Federal Register: March 18, 2005 (Volume 70, Number 52)
Rules and Regulations
Page 13241-13292
[[Page 13241]]
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Part II
Department of Agriculture
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Animal and Plant Health Inspection Service
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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
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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.
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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
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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
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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).
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Interim regulations Final rule
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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.
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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.
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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
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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 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.
Another commenter stated that interim 9 CFR 121.3(c) and 121.3(f)
conflict--Sec. 121.3(c) seems to include fragments, while Sec.
121.3(f) exempts them. The commenter pointed out that all genetic
elements that cause disease can be fragmented into pieces that cannot
cause disease, but that can be reconstituted simply and quickly.
We believe the changes in this final rule will address the
differences identified by this commenter. Accordingly, we are making no
change based on this comment. However, we note that fragments are not
subject to the regulations until reconstituted.
One commenter asked if cDNA is regulated. This commenter also asked
how sequence data of select agents will be protected, since it can be
used to make a select agent.
A cDNA fragment will be subject to the regulations if it can
produce either an infectious form of toxin or a select agent. Sequence
data of select agents is already in the public domain, and APHIS cannot
protect this information. However, we note that an individual or entity
that uses sequence data to produce an infectious agent or toxin will be
subject to the select agent regulations. We are making no changes based
on this comment.
Interim 7 CFR 331.3(b) and 9 CFR 121.3(e) stated that any
biological agent or toxin that is in its naturally occurring
environment will not be subject to the requirements of either part,
provided that the biological agent or toxin has not been intentionally
introduced, cultivated, collected, or otherwise extracted from its
natural source.
To be consistent with CDC, we are adopting the phrase ``excluded
from the requirements of this part'' in place of the phrase ``will not
be subject to the requirements of this part.'' Thus, in this final
rule, newly designated 7 CFR 331.3(d)(1), 9 CFR 121.3(d)(1), and 9 CFR
121.4(d)(1) state that a select agent or toxin that is in its naturally
occurring environment is excluded from the requirements of the
regulations, provided that the agent or toxin has not been
intentionally introduced, cultivated, collected, or otherwise extracted
from its natural source.
One commenter stated that the naturally occurring environment of a
virus is its host. The commenter pointed out that Coxiella burnetii can
be found in milk samples and asked if the truck moving milk to a
processing plant would be subject to the regulations or if
[[Page 13251]]
the milk sample submitted to a laboratory for mastitis testing would be
subject to the regulations as the milk sample is being collected.
Coxiella burnetii that is contained in milk in a truck or in a
diagnostic sample is considered to be in its naturally occurring
environment as long as it has not been intentionally introduced,
cultivated, collected, or otherwise extracted from its natural source.
We are making no changes in response to these comments.
Another commenter stated that the regulations suggest that an agent
found in the lymph node of a slaughtered animal (found on
histopathology but not cultivated or extracted) is in its naturally
occurring environment and, therefore, exempt from notification.
This comment appears to combine the requirements for exclusions and
exemptions. A select agent or toxin that has not been intentionally
introduced, cultivated, collected, or otherwise extracted from its
natural source is considered to be in its naturally occurring
environment and, therefore, excluded from the requirements of the
regulations. The exemption provisions for overlap select agents and
toxins are set forth in newly designated 9 CFR 121.6. Histopathology
alone is not a definitive identification of a select agent. However, a
select agent that has been identified by a histopathology method that
has been validated would need to be reported to APHIS or CDC in
accordance with the regulations. We are making no changes in response
to this comment.
A commenter stated that any naturally occurring organism expressing
a Shigatoxin should be specifically excluded from the list of select
agents and toxins.
As previously noted, we are regulating the toxin and not the
organisms that produce the toxin. Therefore, it is not necessary to
exclude from the requirements of the regulations any naturally
occurring organism expressing a Shigatoxin. However, we note that
Shigatoxin under the control of a principal investigator, treating
physician or veterinarian, or commercial manufacturer or distributor is
excluded from the requirements of 9 CFR part 121 if the aggregate
amount does not, at any time, exceed 100 mg (newly designated 9 CFR
121.4(d)(3)).
Interim 7 CFR 331.3(c)(1) (newly designated 7 CFR 331.3(d)(2))
provided that nonviable agents that are, bear, or contain listed agents
or toxins will not be subject to the requirements of the part because
they do not have the potential to pose a severe threat to plant health
or plant products. Similarly, interim 9 CFR 121.3(f) (newly designated
9 CFR 121.3(d)(2) and 121.4(d)(2)) provided that nonviable agents or
fixed tissues that are, bear, or contain listed agents or toxins will
not be subject to the requirements of the part because they do not have
the potential to pose a severe threat to both human and animal health,
or to animal health or animal products.
In this final rule, we are amending both sections to clarify that
these provisions apply to nonviable agents and nonfunctional toxins.
These changes will make the provisions in the APHIS and CDC regulations
consistent.
A commenter requested clarification of the terms ``nonviable'' and
``nonfunctional'' select agents or toxins. The commenter noted that
some organisms can survive in nature, others only under lab conditions,
and others not under any conditions.
A nonviable agent is not capable of replicating, infecting a plant
or animal, or causing disease, while a nonfunctional toxin is not able
to produce a toxic effect. These terms are generally understood in the
scientific community, and we do not believe that further clarification
is needed in the regulations. Therefore, we are making no change in
response to this comment.
Footnotes in interim 9 CFR 121.3 stated that the importation and
interstate movement of nonviable agents and genetic elements are
subject to the permit requirements under 9 CFR part 122.
One commenter asked why a permit is needed for nonviable agents and
genetic elements that are excluded from regulation under 9 CFR part
121. The commenter argued that nonviable agents and genetic elements
that are not capable of causing disease do not meet the definition of
``organism'' in part 122. Another commenter requested clarification of
the permit requirement for nonviable agents or fixed tissues. The
commenter stated that the provision seems to suggest that, for as long
as you retain the tissues, you would need to get yearly interstate
transport permits even though no further receipt/transport is taking
place.
