Kirkpatrick & Lockhart LLP
Homeland Security Bulletin
DECEMBER 2003
With Tighter Homeland Security Measures, Users of Biological
Agents Must Meet Substantial New Regulatory ObligationsApplications for Clearance Due November 12, 20031
Two of the most significant legal tools developed in the
nation’s efforts to protect itself from terrorist attacks are
the USA PATRIOT Act (“Patriot Act”)2 and the Public
Health Security and Bioterrorism Preparedness and
Response Act (“PHSBPRA”).3 Together the measures
have created new and substantial regulatory obligations
for users of certain biological agents. The Patriot Act
set standards for the appropriate use of select biological
agents, requires new background checks applicable to
those desiring to work with these substances and their
corporate supervisors, and establishes new and severe
criminal and civil penalties for failure to comply. Most
significantly, the PHSBPRA expanded the control
regime that previously governed the use of dangerous
biological agents and toxins by requiring facilities to
register if they possess any of several types of
enumerated agents, and is no longer triggered by the
transport or movement of such agents. Most deadlines
for registration have now passed, the most recent being
November 12, 2003. Those that have not complied
should consider doing so quickly.
This Alert outlines some key requirements of this new
regulatory regime, and some of the issues that remain
unresolved.
OVERVIEW OF THE NEW REQUIREMENTS
FOR ENTITIES HANDLING SELECT AGENTS
Most of the regulations promulgated pursuant to these
two statutes employ the PHSBPRA as the predicate
statute, but utilize terms defined by Congress in the
Patriot Act, most notably the term “restricted persons,” 4
which designates on individual who may not handle
certain substances. The PHSBPRA specifies the
substances that are the focus of the law. The Patriot Act
prohibits “restricted persons” from transporting, shipping,
possessing, or receiving any “biological agent or toxin.”5
To ensure that “restricted persons” do not have improper
access to these materials, the regulations require that the
Attorney General conduct a “security risk assessment” on
entities and individuals who have requested access to
regulated agents.6 The results of this assessment are given
to the appropriate agency (see below), which can grant,
deny, or revoke access accordingly.7
Responsibility for the implementation of these laws and
regulations fell first to the Department of Health and
Human Services (“HHS”) and the Department of
Agriculture (“USDA”), according to the statutory
distinction between threats to persons and threats to
agriculture. These agencies in turn delegated enforcement
responsibilities to the Center for Disease Control and
Prevention (“CDC”) and the Animal and Plant Health
Inspection Service (“APHIS”), respectively. Although
each agency has promulgated separate regulations,8 they
jointly created a uniform registration system that utilizes a
common registration document: the Application for
Laboratory Registration for Possession, Use, and Transfer
of Select Biological Agents and Toxins (“Application”).9
What is regulated? The substances that the PHSBPRA
regulates can be broken down into two basic categories:
substances that pose a threat to human life, and substances
that pose a threat to agricultural production. The
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Homeland Security Bulletin
substances that pose a threat to human life are
identified as “Select Agents or Toxins,” and include
viruses, bacteria, fungi, toxins, genetic elements,
recombinant nucleic acids and recombinant
organisms.10 The substances posing a threat to
agricultural production are “Listed Plant Pathogens” or
“High Consequence Livestock Pathogens and
Toxins.”11 Because some substances pose a threat to
both human life and agricultural production, these
agents have been identified as “Overlap agents.”12
Since the law regulates these varying types of
substances similarly, the above substances will be
referred to collectively as “regulated agents.”13 Mere
possession of a regulated agent now warrants
registration, whereas prior to the passage of the
PHSBPRA, only the transfer of regulated agents
triggered the need to register. Prior registrations
undertaken in accordance with previous regulations
must now be updated to meet the new standards.
