[Federal Register Volume 67, Number 240 (Friday, December 13, 2002)]
[Rules and Regulations]
[Pages 76908-76938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31373]



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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

  Federal Register / Vol. 67, No. 240 / Friday, December 13, 2002 / 
Rules and Regulations  

[[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 [email protected]. 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.

[[Page 76910]]

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

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

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

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

    \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).
---------------------------------------------------------------------------

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

    \12\ This space is larger and assumed to be able to house more 
than 50 employees.
---------------------------------------------------------------------------

    [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
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Activity                                     One-time costs                                            Recurring costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions from the regulations:
    Applications...................  .........................................................  $72,000/year.
    Notifications of identification  .........................................................  $21,000/year.
Registration:
    Application....................  $315,980.................................................  ........................................................
    Renewal........................  .........................................................  $214,809/every 3 years.
    Amendments to registration.....  .........................................................  $100,964/year (first year).
    Biosafety/Biocontainment plan..  $1.5 million.............................................  ........................................................
    Inactivations..................  .........................................................  $1,376.
    Security plan/security           $11.4 million \1\........................................  ........................................................
     assessment.
Transfer...........................  .........................................................  $808,480/year.
Physical security procedures \2\:
    Electronic security (cameras,    $51 million \4\..........................................  ........................................................
     card readers, etc.) \3\.
    Entry control (X-ray, metal      $20,000-$40,000 each (as needed).........................  ........................................................
     detectors).
    Off-site monitoring............  .........................................................  $10,000-$45,000/year (as needed).
    Maintenance agreement..........  .........................................................  $12,000-$30,000/year (as needed).
    Guard service..................  .........................................................  $30-$40/hour (as needed).
Other costs:
    Recordkeeping..................  .........................................................  $425,265/year.
    Theft/loss/release notification  .........................................................  $144/year.
    Appeals........................  .........................................................  $311/year.
    Expedited reviews..............  .........................................................  $14,018/year.
Costs to APHIS:
    Processing paperwork...........  .........................................................  $744,705/year.
    Inspections....................  .........................................................  $156,000-$650,000 every 3 years.
    Inspector training.............  .........................................................  $35,480/year.
    Inspector security clearances..  $45,000..................................................  ........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Assumes $17,000 for small facility, $25,000 for large facility.
\2\ Because security needs are site specific and the rule allows for site specific security solutions, the approaches and applications will be varied.
  Actual additional physical security measures added will vary (including none) based on the current level of security and the specific security needs
  of a given facility.
\3\ Estimate of the aggregate cost is based on an average facility cost per square foot to upgrade to state of the art technology.
\4\ Based on $62,500 for 10,000 ft \2\ (assuming 80 percent of facilities), $187,500 for 30,000 ft \2\ (assuming 15 percent of facilities), and $0 for
  no upgrades (assuming 5 percent of facilities).

    The above is given to provide perspective on the magnitude of the 
potential costs associated with the rule. The facilities covered in 
this rule can and do vary from a small laboratory contained within a 
larger facility to large dedicated buildings to large groups of 
buildings and land. Because security needs are site specific and the 
rule allows for site specific security solutions, the approaches and 
applications will be varied. Physical security measures may have to be 
added in various quantities (including none) to meet the specific 
security needs of a facility. Also, some of the impacts of this rule 
are somewhat offset by previous requirements, funding from other 
sources for upgrades that would otherwise be mandated by this rule, and 
flexibility in the rule that allows for site-specific needs to be met 
in the most cost effective manner possible.

Summary

    While the costs associated with this rule could be considerable, 
some of those impacts are somewhat offset by previous requirements, 
funding from other sources for upgrades that would otherwise be 
mandated by this rule, and flexibility in the rule that allows for site 
specific needs to be met in the most cost effective manner possible. In 
addition, these costs are greatly outweighed by the benefits of 
preventing a deliberate introduction of a listed agent or toxin into 
the United States. Should any listed agent or toxin be intentionally 
introduced, the consequences would be significant as demonstrated by 
natural outbreaks that have occurred.

[[Page 76925]]

Consequences could include costs of eradication efforts, disruption of 
markets, difficulties in sustaining an adequate food and fiber supply, 
and the potential spread of disease infestations over large areas. 
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.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in this interim rule have been 
submitted for emergency approval to the Office of Management and Budget 
(OMB). When OMB notifies us of its decision, we will publish a document 
in the Federal Register providing notice of the assigned OMB control 
number or, if approval is denied, providing notice of what action we 
plan to take.
    We plan to request continuation of that approval for 3 years. 
Please send written comments on the 3-year approval request to the 
following addresses: (1) Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) 
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 comments refer to Docket No. 02-088-1 and send 
your comments within 60 days of publication of this rule.
    This interim rule establishes regulations 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 
products and plant products. Unless specifically exempted under the 
regulations, an individual or entity must register with APHIS or, for 
overlap agents or toxins, APHIS or CDC, in order to possess, use, or 
transfer biological agents or toxins.
    To register, an individual or entity must submit a registration 
application package; develop and implement a Biocontainment and 
Security Plan or Biosafety and Security Plan, as applicable; and 
request access approval for individuals who have been identified as 
having a legitimate need to handle or use listed agents or toxins and 
who have the appropriate training and skills to handle or use such 
agents or toxins.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our information collection and recordkeeping 
requirements. These comments will help us:
    (1) Evaluate whether the information collection is necessary for 
the proper performance of our agency's functions, including whether the 
information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
information collection, including the validity of the methodology and 
assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    For 7 CFR part 331:
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 4.5590 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories and other interested parties who 
possess, use, or transfer agents or toxins deemed a severe threat to 
animal or plant health, or animal or plant products.
    Estimated annual number of respondents: 33
    Estimated annual number of responses per respondent: 4.8787.
    Estimated annual number of responses: 161.
    Estimated total annual burden on respondents: 734.
    For 9 CFR part 121:
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2.56493 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories and other interested parties who 
possess, use, or transfer agents or toxins deemed a severe threat to 
animal or plant health, or animal or plant products.
    Estimated annual number of respondents: 619.
    Estimated annual number of responses per respondent: 15.573.
    Estimated annual number of responses: 9,640.
    Estimated total annual burden on respondents: 24,726.
    (Due to averaging, the total annual burden hours may not equal the 
product of the annual number of responses multiplied by the reporting 
burden per response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this interim rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects

7 CFR Part 331

    Agricultural research, Laboratories, Plant diseases and pests, 
Reporting and recordkeeping requirements.

9 CFR Part 121

    Agricultural research, Animal diseases, Laboratories, Medical 
research, Reporting and recordkeeping requirements.

    Accordingly, we are revising 7 CFR part 331 and 9 CFR part 121 to 
read as follows:

7 CFR Chapter III

PART 331--POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND 
TOXINS

Sec.

[[Page 76926]]

331.0 Effective and applicability dates.
331.1 Definitions.
331.2 Purpose and scope.
331.3 List of biological agents and toxins.
331.4 Exemptions.
331.5 Registration; who must register.
331.6 Registration; general provisions.
331.7 Denial, revocation, or suspension of registration.
331.8 Registration; how to register.
331.9 Responsibilities of the responsible official.
331.10 Restricting access to biological agents and toxins.
331.11 Biocontainment and security plan.
331.12 Training.
331.13 Transfer of biological agents and toxins.
331.14 Records.
331.15 Inspections.
331.16 Notification in the event of theft, loss, or release of a 
biological agent or toxin.
331.17 Administrative review.

    Authority: Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 
647 (7 U.S.C. 8401).


Sec.  331.0  Effective and applicability dates.

