We proposed to 
specify that each incident response plan be based upon a site-specific 
risk assessment. We also proposed that the incident response procedures 
contain stipulations concerning animals and plants accidentally or 
intentionally exposed to or infected with a select agent.
    One commenter argued that the requirements in 7 CFR 331.14(a) and 9 
CFR 121.14(a), which stipulate that regulated entities must develop and 
implement a written incident response plan based on a site-specific 
risk assessment, are misleading. The commenter stated that, since there 
is no standard methodology for conducting such risk assessments, the 
addition of specific issues that must be addressed by a risk assessment 
should be included in order to provide additional guidance for the 
regulated community. The commenter further observed that, in general, 
the risk assessment requirements for agricultural select agents and 
toxins are somewhat different from those for human select agents and 
toxins. The commenter concluded that a one size fits all approach may 
be overly burdensome or scientifically inaccurate.
    We are making no changes based on this comment. The site-specific 
risk assessments required by the regulations in 7 CFR 331.14(a) and 9 
CFR 121.14(a) are necessary in order to ensure the physical security of 
regulated entities. The risks cited by the commenter are matters of the 
biological risk presented by various select agents and toxins, which is 
a separate issue from the physical security of these select agents and 
toxins. The regulations are intended to prevent the theft, loss, or 
release of select agents and toxins. We also disagree with the 
commenter's assertion that there is no standard methodology for 
conducting site-specific risk assessments. We have developed guidance 
on this subject that may be found on the National Select Agent Registry 
at www.selectagents.gov.
    We proposed to amend the regulations in 7 CFR 331.15 and 9 CFR 
121.15, which concern provision of mandatory training for staff and 
visitors who work in or visit areas where select agents or toxins are 
handled or stored. We proposed to require all registered entities to 
provide security awareness and incident response training. We also 
proposed to establish that training for escorted personnel would be 
based on

[[Page 61072]]

the risk associated with accessing areas where select agents and toxins 
are used and/or stored. We further proposed to require that refresher 
training, currently required on an annual basis, also be provided if a 
registered entity's security, incident response, biosafety, or 
biocontainment plans are substantively altered. Finally, we proposed to 
specify that the responsible official ensure maintenance of training 
records. Currently there is no particular person designated as the 
entity's required recordkeeper, only that a training record must be 
kept.
    One commenter suggested that 7 CFR 331.15(a) should specify that 
information and training on both biocontainment and biosafety be 
provided, as only information and training on biosafety had been 
specified in the proposed rule.
    We agree with the commenter and have amended 7 CFR 331.15(a) in 
order to reflect the proper terminology in dealing with plant 
pathogens.
    We proposed that the regulations in 7 CFR 331.15(a)(ii) concerning 
escorted personnel stipulate that training for such individuals must be 
based on the risk associated with accessing areas where select agents 
and toxins are used and/or stored. One commenter inquired what would 
represent an ``appropriate level of training.'' The commenter further 
wished to know how an entity would determine the risk associated with 
accessing such areas. Finally, the commenter asserted that there should 
be no need for non-approved individuals to potentially access areas 
where select agents and toxins are used and/or stored given that 
unsecured select agents or toxins could be moved elsewhere prior to the 
arrival of any escorted personnel.
    We disagree with the commenter's assertion that non-approved 
individuals would never need to access areas where select agents and 
toxins are used and/or stored. For example, there may be a need for the 
repair of a refrigeration unit in a laboratory where employees are 
utilizing select agents or toxins as a part of concurrent research 
work. In addition, inventories of select agents and toxins may be large 
enough to make moving them impractical and overly time-consuming. It is 
therefore necessary for any visitors to know and understand the 
biological risks associated with the select agents or toxins used and/
or stored in the area to which they will have access. This training 
would necessarily vary depending upon the areas that the escorted 
personnel would need to access, which would be determined by the 
entity. Visitors should ideally be made aware of the safety and 
security procedures as defined by the entity in question; however, we 
are leaving the regulations in their broadly written state in order to 
provide the greatest amount of flexibility for the wide variety of 
entities subject to the requirements.
    We proposed to amend the regulations in 7 CFR 331.16 and 9 CFR 
121.16, which concern the transfer of select agents and toxins from one 
registered entity to another, in order to codify practices for 
shipping, receiving, and storage of select agents and toxins to ensure 
that all registered entities have documented processes for securing and 
monitoring the shipment, receipt, and storage of select agents and 
toxins that make it extremely unlikely that such materials would be 
made available to an unauthorized individual.
    Two commenters asserted that the provisions concerning transfer are 
unclear with regard to the subject of the transfer of materials covered 
by the exemptions for diagnostic or clinical laboratories under 7 CFR 
331.5, 9 CFR 121.5, and 9 CFR 121.6. The commenters requested that we 
clearly establish whether the new requirements supersede the existing 
provisions for transfer by exempt entities.
    We are making no changes as a result of this comment. Those 
materials which qualify for exemption from the regulations have always 
been considered separately from the rest of the listed select agents or 
toxins. This may be a result of the exemptions granted for diagnostic 
or clinical laboratories, a result of a specific exemption request, or 
for other reasons which may be found in 7 CFR 331.5, 9 CFR 121.5, and 9 
CFR 121.6. As a result, these materials are not subject to the 
regulations, including those portions of the regulations concerning 
transfers, apart from those sections pertaining to exemptions.
    However, given that some commenters on the CDC proposed rule 
expressed confusion associated with the proposed provision, we have 
revised the language in order to clarify our original intent. Packaging 
of select agents and toxins for transfer must be made by an APHIS or 
CDC-approved individual.
    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. We proposed to add language to address 
synthetic select agent organisms and animals and plants inoculated with 
select agents. We also proposed to add recordkeeping requirements 
whereby regulated entities maintain an accurate, current inventory of 
any animals or plants intentionally or accidentally exposed to or 
infected with a select agent (including number and species, location, 
and appropriate disposition). As previously stated, we did not propose 
to require regulated entities to keep records regarding animals or 
plants exposed to select toxins.
    Four commenters argued that counting individual vials of 
replicating biological agents is costly, burdensome, and a major source 
of frustration for investigators. The commenters went on to say that 
the requirement to measure volumes within each vial is problematic 
given both the ease with which volumes can change through natural 
processes and the difficulty in correctly assessing them in the frozen 
state during inventory verifications. The commenters stated that both 
counting vials and measuring volumes of individual vials are not 
effective means of increasing security.
    We are making no changes to the regulations based on these 
comments. While we are aware of the burden resulting from the 
requirement to maintain an accurate and current inventory of each 
select agent and toxin held in long-term storage, we believe this is an 
essential element in establishing the security of select agents or 
toxins. We recognize that it may still be possible for an insider to 
steal a sample of an agent either from working stock or from an 
inventory without being detected; however, if an entity has a robust 
inventory management system, such incidents have a better chance of 
being detected. To assist registered entities in meeting the 
requirements for maintaining accurate inventories of materials in long 
term storage, we have developed guidance that may be found on the 
National Select Agent Registry at www.selectagents.gov. It should be 
noted that, while the volume measurements the commenter references are 
required for inventories of select toxins, they are not required in the 
case of inventory of select agents held in long-term storage due, in 
part, to the points raised by the commenter. However, we disagree with 
the commenter's assessment that measuring volume in the case of select 
toxins and counting vials in general as part of required inventory 
tracking of both select agents and toxins for registered entities is 
not necessary.
    Another commenter stated that there is concern that the additional 
requirements for inventory each time a select agent is moved will 
adversely impact the viability and quality of the material in question.
    We are making no changes as a result of this comment. In the case 
of those select agents and toxins in long-term