The regulations in 9 CFR part 122 pertain to the movement of
organisms and vectors. A nonviable agent or genetic material could
serve as a vector of a disease agent through ineffective or
insufficient processing methods, and, therefore, require a permit for
importation or interstate movement. However, since a permit may not
always be required, in this final rule we are revising the footnotes so
that, in newly designated 9 CFR 121.3 and 121.4, they state that a
permit may be needed for nonviable agents and genetic elements. We note
that permits may contain restrictions that extend beyond the expiration
of the permit if the agent/genetic element is not destroyed. If so, an
individual or entity would be required to obtain a new permit as long
as the nonviable agent or genetic element is possessed by the
permittee.
A commenter asked if a positive chain reaction (PCR) test done on
formalin fixed tissue that detects Eastern equine encephalitis virus
would be exempt because it is nonviable.
This comment is not entirely clear. We believe the commenter is
asking about the reporting requirements for identifications of a select
agent or toxin. If Eastern equine encephalitis virus is identified from
formalin tissue, an individual or entity must report the identification
to APHIS in accordance with either newly designated 9 CFR 121.6 or
121.9, whichever is applicable. However, nonviable overlap select
agents or nonfunctional toxins are excluded from the regulations (newly
designated 9 CFR 121.4(d)(2)). We are making no changes in response to
this comment.
Interim 9 CFR 121.3(f)(3) provided an exclusion from the
regulations for ``[o]verlap toxins under the control of a principal
investigator (or equivalent), if the total aggregate amount does not,
at any time, exceed the following amounts: 0.5 mg of Botulinum
neurotoxins (types A-G), 100 mg of Clostridium perfringens epsilon
toxin, 100 mg of Shigatoxin, 5 mg of Staphylococcal enterotoxins, and
1,000 mg of T-2 toxin.
APHIS and CDC have determined that this exclusion is too narrow and
has the unintended consequence of requiring treating physicians or
veterinarians and commercial manufacturers or distributors that
possess, use, or transfer otherwise excluded toxins to register.
Accordingly, in this final rule, 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 (newly designated Sec.
121.4(d)(3)). To be consistent with CDC, we are also removing the words
``(types A-G)'' after Botulinum neurotoxins.
One commenter requested that APHIS clarify that there is no limit
to the amount of overlap toxins an individual or entity may possess or
use, as long as the amount of toxin under the control of each principal
investigator does not exceed the specified amounts.
We believe that newly designated Sec. 121.4(d)(3) clearly
indicates that the exclusion is based upon the amount of
[[Page 13252]]
overlap toxin under the control of a principal investigator, treating
physician or veterinarian, or commercial manufacturer or distributor.
Therefore, we are making no change based on this comment.
Another commenter asked if the toxin amounts refer to quantities of
isolated toxin (i.e., toxin that has been extracted and is separate
from the cell) or toxin that is in the process of being produced by
living cells and may increase in quantity. The commenter stated that
measuring the exact quantities of a toxin can only reasonably be
achieved if the toxin has been isolated from the cell.
We agree that an exact measurement of a toxin can only reasonably
be achieved if the toxin has been isolated from the cell. The amounts
listed in newly designated Sec. 121.4(d)(3) refer to the amount of
toxin that has been isolated from the cell, not the amount of toxin
that is being produced in living cells. We are making no change based
on this comment.
Interim 9 CFR 121.3(g) (newly designated Sec. Sec. 121.3(e) and
121.4(e)) provided a procedure by which an individual or entity may
request a determination by the Administrator that an attenuated strain
of a biological agent does not pose a severe threat to both human and
animal health, or to animal health or animal products.
In this final rule, we are adding this provision to 7 CFR 331.3 so
that the regulations in part 331 are consistent with the regulations in
9 CFR part 121. We are also amending both parts to clarify the
requirements and streamline the process for excluding an attenuated
strain of a select agent or toxin. Specifically, paragraph (e) in 7 CFR
331.3, 9 CFR 121.3, and 9 CFR 121.4 provides that an individual or
entity may apply for an exclusion by submitting a written request and
supporting scientific information. A written decision granting or
denying the request will be issued and the exclusion will be effective
upon notification of the applicant. Exclusions will be published
periodically in the notice section of the Federal Register and will be
listed on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.html.
Paragraph (e) also provides that, if an
excluded attenuated strain is subjected to any manipulation that
restores or enhances its virulence, the resulting select agent or toxin
will be subject to the requirements of each part. This has always been
the way the exclusion for attenuated strains has been interpreted;
however, we are adding this provision to both parts to facilitate
compliance.
One commenter claimed that the microbiological community, not just
government agency representatives, must be involved in the process for
excluding attenuated strains. The commenter recommended the
establishment of a broadly representative group to act as an advisory
body to APHIS and CDC. This commenter also stated that the regulations
should state that determinations regarding overlap agents require the
concurrence of APHIS and CDC.
APHIS may exclude attenuated strains of select agents or toxins
after consultation with subject matter experts, including those in the
microbiology community. For overlap select agents and toxins, APHIS may
exclude attenuated strains after consultation with subject matter
experts and CDC. We do not believe it is necessary to include these
administrative procedures in the regulations. Accordingly, we are
making no change based on this comment.
A commenter stated that APHIS should specify the criteria for
exclusion of attenuated strains because the current standard (``poses a
severe threat'') is insufficiently specific.
The Act requires APHIS to regulate the possession, use, and
transfer of biological agents and toxins that have been determined to
pose a severe threat to public health and safety, to animal health, to
plant health, or to animal or plant products. Thus, the Act establishes
the standard by which APHIS may exclude an attenuated strain (i.e., the
strain does not pose a severe threat). We are making no change to the
regulations in response to this comment.
A commenter asserted that the excluded attenuated strains should be
listed in the regulations so that an entity may be able to determine if
an agent is excluded before registering the strain and installing any
additional security.