Who is regulated? Recently promulgated regulations
establish the means by which entities possessing
regulated agents may comply with the PHSBPRA and
the Patriot Act. As noted, mere possession of a
regulated agent warrants registration,14 and prior
registration undertaken for transfers must be updated to
meet the new standards. Any entity possessing such
regulated agents must now register with the
government, unless subject to an exemption. There are
also new or expanded regulations governing safety,
security, disaster planning, training, recordkeeping, and
transfers. In addition to these new requirements,
entities in possession of regulated agents are subject to
inspections by the Department of Health and Human
Services (“HHS”).15
MEETING THE REGISTRATION
REQUIREMENTS
An entity seeking to register under the PHSBPRA must
identify a Responsible Official (“RO”), who must “be
familiar with the regulations of this part [42 C.F.R. Part
73].”16 The RO must also be responsible for ensuring
2
that the requirements of the appropriate regulations are
met.17 By registering, the RO is certifying that the
facility meets the requirements to work safely with
regulated agents, that only authorized personnel have
access to regulated agents, and that the entity will keep
accurate records of the regulated agents transferred to
and from its facilities.18
An entity possessing regulated agents must either
register or be the subject of an exemption. Clinical or
diagnostic laboratories are exempt from registration,19
as are those entities in possession of products approved
under another federal act.20 Entities seeking to utilize
either of these exemptions need not register, nor apply
for an exemption.
Entities handling investigational products, or those
dealing with public health or agricultural emergencies,
may also be exempt, but they must affirmatively seek
exempt status.21 Similarly, entities dealing with
attenuated strains of regulated agents which no longer
pose a threat to human health or agricultural
production, and have been so identified on the CDC
website,22 are exempt. They must, however,
affirmatively seek exempt status. Entities can apply for
exempt status by utilizing CDC Form 0.1317/APHIS
Form 2042.23
Whether an entity must register with the CDC or
APHIS depends on the type of regulated agent the
entity possesses. A categorized list of regulated agents
is available from the CDC website.24 Since “Select
Agents or Toxins” have been deemed to pose a threat
primarily to human health, possession of such agents
requires registration with the CDC. “High
Consequence Livestock Pathogens and Toxins” and
“Listed Plant Pathogens” must be registered with
APHIS since they pose a threat to agricultural
production.25 “Overlap” agents that pose a threat to
both human health and agricultural production can be
registered with either the CDC or APHIS. If an entity
possesses agents regulated exclusively by HHS and
also possesses agents regulated exclusively by APHIS,
KIRKPATRICK & LOCKHART LLP HOMELAND SECURITY BULLETIN
the entity must register with both agencies. Since the
forms have been standardized, this burden is somewhat
eased.
REGISTRATION ISSUES
Registration application packages can be accessed on
the CDC website.26 The RO is responsible for filling
out the first four sections of the Application. Section
one covers the entity information (address, name of
RO, etc.), while Section two is the certification by the
RO and Alternate RO that the entity meets the
requirements specified in the regulations. Section three
is a checklist of select agents used, possessed or
transferred by an entity. Section four has two parts, the
first of which (4A) requires detailed information about
the select agents and the laboratories where they will be
stored or used. Part 4B requires extensive information
about the persons authorized to work with the select
agents (name, date of birth, address, supervising
principal investigator, agents/toxins, laboratory
building, laboratory room, and job title). A “principal
investigator” or “laboratory supervisor” chosen from
each distinct building/laboratory controlled by the
parent entity must complete Section five, “Laboratory
Information.” In addition to providing his or her
resume, the principal investigator must provide detailed
information about each agent worked with or stored in
the laboratory buildings and rooms listed in Section 4B
(including the name, strain designation, date acquired,
address of facility from which it was acquired, etc.).
The regulations suggest that an entity with several nonadjacent laboratories would be well advised to select
several RO’s, rather than several laboratory supervisors,
since “[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.)”27
There is little guidance on this issue, however, and it
remains to be seen how this provision will be enforced,
especially at large facilities with multiple (nonadjacent)
buildings. Section five also requires entities to submit a
floor plan for each laboratory where select agents are
DECEMBER 2003
used or stored, and includes 44 questions about the
interior, safety features, architecture and infrastructure
of the laboratory.
