[Federal Register: December 13, 2002 (Volume 240, Number 67)]
[Rules and Regulations]
[Page 76885-76905]
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Part IV
Department of Health and Human Services
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42 Part 73
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Office of the Inspector General
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42 CFR Part 1003
Possession, Use, and Transfer of Select Agents and Toxins; Interim
Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
Office of Inspector General
42 CFR Part 1003
RIN 0920-AA08
Possession, Use, and Transfer of Select Agents and Toxins
AGENCY: Centers for Disease Control and Prevention, Office of Inspector
General, HHS.
ACTION: Interim final rule.
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SUMMARY: This document establishes 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.
This includes requirements concerning registration, security risk
assessments, safety plans, security plans, emergency response plans,
training, transfers, record keeping, inspections, and notifications.
This document also contains delegations of authority to the Office of
Inspector General concerning civil money penalties. The interim final
rule implements provisions of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 and is designed to
provide protection against 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. In addition and in accordance with the Agricultural
Bioterrorism Protection Act of 2002, the Department of Agriculture is
establishing, by separate 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 and plant products. This action is necessary to
protect animal and plant health, and animal and plant products.
DATES: The interim final rule is effective as of February 7, 2003.
However, for dates of specific applicability see Sec. 73.0. Written
comments must be submitted on or before February 11, 2003. The final
rule will be published after consideration of the comments.
ADDRESSES: Select Agent Program, Centers for Disease Control and
Prevention, 1600 Clifton Rd., E-79, Atlanta, GA 30333. Comments may be
e-mailed to: SAPcomments@CDC.GOV.
FOR FURTHER INFORMATION CONTACT: Minh Thomas, Select Agent Program,
Centers For Disease Control and Prevention, 1600 Clifton Rd., MS E-79,
Atlanta Ga. 30333. (404) 498-2259.
SUPPLEMENTARY INFORMATION: This document establishes 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 Act requires an interim final rule and mandates its
effective date and transition provisions. The new regulations are set
forth in a new 42 CFR part 73 (referred to below as the part 73
regulations).
The part 73 regulations implement provisions of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002, Public
Law 107-188 (referred to below as the Act).
In general, the entities regulated under the part 73 regulations
are academic institutions and biomedical centers; commercial
manufacturing facilities (the pharmaceutical industry); federal, state,
and local laboratories, including clinical and diagnostic laboratories;
and research facilities.
Based on provisions of the Act (42 U.S.C. 262a, note), the part 73
regulations supersede the regulations at 42 CFR 72.6 (referred to below
as the Sec. 72.6 regulations). The Sec. 72.6 regulations, which
became effective April 15, 1997, established certain shipping and
handling requirements on laboratory facilities that send or receive
``select agents.'' In addition to regulating transfers, the part 73
regulations, among other things, cover the ``possession and use'' of
select agents and toxins and include requirements for security risk
assessments conducted by Department of Justice. The Act bolstered the
authority to protect against 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 gives the 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 Department of Health
and Human Services (referred to below as 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 this part 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.
Purpose and Scope--Sec. 73.2
In addition to explaining information discussed above, Sec. 73.2
explains that the part 73 regulations do not apply in two types of
situations. Paragraph (b) states that the part 73 regulations do not
set requirements for the exportation of select agents or toxins. The
Department of Commerce has primary responsibility for regulating the
exportation of microorganisms and toxins at 15 CFR. Paragraph (c)
states that the part 73 regulations do not set requirements for the
transportation in commerce of select agents or toxins. The Department
of Transportation has primary responsibility for regulating the
transportation of such select agents and toxins as hazardous materials
under 49 CFR parts 171 through 180. Other agencies may also have
authority over microorganisms that are exported or transported. For
example, FDA regulates unapproved products used in clinical trials and
such products would be subject to FDA's provisions as well as the
provisions of the Department of Commerce or the Department of
Transportation. The regulation only lists the agencies with primary
authority over transportation and exports.
General Prohibition--Sec. 73.3
The provisions of Sec. 73.3, consistent with the intent of the
Act, provide that entities and individuals are allowed to conduct
activities regulated by the part 73 regulations only if they are
conducted for a lawful purpose and in accordance with the part 73
regulations.
List of Select Agents and Toxins--Sec. Sec. 73.4 and 73.5
The HHS select agents and toxins are listed in Sec. 73.4 and the
overlap select agents and toxins are listed in Sec. 73.5.
In a notice of intent to issue regulations published in the Federal
Register on August 23, 2002, we specified those agents and toxins that
we were considering for inclusion in the HHS and overlap lists and
requested
[[Page 76887]]
comments regarding whether changes should be made. The comment period
closed September 17, 2002. We received 22 comments. The select agents
and toxins specified in Sec. Sec. 73.4 and 73.5 are the same as those
listed in the notice of intent to issue regulations, except for changes
made based on comments, including changes to reflect current taxonomic
classification and nomenclature. A number of commenters simply agreed
with entries on the list. Those comments requesting substantive changes
to the list are discussed below.
We prepared the list for the notice of intent to issue regulations
after receiving extensive input from a group of scientists from 21
Federal government entities. We made all of the determinations
discussed below in response to the comments based on recommendations
from the same group of scientists.
The Act (42 U.S.C. 262a (a)(1)(B)) provides the following criteria
that the HHS Secretary must consider for establishing the list:
[sbull] The effect on human health of exposure to the agent or
toxin;
[sbull] The degree of contagiousness of the agent or toxin and the
methods by which the agent or toxin is transferred to humans;
[sbull] The availability and effectiveness of pharmacotherapies and
immunizations to treat and prevent any illness resulting from infection
by the agent or toxin; and
[sbull] Any other criteria, including the needs of children and
other vulnerable populations that the HHS Secretary considers
appropriate.
The interim final rule does not make distinctions concerning
children or other specific populations because we are unaware of any
basis for making such distinctions.
The notice did not include ``viruses causing hantavirus pulmonary
syndrome'' and ``yellow fever virus'' on the list of select viruses.
One commenter, without providing reasons, asserted that they should be
included on the list. We have not included them on the list in the
interim final rule. ``Viruses causing hantavirus pulmonary syndrome''
are difficult to propagate and there is a lack of data establishing
laboratory acquired infections. Also, there is an available and
effective vaccine for ``Yellow fever virus.''
The notice included ``Monkeypox virus'' on the list of select
viruses. One commenter indicated that it is not easily transmissible to
humans, there is no indication that this agent has ever been chosen as
a potential bioweapon, and this agent has not been demonstrated to
result in high levels of mortality. We have included ``Monkeypox
virus'' on the list of non-overlap viruses. Monkeypox has similarities
with smallpox virus in that monkeypox has a similar clinical
presentation, causes similar mortality rates as observed in recent
outbreaks, is highly infectious when aerosolized, and is reported to
have chains of transmission for several generations.
The notice included ``Herpes B virus'' on the list of select
viruses. Six commenters indicated that it should be deleted based on
assertions that there is no indication that this agent has ever been
chosen as a potential bioweapon, the agent has not been shown to be
easily transmissible to humans, the agent has not been demonstrated to
result in high levels of mortality, and there is little evidence in the
literature of true aerosol transmission of the naturally occurring
virus. With changes to reflect current taxonomic classification and
nomenclature, we have included it on the list of HHS agents and toxins
as ``Cercopithecine herpesvirus 1 (Herpes B virus)'' based on the
scientific data that it is lethal to humans, can be replicated in large
concentrations, and can cause infection via the aerosol route.
The notice did not include ``Camelpox'' on the list of select
viruses. One commenter asserted that ``Camelpox'' should be included on
the list based on the assertion that recent publications have raised
concerns about its potential use as a biological weapon. We have not
included ``Camelpox'' on the list because it has not been associated
with human illness or disease.
The notice included ``Variola major (smallpox)'' on the list of
select viruses. One commenter requested that we change ``Variola major
(smallpox)'' to ``Variola major and variola minor associated viruses
including alastrim.'' We have made this change by including ``Variola
major virus (Smallpox virus) and Variola minor (Alastrim)'' on the list
of HHS select agents and toxins. ``Variola minor virus,'' also known as
``Variola Alastrim,'' is another virus that causes smallpox and like
``Variola major virus'' is highly infectious and lethal and can be
spread by inhalation.
The notice included ``Coccidioides immitis'' and ``Coccidioides
posadasii'' on the list of select fungi. One commenter indicated that
both should be deleted based on the assertion that neither species of
``Coccidioides'' presented a risk for use as biological weapons.
Another commenter asserted that ``Coccidioides immitis'' should be
deleted based on the assertion that most infections with ``Coccidioides
immitis'' do not cause severe illness. We have included ``Coccidioides
immitis'' on the overlap list and ``Coccidioides posadasii'' on the HHS
list because they are highly infectious when aerosolized and sporulate
easily in culture.
The notice did not include ``Histoplasma capsulatum'' or
``Blastomyces species'' in the list of select fungi. One commenter
asserted that these organisms should be included on the list since they
easily can be spread by aerosol. We have not included them on the list
because they are difficult to cultivate and do not sporulate readily.
The notice did not include ``aflatoxins'' on the list of select
toxins. One commenter asserted, without reasons, that these organisms
should be included on the list. We have not included them on the list
because the acute toxicity is too low to pose a significant mass
casualty threat.
The notice included ``Shigatoxin and Shiga-like toxins'' on the
list of select toxins. One commenter asserted that a change is needed
in the reference to ``Shiga-like toxins'' to clarify that it does not
include analogous proteins that are not toxic, and another commenter
similarly asserted that the same term should identify or at least
quantify the specific ``Shiga-like toxins'' to be included. We agree
with the commenters and clarified the list of select toxins to include
``Shigatoxin and Shiga-like ribosome inactivating proteins.''
In the notice, certain toxins were on the list of select toxins
only if the aggregate amount were more than a specified amount. Three
commenters argued in favor of the principle that a toxin should be
listed without distinctions regarding amounts. One commenter asserted
that the aggregate amounts for toxins are too low and do not take into
account the vastly different toxicities of these listed materials. We
made no changes based on these comments. The Act (42 U.S.C. 262a
(a)(1)(A)) states that the list is to include those toxins that have
the potential to pose a severe threat to public health and safety. We
believe that the specified toxins at levels below the threshold levels
do not meet the Act's criteria for inclusion. Further, as evidenced by
the different amounts for certain toxins, we did take into account the
different toxicities of toxins.
One commenter recommended that the list of toxins include only
those with an LD50 for vertebrates of less than 100
nanograms per kilogram body weight and two other commenters recommended
that the list of toxins include only those that would theoretically
contain one million LD50's
[[Page 76888]]
for vertebrates for each listed toxin. No changes were made based on
these comments. These comments do not take into account the potential
threat of large quantities of the toxins.
One commenter asserted that the ``Botulinum neurotoxins'' should be
included only if quantities are greater than 13 milligrams and the
listing for ``Clostridium perfringens epsilon toxin'' should be
included only if quantities are greater than 68 milligrams. No changes
are made based on this comment. The comment does not take into account
that even the specified amounts could cause significant numbers of
mortalities.
With respect to the listing in the notice of ``full-length''
nucleic acids, commenters raised concern that the deletion of one
nucleic acid would not constitute ``full-length'' even though capable
of causing harm similar to a ``full-length.'' We agree with the
commenters and changed the listings to exclude only those forms that
are not capable of yielding infectious and/or replication-competent
forms of any of the viruses listed (accordingly, forms such as
microarrays are not on the list).
Regarding the proposed regulation of ``Nucleic acids (synthetic or
naturally derived) of Variola major virus (smallpox virus) and Variola
minor virus (Alastrim) that are 100 nucleotides or more in length,''
one commenter noted that Variola virus shares many conserved nucleic
acid sequences with other Orthopoxviruses (e.g., vaccinia virus). Thus,
the proposed requirement could result in the unintentional regulation
of nucleic acids from other viruses. Because nucleic acids from Variola
major virus and Variola minor virus that are capable of infection or
replication are already listed as select agents in Sec. 73.4 (d)(1),
this requirement is being deleted.
The provisions of Sec. Sec. 73.4 and 73.5 include procedures for
excluding attenuated strains of select agents and toxins upon a
determination that they do not meet the Act's criteria for inclusion,
i.e., they do not pose a severe threat to the public health and safety.
The procedures also include provisions for providing notice for
determinations. A written decision to an applicant granting the request
for an exclusion will apply to all others.
Exemption Regarding Diagnosis, Verification, or Proficiency Testing--
Sec. 73.6(a)
Paragraph (a) of Sec. 73.6 states that an entity is exempt from
the provisions of this part, other than Sec. 73.14 (transfer), if all
of the following apply:
[sbull] The only activities conducted by the entity that are
subject to the part 73 regulations concern select agents or toxins that
are contained in specimens or in isolates from the specimens presented
for diagnosis, verification, or proficiency testing;
[sbull] Upon identification as the result of diagnosis or
verification, the entity immediately reports to HHS any of the
following: Variola major virus (Smallpox virus) and Variola minor
(Alastrim), Bacillus anthracis, Yersinia pestis, Botulinum neurotoxins,
Francisella tularensis, Ebola viruses, Marburg virus, Lassa fever
virus, and South American Haemorrhagic Fever viruses (Junin, Machupo,
Sabia, Flexal, Guanarito);
[sbull] The entity reports as required under Federal, State, or
local law, to appropriate authorities;
[sbull] After diagnosis, verification, or proficiency testing, the
entity either transfers the specimens or isolates from the specimens to
a facility eligible for receiving them, or destroys them on-site by
autoclaving, incineration, or by means of a sterilization or
neutralization process sufficient to cause inactivation;
[sbull] The entity transfers or destroys those select agents or
toxins used for diagnosis or verification within seven calendar days
after identification, unless directed otherwise by the Federal Bureau
of Investigation or other law enforcement entity after consultation
with the HHS Secretary;
[sbull] The entity transfers or destroys those select agents or
toxins used for proficiency testing within 90 calendar days after
receipt; and
[sbull] The entity prepares a record of the identification and
transfer or destruction on CDC Form 0.1318, submits the completed form
to the HHS Secretary within seven calendar days after the transfer or
destruction, and maintains a copy of the record for a period of three
years.