APHIS is not including the lists of excluded attenuated strains of
select agents or toxins in the regulations because any change to the
lists of exclusions would require rulemaking. To minimize the potential
delays related to rulemaking, in this final rule we are providing that
exclusions will be published periodically in the notices section of the
Federal Register and will be listed on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.html.
We believe
these measures will provide sufficient notice to the public.
A commenter stated that the exclusion for attenuated strains would
not make agents such as the Sterne strain of Bacillus anthracis and the
vaccine strain of Brucella abortus available for the critical need of
quality control, without registration of the laboratory.
An attenuated strain of a select agent may be excluded from the
requirements of regulations based upon a determination that the
attenuated strain does not pose a severe threat to plant health or
plant products (newly designated 7 CFR 331.3(e)) or to public health
and safety, to animal health, or animal products (newly designated 9
CFR 121.3(e) and 121.4(e)). Once an attenuated strain of a select agent
has been excluded, it may be used for quality control or for other
purposes, as long as its virulence is not restored or enhanced. To
date, a number of attenuated strains have been excluded, including
Bacillus anthracis Sterne, pX01+pX02- and
Brucella abortus strain RB51 (vaccine strain). For these reasons, we
are making no change in response to this comment.
One commenter asked if the TC-83 vaccine strain of Venezuelan
equine encephalitis is subject to the regulations. The commenter
pointed out that the CDC regulations specifically exclude this strain
from regulation but the APHIS regulations do not.
Both APHIS and CDC have excluded the TC-83 vaccine strain of
Venezuelan equine encephalitis virus from the requirements of the
regulations. We note that a current list of exclusions is available on
the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index/html.
We are making no change based on this comment.
To address concerns raised by Federal law enforcement agencies
related to seizures (i.e., possession) of select agents or toxins, in
this final rule we are adding a new paragraph (f) to 7 CFR 331.3, 9 CFR
121.3, and 9 CFR 121.4 to address situations in which the select agents
or toxins have been identified prior to seizure. In the event that a
Federal law enforcement agency seizes a suspected select agent or toxin
or unknown material, this material will be regarded as a specimen
presented for diagnosis or verification and, therefore, will not be
subject to the regulations until it has been identified as a select
agent or toxin.
Paragraph (f) provides that any select agent or toxin seized by a
Federal law enforcement agency will be excluded from the requirements
of the regulations during the period between seizure of the agent or
toxin and the transfer or destruction of such agent or toxin provided
that:
As soon as practicable, the Federal law enforcement agency
transfers the
[[Page 13253]]
seized agent or toxin to an entity eligible to receive such agent or
toxin or destroys the agent or toxin by a recognized sterilization or
inactivation process;
The Federal law enforcement agency safeguards and secures
the seized agent or toxin against theft, loss, or release and reports
any theft, loss, or release of such agent or toxin; and
The Federal law enforcement agency reports the seizure of
the select agent or toxin to APHIS or CDC.
This provision will allow Federal law enforcement agencies to
conduct certain law enforcement activities (e.g., collecting evidence
from a laboratory crime scene) without being in violation of the
regulations. We note, however, that this provision does not authorize
the seizure of a select agent or toxin by a Federal law enforcement
agency; rather, it establishes the conditions under which a Federal law
enforcement agency may seize a select agent or toxin without violating
the regulations. Seizure of a select agent or toxin by a Federal law
enforcement agency would have to be in accord with that agency's
statutory authority.
Exemptions
Interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5 (newly designated
7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6) set out exemptions.
Interim 9 CFR 121.4(a) provided that clinical or diagnostic
laboratories and other entities possessing, using, or transferring
overlap agents or toxins that are contained in specimens presented for
diagnosis or verification will be exempt from the requirements of part
121, provided that the identification of such agents or toxins is
immediately reported to APHIS or CDC, and to other appropriate
authorities when required by Federal, State, or local law; and, within
7 days after identification, such agents or toxins are transferred or
inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. Interim
7 CFR 331.4(a) and 9 CFR 121.5(a) contained similar exemption
provisions for diagnostic laboratories (the term clinical laboratories
is not applicable to the plant-related regulations in 7 CFR part 331 or
the animal-related regulations in 9 CFR part 121). Exemption provisions
for laboratories and other entities that perform proficiency testing
were set out in interim 9 CFR 121.4(b) and 121.5(b).
In this final rule, we are amending both parts to clarify the
exemption provisions related to clinical or diagnostic laboratories and
other entities (for overlap select agents and toxins) and diagnostic
laboratories and other entities (for PPQ and VS select agents and
toxins). Specifically, paragraph (a) in newly designated 7 CFR 331.5
and paragraphs (a) and (b) in newly designated 9 CFR 121.5 and 121.6
make clear that laboratories and other entities must meet the exemption
requirements for each select agent or toxin contained in a specimen
that it possesses, uses, or transfers. This change takes into account
situations in which a diagnostic laboratory or other entity could be
registered for a select agent or toxin but still meet the exemption
requirements for other select agents or toxins contained in specimens.
We are also amending both parts to clarify that, as a condition of
exemption, clinical or diagnostic laboratories and other entities must
transfer a select agent or toxin in accordance with the transfer
requirements in each part (newly designated 7 CFR 331.16 and 9 CFR
121.16, respectively) or destroy the agent or toxin on-site by a
recognized sterilization or inactivation process.
In this final rule, we are also deleting in both parts the
requirement that the identification of a select agent or toxin be
reported to appropriate authorities when required by Federal, State, or
local law (interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5). Because
this provision merely indicates that additional reporting requirements
may exist under Federal, State, or local law, it is not necessary to
include this provision in the regulations. It is the entity's
responsibility to be familiar with all legal requirements for select
agents and toxins.
In addition, newly designated 9 CFR 121.5 and 121.6 require
immediate reporting after identification for specified select agents
and toxins; identification of the other select agents and toxins must
be reported within 7 calendar days after identification. This change
will reduce the reporting burden on the public while continuing to
provide information that will help us to identify outbreaks and to
monitor activities related to select agents and toxins.