    The regulations in this part are effective on February 11, 2003.On 
and after that date, any person possessing, using, or transferring any 
agent or toxin listed in Sec.  331.3 must be in compliance with the 
provisions of this part. However, so as not to disrupt research or 
educational projects involving listed agents or toxins that were 
underway as of the effective date of this part, any person possessing 
such agents or toxins as of the effective date (current possessors) 
will be afforded additional time to reach full compliance with this 
part. Any provision not specifically cited in paragraphs (a) through 
(f) of this section will be applicable as of February 11, 2003. In 
addition, any individual or entity who does not possess listed agents 
or toxins by the effective date of this part, but who wishes to 
initiate a research or educational project prior to November 12, 2003, 
must be in compliance with the provisions of this part that are 
applicable for current possessors at the time of application, as 
provided in paragraphs (a) through (e) of this section.
    (a) During the period from February 11, 2003, to November 12, 2003, 
biological agents or toxins listed in Sec.  331.3 may only be 
transferred to an individual or entity that is not registered under 
this part if the individual or entity has been issued a permit by the 
Administrator under part 330 of this chapter to import or move 
interstate that specific agent or toxin. If an individual or entity has 
not been issued a permit under part 330 of this chapter, the individual 
or entity may apply for a permit. To receive an agent or toxin, an 
individual or entity will also be required to submit APHIS Form 2041, 
in accordance with Sec.  331.13(c). 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 this part.
    (b) By March 12, 2003, the responsible official must submit the 
registration application package as required in Sec.  331.8. In 
addition, the responsible official must submit to 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.
    (c) By April 11, 2003, the responsible official must submit to the 
Attorney General the names and identifying information for all 
individuals whom the responsible official has identified as having 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, as 
required in Sec.  331.10.
    (d) By June 12, 2003, the responsible official must submit to APHIS 
the security section of the Biocontainment and Security Plan required 
in Sec.  331.11.
    (e) By September 12, 2003, the responsible official must implement 
the security section of the Biocontainment and Security Plan, as 
required in Sec.  331.11, and provide security training in accordance 
with 7 CFR 331.12.
    (f) By November 12, 2003, the registration application process must 
be complete and the entity in full compliance with the regulations in 
this part.


Sec.  331.1  Definitions.

    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Attorney General. The Attorney General of the United States or any 
person authorized to act for the Attorney General.
    Biological agent. Any microorganism (including, but not limited to, 
bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious 
substance, or any naturally occurring, bioengineered, or synthesized 
component of any such microorganism or infectious substance, capable of 
causing:
    (1) Death, disease, or other biological malfunction in a human, an 
animal, a plant, or another living organism;
    (2) Deterioration of food, water, equipment, supplies, or material 
of any kind; or
    (3) Deleterious alteration of the environment.
    Centers for Disease Control and Prevention (CDC). The Centers for 
Disease Control and Prevention of the United States Department of 
Health and Human Services.
    Diagnostic laboratory. A laboratory facility that receives 
specimens for the purpose of determining the identities of pests, 
pathogens, contaminants, or causes of disease.
    Entity. Any government agency (Federal, State, or local), academic 
institution, corporation, company, partnership, society, association, 
firm, sole proprietorship, or other legal entity.
    Import. To move into, or the act of movement into, the territorial 
limits of the United States.
    Interstate. 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.
    Permit. A written authorization by the Administrator to import or 
move interstate biological agents or toxins, under conditions 
prescribed by the Administrator.
    PPQ. The Plant Protection and Quarantine Programs of the Animal and 
Plant Health Inspection Service
    Responsible official. 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.
    Specimen. 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.
    State. 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.
    Toxin. The toxic material or product of plants, animals, 
microorganisms (including, but not limited to, bacteria, viruses, 
fungi, rickettsiae, or protozoa), or infectious substances, or a 
recombinant or synthesized molecule, whatever their origin and method 
of production, and includes:
    (1) Any poisonous substance or biological product that may be 
engineered as a result of biotechnology produced by a living organism; 
or

[[Page 76927]]

    (2) Any poisonous isomer or biological product, homolog, or 
derivative of such a substance.
    United States. All of the States.
    USDA. The United States Department of Agriculture.


Sec.  331.2  Purpose and scope.

    (a) This part 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 to plant 
products. The purpose of this part 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.
    (b) Accordingly, this part provides that any individual or entity 
that possesses, uses, or transfers any agent or toxin listed in Sec.  
331.3 must register in accordance with Sec.  331.6. 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. The responsible official must complete and submit the 
registration application package to APHIS. As part of registration, the 
responsible official, the entity, and, where applicable, the individual 
who owns or controls such entity will be subject to a security risk 
assessment by the Attorney General.
    (c) The responsible official is responsible for ensuring compliance 
with the safety procedures in this part, including implementing the 
Biocontainment and Security Plan in accordance with Sec.  331.11, 
providing the proper training to individuals who handle or use agents 
or toxins listed in Sec.  331.3, 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 this part, 
including restricting access to only those individuals who have a 
legitimate need to handle or use agents or toxins and who have been 
approved in accordance with Sec.  331.10, and transferring such agents 
or toxins only to registered individuals or entities in accordance with 
Sec.  331.13.


Sec.  331.3  List of biological agents and toxins.

    (a) The biological agents and toxins listed in this section have 
been determined to have the potential to pose a severe threat to plant 
health or to plant products.

Liberobacter africanus, Liberobacter asiaticus
Peronosclerospora philippinensis
Phakopsora pachyrhizi
Plum pox potyvirus
Ralstonia solanacearum, race 3, biovar 2
Sclerophthora rayssiae var. zeae
Synchytrium endobioticum
Xanthomonas oryzae pv. oryzicola
Xylella fastidiosa (citrus variegated chlorosis strain)

    (b) The Administrator has determined that it would be impractical 
to regulate a biological agent or toxin that is in its naturally 
occurring environment. Therefore, any biological agent or toxin listed 
in this section that is in its naturally occurring environment will not 
be subject to the requirements of this part, provided that the 
biological agent or toxin has not been intentionally introduced, 
cultivated, collected, or otherwise extracted from its natural source.
    (c) The Administrator has determined that biological agents or 
toxins that meet any of the following criteria do not have the 
potential to pose a severe threat to plant health or to plant products. 
Therefore, 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;
    (2) Genetic elements or subunits of listed agents or toxins, if the 
genetic elements or subunits are not capable of causing disease.


Sec.  331.4  Exemptions.


    (a) Diagnostic laboratories \1\ and other entities possessing, 
using, or transferring agents or toxins that are contained in specimens 
presented for diagnosis or verification will be exempt from the 
requirements of this part, provided that:
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    \1\ However, diagnostic laboratories and other persons will 
still be required to obtain a permit under part 330 of this chapter 
in order to import or move interstate any listed agent or toxin.
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    (1) The identification of such agents or toxins is immediately 
reported to the Administrator and to other appropriate authorities when 
required by Federal, State, or local law; and
    (2) Within 7 days after identification, the agents or toxins are 
transferred or inactivated, and APHIS Form 2040 is submitted to the 
Administrator.\2\ During agricultural emergencies or outbreaks, or in 
endemic areas, the Administrator may require less frequent reporting. A 
copy of the completed form must be maintained for 3 years.
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    \2\ A diagnostic laboratory or other person must immediately 
notify APHIS by calling (301) 734-5519. APHIS Form 2040 may be 
obtained by calling (301) 734-5519 or faxing a request to (301) 734-
8700. The form is also available on the Internet at http://www.aphis.usda.gov/ppq/permits. The completed form may be mailed to 
Biological and Technical Services, PPQ, APHIS, 4700 River Road Unit 
133, Riverdale, MD 20737-1236; or faxed to (301) 734-8700.
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    (b) In addition to the exemption provided in paragraph (a) of this 
section, the Administrator may grant a specific exemption upon a 
showing of good cause and upon his or her determination that such 
exemption is consistent with protecting animal or plant health, and 
animal or plant products. An individual or entity that possesses, uses, 
or transfers agents or toxins may request in writing an exemption from 
the requirements of this part. If granted, such exemptions are valid 
for a maximum of 3 years; thereafter, an individual or entity must 
request a new exemption. If a request for exemption is denied, an 
individual or entity may request reconsideration in writing to the 
Administrator. The request for reconsideration must state all of the 
facts and reasons upon which the individual or entity relies to show 
that the exemption was wrongfully denied. The Administrator will grant 
or deny the request for reconsideration as promptly as circumstances 
allow and will state, in writing, the reasons for the decision. If 
there is a conflict as to any material fact, the individual or entity 
may request a hearing to resolve the conflict.\3\
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    \3\ A request for exemption may be mailed to biological and 
Technical Services, PPQ, APHIS, 4700 River road Unit 133, Riverdale, 
MD 20737-1236; or faxed to (301) 734-8700.
---------------------------------------------------------------------------


Sec.  331.5  Registration; who must register.

    (a) Unless exempted under Sec.  331.4, any individual or entity 
that possesses, uses, or transfers any agent or toxin listed in Sec.  
331.3 must register with APHIS.
    (b) Each entity must designate an individual to be its 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 if any questions arise concerning 
the application or subsequent compliance with the regulations in this 
part. 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, in the event that an 
individual applies for and is granted a certificate of registration, 
APHIS will consider the individual to be the responsible official.
    (c) An entity may designate an individual to be an alternate 
responsible official, who may act for the responsible

[[Page 76928]]

official when he/she is unavailable. This individual must have the 
authority and control to ensure compliance with the regulations when 
acting for the responsible official. This individual will also be 
subject to a security risk assessment by the Attorney General as part 
of registration.


Sec.  331.6  Registration; general provisions.