The provisions of this exemption meet the requirements of the Act
(42 U.S.C. 262a (g)(1)). The Act mandates such an exemption for
diagnosis, verification, or proficiency testing regarding select agents
and toxins. It also requires reporting to HHS and when required under
Federal, State, or local law, to other appropriate authorities, and
further requires the agents or toxins to be transferred or destroyed
after use.
This requirement that the entity immediately reports to HHS upon
identification of any of biological agents listed in Sec. 73.6 (a)(2)
is warranted because HHS has determined that these pose the greatest
risk to public health and safety and national security.
Allowing seven calendar days for transfer or destruction for select
agents or toxins identified through diagnosis or verification and 90
calendar days for transfer or destruction of select agents or toxins
used for proficiency testing will provide sufficient time to accomplish
the intended purpose.
The requirements that the entity must notify HHS within seven
calendar days after identification and maintain the record of
notification, provide a means for documenting that the transfer or
destruction actually occurred. We request comment on the sufficiency of
the 7-day and 90-day requirements for the transfer or destruction of
the select agent or toxin after identification.
Exemption Regarding Products Cleared, Approved, Licensed, or Registered
Under Certain Laws--Sec. 73.6(b)
Paragraph (b) of Sec. 73.6 states that unless the HHS Secretary
issues an order to an entity making specific provision of this part
applicable to protect the public health and safety, products that are,
bear, or contain listed select agents or toxins that are cleared,
approved, licensed, or registered under any of the following laws are
exempt from the provisions of the part 73 regulations insofar as their
use is only for the approved purposes and meets the requirements of
such laws:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.);
(2) Section 351 of the Public Health Service Act pertaining to
biological products (42 U.S.C. 262);
(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C.
151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136 et seq.).
This exemption is mandated by the Act (42 U.S.C. 262a (g)(2)).
Exemption Regarding Investigational Products--Sec. 73.6(c)
Paragraph (c) of Sec. 73.6 states that the HHS Secretary may
exempt on a case-by-case basis an investigational product that is,
bears, or contains a listed select agent or toxin from the requirements
of the regulations when such product is being used in an investigation
authorized under a Federal Act referred to above in the discussion
concerning Sec. 73.6 (b) and additional regulation under this part is
not necessary to protect public health and safety. Paragraph (c) also
sets forth application provisions and requires the HHS Secretary to
make a determination within 14 calendar days after receipt of the
application if the application meets certain requirements.
The Act specifically provides for this exemption, including the
time frame for
[[Page 76889]]
making a decision (42 U.S.C. 262a (g)(2)). We limited the exemption to
investigational products authorized under those Acts specified in Sec.
73.6 (b) because we are unaware of any other acts that could be used to
meet the specified criteria. There is a requirement that applicant
notify the HHS Secretary when authorization is no longer in effect
(e.g., IND is put on clinical hold). An exemption granted under this
paragraph continues in effect only so long as the investigation
continues in accordance with the authorization under a Federal Act
referred to in paragraph (b) of this section.
Exemption Regarding Domestic or Foreign Public Health Emergency Sec.
73.6(d)
Paragraph (d) of Sec. 73.6 states that the HHS Secretary may
temporarily exempt an entity from the requirements of the regulations,
in whole or in part, based on a determination that the exemption is
necessary to provide for the timely participation of the entity in
response to a domestic or foreign public health emergency. Paragraph
(d) further provides that the exemption may not exceed 30 calendar
days, except that the HHS Secretary may grant one extension of an
additional 30 calendar days. In addition, it sets forth application
provisions.
The Act specifically provides for this exemption, including the
time limits (42 U.S.C. 262a (g)(3)).
Exemption Based on Agricultural Emergency Sec. 73.6(e)
Paragraph (e) of Sec. 73.6 states that upon request of the USDA
Secretary, after the granting by the USDA Secretary of an exemption
under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection
Act of 2002 based on a finding that there is an agricultural emergency,
the HHS Secretary may temporarily exempt an entity from the
applicability of the requirements of this part, in whole or in part, to
provide for the timely participation of the entity in response to the
agricultural emergency. Paragraph (e) further provides that the
exemption may not exceed 30 calendar days, except that upon the request
of the USDA Secretary, the HHS Secretary may grant one extension of an
additional 30 calendar days.
The Act specifically provides for this exemption, including the
time limits (42 U.S.C. 262a (g)(4)).
Registration--Sec. 73.7
Paragraph (a) of Sec. 73.7 states that an entity may not possess
or use in the United States, receive from outside the United States, or
transfer within the United States, any select agent or toxin unless the
entity has been granted a certificate of registration by HHS or USDA.
This reflects requirements in the Act (42 U.S.C. 262a (d)).
Paragraph (b) contains information concerning the submission of an
application for a certificate of registration to HHS or USDA and sets
forth the information required to be included in the application. The
requested information is needed to determine whether an applicant is
eligible for a certificate of registration by meeting the requirements
of the part 73 regulations. The requested information is necessary to
make a preliminary determination if the entity meets the requirements
of this part. We are requesting comments on the information required in
the application for registration.
Paragraph (c) explains that an application that covers any HHS
select agent or toxin (regardless of whether it also covers overlap
select agents or toxins) must be submitted to HHS and an application
that covers only overlap select agents or toxins may be submitted
either to HHS or USDA. This reflects the intent of the Act to provide
joint jurisdiction over activities and avoid unnecessary burden
regarding overlap select agents and toxins (7 U.S.C. 8411). Regardless
of which agency receives the application regarding an overlap select
agent or toxin, both agencies will provide input before a determination
is made to grant or deny a certificate of registration.
Paragraph (d) provides that a certificate of registration will be
valid only for the specific select agents and toxins and the specified
activities and locations consistent with the information upon which the
certificate of registration or amendment was granted. This requirement
reflects the conclusion that each situation for conducting activities
involving select agents and toxins is unique, and HHS or USDA can only
issue a certificate of registration based on the information submitted.
Paragraph (d) also provides that the Responsible Official of an
agency must get prior approval by promptly notifying the HHS Secretary
in writing in accordance with Sec. 73.21, if any change occurs in any
information submitted in the application for the certificate of
registration or amendments. This includes modifications to the list of
individuals approved under Sec. 73.8, changes in area of work, or
changes in protocols or objectives of studies. This requirement is
necessary to enable HHS to ensure that the entity continues to meet the
requirements of the part 73 regulations.
Paragraph (d) contains provisions for obtaining amendments to a
certificate of registration to add select agents or toxins or to change
specified activities or locations.
Paragraph (e) contains provisions for granting a certificate of
registration if the requirements of the part 73 regulations are met.
Paragraph (e) also notes, consistent with the discussion above, that
HHS will issue a certificate of registration or amendment for an HHS
overlap select agent or toxin only if the USDA Secretary concurs that
the requirements for obtaining a certificate of registration or
amendment under 9 CFR part 121 have been met.
Paragraph (f) provides that a certificate of registration will
cover activities at only one general physical location (a building or a
complex of buildings at a single mailing address). This is designed to
ensure that the Responsible Official is not over-extended and will be
able to perform the activities required under Sec. 73.9.
Paragraph (g) provides that a certificate of registration will be
valid for up to three years. This will allow for varied expiration
dates and thereby lessen the subsequent administrative burden regarding
the processing of renewals. We are seeking comments on this time period
for renewal of a registration.
Paragraph (h) provides that an entity must provide notice in
writing to the HHS Secretary in accordance with Sec. 73.21 at least
five business days before destroying a select agent or toxin, if the
destruction is for the purpose of discontinuing activities with an
agent or toxin covered by a certificate of registration. This will
allow the HHS Secretary to observe the destruction or take other action
as appropriate.
Security Risk Assessments--Sec. 73.8
Paragraph (a) of Sec. 73.8 states that an entity may not possess
or use in the United States, receive from outside the United States, or
transfer within the United States, any select agent or toxin unless the
entity and any individual who owns or controls the entity are approved
by the HHS Secretary or the USDA Secretary based on security risk
assessments by the Attorney General. Paragraph (b) of Sec. 73.8 states
that an individual may not have access to a select agent or toxin
unless approved by the HHS Secretary or the USDA Secretary based on a
security risk assessment by the Attorney General. These security risk
assessments are required by the Act (42 U.S.C. 262a (e)).
[[Page 76890]]
Based on specific authority in the Act, paragraph (a) provides that
the security risk assessment requirements do not apply to Federal,
State, or local governmental agencies (42 U.S.C. 262a (e)), but the
security risk assessments do apply to the Responsible Official and
other individuals working for such agencies.
Paragraph (c) sets forth procedures for obtaining the security risk
assessments.
Paragraph (d) restates the criteria in the Act for disapproving
entities and individuals (42 U.S.C. 262a (e)). The Act states that
``restricted persons,'' as defined in 18 U.S.C. 175b, may not be
granted access to select agents and toxins (42 U.S.C. 262a (e)). A
restricted person is a person who:
[sbull] Is under indictment for a crime punishable by imprisonment
for a term exceeding 1 year;
[sbull] Has been convicted in any court of a crime punishable by
imprisonment for a term exceeding 1 year;
[sbull] Is a fugitive from justice;
[sbull] Is an unlawful user of any controlled substance (as defined
in section 102 of the Controlled Substances Act (21 U.S.C. 802));
[sbull] Is an alien illegally or unlawfully in the United States;
[sbull] Has been adjudicated as a mental defective or has been
committed to any mental institution;
[sbull] Is an alien (other than an alien lawfully admitted for
permanent residence) who is a national of a country as to which the
Secretary of State has made a determination (that remains in effect)
that such country has repeatedly provided support for acts of
international terrorism; or
[sbull] Has been discharged from the Armed Services of the United
States under dishonorable conditions.
In addition, the HHS Secretary may deny or limit access if the
individual is reasonably suspected by any Federal law enforcement or
intelligence agency of: Committing a crime set forth in section
2332b(g)(5) of title 18 U.S.C.; knowing involvement with an
organization that engages in domestic or international terrorism (as
defined in section 2331of such title18) or with any other organization
that engages in intentional crimes of violence; or being an agent of a
foreign power (as defined in section 1801 of title 50 U.S.C.
Consistent with specific provisions in the Act, paragraph (e) also
allows for limited approvals (42 U.S.C. 262a (e)).
Paragraph (f) provides that unless a shorter period is granted
under paragraph (e), an approval for an entity or individual will be
valid for three years unless terminated sooner at the request of the
entity or individual, or terminated for cause.
Paragraph (g) implements specific provisions of the Act for
requesting the Attorney General to expedite the security risk
assessment process and for expediting the HHS Secretary's review
process (42 U.S.C. 262a (e)). The Act allows expedited processing only
for individuals (not entities). Expedited processing will be given to
those cases showing good cause (e.g., public health or agricultural
emergencies, national security, impending expiration of a research
grant, a short-term visit by a prominent researcher).
Responsible Official--Sec. 73.9
Under Sec. 73.9, an entity conducting regulated activities must
identify and authorize an individual as the Responsible Official. The
Responsible Official must:
[sbull] Be approved for access to biological agents and toxins
under Sec. 73.8;
[sbull] Be familiar with the requirements of the part 73
regulations, and
[sbull] Have authority and responsibility to ensure that the
requirements of the part 73 are met, on behalf of the entity.
These requirements regarding a Responsible Official are necessary
to ensure management oversight of the implementation of the part 73
regulations and to establish a point of contact.
This section also provides for the designation of Alternate
Responsible Officials to conduct the duties of the Responsible
Official. The Responsible Official may identify one or more
individuals, any of whom may serve as the Alternate Responsible
Official when the Responsible Official is unavailable. The Responsible
Official and all individuals identified to serve as the Alternate
Responsible Official must meet all of the qualifications for a
Responsible Official.
We recommend that the Responsible Official and Alternate
Responsible Officials be either biosafety officers or senior management
officials of the entity, or both. Although we understand that some
entities have limited staff, to help foster objectivity we strongly
recommend where feasible that the Responsible Official should not be an
individual actually using, working with, or transferring or receiving
the select agents and toxins.
Safety--Sec. 73.10
Paragraph (a) of Sec. 73.10 states that an entity subject to the
provisions of the part 73 regulations must develop and implement a
safety plan that:
[sbull] Considers the biosafety standards and requirements
appropriate for BSL2, 3, or 4 operations,
as those standards and requirements pertain to the respective select
agents. Guidance for biosafety standards for BSL2, 3, or 4 operations
is contained in the CDC/NIH publication, ``Biosafety in Microbiological
and Biomedical Laboratories,'' including all appendices except Appendix
F.
[sbull] Meets the specific requirements for handling toxins found
in 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in
Laboratories' and/or 29 CFR 1910.1200, ``Hazard Communication,''
whichever applies.
[sbull] Considers the requirements for handling toxins found in
Appendix I in the CDC/NIH publication, ``Biosafety in Microbiological
and Biomedical Laboratories.''
[sbull] Considers the requirements for handling genetic elements,
recombinant nucleic acids, and
recombinant organisms found in ``NIH Guidelines for Research Involving
Recombinant DNA Molecules.'' This includes, among other things,
provisions regarding security assessments, physical containment,
biological containment, and local review.
These provisions are designed to implement the mandate in the Act
to establish safety provisions commensurate with the risk the
biological agent or toxin poses to the public health and safety (42
U.S.C. 262a (b)). Both BMBL and the NIH Guidelines provide for graded
requirements based on the level of hazard posed by the specific agents
and toxins. The work with these agents and toxins are classified into
biosafety levels (BSL 1 through 4) based on their hazards and the
quantities being handled. As the level of risk increases, the
guidelines impose more stringent requirements for safety practices.