In addition to filling out the CDC/APHIS Application,
all entities,28 persons who own or control the entity,29
the RO, the alternate RO, and all individuals
authorized to have access to select agents or toxins are
required to have an approved security risk assessment
by the Attorney General.30 To obtain a security risk
assessment, regulated entities must submit a
“Bioterrorism Preparedness and Response Act, FBI
Information Form” (Form FD-961).31 This form
applies to RO’s, individuals with access to select
agents, and those in a position of authority such that
they could issue orders to those responsible for
controlling access (for example, corporate officers and
principal stockholders).32 It is unclear how far up a
corporate ladder this registration obligation extends
(e.g., board of directors, etc). Section I of the FBI form
requires the name, address, and type of entity, while
Section II requires the Federal Income Tax Employee
Identification Number and information about the
entity’s leadership personnel, including the names,
dates of birth, and Social Security numbers of corporate
officers, directors and principal stockholders. Private
academic institutions must complete Section II.
Like the CDC/APHIS Application, the FBI Form
requires the RO, Alternate RO and individuals with
access to regulated agents to provide extensive personal
information in section III.33 The FBI also requires
those persons to submit a fingerprint kit.34 Note that
the RO and Alternate RO must submit the more
extensive information (including the fingerprint kit)
whether or not the RO personally accesses regulated
agents. Indeed, the HHS suggests that, in choosing an
RO, “the [RO] should not be an individual actually
using, working with, or transferring and receiving the
select agents and toxins.”35
Because both forms are required, FBI Form FD-961
and CDC Form 0.1319 should be considered in tandem
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Homeland Security Bulletin
to complete one’s registration. The original deadline
for the submission of forms FD-961 and CDC Form
0.1319 (APHIS Form 2044) was April 12, 2003.36
Because of the unavailability of fingerprint kits and
other administrative problems, HHS and the
Department of Agriculture recently extended that
deadline to November 12, 2003. 37 As a result, entities
who submitted the required information to the Attorney
General by that date will be eligible for a provisional
registration certificate if they meet the other regulatory
requirements. This extension allows entities that have
submitted the required forms to continue to have access
to regulated agents in the interim period while the
Attorney General completes the security risk
assessment.
The Attorney General is required to report the results of
the security risk assessment to the relevant agency head
(HHS or APHIS), which can in turn grant or deny
access based on the assessment. Entities who are
denied access will be given an opportunity to provide
information rebutting the reason for the denial (e.g.,
proof that a denied employee is not a “restricted
person” under 18 U.S.C. 175b).
Neither the statute nor implementing regulations
specify what, if any, judicial review is available from
an erroneous assessment issued by the Attorney
General or the administering agency. Arguably such
action is “final agency action” subject to judicial
review in the appropriate United States District Court
pursuant to federal question jurisdiction, as final
agency action under the Administrative Procedures
Act. But it is unclear how the record for such a
decision will be compiled by the Attorney General or
the administering agency.
BEYOND REGISTRATION:
ADDITIONAL REQUIREMENTS
In addition to registration, there are a number of other
regulations with which entities must comply. Section
73.10 imposes safety requirements, including the
development and implementation of a safety plan, and
4
annual inspections by the RO.38 Instead of containing
substantive safety provisions, the regulation directs
entities to “consider” already-promulgated standards for
safety, enunciated in several CDC/NIH publications,
and the Code of Federal Regulations.39 RO’s should
read Section 73.10 carefully, as there are some parts of
the referenced publications that are highlighted and
others excluded. This raises the question of whether a
violation of the regulation can be established by
showing a violation of a preexisting standard.
Additionally, subsection (c) indicates certain types of
experiments that may not be conducted “unless
approved by the HHS Secretary.”40
Section 73.11 details security measures that must be
implemented at facilities housing regulated agents.
