[Federal Register Volume 68, Number 212 (Monday, November 3, 2003)]
[Rules and Regulations]
[Pages 62245-62247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27659]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
Possession, Use, and Transfer of Select Agents and Toxins
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Interim final rule and request for comments.
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SUMMARY: We are amending an interim final rule published on December
13, 2002, that established requirements regarding possession and use in
the United States, receipt from outside the United States, and transfer
within the United States, of select agents and toxins. The requirements
were established to implement provisions of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002. The December
2002 interim final rule established a phase-in period for certain
requirements to allow entities to comply without causing disruption or
termination of research or educational projects. The phase-in for
entities that on February 7, 2003, were already conducting activities
under a certificate of registration issued under 42 CFR 72.6, or
already were lawfully possessing select agents and toxins, required
entities applying for registration with the select agent program, and
individuals requiring access to select agents and toxins, to undergo a
security risk assessment by the Attorney General before November 12,
2003. The regulations also provided that an entity that on February 7,
2003, was not already conducting activities under a certificate of
registration issued under 42 CFR 72.6, or was not already lawfully
possessing select agents and toxins, would be eligible for registration
to possess, use, or transfer select agents and toxins as soon as the
entity met all of the applicable requirements of Part 73, including the
requirement for the Attorney General to conduct a security risk
assessment. We are now amending the applicability requirements to allow
for the issuance of provisional registration certificates for all
entities, and provisional grants of access for all individuals, from
whom, prior to November 12, 2003, the Attorney General has received all
of the information required by the Attorney General to conduct a
security risk assessment if those entities and individuals otherwise
meet all of the requirements of Part 73. This action is necessary to
ensure that both ongoing and new research and educational efforts
important to the national defense are not disrupted.
DATES: This interim final rule is effective as of November 3, 2003.
Written comments must be submitted on or before January 2, 2004.
ADDRESSES: Select Agent Program, Centers for Disease Control and
Prevention, 1600 Clifton Rd., E-79, Atlanta, GA 30333. Comments may be
e-mailed to: [email protected].
FOR FURTHER INFORMATION CONTACT: Mark Hemphill, Chief of Policy, Select
Agent Program, Centers For Disease Control and Prevention, 1600 Clifton
Rd., MS E-79, Atlanta Ga. 30333. (404) 498-2255.
SUPPLEMENTARY INFORMATION: The December 2002 interim final rule
implements provisions of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, Public Law 107-188 (referred to
below as the Act). The Act bolstered the authority of the Secretary of
the United States Department of Health and Human Services (referred to
below as HHS) to protect the American public against the misuse of
select agents and toxins whether inadvertent or the result of terrorist
acts against the United States homeland (such as the recent terrorist
acts involving anthrax) or other criminal acts. The Act gave to the
Secretary broad discretion in establishing and enforcing the new
regulations to ensure that select agents and toxins would remain
available for research, education, and other legitimate purposes.
In a document published in the Federal Register on December 13,
2002 (67 FR 76886), we promulgated an interim final rule to establish
requirements regarding possession and use in the United States, receipt
from outside the United States, and transfer within the United States,
of certain biological agents and toxins (referred to below as select
agents and toxins). This includes requirements concerning registration,
security risk assessments, safety plans, security plans, emergency
response plans, training, transfers, record keeping, inspections, and
notifications. The December 2002 interim final rule is set forth at 42
CFR part 73.
In general, the entities regulated under the December 2002 interim
final rule are academic institutions and biomedical centers; commercial
manufacturing (the pharmaceutical industry) or distribution facilities;
federal, state, and local laboratories, including clinical and
diagnostic laboratories; and research facilities.
The Act also gives the United States Department of Agriculture
(referred to below as USDA) the authority and responsibility for
regulating activities regarding select agents and toxins to protect
animal and plant health and animal and plant products. The Act gives
the Secretary of HHS the authority and responsibility for regulating
activities regarding select agents and toxins to protect the public
health and safety. Some of the select agents and toxins regulated under
the HHS December 2002 interim final rule are also regulated by USDA
under 9 CFR part 121. The select agents and toxins subject to
regulation by both agencies are identified as ``overlap'' select agents
and toxins and those regulated solely by HHS are identified as HHS
select agents and toxins. The Act provides for interagency coordination
between the two departments regarding overlap select agents and toxins.