These guidelines are accepted standards in the biomedical sector. In
addition, grants that are awarded for funding improvements to public
health agencies mandate compliance with the NIH Guidelines. Similarly,
new grants from NIH to fund research on select agents and toxins
mandate compliance with the NIH guidelines. Consequently, we expect
that entities subject to this rule either are complying with these
guidelines or are making provisions to comply. Further, these are
essentially the same requirements imposed on entities under the Sec.
72.6 regulations. We are seeking comments on the incorporation of these
guidelines as requirements.
Paragraph (b) of Sec. 73.10 states that:
[[Page 76891]]
[sbull] The Responsible Official must conduct regular inspections
of the laboratory where select agents and toxins are stored or used to
ensure compliance with all of the procedures and protocols of the
safety plan,
[sbull] The results of these inspections must be documented, and
[sbull] Any problems identified during inspections must be
addressed.
These provisions are added to help ensure that the safety
provisions are met.
The concerns that prompted this rule and its authorizing statute
are not limited to the Select Agents listed herein. Laboratory
manipulation of microbes can alter their characteristics, either
intentionally or inadvertently, so as to increase their virulence,
pathogenicity, or host range or alter their mode of transmission or
route of exposure in ways that increase risks to human, animal, or
plant health. In particular, the resulting modified organisms could
present risks equal to or even greater than the current select agents
and toxins.
In recognition of this prospect, and to protect public health and
safety and ensure security, paragraph (c) states that an entity may not
conduct the following experiments unless approved by the HHS Secretary,
after consultation with experts:
[sbull] Experiments utilizing recombinant DNA that involve the
deliberate transfer of a drug resistance trait to select agents that
are not known to acquire the trait naturally, if such acquisition could
compromise the use of the drug to control disease agents in humans,
veterinary medicine, or agriculture.
[sbull] Experiments involving the deliberate formation of
recombinant DNA containing genes for the biosynthesis of select toxins
lethal for vertebrates at an LD50 < 100 ng/kg body weight.
This is to ensure that these categories of experiments with select
agents and toxins involving recombinant DNA (as defined in the NIH
Guidelines) are conducted only if safe to do so.
Also, we have reserved paragraph (d) for possible future
specification of additional types of experiments that might warrant
stringent scrutiny in the interest of safety; and we hereby request
comments concerning what additional experiments, regardless if
regulated under the part 73 regulations, might warrant such attention.
In particular, we request comments addressing issues concerning
experiments with biological agents that could possibly increase their
virulence or pathogenicity; change their natural mode of transmission,
route of exposure, or host range in ways adverse to human, animal, or
plant health; result in the deliberate transfer of a drug resistant
trait or a toxin-producing capability to a microorganism by means that
do not involve recombinant DNA techniques; or involve research with
Variola major virus and Variola minor virus (e.g., experiments
involving the transfer of Variola nucleic acid sequences into any other
orthopoxvirus). In light of the deletion from the select agent list of
Variola nucleic acids that are 100 nucleotides or more in length, we
request comments on whether a less restrictive, but scientifically
sound threshold is needed. We also request comments regarding the form
such special oversight should take; for example, the rule could require
that, whenever laboratory manipulation of a microorganism increases its
risk profile significantly, whether intentionally or inadvertently, the
Responsible Official report such to the HHS Secretary and discontinue
work with the modified organism until the HHS Secretary has made
recommendations regarding appropriate safety practices.
Security--Sec. 73.11
The provisions of Sec. 73.11 require entities subject to the
provisions of the part 73 regulations to develop and implement a
security plan establishing policy and procedures that ensure the
security of areas containing select agents and toxins. The provisions
of Sec. 73.11 are designed to meet these objectives and the Act's
mandate to establish security requirements for the purpose of
protecting the public health and safety (42 U.S.C.262a (e)). We invite
comments on these provisions, and are particularly interested in views
on whether the provisions are sufficient to meet the purposes stated
above.
Emergency Response--Sec. 73.12
The provisions of Sec. 73.12 state that entities required to
register under the part 73 regulations must develop and implement an
emergency response plan. The requirements for the plan are designed to
ensure that entities plan ahead to be ready to take appropriate action
to deal with any hazard that could arise.
We also note that if the entity has prepared and implemented an
emergency response plan or is part of a larger institution's plan
developed under other Federal, State, or local emergency response
planning laws (e.g., OSHA's hazardous waste operations and emergency
response standard), that plan, with any necessary amendments, may be
used to meet the requirements of Sec. 73.12.
Training--Sec. 73.13
The provisions of Sec. 73.13 state that an entity required to
register under this part must provide information and training on
safety and security for working with select agents or toxins on a
timely basis to each individual approved for access under Sec. 73.8
and each unapproved individual working in, or visiting, areas where
select agents and toxins are handled or stored. The criteria in Sec.
73.13 are designed, consistent with the Act's mandate concerning
training (42 U.S.C. 262a (b), to ensure that individuals understand the
hazards and how to deal with them.
We also note that if the entity has an existing training program
under OSHA or other government or entity programs, that training
program, with any necessary amendments, may be used to meet the
requirements of Sec. 73.13.
Transfers--Sec. 73.14
The transfer provisions in Sec. 73.14, consistent with specific
provisions of the Act (42 U.S.C. 262a (b)), state that a select agent
or toxin may not be transferred from one entity to another entity
within the United States (regardless of whether the transfer is
interstate or intrastate), or received by an entity in the United
States from an entity outside the United States, unless the transfer
meets specified requirements. The transfer provisions are designed to
ensure that select agents and toxins are shipped only to recipients
that have authority to use or possess them. Also, the transfer
provisions are designed to ensure that HHS and the participants monitor
the shipments and that any problems are quickly reported to HHS so that
any required action could be taken.
Records--Sec. 73.15
The provisions of Sec. 73.15 set forth record keeping requirements
concerning the list of approved individuals, inventories, access to
agents and toxins, and areas where agents are used. These requirements
are designed to allow determinations concerning compliance with the
requirements of the part 73 regulations and to help assign what action
should be taken if an emergency were to arise. Some of the requirements
concerning quantities apply only to toxins since quantity data
concerning replicating organisms may not be meaningful. We invite
comments on these requirements.
Inspections--Sec. 73.16
The part 73 regulations at Sec. 73.16 set forth inspection
provisions that apply during the time an application is pending and any
time when a certificate
[[Page 76892]]
of registration is in effect. This allows the HHS Secretary, without
prior notification and with or without cause, to inspect any site at
which activities regulated by part 73 are conducted and to inspect and
copy any records relating to the activities covered by this part. This
section implements the provisions of the Act that authorize inspections
as necessary to ensure compliance with the part 73 regulations (42
U.S.C. 262a (f)).
Notification for Theft, Loss, or Release--Sec. 73.17
Consistent with the mandate in the Act, Sec. 73.17 sets forth
requirements for reporting thefts, losses, or releases of select agents
or toxins (42 U.S.C. 262a (g)(8) and (j)). This is intended to
determine responsibility for reporting and to help ensure that the
appropriate information is reported so that effective and timely
responses can be made.
Administrative Review--Sec. 73.18
To implement requirements of the Act (42 U.S.C. 262a (e)(7)), Sec.
73.18 provides that an entity may obtain review of a decision denying
or revoking a certificate of registration under 73.7 and the affected
entity or individual may obtain review of a decision denying or
revoking approval under 73.8. To help ensure timely resolution of
disputes, the request for such review must be submitted in writing
within 30 calendar days after the adverse decision. Under this section,
the request for review must state the factual basis for the review,
which will be carried out in accordance with 42 U.S.C. 262a(e)(7).
Where the adverse decision is in whole or in part based upon
notification by the Attorney General under 42 U.S.C. 262a(e)(3), the
request for review will be forwarded to the Attorney General for the
Attorney General's review and final notification to the HHS Secretary.
Civil Money Penalties--Sec. 73.19
A discussion regarding the authority for, and the implementation
of, civil money penalties by the Office of Inspector General is set
forth below under the heading ``Civil money penalties.''
Criminal Penalties--Sec. 73.20
The provisions of Sec. 73.20 are informational. They note that the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (Public Law 107-188) provides specific criminal penalties for
violation of provisions of the part 73 regulations. They also note that
other criminal penalties may apply for violation of the part 73
regulations.
Submissions and Forms--Sec. 73.21
Paragraphs (a), (b), and (c) of Sec. 73.21 explain how to obtain
forms and how to submit applications, requests, notifications, and
other information under the part 73 regulations.
To help ensure the timely resolution of matters, paragraph (d) of
Sec. 73.21 sets forth a mechanism for considering applications or
requests to be abandoned if the applicant or requester fails to respond
within 30 calendar days (or within such time period agreed upon by the
applicant or requester and the HHS Secretary) to an HHS request for
additional information.
Applicability and Related Requirements--Sec. 73.0
The provisions of Sec. 73.0 include 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, already were
conducting activities under a certificate of registration issued under
Sec. 72.6 of this chapter or already were lawfully possessing select
agents and toxins are as follows:
1. On and after February 7, 2003, the following provisions of part
73 are applicable: Sec. 73.1 Definitions; Sec. 73.2 Purpose and
scope; Sec. 73.3 General prohibition; Sec. 73.4 HHS select agents and
toxins; Sec. 73.5 Overlap select agents and toxins; Sec. 73.6
Exemptions from requirements under this part; Sec. 73.9 Responsible
Official; Sec. 73.10 Safety; Sec. 73.12 Emergency response; Sec.
73.13 Training, but only those training provisions relating to safety
and emergency response; Sec. 73.15 Records; Sec. 73.16 Inspections;
Sec. 73.17 Notification for theft, loss, or release; Sec. 73.18
Administrative review; Sec. 73.19 Civil money penalties; Sec. 73.20
Criminal penalties; and Sec. 73.21 Submissions and forms.
2. Before conducting activities subject to the interim final during
the period from March 12, 2003, through November 11, 2003, such an
entity must have submitted to HHS or USDA an application package under
Sec. 73.7 certifying compliance with the provisions referred to in (1)
above.
3. Before conducting activities subject to the interim final during
the period from March 12, 2003, through April 11, 2003, such an entity
must have submitted applications for security risk approvals under
Sec. 73.8 to the Attorney General for the entity, the Responsible
Official, and any individual who owns or controls the entity.
4. On and after March 12, 2003, such an entity must comply with the
transfer requirements in Sec. 73.14.
5. On and after April 12, 2003, such an entity must comply with the
requirement to obtain security risk approvals under Sec. 73.8 for the
entity, the Responsible Official, and any individual who owns or
controls the entity.
6. Before conducting activities subject to the interim final during
the period from April 12, 2003, through June 11, 2003, such an entity
must have submitted applications for security risk approvals under
Sec. 73.8 for all individuals with access to select agents and toxins.
7. On and after June 12, 2003, such an entity must comply with the
requirement to obtain security risk approvals under Sec. 73.8 for all
individuals with access to select agents and toxins.
8. Before conducting activities subject to the interim final during
the period from June 12, 2003, through September 11, 2003, such an
entity must comply with the requirement in Sec. 73.11 to develop a
security plan.
9. On and after September 12, 2003, such an entity must fully
comply with the provisions of Sec. 73.11, including the provisions
regarding the implementation of a security plan, and must fully comply
with the provisions of Sec. 73.13, including the training provisions
relating to security.
10. On and after November 12, 2003, such an entity must comply with
the requirement in Sec. 73.7 to obtain a certificate of registration.
11. Such an entity also remains:
[sbull] Subject to the registration provisions of the Sec. 72.6
regulations until November 12, 2003, when superseded by Sec. 73.7;
[sbull] Subject to the security provisions regarding development of
a security plan until June 12, 2003, when superseded by the requirement
to develop a security plan under Sec. 73.11;
[sbull] Subject to the security provisions of the Sec. 72.6
regulations regarding implementation of a security plan until September
12, 2003, when superseded by the requirement to fully comply with Sec.
73.11;
[sbull] Subject to the training provisions of the Sec. 72.6
regulations related to security until September 12, 2003, when
superseded by the requirement to fully comply with Sec. 73.13; and
[sbull] Subject to the transfer provisions of the Sec. 72.6
regulations until March 12, 2003, when superseded by Sec. 73.14.
The following is a timeline of the registration phase-in period
that is described in the previous paragraph:
[[Page 76893]]
----------------------------------------------------------------------------------------------------------------
2/7/03 Rule effective 3/12/03 Application due 4/12/03 DOJ review
----------------------------------------------------------------------------------------------------------------
73.1 Definitions --Application certifies 73.8 Application for DOJ review
73.2 Purpose and scope compliance with effective for individuals submitted.
sections.
73.3 General prohibition 73.8--Certifies that --Entity and RO DOJ review
73.4 Non-overlap select biological agents and applications for DOJ review for completed.
toxins entity and RO submitted.
73.5 Overlap select biological agents and 73.14--Transfer section ...............................
toxins effective.