This provision requires entities to develop security
plans that must be reviewed by the RO at least annually,
or following any undefined “incident.”41 Again, RO’s
should read this section of the regulation in detail, as it
contains numerous specific provisions, including
required reporting to the RO of a number of events that
may trigger additional measures or investigation.42 The
security plans were required to be implemented by
September 12, 2003, including any additional training
of personnel required by the plan.43
In addition to the training required for compliance with
the security provisions, Section 73.13 details other
training that should be undertaken under the plan. This
includes orientation training for new employees and
annual “refresher” courses.44 Section 73.14 governs
transfers of regulated agents, and mandates the use of
CDC Form EA-101/APHIS form 2041.45 Section
73.15 describes the records that must be kept by a
registered entity. These records include an up-to-date
accurate list of individuals approved for access to
regulated agents, training records, and an accurate and
current inventory of regulated agents, among others.46
Section 73.16 allows for inspections of facilities by the
HHS Secretary “without prior notification and with or
without cause.”47 The constitutionality of the “without
cause” provision is open to questions.
KIRKPATRICK & LOCKHART LLP HOMELAND SECURITY BULLETIN
Section 73.17 requires registered entities to report
“theft, loss or release” to the appropriate authorities. A
form has been created, which must be filled out, in
addition to any other forms of notification.48
CONCLUSION
regulated agent to an unregistered person or entity is
also a crime, punishable by a fine and up to five years
in prison.51 Meeting these obligations is important for
the regulated community. It may also be important to
local governments and others where regulated entities
are located.
The Patriot Act significantly increased the sanctions for
violations of the laws governing the use of regulated
agents. Even appropriate possession of regulated
agents without registration can result in a fine and up to
five years in prison,49 whereas improper possession,
defined as possession for a purpose other than
“prophylactic, protective, bona fide research or other
peaceful purpose,” is punishable by a fine and up to ten
years in prison.50 Engaging in the transfer of a
BARRY M. HARTMAN
202.778.9338
bhartman@kl.com
CRAIG P. WILSON
717.231.4509
cwilson@kl.com
THOMAS D. MANGANELLO
202.778.9213
tmanganello@kl.com
For further information regarding this Homeland Security Bulletin,
or our law firm’s Homeland Security practice, please contact:
Boston
Roger C. Zehntner
617.261.3149
Dallas
Julie E. Lennon
214.939.4920
Harrisburg
Craig P. Wilson
717.231.4509
Los Angeles
David P. Schack
310.552.5061
Miami
Daniel A. Casey
305.539.3324
Troy J. Rillo
305.539.3355
Newark
William H. Hyatt
973.848.4045
Brian S. Montag
973.848.4044
New York
Eva M. Ciko
212.536.3905
Pittsburgh
Thomas J. Smith
412.355.6758
Mark A. Rush
412.355.8333
San Francisco
Robert J. Sherry
415.249.1032
Washington
Barry M. Hartman
202.778.9338
Dick Thornburgh
202.778.9080
DECEMBER 2003
rzehntner@kl.com
jlennon@kl.com
cwilson@kl.com
dschack@kl.com
dcasey@kl.com
trillo@kl.com
whyatt@kl.com
bmontag@kl.com
eciko@kl.com
tsmith@kl.com
mrush@kl.com
rsherry@kl.com
bhartman@kl.com
dthornburgh@kl.com
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Homeland Security Bulletin
Comparison of Select CDC and APHIS Regulations
Subject
CDC Rules
(apply to select agents)
APHIS Rules
(apply to plant pathogens)
Regulations in C.F.R.