Finally, we are deleting footnote 1 in interim 7 CFR 331.4 (newly
designated 7 CFR 331.5) because this information is contained in the
transfer section in this final rule (newly designated Sec. 331.16). We
are also deleting the application and contact information contained in
footnotes in interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5 because
addresses and telephone numbers are subject to change. Information
about the submission of forms, notices, and requests for exemptions or
exclusions is available on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index/html
.
A commenter asserted that clinical or diagnostic laboratories
should be required to secure the agent or toxin prior to transfer or
destruction.
We agree. Taking into account the risks posed by select agents and
toxins and the security requirements for registered entities, it is
reasonable to require that a clinical or diagnostic laboratory or other
entity secure the agent or toxin prior to transfer or destruction.
Furthermore, we believe it is reasonable to require that a clinical or
diagnostic laboratory or other entity report any theft, loss, or
release of a select agent or toxin prior to transfer or destruction.
Therefore, newly designated 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6
require, 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, and that any theft, loss, or
release of such agent or toxin be reported.
Another commenter argued that the exemptions for clinical and
diagnostic laboratories should require, at the very least, that
employees of such labs be subject to security risk assessments by the
Attorney General.
The Act does not require security risk assessments for employees of
entities that are exempt from registration under the regulations
(section 212(e)). We believe that the conditions for exemption in this
final rule provide adequate safeguard and security measures to protect
animal and plant health, and animal and plant products. Accordingly, we
are making no change based on this comment.
One commenter requested that APHIS define the term
``identification.'' The commenter asked if a PCR positive reaction
constituted identification or simply detection. This commenter also
wondered if an entity must report an identification done on a nonviable
organism.
If a PCR test is recognized in the scientific community as an
identification method, then a result utilizing this test must be
reported. If not, reporting is not required. An individual or entity
must report an identification done on a nonviable organism in
accordance with the regulations. We require this reporting in order to
obtain surveillance information about select agents or toxins. We are
making no changes in response to this comment.
Several commenters argued that the requirement to transfer an agent
or toxin
[[Page 13254]]
within 7 calendar days of identification was unrealistic. One commenter
stated that delays in transfer approval by APHIS or CDC could result in
delays in shipping the samples. Several commenters expressed concern
about this deadline due to the unreliability of shippers. Another
commenter stated that it is unreasonable and counterproductive to
require diagnostic labs to destroy or transfer select agents within 7
days after identification. The commenter said that some labs may
process hundreds or thousands of samples each week and generate large
numbers of select agent isolates, and transferring these isolates to a
qualified lab within 1 week will be very difficult and costly. The
commenter claimed that most labs will simply destroy the isolates and
that such destruction will result in the loss of valuable scientific
material.
Based on information provided by CDC and APHIS' National Veterinary
Services Laboratories (NVSL), and taking into consideration the risks
posed by select agents and toxins, we believe that 7 days will provide
ample time after identification to destroy the agent or toxin, or to
make transfer arrangements and to transfer the agent or toxin. However,
in this final rule, we are amending newly designated 7 CFR 331.5(a) and
9 CFR 121.5(a) to allow the Administrator to make exceptions to these
timeframes, as necessary. We are also amending newly designated 9 CFR
121.6(a) to allow the Administrator or the HHS Secretary to make
exceptions to these timeframes for overlap select agents or toxins, as
necessary. Finally, we are making similar changes to newly designated 9
CFR 121.5(b) and 9 CFR 121.6(b) to allow for exceptions to the
timeframes for proficiency testing, which require that an agent or
toxin be transferred or destroyed within 90 calendar days of receipt.
Another commenter recommended a longer holding period for agents
and toxins before mandatory inactivation--30 to 45 days instead of 7
days--because the destruction of isolates of select agents after only 7
days is counter to good quality control in labs, which often specifies
that isolates and specimens be kept for 30 days, and labs often have
cases pending for at least 30 days awaiting additional results. The
commenter went on to note that it is good lab practice to maintain the
original sample until a case is complete, and labs often maintain
samples so that additional testing can be done as needed.
The exemption provisions in interim 7 CFR 331.4(a), 9 CFR 121.4(a),
and 9 CFR 121.5(a) (newly designated 7 CFR 331.5(a), 9 CFR 121.5(a),
and 9 CFR 121.6(a)) do not require mandatory inactivation of a select
agent or toxin. To qualify for an exemption, an individual or entity
must satisfy the conditions for exemption, including transferring or
destroying the select agent or toxin within 7 calendar days of
identification unless directed otherwise by the Administrator or HHS
Secretary. However, an individual or entity could continue to hold a
select agent or toxin if it registers with APHIS or, for overlap select
agents and toxins, if it registers with APHIS and CDC. While we
recognize that the select agent regulations may have an effect on
internal quality assurance procedures, lengthening the time that a
diagnostic laboratory or other entity can possess a sample without
being registered is inconsistent with the intent of the Act. We are
making no changes based on this comment.
One commenter asked if diagnostic facilities could preregister for
potential isolates they might obtain from future diagnostic cases. The
commenter stated the regulations suggest that a facility has to have
the agent before it can register. The commenter stated that, once an
agent is isolated, it appears that the facility would only have 7 days
to become registered before it would have to destroy or transfer the
agent. The commenter noted that even the process to amend a certificate
of registration would likely take longer than 7 days.
The regulations do not preclude preregistration for a select agent
or toxin. A certificate of registration may be issued to an entity as
long as the entity meets the regulatory requirements for such agent or
toxin, even if the entity does not currently possess that particular
agent or toxin.
The regulations (interim 7 CFR 331.4(b) and 9 CFR 121.5(f); newly
designated 7 CFR 331.5(b) and 9 CFR 121.5(f)) provide that the
Administrator may grant exemptions from the requirements of 7 CFR part
331 and 9 CFR part 121 upon a showing of good cause and a determination
that such an exemption is consistent with protecting animal or plant
health or animal or plant products.