73.6 Exemptions from requirements under this
part
73.9 Responsible Official
73.10 Safety
73.12 Emergency Response
73.13 Training (Safety and Emergency Response
Provisions)
73.15 Records
73.16 Inspections
73.17 Notification for theft, loss, or
release
73.18 Appeals
73.19 Civil money penalties
73.20 Criminal penalties
73.21 Submissions and forms
----------------------------------------------------------------------------------------------------------------
6/12/03 DOJ review/security 9/12/03 Security/Training plan 11/12/03 Full compliance
----------------------------------------------------------------------------------------------------------------
73.8--Individual DOJ review complete 73.11 Security plan implemented. 73.7--Registration section
effective
73.11--Development of security plan 73.13 Training (security --Entity must be in full
provisions. compliance with Part 73
----------------------------------------------------------------------------------------------------------------
We have also provided a more limited phase-in for entities that on
February 7, 2003, were not already conducting activities under a
certificate of registration issued under Sec. 72.6 of this chapter and
were not already lawfully possessing select agents as follows:
(1) On and after February 7, 2003, the following sections are
applicable: Sec. Sec. 73.1 through 73.6 (definitions, purpose and
scope, general prohibition, HHS select agents and toxins, overlap
select agents and toxins, exemptions from requirements under this
part); Sec. Sec. 73.8 through 73.10 (Security risk assessments,
Responsible Official, Safety); Sec. Sec. 73.12 through 73.21
(emergency response, training, transfers, records; inspections;
notification for theft, loss, or release; administrative review; civil
money penalties; criminal penalties; and submissions and forms) and
must hold a valid permit under 9 CFR part 122 and/or 42 CFR part 71.54.
(2) On and after September 12, 2003, the provisions of Sec. 73.11
(security) are applicable.
(3) On and after November 12, 2003, the provisions of Sec. 73.7
(registration) are applicable.
(4) During the period from February 7, 2003, through November 11,
2003, such an entity may not conduct activities regulated under this
part unless the entity has submitted to HHS or USDA an application
package under Sec. 73.7 certifying compliance with the provisions
referred to in paragraph (b)(2) of this section.
Civil Money Penalties
In 1981, Congress enacted the civil money penalty statute, section
1128A of the Social Security Act (42 U.S.C. 1320a-7a), as one of
several administrative remedies to combat increases in fraud and abuse.
The civil money penalty law authorized the HHS Secretary and the
Inspector General to impose civil money penalties and program
exclusions on individuals and entities whose wrongdoing caused injury
to HHS programs or their beneficiaries. Since 1981, the civil money
penalty provisions have been expanded to apply by reference to numerous
types of fraudulent and abusive activities.
The Act specifically authorized civil money penalties against any
individual or other person violating the part 73 regulations (42 U.S.C.
262a (i)). The Act incorporates by reference many of the provisions of
section 1128A of the Social Security Act. As a result, and in
accordance with section 1128A(j)(2) of the Social Security Act, the
Office of the Inspector General may impose a civil money penalty in an
amount not exceeding $250,000 in the case of an individual, and up to
$500,000 in the case of any other person, who violates the Act.
Accordingly, to address this new civil money penalty authority, we
added provisions to the part 73 regulations at Sec. 73.19 and are
amending 42 CFR parts 1003 as follows:
[sbull] In Sec. 1003.100, Basis and purpose, we are revising
paragraph (a), redesignating paragraph (b)(3) to read as (b)(4), and
adding a new paragraph (b)(3), stating the broad purpose of this new
civil money penalty authority.
[sbull] In Sec. 1003.101, Definitions, we are adding a definition
for the term ``Select agents and toxins'' consistent with the
definition in the part 73 regulations.
[sbull] In Sec. 1003.102, Basis for CMPs and assessments, we are
redesignating existing paragraphs (d) and (e) to read respectively as
paragraphs (e) and (f), and adding a new paragraph (d) to cross-
reference the implementing regulations and the OIG's authority to
impose penalties for determined violations.
[sbull] In Sec. 1003.103, Amount of penalty, we are adding a new
paragraph (l) to address the $250,000/$500,000 maximum penalty amounts.
The OIG specifically seeks public comments on the possible
inclusion of specific mitigating and aggravating factors in considering
penalty amounts.
Disclosure Provisions
The Act (42 U.S.C. 262a (h)) prohibits the disclosure under the
Freedom of Information Act (5 U.S.C. 552) of certain information
concerning registrations; transfer documentation; safeguard and
security measures; notifications of
[[Page 76894]]
releases; and evaluations and reports of inspections.
Authority for Interim Final Rule
The Act requires this document to be published as an interim final
rule (42 U.S.C. 262a, note).
Paperwork Reduction Act
The Centers for Disease Control and Prevention (referred to below
as the CDC) has determined that the Paperwork Reduction Act (44 U.S.C.
Chapter 35) applies to the data collection activities in this Interim
Final Rule. In compliance with the Paperwork Reduction Act, CDC
publishes a list of information collection requests under review by the
Office of Management and Budget (OMB). To request more information on
the proposed data collection or to obtain a copy of the data collection
plans and instruments, call the CDC Reports Clearance Officer at (404)
498-1210.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. CDC is requesting an emergency
clearance from OMB to collect data under the Interim Final Rule.
Written comments should be received within 30 days of this notice. Send
written comments to Anne O'Connor, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS D-24, Atlanta, Georgia 30333. OMB is
expected to act on this request within 60 days of publication of this
notice.
Proposed Project: Possession, Use, and Transfer of Select Agents
and Toxins--New--Office of the Director (OD), Centers for Disease
Control and Prevention. As explained above, the Act specifies that the
HHS Secretary shall provide for the establishment and enforcement of
standards and procedures governing the possession and use of Select
Agents. Also as explained above, the part 73 regulations provide that
facilities that possess or use within the United States, receive from
outside the United States, or transfer within the United States, select
agents or toxins must register with the HHS Secretary. The HHS
Secretary has designated CDC as the agency responsible for collecting
this information.
CDC is proposing to collect this information through the use of
five separate forms. These forms are: (1) Application for Registration;
(2) Facility Notification Form; (3) Request for Exemption; (4) Transfer
of Select Agent Form; and (5) Clinical and Diagnostic Laboratory
Reporting Form.
The Application for Registration (CDC Form 0.1319) will be used by
facilities to register with CDC. The Application for Registration
requests facility information, a list of select agents and toxins in
use, possession, or for transfer by the facility, characterization of
the select agent, and laboratory information. This form is a
modification of an existing form approved under OMB Control No. 0920-
0199. Estimated average time to complete this form is 3 hours, 45
minutes for an entity with one principal investigator working with one
select agent. CDC estimates that entities will need an additional 45
minutes for each additional investigator or select agent. This is an
increase of 1 hour, 45 minutes over the previous form due to new
reporting requirements for security and identification of those
individuals the entity has designated to have a legitimate need to
handle or use select agents or toxins.
Facilities must amend their registration if certain changes occur
in the information submitted to the HHS Secretary. To apply for an
amendment to a certificate of registration, an entity must obtain the
relevant portion of the application package and submit the information
requested in the package to CDC. Estimated time to amend a registration
package is 60 minutes.
The Facility Notification Form (CDC Form 0.1316) must be completed
by facilities whenever there is release of a select agent or theft or
loss of a select agent. This is a new form. Estimated average time to
complete this form is 60 minutes.
The Request for Exemption Form (CDC Form 0.1317) will be used by
facilities that are using select agents or toxins in investigational
new drug testing or in cases of public health emergency. This is a new
form. Estimated average time to complete this form is 70 minutes.
The Transfer of Select Agent Form (CDC Form EA-101) will be used by
facilities requesting transfer of a select agent or toxin to their
facilities and by the facility transferring the agent. This is a
modification of an existing form approved under OMB Control No. 0920-
0199. Estimated average time to complete this form is 1 hour, 45
minutes. This is an increase of 75 minutes due to procedural changes.
The Clinical and Diagnostic Laboratory Exemption Report (CDC Form
0.1318) will be used by clinical and diagnostic laboratories to notify
the HHS Secretary that select agents or toxins identified as the result
of diagnosis or proficiency testing have been properly disposed of.
This is a new form. Estimated average time to complete this form is 60
minutes.
In addition to the standardized forms, the part 73 regulations also
outline situations in which an entity must notify or make a request of
the HHS Secretary in writing and CDC is requesting OMB approval to
collect this information. The regulation states that an entity must
notify the HHS Secretary in writing at least five business days before
destroying select agents or toxins. The estimated time to gather the
information and submit this notification is 30 minutes. An entity may
also apply to the HHS Secretary for an expedited review of an
individual by the Attorney General. To apply for this expedited review,
an entity must submit a request in writing to the HHS Secretary
establishing the need for such action. The estimated time to gather the
information and submit this request is 30 minutes. Entities should be
aware that CDC is not developing standardized forms to use in these
situations. Rather, the entity should provide the information as
requested in the appropriate section of the regulation.
As part of the safety requirements of this regulation, the
Responsible Officer is required to conduct regular inspections (at
least annually) of the laboratory where the select agents and toxins
are stored. The results of these inspections must be documented. CDC
estimates that, on the average, such documentation will take one hour.
Finally, as part of the safety requirements of this regulation, the
entity is required to record the identity of the individual trained,
the date of training, and the means used to verify that the employee
understood the training. Estimated time for this documentation is 2
hours per principal investigator.
An entity or an individual may request administrative review of a
decision denying or revoking certification of registration in writing
within 30 calendar days after the adverse decision. This request should
include a statement of the factual basis for the review. CDC estimates
the time to prepare and submit such a request is four hours.
Finally, an entity must implement a system to ensure that certain
records
[[Page 76895]]
and databases are accurate and that the authenticity of records may be
verified. The time to implement such a system is estimated to average
four hours.
The total annualized burden for this data collection is 30,777
hours.
----------------------------------------------------------------------------------------------------------------
Responses
CFR reference Data collection Number of per Average
respondents respondent hourly burden
----------------------------------------------------------------------------------------------------------------
73.7(b) Registration Application......... 817 1 3.75
73.7(d) Amendment to Registration 817 2 1
Application.
73.17(a)(e) Notification Form................ 10 1 1
73.6(c-e) Request for Exemption............ 17 1 70/60
73.14 Transfer of Select Agent......... 1,000 5 1.75
73.6(a)(2) Clinical and Diagnostic 1,000 4 1
Laboratory Exemption Report.
73.7(h) Notification of inactivation..... 6 1 30/60
73.9(g) Request expedited review......... 6 1 30/60
73.10(b) Documentation of Self-Inspection. 817 1 1
73.13(f) Documentation of training........ 817 1 2
73.18 Administrative Review............ 14 1 4
73.15(d) Ensure secure Recordkeeping 817 1 4
System.
----------------------------------------------------------------------------------------------------------------
Executive Order 12866 and Regulatory Flexibility Act
This document has been reviewed by the Office of Management and
Budget under Executive Order 12866.
In the course of developing the rule, CDC considered the rule's
costs and benefits. CDC's analysis is summarized below.
Affected Entities. At least 1,653 entities have indicated that they
possess select agents or toxins. Of these, 1,167 entities are expected
to have HHS select agents or toxins or overlap select agents or toxins
used in non-agricultural research. Of these 1,167 entities, only 817
are expected to register under the rule. The remaining 350 entities
perform only diagnostic work and would be exempted from most of the
provisions of the rule, thereby avoiding most of the regulatory burden
associated with the rule.
The entities generally fall into one of four categories: academic
institutions and biomedical centers; commercial manufacturing
facilities (the pharmaceutical industry); federal, state, and local
laboratories, including clinical and diagnostic laboratories; and
research facilities. Based on the initial notifications, academic
institutions and commercial facilities comprise 81 percent of the
regulated entities.
The expected registered entities are estimated to have about 20,000
staff that will be required to submit information to the Attorney
General for approval. In general, entities limit access to select
agents or toxins to a far smaller population than their overall
workforce. In most cases, this smaller population is composed of
scientific staff. The number of employees directly handling select
agents or toxins typically ranges from approximately three individuals
at smaller commercial and state entities to more than one hundred
researchers at some large academic institutions. On average, commercial
entities authorize approximately 12 individuals to work with select
agents or toxins. Similarly, at state entities the average number of
authorized employees is estimated at about 15. Authorized populations
at research institutes and at federal entities are larger, with
approximately 25 employees handling select agents or toxins on average.
Academic institutions have the largest staff directly working with
select agents or toxins, averaging almost 40 authorized persons per
entity.
Costs. To determine the burden that the interim final rule will
impose, CDC contacted a number of entities to discuss existing
practices. To protect staff as well as the public, entities using
select agents or toxins already employ a variety of laboratory safety
practices. In general, entities are adhering to guidance in the
``Biosafety in Microbiological and Biomedical Laboratories (BMBL),''
4th Edition, as applicable to their specific biosafety level category
(e.g., BSL2, BSL3, BSL4) category. Biosafety levels range from BSL1
through BSL4, although BSL2 represents the minimum level at which
laboratories might reasonably work with limited quantities of certain
select agents. The analysis assumes that only a relatively small number
of laboratories (52 laboratories, or 6.4 percent of the 817 expected to
register) use safety practices that are inadequate for appropriate
handling of select agents.
There is wide variation in current security practices, although
there is a correlation between BSL levels and security levels. For
example, BSL-3 laboratories tend to have more security than BSL-2
laboratories. Nevertheless, even for laboratories of the same type or
BSL level, some variation exists. There also appears to be systematic
variation across laboratories of different types. In general, security
is relatively strong at federal laboratories, research institutes, and
commercial laboratories; security practices at academic institutions
and state laboratories are more variable.
Most entities (approximately 70 percent) have a training program in
place that addresses the safety of staff that is in proximity to or
handling select agents. Of the remaining entities (that do not have a
standard safety training program in place), some of them train people
on the job as necessary for the employee to learn some skills or
improve his or her proficiency. All commercial entities have a
standardized safety training program in place--at the very least for
the technical staff that work in the laboratories. The vast majorities
of entities (85 percent) have a system in place to record and monitor
the inventory of select agents or toxins.
Because many of the laboratories that will register under this rule
are already substantially in compliance with the practices required,
the costs of the rule are limited. The median annualized cost of the
rule is estimated to range from $9,300 to $201,000 (annualized over 20
years). The estimated first year cost of the rule ranges from $23,400
for a small commercial entity with a BSL 3 lab to $730,400 for a medium
university with a BSL2-3 lab. The total annualized cost of the rule is
estimated to be $41 million.