    (a) Unless exempted under this part, an individual or entity shall 
not possess, use, or transfer any agent or toxin listed in Sec.  331.3 
without a certificate of registration issued by APHIS.
    (b) A certificate of registration may be issued upon:
    (1) Approval of the responsible official; the alternate responsible 
official, where applicable; the entity; and, where applicable, the 
individual who controls the entity following a security risk assessment 
by the Attorney General; \4\ and
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    \4\ The security risk assessment of the entity and the 
individual who owns or controls such entity may be waived for 
Federal, State, or local governmental agencies.
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    (2) Approval of the containment and security of the entity. The 
entity's 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, and may inspect and 
evaluate the premises and records to determine compliance with the 
regulations and the 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.
    (c) A certificate of registration will be valid for only the 
specific agents or toxins listed on the certificate 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.
    (d) 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,\5\ changes in the activities 
involving the agent or toxin). The responsible official must 
immediately notify APHIS of such changes in circumstances that occur 
after submission of the application for registration or after receipt 
of a certificate of registration.
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    \5\ Any 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.
---------------------------------------------------------------------------

    (e) If a responsible official wishes to discontinue possessing, 
using, or transferring a particular agent or toxin, the responsible 
official may inactivate the agent or toxin or he/she may transfer the 
agent or toxin to a registered individuals or entities in accordance 
with Sec.  331.12. The responsible official must notify APHIS 5 
business days prior to the planned inactivation so that we may have the 
opportunity to observe the inactivation of the agents or toxins. We 
will notify the responsible official if we wish to observe the 
inactivation of the agents or toxins.
    (f) A certificate of registration will be valid for a maximum of 3 
years.


Sec.  331.7  Denial, revocation, or suspension of registration.

    (a) APHIS may deny an application for registration or revoke 
registration if:
    (1) The Attorney General identifies the responsible official, 
entity, or the individual who owns or controls the entity as within any 
of the categories described in 18 U.S.C. 175b; or
    (2) The Attorney General identifies the responsible official, 
entity, or the individual who owns or controls the entity as reasonably 
suspected by any Federal law enforcement or intelligence agency of:
    (i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
    (ii) Knowing involvement with an organization that engages in 
domestic or international terrorism (as defined in 18 U.S.C. 2331) or 
with any other organization that engages in intentional crimes of 
violence; or
    (iii) Being an agent of a foreign power as defined in 50 U.S.C. 
1801; or
    (3) The responsible official does not have a lawful purpose to 
possess, use, or transfer agents or toxins listed in Sec.  331.3; or
    (4) 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; or
    (5) The entity does not meet the containment and security 
requirements prescribed by the Administrator; \6\ or
---------------------------------------------------------------------------

    \6\ If registration is denied for this reason, we may provide 
technical assistance and guidance.
---------------------------------------------------------------------------

    (6) There are egregious or repeated violations of the containment 
or security requirements; or
    (7) The Administrator determines that such action is necessary to 
protect animal or plant health, and animal or plant products.
    (b) APHIS may summarily revoke or suspend registration for any of 
the reasons set forth in paragraph (a) of this section.
    (c) APHIS will notify the responsible official in writing if an 
application for registration is denied or a certificate of registration 
is revoked or suspended.
    (d) Denial of an application for registration, revocation of 
registration, and suspension of registration may be appealed under 
Sec.  331.16.


Sec.  331.8  Registration; how to register.

    (a) To apply for a certificate of registration, an individual or 
entity 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.
    (b) The registration application package may be obtained by calling 
(301) 734-5519 or faxing a request to (301) 734-8700. It is also 
available on the Internet at http://www.aphis.usda.gov/ppq/permits. The 
completed registration application package may be mailed to APHIS, 
Plant Protection and Quarantine, Biological and Technical Services, 
4700 River Road Unit 133, Riverdale, MD 20737-1236; or faxed to (301) 
734-8700. Assistance in completing the registration application may be 
requested by calling (301) 734-5519.


Sec.  331.9  Responsibilities of the responsible official.

    (a) The responsible official is responsible for ensuring compliance 
with the regulations, including:
    (1) Developing and implementing a Biocontainment and Security Plan 
in accordance with Sec.  331.11;
    (2) Allowing only approved individuals within the entity to have 
access to any agents or toxins listed in Sec.  331.3 in accordance with 
Sec.  331.10;
    (3) Providing appropriate training in containment and security 
procedures for all personnel in accordance with Sec.  331.12;
    (4) Transferring agents or toxins only to registered individuals or 
entities in accordance with Sec.  331.13;
    (5) Ensuring that all visitors are informed of and follow the 
entity's security requirements and procedures;
    (6) Notifying APHIS of changes in circumstances in accordance with 
Sec.  331.6;
    (7) Providing timely notice of any theft, loss, or release of a 
biological agent or toxin in accordance with Sec.  331.16;
    (8) Maintaining detailed records of information necessary to give a 
complete accounting of all of the activities related to agents or 
toxins listed in Sec.  331.3 in accordance with Sec.  331.14.

[[Page 76929]]

    (b) In addition to the requirements in paragraph (a) of this 
section, the responsible official for a diagnostic laboratory or other 
entity possessing, using, or transferring agents or toxins listed in 
Sec.  331.3 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.\7\ During agricultural emergencies or 
outbreaks, or in endemic areas, the Administrator may require less 
frequent reporting.
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    \7\ A diagnostic laboratory or other person must immediately 
notify APHIS by calling (301) 734-5519.
---------------------------------------------------------------------------


Sec.  331.10  Restricting access to biological agents and toxins.

    (a) An individual may not have access to biological agents or 
toxins listed in Sec.  331.3 unless approved by APHIS. APHIS will 
grant, limit, or deny access of individuals to listed agents or toxins.
    (b) The responsible official is responsible for ensuring that only 
approved individuals within the entity have access to any agents or 
toxins listed in Sec.  331.3. 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.
    (c) The responsible official must provide appropriate training in 
containment and security procedures to all individuals with access to 
agents and toxins listed in Sec.  331.3, in accordance with Sec.  
331.12.
    (d) 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.
    (e) In addition, the responsible official must submit information 
about the individual's training and skills to APHIS (e.g., curriculum 
vitae for principal investigators and researchers, and a description of 
training completed by support personnel).
    (f) APHIS may expedite the access approval process for individuals 
upon request by the responsible official and a showing of good cause 
(e.g., agricultural emergencies, national security, impending 
expiration of a research grant, a short-term visit by a prominent 
researcher).
    (g) APHIS will notify the responsible official if an individual is 
granted full or limited access, or denied access to listed agents or 
toxins. APHIS will also notify the individual if he/she is denied 
access or granted only limited access.
    (h) APHIS may deny or limit access of an individual to listed 
agents or toxins if:
    (1) The Attorney General identifies the individual as within any of 
the categories described in 18 U.S.C. 175b;
    (2) The Attorney General identifies the individual as 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;
    (3) The individual does not have a legitimate need to handle listed 
agents or toxins;
    (4) The individual does not have the necessary training or skills 
to handle listed agents or toxins;
    (5) The Administrator determines that such action is necessary to 
protect plant health or plant products.
    (i) An individual may appeal the Administrator's decision to deny 
or limit access under Sec.  331.15.
    (j) Access approval is valid for 5 years; thereafter, the 
responsible official shall request renewal of access approval every 5 
years for as long as the individual needs access to agents or toxins 
listed in Sec.  331.3.
    (k) The responsible official must immediately notify APHIS when an 
individual's access to listed agents or toxins is terminated by the 
entity and the reasons therefor.


Sec.  331.11  Biocontainment and security plan.

