Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins, 13242-13292 [05-5063]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 70, Number 52 (Friday, March 18, 2005)]
[Rules and Regulations]
[Pages 13242-13292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5063]



[[Page 13241]]

-----------------------------------------------------------------------

Part II





Department of Agriculture





-----------------------------------------------------------------------



Animal and Plant Health Inspection Service



-----------------------------------------------------------------------



7 CFR Part 331 and 9 CFR Part 121



Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and 
Transfer of Biological Agents and Toxins; Final Rule

Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules 
and Regulations

[[Page 13242]]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331 and 9 CFR Part 121

[Docket No. 02-088-4]
RIN 0579-AB47


Agricultural Bioterrorism Protection Act of 2002; Possession, 
Use, and Transfer of Biological Agents and Toxins

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are adopting as a final rule, with changes, an interim rule 
that established regulations governing the possession, use, and 
transfer of biological agents and toxins that have been determined to 
have the potential to pose a severe threat to public health and safety, 
to animal health, to plant health, or to animal or plant products. This 
action is necessary to protect animal and plant health, and animal and 
plant products.

DATES: Effective Date: The amendments to the list of PPQ select agents 
and toxins in 7 CFR 331.3(b) are effective March 10, 2005. The 
remaining provisions of this final rule are effective April 18, 2005.

FOR FURTHER INFORMATION CONTACT: For information concerning the 
regulations in 7 CFR part 331, contact Dr. Charles L. Divan, Senior 
Agricultural Microbiologist, Pest Permit Evaluations, Biological and 
Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 
20737-1236, (301) 734-8758.
    For information concerning the regulations in 9 CFR part 121, 
contact Dr. Lee Ann Thomas, Director, Animals, Organisms and Vectors, 
and Select Agents, VS, APHIS, 4700 River Road Unit 2, Riverdale, MD 
20737-1231, (301) 734-5960.

SUPPLEMENTARY INFORMATION:

Background

    On June 12, 2002, the President signed into law the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. 
L. 107-188). Title II of Pub. L. 107-188, ``Enhancing Controls on 
Dangerous Biological Agents and Toxins'' (sections 201 through 231), 
provides for the regulation of certain biological agents and toxins by 
the Department of Health and Human Services (subtitle A, sections 201-
204) and the Department of Agriculture (subtitle B, sections 211-213), 
and provides for interagency coordination between the two departments 
regarding overlap agents and toxins (subtitle C, section 221). Subtitle 
D (section 231) provides for criminal penalties regarding certain 
biological agents and toxins. For the Department of Health and Human 
Services, the Centers for Disease Control and Prevention (CDC) has been 
designated as the agency with primary responsibility for implementing 
the provisions of the Act; the Animal and Plant Health Inspection 
Service (APHIS) is the agency fulfilling that role for the Department 
of Agriculture (USDA). The Criminal Justice Information Services (CJIS) 
Division of the Federal Bureau of Investigation has been designated as 
the agency with primary responsibility for implementing the Attorney 
General's responsibilities under the Act (i.e., the security risk 
assessments).
    In 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. The Act further requires (under section 213(b)) that all 
persons in possession of any listed biological agent or toxin must, 
within 60 days of the publication of that regulation, notify the 
Secretary of such possession.
    In accordance with these statutory requirements, on August 12, 
2002, we published in the Federal Register (67 FR 52383-52389, Docket 
No. 02-082-1) an interim rule that established the initial lists of 
biological agents and toxins and set out the manner in which persons in 
possession of listed agents and toxins were to provide notice of such 
possession.
    Section 212 of the Act also required the Secretary to provide by 
regulation for the establishment and enforcement of standards and 
procedures governing the possession, use, and transfer of listed 
biological agents and toxins in order to protect animal and plant 
health, and animal and plant products. Specifically, sections 212(b) 
and (c) required that the Secretary:
     Establish and enforce safety procedures for listed agents 
and toxins, including measures to ensure proper training and 
appropriate skills to handle agents and toxins, and proper laboratory 
facilities to contain and dispose of agents and toxins;
     Establish and enforce safeguard and security measures to 
prevent access to listed agents and toxins for use in domestic or 
international terrorism or for any other criminal purpose;
     Establish procedures to protect animal and plant health, 
and animal and plant products, in the event of a transfer or potential 
transfer of a listed agent or toxin in violation of the safety 
procedures and safeguard and security measures established by the 
Secretary; and
     Ensure appropriate availability of biological agents and 
toxins for research, education, and other legitimate purposes.
    In an interim rule published in the Federal Register on December 
13, 2002 (67 FR 76908-76938, Docket No. 02-088-1) and effective on 
February 11, 2003, we established regulations in 7 CFR part 331 and 9 
CFR part 121 governing the possession, use, and transfer of biological 
agents and toxins that have been determined to have the potential to 
pose a severe threat to both human and animal health, to animal health, 
to plant health, or to animal or plant products. These CFR parts are 
referred to below as the regulations. We solicited comments concerning 
the interim rule for 60 days ending February 11, 2003. We received 36 
written comments. They were from academic institutions, professional 
associations, corporations, nonprofit organizations, individuals, and 
representatives of State and Federal Governments. These comments, as 
well as oral comments presented at a public meeting on December 16, 
2002, are discussed by topic below.
    Also on December 13, 2002, CDC published in the Federal Register 
(67 FR 76886-76905) an interim rule that established the standards and 
procedures governing the possession, use, and transfer of certain 
biological agents and toxins (referred to by CDC as select agents and 
toxins) (42 CFR part 73).
    On November 3, 2003, APHIS and CDC published in the Federal 
Register (68 FR 62218-62221, Docket No. 02-088-3; and 68 FR 62245-
62247) interim rules that amended both agencies' regulations in order 
to allow for the issuance of provisional registration certificates for 
individuals and entities and provisional grants of access to listed 
biological agents and toxins for individuals. These provisional 
measures provided additional time for the Attorney General to complete 
security risk assessments for those individuals and entities for which 
the Attorney General received, by November 12, 2003, all of the 
information required to conduct a security risk assessment. We 
solicited comments concerning the

[[Page 13243]]

interim rules for 60 days ending January 2, 2004. We did not receive 
any comments by that date.
    APHIS and CDC collaborated closely on the December 13, 2002, and 
November 3, 2003, interim rules, as well as on this final rule and 
CDC's final rule also issued in today's Federal Register. Below is a 
summary of the changes we are making to the regulations in this final 
rule. We refer to the regulations in place prior to the effective date 
of this final rule as the ``interim'' regulations, or ``interim'' 7 CFR 
331.4, for example, when we need to distinguish between the regulations 
established by the interim rules of December 2002 and November 2003 and 
this final rule.