Most of the cost of the rule (over 60 percent) is attributable to
four initial activities: limiting access to select agents and work
areas; developing and implementing a security plan; developing and
implementing a safety plan; and obtaining risk assessments for existing
staff.
Benefits. The benefits to public health and safety from
implementation of the rule are clear, although difficult to quantify.
The benefits of the interim final rule result from the strengthened
prevention that the rules provide against
[[Page 76896]]
either accidental or intentional release of a select agent or toxin.
The cost of such an event in human life could be very high. A release
caused by one of the select agents or toxins would require a
complicated and expensive emergency response effort. This effort could
include extensive public health measures, such as quarantine,
preventative treatment and health testing for large numbers of
potentially exposed persons, and extensive decontamination. Substantial
costs could be incurred by hospitals and other medical facilities and
institutions of government at all levels. A release, or widespread fear
of one, also would create significant secondary effects. It could
disrupt business, transportation, and many other aspects of normal
behavior, on both a short-term and potentially a long-term basis.
The impacts resulting from the October 2001 anthrax attacks provide
an example of the costs that a limited release could incur. The anthrax
attacks caused five fatalities and 17 illnesses, disrupted business and
government activities, closed substantial parts of the postal service,
and caused widespread apprehension and changes in behavior. Costs
included more than $23 million to decontaminate one Senate office
building; approximately $2 billion in revenues lost to the postal
service, and as much as $3 billion in additional costs to the postal
service for cleanup of contamination and procurement of mail-sanitizing
equipment. Substantial costs due to lost productivity throughout the
economy and from ongoing costs of the investigations into the incident
are additional impacts.
Implementation of the interim final rule will provide a means of
determining where select agents and toxins are located; ensure that
their transfer, storage, and use can be tracked; provide for the
screening of personnel with access to such agents or toxins; and
require that entities in possession of such agents or toxins develop
and implement effective means of biosafety and physical security. The
benefit of these provisions is a reduced likelihood of either an
accidental or intentional release of select agents and toxins and the
consequent avoidance of costs associated with such a release.
In large part, the rule establishes common sense rules that already
should be followed by entities conducting activities under the rule.
Moreover, any costs of compliance should not be significant. The
annualized cost on small entities would not exceed one percent of sales
or revenue stream and the initial cost would not exceed three percent
of sales or revenue stream. A copy of the economic analysis,
``Regulatory Impact Analysis, 42 CFR part 73, Select Biological Agents
and Toxins, Interim Final Rule,'' is available from on the CDC Web site
at http://www.cdc.gov.
Therefore, the HHS Secretary hereby certifies that the interim
final rule will not have a significant economic impact on a substantial
number of small entities.
Unfunded Mandates
The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532 that
agencies prepare an assessment of anticipated costs and benefits before
developing any rule that may result in an 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 rule would have no
consequential effect on State, local, or tribal governments.
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers, Penalties, Reporting and
recordkeeping requirements, Transportation.
List of Subjects in 42 CFR Part 1003
Administrative practice and procedure, Fraud, Grant programs-
health, Health facilities, Health professions, Maternal and child
health, Medicaid, Medicare, Penalties, Social security.
Dated: December 4, 2002.
Tommy G. Thompson,
Secretary.
For the reasons stated in the preamble, 42 CFR Chapters I and V are
amended as follows:
1. Part 73 is added to 42 CFR chapter I to read as follows:
PART 73--SELECT AGENTS AND TOXINS
73.0 Applicability and related requirements.
73.1 Definitions.
73.2 Purpose and scope.
73.3 General prohibition.
73.4 HHS select agents and toxins.
73.5 Overlap select agents and toxins.
73.6 Exemptions from requirements under this part.
73.7 Registration.
73.8 Security risk assessments.
73.9 Responsible Official.
73.10 Safety.
73.11 Security.
73.12 Emergency response.
73.13 Training.
73.14 Transfers.
73.15 Records.
73.16 Inspections.
73.17 Notification for theft, loss, or release.
73.18 Administrative review.
73.19 Civil money penalties.
73.20 Criminal penalties.
73.21 Submissions and forms.
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 Applicability and related requirements.
(a) For those entities that on February 7, 2003, were conducting
activities under a certificate of registration issued under Sec. 72.6
of this chapter, or were lawfully possessing select agents and toxins,
the provisions of part 73 and Sec. 72.6 of this chapter are applicable
as follows:
(1) On and after February 7, 2003, the following sections are
applicable: Sec. Sec. 73.1 through 73.6 (definitions, purpose and
scope, general prohibition, HHS select agents and toxins, overlap
select agents and toxins, exemptions from requirements under this
part); Sec. 73.9 (Responsible Official); Sec. 73.10 (Safety); Sec.
73.12 (emergency response); and Sec. Sec. 73.15 through 73.21
(records; inspections; notification for theft, loss, or release;
administrative review; civil money penalties; criminal penalties; and
submissions and forms).
(2) On and after February 7, 2003, the provisions of Sec. 73.13
concerning training related to safety and emergency response are
applicable; and on and after September 12, 2003, the remaining
provisions of Sec. 73.13, including those concerning training related
to security, are applicable.
(3) On and after March 12, 2003, the provisions of Sec. 73.14
(transfers) are applicable.
(4) On and after April 12, 2003, the provisions of Sec. 73.8
regarding security risk assessments for the entity, the Responsible
Official, and any individual who owns or controls the entity are
applicable; and on and after June 12, 2003, the remainder of Sec. 73.8
(including the provisions regarding individual risk assessments for
other than the Responsible Official or any individual who owns or
controls the entity) is applicable.
(5) On and after June 12, 2003, the provisions of Sec. 73.11
regarding the development of a security plan are applicable, and on and
after September 12, 2003, the remainder of the provisions of Sec.
73.11, including the provisions regarding the implementation of a
security plan, is applicable.
(6) On and after November 12, 2003, the provisions of Sec. 73.7
(registration) are applicable.
(b) The following also applies to those entities that on February
7, 2003, already were conducting activities under a certificate of
registration issued
[[Page 76897]]
under Sec. 72.6 of this chapter or already were lawfully possessing
select agents and toxins:
(1) During the period from March 12, 2003, through November 11,
2003, such an entity may not conduct activities regulated under this
part unless the entity has submitted to HHS or USDA an application
package under Sec. 73.7 certifying compliance with the provisions
referred to in paragraph (a)(1) of this section and the provisions in
Sec. 73.13 concerning training related to safety and emergency
response.
(2) During the period from March 12, 2003, through April 11, 2003,
such an entity may not conduct activities regulated under this part
unless the entity has submitted applications for approval under Sec.
73.8 (security risk assessment) to the Attorney General for the entity,
the Responsible Official, and any individual who owns or controls the
entity.
(3) During the period from April 12, 2003, through June 11, 2003,
such an entity may not conduct activities regulated under this part
unless the entity has submitted applications for approval under Sec.
73.8 (security risk assessments) to the Attorney General for all
individuals (other than the Responsible Official and any individual who
owns or controls the entity) with access to select agents and toxins.
(4) Such an entity remains:
(i) Subject to the registration provisions of Sec. 72.6 of this
chapter until November 12, 2003, when superseded by Sec. 73.7;
(ii) Subject to the security provisions of Sec. 72.6 of this
chapter regarding development of a security plan until June 12, 2003,
when superseded by the requirement to develop a security plan under
Sec. 73.11;
(iii) Subject to the security provisions of Sec. 72.6 of this
chapter regarding implementation of a security plan until September 12,
2003, when superseded by the requirement to fully comply with Sec.
73.11;
(iv) Subject to the training provisions of Sec. 72.6 of this
chapter related to security until September 12, 2003, when superseded
by the training provisions of Sec. 73.13 relating to security; and
(v) Subject to the transfer provisions of Sec. 72.6 of this
chapter until March 12, 2003, when superseded by Sec. 73.14.
(c) For those entities that on February 7, 2003, were not already
were conducting activities under a certificate of registration issued
under Sec. 72.6 of this chapter and were not already lawfully
possessing select agents and toxins, the provisions of part 73 are
applicable as follows:
(1) On and after February 7, 2003, the following sections are
applicable: Sec. Sec. 73.1 through 73.6 (definitions, purpose and
scope, general prohibition, HHS select agents and toxins, overlap
select agents and toxins, exemptions from requirements under this
part); Sec. Sec. 73.8 through 73.10 (Security risk assessments,
Responsible Official, Safety); Sec. Sec. 73.12 through 73.21
(emergency response, training, transfers, records; inspections;
notification for theft, loss, or release; administrative review; civil
money penalties; criminal penalties; and submissions and forms) and
must hold a valid permit under 9 CFR part 122 and/or 42 CFR part 71.54.
(2) The provisions of Sec. 73.11 are applicable on and after
September 12, 2003.
(3) On and after November 12, 2003, the provisions of Sec. 73.7
(registration) are applicable.
(4) During the period from February 7, 2003, through November 11,
2003, such an entity may not conduct activities regulated under this
part unless the entity has submitted to HHS or USDA an application
package under Sec. 73.7 certifying compliance with the provisions
referred to in paragraph (b)(2) of this section.
Sec. 73.1 Definitions.
For purposes of this part:
Biological agent means any microorganism (including, but not
limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or
infectious substance, or any naturally occurring, bioengineered, or
synthesized component of any such microorganism or infectious
substance, capable of causing death, disease, or other biological
malfunction in a human, an animal, a plant, or another living organism;
deterioration of food, water, equipment, supplies, or material of any
kind; or deleterious alteration of the environment.
CDC means Centers for Disease Control and Prevention of the
Department of Health and Human Services.
Diagnosis means the analysis of specimens for the purpose of
identifying or confirming the presence of a listed select agent or
toxin provided that such analysis is directly related to protecting the
public health or safety.
Entity means any government agency (Federal, State, or local),
academic institution, corporation, company, partnership, society,
association, firm, sole proprietorship, or other legal entity.
HHS means the Department of Health and Human Services.
HHS Secretary means the Department of Health and Human Services or
his or her designee, unless otherwise specified.
HHS select agent or toxin means a biological agent or toxin
included in Sec. 73.4.
Overlap select agent or toxin means a biological agent or toxin
included in Sec. 73.5.
Proficiency testing means a sponsored, time-limited analytical
trial whereby one or more analytes, previously confirmed by the
sponsor, are submitted to the testing laboratory for analysis and where
final results are graded, scores are recorded and provided to
participants, and scores for participants are evaluated.
Principal investigator means the one individual who is designated
by the entity to direct a project or program and who is responsible to
the entity for the scientific and technical direction of that project
or program.
Select agent or toxin or select agent and toxin without
identification as HHS or overlap means all of those biological agents
or toxins included in Sec. Sec. 73.4 and 73.5 of this part.
Toxin means the toxic material or product of plants, animals,
microorganisms (including, but not limited to, bacteria, viruses,
fungi, rickettsiae, or protozoa), or infectious substances, or a
recombinant or synthesized molecule, whatever their origin and method
of production, and includes any poisonous substance or biological
product that may be engineered as a result of biotechnology, produced
by a living organism; or any poisonous isomer or biological product,
homolog, or derivative of such a substance.
United States means the United States of America, the District of
Columbia, Puerto Rico, and the territories and possessions of the
United States.
USDA means the United States Department of Agriculture.
USDA Secretary means the Department of Agriculture or his or her
designee, unless otherwise specified.
Verification means the processes required to assure the accuracy,
precision, and the analytical sensitivity and specificity of any
procedure used for diagnosis.
Sec. 73.2 Purpose and scope.
(a) This part sets forth requirements regarding the possession or
use in the United States, receipt from outside the United States, or
transfer within the United States, of select agents and toxins. The
requirements are designed to implement provisions of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (Public
Law 107-188). The Act was
[[Page 76898]]
designed to provide protection against the effects of misuse of select
agents and toxins whether inadvertent or the result of terrorist acts
against the United States homeland or other criminal acts. The agents
and toxins subject to requirements under this part are those that have
the potential to pose a severe threat to public health and safety. They
are further identified as either HHS select agents and toxins or
overlap select agents and toxins. The term HHS select agents and toxins
refers to those select agents and toxins subject to these regulations
but not subject to USDA requirements at 9 CFR part 121. The overlap
group consists of those select agents and toxins subject to
requirements promulgated by the HHS Secretary under this part and also
subject to corresponding requirements promulgated by USDA at 9 CFR part
121.
(b) This part does not set requirements for the exportation of
select agents or toxins. The Department of Commerce has primary
responsibility for regulating the exportation of microorganisms and
toxins in Title 15 of the Code of Federal Regulations.
(c) This part does not set requirements for the transportation in
commerce of select agents or toxins. The Department of Transportation
has primary responsibility for regulating the transportation of such
select agents and toxins as hazardous materials under 49 CFR parts 171
through 180.
Sec. 73.3 General prohibition.
An entity or individual may not possess or use in the United
States, receive from outside the United States, or transfer within the
United States, a select agent or toxin unless such activities are
conducted for a lawful purpose and in accordance with the provisions of
this part. Registration, exclusions, and exemptions are automatically
revoked when any event occurs that results in an entity or individual
no longer being eligible.
Sec. 73.4 HHS select agents and toxins.
Except for exclusions under paragraph (f) of this section, the
viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic
acids, and recombinant organisms specified in paragraphs (a) through
(e) of this part are HHS select agents and toxins.
(a) Viruses:
(1) Crimean-Congo haemorrhagic fever virus.
(2) Ebola viruses.
(3) Cercopithecine herpesvirus 1 (Herpes B virus).
(4) Lassa fever virus.
(5) Marburg virus.
(6) Monkeypox virus.
(7) South American Haemorrhagic Fever viruses (Junin, Machupo,
Sabia, Flexal, Guanarito).
(8) Tick-borne encephalitis complex (flavi) viruses (Central
European Tick-borne encephalitis, Far Eastern Tick-borne encephalitis
[Russian Spring and Summer encephalitis, Kyasanur Forest disease, Omsk
Hemorrhagic Fever]).