The December 2002 interim final rule established a phase-in period
for certain requirements to allow entities to comply without causing
disruption or termination of research or educational projects. The
phase-in for entities that on February 7, 2003, were already conducting
activities under a certificate of registration issued under 42 CFR
72.6, or already were lawfully possessing select agents and toxins,
required that entities applying for registration with the select agent
program, and individuals requiring access to select agents and toxins,
to undergo a security risk assessment by the Attorney General before
November 12, 2003. The regulations also provided that an entity that on
February 7, 2003, was not already conducting activities under a
certificate of registration issued under 42 CFR 72.6, or was not
already lawfully possessing select agents and toxins, would be eligible
for registration to possess, use, or transfer select agents and toxins
as soon as the entity met all of the applicable requirements of Part
73, including the requirement for the Attorney General to conduct a
security risk assessment.
The Attorney General has assigned the responsibility to conduct the
security risk assessments required by the Act to the Federal Bureau of
Investigation (FBI). The Criminal Justice Information Services (CJIS)
Division is the component of the FBI responsible for implementing this
program. The CJIS Division continues to receive complete application
packages, which consist of completed FBI Information Forms (FD-961) and
usable fingerprint cards, and has finalized over 5,000 security risk
[[Page 62246]]
assessments.\1\ The CJIS Division had diverted personnel from other key
programs in order to finalize as many security risk assessments as
possible without compromising its other missions. It is important to
note that the time needed to process a security risk assessment varies
in relation to the complexity of each application. Some individuals may
be processed in as little as two weeks once processing begins, while
other individuals can take several months. At its current processing
rate, the CJIS Division expects to be able to finalize by the November
12, 2003, deadline the security risk assessments of almost all of the
completed applications that were pending as of October 1, 2003.
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\1\ To avoid delays related to incomplete applications,
individuals and entities should submit their FD-961 forms and
fingerprint cards to the CJIS Division in one package. However, this
does not apply to applicants who are submitting follow-up
information or fingerprint cards for an existing incomplete
application.
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However, in addition to the complete application packages, the CJIS
Division also has received incomplete packages. The CJIS Division has
sent more than 2,450 letters informing Responsible Officials of the
incomplete applications of their personnel. In light of its present
capacity and processing times, the CJIS Division has projected that
even if immediately completed, these outstanding applications could not
be processed by the November 12, 2003 regulatory deadline.
We believe that the continued operation of these facilities is
vital to the public interest. We also believe that those entities and
individuals that have submitted all of the required information and
forms by November 12, 2003, have made a good faith effort to comply
with these regulations. We are therefore amending the applicability
requirements to allow for the issuance of provisional registration
certificates for entities, and provisional grants of access for
individuals, from whom, prior to November 12, 2003, the Attorney
General has received all of the information required by the Attorney
General to conduct a security risk assessment if those entities and
individuals otherwise meet all of the requirements of Part 73. This
action is necessary to ensure that, as required by the Act, ongoing
research and educational efforts important to the national defense are
not disrupted. We are also amending the applicability requirements to
allow for the issuance of provisional registration certificates for
entities not currently in possession of select agents or toxins from
whom, prior to November 12, 2003, the Attorney General has received all
the information required by the Attorney General to conduct a security
risk assessment if those entities and individuals otherwise meet all of
the requirements of Part 73 and the Secretary, HHS, determines such
action is in the interest of the public health and national security.
An entity's provisional registration will stay in effect until the
Secretary either grants the entity a certificate of registration or
revokes the entity's provisional registration. An individual's
provisional grant of access will remain in effect until the Secretary
either grants access or revokes the individual's provisional grant of
access. This action is necessary to ensure that new research,
educational, and national security preparedness efforts are not
impeded.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register. The document
will include a discussion of any comments we receive and any amendments
we are making to the rule.