A commenter stated that APHIS should establish timelines for
responding to requests for exemptions. APHIS is committed to processing
requests for exemptions in a timely manner. We do not believe it is
necessary to include in the regulations timelines for responding to
requests for exemptions. Therefore, we are making no change based on
this comment.
Interim 9 CFR 121.4(c) and 121.5(d) provided that, unless the
Administrator by order determines that additional regulation is
necessary to protect animal health, or animal products, an individual
or entity possessing, using, or transferring products that are, bear,
or contain agents or toxins will be exempt from the requirements of
this part if the products have been cleared, approved, licensed, or
registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.);
(2) Section 351 of the Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 131 et seq.).
In this final rule, newly designated Sec. Sec. 121.5(d) and
121.6(c) clarify that the product is exempt from the requirements of
the regulations. This change is designed to address those situations in
which an entity produces an exempt product but conducts other
activities that would require registration under this part.
A commenter requested that APHIS and CDC provide a list of agents
exempted under the Federal laws listed in interim 9 CFR 121.4(c) so
that investigators would know if the agents they possess or wish to
study are exempt.
It is not administratively feasible for APHIS to maintain a list of
select agents exempted under the Federal laws described above. The
regulations provide sufficient information for an individual or entity
to determine if the agents they possess or wish to study are exempt.
Accordingly, we are making no changes based on this comment.
In interim 9 CFR 121.5(c), we provided that an individual or entity
receiving diagnostic reagents and vaccines that are, bear, or contain
select agents or toxins that are produced at USDA diagnostic facilities
will be exempt from the requirements of part 121.
A commenter stated that agents approved by APHIS' Center for
Veterinary Biologics for use in USDA licensed facilities should be
exempt from the requirements of the rule.
We disagree. We included this provision in the regulations in order
to exempt products, not agents, that would be cleared, approved,
licensed, or registered pursuant to the Virus-Serum-Toxin Act (21
U.S.C. 151-159), but for the fact that they are produced by USDA. In
order to clarify that this exemption applies to products, in this final
rule, newly designated 9 CFR 121.5(c) provides that diagnostic reagents
and vaccines that are, bear, or contain VS select agents or toxins that
[[Page 13255]]
are produced at USDA diagnostic facilities will be exempt from the
requirements of this part.
The regulations (interim 9 CFR 121.4(e); newly designated Sec.
121.6(e)) provide that the Administrator may exempt an individual or
entity from the requirements of the part for 30 days if it is necessary
to respond to a domestic or foreign agricultural emergency involving an
overlap agent or toxin. This exemption may be extended for an
additional 30 days.
One commenter argued that the 30-day special exemption granted
during an emergency is insufficient to deal with a foreign animal or
outbreak emergency. This commenter stated that neither exotic Newcastle
disease or the low pathogenic avian influenza outbreaks were resolved
in 60 days.
Section 212(g)(1)(D) of the Act sets forth the exemption for
agricultural emergencies involving overlap select agents and toxins.
The Act specifies that such exemptions may not exceed 60 days.
Accordingly, we are making no changes based on this comment.
Registration
Interim 7 CFR 331.5, 331.6, and 331.8 and 9 CFR 121.6, 121.7, and
121.9 (newly designated 7 CFR 331.7 and 9 CFR 121.7) set out
registration requirements and procedures.
One commenter stated that the regulations do not contemplate or
address a situation where an entity has employees that possess, use, or
transfer select agents at locations owned and controlled by another
entity. The commenter stated that it is a nonprofit organization that
provides medical research personnel to Federal agencies. The commenter
asserted that the regulations and the registration application should
be revised to require registration for the entity that owns or controls
the location where agents and toxins are used and stored.
This final rule requires that, unless exempted under the
regulations, an individual or entity that possesses, uses, or transfers
select agents or toxins must register with APHIS or, for overlap select
agents or toxins, APHIS and CDC. The regulations provide for both
individuals and entities, even though we expect that most registrants
will be entities. Using the example given by the commenter, the Federal
agency that possesses, uses, or transfers select agents or toxins would
be required to register and restrict access to such agents or toxins to
only those individuals approved by the Administrator or HHS Secretary
following a security risk assessment by the Attorney General. We are
making no change based on this comment.
One commenter requested that USDA and CDC consider a single
clearinghouse for registration of select agents. The commenter said the
rules require an entity that possesses only human and animal/plant
agents (no overlaps) to register separately with each agency; however,
this would place an undue burden on the entity by requiring dual
registration packages and safety/security plans. Another commenter
recommended that APHIS indicate what an entity can do to assist or
mitigate conflict between APHIS and CDC on registration applications
for overlap agents.
To simplify the registration process and minimize the burden on the
public, APHIS and CDC have established a framework by which individuals
and entities with various combinations of select agents and toxins may
submit their registration applications to either APHIS or CDC. For
instance, to apply for a certificate of registration for only PPQ or VS
select agents or toxins, or for PPQ and VS select agents or toxins, an
individual or entity must submit the registration application package
to APHIS. However, to apply for a certificate of registration for
overlap select agents or toxins, overlap select agents or toxins and
any combination of PPQ or VS select agents or toxins, or HHS select
agents or toxins and any combination of PPQ or VS select agents or
toxins, an individual or entity must submit the registration
application package to APHIS or CDC, but not both. In this final rule,
we are amending both sections to set out this new framework for
submitting registration applications (newly designated 7 CFR 331.7(d)
and 9 CFR 121.7(d)).
As previously discussed, APHIS and CDC are also developing a single
shared web-based system that will allow the regulated community to
conduct transactions electronically with either agency 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.
Several commenters requested more information about the
registration process. One commenter asked how long will it take to
receive a certificate of registration after all the paperwork has been
submitted. The commenter urged APHIS to promptly process registration
applications so as not to disrupt valuable research and impede academic
planning. Another commenter suggested that APHIS add information to the
final rule to indicate when an entity should submit renewal
applications (i.e., at least 90 days prior to expiration).