[[Page 61073]]

storage, collections of vials of materials can be recorded and grouped 
into tamper-evident containers and audits made of intact containers 
rather than audits of individual vials. This practice is stipulated in 
the current guidance document regarding long term storage, which is 
available on the National Select Agent Registry at 
www.selectagents.gov. Those select agents and toxins that are part of 
an entity's working stock are already in regular use and we therefore 
do not anticipate adverse effects arising from any required accounting.
    Based on comments received on the CDC rule, we now recognize that 
there has been some confusion between those animals (including 
arthropods) and plants considered to be ``working stock'' and those 
considered to be ``inventory.'' To that end, we have developed guidance 
that will enable entities to better differentiate between these two 
categories. This guidance is available at www.selectagents.gov. It was 
not our intent to require a formal inventory of animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent, but merely to state that entities should keep some record of 
such animals or plants. In order to clarify our intent regarding 
``working stock'' and ``inventory,'' we are revising 7 CFR 331.17(a)(2) 
and 9 CFR 121.17(a)(2) to require an accurate, current accounting of 
any animals or plants intentionally or accidentally exposed to or 
infected with a select agent (including number and species, location, 
and appropriate disposition) instead of an accurate, current inventory 
of those animals or plants.

Indirect and Economic Consequences

    Eight commenters requested that we consider the indirect 
consequences of continuing to include agents and toxins on the select 
agent list, the negative effect of the proposed rule changes on the 
potential workforce for select agent research, and the possibility that 
additional regulations concerning Tier 1 agents and toxins will mandate 
more Federal oversight and institutional compliance requirements, 
resulting in increased costs to taxpayers both directly and indirectly 
through reduced research efficiency. Commenters requested that the full 
economic and scientific impact of these added requirements be carefully 
assessed prior to implementation, especially the increased costs to 
academic institutions with no associated funding, and the increased 
burden on investigators already having difficulty finding time for 
research and experimentation. The commenters also stated that the 
timeline for implementation of the new requirements should be 
considered and disclosed to affected entities.
    A cornerstone of the select agent program is to establish and 
enforce safety and security measures to prevent access to select agents 
and toxins for use in domestic or international terrorism or for any 
other criminal purpose. An equally important function of the select 
agent program is to ensure the appropriate availability of biological 
agents and toxins for research, education, and other legitimate 
purposes. To achieve both requires balancing the need for continuing 
biological research with requiring a level of safety and security 
commensurate with the risks posed by these select agents and toxins. We 
understand that safety and security requirements cost money and that 
money in the area of biological research is often a scarce commodity. 
We are, however, also aware that a lack of adequate safety and security 
requirements could result in damages measured not only in dollars but 
in human lives. It is our determination, based on the information 
available to us, that the additional requirements would, in many cases, 
codify systems and procedures already in use by a majority of regulated 
entities.
    We are also renumbering several sections of the PPQ regulations so 
that they will match the numbering of the VS regulations, which we 
believe may be useful for those entities housing both PPQ select agents 
and toxins and VS select agents and toxins. As proposed, the section 
numbering did not match up because we did not propose to classify any 
PPQ select agents and toxins as Tier 1, so there were sections being 
added to the VS regulations that were not included in the PPQ 
regulations.

Effective Date

    In response to comments received by the CDC requesting guidance and 
a timetable of when the proposed changes would need to be addressed, we 
have included a phase-in period for the effective date for certain 
requirements of the revised regulations, which should allow entities to 
comply without causing disruption or termination of research or 
educational projects. As noted in the ``Dates'' portion of this 
document, 60 days from the publication of the final rule, entities will 
be required to be in compliance with 7 CFR 331.1 through 331.10, 
331.13, and 331.16 through 331.20 and 9 CFR 121.1 through 121.10, 
121.13, 121.16, 121.17, and 121.20. One hundred and eighty days after 
the publication of the final rule, entities will be required to be in 
compliance with 7 CFR 331.11, 331.12, 331.14, and 331.15 and 9 CFR 
121.11, 121.12, 121.13, 121.14, and 121.15.
    The staggered effective dates for the provisions of the final rule 
are based on the effective dates previously used for a final rule 
published by the Select Agent Program on March 18, 2005 (70 FR 13242-
13292, Docket No. 02-088-4). If the regulated community has concerns 
about the established timeline, they can contact the Federal select 
agent program for technical assistance.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This final rule has been determined to be significant/economically 
significant for the purposes of Executive Order 12866 and, therefore, 
has been reviewed by the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides a final regulatory flexibility analysis that examines the 
potential economic effects of this rule on small entities, as required 
by the Regulatory Flexibility Act. The economic analysis is summarized 
below. Copies of the full analysis are available on the Regulations.gov 
Web site (see footnote 1 in this document for a link to 
Regulations.gov) or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    Based on information obtained through site-specific inspections, we 
believe most registered entities already have in place many of the 
information security requirements set forth in the final rule, and 
compliance costs of the rules are therefore expected to be minimal. 
Entities more likely to be affected will be laboratories and other 
institutions conducting research and related activities that involve 
the use of select agents and toxins categorized as Tier 1. These 
entities will be required to conduct a pre-access suitability

