Federal Register: August 12, 2002 (Volume 67, Number 155)
Rules and Regulations               
Page 52383-52389
                     

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. 02-082-1]
RIN 0579-AB47

 
Agricultural Bioterrorism Protection Act of 2002; Listing of 
Biological Agents and Toxins and Requirements and Procedures for 
Notification of Possession

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, an initial list of 
biological agents and toxins determined to have the potential to pose a 
severe threat to animal or plant health, or to animal or plant 
products. The Act requires that all persons in possession of any listed 
biological agent or toxin must, within 60 days of the publication of 
this interim rule, notify the Secretary of such possession. This 
interim rule establishes the initial list of biological agents and 
toxins and provides guidance on the manner in which the required notice 
is to be provided.

DATES: This interim rule is effective August 12, 2002. We will consider 
all comments that we receive on or before October 11, 2002.

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. 02-082-1, 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. 02-082-1. 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. 
02-082-1" on the subject line.

[[Page 52384]]

    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. Arnold T. Tschanz, Senior 
Staff Officer, Regulatory Coordination, Plant Health Programs, PPQ, 
APHIS, 4700 River Road Unit 141, Riverdale, MD 20737-1236, (301) 734-
8790.
    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

    The President signed into law the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) on 
June 12, 2002. Title II of Public Law 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. In 
determining whether to include an agent or toxin on the list, the Act 
requires the Secretary to consider:
     The effect of exposure to the agent or toxin on animal or 
plant health, and on the production and marketability of animal or 
plant products;
     The pathogenicity of the agent or the toxicity of the 
toxin and the methods by which the agent or toxin is transferred to 
animals or plants;
     The availability and effectiveness of pharmacotherapies 
and prophylaxis to treat and prevent any illness caused by the agent or 
toxin; and
     Any other criteria that the Secretary considers 
appropriate to protect animal or plant health, or animal or plant 
products.
    The Act also calls on the Secretary to consult with appropriate 
Federal departments and agencies and with scientific experts 
representing appropriate professional groups.
    Under section 213(a) of the Act, the Secretary must, not later than 
60 days after the Act's date of enactment (i.e., by August 11, 2002), 
promulgate an interim final rule that establishes the initial list 
required under section 212(a). 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; the Act provides that the 
interim rule establishing the list must also furnish written guidance 
on the manner in which the required notice is to be provided.
    In accordance with the statutory requirements discussed above, this 
interim rule establishes the initial lists of biological agents and 
toxins and sets out the manner in which persons in possession of listed 
agents and toxins are to provide notice of such possession. To 
accomplish this, we are establishing 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.
    The two new parts, 7 CFR part 331 and 9 CFR part 121, are both 
titled "Possession of Biological Agents and Toxins" and are 
constructed similarly: Each contains a section that provides 
definitions for specific terms used in the part, a section in which the 
list of biological agents and toxins is set out, and a section that 
provides guidance on the manner in which the required notice is to be 
provided. The main difference between the two parts is in the lists: 
The regulations in 7 CFR part 331 list only those agents and toxins 
determined to have the potential to pose a severe threat to plant 
health or to the production and marketability of plant products, while 
the regulations in 9 CFR part 121 list those agents and toxins 
determined to have the potential to pose a severe threat to both human 
and animal health ("overlap agents and toxins"), to animal health, or 
to the production and marketability of animal products. These new parts 
are discussed in detail below.

Definitions

    Both 7 CFR part 331 and 9 CFR part 121 begin with a definitions 
section, Secs. 331.1 and 121.1, respectively. With one exception, the 
terms defined in each section are the same. Specifically, we define the 
terms biological agent, facility, person, responsible facility 
official, and toxin in both parts, while the term overlap agent or 
toxin is defined only in 9 CFR 121.1 (this term is not applicable to 
the plant-related regulations in 7 CFR part 331).
    The definitions of biological agent and toxin are taken from 18 
U.S.C. 178. Section 212(l) of the Act provides that "[t]he terms 
"biological agent" and "toxin" have the meanings given such terms 
in section 178 of title 18, United States Code." Thus, we define 
biological agent as "any microorganism, virus, infectious substance, 
or biological product that may be engineered as a result of 
biotechnology, or any naturally occurring or bioengineered component of 
any such microorganism, virus, infectious substance, or biological 
product, 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." Toxin is 
defined as "the toxic material of plants, animals, microorganisms, 
viruses, fungi, or infectious substances, or a recombinant molecule, 
whatever its origin or method of production, including: (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."