We are committed to promptly processing initial registration
applications and renewal applications. The time needed to process a
registration application and issue a certificate of registration
depends on the complexity and completeness of the application. However,
to provide more guidance about the submission of renewal applications,
we recommend that the registration application and the information
necessary to conduct the required security risk assessments be
submitted at least 8 weeks prior to the expiration of the date of the
certificate of registration.
Interim 7 CFR 331.6(b)(1) and 9 CFR 121.7(b)(1) (newly designated 7
CFR 331.7 and 9 CFR 121.7) indicated that, as one of the conditions of
registration, the owner or controller of an entity must be approved by
APHIS following a security risk assessment by the Attorney General.
A commenter asked who would be deemed to own or control the entity
in the context of an academic institution. Another commenter thought
the phrase ``individual who controls the facility'' meant the senior
administrators to whom the responsible official reports and not the
members of the Board of Trustees.
The determination of who is an owner or controller of an academic
institution (i.e., institution of higher education) depends on whether
it is a public or private institution of higher education. 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. However,
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
[[Page 13256]]
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. We consider an entity to be an
institution of higher education if it is an institution of higher
education as defined in the Higher Education Act of 1965 (20 U.S.C.
1001(a)) or an organization described in the Internal Revenue Code of
1986 (26 U.S.C. 501(c)(3)). Because entities that meet this criteria do
not have an owner, the individual(s) in control of the entity must be
approved by the Administrator or the HHS Secretary following a security
risk assessment by the Attorney General. For all other entities, 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.
To clarify the requirements for owners or controllers of an entity,
we are making several changes to the registration sections in this
final rule. We are making clear that the individuals must be approved
by the Administrator or HHS Secretary based on a security risk
assessment by the Attorney General (7 CFR 331.7(c)(1) and 9 CFR
121.7(c)(1)). We are also moving the information contained in footnote
4 in interim 7 CFR 331.6 and footnote 7 in interim 9 CFR 121.7 to a new
paragraph in both sections, 7 CFR 331.7(c)(2) and 9 CFR 121.7(c)(2),
which states that 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. In addition, we are adding the following
paragraphs to both 7 CFR 331.7 and 9 CFR 121.7 to clarify who will be
deemed to own or control an entity and to indicate the criteria by
which an entity will be considered an institution of higher education:
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)).
Finally, we are adding a footnote to 7 CFR 331.7 and 9 CFR 121.7 to
clarify that more than one individual may meet the criteria for
ownership or control of an entity.
Interim 7 CFR 331.6(b)(2) and 9 CFR 121.7(b)(2) provided that APHIS
may issue a certificate of registration if, among other things, the
Administrator approves an entity's biosafety, containment, and
security.
In drafting this provision, we intended to stress to the regulated
community the importance of the biosafety, containment, and security
requirements. However, we did not intend to suggest that an individual
or entity did not have to meet the other requirements of the
regulations. Since the issuance of a certificate of registration is an
administrative action taken by APHIS, it is not necessary to include
this provision in the regulations. Accordingly, we are deleting this
provision in both sections.
Interim 7 CFR 331.6(b)(3) and 9 CFR 121.7(b)(3) provided that APHIS
may issue a certificate of registration if, among other things, the
Administrator determines that the individual or entity seeking to
register has a lawful purpose to possess, use, or transfer agents or
toxins.
One commenter stated that it is unclear how APHIS will determine if
the entity has an unlawful purpose to possess, use, or transfer select
agents. The commenter asked what information APHIS will use to make
this determination.
To determine whether an entity has a lawful purpose to possess,
use, or transfer select agents or toxins, APHIS will consider the
information contained in the registration application and any other
information available to APHIS about the entity. This determination
will be made on a case-by-case basis. However, since this is an
administrative action taken by APHIS, it is unnecessary to include this
provision in the regulations. Accordingly, we are deleting this
provision in both sections. In addition, we are amending newly
designated 7 CFR 331.7(f) and 9 CFR 121.7(f) to clarify that the
issuance of a certificate of registration may be contingent upon
inspection or submission of additional information, such as the
security plan, biocontainment/biosafety plan, incident response plan,
or any other documents required to be prepared under each part. These
changes will make the APHIS and CDC regulations consistent.
In interim 7 CFR 331.5(b) and 9 CFR 121.6(b), we provided that each
entity must designate an individual to be its responsible official and
that this individual must have the authority and control to ensure
compliance with the regulations. Furthermore, in interim 7 CFR 331.6(c)
and 9 CFR 121.7(d), we provided that a certificate of registration will
be valid for only the specific agents or toxins and specific activities
and locations listed on the certificate.
One commenter stated an entity should be able to apply for a single
certificate of registration to cover activities at all buildings on a
campus or site under the control and authority of the responsible
official, which would include both contiguous and dispersed sites
within a local geographical area. The commenter stated that it is
overly burdensome to require separate registrations for each general
physical location (defined as a building or a complex of buildings at a
single mailing address). The commenter claimed that the administrative
and control functions at research and academic institutions are
efficiently managed by a centralized department responsible for more
than one physical location. Similarly, a commenter stated that the
provisions concerning location should be amended to cover a single
administrative organization under a single responsible official.
Another commenter requested that the final regulations allow campuses
to designate responsible officials with responsibility for an entire
campus.
APHIS designed these provisions to ensure that the responsible
official has the requisite authority and control to ensure compliance
with the select agent regulations. We reasoned that a responsible
official would be better able to ensure compliance with the regulations
if he/she managed only one general physical location. While we still
believe that to be true, we recognize that some responsible officials
will be able to ensure compliance for an entire campus or business
complex. Therefore, in this final rule, the registration sections
(newly designated 7 CFR 331.7(g) and 9 CFR 121.7(g)) provide that a
certificate
[[Page 13257]]
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. We
believe this change will provide more flexibility and guidance to
entities seeking to register.
In interim 7 CFR 331.6(d) and 9 CFR 121.7(e), we provided that a
certificate of registration may be amended to reflect changed
circumstances and that the responsible official must immediately notify
APHIS of such changes in circumstances that occur after submission of
the application for registration or after receipt of a certificate of
registration.