    (a) As a condition of registration, an individual or entity must 
develop and implement a Biocontainment and Security Plan.\8\ The 
Biocontainment and Security Plan must contain sufficient information 
and documentation to describe the containment procedures and the 
security systems and procedures. The plan must be commensurate with the 
risk of the agent or toxin, given its intended use.
---------------------------------------------------------------------------

    \8\ Technical assistance and guidance may be obtained by calling 
(301) 734-5519.
---------------------------------------------------------------------------

    (1) Containment procedures. The 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). At 
a minimum, the plan must address containment and inventory control.
    (2) Security systems and procedures.\9\ 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.
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    \9\ For guidance, see the USDA Departmental Manual No. 9610-001, 
``USDA Security Policies and Procedures for Biosafety Level-3 
Facilities'' (August 30, 2002). The manual may be obtained by 
calling (301) 734-5519. The manual is also available on the Internet 
at http://www.usda.gov/ocio/directives/DM/DM9610-001.htm. See also 
Appendix F, ``Biosafety in Microbiological and Biomedical 
Laboratories,'' in Morbidity and Mortality Weekly Report (2002). 
This document may be obtained by writing to Select Agent Program, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE, 
Mail Stop E 79, Atlanta, GA 30333. It is also available on the 
Internet at http://www.cdc.gov/mmwr.
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    (i) The 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.
    (ii) 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 
under paragraph (a)(2)(i) of this section.
    (iii) The plan must describe inventory control procedures, 
personnel suitability for those individuals with access to agents or 
toxins listed in Sec.  331.3, physical security, and cybersecurity. The 
plan must also contain 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; provisions for routine cleaning, 
maintenance, and repairs; and procedures for reporting and removing 
unauthorized persons.
    (iv) 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:
    (A) Allow unescorted access only to approved individuals who are 
performing a specifically authorized function during hours required to 
perform that job;

[[Page 76930]]

    (B) Allow individuals not approved under Sec.  331.10 to conduct 
routine cleaning, maintenance, repairs, and other non-laboratory 
functions only when escorted and continually monitored by approved 
individuals;
    (C) 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;
    (D) Require the inspection of all packages upon entry and exit;
    (E) 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;
    (F) Require that approved individuals do not share with any other 
person their unique means of accessing the area or listed agents or 
toxins; and
    (G) Require that approved individuals immediately report any of the 
following to the responsible official:
    (1) Any loss or compromise of keys, passwords, combinations, etc.;
    (2) Any suspicious persons or activities;
    (3) Any loss or theft of listed agents or toxins;
    (4) Any release of a listed agent or toxin; and
    (5) Any sign that inventory and use records for listed agents and 
toxins have been altered or otherwise compromised.
    (3) Incident response procedures.\10\ The Biocontainment and 
Security Plan must also include incident response plans for containment 
breach, security breach, inventory violations, non-biological incidents 
such as workplace violence, and cybersecurity breach. The incident 
response plans must address containment, inventory control, and 
notification of managers and responders. The incident response plans 
must also address such events as bomb threats, severe weather (floods, 
hurricanes, tornadoes), earthquakes, power outages, and other natural 
disasters or emergencies.
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    \10\ The requirements in this paragraph do not supercede or 
preempt the enforcement of emergency response requirements imposed 
by other statutes or regulations.
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    (b) The Biocontainment and Security Plan must be reviewed, 
performance tested, and updated annually. The plan must also be 
reviewed and revised, as necessary, after any incident.


Sec.  331.12  Training.

    (a) The responsible official must provide appropriate training in 
containment and security procedures to all individuals with access to 
agents and toxins listed in Sec.  331.3.
    (b) 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. The responsible official must provide refresher 
training annually.


Sec.  331.13  Transfer of biological agents and toxins.

    Biological agents and toxins listed in Sec.  331.3 may only be 
transferred to an individual or entity 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 this part, or an individual or entity 
located outside of the United States. Biological agents or toxins may 
only be transferred under the conditions of this section and must be 
authorized by APHIS prior to the transfer.
    (a) Importation and interstate movement. In addition to the permit 
required under part 330 of this chapter, biological agents or toxins 
listed in Sec.  331.3 may be imported or moved interstate only with the 
prior authorization of APHIS. To obtain such authorization, the sender 
and the responsible official for the recipient must complete and submit 
APHIS Form 2041 to APHIS, in accordance with paragraph (c) of this 
section.
    (b) Intrastate movement. Biological agents or toxins listed in 
Sec.  331.3 may be moved intrastate only with the prior authorization 
of APHIS. To obtain authorization, the sender and the responsible 
official for the recipient must complete and submit APHIS Form 2041 to 
APHIS prior to each transfer, in accordance with paragraph (c) of this 
section.
    (c) APHIS Form 2041; process and procedures. (1) Prior to each 
transfer, the sender and the responsible official for the recipient 
must complete APHIS Form 2041, and the sender must submit the form to 
APHIS.\11\
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    \11\ APHIS Form 2041 may be obtained by calling (301) 734-5519 
or faxing a request to (301) 734-8700. The form is also available on 
the Internet at http://www.aphis.usda.gov/ppq/permits. APHIS Form 
2041 may be mailed to Biological and Technical Services, PPQ, APHIS, 
4700 River Road Unit 133, Riverdale, MD 20737-1236; or faxed to 
(301) 734-8700.
---------------------------------------------------------------------------

    (2) 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.
    (3) The responsible official for the recipient entity must notify 
APHIS and the sender upon receipt of the agent or toxin by mailing or 
faxing a completed APHIS Form 2041 within 2 business days.
    (4) The responsible official for the recipient must notify APHIS 
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.
    (d) The sender must comply with all applicable laws governing 
packaging and shipping.


Sec.  331.14  Records.

    (a) The responsible official must maintain complete, up-to-date 
records of information necessary to give an accounting of all of the 
activities related to agents or toxins listed in Sec.  331.3. Such 
records must include the following:
    (1) The Biocontainment and Security Plan;
    (2) A current list of all individuals with access to agents or 
toxins listed in Sec.  331.3;
    (3) Training records for individuals with access to such agents or 
toxins;
    (4) Accurate and current inventory records (including source and 
characterization data);
    (5) Permits and transfer documents (APHIS Form 2041) issued by 
APHIS;
    (6) Security records (e.g., transactions from automated access 
control systems, testing and maintenance of security systems, visitor 
logs); and
    (7) Containment and security incident reports.
    (b) The responsible official must maintain such records for 3 
years.
    (c) All records must be produced upon request to APHIS inspectors, 
and appropriate Federal, State, or local law enforcement authorities.


Sec.  331.15  Inspections.

    (a) To ensure compliance with the regulations, any APHIS inspector 
must be allowed, without previous notification, to enter and inspect 
the entire premises, all materials and equipment, and all records 
required to be maintained by this part.
    (b) Prior to issuing a certificate of registration to an entity or 
individual, APHIS may inspect and evaluate their premises and records 
to ensure compliance with the regulations and the containment and 
security requirements.


Sec.  331.16  Notification in the event of theft, loss, or release of a 
biological agent or toxin.

    (a) The responsible official must orally notify APHIS and 
appropriate Federal, State, or local law enforcement

[[Page 76931]]

agencies immediately upon discovery of the theft or loss of agents or 
toxins listed in Sec.  331.3. The oral notification must be followed by 
a written report (APHIS Form 2043) within 7 days.
    (b) The responsible official must orally notify APHIS immediately 
upon discovery that a release of an agent or toxin has occurred outside 
of the biocontainment area. The oral notification must be followed by a 
written report (APHIS Form 2043) within 7 days. Upon notification and a 
finding that the release poses a threat to animal or plant health, or 
animal or plant products, APHIS will notify relevant Federal, State, 
and local authorities, and the public, if necessary.
    (c) The responsible official must orally notify APHIS of a theft, 
loss, or release of an agent or toxin by calling (301) 734-5519. A copy 
of APHIS Form 2043 may be obtained by writing to Biological and 
Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 
20737-1236, or by calling (301) 734-5519. APHIS Form 2043 may be mailed 
to the same address or faxed to (301) 734-8700.


Sec.  331.17  Administrative review.

    An individual or entity may appeal a denial or revocation of 
registration under this part. 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 under this part may appeal that 
decision.\12\ 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. The 
Administrator's decision constitutes final agency action.
---------------------------------------------------------------------------

    \12\ An entity may not appeal the denial or limitation of an 
individual's access to listed agents or toxins.
---------------------------------------------------------------------------

9 CFR Chapter I

PART 121--POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND 
TOXINS

Sec.
121.0 Effective and applicability dates.
121.1 Definitions.
121.2 Purpose and scope.
121.3 List of biological agents and toxins.
121.4 Exemptions for overlap agents or toxins.
121.5 Exemptions for animal agents and toxins.
121.6 Registration; who must register.
121.7 Registration; general provisions.
121.8 Denial, revocation, or suspension of registration.
121.9 Registration; how to register.
121.10 Responsibilities of the responsible official.
121.11 Restricting access to biological agents and toxins.
121.12 Biosafety and security plan.
121.13 Training.
121.14 Transfer of biological agents and toxins.
121.15 Records.
121.16 Inspections.
121.17 Notification in the event of theft, loss, or release of a 
biological agent or toxin.
121.18 Administrative review.

    Authority: Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 
647 (7 U.S.C. 8401).


Sec.  121.0  Effective and applicability dates.

