[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.

0
For the reasons stated in the preamble, 42 CFR part 73 is amended as 
follows:
0
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]

0
2. Amend Sec.  73.0 by adding paragraphs (b)(5), through (b)(8) and 
paragraphs (c)(5) through (c)(8) to read as follows:

[[Page 62247]]

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]
BILLING CODE 4160-17-P