(9) Variola major virus (Smallpox virus) and Variola minor virus
(Alastrim).
(b) Bacteria:
(1) Rickettsia prowazekii.
(2) Rickettsia rickettsii.
(3) Yersinia pestis.
(c) Fungi: Coccidioides posadasii.
(d) Toxins:
(1) Abrin.
(2) Conotoxins.
(3) Diacetoxyscirpenol.
(4) Ricin.
(5) Saxitoxin.
(6) Tetrodotoxin.
(7) Shiga-like ribosome inactivating proteins.
(e) Genetic Elements, Recombinant Nucleic Acids, and Recombinant
Organisms:
(1) Select agent viral nucleic acids (synthetic or naturally
derived, contiguous or fragmented, in host chromosomes or in expression
vectors) that can encode infectious and/or replication competent forms
of any of the select agent viruses.
(2) Nucleic acids (synthetic or naturally derived) that encode for
the functional form(s) of any of the toxins listed in paragraph (d) of
this section if the nucleic acids:
(i) Are in a vector or host chromosome;
(ii) Can be expressed in vivo or in vitro; or
(iii) Are in a vector or host chromosome and can be expressed in
vivo or in vitro.
(3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a)
through (d) of this section that have been genetically modified.
(f) Exclusions:
(1) This section does not include any select agent or toxin that is
in its naturally occurring environment provided it has not been
intentionally introduced, cultivated, collected, or otherwise extracted
from its natural source.
(2) This section does not include non-viable select agent organisms
or nonfunctional toxins.
(3) Paragraph (a) of this section does not include the vaccine
strain of Junin virus (Candid 1).
(4) Paragraph (d) of this section does not include the following
toxins (in the purified form or in combinations of pure and impure
forms) if the aggregate amount under the control of a principal
investigator does not, at any time, exceed the amount specified: 100 mg
of Abrin; 100 mg of Conotoxins; 1,000 mg of Diacetoxyscirpenol; 100 mg
of Ricin; 100 mg of Saxitoxin; 100 mg of Shiga-like ribosome
inactivating proteins; or 100 mg of Tetrodotoxin.
(5) The HHS Secretary may exclude from this section attenuated
strains of HHS select agents or toxins upon a determination that they
do not pose a severe threat to the public health and safety. To apply
for an exclusion an applicant must submit a request in writing in
accordance with Sec. 73.21 to the HHS Secretary establishing that the
attenuated strain or toxin is eligible for exclusion. The HHS Secretary
will provide a written decision granting the request, in whole or in
part, or denying the request. An exclusion will be effective upon
notification to the applicant. Exclusions will be published in the
notice section of the Federal Register and will be listed on the CDC
Web site at http://www.cdc.gov. Exclusions also will be referenced in
this section when changes are made based on periodic reviews.
Sec. 73.5 Overlap select agents and toxins.
Except for exclusions under paragraph (f) of this section, the
viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic
acids, and recombinant organisms specified in paragraphs (a) through
(e) of this part are overlap select agents and toxins.
(a) Viruses:
(1) Eastern Equine Encephalitis virus.
(2) Nipah and Hendra Complex viruses.
(3) Rift Valley fever virus.
(4) Venezuelan Equine Encephalitis virus.
(b) Bacteria:
(1) Bacillus anthracis.
(2) Brucella abortus.
(3) Brucella melitensis.
(4) Brucella suis.
(5) Burkholderia mallei (formerly Pseudomonas mallei).
(6) Burkholderia pseudomallei (formerly Pseudomonas pseudomallei).
(7) Botulinum neurotoxin producing species of Clostridium.
(8) Coxiella burnetii.
(9) Francisella tularensis.
(c) Fungi: Coccidioides immitis.
(d) Toxins:
(1) Botulinum neurotoxins.
(2) Clostridium perfringens epsilon toxin.
(3) Shigatoxin.
(4) Staphylococcal enterotoxins.
(5) T-2 toxin.
[[Page 76899]]
(e) Genetic elements, recombinant nucleic acids, and recombinant
organisms:
(1) Select agent viral nucleic acids (synthetic or naturally
derived, contiguous or fragmented, in host chromosomes or in expression
vectors) that can encode infectious and/or replication competent forms
of any of the select agent viruses.
(2) Nucleic acids (synthetic or naturally derived) that encode for
the functional form(s) of any of the toxins listed in paragraph (d) of
this section if the nucleic acids:
(i) Are in a vector or host chromosome;
(ii) Can be expressed in vivo or in vitro; or
(iii) Are in a vector or host chromosome and can be expressed in
vivo or in vitro.
(3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a)
through (d) of this section that have been genetically modified.
(f) Exclusions:
(1) This section does not include any select agent or toxin that is
in its naturally occurring environment provided that it has not been
intentionally introduced, cultivated, collected, or otherwise extracted
from its natural source.
(2) This section does not include non-viable select agent organisms
or nonfunctional toxins.
(3) Paragraph (a) does not include the vaccine strain of Rift
Valley fever virus (MP-12) or Venezuelan Equine encephalitis virus
vaccine strain TC-83.
(4) Paragraph (d) of this section does not include the following
toxins (in the purified form or in combinations of pure and impure
forms) if the aggregate amount under the control of a principal
investigator does not, at any time, exceed the amount specified: 0.5 mg
of Botulinum neurotoxins; 5 mg of Staphylococcal enterotoxins; 100 mg
of Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; or
1,000 mg of T-2 toxin.
(5) The HHS Secretary, after consultation with the USDA Secretary,
may exclude from this section attenuated strains of overlap select
agents or toxins upon a determination that they do not pose a severe
threat to the public health and safety and do not meet the criteria in
9 CFR part 121 for inclusion. To apply for an exclusion, an applicant
must submit a request in writing in accordance with Sec. 73.21 to the
HHS Secretary or the USDA Secretary in accordance with 9 CFR part 121,
establishing that the attenuated strain is eligible for exclusion. In
response to an application submitted to the HHS Secretary, the HHS
Secretary will provide a written decision granting the request, in
whole or in part, or denying the request. An exclusion will be
effective upon notification to the applicant. Exclusions will be
published in the notice section of the Federal Register and will be
listed on the CDC Web site at http://www.cdc.gov. Also, they will be
referenced in this section when changes are made based on periodic
reviews.
Sec. 73.6 Exemptions from requirements under this part.
(a) An entity is exempt from the provisions of this part, other
than Sec. 73.14 (transfer), provided that all of the following apply:
(1) The only activities conducted by the entity that are subject to
this part concern select agents or toxins that are contained in
specimens or in isolates from specimens presented for diagnosis,
verification, or proficiency testing;
(2) Upon identification of a select agent or toxin as the result of
diagnosis or verification, the entity immediately reports to the HHS
Secretary by telephone, facsimile, or e-mail in accordance with Sec.
73.21 any of the following: Variola major virus (Smallpox virus) and
Variola minor (Alastrim), Bacillus anthracis, Yersinia pestis,
Botulinum neurotoxins, Francisella tularensis, Ebola viruses, Marburg
virus, Lassa fever virus, and South American Haemorrhagic Fever viruses
(Junin, Machupo, Sabia, Flexal, Guanarito);
(3) The entity reports as required under Federal, State, or local
law, to appropriate authorities;
(4) After the diagnosis, verification, or proficiency testing, the
entity either transfers the specimens or isolates containing a select
agent or toxin from the specimens to a facility eligible for receiving
them under this part, or destroys them on-site by autoclaving,
incineration, or by a sterilization or neutralization process
sufficient to cause inactivation;
(5) The entity transfers or destroys those select agents or toxins
used for diagnosis or testing within seven days after identification,
unless directed otherwise by the Federal Bureau of Investigation or
other law enforcement entity after consultation with the HHS Secretary;
and
(6) The entity transfers or destroys those select agents or toxins
used for proficiency testing within 90 days after receipt; and
(7) The entity prepares a record of the identification and transfer
or destruction on CDC Form 0.1318, submits the completed form to the
HHS Secretary in accordance with Sec. 73.21 within seven days after
identification, and maintains a copy of the record for a period of
three years.
(b) Unless the HHS Secretary issues an order to an entity making
specific provisions of this part applicable to protect the public
health and safety, products that are, bear, or contain listed select
agents or toxins that are cleared, approved, licensed, or registered
under any of the following laws, are exempt from the provisions of this
part insofar as their use is only for the approved purpose and meets
the requirements of such laws:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.);
(2) Section 351 of the Public Health Service Act pertaining to
biological products (42 U.S.C. 262);
(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C.
151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136 et seq).
(c) The HHS Secretary may exempt from the requirements of this part
on a case-by-case basis an investigational product that is, bears, or
contains a select agent or toxin, when such product is being used in an
investigation authorized under a Federal Act referred to in paragraph
(b) of this section and additional regulation under this part is not
necessary to protect public health and safety. To apply for an
exemption an applicant must submit to the HHS Secretary in accordance
with Sec. 73.21 a completed CDC Form 0.1317 certifying that the
product is being used in an investigation authorized under a Federal
Act referred to in paragraph (b) of this section, and that additional
regulation under this part is not necessary to protect public health
and safety. The HHS Secretary shall make a determination regarding the
application within 14 calendar days after receipt, provided the
application meets all of the requirements of this section and the
application establishes that the investigation has been authorized
under the cited Act. The HHS Secretary will provide a written decision
granting the request, in whole or in part, or denying the request. The
applicant must notify the HHS Secretary when an authorization for an
investigation no longer exists. This exemption automatically ceases
when such authorization is no longer in effect.
(d) The HHS Secretary may temporarily exempt an entity from the
requirements of this part, in whole or in part, based on a
determination that the exemption is necessary to provide for the timely
participation of the entity in
[[Page 76900]]
response to a domestic or foreign public health emergency. With respect
to the emergency involved, the exemption may not exceed 30 days, except
that the HHS Secretary may grant one extension of an additional 30
days. To apply for an exemption or an extension of an exemption, an
applicant must submit to the HHS Secretary in accordance with Sec.
73.21 a completed CDC Form 0.1317 establishing the need to provide for
the timely participation of the entity in a response to a domestic or
foreign public health emergency. The HHS Secretary will provide a
written decision granting the request, in whole or in part, or denying
the request.
(e) Upon request of the USDA Secretary, after the USDA Secretary
has granted an exemption under section 212(g)(1)(D) of the Agricultural
Bioterrorism Protection Act of 2002 based on a finding that there is an
agricultural emergency, the HHS Secretary may temporarily exempt an
entity from the applicability of the requirements of this part, in
whole or in part, to provide for the timely participation of the entity
in response to the agricultural emergency. With respect to the
emergency, the exemption under this part may not exceed 30 days, except
that upon the request of the USDA Secretary, the HHS Secretary may
grant one extension of an additional 30 days.
Sec. 73.7 Registration.
(a) An entity may not possess or use in the United States, receive
from outside the United States, or transfer within the United States,
any select agent or toxin unless the entity has been granted a
certificate of registration by the HHS Secretary or the USDA Secretary.
(b) To apply for a certificate of registration an entity must:
(1) Obtain a registration application number from the HHS Secretary
and then apply for approval under Sec. 73.8 for the entity, the
Responsible Official, and any individual who owns or controls the
entity; and
(2) In accordance with Sec. 73.21, submit the information
requested to the HHS Secretary or the USDA Secretary as specified in
the registration application package [CDC Form 0.1319]. Information
submitted will be used to determine whether the applicant would be
eligible to conduct activities under this part. Minimum information
required includes:
(i) Identification information (e.g., name, address, contact
numbers, identification number assigned by the Attorney General for
compliance with Sec. 73.8);
(ii) The name, source, and characterization information on select
agents and toxins included in the registration, and quantities held at
the time of the application;
(iii) The location, including building and room and floor plans for
each building and room, where each select agent or toxin will be stored
or used;
(iv) Information addressing safety, security, emergency response
plans, and training, including descriptions of any equivalent measures
adopted pursuant to Sec. 73.11(d);
(v) The name, position, and identification information regarding
the Responsible Official, including the identification number assigned
by the Attorney General for compliance with Sec. 73.8;
(vi) A list of individuals who will need access to select agents
and toxins;
(vii) A certification statement signed by the Responsible Official
attesting to the accuracy of the information submitted; and
(viii) Any other information necessary for the determination.
(c) An application that covers any HHS select agents or toxins
(regardless of whether it also covers overlap select agents or toxins)
must be submitted to the HHS Secretary in accordance with Sec. 73.21.
An application that covers only overlap select agents or toxins may be
submitted to either the HHS Secretary or the USDA Secretary.
(d) A certificate of registration will be valid only for the
specific select agents and toxins, and the specified activities and
locations that are consistent with the information provided by the
entity upon which the certificate of registration or amendment was
granted. The Responsible Official must promptly notify the HHS
Secretary in writing in accordance with Sec. 73.21, if a change occurs
in any information submitted to the HHS Secretary in the application
for the certificate of registration or amendments. This includes
modifications to the list of individuals approved under Sec. 73.8,
changes in area of work, or changes in protocols or objectives of
studies. To apply for an amendment to a certificate of registration to
add select agents or toxins or to change specified activities or
locations, an entity must obtain the relevant portion of the
registration application package and submit the information requested
in the package to the agency that issued the certificate of
registration. The package must be submitted to the appropriate address
specified in the package.
(e) In response to an application to the HHS Secretary for a
certificate of registration or amendment for select agents and toxins,
the HHS Secretary will issue a certificate of registration or amendment
if it is determined that the stated activities would be lawful (based
on information submitted by the applicant or otherwise obtained by the
HHS Secretary) and meet the requirements of this part. Otherwise, the
application for a certificate of registration or amendment will be
denied. The HHS Secretary will issue a certificate of registration or
amendment for an overlap select agent or toxin only if the USDA
Secretary concurs that the requirements for obtaining a certificate of
registration or amendment under 9 CFR part 121 have been met. The
determination of whether a certificate of registration or amendment
will be granted may be contingent upon inspection or submission of
additional information.
