[Federal Register: December 13, 2002 (Volume 67, Number 240)]
[Rules and Regulations]
[Page 76907-76938]
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Part V
Department of Agriculture
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Animal and Plant Health Inspection Service
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7 CFR Part 331
9 CFR Part 121
Agricultural Bioterrorism Protecton Act of 2002; Possession, Use and
Transfer of Biological Agents and Toxins; Interim Final Rule
[[Page 76908]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
[Docket No. 02-088-1]
RIN 0579-AB47
Agricultural Bioterrorism Protection Act of 2002; Possession,
Use, and Transfer of Biological Agents and Toxins
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: In accordance with the Agricultural Bioterrorism Protection
Act of 2002, we are establishing, by regulation, standards and
procedures governing the possession, use, and transfer of biological
agents and toxins that have been determined to have the potential to
pose a severe threat to both human and animal health, to animal health,
to plant health, or to animal and plant products. This action is
necessary to protect animal and plant health, and animal and plant
products.
DATES: This interim rule is effective on February 11, 2003. We will
consider all comments that we receive on or before February 11, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 02-088-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 02-088-1. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
02-088-1'' on the subject line.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: For information concerning the
regulations in 7 CFR part 331, contact Dr. Robert Flanders, Chief, Pest
Permit Evaluations Branch, PPQ, APHIS, 4700 River Road Unit 133,
Riverdale, MD 20737-1236, (301) 734-5930.
For information concerning the regulations in 9 CFR part 121,
contact Dr. Denise Spencer, Senior Staff Veterinarian, Technical Trade
Services, National Center for Import and Export, VS, APHIS, 4700 River
Road Unit 40, Riverdale, MD 20737-1231, (301) 734-3277.
SUPPLEMENTARY INFORMATION:
Background
On June 12, 2002, the President signed into law the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (Pub.
L. 107-188). Title II of Pub. L. 107-188, ``Enhancing Controls on
Dangerous Biological Agents and Toxins'' (sections 201 through 231),
provides for the regulation of certain biological agents and toxins by
the Department of Health and Human Services (subtitle A, sections 201-
204) and the Department of Agriculture (subtitle B, sections 211-213),
and provides for interagency coordination between the two departments
regarding overlap agents and toxins (subtitle C, section 221). Subtitle
D (section 231) provides for criminal penalties regarding certain
biological agents and toxins. For the Department of Health and Human
Services, the Centers for Disease Control and Prevention (CDC) has been
designated as the agency with primary responsibility for implementing
the provisions of the Act; the Animal and Plant Health Inspection
Service (APHIS) is the agency fulfilling that role for the Department
of Agriculture (USDA).
In subtitle B (which is cited as the ``Agricultural Bioterrorism
Protection Act of 2002,'' referred to below as the Act ), section
212(a) provides, in part, that the Secretary of Agriculture (the
Secretary) must establish by regulation a list of each biological agent
and each toxin that she determines has the potential to pose a severe
threat to animal or plant health, or to animal or plant products. The
Act further requires (under section 213(b)) that all persons in
possession of any listed biological agent or toxin must, within 60 days
of the publication of that interim rule, notify the Secretary of such
possession.
In accordance with these statutory requirements, on August 12,
2002, we published in the Federal Register (67 FR 52383-52389, Docket
No. 02-082-1) an interim rule that established the initial lists of
biological agents and toxins and set out the manner in which persons in
possession of listed agents and toxins were to provide notice of such
possession. To accomplish this, we established two new parts in the
Code of Federal Regulations (CFR), one part in the plant-related
provisions of title 7, chapter III, and one part in the animal-related
provisions of title 9, chapter I. Each part was constructed similarly,
with a section that provided definitions for specific terms used in the
part, a section that set out the list of biological agents and toxins,
and a section that provided guidance on the manner in which notice of
possession was to be provided. On September 26, 2002, we published a
technical amendment to the interim rule (67 FR 60519-60520, Docket No.
02-082-2) in which we updated the definitions of biological agent and
toxin in each part.
Under section 212 of the Act, the Secretary must also provide by
regulation for the establishment and enforcement of standards and
procedures governing the possession, use, and transfer of listed
biological agents and toxins in order to protect animal and plant
health, and animal and plant products. Specifically, sections 212(b)
and (c) require that the Secretary:
[sbull] Establish and enforce safety procedures for listed agents
and toxins, including measures to ensure proper training and
appropriate skills to handle agents and toxins, and proper laboratory
facilities to contain and dispose of agents and toxins;
[sbull] Establish and enforce safeguard and security measures to
prevent access to listed agents and toxins for use in domestic or
international terrorism or for any other criminal purpose;
[sbull] Establish procedures to protect animal and plant health,
and animal and plant products, in the event of a transfer or potential
transfer of a listed agent or toxin in violation of the safety
procedures and safeguard and security measures established by the
Secretary; and
[sbull] Ensure appropriate availability of biological agents and
toxins for research, education, and other legitimate purposes.
This interim rule establishes the regulations required under the
Act. To accomplish this, we are amending 7
[[Page 76909]]
CFR part 331 and 9 CFR part 121. First, we are changing the title of
both parts from ``Possession of Biological Agents and Toxins'' to
``Possession, Use, and Transfer of Biological Agents and Toxins'' to
indicate the expanded scope of the regulations. Second, we are adding
and removing definitions in Sec. Sec. 331.1 and 121.1, as detailed
below. Third, we are moving the lists of biological agents and toxins
out of Sec. Sec. 331.2 and 121.2 and adding in their place a new
section that sets out the purpose and scope of each part. Fourth, we
are removing the notification requirements in Sec. Sec. 331.3 and
121.3, which are no longer applicable, and placing the lists of
biological agents and toxins in those sections. We are amending both
lists, as discussed below, and moving the exemption provisions found in
the original Sec. 121.2 to a new section, Sec. 121.4. Finally, we are
adding new sections that set out the effective dates, exemptions,
registration requirements, responsibilities of the responsible
official, safety and security requirements, transfer requirements, and
appeals process. These new sections are discussed in detail below.
Effective and Applicability Dates
Both 7 CFR part 331 and 9 CFR part 121 begin with sections that
discuss the effective dates of the regulations, Sec. Sec. 331.0 and
121.0, respectively. Pursuant to section 213(c) of the Act, the
Secretary must, not later than 180 days after the Act's enactment,
promulgate an interim final rule establishing the standards and
procedures governing the possession, use, and transfer of listed
biological agents and toxins that shall take effect 60 days after the
date on which the rule is promulgated. However, the Act also requires
that the interim final rule include timeframes for the applicability of
the rule that minimize disruption of research or educational projects
that involve biological agents or toxins listed pursuant to section
212(a)(1) and that were underway as of the effective date of such rule.
Accordingly, in 7 CFR 331.0 and 9 CFR 121.0 we provide that the
regulations in both parts are effective on February 11, 2003. On and
after that date, any individual or entity possessing, using, or
transferring any listed agent or toxin must be in compliance with the
provisions of each part.
However, to minimize the disruption of research or educational
projects (e.g., teaching demonstrations) involving listed agents or
toxins that were underway as of the effective date of these
regulations, we provide that any individual or entity possessing such
agents or toxins as of the effective date (current possessors) will be
afforded additional time to reach full compliance with the regulations
in each part. Any provision not specifically cited in paragraphs (a)
through (f) of 7 CFR 331.0 and 9 CFR 121.0 will applicable as of
February 11, 2003.
In recognition of the potential delays in registering individuals
and entities under these regulations during the first year of
implementation and the subsequent delay of research, we will also
afford additional time to reach full compliance with the regulations to
individuals and entities who do not currently possess listed agents or
toxins. Therefore, we provide that any individual or entity who does
not possess listed agents or toxins by the effective date of these
regulations, but who wishes to initiate a research or educational
project prior to November 12, 2003, must be in compliance with the
provisions of these regulations that are applicable for current
possessors at the time of application, as provided in paragraphs (a)
through (e) of 7 CFR 331.0 and 9 CFR 121.0.
In paragraph (a) of both parts, we set forth the transfer
provisions that will be applicable during the phase-in period.
Specifically, we provide that, during the period from February 11,
2003, to November 12, 2003, listed agents or toxins may only be
transferred to an individual or entity that is not registered under 7
CFR part 331 or 9 CFR part 121 if the individual or entity has been
issued a permit by the APHIS Administrator (the Administrator) under 7
CFR part 330 or 9 CFR 122 to import or move interstate that specific
agent or toxin. Since some individuals or entities may not have been
issued a permit prior to the effective date of these regulations, we
further provide that an individual or entity may apply for a permit. In
addition to the permit required under 7 CFR part 330 or 9 CFR 122, an
individual or entity will also be required to submit APHIS Form 2041,
in accordance with Sec. Sec. 331.13(c) and 121.14(c), respectively.
Because USDA permits do not cover intrastate movement, an
individual or entity may not receive a listed agent or toxin that is
being moved intrastate until that individual or entity is registered in
accordance with 7 CFR part 331 or 9 CFR part 121.
With regard to overlap agents and toxins, we provide that from
February 11, 2003, to November 12, 2003, listed overlap agents or
toxins may only be transferred to an individual or entity not
registered under 9 CFR part 121 using the permit provisions described
above or, if the individual or entity is registered under CDC's select
agent program for that specific overlap agent or toxin, in accordance
with CDC's regulations in 42 CFR part 72. The regulations in 42 CFR
part 72 cover all inter-entity transfers of ``select agents,'' which
include overlap agents and toxins, whether interstate or intrastate. We
note, however, that CDC's regulations in 42 CFR part 72 will be
superseded by CDC's new select agent regulations in 42 CFR part 73 on
March 12, 2003, and, thereafter, listed overlap agents or toxins may be
transferred to an individual or entity not registered under 9 CFR part
121 or 42 CFR part 73 using the permit provisions described above.
In paragraph (b) of both parts, we require that the responsible
official submit the registration application package by March 12, 2003,
as required in 7 CFR 331.8 and 9 CFR 121.9. In addition, we require
that the responsible official submit to the United States Attorney
General (the Attorney General) the names and identifying information
for the responsible official; alternate responsible official, where
applicable; entity; and, where applicable, the individual who owns or
controls the entity.
Paragraph (c) of both parts requires the responsible official to
submit to the Attorney General by April 11, 2003, the names and
identifying information for all individuals whom the responsible
official has identified as having a legitimate need and the appropriate
training and skills to handle or use listed agents or toxins. We note
that these individuals must have received appropriate training in
biosafety and/or containment, in accordance with 7 CFR 331.12 or 9 CFR
121.13.
We recognize that developing and implementing the security section
of the Biocontainment and Security Plan (7 CFR 331.11) or the Biosafety
and Security Plan (9 CFR 121.12) may require additional time to consult
with security experts and to obtain the necessary funding. Therefore,
in paragraph (d) of both parts, we provide that the responsible
official will have until June 12, 2003, to submit the security section
of the plan to APHIS or, for overlap agents or toxins, to APHIS or CDC.
Then the responsible official has until September 12, 2003, to
implement that security plan and provide security training in
accordance with 7 CFR 331.12 or 9 CFR 121.13.
Finally, by November 12, 2003, the registration application process
must be complete and the entity must be in full compliance with the
regulations.
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Definitions
In 7 CFR 331.1 and 9 CFR 121.1, we define the terms used in the
regulations. In our August 2002 interim rule establishing the
regulations, we defined the terms biological agent, facility, person,
responsible facility official, and toxin in both parts, while the term
overlap agent or toxin was defined only in 9 CFR 121.1 (this term is
not applicable to the plant-related regulations in 7 CFR part 331).
In this interim rule, we are removing the definition of person in
both parts because the term is no longer used in 7 CFR part 331 and 9
CFR part 121. In addition, we are removing the definition of
responsible facility official from both parts and adding responsible
official in its place. We are removing the definition of responsible
facility official because the term is no longer used in 7 CFR part 331
and 9 CFR part 121. The term responsible facility official (RFO) was
initially adopted by CDC for its select agent program (42 CFR part 72)
and it is too limited in scope for our purposes. Specifically, the term
only refers to transfers (rather than possession, use, and transfers)
and dictates who should be the RFO (a safety officer, a senior
management official, or both). We believe that these individuals may
not always be the appropriate individual to ensure compliance with
these regulations.