[[Page 52385]]

    In 9 CFR 121.1, we also define the term overlap agent or toxin. The 
definition we use is based on the definition provided for the term 
"select agent" in the CDC's regulations in 42 CFR 72.6(j). In 
appendix A to 42 CFR part 72, CDC provides a list of 36 select agents, 
18 of which are microorganisms or toxins that pose a risk to both human 
and animal health. Those 18 microorganisms and toxins are listed as 
"overlap agents or toxins" in our regulations in Sec. 121.2(a) and 
are characterized in the same manner by CDC for the purposes of 
carrying out its responsibilities under the Act.
    Given that the agents and toxins listed in Sec. 121.2(a) were drawn 
from the CDC's list of select agents, we believe that it is appropriate 
to adapt the CDC definition of the term "select agent" for use as our 
definition of the term "overlap agent or toxin" in order to provide 
regulated entities with a consistent frame of reference. Therefore, in 
9 CFR 121.1, overlap agent or toxin is defined as "a microorganism 
(including a virus, bacterium, fungus, rickettsia) or toxin that poses 
a risk to both human and animal health and that is listed in 
Sec. 121.2(a). The term also includes: (1) Genetically modified 
microorganisms or genetic elements from organisms listed in 
Sec. 121.2(a), shown to produce or encode for a factor associated with 
a disease; and (2) genetically modified microorganisms or genetic 
elements that contain nucleic acid sequences coding for any of the 
toxins listed in Sec. 121.2(a), or their toxic subunits."
    The remaining three terms, which are defined in both 7 CFR 331.1 
and 9 CFR 121.1, are facility, responsible facility official, and 
person. Like our definition of overlap agent or toxin, our regulations 
define the first two terms in the same manner as they are defined in 
CDC's regulations in 42 CFR 72.6(j) in order to provide a consistent 
frame of reference. Facility is defined as "any individual or 
government agency, university, corporation, company, partnership, 
society, association, firm, or other legal entity located at a single 
geographic site that may transfer or receive through any means a 
biological agent or toxin subject to this part." Generally speaking, 
"a single geographic site" can be viewed as the complex of buildings 
and laboratories at a single mailing address.
    Responsible facility official is defined as "an official 
authorized to transfer and receive biological agents or toxins covered 
by this part on behalf of a facility. This person should be either a 
safety officer, a senior management official of the facility, or both. 
The responsible facility official should not be an individual who 
actually transfers or receives a biological agent or toxin at the 
facility." For the purposes of clarity, the definition of this term in 
9 CFR 121.1 includes the words "including overlap agents and toxins" 
after the words "authorized to transfer and receive biological agents 
or toxins."
    We have defined person as "any individual, firm, corporation, 
company, society, or association; any Federal, State, or local 
governmental entity; or any organized group of any of the foregoing." 
Where this term is defined elsewhere in our regulations in titles 7 and 
9, the scope of the definition is limited to individuals, companies, 
and other legal entities. However, section 212(l)(5) of the Act, in 
defining "person," stipulates that the term includes Federal, State, 
and local governmental entities.

Lists of Biological Agents and Toxins

    The initial lists of biological agents and toxins required under 
section 212(a)(1) of the Act are located in 7 CFR 331.2 and 9 CFR 
121.2. The Act requires that these lists be reviewed and republished 
biennially, or more often as needed, and revised as necessary.
    The list of nine biological agents and toxins provided in 7 CFR 
331.2 was compiled by APHIS' Plant Protection and Quarantine (PPQ) 
program. The listed agents and toxins are viruses, bacteria, or fungi 
that can pose a severe threat to a number of important crops, including 
potatoes, rice, soybeans, corn, citrus, and stone fruit. PPQ staff, 
after internal discussions and a review of several existing or proposed 
lists of plant pathogens that potentially pose a severe threat to plant 
health or plant products, requested input from USDA's Agricultural 
Research Service, Forest Service, and Cooperative State Research, 
Education, and Extension Service, and consulted with the American 
Phytopathological Society. The resulting list of agents and toxins 
identified as potentially posing a severe threat to plant health or 
plant products is as follows:

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

    The list of 18 overlap agents and toxins in 9 CFR 121.2(a) was, as 
noted previously, drawn from CDC's list of 36 select agents, the 18 
listed in our regulations being those select agents that pose a risk to 
both human and animal health. In June 2002, CDC convened an interagency 
working group to review the list of 36 select agents and develop 
recommendations regarding possible changes to that list. CDC has 
reviewed those recommendations and intends publish a document in the 
Federal Register to solicit comments from the public on potential 
changes to its list of select agents. Because the process of changing 
the list of select agents is still in its initial stages at the time 
this interim rule is being published, the list of overlap agents and 
toxins found in 9 CFR 121.2(a) reflects the select agent list 
promulgated by CDC in October 1996. The overlap agents and toxins 
listed in 9 CFR 121.2(a) are:

Bacillus anthracis
Brucella abortus, B. melitensis, B. suis
Burkholderia (Pseudomonas) mallei
Burkholderia (Pseudomonas) pseudomallei
Clostridium botulinum
Coccidioides immitis
Coxiella burnetii
Eastern equine encephalitis virus
Equine morbillivirus (Hendra virus)
Francisella tularensis
Rift Valley fever virus
Venezuelan equine encephalitis virus
Aflatoxins
Botulinum toxins
Clostridium perfringens epsilon toxin
Shigatoxin
Staphylococcal enterotoxins
T-2 toxin

    The 23 agents and toxins listed in 9 CFR 121.2(b) 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 Sec. 121.2(a).) 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. The diseases drawn from OIE's List A are:

African horsesickness
African swine fever
Bluetongue (exotic)
Classical swine fever
Contagious bovine pleuropneumonia
Foot-and-mouth disease
Highly pathogenic avian influenza
Lumpy skin disease
Newcastle disease (exotic)
Peste des petits ruminants

[[Page 52386]]

Rinderpest
Sheep pox and goat pox
Swine vesicular disease
Vesicular stomatitis (exotic)

    Five of the remaining nine agents and toxins listed in 9 CFR 
121.2(b) 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 List B diseases included in 9 CFR 
121.2(b) are:

Bovine spongiform encephalopathy
Cowdria ruminantium (heartwater)
Japanese encephalitis virus
Malignant catarrhal fever
Contagious caprine pleuropneumonia

    The four remaining diseases/disease agents--two restricted foreign 
animal pathogens (Akabane virus and camel pox virus) and two emerging 
paramyxoviruses (Menangle virus and Nipah virus)--were included on the 
list in 9 CFR 121.2(b) based on our determination that they potentially 
pose a severe threat to animal health or animal products.

Exemptions From the Notification Requirement

Under section 212(g)(1)(C) of the Act, certain products that are, bear, 
or contain overlap agents or toxins may be exempted from regulation if 
those products have been cleared, approved, licensed, or registered 
pursuant to one of the following acts:
     The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.);
     Section 351 of Public Health Service Act (42 U.S.C. 262);
     The Act commonly known as the Virus-Serum-Toxin Act (the 
eighth paragraph under the heading "Bureau of Animal Industry" in the 
Act of March 4, 1913; 21 U.S.C. 151-159); or
     The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 131 et seq.).

    Paragraph (b) of Sec. 213 of the Act extends that exemption 
provision to the notification requirements that are the subject of this 
interim rule. Therefore, the regulations 9 CFR 121.2(c) provide that 
persons possessing products that are, bear, or contain overlap agents 
or toxins listed in 9 CFR 121.2(a) will be exempt from the notification 
requirements of 9 CFR 121.3 if the products have been cleared, 
approved, licensed, or registered pursuant to one of the acts cited 
above.
    Because the exemption under section 212(g)(1)(C) of the Act is 
limited to overlap agents and toxins, none of which appear in 7 CFR 
331.2, we have not included those exemption provisions in the 
regulations in 7 CFR part 331. Further, while the Act, in section 
212(g)(2), does provide general authority for exemptions not involving 
overlap agents or toxins when the Secretary determines that such 
exemptions are consistent with protecting animal and plant health and 
animal and plant products, no determination has yet been made with 
regard to exemptions other than those discussed above.