[[Page 61074]]

assessment of individuals with access to a Tier 1 select agent or 
toxin, as well as enroll these individuals in an occupational health 
program.
    The rule would reduce the period that FBI background checks are 
valid from five to three years. This increased frequency would 
effectively increase the cost of background checks by 67 percent. Based 
on the current number of individuals required to have the background 
checks, we estimate that the present value of these government-borne 
costs over five years will increase by $1.96 million across all 
registered entities. The annual increase in costs will total about 
$432,000.
    While we expect few if any of the registered entities to incur 
significant compliance costs, required documentation of measures 
already regularly performed with respect to biocontainment/biosafety, 
incident response, information security, and ongoing suitability 
assessment may require additional time of personnel. We estimate 
additional recurring costs related to information security, such as for 
software updates, could total about $2 million per year, or about 
$5,500 per entity, in the unlikely event that none of the entities 
already uses equivalent information security measures. As noted, many 
of these costs are already currently borne by entities in their conduct 
of generally recognized best practices.
    For entities possessing a Tier 1 agent or toxin, the costs of pre-
access suitability assessments and occupational health programs are 
estimated to total between $2.8 million and $4.4 million, or between 
about $9,600 and $15,100 per entity, on average. Again, actual costs 
incurred are unlikely to reach these maximum cost ranges; we expect 
that many of the entities with a Tier 1 agent or toxin already conduct 
assessments and have health programs similar or equivalent to those 
required by the final rules.
    The benefits of strengthened safeguards against the unintentional 
or deliberate release of a select agent or toxin greatly exceed 
compliance costs of the rules. As an example of losses that can occur, 
the October 2001 anthrax attacks caused 5 fatalities and 17 illnesses, 
disrupted business and government activities (including $2 billion in 
lost revenues for the Postal Service), and required more than $23 
million to decontaminate one Senate office building and $3 billion to 
decontaminate postal facilities and procure mail-sanitizing equipment. 
Deliberate introduction greatly increases the probability of a select 
agent becoming established and causing wide-ranging and devastating 
impacts to the economy, other disruptions to society, and diminished 
confidence in public and private institutions.
    The amended regulations will enhance the protection of human, 
animal, and plant health and safety. The final rules will reduce 
likelihood of the accidental or intentional release of a select agent 
or toxin. Benefits of the rules will derive from the greater 
probability that a release will be prevented from occurring. While the 
total cost of implementing the regulations is estimated to range 
between $2.8 million-$4.4 million across all entities with a Tier 1 
agent or toxin and approximately $2.4 million in annual cost across all 
registered entities and the Federal Government, we believe many of 
these costs are currently incurred by affected entities as generally 
recognized practices.

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 7 CFR part 3015, subpart V.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, Consultation and Coordination with Indian Tribal 
Governments. The review reveals that this regulation will not have 
substantial and direct effects on Tribal governments and will not have 
significant Tribal implications.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this final rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
When OMB notifies us of its decision, we will publish a document in the 
Federal Register providing notice of the assigned OMB control numbers 
or, if approval is denied, providing notice of what action we plan to 
take.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 851-2908.

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 are amending 7 CFR part 331 and 9 CFR part 121 as 
follows:

Title 7

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 as follows:
0
a. In the introductory text of the definition of biological agent, by 
removing the word ``rickettsiae,'';
0
b. By adding, in alphabetical order, definitions of information 
security, recombinant nucleic acids, security barrier, and synthetic 
nucleic acids; and
0
c. In the introductory text of the definition of toxin, by removing the 
word ``rickettsiae,''.
    The additions read as follows:

Sec.  331.1  Definitions.

* * * * *
    Information security. Protecting information and information 
systems from unauthorized access, use, disclosure, disruption, 
modification, or destruction in order to provide:
    (1) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information 
authenticity;
    (2) Confidentiality, which means preserving authorized restrictions 
on access and disclosure, including means

[[Page 61075]]

for protecting personal privacy and proprietary information; and
    (3) Availability, which means ensuring timely and reliable access 
to and use of information.
* * * * *
    Recombinant nucleic acids. (1) Molecules that are constructed by 
joining nucleic acid molecules and that can replicate in a living cell 
(i.e., recombinant nucleic acids); or
    (2) Molecules that result from the replication of those described 
in paragraph (1) of this definition.
* * * * *
    Security barrier. A physical structure that is designed to prevent 
entry by unauthorized persons, animals, or materials.
* * * * *
    Synthetic nucleic acids. (1) Molecules that are chemically or by 
other means synthesized or amplified, including those that are 
chemically or otherwise modified but can base pair with naturally 
occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
    (2) Molecules that result from the replication of those described 
in paragraph (1) of this definition.
* * * * *

0
3. Section 331.3 is amended as follows:
0
a. By revising paragraph (b);
0
b. In paragraph (c) introductory text, by adding the words ``and/or 
synthetic'' after the word ``recombinant'' each time it appears.
0
c. In paragraph (c)(2) introductory text, by adding the words ``and/or 
synthetic'' after the word ``Recombinant''.
0
d. By adding paragraph (d)(3); and
0
e. By revising paragraph (e)
    The revisions and addition read as follows:.

Sec.  331.3  PPQ select agents and toxins.

* * * * *
    (b) PPQ select agents and toxins: Peronosclerospora philippinensis 
(Peronosclerospora sacchari); Phoma glycinicola (formerly Pyrenochaeta 
glycines); Ralstonia solanacearum; Rathayibacter toxicus; Sclerophthora 
rayssiae; Synchytrium endobioticum; Xanthomonas oryzae.
* * * * *
    (d) * * *
    (3) Any subspecies of Ralstonia solanacearum except race 3, biovar 
2 and all subspecies of Sclerophthora rayssiae except var. zeae, 
provided that the individual or entity can verify that the agent is 
within the exclusion category.
    (e) An attenuated strain of a select agent or an inactive form of a 
select toxin may be excluded from the requirements of this part based 
upon a determination by the Administrator that the attenuated strain or 
inactivated toxin does not pose a severe threat to plant health or 
plant products.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will 
be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
    (2) If an excluded attenuated strain or inactivated toxin is 
subjected to any manipulation that restores or enhances its virulence 
or toxic activity, the resulting select agent or toxin will be subject 
to the requirements of this part.
* * * * *

0
4. Section 331.9 is amended as follows:
0
a. In paragraph (a)(4), by removing the word ``and'';
0
b. By redesignating paragraph (a)(5) as paragraph (a)(6);
0
c. By adding a new paragraph (a)(5);
0
d. By revising the first sentence of paragraph (b)
    The addition and revision read as follows:.

Sec.  331.9  Responsible official.