Therefore, we use the term responsible official in 7 CFR part 331
and 9 CFR part 121. We define responsible official as ``the individual
designated by an entity to act on its behalf. This individual must have
the authority and control to ensure compliance with the regulations in
this part.'' We believe that this definition is broad enough to allow
entities to designate the appropriate individual to be the responsible
official, and it places the responsibility of selecting the appropriate
individual on the entity, rather than on APHIS.
To be consistent with CDC, we are also removing the definition of
facility in both parts and adding entity in its place. We define entity
as ``any government agency (Federal, State, or local), academic
institution, corporation, company, partnership, society, association,
firm, sole proprietorship, or other legal entity.''
Furthermore, in 9 CFR part 121, we are revising the definition of
overlap agent or toxin to reflect changes made to the definitions of
biological agent and toxin in the September 2002 technical amendment
noted previously and changes made to the list in this rule. Thus,
overlap agent or toxin is defined as ``any microorganism (including,
but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa)
or toxin that poses a risk to both human and animal health and that is
listed in Sec. 121.3(b).''
In this interim rule, we define the terms Administrator, APHIS,
Attorney General, CDC, diagnostic laboratory, import, interstate,
permit, State, United States, and USDA in both 7 CFR 331.1 and 9 CFR
121.1. Administrator is defined as ``the Administrator, Animal and
Plant Health Inspection Service, or any person authorized to act for
the Administrator.'' APHIS is defined as ``the Animal and Plant Health
Inspection Service of the United States Department of Agriculture.''
Attorney General is defined as ``the Attorney General of the United
States or any person authorized to act for the Attorney General.'' CDC
is defined as ``the Centers for Disease Control and Prevention of the
United States Department of Health and Human Services.'' Diagnostic
laboratory is defined as ``a laboratory facility that receives
specimens for the purpose of determining identities of pests,
pathogens, contaminants, or causes of disease.'' USDA is defined as
``the United States Department of Agriculture.''
To clarify the transfer provisions in the regulations, we define
permit as ``written authorization by the Administrator to import or
move interstate biological agents or toxins, under conditions
prescribed by the Administrator.'' Import means ``to move into, or the
act of movement into, the territorial limits of the United States,''
while interstate means ``from one State into or through any other
State, or within the District of Columbia, Guam, the Virgin Islands of
the United States, or any other territory or possession of the United
States.'' In addition, we define State as ``any of the several States
of the United States, the Commonwealth of the Northern Mariana Islands,
the Commonwealth of Puerto Rico, the District of Columbia, Guam, the
Virgin Islands of the United States, or any other territory or
possession of the United States.'' Finally, the term United States
means ``all of the States.''
In 7 CFR 331.1, we also define PPQ and specimen. PPQ is defined as
``the Plant Protection and Quarantine Programs of the Animal and Plant
Health Inspection Service.'' Specimen is defined as ``a sample of
material collected for use in testing, such as plant tissues (e.g.,
stems, seeds, flowers, pollen, leaves, roots, fruits, tubers, tissue
cultures, protoplasts), soil, water, swabs, cultures, and
suspensions.''
In 9 CFR 121.1, we also define clinical laboratory, proficiency
testing, and specimen to clarify the exemption provisions for clinical
or diagnostic laboratories in that part. Clinical laboratory is defined
as ``a laboratory facility that receives patients and collects
specimens for processing or shipping to another laboratory,'' while
proficiency testing is defined as ``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 for
acceptance.'' Finally, specimen is defined as ``a sample of material
collected for use in testing, such as tissues, gastrointestinal
contents, feces, bodily fluids (blood, serum, etc.), soil, water, feed
or feed ingredients, swabs, cultures, and suspensions.''
Purpose and Scope
To facilitate understanding of the regulations, both 7 CFR 331.2
and 9 CFR 121.2 discuss the purpose and scope of the regulations.
Specifically, 7 CFR 331.2(a) states that part 331 sets forth the
requirements for possession, use, and transfer of biological agents or
toxins that have been determined to have the potential to pose a severe
threat to plant health or plant products, while 9 CFR 121.2(a) states
that part 121 sets forth the requirements for possession, use, and
transfer of biological agents or toxins that have been determined to
have the potential to pose a severe threat to both human and animal
health, or to animal health or animal products. Both 7 CFR 331.2(a) and
9 CFR 121.2(a) note that the purpose of the regulations is to ensure
the safe handling of such agents or toxins, and to protect against the
use of such agents or toxins in domestic or international terrorism or
for any other criminal purpose.
In 7 CFR 331.2(b) and 9 CFR 121.2(b), we further provide that any
individual or entity that possesses, uses, or transfers any listed
agent or toxin must register in accordance with Sec. Sec. 331.6 and
121.7, respectively. In order for an entity to register, each entity
must designate an individual who has the authority and control to
ensure compliance with the regulations to be the responsible official.
It is the responsible official who must complete and submit the
registration application package to APHIS or, for overlap agents or
toxins, to APHIS or CDC. As part of registration, the responsible
official, the entity, and, where applicable, the
[[Page 76911]]
individual who owns or controls such entity will be subject to a
security risk assessment by the Attorney General.
Finally, 7 CFR 331.2(c) and 9 CFR 121.2(c) state that the
responsible official is responsible for ensuring compliance with the
safety procedures in the regulations, including implementing the
Biocontainment and Security Plan (7 CFR 331.11) or the Biosafety and
Security Plan (9 CFR 121.12); providing the proper training to
individuals that handle or use listed agents or toxins; and providing
proper laboratory facilities to contain and dispose of such agents or
toxins. In addition, the responsible official is responsible for
ensuring compliance with the safeguard and security measures in the
regulations, including restricting access to only those individuals who
have a legitimate need to handle or use agents or toxins and who have
been approved to handle or use such agents or toxins, and transferring
listed agents or toxins only to registered individuals or entities.
List of Biological Agents and Toxins
In our August 2002 interim rule, we established the initial lists
of biological agents and toxins required under section 212(a)(1) of the
Act. In this interim rule, we are amending the lists of biological
agents and toxins in both 7 CFR 331.3 and 9 CFR 121.3.
We have made several changes to 7 CFR 331.3. In 7 CFR 331.3(a), we
have amended the entry for Ralstonia solanacearum, race 3. A comment
submitted in response to our August 2002 interim rule reported that
race 3 strains are common in the United States and should not be
listed; however, race 3, biovar 2 strains are not common in the United
States and would pose a severe threat to plant health or plant products
if introduced. We agree and have amended the entry for Ralstonia
solanacearum to specify race 3, biovar 2.
In addition, we have added several provisions that limit the
applicability of the regulations in part 331. First, in 7 CFR 331.3(b)
we provide that any biological agent or toxin listed in that section
that is in its naturally occurring environment will not be subject to
the requirements of part 331, provided that the biological agent or
toxin has not been intentionally introduced, cultivated, collected, or
otherwise extracted from its natural source. We have included this
provision because we believe that it would be impractical to regulate a
biological agent or toxin that is in its naturally occurring
environment. Listed agents or toxins could be found in castor beans or
corn going to market, for example, and it would be impractical to apply
these regulations in such cases.
Second, in 7 CFR 331.3(c) we provide that biological agents or
toxins that meet certain criteria do not have the potential to pose a
severe threat to plant health or to plant products. Thus, an individual
or entity that only possesses, uses, or transfers an agent or toxin
that meets any of the following criteria will not be subject to the
requirements of this part: (1) Nonviable agents that are, bear, or
contain listed agents or toxins; or (2) genetic elements or subunits of
listed agents or toxins, if the genetic elements or subunits are not
capable of causing disease.
We have also made several changes to the list in 9 CFR 121.3 to be
consistent with CDC and to reflect changes in scientific nomenclature.
In June 2002, CDC convened an interagency working group to review its
list of 36 select agents, some of which are the overlap agents that are
listed in our regulations, and develop recommendations regarding
possible changes to that list. Because that process was in its initial
stages at the time we published the August 2002 interim rule that
established the list of biological agents and toxins, the list of
overlap agents and toxins reflected the select agent list promulgated
by CDC in October 1996. The interagency working group has since
submitted its recommendations to CDC.
Based on the interagency working group's recommendations, we have
removed aflatoxin from the list of overlap agents and toxins in Sec.
121.3(b), and we have moved Nipah virus from the animal agent and toxin
list to the overlap agent and toxin list. In addition, we have added
Botulinum neurotoxin producing species of Clostridium to the overlap
agent and toxin list.
Due to changes in scientific nomenclature, in 9 CFR 121.3(b) we
have replaced the entry for equine morbillivirus (Hendra virus) with
Hendra virus; replaced Burkholderia (Pseudomonas) mallei with
Burkholderia mallei; replaced Burkholderia (Pseudomonas) pseudomallei
with Burkholderia pseudomallei; and replaced Botulinum toxin with
Botulinum neurotoxins.
In 9 CFR 121.3(c), we have adopted CDC's provisions regarding
genetic elements, recombinant nucleic acids, and recombinant organisms
to be consistent with CDC's list of overlap agents and toxins.
To clarify that we are regulating the agent that causes disease
rather than the disease itself and to be consistent with CDC's
approach, in 9 CFR 121.3(d) we have replaced the entry for avian
influenza (highly pathogenic) with avian influenza virus (highly
pathogenic); replaced African swine fever with African swine fever
virus; replaced classical swine fever with classical swine fever virus;
replaced malignant catarrhal fever with malignant catarrhal fever virus
(exotic); replaced Peste des petits ruminants with Peste des petits
ruminants virus; replaced sheep pox with sheep pox virus; and replaced
vesicular stomatitis (exotic) with vesicular stomatitis virus (exotic).
In addition, in 9 CFR 121.3(d) we have replaced the entry for
Newcastle disease virus (exotic) with Newcastle disease virus (VVND) to
make it clear that we are regulating only velogenic strains.
Moreover, in 9 CFR 121.3 we have added several provisions that
limit the applicability of the regulations in part 121. First, in 9 CFR
121.3(e) we provide that any biological agent or toxin listed in that
section that is in its naturally occurring environment will not be
subject to the requirements of part 121, provided that the biological
agent or toxin has not been intentionally introduced, cultivated,
collected, or otherwise extracted from its natural source. We have
included this provision because we believe that it would be impractical
to regulate a biological agent or toxin that is in its naturally
occurring environment. Listed agents or toxins could be found in cattle
or infected humans, for example, and it would be impractical to apply
these regulations in such cases.
Second, in 9 CFR 121.3(f) we provide that biological agents or
toxins that meet certain criteria do not have the potential to pose a
severe threat to both human and animal health, or to animal health or
animal products. Therefore, an individual or entity possessing, using,
or transferring an agent or toxin that meets any of the following
criteria will not be subject to the requirements of part 121:
(1) Nonviable agents or fixed tissues that are, bear, or contain
agents or toxins listed in Sec. 121.3. However, we note that the
importation and interstate movement of these nonviable agents and fixed
tissues are still subject to the permit requirements under 9 CFR part
122; or
(2) Genetic elements or subunits of animal agents or toxins listed
in Sec. 121.3(d), if the genetic elements or subunits are not capable
of causing disease. However, we note that the importation and
interstate movement of these genetic elements or subunits of listed
agents or toxins are still subject to
[[Page 76912]]
the permit requirements under 9 CFR part 122; or
(3) Overlap toxins under the control of a principal investigator
(or equivalent), if the total aggregate amount does not, at any time,
exceed the following amounts: 0.5 mg of Botulinum neurotoxins (types A-
G), 100 mg of Clostridium perfringens epsilon toxin, 100 mg of
Shigatoxin, 5 mg of Staphylococcal enterotoxins, and 1,000 mg of T-2
toxin.