42 C.F.R. § 73.0 et seq.
7 C.F.R. §331 et seq.
Registration
42 C.F.R. § 73.7
7 C.F.R. § 331.8
Registration Form
CDC Form 0.1319;
FBI Information Form FD-961
APHIS Form 2044;
FBI Information Form FD-961
Responsible Official
42 C.F.R. § 73.9
7 C.F.R. § 331.9
Safety
42 C.F.R. § 73.10
7 C.F.R. § 331.11
Security
42 C.F.R. § 73.11
7 C.F.R. § 331.11
Training
42 C.F.R. § 73.13
7 C.F.R. § 331.12
Transfers
42 C.F.R. § 73.14
7 C.F.R. § 331.13
Transfer Form
CDC Form EA-101
APHIS Form 2041
Recordkeeping
42 C.F.R. § 73.15
7 C.F.R. § 331.14
Inspections
42 C.F.R. § 73.16
7 C.F.R. § 331.15
Notification for Theft/
Loss/Release of Agent
42 C.F.R. § 73.17
7 C.F.R. § 331.16
Notification Form
CDC Form 0.1316
APHIS Form 2043
Exemptions
42 C.F.R. § 73.6
7 C.F.R. § 331.4
Exemption Request Form
CDC Form 0.1317
APHIS Form 2042
Appendix A to 42 CFR Part 72-Select Agents
VIRUSES
12. Viruses causing hantavirus pulmonary syndrome
1. Crimean-Congo haemorrhagic fever virus
13. Yellow fever virus
2. Eastern Equine Encephalitis virus
Exemptions: Vaccine strains of viral agents (Junin
Virus strain candid #1, Rift Valley fever virus strain
MP-12, Venezuelan Equine encephalitis virus strain
TC-83, Yellow fever virus strain 17-D) are exempt.
3. Ebola viruses
4. Equine Morbillivirus
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus
8. South American Haemorrhagic fever viruses
(Junin, Machupo, Sabia, Flexal, Guanarito)
9. Tick-borne encephalitis complex viruses
10. Variola major virus (Smallpox virus)
11. Venezuelan Equine Encephalitis virus
6
BACTERIA
1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. Clostridium botulinum
KIRKPATRICK & LOCKHART LLP HOMELAND SECURITY BULLETIN
6. Francisella tularensis
8. Saxitoxin
7. Yersinia pestis
9. Shigatoxin
Exemptions: vaccine strains as described in Title 9
CFR, Part 78.1 are exempt.
10. Staphylococcal enterotoxins
11. Tetrodotoxin
12. T-2 toxin
RICKETTSIAE
1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii
FUNGI
Exemptions: Toxins for medical use, inactivated for
use as vaccines, or toxin preparations for biomedical
research use at an LD50 for vertebrates of more than
100 nanograms per kilogram body weight are exempt.
National standard toxins required for biologic potency
testing as described in 9 CFR Part 113 are exempt.
1. Coccidioides immitis
RECOMBINANT ORGANISMS/MOLECULES
TOXINS
1. Abrin
2. Aflatoxins
3. Botulinum toxins
4. Clostridium perfringens epsilon toxin
5. Conotoxins
6. Diacetoxyscirpenol
1. Genetically modified microorganisms or genetic
elements from organisms on Appendix A, shown to
produce or encode for a factor associated with a
disease.
2. Genetically modified microorganisms or genetic
elements that contain nucleic acid sequences
coding for any of the toxins listed in this Appendix,
or their toxic subunits.
7. Ricin
Endnotes
1
This is the fifth in a series of articles discussing new federal
environmental regulatory requirements arising in connection
with Homeland Security. Background information and the
previous three articles can be found at the K&L website
www.kl.com by following the link to “Practices and
Industries” and “Homeland Security.”
2 Pub. L. No. 107-56.
3 Pub. L. No. 107-188. The PHSBPRA also includes measures
intended to protect food and drug production, which has
resulted in the promulgation of regulations, including
mandatory registration with the FDA, which are not addressed
here. See 21 C.F.R. Parts 1, 11 and 16.
4 A “restricted person” is defined as an individual who:
(A) is under indictment for a crime punishable by imprisonment
for a term exceeding 1 year; (B) has been convicted in any
court of a crime punishable by imprisonment for a term
exceeding 1 year; (C) is a fugitive from justice; (D) is an
unlawful user of any controlled substance (as defined in
section 102 of the Controlled Substances Act (21 U.S.C.