Summary of Changes Made in Final Rule

    1. We are revising the format of the regulations in 7 CFR part 331 
and 9 CFR part 121 so that the sections numbers and, to the extent 
possible, the section titles and the information contained in each 
section is the same in 7 CFR part 331, 9 CFR part 121, and 42 CFR part 
73.
    2. We are changing the terms ``biological agents and/or toxins,'' 
``listed agents and/or toxins,'' and ``high consequence livestock 
pathogens'' to ``select agents and toxins'' or ``select agents or 
toxins'' throughout 7 CFR part 331 and 9 CFR part 121. In addition, in 
9 CFR part 121, we are removing the term ``overlap agents'' each time 
it appears and adding ``overlap select agents and/or toxins'' in its 
place.
    3. We are changing the title of 7 CFR part 331 and 9 CFR part 121 
from ``Possession, Use, and Transfer of Biological Agents and Toxins'' 
to ``Possession, Use, and Transfer of Select Agents and Toxins.''
    4. We are removing Phakopsora pachyrhizi and plum pox potyvirus 
from the list of PPQ select agents and toxins.
    5. We are removing Newcastle disease virus (VVND) from the list of 
VS select agents and toxins and adding Newcastle disease virus 
(velogenic) in its place to make it clear that we are regulating all of 
the velogenic strains.
    6. We are removing Clostridium botulinum from the list of overlap 
select agents and toxins but we are continuing to list Botulinum 
neurotoxin producing species of Clostridium.
    7. We are adopting CDC's approach for genetic elements and, 
therefore, we will consider the following to be select agents and 
toxins:
     Nucleic acids that can produce infectious forms of any of 
the select agent viruses listed in either 7 CFR part 331 or 9 CFR part 
121;
     Recombinant nucleic acids that encode for the functional 
forms of any toxin listed in either 7 CFR part 331 or 9 CFR part 121 if 
the nucleic acids: (1) Can be expressed in vivo or in vitro; or (2) are 
in a vector or recombinant host genome and can be expressed in vivo or 
in vitro; and
     Select agents and toxins listed in either 7 CFR part 331 
or 9 CFR part 121 that have been genetically modified.
    8. We are broadening the scope of the overlap toxin exclusion to 
cover overlap toxins under the control of a principal investigator, 
treating physician or veterinarian, or commercial manufacturer or 
distributor.
    9. We are amending the exemption provisions by requiring, as 
another condition of exemption, that the select agent or toxin be 
secured against theft, loss, or release during the period between 
identification of the agent or toxin and transfer or destruction of 
such agent or toxin.
    10. We are amending the exemption provisions in 9 CFR part 121 by 
requiring immediate reporting after identification of specified select 
agents and toxins; identification of the other select agents and toxins 
must be reported within 7 calendar days after identification.
    11. We are amending the exemption provisions to allow the 
Administrator to make exceptions to the timeframes for transfer or 
destruction of a select agent or toxin, as necessary.
    12. We are amending the registration sections to set out a new 
framework for submitting registration applications to APHIS or CDC.
    13. We are amending the registration sections in 7 CFR part 331 and 
9 CFR part 121 to provide:
     Federal, State, or local governmental agencies, including 
public institutions of higher education, are exempt from the security 
risk assessment for the entity and the individual who owns or controls 
such entity.
     For a private institution of higher education, an 
individual will be deemed to own or control the entity if the 
individual is in a managerial or executive capacity with regard to the 
entity's select agents or toxins or with regard to the individuals with 
access to the select agents or toxins possessed, used, or transferred 
by the entity.
     For entities other than institutions of higher education, 
an individual will be deemed to own or control the entity if the 
individual: (1) Owns 50 percent or more of the entity, or is a holder 
or owner of 50 percent or more of its voting stock; or (2) is in a 
managerial or executive capacity with regard to the entity's select 
agents or toxins or with regard to the individuals with access to the 
select agents or toxins possessed, used, or transferred by the entity.
     An entity will be considered to be an institution of 
higher education if it is an institution of higher education as defined 
in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 
1001(a)), or is an organization described in 501(c)(3) of the Internal 
Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)).
    14. We are amending the registration sections to provide that a 
certificate of registration will be valid for one physical location (a 
room, a building, or a group of buildings) where the responsible 
official will be able to perform the responsibilities required in this 
part, for specific select agents or toxins, and for specific 
activities.
    15. We are amending the registration sections to require that, 
prior to any change, the responsible official must apply for an 
amendment to a certificate of registration by submitting the relevant 
page(s) of the registration application.
    16. We are amending the registration sections to provide that an 
entity must immediately notify APHIS or CDC if it loses the services of 
its responsible official. An entity may continue to possess or use 
select agents or toxins only if it appoints as the responsible official 
another individual who has been approved by the Administrator or the 
HHS Secretary following a security risk assessment by the Attorney 
General and who meets the requirements of the regulations.
    17. We are amending the sections pertaining to denial, revocation, 
and suspension of registration by requiring that, upon notification of 
suspension or revocation, an individual or entity must:
     Immediately stop all use of each select agent or toxin 
covered by the revocation or suspension order;
     Immediately safeguard and secure each select agent or 
toxin covered by the revocation or suspension order from theft, loss, 
or release; and
     Comply with all disposition instructions issued by the 
Administrator for each select agent or toxin covered by the revocation 
or suspension.
    18. We are amending the responsible official sections to require 
the responsible official to report the identification and final 
disposition of any select agent or toxin contained in a specimen 
presented for diagnosis or verification. We are also amending the 
responsible official section in 9 CFR 121.9 to require the responsible 
official to report the identification and final disposition of any 
select agent or toxin

[[Page 13244]]