    (a) * * *
    (5) Have a physical (and not merely a telephonic or audio/visual) 
presence at the registered entity to ensure that the entity is in 
compliance with the select agent regulations and be able to respond in 
a timely manner to onsite incidents involving select agents and toxins 
in accordance with the entity's incident response plan; and
* * * * *
    (b) An entity may designate one or more individuals to serve as an 
alternate responsible official who acts for the responsible official in 
his/her absence. * * *
* * * * *

0
5. Section 331.10 is amended as follows:
0
a. By redesignating paragraphs (e) through (i) as paragraphs (f) 
through (j) respectively;
0
b. By adding a new paragraph (e); and
0
c. In newly redesignated paragraph (i), by removing the number ``5'' 
and adding the number ``3'' in its place.
    The addition reads as follows:

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

* * * * *
    (e) 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 
Administrator provide their approved access status to another 
registered individual or entity for a specified period of time.
* * * * *

0
6. Section 331.11 is amended as follows:
0
a. By revising paragraph (b);
0
b. By revising paragraph (c)(2);
0
c. In paragraph (c)(6), by removing the word ``and'';
0
d. In paragraph (c)(7), by removing the period and adding a semicolon 
in its place;
0
e. By adding new paragraphs (c)(8), (9), and (10);
0
f. By redesignating paragraphs (e) and (f) as paragraphs (g) and (h), 
respectively;
0
g. By adding new paragraphs (e) and reserved (f); and
0
h. By revising newly redesignated paragraph (g).
    The revisions and additions read as follows:

Sec.  331.11  Security.

* * * * *
    (b) The security plan must be designed according to a site-specific 
risk assessment and must provide graded protection in accordance with 
the risk of the select agent or toxin, given its intended use. A 
current security plan must be submitted for initial registration, 
renewal of registration, or when requested.
    (c) * * *
    (2) Contain provisions for the control of access to select agents 
and toxins, including the safeguarding of animals (including 
arthropods) or plants intentionally or accidentally exposed to or 
infected with a select agent, against unauthorized access, theft, loss 
or release.
* * * * *
    (8) Describe procedures for how the Responsible Official will be 
informed of suspicious activity that may be criminal in nature and 
related to the entity, its personnel, or its select agents or toxins; 
and describe procedures for how the entity will notify the appropriate 
Federal, State, or local law enforcement agencies of such activity.
    (9) Contain provisions for information security that:
    (i) Ensure that all external connections to systems which manage 
security for the registered space are isolated or have controls that 
permit only authorized and authenticated users;

[[Page 61076]]

    (ii) Ensure that authorized and authenticated users are only 
granted access to select agent and toxin related information, files, 
equipment (e.g., servers or mass storage devices), and applications as 
necessary to fulfill their roles and responsibilities, and that access 
is modified when the user's roles and responsibilities change or when 
their access to select agents and toxins is suspended or revoked;
    (iii) Ensure that controls are in place that are designed to 
prevent malicious code (such as, but not limited to, computer viruses, 
worms, spyware) from compromising the confidentiality, integrity, or 
availability of information systems which manage access to spaces 
registered under this part or records as specified in Sec.  331.17;
    (iv) Establish a robust configuration management practice for 
information systems to include regular patching and updates made to 
operating systems and individual applications; and
    (v) Establish procedures that provide backup security measures in 
the event that access control systems, surveillance devices, and/or 
systems that manage the requirements of Sec.  331.17 are rendered 
inoperable.
    (10) Contain provisions and policies for shipping, receiving, and 
storage of select agents and toxins, including documented procedures 
for receiving, monitoring, and shipping of all select agents and 
toxins. These provisions must provide that an entity will properly 
secure containers on site and have a written contingency plan for 
unexpected shipments.
* * * * *
    (e) Entities must conduct complete inventory audits of all affected 
select agents and toxins in long-term storage when any of the following 
occur:
    (1) Upon the physical relocation of a collection or inventory of 
select agents or toxins for those select agents or toxins in the 
collection or inventory;
    (2) Upon the departure or arrival of a principal investigator for 
those select agents and toxins under the control of that principal 
investigator; or
    (3) In the event of a theft or loss of a select agent or toxin, all 
select agents and toxins under the control of that principal 
investigator.
    (f) [Reserved]
    (g) In developing a security plan, an individual or entity should 
consider the documents entitled, ``Security Guidance for Select Agent 
or Toxin Facilities.'' This document is available on the National 
Select Agent Registry at http://www.selectagents.gov/.

0
7. Section 331.12 is amended as follows:
0
a. By revising paragraph (a);
0
b. By redesignating paragraph (d) as paragraph (e); and
0
c. By adding reserved paragraph (d).
    The revision reads 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 containment procedures 
for the select agent or toxin, including any animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent.
---------------------------------------------------------------------------

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

* * * * *

0
8. Section 331.13 is amended by removing footnote 5 and revising 
paragraph (a) to read as follows:

Sec.  331.13  Restricted experiments.

    (a) An individual or entity may not conduct, or possess products 
resulting from, the following experiments unless approved by and 
conducted in accordance with the conditions prescribed by the 
Administrator:
    (1) Experiments that involve the deliberate transfer of, or 
selection for, a drug or chemical resistance trait to select agents 
that are not known to acquire the trait naturally, if such acquisition 
could compromise the control of disease agents in humans, veterinary 
medicine, or agriculture.
    (2) Experiments involving the deliberate formation of synthetic or 
recombinant nucleic acids containing genes for the biosynthesis of 
select toxins lethal for vertebrates at an LD[50]kg body 
weight.
* * * * *

0
9. Section 331.14 is amended as follows:
0
a. In the section heading, by redesignating footnote 6 as footnote 5;
0
b. By revising the first sentence in paragraph (a);
0
c. By redesignating footnote 7 as footnote 6;
0
d. By revising paragraph (b);
0
e. By redesignating paragraphs (c) and (d) as paragraphs (d) and (f), 
respectively; and
0
f. By adding new paragraphs (c) and reserved (e).
    The revisions and 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) An individual or entity required to register under this part 
must develop and implement a written incident response plan \6\ based 
upon a site specific risk assessment. * * *
---------------------------------------------------------------------------

    \6\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

    (b) The incident response plan must fully describe the entity's 
response procedures for the 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, and other 
natural and man-made events.
    (c) The response procedures must account for hazards associated 
with the select agent or toxin and appropriate actions to contain such 
select agent or toxin, including any animals (including arthropods) or 
plants intentionally or accidentally exposed to or infected with a 
select agent.
* * * * *
0
10. Section 331.15 is revised to read as follows:

Sec.  331.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biocontainment, biosafety, 
security (including security awareness), and incident response to:
    (1) Each individual with access approval from the HHS Secretary or 
Administrator before that individual has such access to select agents 
and toxins. The training must address the particular needs of the 
individual, the work they will do, and the risks posed by the select 
agents or toxins; and
    (2) Each individual not approved for access to select agents and 
toxins by the HHS Secretary or Administrator before that individual 
enters areas where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage 
areas, shipping/receiving areas, production facilities, etc.). Training 
for escorted personnel must be based on the risk associated with 
accessing areas where select agents and toxins are used and/or stored.
    (b) [Reserved]
    (c) Refresher training must be provided annually for individuals 
with access approval from the HHS Secretary or Administrator or at such 
time as the

[[Page 61077]]

registered individual or entity significantly amends its security, 
incident response, or biocontainment plans.
    (d) The responsible official must ensure a record of the training 
provided to each individual with access to select agents and toxins and 
each escorted individual (e.g., laboratory workers, visitors, etc.) is 
maintained. The record must include the name of the individual, the 
date of the training, a description of the training provided, and the 
means used to verify that the employee understood the training.