Finally, in 9 CFR 121.3(g) we have established a procedure by which
an individual or entity may request a determination by the
Administrator that an attenuated strain of a biological agent does not
pose a severe threat to both human and animal health, or to animal
health or animal products. This provision is necessary because some
attenuated strains of a biological agent may not pose a severe threat
to both human and animal health, or to animal health or animal
products. Therefore, by definition, such attenuated strains would be
excluded from the list of biological agents or toxins in Sec. 121.3.
Accordingly, 9 CFR 121.3(h) provides that an individual or entity
may request review by the Administrator to determine whether or not a
specific attenuated strain poses a severe threat to both human and
animal health, or to animal health or animal products. For overlap
agents, an individual or entity may request review by APHIS or CDC. If
APHIS or CDC determines that a specific attenuated strain does not pose
a severe threat to human and animal health, or to animal health or
animal products, and the individual or entity in possession of that
particular attenuated strain will not be subject to the requirements of
part 121. We note, however, that this determination will be limited to
the specific attenuated strain and to the specific activities involving
that attenuated strain.
APHIS or CDC will notify the applicant and publish a notice in the
Federal Register if it is determined that a specific attenuated strain
does not pose a severe threat to human and animal health, to animal
health, or to animal products, the individual or entity in possession
of that particular attenuated strain will not be subject to the
requirements of part 121. Under 9 CFR 121.3(h)(4), an individual or
entity may request reconsideration of an adverse decision in writing to
the Administrator.
Section 212(a)(2) of the Act requires that the lists of biological
agents and toxins be reviewed and republished biennially, or more often
as needed, and revised as necessary. In addition, the Act requires
that, when determining whether to include an agent or toxin, the
Secretary shall consult with appropriate Federal departments and
agencies and with scientific experts representing appropriate
professional groups. To accomplish this, we may hold public meetings to
provide the opportunity for Federal departments and agencies and
scientific experts to comment on the lists in 7 CFR 331.3 and 9 CFR
121.3.
Exemptions
Section 212(g)(1) of the Act explicitly sets forth the exemptions
for overlap agents and toxins. The exemptions for overlap agents and
toxins in 9 CFR 121.4 match the provisions in the Act. We set forth
similar provisions for exemptions for plant agents and toxins in 7 CFR
331.4 and animal agents and toxins in 9 CFR 121.5.
In accordance with section 212(g)(1)(B) of the Act, 9 CFR 121.4(a)
provides that clinical or diagnostic laboratories and other entities
possessing, using, or transferring overlap agents or toxins that are
contained in specimens presented for diagnosis or verification will be
exempt from the requirements of part 121, provided that the
identification of such agents or toxins is immediately reported to the
APHIS or CDC, and to other appropriate authorities when required by
Federal, State, or local law; and, within 7 days after identification,
such agents or toxins are transferred or inactivated, and APHIS Form
2040 is submitted to APHIS or CDC. We further provide that a copy of
the completed form must be maintained for 3 years.
Based on information provided by CDC and APHIS' National Veterinary
Services Laboratories (NVSL), and taking into consideration the threat
posed by listed agents and toxins, we believe that 7 days will provide
ample time after identification to inactivate the agent or toxin, or to
make transfer arrangements and to transfer the agent or toxin.
To be consistent with the exemptions for overlap agents and toxins,
in 7 CFR 331.4(a) and 9 CFR 121.5(a) we have adopted this exemption for
diagnostic laboratories (the term clinical laboratories is not
applicable to the plant-related regulations in 7 CFR part 331 or the
animal-related regulations in 9 CFR part 121). We note, however, that
diagnostic laboratories and other entities will still be required to
obtain a permit under 7 CFR part 330 and 9 CFR part 122 to import and
move interstate any listed agent or toxin.
In 7 CFR 331.4(a), 9 CFR 121.4(a), and 9 CFR 121.5(a), we further
provide that, during agricultural emergencies or outbreaks, or in
endemic areas, the Administrator may require less frequent reporting.
For example, during an outbreak, we may allow biweekly reporting of
identifications of a specific agent. In such cases, we will inform the
diagnostic laboratories or other entities of this temporary change to
the notification requirements.
In 9 CFR part 121, we also provide an exemption for clinical or
diagnostic laboratories and other entities conducting proficiency
testing. Specifically, in 9 CFR 121.4(b) we provide that clinical or
diagnostic laboratories and other entities possessing, using, or
transferring overlap agents or toxins that are contained in specimens
presented for proficiency testing will be exempt from the requirements
of part 121, provided that the identification of such agents or toxins,
and their derivatives, is reported to the APHIS or CDC and to other
appropriate authorities when required by Federal, State, or local law;
and within 90 days of receipt of the agents or toxins, the agents or
toxins are transferred or inactivated, and APHIS Form 2040 is submitted
to APHIS or CDC. We further provide that a copy of the completed form
must be maintained for 3 years.
Paragraph (a) of 9 CFR 121.5 contains the same exemption provision
for animal agents or toxins that are contained in specimens presented
for proficiency testing. Based on information provided by NVSL, which
conducts such proficiency testing, we believe that 90 days will provide
ample time to run the necessary tests for any listed agent or toxin.
We wish to emphasize that a clinical or diagnostic laboratory, or
other entity, will be exempt only if it satisfies the specific
requirements of these exemptions. Clinical or diagnostic laboratories
and other entities must register in accordance with the regulations if
they wish to maintain a viable agent or active toxin as a positive
control. This is consistent with the ``fundamental premise of the
[Act]--that all those who maintain possession of a [listed biological
agent or toxin] must register and be subject to appropriate security
and safety requirements.'' (H.R. Conf. Rep. No. 107-481, at 122
(2002)).
Pursuant to section 212(g)(1)(C) of the Act, the regulations in 9
CFR part 121 provide exemptions for products that are, bear, or contain
agents or toxins that have been cleared, approved, licensed, or
registered under certain Federal laws. Generally, we believe that it is
unnecessary to impose additional regulation on products that have been
cleared, approved, licensed, or
[[Page 76913]]
registered pursuant to certain Federal laws because these laws already
provide adequate safeguards. However, it is possible there will be some
instances when existing regulation under Federal law is inadequate. In
those instances, the regulations provide that the Administrator may
impose additional regulation if he or she determines that it is
necessary to protect animal or plant health, and animal or plant
products.
Accordingly, for overlap agents or toxins and animal agents or
toxins, 9 CFR part 121 (Sec. Sec. 121.4(c) and 121.5(e), respectively)
provides that, unless the Administrator by order determines that
additional regulation of a specific product is necessary to protect
animal health, or animal products, an individual or entity possessing,
using, or transferring products that are, bear, or contain agents or
toxins will be exempt from the requirements of this part if the
products have been cleared, approved, licensed, or registered pursuant
to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.);
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 131 et seq.).
In addition, in 9 CFR 121.4(d) we provide that an individual or
entity possessing, using, or transferring investigational products that
are, bear, or contain overlap agents or toxins may be exempt from the
requirements of this part if such product is being used in an
investigation authorized by any Federal law and the Administrator
determines that additional regulation under this part is not necessary
to protect animal health or animal products. An individual or entity
possessing, using, or transferring such investigational products may
apply for an exemption from the requirements of this part by submitting
APHIS Form 2042 to APHIS or CDC. Given the time sensitivity of
investigational or clinical trials, the Administrator shall make a
determination regarding an exemption within 14 days after receipt of
the application and notification that the investigation has been
authorized under a Federal law.
We have added a similar provision for experimental products in 9
CFR 121.5(f). However, because it is not required by the Act, in Sec.
121.5(f) we did not stipulate that the Administrator will make a
determination regarding an exemption within 14 days after receipt of
the application and notification that the investigation has been
authorized under a Federal law. We did not include this provision in
order to give the Administrator the discretion to take longer than 14
days to make a determination, when necessary. However, we expect that
the Administrator will make determinations regarding such exemptions in
a timely manner.
Furthermore, in 9 CFR 121.5(c) we provide that an individual or
entity receiving diagnostic reagents and vaccines that are, bear, or
contain listed agents or toxins, also known as high consequence
livestock pathogens or toxins, that are produced at USDA diagnostic
facilities will be exempt from the requirements of part 121. These
diagnostic reagents and vaccines are products that would be cleared,
approved, licensed, or registered pursuant to the Virus-Serum-Toxin Act
(21 U.S.C. 151-159), but for the fact that they are produced by USDA.
In accordance with section 212(g)(1)(D) of the Act, 9 CFR 121.4(e)
provides that the Administrator may exempt an individual or entity from
the requirements of the regulations, in whole or in part, for 30 days
if it is necessary to respond to a domestic or foreign agricultural
emergency involving an overlap agent or toxin. The Administrator may
extend the exemption once for an additional 30 days, as deemed
necessary.
In 9 CFR 121.4(f), we set forth a similar provision for public
health emergencies. Specifically, Sec. 121.4(f) provides that, upon
request of the Secretary of Health and Human Services, the
Administrator may exempt an individual or entity from the requirements
of the regulations, in whole or in part, for 30 days if the Secretary
of Health and Human Services has granted an exemption for a public
health emergency involving an overlap agent or toxin. The Administrator
may extend the exemption once for an additional 30 days, as deemed
necessary.
Finally, section 212(g)(2) of the Act provides that the Secretary
may grant exemptions from the applicability of the regulations if the
Secretary determines that such exemptions are consistent with
protecting animal or plant health and animal or plant products. This
general exemption authority affords the Secretary more discretion to
exempt plant and animal agents and toxins than overlap agents and
toxins, since the Act specifically sets forth the exemptions for
overlap agents and toxins.
Accordingly, 7 CFR 331.4(b) and 9 CFR 121.5(f) indicate that the
Administrator may grant exemptions from the requirements of these parts
upon a showing of good cause and a determination that it is consistent
with protecting animal or plant health and animal or plant products.
For example, such exemptions may be granted for agricultural
emergencies involving plant or animal agents or toxins. An individual
or entity may request in writing an exemption from the requirements of
the regulations.
Registration Requirements and Procedures
In accordance with section 212(d) of the Act, 7 CFR 331.5(a) and 9
CFR 121.6(a) require that, unless exempted under those parts, an
individual or entity possessing, using, or transferring listed agents
or toxins must register with APHIS. Section 121.6(a) of 9 CFR part 121
further requires that an individual or entity possessing, using, or
transferring overlap agents or toxins must register with APHIS or CDC.
We note that Congress expected that most registrants would be
public and private entities, rather than individuals. (H.R. Conf. Rep.
No. 107-481, at 125 (2002)). Thus, 7 CFR 331.5(b) and 9 CFR 121.6(b)
indicate that, to apply for a certificate of registration, each entity
must designate an individual to be the responsible official. The
responsible official must have the authority and control to ensure
compliance with the regulations. The responsible official must complete
and sign the registration application package, and will be the
individual contacted by APHIS or CDC if any questions arise concerning
the application or subsequent compliance. As part of registration, the
responsible official and the entity will be subject to a security risk
assessment by the Attorney General.
While most registrants are likely to be entities, both 7 CFR
331.5(b) and 9 CFR 121.6(b) provide that, in the event that an
individual applies for and is granted a certificate of registration, we
will consider the individual to be the responsible official.
We wish to emphasize that it is the entity's responsibility to
designate the appropriate individual to be the responsible official
(i.e., an individual who has the authority and control to ensure
compliance with the regulations). To satisfy this requirement, a
university may choose to designate the Dean of Agriculture to be the
responsible official rather than the biosafety officer because the Dean
of Agriculture may have better oversight and authority to ensure
compliance with the regulations.
Furthermore, we note that a certificate of registration will apply
to only one general physical location (e.g., a building or complex of
buildings at a
[[Page 76914]]
single mailing address). If an entity has more than one general
physical location, then the entity must register each location and must
designate an individual to be the responsible official for each
location.
Although not contemplated by the Act, we recognize that there may
be times when the responsible official is unavailable. Since some
functions may only be performed by the responsible official (i.e.,
transfers), this may disrupt research or other approved activities.