contained in a specimen presented for proficiency testing.
    19. We are amending the provisions relating to access approvals to 
state that an individual will be deemed to have access at any point in 
time if the individual has possession of a select agent or toxin (e.g., 
carries, uses, or manipulates) or the ability to gain possession of a 
select agent or toxin.
    20. We are amending the provisions pertaining to access approval to 
provide that an individual's access approval may be revoked if the 
individual is within any of the categories specified in the 
regulations.
    21. We are amending the security sections to clarify that the 
security plan must be sufficient to safeguard the select agent or toxin 
against unauthorized access, theft, loss, or release.
    22. We are adding the provisions for restricted experiments to 7 
CFR part 331 and we are amending these provisions in 7 CFR part 331 and 
9 CFR part 121 to indicate that these experiments must be conducted 
under any conditions prescribed by the Administrator.
    23. We are amending the training sections to require that 
information and training on biocontainment/biosafety and security be 
provided to each individual with access approval from the Administrator 
or the HHS Secretary before he/she has access and to each individual 
not approved for access by the Administrator or the HHS Secretary 
before he/she works in or visits areas where select agents or toxins 
are handled or stored (e.g., laboratories, growth chambers, animal 
rooms, greenhouses, storage areas, etc.).
    24. We are amending the transfer section in 9 CFR 121.16 to set out 
the requirements for transfer of a select agent or toxin contained in a 
specimen for proficiency testing.
    25. We are amending the transfer sections to provide that, on a 
case-by-case basis, the Administrator may authorize a transfer of a 
select agent or toxin not otherwise eligible for transfer under the 
regulations under conditions prescribed by the Administrator.
    26. We are amending the transfer sections to provide that an 
authorization for a transfer shall be valid only for 30 calendar days 
after issuance, except that such an authorization becomes immediately 
null and void if any facts supporting the authorization changes (e.g., 
change in the certificate of registration for the sender or recipient, 
change in the application for transfer).
    27. We are amending the records sections to require the maintenance 
of an accurate, current inventory for each toxin held and for each 
select agent held in long-term storage (placement in a system designed 
to ensure viability for future use, such as in a freezer or lyophilized 
materials).
    28. We are amending the section pertaining to notification of 
theft, loss, or release in 7 CFR part 331 to require that APHIS or CDC 
be notified immediately upon discovery of a release of a select agent 
or toxin outside of the primary barriers of the biocontainment area and 
we are amending this section in 9 CFR part 121 to require that APHIS or 
CDC be notified immediately upon discovery of a release of a select 
agent or toxin causing occupational exposure or a release outside of 
the primary barriers of the biocontainment area.
    29. We are amending the administrative review sections to allow an 
individual to appeal revocation of access approval.

Format of the Regulations

    APHIS and CDC are revising the format of the regulations in the 
final rules so that the section numbers and, to the extent possible, 
the section titles and the information contained in each section is the 
same in 7 CFR part 331, 9 CFR part 121, and 42 CFR part 73. These 
changes should make the regulations easier to use and facilitate 
compliance. The chart below sets out the format of 7 CFR part 331 and 9 
CFR part 121 set by the interim rules (interim regulations) and the new 
format for the regulations in 7 CFR part 331 and 9 CFR part 121 (final 
rule).

------------------------------------------------------------------------
          Interim regulations                       Final rule
------------------------------------------------------------------------
331.0 Effective and applicability dates
121.0 Effective and applicability dates
331.1 Definitions......................  331.1 Definitions.
121.1 Definitions......................  121.1 Definitions.
331.2 Purpose and scope................  331.2 Purpose and scope.
121.2 Purpose and scope................  121.2 Purpose and scope.
331.3 List of biological agents and      331.3 PPQ select agents and
 toxins.                                  toxins.
121.3 List of biological agents and      121.3 VS select agents and
 toxins.                                  toxins.
331.4 Exemptions.......................  331.4 [Reserved].
121.4 Exemptions for overlap agents or   121.4 Overlap select agents and
 toxins.                                  toxins.
331.5 Registration; who must register..  331.5 Exemptions.
121.5 Exemptions for animal agents and   121.5 Exemptions for VS select
 toxins.                                  agents and toxins.
331.6 Registration; general provisions.  331.6 [Reserved]
121.6 Registration; who must register..  121.6 Exemptions for overlap
                                          select agents and toxins.
331.7 Denial, revocation, or suspension  331.7 Registration and related
 of registration.                         security risk assessments.
121.7 Registration; general provisions.  121.7 Registration and related
                                          security risk assessments.
331.8 Registration; how to register....  331.8 Denial, revocation, or
                                          suspension of registration.
121.8 Denial, revocation, or suspension  121.8 Denial, revocation, or
 of registration.                         suspension of registration.
331.9 Responsibilities of the            331.9 Responsible official.
 responsible official.
121.9 Registration; how to register....  121.9 Responsible official.
331.10 Restricting access to biological  331.10 Restricting access to
 agents and toxins.                       select agents and toxins;
                                          security risk assessments.
121.10 Responsibilities of the           121.10 Restricting access to
 responsible official.                    select agents and toxins;
                                          security risk assessments.
331.11 Biocontainment and security plan  331.11 Security.
121.11 Restricting access to biological  121.11 Security.
 agents and toxins.
331.12 Training........................  331.12 Biocontainment.
121.12 Biosafety and security plan.....  121.12 Biosafety.
331.13 Transfer of biological agents     331.13 Restricted experiments.
 and toxins.
121.13 Training........................  121.13 Restricted experiments.
331.14 Records.........................  331.14 Incident response.
121.14 Transfer of biological agents     121.14 Incident response.
 and toxins.
331.15 Inspections.....................  331.15 Training.

[[Page 13245]]

 
121.15 Records.........................  121.15 Training.
331.16 Notification in the event of      331.16 Transfers.
 theft, loss, or release of a
 biological agent or toxin.
121.16 Inspections.....................  121.16 Transfers.
331.17 Administrative review...........  331.17 Records.
121.17 Notification in the event of      121.17 Records.
 theft, loss, or release of a
 biological agent or toxin.
121.18 Administrative review...........  331.18 Inspections.
                                         121.18 Inspections.
                                         331.19 Notification of theft,
                                          loss, or release.
                                         121.19 Notification of theft,
                                          loss, or release.
                                         331.20 Administrative review.
                                         121.20 Administrative review.
------------------------------------------------------------------------