A commenter said that it is unclear how great a change would
require notification of APHIS or CDC. The commenter suggested that
investigators should instead submit annual reports of projects done and
projects planned. Another commenter stated that there is no specific
information in the regulations about what information must be reported
and what constitutes immediately (i.e., within 24 hours). The commenter
indicated that, if the entire registration application must be
resubmitted, then APHIS should allow a minimum of 7 to 10 business
days.
To clarify the requirements for amending a registration application
and a certificate of registration, in this final rule we are deleting
the provisions of interim 7 CFR 331.6(d) and 9 CFR 121.7(e). In their
place, we are adding a new paragraph (e) in newly designated 7 CFR
331.7 and 9 CFR 121.7 that requires the responsible official to provide
prompt notification of any changes in the registration application by
submitting the relevant page(s) of the registration application. In
addition, we are adding a new paragraph (h) in both 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. Finally, to clarify the
requirements for when an entity loses the services of its responsible
official, we are adding a new paragraph (i) in both sections to require
an entity to immediately notify APHIS or CDC if it loses the services
of its responsible official. These paragraphs also provide that 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.
Interim 7 CFR 331.6(e) and 9 CFR 121.7(f) stated that a responsible
official who wishes to discontinue possessing, using, or transferring
an agent or toxin may inactivate the agent or toxin or he/she may
transfer the agent or toxin to a registered entity. Both sections
further provided that APHIS must be notified 5 business days prior to a
planned inactivation so that APHIS may have the opportunity to observe
the inactivation.
One commenter asked when APHIS will observe the destruction of a
select agent. Another commenter asked if a responsible official for a
diagnostic laboratory is required to notify APHIS 5 business days prior
to destroying a select agent or toxin.
In the final rule, we are deleting these paragraphs and simply
providing that a certificate of registration will be terminated upon
the written request of the entity if the entity no longer possesses or
uses any select agents or toxins and no longer wishes to be registered
(newly designated 7 CFR 331.7(j) and 9 CFR 121.7(j)). This change
should eliminate any confusion between this reporting requirement and
the reporting requirements for diagnostic exemptions.
The regulations (interim 7 CFR 331.6(f) and 9 CFR 121.7(g); newly
designated 7 CFR 331.7(k) and 9 CFR 121.7(k)) state that a certificate
of registration will be valid for a maximum of 3 years.
A commenter recommended that certificates of registration be valid
for 5 years to be consistent with the security risk assessments,
simplify paperwork requirements for the entity, and reduce cost to
government.
We believe it is reasonable to provide that a certificate of
registration will be valid for a maximum of 3 years. A 3-year
registration period takes into consideration the burden on the public
and the risks posed by select agents and toxins. In addition, it is
consistent with APHIS' permit systems and other established programs
for laboratory certification or registration (e.g., Clinical Laboratory
Improvement Amendments (CLIA) and the College of American Pathologists
(CAP)), which are generally valid for 2 to 3 years. Accordingly, we are
making no change based on this comment.
Denial, Revocation, and Suspension of Registration
Interim 7 CFR 331.7(a)(3) and 9 CFR 121.8(a)(3) provided that APHIS
may deny an application for registration or revoke registration if the
responsible official does not have a lawful purpose to possess, use, or
transfer listed agents or toxins. In addition, interim 7 CFR
331.7(a)(4) and 9 CFR 121.8(a)(4) provided that APHIS may deny an
application for registration or revoke registration if the responsible
official is an individual who handles or uses listed agents or toxins
and he/she does not have the necessary training or skills to handle
such agents or toxins. To be consistent with CDC, we are deleting these
provisions in this final rule.
Interim 7 CFR 331.7(a)(5) provided that APHIS may deny an
application for registration or revoke registration if the entity does
not meet the containment and security requirements prescribed by the
Administrator, while interim 9 CFR 121.8(a)(5) provided that APHIS may
deny an application for registration or revoke registration if the
entity does not meet the biosafety, containment, and security
requirements prescribed by the Administrator. In addition, interim 7
CFR 331.7(a)(6) provided that APHIS may deny an application for
registration or revoke registration if there are egregious or repeated
violations of the containment or security requirements, while interim 9
CFR 121.8(a)(6) provided that APHIS may deny an application for
registration or revoke registration if there are egregious or repeated
violations of the biosafety, containment, or security requirements.
In drafting these provisions, we wished to stress to the regulated
community the importance of the biosafety, containment, and security
requirements. However, we never intended to suggest that an entity did
not have to meet the other requirements of each part. Therefore, we are
amending these provisions in this final rule to provide that an
application may be denied or a certificate of registration revoked or
suspended if the individual or entity does not meet the requirements of
the applicable part (newly designated 7 CFR 331.8(a)(3) and 9 CFR
121.8(a)(3)). These changes will clarify the registration requirements
and make both sections consistent with CDC's regulations.
In addition, in this final rule, we are clarifying the actions an
entity must take in the event that APHIS suspends or revokes a
certificate of registration. Specifically, we are adding a paragraph to
require that, upon notification of suspension or revocation, an
individual or entity must: (1) Immediately stop all use of each select
agent or toxin covered by the revocation or suspension order; (2)
immediately safeguard and secure each select agent or toxin covered by
the revocation or suspension order from theft, loss, or release; and
(3) comply with all disposition instructions issued
[[Page 13258]]
by the Administrator for each select agent or toxin covered by the
revocation or suspension (newly designated 7 CFR 331.8(b) and 9 CFR
121.8(b)).
In a footnote to interim 7 CFR 331.7(a)(5) and 9 CFR 121.8(a)(5),
we indicated that APHIS may provide technical assistance and guidance
on the biosafety, containment, and security requirements. A commenter
requested information on when and to what degree APHIS will provide
such assistance.