Therefore, in 7 CFR 331.5(c) and 9 CFR 121.6(c), we provide that an
entity may designate one or more individuals to be an alternate
responsible official, who may act for the responsible official when
that individual is unavailable. These individuals must have the
authority and control to ensure compliance with the regulations when
acting as the responsible official. These individuals will also be
subject to a security risk assessment by the Attorney General as part
of registration.
To apply for a certificate of registration, 7 CFR 331.8(a) and 9
CFR 121.9(a) provide that the responsible official must submit all of
the information and documentation required in the registration
application package to APHIS, including the name, source, and
characterization data for each agent or toxin to be registered, as
required by section 212(d)(2) of the Act. For overlap agents or toxins,
the responsible official must submit all of the information and
documentation required in the registration package to either APHIS or
CDC. The responsible official must submit the registration application
package to APHIS in cases where he/she is seeking registration for
either plant and animal agents or toxins, and overlap agents or toxins.
In 7 CFR 331.6(b) and 9 CFR 121.7(b), we provide that APHIS may
issue a certificate of registration upon:
(1) Approval of the responsible official; the alternate responsible
official, where applicable; the entity; and, where applicable, the
individual who owns or controls the entity following a security risk
assessment by the Attorney General. As provided for by the Act, we may
waive the security risk assessment of the entity and the individual who
owns or controls such entity for Federal, State, or local governmental
agencies;
(2) Approval of the containment and security of the entity (7 CFR
331.6) or approval of the biosafety, containment, and security of the
entity (9 CFR 121.7). For plant-related agents or toxins, the entity's
containment and security procedures must be commensurate with the risk
of the agent or toxin, given its intended use. Similarly, for overlap
and animal agents or toxins, the entity's biosafety, containment, and
security procedures must be commensurate with the risk of the agent or
toxin, given its intended use. APHIS will review the Biocontainment and
Security Plan or the Biosafety and Security Plan, as applicable, and
may inspect and evaluate the premises and records to determine
compliance with the regulations and the biosafety and/or containment
and security requirements. For overlap agents and toxins, APHIS or CDC
will review the Biosafety and Security Plan, and may inspect and
evaluate the premises and records to determine compliance with the
regulations and the biosafety and/or containment and security
requirements; and
(3) A determination by the Administrator that the individual or
entity seeking to register has a lawful purpose to possess, use, or
transfer such agents or toxins.
Furthermore, 9 CFR 121.7(c) provides that APHIS and CDC will review
applications for registration and amendments to a certificate of
registration for overlap agents or toxins, and a certificate of
registration or amendment to a certificate of registration will only be
issued if APHIS and CDC concur.
As indicated in 7 CFR 331.6(c) and 9 CFR 121.7(d), a certificate of
registration will be valid for only specific agents or toxins, and
specific activities and locations. A certificate of registration may
cover more than one listed agent or toxin, and it may be amended to
cover additional listed agents or toxins. A responsible official may
request an amendment to a certificate of registration by submitting the
relevant pages from the registration application package to the agency
that issued the certificate of registration, either APHIS or CDC.
Furthermore, under 7 CFR 331.6(d) and 9 CFR 121.7(e), a certificate
of registration may be amended to reflect changed circumstances (e.g.,
replacement of the responsible official, changes in ownership or
control of the entity, changes in the activities involving the agent or
toxin). The responsible official must immediately notify the agency
that issued the certificate of registration, either APHIS or CDC, of
such changes in circumstances that occur after submission of the
application for registration or after receipt of a certificate of
registration. We note that replacement of the responsible official or
change in ownership or control of an entity will require a security
risk assessment for the new individual(s) who owns or controls the
entity.
There may be instances where a responsible official wishes to
discontinue possessing, using, or transferring one or more agents or
toxins for which they are registered. In those instances, 7 CFR
331.5(e) and 9 CFR 121.6(f) state that the responsible official may
inactivate the agent or toxin or he/she may transfer the agent or toxin
to a registered individuals or entities. The responsible official must
notify APHIS or, for overlap agents, APHIS or CDC, 5 business days
prior to the planned inactivation so that we may have the opportunity
to observe the inactivation of the agents or toxins. APHIS or CDC will
notify the responsible official if we wish to observe the inactivation
of the agents or toxins.
Finally, 7 CFR 331.6(f) and 9 CFR 121.7(g) indicate that a
certificate of registration will be valid for a maximum of 3 years. To
minimize the administrative burden associated with this new
registration program, initially we will assign expiration dates ranging
from 24 to 36 months to stagger the dates for renewing registration.
Upon renewal, we expect that all certificates of registration will be
valid for 3 years.
Denial, Revocation, and Suspension of Registration
Section 212(e)(6)(A) of the Act provides that an individual who
seeks to register shall be subject to a database check by the Attorney
General. Section 212(e)(6)(B) goes on to provide that other persons
(i.e., entities) shall be subject to a database check by the Attorney
General, and, where applicable, the individual who owns or control such
person (i.e., entity) shall be subject to a database check by the
Attorney General.
Pursuant to section 212(e)(3) of the Act, upon receipt of the names
and identifying information of those seeking to register, the Attorney
General will use criminal, immigration, national security, and other
electronic databases for the purpose of identifying whether the
individuals are within any of the categories described in 18 U.S.C.
175b (relating to restricted persons). According to 18 U.S.C. 175b, the
term ``restricted person'' means an individual who:
(A) Is under indictment for a crime punishable 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
[[Page 76915]]
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) 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 conditions.''
Section 212(e)(3) of the Act further provides that the Attorney
General will use criminal, immigration, national security, and other
electronic databases for the sole purpose of identifying whether the
individuals are reasonably suspected by any Federal law enforcement or
intelligence agency of committing a crime set forth in 18 U.S.C.
2332b(g)(5); 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 being an agent of a foreign power as defined in 50 U.S.C.
1801.
Accordingly, in 7 CFR 331.7(a) and 9 CFR 121.8(a) we provide that
APHIS may deny an application for registration or revoke registration
if the Attorney General identifies the individual as within any of the
categories described in the previous paragraphs.
With regard to overlap agents or toxins, 9 CFR 121.8(b) provides
that APHIS or CDC will deny an application for registration or revoke
registration if the Attorney General identifies the individual as a
``restricted person'' as described in 18 U.S.C. 175b. APHIS or CDC may
deny an application for registration or revoke registration if the
Attorney General identifies the individual as within any of the
remaining categories described above.
Furthermore, in keeping with the safety and security requirements
of the Act, in 7 CFR 331.7(a) and 9 CFR 121.8(a), we provide that APHIS
may deny an application for registration or revoke registration if the
responsible official does not have a lawful purpose to possess, use, or
transfer listed agents or toxins; the responsible official is an
individual who handles or uses listed agents or toxins and he/she does
not have the necessary training or skills to handle such agents or
toxins; the entity does not meet the biosafety and/or containment and
security requirements prescribed by the Administrator; there are
egregious or repeated violations of the biosafety, containment, or
security requirements; or the Administrator determines that such action
is necessary to protect animal or plant health, and animal or plant
products.
We may summarily revoke or suspend registration for any of the
reasons set forth in 7 CFR 331.7(a) and in paragraphs (a) and (b) of 9
CFR 121.8. In accordance with 7 CFR 331.7(c) and 9 CFR 121.8(d), we
will notify the responsible official in writing if an application for
registration is denied or a certificate of registration is revoked or
suspended. For overlap agents or toxins, APHIS or CDC will provide the
necessary notification.
Finally, both parts provide that denial of an application for
registration, revocation of registration, and suspension of
registration may be appealed under Sec. Sec. 331.16 and 121.17,
respectively.
Responsibilities of the Responsible Official
To facilitate compliance with the regulations, 7 CFR 331.9 and 9
CFR 121.10 both set out the responsibilities of the responsible
official. Specifically, the regulations indicate the responsible
official is responsible for:
[sbull] Developing and implementing a Biocontainment and Security
Plan or a Biosafety and Security Plan, as applicable;
[sbull] Allowing only approved individuals within the entity to
have access to listed agents or toxins;
[sbull] Providing appropriate training in biosafety and/or
containment and security procedures for all personnel;
[sbull] Transferring agents or toxins only to registered
individuals or entities;
[sbull] Ensuring that all visitors are informed of and follow the
entity's security requirements and procedures;
[sbull] Notifying APHIS or, for overlap agents, APHIS or CDC, of
changes in circumstances;
[sbull] Providing timely notice of any theft, loss, or release of a
biological agent or toxin; and
[sbull] Maintaining detailed records of information necessary to
give a complete accounting of all of the entity's activities related to
agents or toxins.
In addition, both parts provide that the responsible official for a
diagnostic laboratory or other entity possessing, using, or
transferring listed agents or toxins that are contained in specimens
presented for diagnosis must immediately report the identification of
such agents or toxins to the Administrator and to other appropriate
authorities when required by Federal, State, or local law. Furthermore,
both parts provide that the Administrator may require less frequent
reporting during agricultural emergencies or outbreaks, or in endemic
areas. We are adopting these reporting requirements because this
information will help us to identify outbreaks and to monitor
activities related to listed agents and toxins.
Finally, to be consistent with CDC, we have adopted the CDC's
approach on experiments involving recombinant DNA. We believe this
provision will address concerns about laboratory manipulation of
microbes that alter their characteristics (e.g., increased virulence,
pathogenicity, or host range; alter mode of transmission or route of
exposure) and increase the risks to human, animal, or plant health.
Accordingly, in 9 CFR 121.10(c) we provide that a responsible
official must ensure that the following experiments are not conducted
unless approved by the Administrator, after consultation with experts:
(1) Experiments utilizing recombinant DNA that involve the
deliberate transfer of a pathogenic trait or drug resistance trait to
biological 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; and
(2) Experiments involving the deliberate formation of recombinant
DNA containing genes for the biosynthesis of toxins lethal for
vertebrates at an LD50<100 ng/kg body weight.
In addition, we request comments concerning what additional
experiments, regardless if regulated under these regulations, might
warrant similar scrutiny in the interest of safety. 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; or result in the deliberate transfer a drug resistant trait or
a toxin-producing capability to a microorganism by means that do not
involve recombinant DNA techniques. We also request comments regarding
the form oversight should
[[Page 76916]]
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 Administrator and discontinue work with the
modified organism until the Administrator has made recommendations
regarding appropriate safety practices.
Restricting Access to Biological Agents and Toxins
Section 212(e)(1) of the Act provides that the Secretary shall
establish appropriate safeguard and security requirements for persons
possessing, using, or transferring biological agents or toxins
commensurate with the risk such agent poses to animal and plant health,
and animal and plant products (including the risk of use in domestic or
international terrorism). Section 212(e)(2)(A) goes on to state that
the regulations must include provisions to ensure that the registered
person provides access to listed agents and toxins to only those
individuals whom the registered person has determined have a legitimate
need to handle or use such agents or toxins. In addition, section
212(b)(1)(A) requires that the Secretary establish and enforce safety
procedures for agents and toxins, including measures to ensure proper
training and appropriate skills to handle such agents and toxins.
Accordingly, 7 CFR 331.10(a) and 9 CFR 121.11(a) provide that an
individual may not have access to biological agents or toxins listed in
Sec. Sec. 331.3 and 121.3, respectively, unless approved by APHIS or,
for overlap agents, APHIS or CDC. Both parts require the responsible
official to ensure that only approved individuals within the entity
have access to listed agents or toxins. In addition, the responsible
official must request such access for only those individuals who have a
legitimate need to handle or use listed agents or toxins, and who have
the appropriate training and skills to handle such agents or toxins.
We recognize that a responsible official may want to minimize the
number of individuals who require access approval. Accordingly, we
reiterate that such approval is necessary only for those individuals
who have a legitimate need to handle or use agents or toxins, and who
have the appropriate training and skills to handle such agents or
toxins. For those individuals who do not have a legitimate need to
handle or use agents or toxins, or who do not have the appropriate
training and skills to handle agents or toxins (e.g., visitors,
janitorial and maintenance staff, and contractors), a responsible
official may restrict access to agents or toxins by requiring that such
individuals be escorted at all times by an individual with access
approval from APHIS or CDC. If a responsible official adopts such a
practice, it should be contained in the Biocontainment and Security
Plan or the Biosafety and Security Plan, as applicable.