    The regulations in this part are effective on February 11, 2003. On 
and after that date, any person possessing, using, or transferring any 
agent or toxin listed in Sec.  121.3 must be in compliance with the 
provisions of this part. However, so as not to disrupt research or 
educational projects involving listed agents or toxins that were 
underway as of the effective date of this part, any person possessing 
such agents or toxins as of the effective date (current possessors) 
will be afforded additional time to reach full compliance with this 
part. Any provision not specifically cited in paragraphs (a) through 
(f) of this section will be applicable as of February 11, 2003. In 
addition, any person who does not possess listed agents or toxins by 
the effective date of this part, but who wishes to initiate a research 
or educational project prior to November 12, 2003, must be in 
compliance with the provisions of this part that are applicable for 
current possessors at the time of application, as provided in 
paragraphs (a) through (e) of this section.
    (a) During the period from February 11, 2003, to November 12, 2003, 
biological agents or toxins listed in Sec.  121.3 may only be 
transferred to an individual or entity that is not registered under 
this part if:
    (1) The individual or entity is registered by CDC for that specific 
overlap agent or toxin in accordance with 42 CFR part 72; or
    (2) The individual or entity has been issued a permit by the 
Administrator under part 122 of this subchapter to import or move 
interstate that specific agent or toxin. If an individual or entity has 
not been issued a permit under part 122 of this subchapter, the 
individual or entity may apply for a permit. To receive an agent or 
toxin, an individual or entity will also be required to submit APHIS 
Form 2041, in accordance with Sec.  121.14(c). Because USDA permits do 
not cover intrastate movement, unless registered by CDC under 42 CFR 
part 72, 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 this part.
    (b) By March 12, 2003, the responsible official must submit the 
registration application package as required in Sec.  121.9. In 
addition, the responsible official must submit to 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.
    (c) By April 11, 2003, the responsible official must submit to the 
Attorney General the names and identifying information for all 
individuals whom the responsible official has identified as having 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, as 
required in Sec.  121.11.
    (d) By June 12, 2003, the responsible official must submit the 
security section of the Biosafety and Security Plan required in Sec.  
121.12 to APHIS or, for overlap agents or toxins, to APHIS or CDC.
    (e) By September 12, 2003, the responsible official must implement 
the security section of the Biosafety and Security Plan, as required in 
Sec.  121.12, and provide security training in accordance with 9 CFR 
121.13.
    (f) By November 12, 2003, the registration application process must 
be complete and the entity in full compliance with the regulations in 
this part.


Sec.  121.1  Definitions.

    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Attorney General. The Attorney General of the United States or any 
person authorized to act for the Attorney General.
    Biological agent. Any microorganism (including, but not limited to, 
bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious 
substance, or any naturally occurring, bioengineered, or synthesized 
component of any such microorganism

[[Page 76932]]

or infectious substance, capable of causing:
    (1) Death, disease, or other biological malfunction in a human, an 
animal, a plant, or another living organism;
    (2) Deterioration of food, water, equipment, supplies, or material 
of any kind; or
    (3) Deleterious alteration of the environment.
    Centers for Disease Control and Prevention (CDC). The Centers for 
Disease Control and Prevention of the United States Department of 
Health and Human Services.
    Clinical laboratory. A laboratory facility that receives patients 
and collects specimens for processing or shipping to another 
laboratory.
    Diagnostic laboratory. A laboratory facility that receives 
specimens for the purpose of determining the identities of pests, 
pathogens, contaminants, or causes of disease.
    Entity. Any government agency (Federal, State, or local), academic 
institution, corporation, company, partnership, society, association, 
firm, sole proprietorship, or other legal entity.
    Import. To move into, or the act of movement into, the territorial 
limits of the United States.
    Interstate. 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.
    Overlap agent or toxin. 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).
    Permit. A written authorization by the Administrator to import or 
move interstate biological agents or toxins, under conditions 
prescribed by the Administrator.
    Proficiency testing. 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.
    Responsible official. 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.
    Specimen. 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.
    State. 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.
    Toxin. The toxic material or product of plants, animals, 
microorganisms (including, but not limited to, bacteria, viruses, 
fungi, rickettsiae, or protozoa), or infectious substances, or a 
recombinant or synthesized molecule, whatever their origin and method 
of production, and includes:
    (1) Any poisonous substance or biological product that may be 
engineered as a result of biotechnology produced by a living organism; 
or
    (2) Any poisonous isomer or biological product, homolog, or 
derivative of such a substance.
    United States. All of the States.
    USDA. The United States Department of Agriculture.


Sec.  121.2  Purpose and scope.

    (a) This part 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, to animal health, or to animal products. The purpose of this 
part 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.
    (b) Accordingly, this part provides that any individual or entity 
that possesses, uses, or transfers any agent or toxin listed in Sec.  
121.3 must register in accordance with Sec.  121.7. 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. The responsible official 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 individual who owns or 
controls such entity will be subject to a security risk assessment by 
the Attorney General.
    (c) The responsible official is responsible for ensuring compliance 
with the safety procedures in this part, including implementing the 
Biosafety and Security Plan in accordance with Sec.  121.12, providing 
the proper training to individuals who handle or use agents or toxins 
listed in Sec.  121.3, 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 this part, including restricting 
access to only those individuals who have a legitimate need to handle 
or use agents or toxins and who have been approved in accordance with 
Sec.  121.11, and transferring such agents or toxins only to registered 
individuals or entities in accordance with Sec.  121.13.


Sec.  121.3  List of biological agents and toxins.

    (a) Except as provided in paragraphs (f) and (g) of this section, 
the Administrator has determined that the biological agents and toxins 
listed in this section have the potential to pose a severe threat to 
both human and animal health, to animal health, or to animal products.
    (b) Overlap agents and toxins.

Bacillus anthracis
Botulinum neurotoxins
Botulinum neurotoxin producing species of Clostridium
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei
Burkholderia pseudomallei
Clostridium botulinum
Clostridium perfringens epsilon toxin
Coccidioides immitis
Coxiella burnetii
Eastern equine encephalitis virus
Francisella tularensis
Hendra virus
Nipah virus
Rift Valley fever virus
Shigatoxin
Staphylococcal enterotoxins
T-2 toxin
Venezuelan equine encephalitis virus

    (c) Genetic elements, recombinant nucleic acids, and recombinant 
organisms of overlap agents or toxins:
    (1) Biological agent viral nucleic acids (synthetic or naturally 
derived, contiguous or fragmented, in host chromosomes or in expression 
vectors) that can encode infectious and/or replication competent forms 
of any of the biological agent viruses.
    (2) Nucleic acids (synthetic or naturally derived) that encode for 
the functional form(s) of any of the toxins listed in paragraph (b) of 
this section, if the nucleic acids:
    (i) Are in a vector or host chromosome;
    (ii) Can be expressed in vivo or in vitro; or
    (iii) Are in a vector or host chromosome and can be expressed in 
vivo or in vitro.

[[Page 76933]]

    (3) Viruses, bacteria, fungi, and toxins listed in paragraph (b) of 
this section that have been genetically modified.
    (d) Animal agents and toxins.

African horse sickness virus
African swine fever virus
Akabane virus
Avian influenza virus (highly pathogenic)
Bluetongue virus (exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Cowdria ruminantium (Heartwater)
Foot-and-mouth disease virus
Goat pox virus
Japanese encephalitis virus
Lumpy skin disease virus
Malignant catarrhal fever virus (exotic)
Menangle virus
Mycoplasma capricolum/M. F38/M. mycoides capri (contagious caprine 
pleuropneumonia)
Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia)
Newcastle disease virus (VVND)
Peste des petits ruminants virus
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Vesicular stomatitis virus (exotic)

    (e) The Administrator has determined that it would be impractical 
to regulate a biological agent or toxin that is in its naturally 
occurring environment. Therefore, any biological agent or toxin listed 
in this section that is in its naturally occurring environment will not 
be subject to the requirements of this part, provided that the 
biological agent or toxin has not been intentionally introduced, 
cultivated, collected, or otherwise extracted from its natural source.
    (f) The Administrator has determined that biological agents or 
toxins that meet any of the following 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 
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 or fixed tissues that are, bear, or contain 
agents or toxins listed in this section.\1\
---------------------------------------------------------------------------

    \1\ However, the importation and interstate movement of these 
genetic elements or subunits of listed agents or toxins are still 
subject to the permit requirements under part 122 of this 
subchapter.
---------------------------------------------------------------------------

    (2) Genetic elements or subunits of agents or toxins listed in 
paragraph (d) of this section, if the genetic elements or subunits are 
not capable of causing disease.\2\
---------------------------------------------------------------------------

    \2\ See footnote 1.
---------------------------------------------------------------------------