(f) A certificate of registration will cover activities at only one
general physical location (a building or a complex of buildings at a
single mailing address).
(g) Unless terminated sooner in accordance with this paragraph, a
certificate of registration will be valid for up to three years. To
obtain a new certificate of registration an entity must submit a new
application. (Note: To help ensure timely processing of an application
for a certificate of registration or amendment, the applicant should
submit the application at least eight weeks prior to the expiration
date.)
(1) The HHS Secretary will terminate a certificate of registration
based on a determination that the recipient no longer conducts
activities covered by the certificate.
(2) Also, the HHS Secretary may terminate a certificate of
registration based on a security risk assessment under Sec. 73.8 or
failure to comply with the provisions of this part, and may take such
action immediately if necessary to protect the public health or safety.
Upon such termination, any select agent or toxin in the possession of
the entity must be destroyed or transferred as directed by the HHS
Secretary.
(h) An entity must provide notice in writing to the HHS Secretary
in accordance with Sec. 73.21 at least five business days before
destroying a select agent or toxin, if the destruction would be for the
purpose of discontinuing activities with a select agent or toxin
covered by a certificate of registration. This will allow the HHS
Secretary to observe the destruction or take other action as
appropriate.
[[Page 76901]]
Sec. 73.8 Security risk assessment.
(a) An entity may not possess or use in the United States, receive
from outside the United States, or transfer within the United States,
any select agent or toxin unless approved by the HHS Secretary or the
USDA Secretary based on a security risk assessment by the Attorney
General. This paragraph does not apply to Federal, State, or local
governmental agencies, but does apply to the Responsible Official and
others working for or otherwise acting on behalf of such agencies.
(b) An entity may not provide an individual access to a select
agent or toxin and an individual may not access a select agent or
toxin, unless the individual is approved by the HHS Secretary or the
USDA Secretary, based on a security risk assessment by the Attorney
General.
(c) To obtain a security risk assessment under this section, an
entity must submit to the Attorney General the information requested
for the entity, the Responsible Official, any individual who owns or
controls the entity, and any other individuals required to obtain
approval under this section. The determinations regarding approval will
be made by the agency that is responsible for making determinations
regarding the corresponding certificate of registration. An entity will
receive prompt notice of action taken in response to a request for
approval for the entity, the Responsible Official, and individuals. An
individual will receive prompt notice of a denial of approval.
(d) The Attorney General will conduct a security risk assessment on
entities and individuals whose identifying information is properly
submitted. Based on the security risk assessment, the Attorney General
will notify the HHS Secretary if the Attorney General identifies any
entity, individual who owns or controls the entity, or any other
individual who is:
(1) A restricted person under 18 U.S.C. 175b; or
(2) Reasonably suspected by any Federal law enforcement or
intelligence agency of:
(i) Committing a crime specified in 18 U.S.C. 2332b(g)(5);
(ii) Having a 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
(iii) Being an agent of a foreign power (as defined in 50 U.S.C.
1801).
(e) The HHS Secretary will deny or revoke access to any select
agent or toxin to an entity or individual identified by the Attorney
General as a restricted person under paragraph (d)(1). The HHS
Secretary will deny or revoke access to any select agent or toxin to an
entity or individual identified by the Attorney General as meeting the
criteria of paragraph (d)(2) unless determined by the HHS Secretary to
be warranted in the interest of the public health and safety or
national security. For individuals meeting the criteria of paragraph
(d)(2) the HHS Secretary may provide a limited approval for a specified
time based upon the finding that circumstances warrant such action in
the interest of the public health and safety or national security.
(f) Unless a shorter period is granted under paragraph (e) of this
section, an approval for an entity or individual under this section
will be valid for five years unless terminated sooner. The HHS
Secretary may terminate an approval for an entity or an individual
based on a request from the entity or individual, a security risk
assessment under this section, or a failure to comply with the
provisions of this part, and may take such action immediately if
necessary to protect the public health and safety, or national
security.
(g) The HHS Secretary will request the Attorney General to expedite
the review process for an individual and will take action to expedite
the HHS Secretary's review process for an individual upon a showing of
good cause (e.g., public health or agricultural emergencies, national
security, impending expiration of a research grant, a short-term visit
by a prominent researcher). To apply for an expedited review, an entity
must submit a request in writing in accordance with Sec. 73.21 to the
HHS Secretary establishing the need for such action. The HHS Secretary
will provide a written decision granting the request, in whole or in
part, or denying the request.
Sec. 73.9 Responsible Official.
(a) As a condition of conducting activities regulated under this
part, an entity must identify and authorize an individual as the
Responsible Official. The Responsible Official may identify one or more
individuals, any of whom may serve as the Alternate Responsible
Official when the Responsible Official is unavailable. The Responsible
Official and all individuals identified to serve as the Alternate
Responsible Official must meet all of the qualifications for a
Responsible Official. The Responsible Official and all Alternate
Responsible Officials must:
(1) Be approved under Sec. 73.8;
(2) Be familiar with the requirements of this part; and
(3) Have authority and responsibility to ensure that the
requirements of this part are met, on behalf of the entity.
(b) For purposes of this part, the Alternate Responsible Official
acting in the absence of the Responsible Official may conduct all of
those activities required under this part to be performed by the
Responsible Official.
(c) The Responsible Official is responsible for ensuring compliance
with the regulations, including:
(1) Developing and implementing safety, security and emergency
response plans in accordance with Sec. 73.10--Sec. 73.12;
(2) Allowing only approved individuals to have access to select
agents or toxins in accordance with Sec. 73.8 and Sec. 73.11;
(3) Providing appropriate training for safety, security and
emergency response in accordance with Sec. 73.13;
(4) Transferring select agents or toxins in accordance with Sec.
73.14;
(5) Providing timely notice of any theft, loss, or release of a
select agent or toxin in accordance with Sec. 73.13;
(6) Maintaining detailed records of information necessary to give a
complete accounting of all activities related to select agents or
toxins in accordance with Sec. 73.15.
(7) The reporting of the identification of a select agent or toxin
as a result of diagnosis, verification or proficiency testing in
accordance with Sec. 73.6.
Sec. 73.10 Safety.
(a) An entity subject to the provisions of this part, must develop
and implement a safety plan. In developing a safety plan, an entity
should consider:
(1) The biosafety standards and requirements for BSL 2, 3, or 4
operations, as they pertain to the respective select agents, that are
contained in the CDC/NIH publication, ``Biosafety in Microbiological
and Biomedical Laboratories,'' including all appendices except Appendix
F. Copies may be obtained from the Superintendent of Documents, U.S.
Government Printing Office, Post Office Box 371954, Pittsburgh,
Pennsylvania, 75250-7954 or call in the Washington, DC metropolitan
area 202-512-1800 or outside that area call toll free 1-866-512-1800.
Copies may be inspected at the Centers for Disease Control and
Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia. This
publication is also available on the CDC Web site at http://www.cdc.gov
.
(2) The specific requirements for handling toxins found in 29 CFR
1910.1450, ``Occupational Exposure to Hazardous Chemicals in
Laboratories'' and/or 29 CFR 1910.1200, ``Hazard
[[Page 76902]]
Communication,'' whichever applies and specific provisions for handling
toxins found in Appendix I in the CDC/NIH publication, ``Biosafety in
Microbiological and Biomedical Laboratories,''
(3) For provisions of the safety plan relating to genetic elements,
recombinant nucleic acids and recombinant organisms, the ``NIH
Guidelines for Research Involving Recombinant DNA Molecules,'' (NIH
Guidelines). This includes, among other things, provisions regarding
risk assessment, physical containment, biological containment, and
local review and applies to all recombinant DNA research, regardless of
funding. Copies may be obtained from the Centers for Disease Control
and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia,
30333. Copies may be inspected at the Centers for Disease Control and
Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia. The
``NIH Guidelines for Research Involving Recombinant DNA Molecules,'' is
also available on the CDC Web site at http://www.cdc.gov.
(b) The Responsible Official or his or her designee must conduct
regular inspections (at least annually) of the laboratory where select
agents and toxins are stored or used to ensure compliance with all of
the procedures and protocols of the safety plan. The results of these
inspections must be documented, and any deficiencies identified during
inspections must be corrected.
(c) An entity may not conduct the following experiments unless
approved by the HHS Secretary after consultation with experts:
(1) Experiments utilizing recombinant DNA that involve the
deliberate transfer of a drug resistance trait to select agents that
are not known to acquire the trait naturally, if such acquisition could
compromise the use of the drug to control disease agents in humans,
veterinary medicine, or agriculture.
(2) Experiments involving the deliberate formation of recombinant
DNA containing genes for the biosynthesis of select toxins lethal for
vertebrates at an LD50 < 100 ng/kg body weight.
(d) [Reserved]
Sec. 73.11 Security.
(a) An entity must develop and implement a security plan
establishing policy and procedures that ensure the security of areas
containing select agents and toxins. The security plan must be based on
a systematic approach in which threats are defined, vulnerabilities are
examined, and risks associated with those vulnerabilities are mitigated
with a security systems approach.
(b) The plan must:
(1) Describe inventory control procedures, minimal education and
experience criteria for those individuals with access to select agents
or toxins, physical security, and cyber security;
(2) Contain provisions for routine cleaning, maintenance, and
repairs; provisions for training personnel in security procedures;
provisions for securing the area (e.g., card access, key pads, locks)
and protocols for changing access numbers or locks following staff
changes;
(3) Describe procedures for loss or compromise of keys, passwords,
combinations, etc.;
(4) Contain procedures for reporting suspicious persons or
activities, loss or theft of listed agents or toxins, release of listed
agents or toxins, or alteration of inventory records;
(5) Contain provisions for the control of access to containers
where listed agents and toxins are stored; and procedures for reporting
and removing unauthorized persons;
(6) Contain provisions for ensuring that all individuals with
access, including workers and visitors, understand security
requirements and are trained and equipped to follow established
procedures;
(7) Establish procedures for reporting and removing unauthorized
persons; and
(8) Establish procedures for securing the area when individuals
approved under Sec. 73.8 are not present (e.g., card access system,
key pads, locks), including protocols for changing access numbers or
locks following staff changes.
(c) The security plan must be reviewed by the RO at least annually
and after any incident.
(d) With respect to areas containing select agents and toxins, the
entity must adhere to the following security requirements or implement
measures to achieve an equivalent or greater level of security as the
provisions below:
(1) Allow unescorted access only to individuals who have been
approved under Sec. 73.8 and who are performing a specifically
authorized function during hours required to perform the defined job
(including delivery to an outside shipping agent for transportation in
commerce);
(2) Allow individuals not approved under Sec. 73.8 to conduct
routine cleaning, maintenance, repairs, and other non-laboratory
functions only when escorted and continually monitored by individuals
approved under Sec. 73.8;
(3) Provide for the control of access to containers where select
agents and toxins are stored by requiring freezers, refrigerators,
cabinets, and other containers where stocks of select agents and toxins
are stored to be locked (e.g., card access system, lock boxes) when
they are not in the direct view of approved staff, and by using other
monitoring measures as needed, such as video surveillance;
(4) Require the inspection of all packages upon entry to and exit
from the area;
(5) Establish a protocol for intra-entity transfers, including
provisions for ensuring that the packaging, and movement from a
laboratory to another laboratory or from a laboratory to a shipping
place, is conducted under the supervision of an individual approved
under Sec. 73.8;
(6) Require that each approved individual under 73.8 does not share
with any other person, his or her unique means (e.g., keycards or
passwords) of accessing the area or select agent or toxin;
(7) Require that each individual approved under Sec. 73.8 report
any of the following immediately to the Responsible Official:
(i) Any loss or compromise of their keys, passwords, combinations,
etc.;
(ii) Any suspicious persons or activities;
(iii) Any loss or theft of select agents or toxins;
(iv) Any release of select agents or toxins; and
(v) Any sign that inventory and use records of select agents or
toxins have been altered or otherwise compromised.
(e) The entity must separate areas where select agents and toxins
are stored or used from the public areas of the buildings.
(f) Upon termination of the use, a select agent or toxin must be
(1) Securely stored in accordance with the requirements of this
section;
(2) Transferred to another registered facility in accordance with
Sec. 73.14; or
(3) Destroyed on-site by autoclaving, incineration, or another
recognized sterilization or neutralization process.
Sec. 73.12 Emergency response.
(a) An entity required to register under this part must develop and
implement an emergency response plan that meets the requirements of
OSHA Hazardous waste operations and emergency response standard at 29
CFR 1910.120. Nothing in this section is to supersede or preempt the
enforcement of the emergency response requirements
[[Page 76903]]
imposed by the other statute or regulation.
(b) The emergency response plan must be coordinated with any
entity-wide plans. The plan must address such events as bomb threats,
severe weather (hurricanes, floods), earthquakes, power outages, and
other natural disasters or emergencies.
(c) The emergency response plan must address the following:
(1) The hazards associated with the use of the select agents and
toxins;
(2) Any hazards associated with response actions that could lead to
a spread of a select agent or toxin;
(3) Planning and coordination with outside parties;
(4) Personnel roles, lines of authority, training, and
communication;
(5) Emergency recognition and prevention;
(6) Safe distances and places of refuge;
(7) Site security and control;
(8) Evacuation routes and procedures;
(9) Decontamination;
(10) Emergency medical treatment and first aid;
(11) Emergency alerting and response procedures;
(12) Critique of response and follow-up;
(13) Personal protective and emergency equipment; and
(14) Special procedures needed to address the hazards of specific
agents.
Sec. 73.13 Training.