To ensure that individuals who handle or use listed agents or
toxins have the appropriate training and skills, 7 CFR 331.10(c)
requires that the responsible official must provide appropriate
training in containment and security procedures to all individuals with
access to agents and toxins in accordance with 7 CFR 331.12. Similarly,
9 CFR 121.11(c) requires that the responsible official must provide
appropriate training in biosafety and/or containment and security
procedures to all individuals with access to agents and toxins in
accordance with 9 CFR 121.13.
Furthermore, the responsible official must provide APHIS with
information about the individual's training and skills, such as a
curriculum vitae for principal investigators and researchers, and a
description of training completed by support personnel (7 CFR 331.10(e)
and 9 CFR 121.11(e)).
In order to obtain access approval for an individual, section
212(e)(2)(B) of the Act requires that the responsible official submit
the names and identifying information for those individuals deemed to
have a legitimate need to handle or use listed agents or toxins to the
Secretary and the Attorney General, promptly after determining the
individuals need access, and periodically thereafter, not less
frequently than once every 5 years. We note that the screening of
employees working with agents or toxins is the primary responsibility
of the responsible official, not the individual employee. (H.R. Conf.
Rep. No. 107-481, at 125 (2002)).
Both 7 CFR 331.10(d) and 9 CFR 121.11(d) indicate that, for each
individual identified by the responsible official as having a
legitimate need to handle or use listed agents or toxins, the
responsible official must submit that individual's name and identifying
information to APHIS and the Attorney General. Paragraph (d) of 9 CFR
121.11 further provides that, for overlap agents, the responsible
official must submit this information to either APHIS or CDC and the
Attorney General.
Pursuant to section 212(e)(3) of the Act, upon receipt of the names
and identifying information, the Attorney General will use criminal,
immigration, national security, and other electronic databases for the
purpose of identifying whether the individuals are within any of the
categories described in 18 U.S.C. 175b (relating to restricted
persons). Section 212(e)(3) of the Act further provides that the
Attorney General will use criminal, immigration, national security, and
other electronic databases for the purpose of identifying whether the
individuals are reasonably suspected by any Federal law enforcement or
intelligence agency of committing a crime set forth in 18 U.S.C.
2332b(g)(5); 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 being an agent of a foreign power as defined in 50 U.S.C.
1801.
In 7 CFR 331.10(h) and 9 CFR 121.11(h), we provide that we may deny
or limit access of an individual to listed agents or toxins if the
Attorney General identifies the individual as within any of the
categories described in the previous paragraph. This is consistent with
the requirements in section 212(e)(2)(C)(i) of the Act.
With regard to overlap agents or toxins, 9 CFR 121.11(i) provides
that APHIS or CDC will deny an individual access to overlap agents or
toxins if the Attorney General identifies the individual as a
``restricted person'' as described in 18 U.S.C. 175b. APHIS or CDC may
deny or limit access of an individual if the Attorney General
identifies the individual as within any of the remaining categories
described above.
Furthermore, in keeping with the safety and security requirements
of the Act, both 7 CFR 331.10(h) and 9 CFR 121.11(h) provide that we
may deny or limit access if the individual does not have a legitimate
need to handle listed agents or toxins; the individual does not have
the necessary training or skills to handle listed agents or toxins; or
the Administrator determines that such action is necessary to protect
animal or plant health or animal or plant products.
The Administrator will determine what constitutes limited access on
a case-by-case basis. The determination will take into consideration
all the facts at hand and be commensurate with the risks posed by the
agent or toxin. Generally, we expect that an individual granted limited
access will only be allowed to handle or use an agent or toxin under
the direct supervision of an approved individual.
Section 212(e)(3)(C) of the Act provides that the Attorney General
will
[[Page 76917]]
notify the Secretary whether the individual is within any of the
categories discussed previously. Then the Secretary will notify the
responsible official if an individual is granted or denied access to
listed agents or toxins (section 212(e)(4)).
Accordingly, both 7 CFR 331.10(g) and 9 CFR 121.11(g) provide that
we will notify the responsible official if an individual is granted
full or limited access, or denied access, to biological agents or
toxins, and we will notify the individual if he/she is denied access or
granted only limited access to such agents or toxins. Paragraph (g) of
9 CFR 121.11 further provides that, for overlap agents or toxins, APHIS
or CDC will provide the necessary notification.
Pursuant to section 212(e)(5) of the Act, 7 CFR 331.10(f) and 9 CFR
121.11(f) indicate that we may expedite the access approval process for
individuals upon request by the responsible official and a showing of
good cause, such as public health or agricultural emergencies, national
security, impending expiration of a research grant, or a short-term
visit by a prominent researcher. We note, however, that the Act
specifically provides that expedited review is not available for
individuals or entities seeking to register (section 212(e)(6)).
Both 7 CFR 331.10(j) and 9 CFR 121.11(k) provide that access
approval for individuals is valid for 5 years and, thereafter, the
responsible official shall request access approval every 5 years for as
long as the individual needs access to such agents or toxins. This is
consistent with the requirements of the Act.
In 7 CFR 331.10(k) and 9 CFR 121.11(l), we further provide that the
responsible official must immediately notify APHIS or, for overlap
agents or toxins, APHIS or CDC, when an individual's access to listed
agents or toxins is terminated by the entity and the reasons therefore.
We believe this information will be relevant to any subsequent
determinations to allow that individual access to listed agents or
toxins.
Section 212(e)(7)(A)(i) of the Act requires that the regulations
provide for an opportunity for review by the Secretary, when requested
by the individual involved, of a determination to deny that individual
access to listed agents or toxins. Thus, 7 CFR 331.10(i) and 9 CFR
121.11(j) provide that an individual may appeal the Administrator's
decision to deny or limit access to biological agents or toxins, in
accordance with Sec. Sec. 331.16 and 121.17, respectively.
Biocontainment and Security Plan/Biosafety and Security Plan
Sections 212(b) and (c) of the Act require that the Secretary
establish and enforce safety procedures for listed agents and toxins,
including measures to ensure proper training and appropriate skills to
handle agents and toxins, and proper laboratory facilities to contain
and dispose of agents and toxins. In addition, sections 212(b) and (c)
of the Act require that the Secretary establish and enforce safeguard
and security measures to prevent access to listed agents and toxins for
use in domestic or international terrorism or for any other criminal
purpose. Pursuant to section 212(e)(1), the safeguard and security
requirements must be commensurate with the risk posed by the agent or
toxin.
Because different agents and toxins pose differing degrees of risk,
depending on factors such as their escape potential and availability of
a suitable habitat (for plant-related agents) and transmission and
effect of exposure to the agent or toxin (for overlap and animal agents
or toxins), we believe that it would be counterproductive to attempt to
prepare a detailed list of prescriptive requirements for entities
(i.e., a ``one size fits all'' design standard). Rather, we have
prepared a brief set of performance standards that we will consider to
the degree to which they are appropriate to the risks presented by a
particular agent or toxin, given its intended use and the location of
the entity.
Accordingly, 7 CFR 331.11 requires that, as a condition of
registration, an individual or entity must develop and implement a
Biocontainment and Security Plan. Similarly, 9 CFR 121.12 requires
that, as a condition of registration, an individual or entity must
develop and implement a Biosafety and Security Plan. The titles and
provisions of the plans are different because the agents listed under 7
CFR 331.3 do not pose a severe threat to human health and, therefore,
it is unnecessary to require that the plant-related plan address
personnel safety and health.
In 7 CFR 331.11, we provide that the plan must contain sufficient
information and documentation to describe the containment procedures
and the security systems and procedures. The plan's containment and
security provisions must be commensurate with the risk posed by the
agent or toxin, given its intended use.
Similarly, in 9 CFR 121.12 we provide that the plan must contain
sufficient information and documentation to describe the biosafety and
containment procedures, and the security systems and procedures. The
plan's biosafety, containment, and security provisions must be
commensurate with the risk posed by the agent or toxin, given its
intended use.
Pursuant to section 212(e)(9) of the Act, we will provide technical
assistance and guidance upon request to help individuals and entities
develop their plans.
In 7 CFR 331.11(a)(1), we provide that the plan's containment
procedures must be sufficient to contain the agent or toxin (e.g.,
physical structure and features of the entity, and operational and
procedural safeguards) while in 9 CFR 121.12(a)(1) we provide that the
plan's biosafety and containment procedures must be sufficient to
contain the agent or toxin (e.g., physical structure and features of
the entity, and operational and procedural safeguards). As previously
noted, these provisions are different because the agents listed under 7
CFR 331.3 do not pose a severe threat to human health and, therefore,
it is unnecessary to require that the plant-related plan address
personnel safety and health.
We expect that a number of the individuals or entities seeking to
register under these regulations will have previously been issued
permits under 7 CFR part 330 or 9 CFR part 122, or will have been
registered under CDC's select agent regulations in 42 CFR part 72 and
thus will have appropriate biosafety and/or containment procedures
already in place. It is likely that these biosafety and/or containment
procedures will meet the requirements of the regulations or could be
easily modified to meet the requirements of the regulations. Therefore,
we encourage individuals or entities seeking to register to make use of
existing biosafety and/or containment procedures, and to modify such
procedures as necessary.
In 7 CFR 331.11(a)(2) and 9 CFR 121.12(a)(2), we further provide
that the security systems and procedures must be designed according to
a site-specific risk assessment and must provide graded protection in
accordance with the threat posed by the agent or toxin. This site-
specific risk assessment should involve a threat assessment and risk
analysis in which threats are defined, vulnerabilities examined, and
risks associated with those vulnerabilities are identified.
The security systems and procedures must be tailored to address
site-specific characteristics and requirements, ongoing programs, and
operational needs and must mitigate the risks identified in the risk
assessment. The
[[Page 76918]]
plan must describe inventory control procedures, personnel suitability
for those individuals with access to listed agents or toxins, physical
security, and cybersecurity. The plan must also contain provisions for
routine cleaning, maintenance, and repairs; provisions for securing the
area (e.g., card access, key pads, locks) and protocols for changing
access numbers or locks following staff changes; procedures for loss or
compromise of keys, passwords, combinations, etc.; 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; provisions for the control of access to containers
where listed agents and toxins are stored; and procedures for reporting
and removing unauthorized persons.
Moreover, with respect to areas containing listed agents or toxins,
an entity or individual must adhere to the following security
requirements or implement measures to achieve an equivalent or greater
level of security as the provisions below:
[sbull] Allow unescorted access only to approved individuals who
are performing a specifically authorized function during hours required
to perform that job;
[sbull] Allow individuals not approved under 7 CFR 331.10 or 9 CFR
121.11 to conduct routine cleaning, maintenance, repairs, and other
non-laboratory functions only when escorted and continually monitored
by approved individuals;
[sbull] Provide for the control of access to containers where
listed agents and toxins are stored by requiring that such containers
be locked when not in the direct view of an approved individual and by
using other monitoring measures, as needed;
[sbull] Require the inspection of all packages upon entry and exit;
[sbull] Establish a protocol for intra-entity transfers, including
provisions for ensuring that the packaging and movement, is conducted
under the supervision of an approved individual;
[sbull] Require that approved individuals do not share with any
other person their unique means of accessing the area or listed agents
or toxins; and
[sbull] Require that approved individuals immediately report any of
the following to the responsible official: Any loss or compromise of
keys, passwords, combinations, etc.; any suspicious persons or
activities; any loss or theft of listed agents or toxins; any release
of a listed agent or toxin; and any sign that inventory and use records
for listed agents and toxins have been altered or otherwise
compromised.
We recommend that security experts be consulted to ensure that the
individual or entity develops security systems and procedures that will
meet the requirements of this section. However, we recognize that this
may not be possible in every instance. Therefore, we reiterate that we
will provide technical assistance and guidance upon request.