    (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.
    (g) Attenuated strains. Attenuated strains of biological agents 
listed in this section may not have the potential to pose a severe 
threat to both human and animal health, to animal health, or to animal 
products. Thus, an individual or entity may request review by the 
Administrator to determine whether 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.
    (1) 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, an individual or entity will not be subject 
to the requirements of this part. This determination will be limited to 
the specific attenuated strain and to the specific activities involving 
that attenuated strain.
    (2) An individual or entity may request a review by writing to the 
Administrator or, for overlap agents, by writing to the Administrator 
or CDC.\3\
---------------------------------------------------------------------------

    \3\ A request to review an attenuated strain may be mailed to 
National Center for Import and Export, VS, APHIS, 4700 River Road 
Unit 40, Riverdale, MD 20737-1231; or faxed to (301) 734-3652. For 
overlap agents, a request for review may be mailed to the above 
address or to Select Agent Program, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE, Mail Stop E 79, Atlanta, GA 
30333; or faxed to (404) 498-2265.
---------------------------------------------------------------------------

    (3) If it is determined that a specific attenuated strain does not 
pose a severe threat, APHIS or CDC will notify the applicant and 
publish a notice in the Federal Register.
    (4) An individual or entity may request reconsideration of an 
adverse decision in writing to the Administrator. The request for 
reconsideration must state all of the facts and reasons upon which the 
individual or entity relies upon to show the decision was incorrect. 
The Administrator will grant or deny the request for reconsideration as 
promptly as circumstances allow and will state, in writing, the reasons 
for the decision. If there is a conflict as to any material fact, the 
individual or entity may request a hearing to resolve the conflict.


Sec.  121.4  Exemptions for overlap agents or toxins.

    (a) 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 this part, provided that:
    (1) The identification of such agents or toxins is immediately 
reported to APHIS or CDC, and to other appropriate authorities when 
required by Federal, State, or local law; and
    (2) Within 7 days after identification, the agents or toxins are 
transferred or inactivated, and APHIS Form 2040 is submitted to APHIS 
or CDC.\4\ During agricultural emergencies or outbreaks, or in endemic 
areas, the Administrator may require less frequent reporting. A copy of 
the completed form must be maintained for 3 years.
---------------------------------------------------------------------------

    \4\ A clinical or diagnostic laboratory, or other entity, may 
immediately notify APHIS by faxing (301) 734-3652. APHIS Form 2040 
may be obtained by calling APHIS at (301) 734-3277 or by calling CDC 
at (404) 498-2265. The form is also available on the Internet at 
http://www.aphis.usda.gov/vs/ncie.bta.html or http://www.cdc.gov/od/ohs/lrsat.htm. The completed form may be mailed or faxed to APHIS or 
CDC, as provided in footnote 3.
---------------------------------------------------------------------------

    (b) 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 this part, provided that:
    (1) The identification of such agents or toxins, and their 
derivatives, is immediately reported to the APHIS or CDC, and to other 
appropriate authorities when required by Federal, State, or local law; 
and
    (2) Within 90 days of receipt, the agents or toxins are transferred 
or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. A 
copy of the completed form must be maintained for 3 years.
    (c) Unless the Administrator by order determines that additional 
regulation of a specific product is necessary to protect animal or 
plant health, or animal or plant products, an individual or entity 
possessing, using, or transferring products that are, bear, or contain 
overlap 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.).
    (d) An individual or entity possessing, using, or transferring 
investigational products that are, bear, or contain

[[Page 76934]]

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 or plant 
health, and animal or plant products.
    (1) 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.
    (2) For investigational products authorized under any of the 
Federal laws specified in paragraph (c) of this section, 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.
    (e) The Administrator may exempt an individual or entity from the 
requirements of this part, 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.
    (f) Upon request of the Secretary of Health and Human Services, the 
Administrator may exempt an individual or entity from the requirements 
of this part, 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.


Sec.  121.5  Exemptions for animal agents and toxins.

    (a) Diagnostic laboratories and other entities possessing, using, 
or transferring agents or toxins that are contained in specimens 
presented for diagnosis or verification will be exempt from the 
requirements of this part, provided that:
    (1) The identification of such agents or toxins is immediately 
reported to the Administrator and to other appropriate authorities when 
required by Federal, State, or local law; and
    (2) Within 7 days after identification, the agents or toxins are 
transferred or inactivated, and APHIS Form 2040 is submitted to the 
Administrator.\5\ During agricultural emergencies or outbreaks, or in 
endemic areas, the Administrator may require less frequent reporting. A 
copy of the completed form must be maintained for 3 years.
---------------------------------------------------------------------------

    \5\ A diagnostic laboratory or other entity must immediately 
notify APHIS by faxing (301) 734-3652. APHIS Form 2040 may be 
obtained by calling (301) 734-3277. The form is also available on 
the Internet at http://www.aphis.usda.gov/vs/ncie.bta.html. The 
completed form may be mailed to National Center for Import and 
Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-
1231; or faxed to (301) 734-3652.
---------------------------------------------------------------------------

    (b) Diagnostic laboratories and other entities possessing, using, 
or transferring agents or toxins that are contained in specimens 
presented for proficiency testing will be exempt from the requirements 
of this part, provided that:
    (1) The identification of such agents or toxins, and their 
derivatives, is immediately reported to the Administrator, and to other 
appropriate authorities when required by Federal, State, or local law; 
and
    (2) Within 90 days of receipt, the agent or toxins are transferred 
or inactivated, and APHIS Form 2040 is submitted to the Administrator. 
A copy of the completed form must be maintained for 3 years.
    (c) 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 this 
part.
    (d) Unless the Administrator by order determines that additional 
regulation is necessary to protect animal health or animal products, an 
individual or entity possessing, using, or transferring products that 
are, bear, or contain listed 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.).
    (e) An individual or entity possessing, using, or transferring 
experimental products that are, bear, or contain listed 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 or plant health, and animal or plant 
products. An individual or entity possessing, using, or transferring 
such experimental products may apply for an exemption from the 
requirements of this part by submitting APHIS Form 2042 to APHIS.
    (f) In addition to the exemptions provided in paragraphs (a) 
through (e) of this section, the Administrator may grant a specific 
exemption upon a showing of good cause and upon his or her 
determination that such exemption is consistent with protecting animal 
health and animal products. An individual or entity that possesses, 
uses, or transfers agents or toxins may request in writing an exemption 
from the requirements of this part. If granted, such exemptions are 
valid for a maximum of 3 years; thereafter, an individual or entity 
must request a new exemption. If a request for exemption is denied, an 
individual or entity may request reconsideration in writing to the 
Administrator. The request for reconsideration must state all of the 
facts and reasons upon which the individual or entity relies to show 
that the exemption was wrongfully denied. The Administrator will grant 
or deny the request for reconsideration as promptly as circumstances 
allow and will state, in writing, the reasons for the decision. If 
there is a conflict as to any material fact, the individual or entity 
may request a hearing to resolve the conflict.\6\
---------------------------------------------------------------------------

    \6\ A request for exemption may be mailed to National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 
20737-1231; or faxed to (301) 734-3652.
---------------------------------------------------------------------------


Sec.  121.6  Registration; who must register.

    (a) Unless exempted under Sec. Sec.  121.4 or 121.5, any individual 
or entity that possesses, uses, or transfers any agent or toxin listed 
in Sec.  121.3 must register with APHIS or, for overlap agents or 
toxins, APHIS or CDC.
    (b) Each entity must designate an individual to be its 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 with the 
regulations in this part. 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, in the event that an individual applies for and is granted a 
certificate of registration, APHIS will consider the individual to be 
the responsible official.

[[Page 76935]]

    (c) An entity may designate one or more individuals to be an 
alternate responsible official, who may act for the responsible 
official when he/she 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.


Sec.  121.7  Registration; general provisions.

    (a) Unless exempted under Sec. Sec.  121.4 or 121.5, an individual 
or entity shall not possess, use, or transfer any agent or toxin listed 
in Sec.  121.3 without a certificate of registration issued by APHIS or 
CDC.
    (b) A certificate of registration may be issued 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; \7\ and
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    \7\ The security risk assessment of the entity and the 
individual who owns or controls such entity may be waived for 
Federal, State, or local governmental agencies.
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    (2) Approval of the biosafety, containment, and security of the 
entity. The entity's biosafety, containment, and security procedures 
must be commensurate with the risk of the agent or toxin, given its 
intended use. 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, 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.
    (c) For overlap agents, APHIS and CDC will review applications for 
registration and amendments to a certificate of registration, and a 
certificate of registration or amendment to a certificate of 
registration will only be issued if APHIS and CDC concur.
    (d) A certificate of registration will be valid for only the 
specific agents or toxins listed in the certificate 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.
    (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,\8\ 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.
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    \8\ Any 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.
---------------------------------------------------------------------------

    (f) If a responsible official wishes to discontinue possessing, 
using, or transferring a particular agent or toxin, the responsible 
official may inactivate the agent or toxin or he/she may transfer the 
agent or toxin to a registered individual or entity in accordance with 
Sec.  121.13. The responsible official must notify APHIS or, for 
overlap agents or toxins, 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.
    (g) A certificate of registration will be valid for a maximum of 3 
years.