General Comments

    A commenter suggested that APHIS and CDC adopt consistent 
terminology when referring to biological agents and toxins. The 
commenter pointed out that the regulations use the following terms: 
biological agents and toxins, select agents and toxins, overlap agents, 
and high consequence pathogens.
    We agree that APHIS and CDC should use consistent terminology. 
Therefore, in this final rule, we are removing the terms ``biological 
agents and/or toxins,'' ``listed agents and/or toxins,'' and ``high 
consequence livestock pathogens'' each time they appear in 7 CFR part 
331 and/or 9 CFR part 121 and adding ``select agents and/or toxins'' in 
their place. In addition, in 9 CFR part 121, we are removing the term 
``overlap agents'' each time it appears and adding ``overlap select 
agents and/or toxins'' in its place. To reflect this change in 
terminology, we are also changing the title of both parts from 
``Possession, Use, and Transfer of Biological Agents and Toxins'' to 
``Possession, Use, and Transfer of Select Agents and Toxins.'' In 
accordance with these changes, we will be using the term ``select agent 
and/or toxin'' throughout the preamble of this rule. When it is 
necessary to specify the type of select agent or toxin, we will use the 
following terms: ``PPQ select agent and/or toxin'' (for the plant 
agents and toxins), ``VS select agent and/or toxin'' (for the animal 
agents and toxins), or ``overlap select agent and/or toxin.'' Unless 
otherwise specified, the term ``select agent and/or toxin'' will refer 
to all agents or toxins listed by APHIS.
    One commenter stated that APHIS and CDC should harmonize the 
regulations and provide consistent guidance to entities. This commenter 
also recommended close collaboration between the agencies for 
registration, enforcement, and compliance assistance. Another commenter 
recommended that APHIS and CDC establish one regulatory and reporting 
mechanism and one office of compliance assistance and enforcement in 
order to enhance coordination between APHIS and CDC.
    We agree that APHIS and CDC should harmonize the regulations and 
provide consistent guidance to entities. APHIS and CDC have worked 
closely together to identify and resolve differences between the 
regulations. This final rule is consistent with CDC's final rule in 
both structure and substance. APHIS and CDC have also established 
procedures that will allow an entity to interact with only one agency--
either APHIS or CDC--with respect to most matters involving select 
agents and toxins. These changes will ensure the close coordination of 
APHIS and CDC and create a uniform and consistent approach to the 
regulation of select agents and toxins. APHIS and CDC are also 
developing a single shared web-based system that will allow the 
regulated community to conduct transactions electronically with APHIS 
and CDC via a single web portal. By providing a single web portal, 
APHIS and CDC will be able to interact efficiently and effectively with 
the regulated community while reducing the burden on the public. We 
envision that this system will enable the entity to dynamically 
communicate with APHIS and CDC in a digitally secured environment using 
a single web portal. The web portal will provide a platform for 
electronic exchange of information. It will allow entities to access 
data related to their own registration data and allow them to create, 
amend, and submit registration applications; requests for approvals for 
transfers, exemptions, or exclusions; and any other required forms 
without the need to print, mail, or e-mail hard copies. Hard copy 
registration materials and other required forms will still be accepted. 
The single web portal will be available in winter 2005.
    A number of commenters expressed concern about the effect of the 
regulations on the scientific community. Several commenters stated that 
the regulations will limit the free exchange of scientific information 
and make it difficult to recruit foreign researchers and technical 
workers in areas of short supply in the United States. Several 
commenters asserted that the costs of the regulations (especially the 
security requirements) will result in the termination of important 
research projects and the destruction of specimens. One commenter 
stated that research programs will be terminated because researchers 
will not want to deal with the new regulatory requirements or their 
institutions will not want to be liable for violations of the 
regulations. This commenter also noted that the costs of adhering to 
the regulations will limit the money available for the research. 
Another commenter stated that scientists will end up spending more time 
dealing with bureaucratic requirements rather than working in the 
laboratory or supervising their employees.
    The Act requires the Secretary to establish, by regulation, 
standards and procedures governing the possession, use, and transfer of 
listed biological agents and toxins in order to protect animal and 
plant health, and animal and plant products. In an interim rule 
published in the Federal Register on December 13, 2002, and effective 
on February 11, 2003, APHIS established the regulations required under 
the Act. To date, the commenters' concerns about the costs or 
difficulties of complying with the regulations have failed to 
materialize. Accordingly, we are making no changes in response to these 
comments.
    Several commenters requested that APHIS and CDC create a grant 
program to assist entities with the costs of implementing the security 
requirements.
    At this time APHIS is unable to assist entities with the costs of 
implementing the security requirements because

[[Page 13246]]

Congress has not appropriated any funds to establish such a grant 
program. Accordingly, we are making no change based on these comments.
    One commenter requested that APHIS specify in the final rule that 
it is the regulatory agency for the veterinary biologics industry.
    An entity in the veterinary biologics industry may be regulated by 
APHIS and/or CDC, depending on the agent or toxin that it possesses, 
uses, or transfers--overlap select agents and toxins are regulated by 
both APHIS and CDC, while VS select agents and toxins are regulated 
only by APHIS. For this reason, we are making no change in response to 
this comment.
    A commenter stated that the regulations should be revoked and 
replaced with prohibitions on owning, working with, or importing any of 
the agents or products. This commenter recommended that the penalty for 
possession of a select agent be a fine of $500,000 or imprisonment for 
up to 25 years.
    The Act does not authorize APHIS to prohibit the possession, use, 
or transfer of biological agents and toxins. Rather, section 212 of the 
Act directs APHIS to establish, by regulation, standards and procedures 
governing the possession, use, and transfer of biological agents and 
toxins that have been determined to have the potential to pose a severe 
threat to both human and animal health, to animal health, to plant 
health, or to animal or plant products. The Act also sets forth the 
civil and criminal penalties for violations of the Act. For these 
reasons, we are making no changes based on this comment.
    One commenter warned of the potential for international travelers 
to bring biological ``suitcase bombs'' into the United States from 
countries with bovine spongiform encephalopathy, foot-and-mouth 
disease, or other exotic animal disease pathogens.
    This commenter appears to be concerned about the introduction of 
animal disease pathogens into the United States in the luggage of 
international travelers. This comment is outside the scope of this 
rulemaking. However, we note that VS select agents or toxins and 
overlap select agents or toxins may only be imported into the United 
States in accordance with 9 CFR parts 121 and 122. We are making no 
change based on this comment.