Notification Requirements and Procedures

Under section 213(b) of the Act, all persons (unless exempt under 
section 212(g) of the Act) in possession of a listed biological agent 
or toxin must notify the Secretary of such possession not later than 60 
days after the date on which the interim rule required under section 
212(a)(1) of the Act-- i.e., this interim rule--is promulgated. 
Therefore, 7 CFR 331.3 and 9 CFR 121.3 both provide that any person or 
facility that possesses any listed biological agent or toxin must 
notify APHIS of such possession by 60 days after the publication date 
of this interim rule. However, the regulations in 9 CFR 121.3 provide 
that persons possessing overlap agents or toxins listed in 
Sec. 121.2(a)--which, as noted previously, are among CDC's select 
agents--must provide the required notification by September 10, 2002, 
which is the date that notice must be provided to CDC under subtitle A 
of Public Law 107-188. Further, the regulations in 9 CFR 121.3 make 
note of the exemptions discussed above and state that notification is 
not required for those products that meet the criteria of 9 CFR 
121.2(c). The regulations in both 7 CFR 331.3 and 9 CFR 121.3 indicate 
the form to be used to provide the required notification (one form will 
be used for notification under 7 CFR part 331, and a different form 
will be used for notification under 9 CFR part 121) and explain where 
copies of each form may be obtained.
    To facilitate the notification process, both sections provide that 
a single form should be submitted for each facility by a responsible 
facility official designated by the facility to ensure management 
oversight of the notification requirement, and that the responsible 
facility official should consult with others in the facility (e.g., 
principal investigators) in order to obtain the information necessary 
to complete the notification form. The responsible facility official 
must review and sign the notification form and will be the individual 
contacted by APHIS if any questions arise concerning the facility's 
response.
    Finally, both sections provide a mailing address for the submission 
of completed forms, as well as a telephone number to call if assistance 
in completing the form is required.

Immediate Action

    Immediate action is necessary in order for USDA to comply with the 
requirements of Title II, subtitle B, of Public Law 107-188, which 
requires the publication of this interim rule not later than August 11, 
2002. Under these circumstances, the Administrator has determined that 
prior notice and opportunity for public comment are contrary to the 
public interest and that there is good cause under 5 U.S.C. 553 for 
making this rule effective less than 30 days after publication in the 
Federal Register.
    We will consider comments that are received within 60 days of 
publication of this rule in the Federal Register. 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 as a result of the 
comments.

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.
    In this interim rule, we are establishing, by regulation, an 
initial list of biological agents and toxins determined to have the 
potential to pose a severe threat to animal or plant health, or to 
animal or plant products. The Agricultural Bioterrorism Protection Act 
of 2002 requires that all persons in possession of any listed 
biological agent or toxin must, within 60 days of the publication of 
this interim rule, notify the Secretary of such possession. This 
interim rule establishes the initial list of biological agents and 
toxins and provides guidance on the manner in which the required notice 
is to be provided.
    The Regulatory Flexibility Act requires that agencies specifically 
consider the economic effects of their rules on small entities. We 
expect that the entities that will be affected by this rule will be 
laboratories and other institutions conducting research and related 
activities that involve the use of the biological agents and toxins 
listed in this rule. Most affected entities (apart

[[Page 52387]]

from Federal or State governmental entities) could be considered as 
falling under North American Industry Classification System (NAICS) 
code 541710, "Research and Development in the Physical, Engineering, 
and Life Sciences." The small business size standard established by 
the Small Business Administration for NAICS 541710 is 500 or fewer 
employees. Potentially affected entities could also fall under NAICS 
541990, "All Other Professional, Scientific and Technical Services," 
and NAICS 611310, "Colleges, Universities and Professional Schools." 
The small business size standard for both of those classifications is 
annual receipts of $6 million or less.
    Given that this interim rule simply requires that persons 
possessing a listed biological agent or toxin provide notice to APHIS 
of such possession, we do not expect that this rule will have any 
substantive economic effect on any entities, large or small. We expect 
that any costs associated with this rule will be limited to the staff 
time expended in completing a notification form. This rule provides for 
the submission of only one form for each facility, which should limit 
the amount of time necessary for the preparation of a facility's 
response. Further, we would expect that any facility handling the kinds 
of biological agents and toxins listed in this rule would have a 
database or other records containing a listing of agents and toxins 
currently in the facility. Therefore, we anticipate that any personnel 
costs resulting from compliance with this rule should be minimal.
    The benefit of this action is enhanced protection of the U.S. 
agricultural sector as APHIS will have a detailed inventory of 
biological agents and toxins that could pose a threat to the sector.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