In 7 CFR 331.11(a)(3) and 9 CFR 121.12(a)(3), we also require that
the plans include incident response plans for containment breach,
security breach, inventory violations, non-biological incidents such as
workplace violence, and cybersecurity breach. Under 7 CFR 331.11(a)(3),
the incident response plans must address containment, inventory
control, and notification of managers and responders; while under 9 CFR
121.12(a)(3) the incident response plans must address containment,
personnel safety and health, inventory control, and notification of
managers and responders. As discussed above, it is unnecessary for 7
CFR 331.11(a)(3) to address personnel safety and health because the
plant-related agents do not pose a severe threat to human health.
Finally, to ensure that the Biocontainment and Security Plan
continues to meet the entity's containment and security needs, in 7 CFR
331.11(b) we require that the plan be reviewed, performance tested, and
updated annually. The plan must also be reviewed and revised, as
necessary, after any incident. We include these same requirements in 9
CFR121.12(b) in order to ensure that the Biosafety and Security Plan
continues to meet the entity's biosafety, containment, and security
needs.
Training
To ensure that individuals who handle or use listed agents or
toxins have the appropriate training and skills, 7 CFR 331.12(a)
provides that the responsible official must provide appropriate
training in containment and security procedures to all individuals with
access to listed agents and toxins while 9 CFR 121.13(a) provides that
the responsible official must provide appropriate training in
biosafety, containment, and security procedures to all individuals with
access to listed agents and toxins. These provisions are different
because the agents listed under 7 CFR 331.3 do not pose a severe threat
to human health and, therefore, it is unnecessary to require that the
plant-related plan address personnel safety and health.
Both 7 CFR 331.12 and 9 CFR 121.13 provide that the responsible
official must provide information and training to an individual at the
time the individual is assigned to work with a listed agent or toxin.
In addition, the responsible official must provide refresher training
annually.
Transfer of Biological Agents and Toxins
In accordance with 212(b) of the Act, 7 CFR 331.13 and 9 CFR 121.14
set forth the transfer requirements for biological agents and toxins.
Both 7 CFR 331.13 and 9 CFR 121.14 provide that a listed biological
agent or toxin may only be transferred to individuals or entities
registered to possess, use, or transfer that particular agent or toxin.
However, the sender of an agent or toxin may be an individual or entity
that has a certificate of registration for the agent or toxin, an
individual or entity that is exempt from the requirements of the
regulations, or an individual or entity located outside of the United
States. Biological agents or toxins may only be transferred under the
conditions in each section and must be authorized by APHIS or, for
overlap agents or toxins, by APHIS or CDC, prior to the transfer.
Both 7 CFR 331.13(a) and 9 CFR 121.14(a) incorporate the existing
permit requirements under the plant pest regulations in 7 CFR part 330
and the organisms and vectors regulations in 9 CFR part 122,
respectively. We believe the current permitting systems provided for by
the existing plant pest and organisms and vectors regulations will
complement the requirements under these new regulations, and will
provide additional protections for the transfer of listed agents and
toxins. We do not expect that these permit requirements will be
burdensome, since permits for listed biological agents or toxins issued
under 7 CFR part 330 and 9 CFR part 122 are valid for up to 1 year and
can be renewed.
Thus, Sec. Sec. 331.13(a) and 121.14(a) provide that, in addition
to the permit required under 7 CFR part 330 or 9 CFR part 122,
respectively, biological agents or toxins may only be imported or moved
interstate with the prior authorization of APHIS or, for overlap agents
or toxins, APHIS or CDC. To obtain such authorization, the sender and
the responsible official for the recipient must complete and submit
APHIS Form 2041 to APHIS or CDC, in accordance with Sec. Sec.
331.13(c) and 121.14(c).
Furthermore, under 7 CFR 331.12(b), plant agents or toxins listed
in 7 CFR 331.3 may be moved intrastate only with the prior
authorization of APHIS,
[[Page 76919]]
and under 9 CFR 121.14(b), animal agents or toxins listed in 9 CFR
121.3(c) may be moved intrastate only with the prior authorization of
APHIS and overlap agents or toxins listed in 9 CFR 121.3(b) may be
moved intrastate only with the prior authorization of APHIS or CDC.
Again, to obtain such authorization, the sender and the responsible
official for the recipient must complete and submit APHIS Form 2041 to
APHIS or CDC, in accordance with Sec. Sec. 331.13(c) and 121.14(c).
To track the actual transfer of the agents and toxins, we are
adopting CDC's transfer process to be consistent with CDC and because a
number of regulated parties are already familiar with this transfer
process. This transfer process is designed to provide an accurate
record of the transfer; such information may be crucial in the event of
a criminal or epidemiological investigation.
Both 7 CFR 331.13(c) and 9 CFR 121.14(c) set out the transfer
process and procedures (APHIS Form 2041). Specifically, both parts
provide that, prior to each transfer, the sender and the responsible
official for the recipient must complete APHIS Form 2041. Then the
sender must submit the form to APHIS or, for overlap agents or toxins,
to APHIS or CDC.
After reviewing the form, APHIS will authorize the transfer based
on a finding that the recipient has a certificate of registration
covering the transfer of the listed agent or toxin. For overlap agents
and toxins, APHIS or CDC will authorize the transfer based on a finding
that the recipient has a certificate of registration covering the
transfer of the listed agent or toxin.
To confirm the transfer, 7 CFR 331.13(c)(3) and 9 CFR 121.14(c)(3)
provide that the responsible official for the recipient must notify the
agency authorizing the transfer (either APHIS or CDC) and the sender
upon receipt of the agent or toxin by mailing or faxing a completed
APHIS Form 2041 to APHIS or CDC within 2 business days.
Furthermore, 7 CFR 331.13(c)(4) and 9 CFR 121.14(c)(4) provide that
the recipient must notify APHIS or, for overlap agents, APHIS or CDC,
immediately if the agent or toxin has not been received within 48 hours
after the expected delivery or if the package containing the agent or
toxin is leaking or has been damaged.
Finally, both 7 CFR 331.13(d) and 9 CFR 121.14(d) provide that the
sender must comply with all applicable laws governing packaging and
shipping.
Although not contained in this interim rule, pursuant to section
212(b) of the Act, we note that APHIS has incident response procedures
in place to protect animal and plant health and animal and plant
products in the event of a transfer or potential transfer in violation
of the safety procedures and safeguard and security measures
established by these regulations. Generally, these incident response
procedures consist of coordinating with appropriate Federal, State, and
local agencies; communicating with stakeholders, industry partners, and
diagnostic laboratories about the potential threat; elevating
surveillance; and communicating with international agencies, if
necessary.
Records
The recordkeeping requirements in 7 CFR 331.14 and 9 CFR 121.15 are
designed to document an entity's compliance with the regulations and to
satisfy the investigational needs of APHIS and the Attorney General, in
accordance with section 212 of the Act. In 7 CFR 331.14 and 9 CFR
121.15, we provide that the responsible official must maintain complete
records of information necessary to give an accounting of all of the
activities related to agents or toxins listed in Sec. Sec. 331.3 and
121.3, respectively. Such records must include the Biocontainment and
Security Plan or the Biosafety and Security Plan, as applicable; a
current list of all individuals with access to agents or toxins;
training records for such individuals; accurate and current inventory
records (including source and characterization data); permits and
transfer documents (APHIS Form 2041) issued by APHIS or, for overlap
agents and toxins, APHIS or CDC; security records (e.g., transactions
from automated access control systems, testing and maintenance of
security systems, visitor logs); and biosafety, containment, and
security incident reports.
We require that the responsible official maintain such records for
3 years and produce such records, upon request, to APHIS or CDC
inspectors, and appropriate Federal, State, or local law enforcement
authorities.
Inspections
Section 212(f) of the Act provides that the Secretary shall have
the authority to inspect persons to ensure compliance with the
regulations, including prohibitions on restricted persons and other
provisions of subsection 212(e) of the Act. Accordingly, in 7 CFR
331.15(a) we require that any APHIS inspector be allowed, without
previous notification, to enter and inspect the entire premises, all
materials and equipment, and all records required to be maintained by
the regulations. Likewise, in 9 CFR 121.16(a) we require that any APHIS
or CDC inspector be allowed to conduct such inspections.
As previously noted, APHIS may inspect and evaluate the premises
and records prior to issuing a certificate of registration in order to
ensure compliance with the regulations (7 CFR 331.15(b) and 9 CFR
121.16(b)). APHIS or CDC may conduct such inspections for overlap
agents or toxins. Once registered, inspections of the premises and
records will be conducted to ensure compliance with the regulations.
Notification in the Event of Theft, Loss, or Release
The Act specifically requires notification in the event of theft,
loss, or release of a biological agent or toxin. Therefore, 7 CFR
331.16(a) and 9 CFR 121.17(a) provide that the responsible official
must orally notify APHIS and appropriate Federal, State, and local law
enforcement agencies immediately upon discovery of the theft or loss of
agents or toxins listed in Sec. Sec. 331.3 and 121.3, respectively.
The regulations further provide that the oral notification must be
followed by a written report within 7 days. We are allowing 7 days for
the submission of the written report to give the responsible official
ample time to compile information and investigate the theft or loss in
order to provide a more detailed report.
Similarly, 7 CFR 331.16(b) and 9 CFR 121.17(b) provide that the
responsible official must orally notify APHIS immediately upon
discovery that a release of a listed agent or toxin has occurred
outside of the biocontainment area. As with notification of theft or
loss, the regulations provide that oral notification of a release must
be followed by a written report within 7 days. The regulations further
provide that APHIS will notify relevant Federal, State, and local
authorities, and the public, if necessary. In Sec. 121.17(b), we
additionally provide that, if the release involves an overlap agent or
toxin, we will also notify the Secretary of Health and Human Services.
Administrative Review
Section 212(e)(7)(A)(i) of the Act states that the regulations
shall provide for an opportunity for review by the Secretary, when
requested by the individual involved, of a determination to deny that
individual access to listed agents or toxins and, when requested by the
person involved, of a determination to deny or revoke registration for
that person.
Accordingly, both 7 CFR 331.17 and 9 CFR 121.18 provide that an
individual
[[Page 76920]]
or entity may appeal a denial or revocation of registration. An
individual who has been denied access to listed agents or toxins or who
has been granted only limited access to listed agents or toxins may
appeal that decision. We note that an entity may not appeal the denial
or limitation of an individual's access to listed agents or toxins.
Both 7 CFR 331.17 and 9 CFR 121.18 provide that the appeal must be
in writing and submitted to the Administrator within 30 days of the
decision. The appeal must state all of the facts and reasons upon which
the individual or entity disagrees with the decision. Where the denial
or revocation of registration or the denial or limitation of an
individual's access approval is based solely upon an identification by
the Attorney General, APHIS will forward the request for review to the
Attorney General to review.
In accordance with section 212(e)(7)(A)(iii), the decision of the
Administrator constitutes final agency action for purposes of 5 U.S.C.
702.
Section 212(e)(7)(A)(ii) of the Act provides that the Secretary,
during a review of a determination, may consider information relevant
to the review ex parte to the extent that disclosure of the information
could compromise national security or an investigation by any law
enforcement agency.
Civil and Criminal Penalties
While not reflected in the regulations, we note that the Act
provides for civil and criminal penalties for violations of the
regulations. Under section 212(i) of the Act, any person who violates
any provision of these regulations will be subject to a civil money
penalty, in addition to any other penalties that may apply under law.
The civil money penalty shall not exceed $250,000 for an individual and
$500,000 for any other person.
Section 231 of the Act sets out the criminal penalties for
violations of the regulations. Section 231(b)(2) of the Act provides
that whoever transfers a biological agent or toxin to a person who the
transferor knows or has reasonable cause to believe is not registered
shall be fined or imprisoned for no more than 5 years, or both.
Similarly, section 231(c)(2) provides that whoever knowingly possesses
a biological agent or toxin without registering under the regulations
shall be fined or imprisoned no more than 5 years, or both.