Protection of Information Collected by APHIS

    Several commenters expressed concern about APHIS' ability to 
protect the information collected under the regulations. One commenter 
asked how APHIS would store and protect the information collected. 
Another commenter stated that USDA should ensure that the information 
collected is not available through Freedom of Information Act requests.
    Section 212(h) of the Act sets forth the requirements relating to 
the disclosure of information by APHIS and other Federal agencies. 
Specifically, section 212(h)(1) provides that the specified Federal 
agencies may not disclose under 5 U.S.C. 552 any of the following: (1) 
Any registration or transfer documentation, permits issued prior to the 
enactment of the Act, or information derived therefrom to the extent 
that it identifies the agent or toxin possessed, used, or transferred 
by a specific person or discloses the identity or location of a 
specific person; (2) the national database or any other compilation of 
the registration or transfer information to the extent that such 
compilation discloses site-specific registration or transfer 
information; (3) any portion of a record that discloses the site-
specific or transfer-specific safeguard and security measures used by a 
registered person to prevent unauthorized access to agents and toxins; 
(4) any notification of a theft, loss, or release of an agent or toxin; 
and (5) any portion of an evaluation or report of an inspection of a 
specific registered person that identifies the agent or toxin possessed 
by a specific registered person if the agency determines that public 
disclosure of the information would endanger animal or plant health, or 
animal or plant products. We believe the Act provides sufficient 
protection for the information collected under the regulations. 
Accordingly, we are making no changes based on these comments.
    A commenter stated the rule should explicitly state that the 
security risk assessment is confidential.
    As previously noted, we believe the Act provides sufficient 
protection for the information collected under the regulations. We do 
not believe it is necessary to state in the regulations that the 
security risk assessment is confidential. Therefore, we are making no 
change based on this comment.
    Another commenter asserted that the information collected by APHIS 
for the security risk assessment should not be used more broadly than 
to determine who is a ``restricted person.'' The commenter noted that 
California State law prohibits discrimination in employment based upon 
citizenship and prohibits the disclosure of citizenship information to 
a third party in a manner that links that information to the 
individual, except in limited and compelling circumstances. The 
commenter expressed concern that the data collected for registration or 
a security risk assessment might be used inappropriately by a Federal 
agency to assess a proposal for funding. The commenter recommended that 
APHIS, CDC, and the Department of Justice take steps to ensure the 
security and confidentiality of submitted information.
    In accordance with the Act, the information submitted by an 
individual as part of a security risk assessment may only be used to 
determine if an individual is a restricted person under 18 U.S.C. 175b 
or is reasonably suspected by any Federal law enforcement or 
intelligence agency of (1) committing a crime set forth in 18 U.S.C. 
2332b(g)(5), (2) knowing involvement with an organization that engages 
in domestic or international terrorism (as defined in 18 U.S.C. 2331) 
or with any other organization that engages in intentional crimes of 
violence, or (3) being an agent of a foreign power as defined in 50 
U.S.C. 1801. We believe that the Act and other applicable Federal laws, 
such as the Privacy Act, are sufficient to ensure the confidentiality 
of the submitted information. We are making no change in response to 
this comment.
    A commenter asked how APHIS inspectors will mark and protect their 
inspection reports. APHIS inspection reports and related documents will 
be protected in accordance with the Act and agency and departmental 
policies.

Economic Impact

    Several commenters argued that the costs of compliance were grossly 
understated in the economic analysis for the December 2002 interim 
rule. One commenter stated that the one-time cost to retrofit existing 
facilities will easily exceed $1 million and that recurring annual 
costs could top $100,000.
    Although the commenter didn't specify, we believe that the 
commenter is referring to the costs to upgrade security. In our 
December 2002 economic analysis, we provided estimates of the costs of 
the interim security requirements. However, we noted that these 
estimates may not apply to every entity due to the diversity in 
existing security levels and security needs, as well as the various 
methods of meeting the interim security requirements. In the economic 
analysis in this final rule, we reiterate that the costs to comply with 
the security requirements are site specific and will vary accordingly.
    Another commenter stated that the interim rule ignored or grossly 
underestimated financial costs,

[[Page 13247]]

including the costs of verifying the baseline inventory and the costs 
of responding to lost vial reports. The commenter estimated that the 
one-time cost to verify the baseline inventory will be $2 million with 
recurring costs of about $1 million per year. The commenter also 
estimated that it will cost about $5 million per year to respond to 
reports of lost vials of select agents because the response would 
require, at least, a verification of the inventory.
    In response to this comment, the economic analysis in this final 
rule provides more information about the costs of the inventory 
recordkeeping requirements. In this final rule, we estimate that it 
would cost an entity $7,200 to create a baseline inventory (assuming an 
average of 10 freezers and 3 toxin containers per entity). Assuming 
that registered entities would have to re-inventory one-half of their 
freezers each year to maintain an accurate and current inventory, we 
estimate the total yearly inventory cost for all affected entities to 
be $274,000. Finally, in the event of a theft or loss, we expect an 
entity would conduct an inventory of the affected storage freezer or 
toxin container. We estimate that such an inventory would cost $560 per 
occurrence.

Effective and Applicability Dates

    Interim 7 CFR 331.0 and 9 CFR 121.0 provided that the regulations 
in each part became effective on February 11, 2003. To minimize the 
disruption of research or educational projects, both sections also 
provided additional time for individuals and entities to reach full 
compliance with the regulations in each part (i.e., a phase-in period). 
Finally, as established in the November 3, 2003, interim rule, both 
sections provided for the issuance of provisional certificates of 
registration and provisional grants of access for individuals under 
certain conditions.
    A number of commenters requested clarification of the provisions 
for the phase-in period and several commenters requested additional 
time to comply with certain provisions. Given that all of the dates in 
7 CFR 331.0 and 9 CFR 121.0 have passed, the sections are no longer 
applicable and the issues raised by the commenters are moot. 
Accordingly, in this final rule, we are removing 7 CFR 331.0 and 9 CFR 
121.0.