0
11. Section 331.16 is amended as follows:
0
a. By redesignating footnote 8 as footnote 7;
0
b. By redesignating paragraphs (e) through (h) as paragraphs (h), (i), 
(j), and (f) respectively;
0
c. By adding a new paragraph (e);
0
d. In newly redesignated paragraph (f), by removing the words 
``packaging and''; and
0
e. By adding a new paragraph (g).
    The additions read as follows:

Sec.  331.16  Transfers.

* * * * *
    (e) After authorization is provided by APHIS or CDC, the packaging 
of the select agent(s) and toxin(s) is performed by an individual 
approved by the HHS Secretary or Administrator to have access to select 
agents and toxins and is in compliance with all applicable laws 
concerning packaging.
* * * * *
    (g) Transportation in commerce starts when the select agent(s) or 
toxin(s) are packaged for shipment and ready for receipt by a courier 
transporting select agent(s) or toxin(s) and ends when the package is 
received by the intended recipient who is an individual approved by the 
HHS Secretary or Administrator to have access to select agents and 
toxins, following a security risk assessment by the Attorney General.
* * * * *

0
12. Section 331.17 is amended as follows:
0
a. By revising paragraph (a)(1) introductory text;
0
b. By redesignating paragraphs (a)(2) through (6) as paragraphs (a)(3) 
through (7), respectively; and
0
c. By adding a new paragraph (a)(2).
    The revision and addition read as follows:

Sec.  331.17  Records.

    (a) * * *
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
organisms containing recombinant and/or synthetic nucleic acids) held 
in long-term storage (placement in a system designed to ensure 
viability for future use, such as in a freezer or lyophilized 
materials), including:
* * * * *
    (2) An accurate, current accounting of any animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent (including number and species, location, and appropriate 
disposition);
* * * * *

Sec.  331.19  [Amended]

0
13. Section 331.19 is amended as follows:
0
a. By removing paragraph (b)(1)(iv); and
0
b. By redesignating paragraphs (b)(1)(v) through (b)(1)(viii) as 
paragraphs (b)(1)(iv) through (b)(1)(vii), respectively.

0
14. Section 331.20 is revised to read as follows:

Sec.  331.20  Administrative review.

    (a) An individual or entity may appeal a denial, revocation, or 
suspension of registration under this part. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to 
the Administrator within 30 calendar days of the decision.
    (b) An individual may appeal a denial, limitation, or revocation of 
access approval under this part. The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the Administrator 
within 180 calendar days of the decision.
    (c) The Administrator's decision constitutes final agency action.

Title 9

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

0
15. 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
16. Section 121.1 is amended as follows:
0
a. In the introductory text of the definition of biological agent, by 
removing the word ``rickettsiae,'';
0
b. By adding, in alphabetical order, definitions of information 
security, occupational exposure, recombinant nucleic acids, security 
barrier, and synthetic nucleic acids; and
0
c. In the introductory text of the definition of toxin, by removing the 
word ``rickettsiae,''.
    The additions read as follows:

Sec.  121.1  Definitions.

* * * * *
    Information security. Protecting information and information 
systems from unauthorized access, use, disclosure, disruption, 
modification, or destruction in order to provide:
    (1) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information 
authenticity;
    (2) Confidentiality, which means preserving authorized restrictions 
on access and disclosure, including means for protecting personal 
privacy and proprietary information; and
    (3) Availability, which means ensuring timely and reliable access 
to and use of information.
* * * * *
    Occupational exposure. Any reasonably anticipated skin, eye, mucous 
membrane, parenteral contact, or respiratory aerosol exposure to select 
agents or toxins that may result from the performance of an employee's 
duties.
* * * * *
    Recombinant nucleic acids. (1) Molecules that are constructed by 
joining nucleic acid molecules and that can replicate in a living cell; 
or
    (2) Molecules that result from the replication of those described 
in paragraph (1) of this definition.
* * * * *
    Security barrier. A physical structure that is designed to prevent 
entry by unauthorized persons.
* * * * *
    Synthetic nucleic acids. (1) Molecules that are chemically or by 
other means synthesized or amplified, including those that are 
chemically or otherwise modified but can base pair with naturally 
occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
    (2) Molecules that result from the replication of those described 
in paragraph (1) of this definition.
* * * * *

0
17. Section 121.3 is amended as follows:
0
a. By adding a sentence at the end of paragraph (a);
0
b. By revising paragraph (b);
0
c. In paragraph (c) introductory text, by adding the words ``and/or 
synthetic'' after the word ``recombinant'' each time it appears;
0
d. In paragraph (c)(2), by adding the words ``and/or synthetic'' after 
the word ``Recombinant'';
0
e. By adding paragraph (d)(3);
0
f. By revising paragraph (e); and

[[Page 61078]]

0
g. In paragraph (f)(3)(i), by removing the words ``Newcastle disease 
virus``(velogenic)'' and adding the words ``virulent Newcastle disease 
virus'' in their place.
    The revisions and additions read as follows:

Sec.  121.3  VS select agents and toxins.

    (a) * * * The select agents and toxins marked with an asterisk (*) 
are designated as Tier 1 select agents and toxins and are subject to 
additional requirements as listed in this part.
    (b) VS select agents and toxins: African horse sickness virus; 
African swine fever virus; Avian influenza virus; Classical swine fever 
virus; *Foot-and-mouth disease virus; Goat pox virus; Lumpy skin 
disease virus; Mycoplasma capricolum; Mycoplasma mycoides; Newcastle 
disease virus; \1\ Peste des petits ruminants virus; *Rinderpest virus; 
Sheep pox virus; Swine vesicular disease virus.
---------------------------------------------------------------------------

    \1\ A virulent Newcastle disease virus (avian paramyxovirus 
serotype 1) has an intracerebral pathogenicity index in day-old 
chicks (Gallus gallus) of 0.7 or greater or has an amino acid 
sequence at the fusion (F) protein cleavage 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.
---------------------------------------------------------------------------