Sec.  121.8  Denial, revocation, or suspension of registration.

    (a) APHIS may deny an application for registration or revoke 
registration if:
    (1) The Attorney General identifies the responsible official, 
entity, or individual who owns or controls the entity as within any of 
the categories described in 18 U.S.C. 175b; or
    (2) The Attorney General identifies the responsible official, 
entity, or individual who owns or controls the entity as reasonably 
suspected by any Federal law enforcement or intelligence agency of:
    (i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
    (ii) Knowing involvement with an organization that engages in 
domestic or international terrorism (as defined in 18 U.S.C. 2331) or 
with any other organization that engages in intentional crimes of 
violence; or
    (iii) Being an agent of a foreign power as defined in 50 U.S.C. 
1801; or
    (3) The responsible official does not have a lawful purpose to 
possess, use, or transfer agents or toxins listed in Sec.  121.3; or
    (4) The responsible official is an individual who handles or uses 
agents or toxins listed in Sec.  121.3 and he/she does not have the 
necessary training or skills to handle such agents or toxins; or
    (5) The entity does not meet the biosafety, containment, and 
security requirements prescribed by the Administrator; \9\ or
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    \9\ If registration is denied for this reason, we may provide 
technical assistance and guidance.
---------------------------------------------------------------------------

    (6) There are egregious or repeated violations of the biosafety, 
containment, or security requirements; or
    (7) The Administrator determines that such action is necessary to 
protect animal or plant health, and animal or plant products.
    (b) For overlap agents or toxins, APHIS or CDC shall deny an 
application for registration or revoke registration if the Attorney 
General identifies the responsible official, entity, or individual who 
owns or controls the entity as within any of the categories described 
in 18 U.S.C. 175b. APHIS or CDC may also deny registration or revoke 
registration for the reasons set forth in paragraphs (a)(2) through 
(a)(7) of this section.
    (c) APHIS may summarily revoke or suspend registration for any of 
the reasons set forth in paragraphs (a) and (b) of this section.
    (d) APHIS 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 notify the responsible official in writing if an application for 
registration is denied or a certificate of registration is revoked or 
suspended.
    (e) Denial of an application for registration, revocation of 
registration, and suspension of registration may be appealed under 
Sec.  121.17.


Sec.  121.9  Registration; how to register.

    (a) To apply for a certificate of registration, 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. 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 both animal and overlap agents 
and toxins.
    (b) For animal agents and toxins, the registration application 
package may be obtained by calling (301) 734-3277 or faxing a request 
to (301) 734-3652. It is also available on the Internet at http://www.aphis.usda.gov/vs/ncie.bta.html. The completed registration 
application package must be mailed to National Center for Import and 
Export, VS, APHIS, 4700 River Road Unit 40,

[[Page 76936]]

Riverdale, MD 20737-1231. Assistance in completing the registration 
application may be requested by calling (301) 734-3277.
    (c) For overlap agents and toxins, the registration application 
package may be obtained by contacting APHIS, as set forth in paragraph 
(b) of this section, or by calling CDC at (404) 498-2255; faxing a 
request to (404) 498-2265; or writing to Select Agent Program, Centers 
for Disease Control and Prevention, 1600 Clifton Road, NE, Mail Stop E 
79, Atlanta, GA 30333. It is also available on the Internet at http://www.cdc.gov/od/ohs/lrsat.htm. The completed registration application 
package may be mailed to APHIS at the address provided in paragraph (b) 
of this section or to CDC's Select Agent Program at the address 
provided in this paragraph. Assistance in completing the registration 
application may be requested by calling APHIS or CDC at the telephone 
numbers provided in this section.


Sec.  121.10  Responsibilities of the responsible official.

    (a) The responsible official is responsible for ensuring compliance 
with the regulations, including:
    (1) Developing and implementing a Biosafety and Security Plan in 
accordance with Sec.  121.12;
    (2) Allowing only approved individuals within the entity to have 
access to any agents or toxins listed in Sec.  121.3 in accordance with 
Sec.  121.11;
    (3) Providing appropriate training in biosafety, containment, and 
security procedures for all personnel in accordance with Sec.  121.13;
    (4) Transferring agents or toxins only to registered individuals or 
entities in accordance with Sec.  121.14;
    (5) Ensuring that all visitors are informed of and follow the 
entity's security requirements and procedures;
    (6) Notifying APHIS or, for overlap agents or toxins, APHIS or CDC, 
of changes in circumstances in accordance with Sec.  121.7;
    (7) Providing timely notice of any theft, loss, or release of a 
biological agent or toxin in accordance with Sec.  121.17;
    (8) Maintaining detailed records of information necessary to give a 
complete accounting of all of the activities related to agents or 
toxins listed in Sec.  121.3 in accordance with Sec.  121.15.
    (b) In addition to the requirements in paragraph (a) of this 
section, the responsible official for a diagnostic laboratory or other 
entities possessing, using, or transferring agents or toxins listed in 
Sec.  121.3 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.\10\ During agricultural emergencies or 
outbreaks, or in endemic areas, the Administrator may require less 
frequent reporting.
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    \10\ A diagnostic laboratory or other entity must immediately 
notify APHIS by faxing (301) 734-3652.
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    (c) In addition to the requirements in paragraph (a) of this 
section, the 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.
    (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.


Sec.  121.11  Restricting access to biological agents and toxins.

    (a) An individual may not have access to biological agents or 
toxins listed in Sec.  121.3 unless approved by APHIS or CDC. APHIS 
will grant, limit, or deny access of individuals to listed agents or 
toxins. APHIS or CDC will grant, limit, or deny access of individuals 
to overlap agents or toxins.
    (b) The responsible official is responsible for ensuring that only 
approved individuals within the entity have access to any agents or 
toxins listed in Sec.  121.3. The responsible official must request 
such access for only 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.
    (c) The responsible official must provide appropriate training in 
biosafety, containment, and security procedures to all individuals with 
access to agents and toxins listed in Sec.  121.3.
    (d) For each individual identified by the responsible official as 
having a legitimate need to handle or use agents or toxins, the 
responsible official must submit that individual's name and identifying 
information to APHIS and the Attorney General. For overlap agents or 
toxins, the responsible official must submit this information to either 
APHIS or CDC and the Attorney General.
    (e) In addition, the responsible official must submit information 
about the individual's training and skills to APHIS or, for overlap 
agents or toxins, APHIS or CDC (e.g., curriculum vitae for principal 
investigators and researchers, and a description of training completed 
by support personnel).
    (f) APHIS may expedite the access approval process for individuals 
upon request by the responsible official and a showing of good cause 
(e.g., public health or agricultural emergencies, national security, 
impending expiration of a research grant, a short-term visit by a 
prominent researcher).
    (g) APHIS will notify the responsible official if an individual is 
granted full or limited access, or denied access to listed agents or 
toxins. APHIS will also notify the individual if he/she is denied 
access or granted only limited access. For overlap agents or toxins, 
APHIS or CDC will provide the necessary notification.
    (h) APHIS may deny or limit access of an individual to listed 
agents or toxins if:
    (1) The Attorney General identifies the individual as within any of 
the categories described in 18 U.S.C. 175b;
    (2) The Attorney General identifies the individual as 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;
    (3) The individual does not have a legitimate need to handle listed 
agents or toxins;
    (4) The individual does not have the necessary training or skills 
to handle listed agents or toxins;
    (5) The Administrator determines that such action is necessary to 
protect animal health or animal products.
    (i) For overlap agents or toxins, APHIS or CDC will deny an 
individual access to such agents or toxins if the Attorney General 
identifies the individual as within any of the categories described in 
18 U.S.C. 175b. APHIS or CDC may also deny or limit access of an 
individual for the reasons set forth in paragraphs (f)(2) through 
(f)(5) of this section.
    (j) An individual may appeal the Administrator's decision to deny 
or limit access under Sec.  121.17.

[[Page 76937]]

    (k) Access approval is valid for 5 years; thereafter, the 
responsible official shall request renewal of access approval every 5 
years for as long as the individual needs access to agents or toxins 
listed in Sec.  121.3.
    (l) The responsible official must immediately notify APHIS or, for 
overlap agents or toxins, APHIS or CDC, when an individual's access to 
agents or toxins listed in Sec.  121.3 is terminated by the entity and 
the reasons therefore.


Sec.  121.12  Biosafety and security plan.