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). OMB has assigned control numbers 0579-0201 and 0579-0204 to the 
information collection and recordkeeping requirements.
    We plan to request continuation of that approval for 6 months. 
Please send written comments on the 6-month 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. 02-082-1, 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. 02-082-1 and send 
your comments within 60 days of publication of this rule.
    This rule establishes an initial list of biological agents and 
toxins determined to have the potential to pose a severe threat to 
animal or plant health, or to animal or plant products, and requires 
that all persons in possession of any listed biological agent or toxin 
must, within 60 days of the publication of this interim rule, notify 
the Secretary of such possession.
    Two forms have been developed to provide the means by which persons 
in possession of listed agents or toxins will notify the Secretary of 
such possession. The first form, "Notification of Possession of Select 
Agents or High Consequence Livestock Pathogens and Toxins," was 
developed jointly by APHIS and the Centers for Disease Control and 
Prevention and will be used by persons possessing those agents and 
toxins determined to have the potential to pose a severe threat to 
human health, to both human and animal health ("overlap agents and 
toxins"), to animal health, or to the production and marketability of 
animal products. The second form, PPQ form 655, was developed by APHIS 
and will be used by persons possessing those agents and toxins 
determined to have the potential to pose a severe threat to plant 
health or to the production and marketability of plant products. We 
expect that the scope and nature of the research required to complete 
PPQ form 655 will be less complex than that associated with the first 
form, thus we have estimated a smaller reporting burden per response 
for this form.
    We are soliciting comments from the public 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 "Notification of Possession of Select Agents or High Consequence 
Livestock Pathogens and Toxins," (OMB Control No. 0579-0201):

    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories, and other entities that possess 
listed agents and toxins determined to have the potential to pose a 
severe threat to human health, to both human and animal health, to 
animal health, or to the production and marketability of animal 
products.
    Estimated annual number of respondents: 50,000.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 50,000.
    Estimated total annual burden on respondents: 100,000 hours.

For PPQ form 655 (OMB Control No. 0579-0204):

    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.5 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories, and other entities that possess 
listed agents and toxins determined to have the potential to pose a 
severe threat to plant health or to the production and marketability of 
plant products.

[[Page 52388]]

    Estimated annual number of respondents: 1,000.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 1,000.
    Estimated total annual burden on respondents: 500 hours.
    (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.

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 amending 7 CFR chapter III by removing the 
heading for reserved part 331 and adding a new part 331; and we are 
amending 9 CFR chapter I, subchapter E, by adding a new part 121 to 
read as follows:

7 CFR Chapter III

PART 331--POSSESSION OF BIOLOGICAL AGENTS AND TOXINS

Sec.
331.1   Definitions.
331.2   List of biological agents and toxins.
331.3   Notification requirements and procedures.

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


Sec. 331.1  Definitions.

    Biological agent. Any microorganism, virus, infectious substance, 
or biological product that may be engineered as a result of 
biotechnology, or any naturally occurring or bioengineered component of 
any such microorganism, virus, infectious substance, or biological 
product, 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.
    Facility. Any individual or government agency, university, 
corporation, company, partnership, society, association, firm, or other 
legal entity located at a single geographic site that may transfer or 
receive through any means a biological agent or toxin subject to this 
part.
    Person. Any individual, firm, corporation, company, society, or 
association; any Federal, State, or local governmental entity; or any 
organized group of any of the foregoing.
    Responsible facility official. An official authorized to transfer 
and receive biological agents or toxins covered by this part on behalf 
of a facility. This person should be either a safety officer, a senior 
management official of the facility, or both. The responsible facility 
official should not be an individual who actually transfers or receives 
a biological agent or toxin at the facility.
    Toxin. The toxic material of plants, animals, microorganisms, 
viruses, fungi, or infectious substances, or a recombinant molecule, 
whatever its origin or method of production, including:
    (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.


Sec. 331.2  List of biological agents and toxins.

    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 the production and marketability of plant products. Any 
person who possesses any listed agent or toxin or, in the case of a 
listed disease, the causative agent of that disease, must notify the 
Animal and Plant Health Inspection Service of that possession in 
accordance with Sec. 331.3.

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

Sec. 331.3  Notification requirements and procedures.