Definitions

    In 7 CFR 331.1 and 9 CFR 121.1, we define the terms used in the 
regulations. We are adding definitions of diagnosis and verification in 
both sections in this final rule. Diagnosis is defined as ``the 
analysis of specimens for the purpose of identifying or confirming the 
presence or characteristics of a select agent or toxin provided that 
such analysis is directly related to protecting the public health or 
safety, animal health or animal products, or plant health or plant 
products.'' Verification is defined as ``the demonstration of obtaining 
established performance (e.g., accuracy, precision, and the analytical 
sensitivity and specificity) specifications for any procedure used for 
diagnosis.'' In addition, in 9 CFR 121.1, we are amending the 
definition of proficiency testing. Proficiency testing is defined as 
``the process of determining the competency of an individual or 
laboratory to perform a specified test or procedure.'' Finally, we are 
deleting the definition for diagnostic laboratory in both sections and 
we are deleting the definition for clinical laboratory in 9 CFR 121.1. 
These changes will clarify the exemption provisions and help to ensure 
that APHIS and CDC consistently apply these provisions.
    To be consistent with CDC's definitions, we are adopting CDC's 
definitions for HHS Secretary and HHS select agent and/or toxin in both 
sections in this final rule. HHS Secretary is defined as ``the 
Secretary of the Department of Health and Human Services or his or her 
designee, unless otherwise specified.'' HHS select agent and/or toxin 
is defined as ``a biological agent or toxin listed in 42 CFR 73.3.''
    A commenter suggested that APHIS and CDC adopt consistent 
terminology when referring to biological agents and toxins. As 
previously noted, in this final rule we are adopting the terms ``select 
agents and/or toxins'' and ``overlap select agents and/or toxins.'' To 
reflect this change in terminology, we are adding several additional 
definitions to the regulations.
    In 7 CFR 331.1 and 9 CFR 121.1, we are adding a definition for the 
term select agent and/or toxin. However, due to differences between the 
plant-related regulations in 7 CFR part 331 and the animal-related 
regulations in 9 CFR part 121, the term select agent and/or toxin is 
defined differently in both parts. In 7 CFR 331.1, select agent and/or 
toxin is defined as ``a biological agent or toxin listed in Sec.  
331.3'' while in 9 CFR 121.1 it is defined as ``unless otherwise 
specified, all of the biological agents and toxins listed in Sec. Sec.  
121.3 and 121.4.'' The latter definition takes into account the fact 
that overlap select agents and toxins are also regulated under 9 CFR 
part 121.
    In 9 CFR 121.1, we are removing the definition for overlap agent or 
toxin and adding a definition for overlap select agent and/or toxin in 
its place. Overlap select agent and/or toxin is defined as ``a 
biological agent or toxin that is listed in 9 CFR 121.4 and 42 CFR 
73.4.'' We are also adding definitions for VS and VS select agent and/
or toxin in Sec.  121.1. VS is defined as ``the Veterinary Services 
Programs of the Animal and Plant Health Inspection Service'' and VS 
select agent and/or toxin is defined as ``a biological agent or toxin 
listed in Sec.  121.3.''
    One commenter claimed that the term ``entity'' is subject to 
interpretation. The commenter stated that it does not make sense for a 
large multi-campus university to base cumulative limits on toxins or 
the designation of the responsible official on the entity when the 
actual labs are separated by hundreds of miles. Another commenter 
stated the definition of ``entity'' should be amended to permit a 
responsible official to discharge his or her responsibilities at 
several adjacent addresses.
    These issues are addressed below in the registration section. We 
are making no change to the definitions section in 7 CFR 331.1 and 9 
CFR 121.1 based on these comments.
    One commenter recommended that APHIS and CDC adopt a common 
definition for the term ``responsible official.'' The commenter noted 
that APHIS defines the term ``responsible official'' but CDC does not. 
The commenter stated that APHIS indicates a responsible manager should 
be the responsible official for an entity, while CDC would allow a 
biosafety officer to assume this role. The commenter stated that, in 
general, a biosafety officer would not have direct control over either 
the affected staff or budgets in order to ensure compliance with the 
regulations.
    We agree that APHIS and CDC should adopt a common definition for 
the term ``responsible official.'' Accordingly, we are amending the 
definition for responsible official in this final rule. In 7 CFR 331.1 
and 9 CFR 121.1, we define responsible official as ``the individual 
designated by an entity with the authority and control to ensure 
compliance with the regulations in this part.'' CDC is adopting the 
same definition in its final rule.
    A commenter stated that APHIS should clarify the term ``facility.'' 
The commenter said the term appears to refer to a complete building or 
complex in some parts of the rule but to an individual laboratory/room 
in other parts of the rule.
    APHIS uses the term ``facility'' in the definition for diagnostic 
laboratory in 7 CFR 331.1 and in the definitions for clinical 
laboratory and diagnostic

[[Page 13248]]

laboratory in 9 CFR 121.1. The term does not appear elsewhere in the 
regulations. Accordingly, we are making no change based on this 
comment.
    A commenter recommended that APHIS define the term ``access'' to 
mean actual, physical contact with the agent or the realistic 
opportunity for same.
    This issue is addressed below in the sections relating to security 
risk assessments and security. We are making no change to the 
definitions in 7 CFR 331.1 or 9 CFR 121.1 based on this comment.
    One commenter stated that 9 CFR 121.1 should define the term 
``exotic'' so that the term can be removed from the list of agents.
    This issue is addressed below in the section relating to the lists 
of VS and overlap select agents and toxins. Therefore, we are making no 
change to the definitions in 9 CFR 121.1 in response to this comment.

Purpose and Scope

    Interim 7 CFR 331.2 and 9 CFR 121.2 set out the purpose and scope 
of the regulations. Specifically, 7 CFR 331.2(a) stated that part 331 
sets forth the requirements for possession, use, and transfer of 
biological agents or toxins that have been determined to have the 
potential to pose a severe threat to plant health or plant products, 
while 9 CFR 121.2(a) stated that part 121 sets forth the requirements 
for possession, use, and transfer of biological agents or toxins that 
have been determined to have the potential to pose a severe threat to 
both human and animal health, or to animal health or animal products. 
Both sections noted that the purpose of the regulations is to ensure 
the safe handling of such agents or toxins, and to protect against the 
use of such agents or toxins in domestic or international terrorism or 
for any other criminal purpose.
    In this final rule, we are amending both sections to clarify that 
each part implements the provisions of the Agricultural Bioterrorism 
Protection Act of 2002. Furthermore, we are amending 9 CFR 121.2 to 
clarify that overlap select agents and toxins are subject to regulation 
by both APHIS and CDC.
    In interim 7 CFR 331.2 and 9 CFR 121.2, paragraphs (b) and (c) 
summarized the regulatory requirements. Since these provisions are 
already set forth in other sections of the regulations, we believe it 
is unnecessary to summarize them in these sections. Therefore, in this 
final rule, we are removing paragraphs (b) and (c) in 7 CFR 331.2 and 9 
CFR 121.2, and removing the paragraph designation for paragraph (a) in 
both sections since it is no longer necessary.