(a) An entity required to register under this part and falls
outside of the OSHA Bloodborne Pathogen Standard 29 CFR 1910.1030(a)
must provide information and training on safety and security for
working with select agents and toxins to each individual approved for
access under Sec. 73.8 and each unapproved individual working in, or
visiting, areas where select agents and toxins are handled or stored.
The information and training must meet the requirements of this section
and must ensure that all individuals who work in, or visit, the areas
understand the hazards of select agents and toxins present in the area.
(b) The entity must provide information and training at the time of
an individual's initial assignment to a work area where select agents
or toxins are present and prior to assignments involving new exposure
situations. The entity must provide refresher training annually.
(c) The Responsible Official must provide appropriate training in
safety, containment, and security to all individuals with access to
areas where select agents and toxins are handled or stored.
(d) In lieu of initial training for those individuals already
involved in handling select agents or toxins, the Responsible Official
may certify in writing that the individual has the required knowledge,
skills, and abilities to safely carry out the duties and
responsibilities.
(e) The entity must ensure that each individual with access to
areas where select agents or toxins are handled or stored received and
understood the training required by this section unless certified under
paragraph (d) of this section. The entity must record the identity of
the individual trained, the date of training, and the means used to
verify that the employee understood the training.
Sec. 73.14 Transfers.
A select agent or toxin may not be transferred from one entity to
another entity within the United States (regardless of whether the
transfer is interstate or intrastate), or received by an entity in the
United States from an entity outside the United States, unless:
(a) The sender:
(1) Has a certificate of registration that covers the transfer of
the particular select agent or toxin to be transferred,
(2) Meets the exemption requirements under Sec. 73.6 (a) for the
particular select agent or toxin to be transferred, or
(3) Is transferring the select agent or toxin from outside the
United States (and all import requirements are met);
(b) The recipient has a certificate of registration that includes
the particular select agent or toxin to be transferred;
(c) Prior to the transfer, the recipient and sender completes CDC
Form EA-101, and the recipient submits to the HHS Secretary in
accordance with Sec. 73.21 a completed CDC Form EA-101.
(d) CDC has authorized the transfer based on the finding that the
recipient has a certificate of registration covering the transfer of
the select agent or toxin;
(e) The sender complies with all applicable laws concerning
packaging and shipping;
(f) The Responsible Official of the recipient provides a completed
paper copy or facsimile transmission of CDC Form EA-101 to the sender
and to the HHS Secretary within 2 business days of receipt of the
select agent or toxin; and
(g) The recipient immediately reports to the HHS Secretary if the
select agent or toxin has not been received within 48 hours after the
expected delivery time, or if the package received containing select
agents or toxins has been leaking or was otherwise damaged.
(h) When the select agents or toxins are consumed or destroyed
after a transfer, the recipient must within five business days report
such fact to the HHS Secretary in accordance with Sec. 73.21 on a CDC
Form EA-101.
Note to Sec. 73.14: This section does not cover transfers
within an entity when the sender and the recipient are covered by
the same certificate of registration.
Sec. 73.15 Records.
The Responsible Official must maintain complete records relating to
the activities covered by this Part. Such records include:
(a) An entity required to register under this part must maintain an
up-to-date, accurate list of the individuals approved under Sec. 73.8
for access to select agents and toxins.
(b) The entity must maintain an accurate, current inventory of each
select agent and toxin held. The inventory records must include the
following information for each select agent and toxin:
(1) The name, characteristics, and source data;
(2) The quantity held on the date of the first inventory (toxins
only);
(3) The quantity acquired, the source, and date of acquisition;
(4) The quantity, volume, or mass destroyed or otherwise disposed
of and the date of each such action;
(5) The quantity used and date(s) of the use (toxins only);
(6) The quantity transferred, the date of transfer, and individual
to whom it was transferred (this includes transfers within an entity
when the sender and the recipient are covered by the same certificate
of registration);
(7) The current quantity held (toxins only);
(8) Any select agent or toxin lost, stolen, or otherwise
unaccounted for; and
(9) A written explanation of any discrepancies.
(c) The entity must maintain the following records:
(1) For access to the select agents or toxins:
(i) The name of each individual who has accessed any select agent
or toxin;
(ii) The select agent or toxin used;
(iii) The date when the select agent or toxin was removed, if
removed from long-term storage or holdings for stock cultures;
(iv) The quantity removed (toxins only);
(v) The date the select agent or toxin was returned to the long-
term storage or holdings for stock cultures; and
(vi) The quantity returned (toxins only);
(2) For access to the area where select agents are used or stored:
[[Page 76904]]
(i) The name of each individual who has accessed the area;
(ii) The date and time the individual entered the area;
(iii) The date and time the individual left the area; and
(iv) For individuals not approved under Sec. 73.8, the individual
approved under Sec. 73.8 who accompanied the unapproved individual
into the area.
(d) The entity must implement a system to ensure that all records
and databases created under paragraphs (b) and (c) of this section are
accurate, and that the authenticity of records may be verified.
(e) The entity must create a record concerning inspections
conducted under Sec. 73.10(b).
(f) Safety, security, and emergency response plans.
(g) Training records.
(h) Transfer documents (CDC Form EA-101) and permits.
(i) Safety and security incident reports.
(j) The entity must maintain all records created under this part
for three years.
Sec. 73.16 Inspections.
The HHS Secretary, without prior notification and with or without
cause, shall be allowed to inspect any site at which activities
regulated by this part are conducted and shall be allowed to inspect
and copy any records relating to the activities covered by this part.
Sec. 73.17 Notification for theft, loss, or release.
(a) Upon discovery of a theft or loss of a select agent or toxin,
an entity required to register under this part must immediately notify
the HHS Secretary and State and local law enforcement. The notification
must be reported to the HHS Secretary by either telephone, facsimile,
or e-mail in accordance with Sec. 73.21.
(b) Thefts or losses must be reported whether the select agent or
toxin is subsequently recovered or the responsible parties are
identified.
(c) When reporting a theft or loss, the entity must provide the
following information:
(1) The name of the select agent or toxin and any identifying
information (e.g., strain or other characterization information);
(2) An estimate of the quantity lost or stolen;
(3) An estimate of the time during which the theft or loss
occurred; and
(4) The location (building, room) from which the theft or loss
occurred.
(d) The entity shall immediately notify the HHS Secretary and State
and local public health agencies of any release of a select agent or
toxin causing occupational exposure or release outside of the primary
containment barriers. The report must be made to the HHS Secretary by
telephone, facsimile, or e-mail in accordance with Sec. 73.21.
(e) When reporting a release, the entity must provide the following
information:
(1) The name of the select agent or toxin and any identifying
information (e.g., strain or other characterization information);
(2) An estimate of the quantity released;
(3) The time and duration of the release;
(4) The environment into which the release occurred (e.g., in
building or outside of building, waste system);
(5) The location (building, room) from which the release occurred;
(6) The number of individuals potentially exposed at the facility.
(7) Actions taken to respond to the release; and
(8) Hazards posed by the release.
(f) Within seven calendar days of theft, loss, or release, the
entity must submit a follow-up report in writing to the HHS Secretary
on CDC Form 0.1316 in accordance with Sec. 73.21.
Sec. 73.18 Administrative review.
An entity may obtain review of a decision denying or revoking a
certificate of registration under Sec. 73.7 and the affected entity or
individual may obtain review of a decision denying or revoking approval
under Sec. 73.8 by requesting such review in writing within 30
calendar days after the adverse decision. The request for review must
state the factual basis for the review, which will be carried out in
accordance with 42 U.S.C. 262a(e)(7). Where the adverse decision is in
whole or in part based upon notification by the Attorney General under
42 U.S.C. 262a (e)(3), the request for review will be forwarded to the
Attorney General for the Attorney General's review and final
notification to the HHS Secretary.
Sec. 73.19 Civil money penalties.
(a) The Inspector General of the Department of Health and Human
Services is delegated authority to conduct investigation and to impose
civil money penalties against any individual or entity in accordance
with regulations in 42 CFR part 1003 for violation of the regulations
in this part, as authorized by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-
188). The delegation of authority includes all powers contained in
section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).
(b) The administrative law judges in, assigned to, or detailed to
the Departmental Appeals Board (DAB) have been delegated authority to
conduct hearings and to render decisions with respect to the imposition
of civil money penalties, as authorized by the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-
188). This delegation includes, but is not limited to, the authority to
administer oaths and affirmations, to subpoena witnesses and documents,
to examine witnesses, to exclude or receive and give appropriate weight
to materials and testimony offered as evidence, to make findings of
fact and conclusions of law, and to determine the civil money penalties
to be imposed.
(c) The DAB of the Department of Health and Human Services is
delegated authority to make final determinations with respect to the
imposition of civil money penalties for violations of the regulations
of this part.
Sec. 73.20 Criminal Penalties.
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Public Law 107-188) provides specific criminal
penalties for violation of provisions of this part. This is in addition
to any other criminal penalties that would apply for violation of
provisions of this part.
Sec. 73.21 Submissions and forms.
(a) CDC forms referred to in this part, including registration
application packages, may be obtained on the Select Agent Program Web
site at http://www.cdc.gov, or by requesting them in writing from the
Select Agent Program, Centers for Disease Control and Prevention, 1600
Clifton Road, NE., Mail Stop E 79, Atlanta, Georgia 30333. Forms
(including any required attachments) must be submitted in accordance
with the instructions on the form.
(b) Applications, requests, notifications, and other information
required to be submitted to the HHS Secretary in writing, but not
required to be on a form, unless otherwise specified, must be submitted
to the Select Agent Program, Center for Disease Control and Prevention,
1600 Clifton Road, NE., Mail Stop E 79, Atlanta, Georgia 30333, or by
e-mail at lrsat@cdc.gov.
(c) Information not required to be submitted to the HHS Secretary
on a form may be submitted to the Select Agent Program, Center for
Disease Control and Prevention, 1600 Clifton
[[Page 76905]]
Road, NE., Mail Stop E 79, Atlanta, Georgia 30333, or by e-mail at
lrsat@cdc.gov.
(d) If an application or request submitted to the HHS Secretary is
incomplete or additional information is needed to allow the decision
maker to make a determination, the HHS Secretary will notify the
applicant or requester in writing of the deficiency and request
additional information. If the applicant or requester fails to respond
within 30 calendar days (or within such time period agreed upon by the
applicant or requester and the HHS Secretary) the application or
request will be deemed abandoned.
(e) You may request forms or other information from the USDA at the
following address: APHIS, Veterinary Services, National Center for
Import and Export, 4700 River Road Unit 40, Riverdale, MD 20737-1231.
PART 1003--CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS
1. The authority citation for part 1003 is revised to read as
follows:
Authority: 42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10,
1395u(j), 1395u(k), 1395cc(j), 1395dd(d)(1), 1395mm, 1395nn(g),
1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).
2. Section 1003.100 is amended by revising paragraph (a),
republishing the introductory text for paragraphs (b) and (b)(1),
revising paragraphs (b)(1)(xiv) and (b)(1)(xv), and by adding a new
paragraph (b)(1)(xvi) to read as follows:
Sec. 1003.100 Basis and purpose.
(a) Basis. This part implements sections 1128(c), 1128A, 1140,
1876(i)(6), 1877(g), 1882(d) and 1903(m)(5) of the Social Security Act;
sections 421(c) and 427(b)(2) of Pub. L. 99-660; and section 201(i) of
Pub. L. 107-188 (42 U.S.C. 1320-7(c), 1320a-7a, 1320b-10, 1395mm,
1395ss(d), 1396b(m), 11131(c), 11137(b)(2) and 262).
(b) Purpose. This part--
(1) Provides for the imposition of civil money penalties and, as
applicable, assessments against persons who--
* * * * *
(xiv) Have submitted, or caused to be submitted, certain prohibited
claims, including claims for services rendered by excluded individuals
employed by or otherwise under contract with such person, under one or
more Federal health care programs;
(xv) Violate the Federal health care programs' anti-kickback
statute as set forth in section 1128B of the Act; or
(xvi) Violate the provisions of part 73 of this chapter,
implementing section 351A(b) and (c) of the Public Health Service Act,
with respect to the possession and use within the United States,
receipt from outside the United States, and transfer within the United
States, of select agents and toxins in use, or transfer of listed
biological agents and toxins.
* * * * *
3. Section 1003.101 is amended by republishing the introductory
text and by adding, in alphabetical order, a definition for the term
``Select agents and toxins'' to read as follows:
Sec. 1003.101 Definitions.
For purposes of this part:
* * * * *
Select agents and toxins means agents and toxins that are listed by
the HHS Secretary as having the potential to pose a severe threat to
public health and safety, in accordance with section 351A(a)(1) of the
Public Health Service Act.
* * * * *
4. Section 1003.102 is amended by republishing the introductory
text for paragraph (b), and by adding a new paragraph (b)(16) to read
as follows:
Sec. 1003.102 Basis for civil money penalties and assessments.
* * * * *
(b) The OIG may impose a penalty and, where authorized, an
assessment against any person (including an insurance company in the
case of paragraphs (b)(5) and (b)(6) of this section) whom it
determines in accordance with this part--
* * * * *
(16) Is involved in the possession or use in the United States,
receipt from outside the United States, or transfer within the United
States, of select agents and toxins in violation of part 73 of this
chapter as determined by the HHS Secretary, in accordance with sections
351A(b) and (c) of the Public Health Service Act.
* * * * *
5. Section 1003.103 is amended by adding a new paragraph (l) to
read as follows:
Sec. 1003.103 Amount of penalty.
* * * * *
(l) For violations of section 351A(b) or (c) of the Public Health
Service Act and 42 CFR part 73, the OIG may impose a penalty of not
more than $250,000 in the case of an individual, and not more than
$500,000 in the case of any other person.
[FR Doc. 02-31370 Filed 12-9-02; 4:03 pm]
BILLING CODE 4160-17-P