§ 802)); (E) is an alien illegally or unlawfully in the United
States; (F) has been adjudicated as a mental defective or has
been committed to any mental institution; (G) 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, pursuant to section 6(j) of the Export
Administration Act of 1979 (50 U.S.C. App. 2405(j)),
section 620A of chapter 1 of part M of the Foreign
Assistance Act of 1961 (22 U.S.C. § 2371), or section 40(d)
DECEMBER 2003
5
6
of chapter 3 of the Arms Export Control Act (22 U.S.C. §
2780(d)), has made a determination (that remains in effect)
that such country has repeatedly provided support for acts of
international terrorism; or; (H) has been discharged from the
Armed Services of the United States under dishonorable
discharge. 18 U.S.C. §175b(d)(2) (2003).
There are a number of potential legal issues involving the
definition of a “restricted person,” that are only briefly
mentioned here:
1) Currently, aliens from Cuba, Iran, Libya, North Korea,
Sudan, Syria and Iraq are considered “restricted
persons” because of subsection (G). 18 U.S.C. §
175b(d)(2)(G) (2003).
2) The issue as to whether the identification of and
discrimination against aliens (pursuant to 18 U.S.C. §
175b(d)(2)(G)) in matters of employment is constitutional. This question is beyond the scope of this
analysis, but for one discussion of the rights of aliens
see Neal K. Katyal & Laurence H. Tribe, Waging War,
Deciding Guilt: Trying the Military Tribunals, 111 Yale
L.J. 1259, 1300 (2002).
3) The term “mental defective” is not defined in the
statute, although it appears in 18 U.S.C. § 842(a)(6)
(2002), and is defined in 27 C.F.R. § 478.11 (2003)
(governing sales of firearms).
18 U.S.C. § 175b(a)(1) (2003).
42 C.F.R. § 73.8(a) (2003).
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Homeland Security Bulletin
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In addition to examining whether or not a person is a
“restricted person,” there are other criteria that the Attorney
General may utilize, including the person’s involvement in
certain other types of crime, “having a knowing involvement
with an organization that engages in . . . terrorism”, or “being
an agent of a foreign power.” 42 C.F.R. §73.8 (d)(2) (2003).
42 C.F.R. § 73 et seq. (2003) (promulgated by HHS), 7 C.F.R.
§ 331 et seq., and 9 C.F.R. § 121 et seq. (2003) (promulgated
by APHIS). NOTE: To eliminate the need for duplicate
citation throughout this article, regulations are cited to 42
C.F.R. § 73, rather than the 7 C.F.R. § 331. For the reader’s
convenience, a table has been included at the end of this Alert
that cross-references each set of regulations.
CDC Form 0.1319/APHIS Form 2044.
42 C.F.R. § 73.4 (2003); The complete list of select agents is
listed at the end of this article and is available at http://
www.cdc.gov/od/sap/42cfr72.htm.
7 C.F.R. § 331.3 (2003); The complete list of high consequence livestock pathogens and toxins is available at:
www.aphis.usda.gov/vs/ncie/bta.html and the complete list
of plant pathogens is available at: www.aphis.usda.gov/ppq/
permits.
42 C.F.R. § 73.5 (2003); The complete list of overlap agents is
available at: www.aphis.usda.gov/vs/ncie.
It should also be noted that, in addition to the specifically
listed biological agents or toxins, the regulations extend to
forms or elements of these regulated agents, including genetic
elements, recombinant nucleic acids, and recombinant
organisms derived from or encoded with the genetic material
of the regulated agents. See 42 C.F.R. § 73.4(e) and § 73.5(e)
(2003).
42 C.F.R. § 73.7 (2003). Registration is not required for
regulated agents that are in their “naturally occurring
environment,” provided that the agent has not been intentionally introduced, cultivated, collected, or otherwise extracted
from its natural source. 42 C.F.R. § 73.5(f) (2003).