Immediate Action
Immediate action is necessary in order for USDA to comply with the
requirements of Title II, subtitle B, of Pub. L. 107-188, which
requires the publication of this interim rule not later than December
9, 2002. Under these circumstances, the Administrator has determined
that prior notice and opportunity for public comment are contrary to
the public interest.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register. The document
will include a discussion of any comments we receive and any amendments
we are making to the rule.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
For this rule, we have prepared an economic analysis. The economic
analysis provides a cost-benefit analysis as required by Executive
Order 12866, as well as an analysis of the potential economic effects
of this proposed rule on small entities, as required under 5 U.S.C.
603. The economic analysis is summarized below. Copies of the full
analysis are available by contacting the person listed under For
Further Information Contact.
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107-188), the Secretary of Agriculture is
required to provide by regulation for the establishment and enforcement
of standards and procedures governing the possession and use of the
listed biological agents and toxins; the establishment and enforcement
of safety requirements for the transfer of listed agents and toxins;
the establishment and enforcement of safeguard and security measures to
prevent access to listed agents and toxins for use in domestic or
international terrorism or other criminal purpose; and the
establishment of procedures to protect animal and plant health, and
animal and plant products, in the event of a transfer in violation of
the established safety and security measures. For the Health and Human
Services Department (HHS), CDC is taking similar measures related to
biological agents and toxins that have the potential to adversely
affect human health or human and animal health.
Small Entities
The Regulatory Flexibility Act requires that agencies specifically
consider the economic effects of their rules on small entities. The
entities most likely to be affected by this rule are those laboratories
and other institutions conducting research and related activities that
involve the use of listed biological agents and toxins. Most affected
entities (other than Federal or State governmental entities) would be
considered part of North American Industrial Classification System
(NAICS) code 541710, ``Research and Development in the Physical,
Engineering, and Life Sciences.'' Some affected entities would be
considered part of NAICS 541940, ``Veterinary Services;'' NAICS 611310,
``Colleges, Universities and Professional Schools;'' NAICS 325412,
``Pharmaceutical Preparation Manufacturing;'' NAICS 325413, ``In-Vitro
Diagnostic Substance Manufacturing;'' and NAICS 325414, ``Biological
Product (except Diagnostic) Manufacturing.''
The Small Business Administration (SBA) has established guidelines
for determining when establishments are to be considered ``small''
under the Regulatory Flexibility Act. An entity in NAICS 541710,
325413, or 325414 is considered to be a small entity if it has 500 or
fewer employees; for NAICS 325412, that threshold is 750 or fewer
employees. An entity in NAICS 611310 is considered small with annual
receipts/revenues of $6 million or less.
According to the 1997 Economic Census, no less \1\ than 95 percent
of life sciences research and development establishments subject to
Federal income tax, and no less than 92 percent of those establishments
not subject to Federal income taxes, can be considered small. More than
99 percent of ``biological (except diagnostic) manufacturing''
establishments, more than 98 percent of ``diagnostic manufacturing''
establishments, and at least 94 percent of ``pharmaceutical
manufacturing'' establishments are considered small. The economic
census does not contain information on the establishment size of
veterinary service entities. According to data from the U.S. Department
of Education, about 31 percent of reporting postsecondary institutions
had revenue of less than $6 million in fiscal year 1995-96.
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\1\ The establishment size breakdown in the economic census does
not precisely fit the SBA guidelines.
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Benefits of the Rule
Benefits associated with this rule are the avoided losses to
animals or plants that could be attacked by these organisms, and their
products and markets. Losses include reduction in
[[Page 76921]]
yield and productivity of affected hosts, public and private control
costs, and loss in export revenue due to trade embargoes. The listed
agents and toxins include viruses, bacteria, and fungi that potentially
pose a severe threat to plant health or plant products. The listed
pathogens could threaten a number of important crops including citrus,
corn, potatoes, rice, stone fruit, and soybeans. In 2001, soybean
production alone was valued at more than $12 billion. The rule also
covers biological agents and toxins that have been determined to have
the potential to pose a sever threat to both human and animal health,
to animal health, or to animal products. Paragraph (b) of 9 CFR 121.2
lists 21 overlap agents and toxins. This list was drawn from CDC's list
of select agents, the overlap being those select agents that pose a
risk to both human and animal health. The 23 agents and toxins listed
in 9 CFR 121.2(d) include the causative agents of 14 of the 15 diseases
classified by the Office International des Epizooties (OIE) as ``List
A'' diseases. (The causative agent of the fifteenth List A disease,
Rift Valley fever, is an overlap agent listed in the above part.) List
A diseases are, according to OIE, those transmissible diseases that
have the potential for very serious and rapid spread, irrespective of
national borders, that are of serious socioeconomic or public health
consequence and that are of major importance in the international trade
of animals and animal products. Five of the remaining nine agents and
toxins are OIE List B diseases, i.e., transmissible diseases that are
considered to be of socioeconomic and/or public health importance
within countries and that are significant in the international trade of
animals and animal products. The three remaining diseases/disease
agents--two restricted foreign animal pathogens and one emerging
paramyxovirus--were included on the list based on the determination
that they potentially pose a severe threat to animal health or animal
products.
The costs associated with outbreaks can be very high as is
demonstrated by natural outbreaks that have occurred. For example, it
has been estimated that the losses to agriculture and the food chain
from the recent FMD outbreak in the United Kingdom, including the costs
compensated by the government amount to about [pound]3.1 billion ($4.7
billion). In 1999, Ekboir estimated the potential impacts of an FMD
outbreak in California alone at between $8.5 and $13.5 billion.\2\
Also, a BSE crisis occurred in the UK (which has a cattle industry
about 1/10 the size of that in the United States) in 1996. It has been
estimated \3\ that the total resource costs to the UK economy as a
result of BSE in the first 12 months after the onset of the 1996 crisis
were in the range of [pound]740 million to [pound]980 million ($1.2
billion to $1.5 billion), or just over 0.1 percent of the gross
domestic product of the United Kingdom. In addition to these losses,
the UK lost its entire export market for beef following the crisis.
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\2\ Ekboir, J.M., ``Potential impact of foot-and-mouth disease
in California: The role and contribution of animal health
surveillance and monitoring services.'' Davis, CA: Agricultural
Issues Center, Division of Agriculture and Natural Resources,
University of California, Davis, 1999.
\3\ DTZ Pieda Consulting, ``Economic Impact of BSE on the UK
economy.'' A Report commissioned by the UK Agricultural Departments
and HM Treasury.
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The above cited consequences relate to natural or accidental
introduction. Deliberate introduction greatly increases the probability
of an agent or toxin becoming established and causing wide-ranging and
devastating impacts on the economy, disruption to society, diminished
confidence in public and private institutions, and possible loss of
life. The perpetrators would have the advantage of controlling the time
of introduction of the agent, introducing agents into remote or highly
susceptible areas, multiple introductions of the same agent, or
simultaneous release of different agents. Intentional introductions
permit an increased probability of survival of a pathogen, the use of
highly virulent strains and high concentrations of inoculum, and
precise timing of release to coincide with maximal colonization
potential.\4\
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\4\ National Research Council.
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Costs of the Rule
Facilities that possess listed agents and toxins will be affected
by this rule. Those facilities are primarily research and diagnostic
facilities. They include Federal, State, and university laboratories,
and commercial enterprises.
Because affected entities vary widely and the information needed to
determine an individual facility's biosafety, containment and physical
security situation will not be available until the registration process
occurs, information on specific necessary changes at any individual
facility and thus those costs are not available. However, some general
observations regarding the potential costs can be made.
Affected Entities
There are approximately 33 academic, commercial, and State and
Federal government facilities that have indicated their possession of
listed plant pathogens and thus affected by this rule. This information
was obtained from the notifications received by Plant Protection and
Quarantine, APHIS-USDA.
In addition, there are approximately 619 commercial diagnostic
facilities, university research and diagnostic facilities, State and
Federal diagnostic and research facilities, and others in possession of
animal and/or overlap agents or toxins that are expected to be affected
by this rule.\5\
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\5\ As of October 18, 2002, 1,653 entities had submitted
notifications that they possess biological agents or toxins
affecting animals and/or humans listed by either USDA or HHS. In
this analysis, we use 1,653 entities. In coordination with CDC, we
assumed that those facilities with animal agents and those with
animal and overlap agents will be affected by the APHIS rule. Those
facilities with human agents and those human and overlap agents were
assumed to be affected by the CDC rule. About one-half of those
facilities with only overlap agents were assumed to be affected by
the APHIS rule (50 percent of facilities with only overlaps, except
all medical practices which were attributed to the CDC rule and all
veterinary practices which were attributed to the APHIS rule).
Facilities with both animal and human agents were considered in both
analyses. This may cause some double counting if entities with both
animal and human agents do not also have separate laboratories for
that work. Numbers provided by Ed Gaunt, ASI--contractor collecting
and compiling notification information.
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The facilities that deal with listed plant agents and toxins are
academic institutions, commercial diagnostic and research facilities,
and State and Federal Government facilities. Almost 60 percent of the
affected facilities are academic and almost 30 percent government. The
affected facilities tend to be small.
The facilities that deal with animal and overlap agents are
academic, commercial, government, non-profit, and other. Twenty-nine
percent of the facilities with listed agents and toxins are identified
academic institutions, 45 percent as private commercial or non-profit
entities, and 15 percent as government. The remaining 11 percent are
not identified, but include veterinary practices. Animal and overlap
agents are used primarily in diagnostic work and research.
The level of security at the facilities dealing with listed agents
and toxins is currently very diverse, ranging from a locked freezer to
a lock on the door to razor wire perimeter fencing, a guard post, locks
or coded entry, and visitor escorts.
Exemptions From the Rule
Clinical and diagnostic laboratories are specifically exempted from
the provisions of the regulations for possessing, using, or
transferring animal
[[Page 76922]]
or overlap agents or toxins that are contained in specimens presented
for diagnosis or verification, and for agents that are contained in
specimens presented for proficiency testing; provided that the
facilities follow the requirements on disposal, transfer and
notification. Facilities that handle fixed tissues that are, bear, or
contain listed animal agents or toxins will be exempt from the
registration requirements, provided that a permit has been issued to
the facility under 9 CFR part 122. In addition, the Secretary may grant
exemptions from the applicability of the regulations as they apply to
animal only and plant agents and toxins if the Secretary determines
that such exemptions are consistent with protecting animal and plant
health, and animal and plant products. Registered diagnostic
laboratories will also be required to report identifications of listed
agents and toxins when presented for diagnosis. APHIS expects to
receive 1,000 required notifications of identification and 250
exemption applications in a given year. It is estimated that complying
with the exemption requirements will cost $72 per notification and $84
per exemption application.\6\
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\6\ Based on Bureau of Labor Statistics data. Labor rates used
are the same as used by CDC in their analysis of listed agents and
toxins. See Supporting Statement for Information Collection Request
``Part 73--Select Biological Agents and Toxins'' for CDC rule
covering 42 CFR part 73.
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Registration
Under this rule, unless exempted a person or facility shall not
possess, use, or transfer any listed agent or toxin without a
certificate of registration issued by APHIS or CDC. The registration
process is designed to obtain critical information concerning persons
or facilities in possession of certain agents or toxins, as well as the
specific characteristics of the agents and toxins. Information to
determine that persons seeking to register have a lawful purpose to
possess, use, or transfer agents or toxins will also be required as
part of the registration process. This will involve security risk
assessments by the U.S. Department of Justice, and collecting and
providing the required information. Also as a condition of
registration, a Biocontainment and Security Plan or Biosafety and
Security Plan must be developed. It is estimated that it will cost
between $414 and $778 per facility to collect and provide the required
information. Registration amendments are expected to cost $86 each. In
addition, it is estimated that re-applying for registration will cost
$299 to $459 for those facilities to re-apply, as the registration is
valid for up to 3 years.\7\ It is estimated that the development of the
biosafety/biocontainment plan will cost $2,777 at those facilities
needing one. The security plan should be covered in the facility
security assessment below. Complying with inactivation requirements is
estimated to cost $43 per notification.