As discussed below in the biocontainment/biosafety and security
sections, in this final rule we are providing a list of documents in
each part that an entity should consider in developing a
biocontainment/biosafety or security plan. We recommend that an entity
review these documents before contacting APHIS for technical
assistance. We will provide technical assistance and guidance upon
request.
Interim 7 CFR 331.7(b) and 9 CFR 121.8(b) provided that APHIS may
summarily revoke or suspend registration for any of the reasons set
forth in each section.
To clarify the provisions for denial, suspension, and revocation of
registration, in this final rule, we are deleting interim paragraph (b)
in both sections and simply providing that an application may be denied
or a certificate of registration revoked or suspended for the reasons
set forth in each section (newly designated 7 CFR 331.8(a) and 9 CFR
121.8(a)).
Interim 7 CFR 331.7(d) and 9 CFR 121.9(d) provided that the denial
of an application for registration, revocation of registration, and
suspension of registration may be appealed under each part. In this
final rule, newly designated 7 CFR 331.8(c) and 9 CFR 121.8(c) provide
that the denial of an application for registration and revocation of
registration may be appealed under each part. Furthermore, both
paragraphs provide that any denial of an application for registration
or revocation of a certificate of registration will remain in effect
until a final agency decision has been rendered. These changes will
clarify the status of an application for registration or a certificate
of registration during the appeal process.
Responsibilities of the Responsible Official
To facilitate compliance with the regulations, the regulations
(interim 7 CFR 331.9 and 9 CFR 121.10; newly designated 7 CFR 331.9 and
9 CFR 121.9) set out the responsibilities of the responsible official.
One commenter stated that the APHIS and CDC regulations should have
the same responsibilities for the responsible official and that these
responsibilities should be better defined.
We agree that the APHIS and CDC regulations should contain the same
provisions for the responsible official. Therefore, in this final rule,
we are amending newly designated 7 CFR 331.9(a) and 9 CFR 121.9(a) to
require that an individual or entity required to register under each
part designate an individual to be the responsible official. Paragraph
(a) further requires that the responsible official:
Be approved by the Administrator or the HHS Secretary
following a security risk assessment by the Attorney General;
Be familiar with the requirements of this part;
Have the authority and responsibility to act on behalf of
the entity;
Ensure compliance with the requirements of this part; and
Ensure that annual inspections are conducted for each
laboratory where select agents or toxins are stored or used in order to
determine compliance with the requirements of this part. The results of
each inspection must be documented, and any deficiencies identified
during an inspection must be corrected.
In addition, we are deleting the provision for the alternate
responsible official(s) from the registration section and adding it to
the responsible official section (newly designated 7 CFR 331.9(b) and 9
CFR 121.9(b)). These changes will make the APHIS and CDC regulations
consistent.
A commenter recommended that APHIS add the following language to
the regulations: ``This does not preclude the assignment of activities
in Sec. Sec. 121.10(a)(1) through 121.10(a)(8) to other individuals,
provided the activities are performed or supervised by a person
approved under Sec. 121.11 and the results are reviewed and approved
by the Responsible Official or Alternate Responsible Official.'' The
commenter stated that it would be inappropriate for the responsible
official to participate in the actual transferring of an agent or to
perform data entry to maintain records.
In response to this comment, in this final rule we are amending the
regulations to provide that the individual or entity required to
register under each part, and not the responsible official, must
provide training, maintain records, and provide notice of theft, loss,
or release of select agents or toxins (newly designated 7 CFR 331.15
and 9 CFR 121.15, 7 CFR 331.17 and 9 CFR 121.17, and 7 CFR 331.19 and 9
CFR 121.19). This change will allow the responsible official to
delegate certain responsibilities. For instance, interim 7 CFR
331.14(a) and 9 CFR 121.15(a) stated that the responsible official must
maintain complete, up-to-date records of information necessary to give
an accounting of all of the activities related to listed agents or
toxins. In this final rule, we are amending the regulations to require
the individual or entity to maintain such records (newly designated 7
CFR 331.17 and 9 CFR 121.17).
Interim 7 CFR 331.9(b) and 9 CFR 121.10(b) (newly designated 7 CFR
331.9 and 9 CFR 121.9) required the responsible official for a
diagnostic laboratory, or other entity possessing, using, or
transferring listed agents or toxins that are contained in specimens
presented for diagnosis to immediately report the identification of
such agents or toxins to the Administrator and to other appropriate
authorities when required by Federal, State, or local law. Furthermore,
both paragraphs provided that the Administrator may require less
frequent reporting during agricultural emergencies or outbreaks, or in
endemic areas.
In this final rule, we are amending newly designated 7 CFR 331.9(c)
and 9 CFR 121.9(c) to require the responsible official to report the
identification and final disposition of any select agent or toxin
contained in a specimen for diagnosis or verification. In addition, we
are adding a new paragraph (d) to 9 CFR 121.9 to require the
responsible official to report the identification and final disposition
of any select agent or toxin contained in a specimen presented for
proficiency testing. This information will help us to identify
outbreaks and to monitor activities related to select agents and
toxins.
We are also amending newly designated 9 CFR 121.9(c) to require the
responsible official to immediately report the identification of
specified select agents and toxins with a report of the final
disposition of the agent or toxin due within 7 calendar days after
identification. The responsible official must report the identification
and final disposition of the other select agents and toxins within 7
calendar days after identification. This will make the reporting
requirements for registered entities consistent with those in the
exemption sections (newly designated 9 CFR 121.5 and 121.6). Finally,
we are deleting in both sections the requirement that the
identification of a select agent or toxin be reported to appropriate
authorities when required
[[Page 13259]]
by Federal, State, or local law (interim 7 CFR 331.9(b) and 9 CFR
121.10(b)). This change corresponds to a similar change made in the
exemption sections (interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5).
One commenter requested clarification of the diagnostic exemptions
and the provisions of interim 9 CFR 121.10(b) requiring the responsible
official for a diagnostic laboratory to report identifications. The
commenter noted that exempt diagnostic laboratories are not required to
have a responsible official.
The reporting requirements in interim 9 CFR 121.10(b) (ne