List of Biological Agents and Toxins

    In accordance with the Act, interim 7 CFR 331.3 and 9 CFR 121.3 
listed certain biological agents and toxins.
    Section 212(a)(2) of the Act requires that the lists of biological 
agents and toxins be reviewed and republished biennially, or more often 
as needed, and revised as necessary. In addition, the Act requires 
that, when determining whether to include an agent or toxin, the 
Secretary shall consult with appropriate Federal departments and 
agencies and with scientific experts representing appropriate 
professional groups.
    This final rule serves as APHIS' republication of the lists of 
select agents and toxins in 7 CFR 331.3 and 9 CFR 121.3, and in newly 
designated 9 CFR 121.4. As part of APHIS' review of the lists of agents 
and toxins, we reviewed current scientific information and studies and 
consulted with other Federal agencies. We also reviewed and considered 
the comments to the December 2002 interim rule on the lists of agents 
and toxins.
    As previously noted, in this final rule, we are amending the 
structure of both parts to be consistent with CDC's select agent 
regulations. In 9 CFR part 121, we are creating separate sections for 
the lists of VS select agents and toxins and overlap select agents and 
toxins--Sec. Sec.  121.3 and 121.4, respectively. We are also adding a 
new paragraph (a) to 7 CFR 331.3, containing introductory text, so that 
the format of the section is consistent with the format in 9 CFR 121.3 
and 9 CFR 121.4.
    One commenter recommended that APHIS include in the regulations a 
summary of the risk assessment data that supports the listing of each 
agent and toxin. The commenter stated that the data will heighten 
awareness of the risk characteristics of the listed agents and will 
promote safe practice and proficiency in handling such agents.
    APHIS does not include risk assessment data in the regulations; 
rather, such information is discussed in a rule's preamble. As noted in 
the preamble of the August 2002 interim rule, the Act requires APHIS to 
consider the following criteria in determining whether to list an agent 
or toxin: (1) The effect of exposure to the agent or toxin on animal or 
plant health, and on the production and marketability of animal or 
plant products; (2) the pathogenicity of the agent or the toxicity of 
the toxin and the methods by which the agent or toxin is transferred to 
animals or plants; (3) the availability and effectiveness of 
pharmacotherapies and prophylaxis to treat and prevent any illness 
caused by the agent or toxin; and (4) any other criteria the Secretary 
considers appropriate to protect animal or plant health, or animal or 
plant products.
    We do not believe it is necessary to provide a summary of the risk 
assessment data that supports the listing of each select agent or toxin 
in order to heighten awareness of the risk characteristics of such 
agents and toxins and promote safe practice and proficiency in handling 
of such agents and toxins. Information about the risk characteristics 
of a select agent or toxin and safe handling practices is available in 
scientific literature and other publications (e.g., the CDC/NIH 
publication, ``Biosafety in Microbiological and Biomedical 
Laboratories''). For these reasons, we are making no change based on 
this comment.
    Interim 7 CFR 331.3(a) (newly designated Sec.  331.3(b)) listed the 
biological agents and toxins that have been determined to pose a severe 
threat to plant health or to plant products (PPQ select agents and 
toxins).
    In this final rule, we are removing Phakopsora pachyrhizi, also 
known as Asian soybean rust, from the list of PPQ select agents and 
toxins. Asian soybean rust has been introduced into the United States 
by natural means and now it would have virtually no impact if used as a 
weapon of terrorism. Asian soybean rust was detected in the United 
States in November 2004. All available evidence suggests that spores 
were blown into the United States during a series of hurricanes in 
2004. Detection surveys indicate that it is present in at least nine 
southeastern States; however, USDA is conducting additional surveys to 
determine the full extent of the introduction. Because Asian soybean 
rust has a host range of more than 90 plant species and its spores 
disperse naturally on wind currents, this disease will continue to 
spread naturally and it cannot be controlled effectively. We expect 
that this disease will quickly reach the full extent of its ecological 
range in the United States. As a result, there is an urgent need for 
timely research on effective means to manage the disease in the United 
States. For all of these reasons, we are removing Phakopsora pachyrhizi 
from the list of PPQ select agents and toxins. However, we note that a 
permit will still be required for importation or interstate movement of 
Asian soybean rust (7 CFR part 330).
    A commenter claimed that, pursuant to the rules of the 
International Code of Nomenclature of Bacteria, two bacteria

[[Page 13249]]

have been renamed; thus, Liberobacter africanus should be Candidatus 
Liberobacter africanus, and Liberobacter asiaticus should be Candidatus 
Liberobacter asiaticus.
    We agree. Therefore, in this final rule, we are replacing the entry 
for Liberobacter africanus with Candidatus Liberobacter africanus and 
replacing Liberobacter asiaticus with Candidatus Liberobacter 
asiaticus. In addition, we are placing Candidatus Liberobacter 
africanus and Candidatus Liberobacter asiaticus on separate lines in 
order to make it clear that each one is a select agent.
    One commenter argued that plum pox potyvirus should not be listed 
as a select agent because it is only naturally transmitted by aphids, 
and, without the insect vector to transmit the disease from one plant 
to another, the possibility of the virus being used as a weapon of 
terrorism is extremely small. The commenter stated that laboratory 
research of this agent, in the absence of its natural vector and only 
known means of transmission, poses little to no risk to plant health or 
plant products.
    We agree that plum pox potyvirus (PPV) has limited potential as a 
weapon of terrorism given its biological characteristics. PPV is not 
easily transmitted and does not spread easily. The natural host range 
is limited to plants in the genus Prunus (e.g., plums and other stone 
fruits). The natural spread of the disease requires insect vectors 
(aphids), and is a complex biological process, and artificial spread 
requires grafting, which is labor intensive and time-consuming. PPV is 
not spread by pollen or seed. While systemic treatments are not 
completely effective at mitigating the disease, destruction of infected 
trees mitigates the effects of the disease, removal of the diseased 
trees and other susceptible hosts removes the source of infection, and 
transmission can be halted by removing host material from the area. 
Furthermore, most strains of PPV attack only a few varieties of stone 
fruits, which limits the affect of an outbreak on the production and 
marketability of stone fruits. For these reasons, in this final rule, 
we are removing plum pox potyvirus from the list of PPQ select agents 
and toxins. However, we note that PPV continues to be a quarantine pest 
under the domestic plant regulations (7 CFR 301.74 through 301.74-5).
    Another commenter asserted that Ralstonia solanacearum, race 3, 
biovar 2, should not be listed as a select agent. This commenter stated 
that the bacterium is unlikely to become established in the northern 
United States, where potatoes are commercially grown, because it is 
intolerant of freezing and does not generally survive winters in 
regions with sustained temperatures below 20 [deg]F. The commenter 
claimed that, even if the bacterium became established, it is unlikely 
to cause an economically damaging disease outbreak in the climactic 
conditions characteristic of North America. The commenter went on to 
note that the bacterium has been repeatedly introduced into the United 
States without impact.
    APHIS has determined that Ralstonia solanacearum, race 3, biovar 2, 
has the potential to pose a severe threat to plant health or plant 
products. The bacterium is known to attack a number of economically 
significant hosts (e.g., geraniums and tomatoes), not just potatoes. 
Some of the known hosts are grown in greenhouses (e.g., geraniums), 
which protect them from local climatic conditions, and some hosts are 
grown in fields throughout the United States (e.g., tomatoes and 
potatoes). With regard to potatoes, scientific data indicate the 
potential range of the bacterium would include the potato-growing 
regions in the United States. Ralstonia solanacearum, race 3, biovar 2, 
occurs in Europe as far north as the 56th parallel (southern 
Scandinavia), which parallels regions of Canada. Furthermore, there are 
a number of wild hosts that would contribute to the spread of the 
bacterium if it were introduced into the United States. For these 
reasons, we are making no changes based on this comment.
    Interim 9 CFR 121.3(d) (newly designated Sec.  121.3(b)) listed the 
biological agents and toxins that have been determined to have the 
potential to pose a severe threat to animal health or to animal 
products (VS select agents and toxins).
    A commenter asserted that listing Japanese encephalitis virus (JEV) 
as a select agent will negatively impact research on this disease, as 
well as on West Nile virus and dengue virus. This commenter stated that 
there does not appear to be sufficient justification for making 
Japanese encephalitis virus a select agent.
    We disagree that there is insufficient justification for listing 
Japanese encephalitis virus as a VS select agent. The virus can cause 
severe disease in horses and swine for which there is no effective 
treatment and no domestically available veterinary vaccine. While the 
select agent regulations may affect research on JEV, we expect it will 
have a negligible effect on associated research on West Nile virus and 
dengue virus. For these reasons, we are making no change in response to 
this comment.
    Several commenters questioned the inclusion of malignant catarrhal 
fever virus (exotic) on the list of select agents. One commenter stated 
the disease malignant catarrhal fever virus is caused be a variety of 
herpes viruses, none of which is known as malignant catarrhal fever 
virus. The commenter stated that Alcelaphine herpesvirus type 1 infects 
most wildebeest and spreads to domestic cattle causing malignant 
catarrhal fever in Africa. The commenter argued that malignant 
catarrhal fever virus (exotic) should be replaced with Alcelaphine 
herpesvirus type 1. Another commenter argued that the biological 
features of malignant catarrhal fever viruses prevent them from being 
effective bioterror agents. The commenter noted that Alcelaphine 
herpesvirus type 1 can only be transmitted by parenteral injection and 
cow-to-cow transmission does not occur under natural conditions. This 
commenter also argued that it is misleading to label malignant 
catarrhal fever as ``exotic'' since it is present wherever there are 
wildebeests, from zoos to exotic game farms.
    We agree that clarification is needed with regard to the term 
malignant catarrhal fever virus. Accordingly, in this final rule we are 
replacing the entry for malignant catarrhal fever virus with malignant 
catarrhal fever virus (Alcelaphine herpesevirus type 1). However, we 
disagree that the biological features of malignant catarrhal fever 
viruses prevent them from being effective bioterror agents. Malignant 
catarrhal fever virus (Alcelaphine herpesevirus type 1) causes severe 
disease in cattle, and it may be possible for the virus to be 
transmitted from cow to cow. Currently, this virus is not found in U.S. 
cattle populations, and a widespread outbreak of the disease would 
likely result in widespread animal movement restrictions that could be 
long term, at least with respect to exports. We are making no change in 
response to this comment.
    One commenter suggested that Newcastle disease virus (VVND) be 
replaced with Newcastle disease virus (velogenic). The commenter stated 
the background information indicated that only velogenic strains are to 
be regulated; however, the acronym VVND indicates viscerotropic, 
velogenic Newcastle disease.
    In the December 2002 interim rule, we replaced the entry for 
Newcastle disease virus (exotic) with Newcastle disease virus (VVND) to 
make it clear that we are regulating only velogenic strains. 
Viscerotropic, velogenic Newcastle