* * * * *
    (d) * * *
    (3) Any low pathogenic strains of avian influenza virus, any strain 
of Newcastle disease virus which does not meet the criteria for 
virulent Newcastle disease virus, 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 verify that the agent is within the exclusion 
category.
    (e) An attenuated strain of a select agent or an inactive form of a 
select toxin may be excluded from the requirements of this part based 
upon a determination by the Administrator that the attenuated strain or 
inactivated toxin does not pose a severe threat to animal health or to 
animal products.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will 
be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
    (2) If an excluded attenuated strain or inactivated toxin is 
subjected to any manipulation that restores or enhances its virulence 
or toxic activity, the resulting select agent or toxin will be subject 
to the requirements of this part.
* * * * *

0
18. Section 121.4 is amended as follows:
0
a. By adding a sentence at the end of paragraph (a);
0
b. By revising paragraph (b);
0
c. In paragraph (c) introductory text, by adding the words ``and/or 
synthetic'' after the word ``recombinant'' each time it appears;
0
d. In paragraph (c)(2) introductory text, by adding the phrase ``and/or 
synthetic'' after the word ``Recombinant'';
0
e. By adding paragraph (d)(3);
0
f. By revising paragraph (e); and
0
g. In paragraph (f)(3)(i), by removing the words ``Brucella melitensis, 
Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan 
equine encephalitis virus'' and adding the words ``Burkholderia mallei, 
and Burkholderia pseudomallei'' in their place.
    The revisions and additions read as follows:

Sec.  121.4  Overlap select agents and toxins.

    (a) * * * The select agents and toxins marked with an asterisk (*) 
are designated as Tier 1 select agents and toxins and are subject to 
additional requirements as listed in this part.
    (b) Overlap select agents and toxins: *Bacillus anthracis; Bacillus 
anthracis (Pasteur strain); Brucella abortus; Brucella melitensis; 
Brucella suis; *Burkholderia mallei; *Burkholderia pseudomallei; Hendra 
virus; Nipah virus; Rift Valley fever virus; Venezuelan equine 
encephalitis virus.
* * * * *
    (d) * * *
    (3) Any subtypes of Venezuelan equine encephalitis virus except for 
Subtypes IAB or IC, provided that the individual or entity can verify 
that the agent is within the exclusion category.
    (e) An attenuated strain of a select agent or an inactive form of a 
select toxin may be excluded from the requirements of this part based 
upon a determination by the HHS Secretary or Administrator that the 
attenuated strain or inactivated toxin does not pose a severe threat to 
public health and safety, to animal health or to animal products.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will 
be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/.
    (2) If an excluded attenuated strain or inactivated toxin is 
subjected to any manipulation that restores or enhances its virulence 
or toxic activity, the resulting select agent or toxin will be subject 
to the requirements of this part.
* * * * *

Sec.  121.5  [Amended]

0
19. In Sec.  121.5, paragraph (a)(3)(i) is amended by removing the 
words ``bovine spongiform encephalopathy agent,''.

0
20. Section 121.6 is amended as follows:
0
a. In paragraph (a)(3)(i) by removing the words ``Brucella melitensis, 
Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan 
equine encephalitis virus'' and adding the words ``Burkholderia mallei, 
and Burkholderia pseudomallei'' in their place; and
0
b. By revising paragraph (e) to read as follows:

Sec.  121.6  Exemptions for overlap select agents and toxins.

* * * * *
    (e) The Administrator may exempt an individual or entity from the 
requirements of this part for 30 calendar days if it is necessary to 
respond to a domestic or foreign agricultural emergency involving an 
overlap select agent or toxin. The Administrator may extend the 
exemption once for an additional 30 days.
* * * * *

0
21. Section 121.9 is amended as follows:
0
a. In paragraph (a)(4), by removing the word ``and'';
0
b. By redesignating paragraph (a)(5) as paragraph (a)(6);
0
c. By adding a new paragraph (a)(5);
0
d. By revising the first sentence of paragraph (b); and
0
e. By revising the first sentence of paragraph (c)(1).
    The addition and revisions read as follows:

Sec.  121.9  Responsible official.

    (a) * * *
    (5) Have a physical (and not merely a telephonic or audio/visual) 
presence at the registered entity to ensure that the entity is in 
compliance with the select agent regulations and be able to respond in 
a timely manner to onsite incidents involving select agents and toxins 
in

[[Page 61079]]

accordance with the entity's incident response plan; and
* * * * *
    (b) An entity may designate one or more individuals to serve as an 
alternate responsible official who acts for the responsible official in 
his/her absence. * * *
    (c) * * *
    (1) The identification of any of the following select agents or 
toxins must be immediately reported by telephone, facsimile, or email: 
African horse sickness virus, African swine fever virus, avian 
influenza virus (highly pathogenic), Bacillus anthracis, Burkholderia 
mallei, Burkholderia pseudomallei, classical swine fever virus, foot-
and-mouth disease virus, virulent Newcastle disease virus, rinderpest 
virus, and swine vesicular disease virus. * * *
* * * * *

0
22. Section 121.10 is amended as follows:
0
a. By redesignating paragraphs (e) through (j) as paragraphs (f) 
through (k), respectively;
0
b. By adding a new paragraph (e); and
0
c. In newly redesignated paragraph (j), by removing the number ``5'' 
and adding the number ``3'' in its place.
    The addition reads as follows:

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

* * * * *
    (e) 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 
Administrator provide their approved access status to another 
registered individual or entity for a specified period of time.
* * * * *

0
23. Section 121.11 is amended as follows:
0
a. By revising paragraph (b);
0
b. By revising paragraph (c)(2);
0
c. In paragraph (c)(6), by removing the word ``and'';
0
d. By adding new paragraphs (c)(8), (9), and (10);
0
e. By redesignating paragraphs (e) and (f) as paragraphs (g) and (h), 
respectively;
0
f. By adding new paragraphs (e) and (f); and
0
g. By revising newly redesignated paragraph (g).
    The revisions and additions read as follows:

Sec.  121.11  Security.