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\7\ Registrations will be valid for up to 3 years. It is
estimated that approximately two-thirds of all facilities will be
required to reapply within the first 3 years.
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Transfer
Under this rule, listed biological agents and toxins may only be
transferred to persons registered to possess, use, or transfer that
particular agent or toxin. However, the sender may be an individual or
facility exempt from the requirements of this rule, or an individual or
facility located outside the United States. Transfer must occur only
with prior authorization, notification of receipt by the recipient, and
notification of overdue or damaged shipments. It is estimated that
complying with these requirements will cost $124 for each of an
expected 6,520 transfers in a year.
Biosafety and Containment Procedures
Biosafety and containment requirements ensure that the combination
of work practices and physical containment are proportional to the risk
associated with the agent or toxin. USDA permits dealing with the
listed agents and toxins already required the biosafety and containment
level commensurate with the risk associated with the pathogen covered
in the permit or registration. Therefore, to the extent that affected
entities are already permittees, the biosafety and containment
requirements of this rule will have already been required at those
facilities. There are almost 400 individual permittees with listed
agents and toxins representing an unknown number of facilities.\8\ In
addition, some portion of the potentially affected entities will be
exempt from the requirements of this rule, and therefore not affected
by the biosafety requirements.
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\8\ Because of the data on notification of possession of listed
agents and toxins, we cannot directly link permittees to facilities.
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Physical Security Procedures
This rule will require that any facility where listed agents and
toxins are held adequately provide for the physical security of the
premises. This rule does not specify how security needs are to be met,
only that they are adequate. Because the current level of security is
very diverse, physical security components may have to be added in
various quantities (including none) to meet the specific security needs
of a given facility.
An example of security spending at USDA laboratories shows security
upgrades at NVSL in Ames, IA, completed in 2002 cost $550,077 ($6.63/
ft2, 83,000 ft2 total area). Installations of
electronic security components can include closed-circuit television
(CCTV) (e.g., cameras, VCR, and control equipment), intrusion detection
system (access-control card readers, card-keys, operating computer and
software), all cabling associated with the security system, and
integrating the system with the off-site monitoring. Other security
related expenses that could be needed at a given facility included a
facility security assessment (to prepare the security plan required in
the rule) and entry control equipment (x-ray, metal detectors). Other
features would entail yearly recurring costs (i.e., off-site
monitoring, an equipment maintenance agreement, and guard service).
The average cost per square foot of electronic portion of security
for budget purposes ranges from $6.25/ft2 for facilities
under 80,000 ft2 to $8.33/ft2 for facilities in
excess of 150,000 ft2. This is based on average actual
security system installations for APHIS facilities, and includes CCTV,
intrusion detection systems, integration, perimeter protection, design,
construction, and construction management, but not biometric
technology, and assumes single-story facilities and has been adjusted
for laboratory-type facilities.
This rule will require that all information resources related to
listed biological agents and toxins have an appropriate level of
protection in the system that is used to acquire, store, manipulate,
manage, move, control, display, switch, interchange, receive or
transmit that information. Most affected entities have a variety of
compelling reasons, including regulatory requirements, for already
protecting information.
Other Costs
Other costs associated with this rule include the costs of any
additional training that may occur, record keeping, complying with the
requirements for theft/loss/release notification, and appealing
rulings. It is estimated that yearly recordkeeping will cost from $450
to $1,499 per registered facility. It is estimated that theft, loss,
and release reporting will cost $72 for each occurrence. It is
estimated that appeal requirements will cost $311 for each
[[Page 76923]]
occurrence, and that the requests for expedited reviews will cost $43
each.
Costs to APHIS
Costs to APHIS that may be incurred as a result of the rule include
the cost for processing facility registrations, notifications of
identification of agents and toxins, exemption applications, transfer
applications, theft/loss/release notifications and appeals, and
performing facility inspections. It is estimated that APHIS will incur
costs associated with this rule of as much as $1.5 million in the first
year. Paperwork processing will cost APHIS $744,705 per year. In
addition, APHIS may incur costs associated with providing technical
assistance on compliance with this rule. Inspections are expected to
cost between $240 and $997 per facility and occur every 3 years along
with registration, or $156,000 to $650,000 for all facilities.
Additional inspector training to cover the needs of this rule may be
needed as well. The cost may be similar to the current level. In 2002,
APHIS spent $35,480 on inspector training. Background checks or
security clearances for all inspectors could be expected to cost
$45,000. User fees to offset government costs will not be collected by
APHIS under this rule.
Potential Impact of This Rule
Approximately 70 percent of research and development (commercial
and non-profit laboratories dealing with human, animal, and plant
agents), biological (except diagnostic) manufacturing, diagnostic
manufacturing, pharmaceutical manufacturing, and other private
establishments affected by this rule have fewer than 20 employees, and
another 15 percent have between 20 and 49 employees.\9\ Plant
laboratories (Federal, commercial, non-profit, and academic) tend to be
very small with fewer than 10 persons having access to the agents or
toxins. Veterinary diagnostic laboratories (commercial, State or
university) and university research laboratories likely have fewer than
100 employees.\10\ Federal facilities covered by the rule will be
affected by the registration requirements but should not have to make
alterations due to the biosafety, containment and security requirements
of this rule because they already must meet or exceed the requirements
of this rule. In addition, an unknown portion of facilities will be
exempt from the provisions of the rule. The level of security at the
facilities dealing with listed agents and toxins is currently very
diverse, ranging from a lock on the door to razor wire perimeter
fencing, a guard post, locks or coded entry and visitor escorts.
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\9\ 1997 Economic Census. Department of Commerce, Census Bureau.
\10\ AAVLD provided information on 10 diagnostic laboratories.
These laboratories ranged in size from 11 to 100 employees including
faculty, staff (part- and full-time), and students. In addition, the
AAVLD president estimated that diagnostic labs in general would
likely have between 6 and 80 employees. According to Dr. Denise
Spenser, USDA-APHIS, university research on listed agents likely
involves fewer than 100 persons (3 to 5 principal investigators out
of about 25 faculty members in each of 3 or 4 departments--
microbiology (veterinary microbiology), chemistry, and physiology, 3
to 5 (20 at most) investigators, technicians, and students in each
laboratory).
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For the purpose of assessing the impact of the security
requirements of the rule, we make the following assumptions based on
the available information on the size distribution of the affected
entities:
[sbull] Eighty percent of affected facilities have an area to be
secured of approximately 10,000 ft2;\11\
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\11\ In addition to laboratory space, these facilities can have
offices, conference rooms, administration space, mechanical/
electrical rooms and storage space. The building code allowance for
business use type buildings, which includes laboratories, is 100
ft2 per occupant. We assume that the actual space at
these facilities is 2 to 5 times this allowance. This would cover
facilities with fewer than 50 employees.
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[sbull] Five percent of affected facilities are Federal facilities
and will not need security upgrades as a result of this rule;
[sbull] Fifteen percent of affected facilities have an area to be
secured of approximately 30,000 ft2;\12\ and
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\12\ This space is larger and assumed to be able to house more
than 50 employees.
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[sbull] Because facilities will have varying levels of existing
security, security needs, and methods of meeting those needs, the
average security upgrades in APHIS facilities is used as a proxy for
upgrades at these facilities. (The proxy is based on upgrading to state
of the art equipment, which may or may not be used at a given
facility.)
Using an average budget estimate for upgrading the electronic
portion of a security system of $6.25/ft\2\, a facility with 10,000
ft\2\ to secure by installing electronic security countermeasures would
need to budget $62,500 and a facility with 30,000 ft\2\ to secure would
need to budget $187,500. To obtain an aggregate cost estimate we apply
these budget estimates to the 95 percent of facilities with area to be
secured based on the size of that area. It should be noted that, as
indicated above, utilizing APHIS' costs as a proxy implies that all
facilities have baseline levels of electronic security similar to that
of APHIS facilities and will upgrade to state-of-the-art technology.
However, because the baseline level of security present at each
facility is unknown and ultimate security needs are varied, this may or
may not be the case. A given facility may be exempt and need no
upgrade, may already have adequate security in place, or may need an
upgrade but not to state-of-the-art.
Applying a budget cost of $62,500 to the 80 percent of affected
facilities with 10,000 ft\2\ to secure gives an overall cost of $32.6
million. Applying a budget cost of $187,500 to the 15 percent of
affected entities with 30,000 ft\2\ to secure gives a cost of $18.4
million.
In addition, a facility could need none, some, or all of the
following:
[sbull] Facility security assessment, including developing a
security plan as per the rule; $8.9 million if the 80 percent with
smaller spaces all need a $17,000 assessment and $2.5 million if the 15
percent with larger spaces all need a $25,000 assessment.
[sbull] Entry control equipment; includes x-ray--small unit
($28,000 per unit), x-ray--large unit ($40,000 per unit), and metal
detector(s) ($20,000 per unit). Other features would entail yearly
recurring costs.
[sbull] Yearly recurring costs: Off-site monitoring ($10,000 to
$45,000 per year); an equipment maintenance agreement ($12,000 to
$30,000 per year); and guard service--unarmed ($30.00/hr per security
post), armed ($35.00/hr per security post), and a supervisor ($40.00/
hr).
This rule will involve other costs to the regulated community. It
is estimated that complying with the exemption and notification of
identification requirements will have a total cost of $93,000 per year.
The rule will also involve the costs associated with the registration
requirements. It is estimated that it will cost $315,980 to collect and
provide the required information. Registration amendments are expected
to cost $100,964 in the first year. In addition, it is estimated that
it will cost $214,809 for facilities to collect and provide the
required information for re-application. Complying with the
requirements concerning the transfer of listed agents and toxins could
cost $808,480 per year. The rule could also entail costs for any needed
upgrades to biosafety and containment, and cybersecurity. These costs
are expected to be small. To the extent that affected entities are
already permittees, the biosafety and containment requirements of the
new act will have already been required at those facilities. Affected
entities have a variety of compelling reasons, including legislation,
for already protecting information. The rule also requires that a
biosafety and security plan be developed. It is estimated that the
development of the biosafety portion of the plan could cost
[[Page 76924]]
in total $1.5 million if one-half of the 652 affected facilities need
to develop new plans. The security portion would be developed as part
of the facility security assessment above. It is estimated that
notifications of inactivation would cost $1,376 per year. Other costs
of the rule also include record keeping costs, estimated at $425,265
per year. The estimated total cost associated with notifications of
theft, loss and release of listed agents or toxins is $144 per year.
The estimated total cost associated with appeals under this rule is
estimated to be $311 per year. The estimated total cost associated with
expedited reviews under this rule is estimated to be $14,018 per year.
The costs to APHIS include processing facility registrations,
notifications of identification of agents and toxins, exemption
applications, transfer applications, theft/loss notifications, appeals,
performing facility inspections, and providing technical assistance for
compliance. It is estimated that this will cost as much as $1.5 million
in the first year. Paperwork processing is estimated to cost APHIS
$744,705 per year.\13\ In addition, APHIS may incur costs associated
with providing technical assistance on compliance with this rule.
Facility inspections will occur every 3 years and are estimated to cost
between $240 and $997 each, or between $156,480 and $650,044 for all
registered facilities.\14\ Additional inspector training could cost
$35,480 annually and security clearances $45,000 for all inspectors.
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\13\ Costs to Government for information Collections for Select
Agent Registrations.
\14\ These costs are based on current APHIS user fees for
facility inspections: Biosecurity Level (BSL) 3, a flat $997, and
BSL2 $60 to $80/hr for about 4 hours. Under this rule, users will
not be charged for the inspections and thus the Government will
absorb the cost of those inspections.
Table 1.--Summary of Potential Costs
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Activity One-time costs Recurring costs
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Exemptions from the regulations:
Applications................... ......................................................... $72,000/year.
Notifications of identification ......................................................... $21,000/year.
Registration:
Application.................... $315,980................................................. .........................