    (a) As a condition of registration, the responsible official must 
develop and implement a Biosafety and Security Plan.\11\ The Biosafety 
and Security Plan must contain sufficient information and documentation 
to describe the biosafety and containment procedures, and the security 
systems and procedures. The plan must be commensurate with the risk of 
the agent or toxin, given its intended use.
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    \11\ Technical assistance and guidance may be obtained by 
calling (301) 734-3277.
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    (1) Biosafety and containment procedures.\12\ The 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). At a minimum, the plan must address 
containment, personnel safety and health, and inventory control.
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    \12\ For guidance on biosafety and containment procedures, see 
the CDC/NIH publication, ``Biosafety in Microbiological and 
Biomedical Laboratories'' (4th ed. 1999).
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    (2) Security systems and procedures.\13\ 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.
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    \13\ For guidance, see the USDA Departmental Manual No. 9610-
001, ``USDA Security Policies and Procedures for Biosafety Level-3 
Facilities'' (August 30, 2002). The manual may be obtained by 
calling (301) 734-3277. The manual is also available on the Internet 
at http://www.usda.gov/ocio/directives/DM/DM9610-001.htm. See also 
Appendix F, ``Biosafety in Microbiological and Biomedical 
Laboratories,'' in Morbidity and Mortality Weekly Report (2002). 
This document may be obtained by writing to Select Agent Program, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE, 
Mail Stop E 79, Atlanta, GA 30333. It is also available on the 
Internet at http://www.cdc.gov/mmwr.
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    (i) The 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.
    (ii) 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 
under paragraph (a)(2)(i) of this section.
    (iii) The plan must describe inventory control procedures, 
personnel suitability for those individuals with access to agents or 
toxins listed in Sec.  121.3, 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.
    (iv) 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:
    (A) Allow unescorted access only to approved individuals who are 
performing a specifically authorized function during hours required to 
perform that job;
    (B) Allow individuals not approved under Sec.  121.11 to conduct 
routine cleaning, maintenance, repairs, and other non-laboratory 
functions only when escorted and continually monitored by approved 
individuals;
    (C) 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;
    (D) Require the inspection of all packages upon entry and exit;
    (E) 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;
    (F) Require that approved individuals do not share with any other 
person their unique means of accessing the area or listed agents or 
toxins; and
    (G) Require that approved individuals immediately report any of the 
following to the responsible official:
    (1) Any loss or compromise of keys, passwords, combinations, etc.;
    (2) Any suspicious persons or activities;
    (3) Any loss or theft of listed agents or toxins;
    (4) Any release of a listed agent or toxin; and
    (5) Any sign that inventory and use records for listed agents and 
toxins have been altered or otherwise compromised.
    (3) Incident response procedures.\14\ The Biosafety and Security 
Plan must also include incident response plans for containment breach, 
security breach, inventory violations, non-biological incidents such as 
workplace violence, and cybersecurity breach. The incident response 
plans must address personnel safety and health, containment, inventory 
control, and notification of managers and responders. The incident 
response plans must also address such events as bomb threats, severe 
weather (floods, hurricanes, tornadoes), earthquakes, power outages, 
and other natural disasters or emergencies.
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    \14\ The requirements in this paragraph do not supercede or 
preempt the enforcement of emergency response requirements imposed 
by other statutes or regulations.
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    (b) The Biosafety and Security Plan must be reviewed, performance 
tested, and updated annually. The plan must also be reviewed and 
revised, as necessary, after any incident.


Sec.  121.13  Training.

    (a) The responsible official must provide appropriate training in 
biosafety, containment, and security procedures to all individuals with 
access to agents and toxins listed in Sec.  121.3.
    (b) 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. The responsible official must provide refresher 
training annually.


Sec.  121.14  Transfer of biological agents and toxins.

    Biological agents and toxins listed in Sec.  121.3 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 this part, or an individual or entity 
located outside of the United States. Biological agents or toxins may 
only be transferred under the conditions of this section and must be 
authorized by APHIS or, for overlap agents or toxins, by APHIS or CDC, 
prior to the transfer.

[[Page 76938]]

    (a) Importation and interstate movement. In addition to the permit 
required under part 122 of this subchapter, biological agents or toxins 
listed in Sec.  121.3 may be imported or moved interstate only 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 paragraph (c) of this section.
    (b) Intrastate movement. Biological agents or toxins listed in 
Sec.  121.3 may be moved intrastate only 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 paragraph (c) of this section.
    (c) APHIS Form 2041; process and procedures. (1) Prior to each 
transfer, the responsible official for the recipient and sender must 
complete APHIS Form 2041, and the sender must submit the form to APHIS 
or, for overlap agents or toxins, to APHIS or CDC.\15\
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    \15\ APHIS Form 2041 may be obtained by calling APHIS at (301) 
734-3277 or by calling CDC at (404) 498-2265. The form is also 
available on the Internet at http://www.aphis.usda.gov/vs/ncie.bta.html or http://www.cdc.gov/od/ohs/lrsat.htm. APHIS Form 
2041 may be mailed to National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231; or faxed 
to (301) 734-3652. For overlap agents and toxins, it may be mailed 
to the above address or to Select Agent Program, Centers for Disease 
Control and Prevention, 1600 Clifton Road, NE, Mail Stop E 79, 
Atlanta, GA 30333; or faxed to (404) 498-2265.
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    (2) 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.
    (3) 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.
    (4) The responsible official for the recipient must notify 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.
    (d) The sender must comply with all applicable laws governing 
packaging and shipping.


Sec.  121.15  Records.

    (a) The responsible official must maintain complete, up-to-date 
records of information necessary to give an accounting of all of the 
activities related to agents or toxins listed in Sec.  121.3. Such 
records must include the following:
    (1) The Biosafety and Security Plan;
    (2) A current list of all individuals with access to agents or 
toxins listed in Sec.  121.3;
    (3) Training records for individuals with access to such agents or 
toxins;
    (4) Accurate and current inventory records (including source and 
characterization data);
    (5) Permits and transfer documents (APHIS Form 2041) issued by 
APHIS and CDC;
    (6) Security records (e.g., transactions from automated access 
control systems, testing and maintenance of security systems, visitor 
logs);
    (7) Biosafety, containment, and security incident reports.
    (b) The responsible official must maintain such records for 3 
years.
    (c) All records must be produced upon request to APHIS or CDC 
inspectors, and appropriate Federal, State, or local law enforcement 
authorities.


Sec.  121.16  Inspections.

    (a) To ensure compliance with the regulations, any APHIS or CDC 
inspector must be allowed, without previous notification, to enter and 
inspect the entire premises, all materials and equipment, and all 
records required to be maintained by this part.
    (b) Prior to issuing a certificate of registration to an entity or 
individual, APHIS or CDC may inspect and evaluate the premises and 
records to ensure compliance with the regulations and the biosafety, 
containment, and security requirements.


Sec.  121.17  Notification in the event of theft, loss, or release of a 
biological agent or toxin.

    (a) The responsible official must orally notify APHIS and 
appropriate Federal, State, or local law enforcement agencies 
immediately upon discovery of the theft or loss of agents or toxins 
listed in Sec.  121.3. The oral notification must be followed by a 
written report (APHIS Form 2043) within 7 days.
    (b) The responsible official must orally notify APHIS immediately 
upon discovery that a release of an agent or toxin has occurred outside 
of the biocontainment area. The oral notification shall be followed by 
a written report (APHIS Form 2043) within 7 days. Upon notification and 
a finding that the release poses a threat to animal or plant health, or 
animal or plant products, APHIS will notify relevant Federal, State, 
and local authorities, and the public, if necessary. If the release 
involves an overlap agent or toxin, APHIS will also notify the 
Secretary of Health and Human Services.
    (c) The responsible official must orally notify APHIS of a theft, 
loss, or release of an agent or toxin by calling (866) 994-5698. A copy 
of APHIS Form 2043 may be obtained by writing to National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 
20737-1231; or by calling (301) 734-3277. The form is also available on 
the Internet at http://www.aphis.usda.gov/vs/ncie.bta.html. APHIS Form 
2043 may be mailed to the same address or faxed to (301) 734-3652.


Sec.  121.18  Administrative review.

    An individual or entity may appeal a denial or revocation of 
registration under this part. 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 under this part may appeal that 
decision.\16\ 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. The 
Administrator's decision constitutes final agency action.
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    \16\ An entity may not appeal the denial or limitation of an 
individual's access to listed agents or toxins.

    Done in Washington, DC this 9th day of December 2002 .
Charles D. Lambert,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 02-31373 Filed 12-9-02; 4:03 pm]
BILLING CODE 3410-34-P