* * * * *
    (b) The security plan must be designed according to a site-specific 
risk assessment and must provide graded protection in accordance with 
the risk of the select agent or toxin, given its intended use. A 
current security plan must be submitted for initial registration, 
renewal of registration, or when requested.
    (c) * * *
    (2) Contain provisions for the control of access to select agents 
and toxins, including the safeguarding of animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent, against unauthorized access, theft, loss or release.
* * * * *
    (8) Describe procedures for how the responsible official will be 
informed of suspicious activity that may be criminal in nature and 
related to the entity, its personnel, or its select agents or toxins; 
and describe procedures for how the entity will notify the appropriate 
Federal, State, or local law enforcement agencies of such activity.
    (9) Contain provisions for information security that:
    (i) Ensure that all external connections to systems which manage 
security for the registered space are isolated or have controls that 
permit only authorized and authenticated users;
    (ii) Ensure that authorized and authenticated users are only 
granted access to select agent and toxin related information, files, 
equipment (e.g., servers or mass storage devices), and applications as 
necessary to fulfill their roles and responsibilities, and that access 
is modified when the user's roles and responsibilities change or when 
their access to select agents and toxins is suspended or revoked;
    (iii) Ensure that controls are in place that are designed to 
prevent malicious code (such as, but not limited to, computer viruses, 
worms, spyware) from compromising the confidentiality, integrity, or 
availability of information systems which manage access to spaces 
registered under this part or records as specified in Sec.  121.17;
    (iv) Establish a robust configuration management practice for 
information systems to include regular patching and updates made to 
operating systems and individual applications; and
    (v) Establish procedures that provide backup security measures in 
the event that access control systems, surveillance devices, and/or 
systems that manage the requirements of Sec.  121.17 are rendered 
inoperable.
    (10) Contain provisions and policies for shipping, receiving, and 
storage of select agents and toxins, including documented procedures 
for receiving, monitoring, and shipping of all select agents and 
toxins. These provisions must provide that an entity will properly 
secure containers on site and have a written contingency plan for 
unexpected shipments.
* * * * *
    (e) Entities must conduct complete inventory audits of all affected 
select agents and toxins in long-term storage when any of the following 
occur:
    (1) Upon the physical relocation of a collection or inventory of 
select agents or toxins for those select agents or toxins in the 
collection or inventory;
    (2) Upon the departure or arrival of a principal investigator for 
those select agents and toxins under the control of that principal 
investigator; or
    (3) In the event of a theft or loss of a select agent or toxin, all 
select agents and toxins under the control of that principal 
investigator.
    (f) In addition to the requirements contained in paragraphs (c) and 
(d) of this section, the security plan for an individual or entity 
possessing a Tier 1 select agent or toxin must also:
    (1) Describe procedures for conducting a pre-access suitability 
assessment of persons who will have access to a Tier 1 select agent or 
toxin;
    (2) Describe procedures for how an entity's responsible official 
will coordinate their efforts with the entity's safety and security 
professionals to ensure security of Tier 1 select agents and toxins and 
share, as appropriate, relevant information; and
    (3) Describe procedures for the ongoing assessment of the 
suitability of personnel with access to a Tier 1 select agent or toxin. 
The procedures must include:
    (i) Self- and peer-reporting of incidents or conditions that could 
affect an individual's ability to safely have access to or work with 
select agents and toxins, or to safeguard select agents and toxins from 
theft, loss, or release;
    (ii) The training of employees with access to Tier 1 select agents 
and toxins on entity policies and procedures for reporting, evaluation, 
and corrective actions concerning the assessment of personnel 
suitability; and
    (iii) The ongoing suitability monitoring of individuals with access 
to Tier 1 select agents and toxins.
    (4) Entities with Tier 1 select agents and toxins must prescribe 
the following security enhancements:
    (i) Procedures that will limit access to a Tier 1 select agent or 
toxin to only those individuals who are approved by the HHS Secretary 
or Administrator

[[Page 61080]]

following a security risk assessment by the Attorney General, have had 
an entity-conducted pre-access suitability assessment, and are subject 
to the entity's procedures for ongoing suitability assessment;
    (ii) Procedures that limit access to laboratory and storage 
facilities outside of normal business hours to only those specifically 
approved by the responsible official or designee;
    (iii) Procedures for allowing visitors, their property, and 
vehicles at the entry and exit points to the registered space, or at 
other designated points of entry to the building, facility, or compound 
that are based on the entity's site-specific risk assessment;
    (iv) A minimum of three security barriers where each security 
barrier adds to the delay in reaching secured areas where select agents 
and toxins are used or stored. One of the security barriers must be 
monitored in such a way as to detect intentional and unintentional 
circumventing of established access control measures under all 
conditions (day/night, severe weather, etc.) The final barrier must 
limit access to the select agent or toxin to personnel approved by the 
HHS Secretary or Administrator, following a security risk assessment by 
the Attorney General.
    (v) All registered space or areas that reasonably afford access to 
the registered space must be protected by an intrusion detection system 
(IDS) unless physically occupied;
    (vi) Personnel monitoring the IDS must be capable of evaluating and 
interpreting the alarm and alerting the designated security response 
force or law enforcement;
    (vii) For powered access control systems, describe procedures to 
ensure that security is maintained in the event of the failure of 
access control systems due to power disruption affecting registered 
space;
    (viii) The entity must:
    (A) Determine that the response time for security forces or local 
police will not exceed 15 minutes where the response time is measured 
from the time of an intrusion alarm, or report of a security incident, 
to the arrival of the responders at the first security barrier or;
    (B) Provide security barriers that are sufficient to delay 
unauthorized access until the response force arrives in order to 
safeguard the select agents and toxins from theft, intentional release, 
or unauthorized access. The response time is measured from the time of 
an intrusion alarm, or report of a security incident, to the arrival of 
the responders at the first security barrier.
    (5) Entities that possess foot-and-mouth disease virus and 
rinderpest virus must have the following additional security 
requirements:
    (i) A minimum of four barriers, one of which must be a perimeter 
security fence or equivalent which is monitored 24 hours a day, 7 days 
a week (24/7) to detect the presence of unauthorized persons, vehicles, 
materials, or unauthorized activities;
    (ii) Onsite 24/7 armed security response force with roving patrol. 
Response time must not exceed 5 minutes from the time of an intrusion 
alarm or report of a security incident;
    (iii) CCTV surveillance with 24/7 monitoring and recording; and
    (iv) Transport vehicle with GPS tracking designed to serve as a 
containment vehicle.
    (g) In developing a security plan, an individual or entity should 
consider the document entitled, ``Security Guidance for Select Agent or 
Toxin Facilities.'' This document is available on the Internet at 
http://www.selectagents.gov/.
* * * * *

0
24. Section 121.12 is amended as follows:
0
a. By revising paragraph (a);
0
b. By revising paragraph (c)(1);
0
c. By adding a second sentence to paragraph (c)(2);
0
d. In paragraph (c)(3), by removing the address ``http://www.aphis.usda.gov/programs/ag_selectagent/index.html '' and adding in 
its place ``http://www.selectagents.gov/ '';
0
e. By redesignating paragraph (d) as paragraph (e); and
0
f. By adding a new paragraph (d).
    The revisions and addition 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.\9\ 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.
---------------------------------------------------------------------------

    \9\ Technical assistance and guidance may be obtained by 
contacting APHIS.
---------------------------------------------------------------------------

* * * * *
    (c) * * *
    (1) The CDC/NIH publication, ``Biosafety in Microbiological and 
Biomedical Laboratories.'' This document is available on the National 
Select Agent Registry at http://www.selectagents.gov/.
    (2) * * * This document is available on the National Select Agent 
Registry at http://www.selectagents.gov/.
* * * * *
    (d) The biosafety plan must include an occupational health program 
for individuals with access to Tier 1 select agents and toxins, and 
those individuals must be enrolled in the occupational health program.
* * * * *

0
25. Section 121.13 is amended by removing footnote 10 and revising 
paragraphs (a) and (b) to read as follows:

Sec.  121.13  Restricted experiments.