42 C.F.R. § 73.16 (2003).
42 C.F.R. § 73.9(a)(2) (2003).
42 C.F.R. § 73.9(a) and (c) (2003).
42 C.F.R. § 73.9(c) (2003).
42 C.F.R. §73.6(a) (2003). Note that although these facilities
need not register, they are still subject to reporting components of the regulations.
42 C.F.R. §73.6(b) (2003) (An example of one such act would
be the Federal Insecticide, Fungicide, and Rodenticide Act).
42 C.F.R. § 73.6(c)-(e) (2003).
See http://www.cdc.gov/od/sap/exclusion.htm
42 C.F.R. Part §73.6 (2003), forms available at: http://
www.cdc.gov/od/sap/addforms.htm; http://
www.aphis.usda.gov/ppq/permits/agr_bioterrorism/
exempts.pdf
See http://www.aphis.usda.gov/vs/ncie/pdf/
agent_toxin_list.pdf
Note that there are two separate addresses for registration, one
for animal pathogens, and one for plant pathogens: a) for
animal pathogens: Animal and Plant Health Inspection
Service, Veterinary Services, National Center for Import-
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30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
Export, 4700 River Road, Unit 40, Riverdale, MD 207371231; b) for plant pathogens: US Department of Agriculture,
Plant Protection and Quarantine, Biological and Technical
Services, 4700 River Road, Unit 133, Riverdale, MD 207371236. See http://www.fbi.gov/terrorinfo/
bioterrorfd961.htm
42 C.F.R. § 73.21(a) (2003). See http://www.cdc.gov/od/sap/
42 C.F.R. §73.7(f) (2003).
Except for local, state or federal governmental agencies. 42
U.S.C. § 73.8(a) (2003).
42 U.S.C. § 73.8 (c) (2003).
42 C.F.R. § 73.8(b) (2003).
42 C.F.R. § 73.8(c) (2003). Form available at: http://
www.fbi.gov/terrorinfo/bioterrorfd961.htm
See form at: www.fbi.gov/terrorinfo/bioterrorfd961.htm
In Section III, the individual must submit personal information such as residence and citizenship, and certify that they are
not a “restricted person” (by answering a series of questions).
In Section IV the person authorizes an investigation into their
background.
The FBI has established a fax number for obtaining fingerprint kits. 304-625-3984 (as of June 6, 2003).
See Guidance Document for Application for Laboratory
Registration for Possession, Use, and Transfer of Select
Biological Agents and Toxins, http://www.cdc.gov/od/sap/
downloads2.htm.
42 C.F.R. § 73.0(b)(2).
See, 68 Fed. Reg. 62,245 (Nov. 3, 2003) (to be codified at 42
C.F.R. § 73); 68 Fed. Reg. 62,218 (Nov. 3, 2003) (to be
codified at 7 C.F.R. § 331).
42 C.F.R. § 73.10 (2003).
42 C.F.R. § 73.10(a) (2003).
42 U.S.C. § 73.10(c) (2003).
42 C.F.R. § 73.11(c) (2003).
42 C.F.R. §73.11(7) (2003).
42 C.F.R. § 73.0(c)(2) (2003).
42 C.F.R. §73.13(b) (2003).
42 C.F.R. §73.14(c) (2003), form available at:
http://www.cdc.gov/od/sap/addforms.htm;
http://www.aphis.usda.gov/ppq/permits/
agr_bioterrorism/transfer.pdf.
42 C.F.R. § 73.15(a) and (b) (2003).
42 C.F.R. § 73.16 (2003).
42 C.F.R. § 73.17(f); forms are APHIS form 2043, CDC form
0.1316, available at: http://www.cdc.gov/od/sap/
addforms.htm.
18 U.S.C. § 175b(c)(1) (2003).
18 U.S.C. § 175(b) (2003).
18 U.S.C. § 175b(b)(1-2) (2003).
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This bulletin is for informational purposes and does not contain or convey legal advice. The information herein
should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer.
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© 2003 KIRKPATRICK & LOCKHART LLP. KIRKPATRICK
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HOMELAND SECURITY BULLETIN