Authority for Interim Final Rule
We are amending the December 2002 interim final rule to insure that
the provisions of the Part 73 are consistent with the original intent
of the Act. Consequently, the Act also requires this amendment to be
published as an interim final rule (42 U.S.C. 262a, note). Further,
pursuant to 5 U.S.C. 553, we find that notice and public procedure are
impracticable, unnecessary, and contrary to the public interest and
that we have good cause to dispense with notice and comment on this
amendment. The amendment will prevent disruption or termination of
ongoing research and educational projects by hundreds of entities and
thousands of individuals needing access to select agents and toxins.
Immediate action is necessary to prevent the imposition of an
unnecessary burden on the regulated community; and to ensure the
appropriate availability of biological toxins for research, education,
and other legitimate purposes. Under these circumstances, the Secretary
has determined that prior notice and opportunity for public comment are
contrary to the public interest and that there is good cause under 5
U.S.C. 553 for making this action effective less than 30 days after
publication in the Federal Register.
Paperwork Reduction Act
This interim final rule does not contain any new provisions
constituting a collection of information under the Paperwork Reduction
Act (44 U.S.C. Chapter 35).
Executive Order 12866
This interim final rule has been determined to be not significant
for the purposes of Executive Order 12866 and, therefore, has not been
reviewed by the Office of Management and Budget.
Regulatory Flexibility Act
This emergency situation makes timely compliance with section 604
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. )
impracticable. We are currently assessing the potential economic
effects of this action on small entities. Based on that assessment, we
will either certify that the rule will not have a significant economic
impact on a substantial number of small entities or publish a final
regulatory flexibility analysis.
Unfunded Mandates
The Unfunded Mandates Reform Act at 2 U.S.C. 1532 requires that
agencies prepare an assessment of anticipated costs and benefits before
developing any rule that may result in expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector of $100
million or more in any given year. This interim final rule is not
expected to result in any one-year expenditure that would exceed $100
million.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers, Penalties, Reporting and
recordkeeping requirements, Transportation.
Dated: October 30, 2003.
Tommy G. Thompson,
Secretary.
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For the reasons stated in the preamble, 42 CFR part 73 is amended as
follows:
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1. The authority citation for Part 73 continues to read as follows:
Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of
Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).
Sec. 73.0 [Amended]
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2. Amend Sec. 73.0 by adding paragraphs (b)(5), through (b)(8) and
paragraphs (c)(5) through (c)(8) to read as follows:
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Sec. 73.0 Applicability and related requirements.
* * * * *
(b) * * *
(5) A provisional registration certificate may be issued to an
entity if, as of November 12, 2003:
(i) The Attorney General has received all of the information,
including fingerprint cards, required by the Attorney General to
conduct a security risk assessment of the entity, including any
individual who owns or controls the entity; and
(ii) The entity otherwise meets all of the requirements of this
Part.
(6) A provisional registration certificate will be effective until
the Secretary either issues a certificate of registration or suspends
or revokes the provisional registration.
(7) A provisional grant of access may be issued to an individual
identified by an entity as having a legitimate need to have access to a
select agent or toxin from whom, as of November 12, 2003, the Attorney
General has received all of the information, including fingerprint
cards, required by the Attorney General to conduct a security risk
assessment of that individual.
(8) A provisional grant of access will be effective until the
Secretary either grants the individual access or denies access to a
select agent or toxin.
(c) * * *
(5) A provisional registration certificate may be issued to an
entity if, as of November 12, 2003:
(i) The Attorney General has received all of the information,
including fingerprint cards, required by the Attorney General to
conduct a security risk assessment of the entity, including any
individual who owns or controls the entity;
(ii) The entity otherwise meets all of the requirements of this
Part; and
(iii) The HHS Secretary finds that circumstances warrant such
action in the interest of the public health and safety or national
security.
(6) A provisional registration certificate will be effective until
the Secretary either issues a certificate of registration or suspends
or revokes the provisional registration.
(7) A provisional grant of access may be issued to an individual
identified by an entity as having a legitimate need to have access to a
select agent or toxin from whom, as of November 12, 2003, the Attorney
General has received all of the information, including fingerprint
cards, required by the Attorney General to conduct a security risk
assessment of that individual.
(8) A provisional grant of access will be effective until the
Secretary either grants the individual access or denies access to a
select agent or toxin.
[FR Doc. 03-27659 Filed 10-31-03; 8:45 am]
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