    (a) An individual or entity may not conduct, or possess products 
(i.e., select agents that are not known to acquire a drug resistance 
trait naturally, if such acquisition could compromise the control of 
disease agents in humans, veterinary medicine, or agriculture, or 
recombinant and/or synthetic nucleic acids containing genes for the 
biosynthesis of select toxins lethal for vertebrates at an LD[50] kg body weight) resulting from, the following experiments unless 
approved by and conducted in accordance with the conditions prescribed 
by the Administrator:
    (b) Restricted experiments: (1) Experiments that involve the 
deliberate transfer of, or selection for, a drug resistance trait to 
select agents that are not known to acquire the trait naturally, if 
such acquisition could compromise the control of disease agents in 
humans, veterinary medicine, or agriculture.
    (2) Experiments involving the deliberate formation of synthetic or 
recombinant nucleic acids containing genes for the biosynthesis of 
select toxins lethal for vertebrates at an LD[50]kg body 
weight.
* * * * *

0
26. Section 121.14 is amended as follows:
0
a. In the section heading, by redesignating footnote 11 as footnote 10;
0
b. In paragraph (a), by redesignating footnote 12 as footnote 11 and 
revising the first sentence of paragraph (a);
0
c. By revising paragraph (b);
0
d. By redesignating paragraphs (c) and (d) as paragraphs (d) and (f), 
respectively; and
0
e. By adding new paragraphs (c) and (e).
    The revisions and additions read as follows:

[[Page 61081]]

Sec.  121.14  Incident response.\10\
---------------------------------------------------------------------------

    \10\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or 
regulations.
---------------------------------------------------------------------------

    (a) An individual or entity required to register under this part 
must develop and implement a written incident response plan \11\ based 
upon a site specific risk assessment. * * *
---------------------------------------------------------------------------

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

    (b) The incident response plan must fully describe the entity's 
response procedures for the 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, and other 
natural and man-made events.
    (c) The response procedures must account for hazards associated 
with the select agent or toxin and appropriate actions to contain such 
select agent or toxin, including any animals (including arthropods) or 
plants intentionally or accidentally exposed to or infected with a 
select agent.
* * * * *
    (e) Entities with Tier 1 select agents and toxins must have the 
following additional incident response policies or procedures:
    (1) The incident response plan must fully describe the entity's 
response procedures for failure of intrusion detection or alarm system; 
and
    (2) The incident response plan must describe procedures for how the 
entity will notify the appropriate Federal, State, or local law 
enforcement agencies of suspicious activity that may be criminal in 
nature and related to the entity, its personnel, or its select agents 
or toxins.
* * * * *

0
27. Section 121.15 is revised to read as follows:

Sec.  121.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biosafety, security (including 
security awareness), and incident response to:
    (1) Each individual with access approval from the HHS Secretary or 
Administrator before that individual has such access to select agents 
and toxins. The training must address the particular needs of the 
individual, the work they will do, and the risks posed by the select 
agents or toxins; and
    (2) Each individual not approved for access to select agents and 
toxins by the HHS Secretary or Administrator before that individual 
enters areas where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage 
areas, shipping/receiving areas, production facilities, etc.). Training 
for escorted personnel must be based on the risk associated with 
accessing areas where select agents and toxins are used and/or stored.
    (b) Entities with Tier 1 select agents and toxins must conduct 
annual insider threat awareness briefings on how to identify and report 
suspicious behaviors.
    (c) Refresher training must be provided annually for individuals 
with access approval from the HHS Secretary or Administrator or at such 
time as the registered individual or entity significantly amends its 
security, incident response, or biosafety plans.
    (d) The responsible official must ensure a record of the training 
provided to each individual with access to select agents and toxins and 
each escorted individual (e.g., laboratory workers, visitors, etc.) is 
maintained. The record must include the name of the individual, the 
date of the training, a description of the training provided, and the 
means used to verify that the employee understood the training.

0
28. Section 121.16 is amended as follows:
0
a. By redesignating footnote 14 as footnote 12;
0
b. By redesignating paragraphs (f) through (i) as paragraphs (i), (j), 
(k), and (g), respectively;
0
c. By adding a new paragraph (f);
0
d. In newly redesignated paragraph (g), by removing the words 
``packaging and''; and
0
e. By adding a new paragraph (h).
    The additions read as follows:

Sec.  121.16  Transfers.

* * * * *
    (f) After authorization is provided by APHIS or CDC, the packaging 
of the select agent(s) and toxin(s) is performed by an individual 
approved by the HHS Secretary or Administrator to have access to select 
agents and toxins and is in compliance with all applicable laws 
concerning packaging.
* * * * *
    (h) Transportation in commerce starts when the select agent(s) or 
toxin(s) are packaged for shipment and ready for receipt by a courier 
transporting select agent(s) or toxin(s) and ends when the package is 
received by the intended recipient who is an individual approved by the 
HHS Secretary or Administrator to have access to select agents and 
toxins, following a security risk assessment by the Attorney General.
* * * * *

0
29. Section 121.17 is amended as follows:
0
a. By revising paragraph (a)(1) introductory text;
0
b. By redesignating paragraphs (a)(2) through (6) as paragraphs (a)(3) 
through (7), respectively; and
0
c. By adding a new paragraph (a)(2).
    The revision and addition read as follows:

Sec.  121.17  Records.

    (a) * * *
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
organisms containing recombinant and/or synthetic nucleic acids) held 
in long-term storage (placement in a system designed to ensure 
viability for future use, such as in a freezer or lyophilized 
materials), including:
* * * * *
    (2) An accurate, current accounting of any animals or plants 
intentionally or accidentally exposed to or infected with a select 
agent (including number and species, location, and appropriate 
disposition);
* * * * *

0
30. Section 121.20 is revised to read as follows:

Sec.  121.20  Administrative review.

    (a) An individual or entity may appeal a denial, revocation, or 
suspension of registration under this part. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to 
the Administrator within 30 calendar days of the decision.
    (b) An individual may appeal a denial, limitation, or revocation of 
access approval under this part. The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the Administrator 
within 180 calendar days of the decision.
    (c) The Administrator's decision constitutes final agency action.

    Done in Washington, DC, this 28th day of September 2012.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2012-24434 Filed 10-2-12; 11:15 am]
BILLING CODE 3410-34-P
```