[[Page 13250]]

disease (VVND) is a velogenic strain. To ensure that we are regulating 
all of the velogenic strains, in this final rule we are replacing the 
entry for Newcastle disease virus (VVND) with Newcastle disease virus 
(velogenic).
    A commenter stated the distinction between domestic and exotic 
vesicular stomatitis virus cannot be justified scientifically. 
Therefore, it would be more logical to list all vesicular stomatitis 
viruses except specific viruses that are generally recognized as 
attenuated (e.g., the VSV-Indiana Lab strain).
    We do not believe it is necessary to regulate all strains of 
vesicular stomatitis virus, especially those strains that have limited 
morbidity and mortality in the United States. Therefore, we are making 
no change based on this comment.
    Interim 9 CFR 121.3(b) (newly designated Sec.  121.4(b)) listed the 
biological agents and toxins that have been determined to have the 
potential to pose a severe threat to both human and animal health, to 
animal health, or to animal products (overlap select agents and 
toxins).
    Several commenters pointed out that Clostridium botulinum is listed 
in the APHIS regulations but not in the CDC regulations.
    APHIS inadvertently listed both Clostridium botulinum and Botulinum 
neurotoxin producing species of Clostridium as overlap agents in the 
December 2002 interim rule. We always intended to only list Botulinum 
neurotoxin producing species of Clostridium in order to be consistent 
with CDC. Accordingly, we are removing Clostridium botulinum from the 
list of overlap select agents and toxins in this final rule.
    A number of commenters argued that overlap agents that are endemic, 
widespread, and easily isolated from natural sources should not be 
included in the list of overlap select agents. For these reasons, one 
commenter recommended that Francisella tularensis and Coxiella burnetii 
be removed from the list of overlap agents. Several commenters stated 
that Coccidioides immitis should not be included in the list of overlap 
select agents because it is endemic in California's Central Valley and 
is found in many areas of the southwest. Another commenter argued that 
Coxiella burnetii should be removed from the overlap list because ``it 
is so ubiquitous in nature that its identification as a select agent is 
meaningless.'' One commenter argued that Eastern equine encephalitis 
virus should be removed from the overlap list because it is endemic and 
even if it were intentionally introduced into people, horses, or other 
domestic animals, there would be little or no chance of spread to cause 
an adverse agricultural event.
    We agree that Coxiella burnetii, Coccidioides immitis, and 
Francisella tularensis are endemic, widespread, and easily isolated 
from natural sources. However, these factors are not sufficient reason 
to remove these agents from the list of overlap select agents and 
toxins. Furthermore, we disagree that there is little risk of an 
adverse agricultural event involving Eastern equine encephalitis virus 
because it can cause high mortality in horses, and there is no 
mandatory vaccination program in the United States. We are making no 
changes based on this comment.
    A commenter stated that it is pointless to regulate trichothecenes 
such as T-2 toxin as select agents if highly toxigenic strains of the 
toxin-producing organism are not also regulated.
    We are regulating T-2 toxin, and not the organism that produces it, 
because we believe the toxin has the potential to pose a severe threat 
to public health and safety, to animal health, and to animal products. 
Accordingly, we are making no change in response to this comment.
    Interim 7 CFR 331.3(c)(2), 9 CFR 121.3(c), and 9 CFR 121.3(f)(2) 
(newly designated 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 121.4) set out 
the provisions for genetic elements.
    One commenter stated there are differences between the APHIS and 
CDC regulations regarding genetic elements. For example, the 
regulations seem to imply that no bacterial sequences are regulated, 
except those from animal agents.
    We agree. In the interim regulations, CDC provided that infectious 
viral sequences of HHS and overlap select agents are regulated, while 
APHIS provided that infectious viral sequences of overlap agents are 
regulated and infectious viral and bacterial sequences of PPQ and VS 
select agents are regulated. To resolve these differences, in this 
final rule we are adopting CDC's approach for genetic elements. 
Specifically, newly designated 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 
121.4 provide that the following will be considered select agents and 
toxins:
     Nucleic acids that can produce infectious forms of any of 
the select agent viruses listed in either 7 CFR part 331 or 9 CFR part 
121;
     Recombinant nucleic acids that encode for the functional 
forms of any toxin listed in either 7 CFR part 331 or 9 CFR part 121 if 
the nucleic acids: (1) Can be expressed in vivo or in vitro; or (2) are 
in a vector or recombinant host genome and can be expressed in v