    (a) Any person or facility that possesses any biological agent or 
toxin listed in Sec. 331.2 must notify the Animal and Plant Health 
Inspection Service (APHIS) of such possession by October 11, 2002. 
Notice must be provided using Plant Protection and Quarantine (PPQ) 
form 655, which may be obtained by calling PPQ at (301) 734-8896. The 
form is also available on the Internet at http://www.aphis.usda.gov/
ppq/permits.
    (b) Each facility should designate a responsible facility official 
to complete PPQ form 655, and a single form that reflects all listed 
agents and toxins possessed by all persons within the facility should 
be submitted for each facility. The responsible facility official for 
each facility should consult with others in the facility (e.g., 
principal investigators) in order to obtain the information necessary 
to complete the notification form. The responsible facility official 
must review and sign the notification form and will be the individual 
contacted by APHIS if any questions arise concerning the facility's 
response.
    (c) Completed forms must be mailed to: U.S. Department of 
Agriculture, Animal and Plant Health Inspection Service, Plant 
Protection and Quarantine, Permits and Risk Assessment, 4700 River Road 
Unit 133, Riverdale, Md 20737-1236.
    (d) Assistance in completing the form may be requested by calling 
(301) 734-8896.

(Approved by the Office of Management and Budget under control number 
0579-0204)

9 CFR Chapter I

PART 121--POSSESSION OF BIOLOGICAL AGENTS AND TOXINS

Sec.
121.1   Definitions.
121.2   List of biological agents and toxins.
121.3   Notification requirements and procedures.

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


Sec. 121.1  Definitions.

    Biological agent. Any microorganism, virus, infectious substance, 
or biological product that may be engineered as a result of 
biotechnology, or any naturally occurring or bioengineered component of 
any such microorganism, virus, infectious substance, or biological 
product, 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.
    Facility. Any individual or government agency, university, 
corporation, company, partnership, society, association, firm, or other 
legal entity located at a single geographic site that may transfer or 
receive through any

[[Page 52389]]

means a biological agent or toxin subject to this part.
    Overlap agent or toxin. A microorganism (including a virus, 
bacterium, fungus, rickettsia) or toxin that poses a risk to both human 
and animal health and that is listed in Sec. 121.2(a). The term also 
includes:
    (1) Genetically modified microorganisms or genetic elements from 
organisms listed in Sec. 121.2(a), shown to produce or encode for a 
factor associated with a disease; and
    (2) Genetically modified microorganisms or genetic elements that 
contain nucleic acid sequences coding for any of the toxins listed in 
Sec. 121.2(a), or their toxic subunits.
    Person. Any individual, firm, corporation, company, society, or 
association; any Federal, State, or local governmental entity; or any 
organized group of any of the foregoing.
    Responsible facility official. An official authorized to transfer 
and receive biological agents or toxins, including overlap agents and 
toxins, covered by this part on behalf of a facility. This person 
should be either a safety officer, a senior management official of the 
facility, or both. The responsible facility official should not be an 
individual who actually transfers or receives a biological agent or 
toxin at the facility.

    Toxin. The toxic material of plants, animals, microorganisms, 
viruses, fungi, or infectious substances, or a recombinant molecule, 
whatever its origin or method of production, including:
    (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.


Sec. 121.2  List of biological agents and toxins.

    The biological agents and toxins listed in this section have been 
determined to have the potential to pose a severe threat to both human 
and animal health, to animal health, or to the production and 
marketability of animal products. Unless exempted under paragraph (c) 
of this section, any person who possesses any listed agent or toxin or, 
in the case of a listed disease, the causative agent of that disease, 
must notify the Animal and Plant Health Inspection Service of that 
possession in accordance with Sec. 121.3.
    (a) Overlap agents and toxins.
    (1) Bacillus anthracis.
    (2) Brucella abortus, B. melitensis, B. suis.
    (3) Burkholderia (Pseudomonas) mallei.
    (4) Burkholderia (Pseudomonas) pseudomallei.
    (5) Clostridium botulinum.
    (6) Coccidioides immitis.
    (7) Coxiella burnetii.
    (8) Eastern equine encephalitis virus.
    (9) Equine morbillivirus (Hendra virus).
    (10) Francisella tularensis.
    (11) Rift Valley fever virus.
    (12) Venezuelan equine encephalitis virus.
    (13) Aflatoxins.
    (14) Botulinum toxins.
    (15) Clostridium perfringens epsilon toxin.
    (16) Shigatoxin.
    (17) Staphylococcal enterotoxins.
    (18) T-2 toxin.
    (b) Animal agents and toxins.

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

    (c) Exemptions. Persons possessing products that are, bear, or 
contain overlap agents or toxins listed in paragraph (a) of this 
section will be exempt from the notification requirements of Sec. 121.3 
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 Act commonly known as the Virus-Serum-Toxin Act (the eighth 
paragraph under the heading "Bureau of Animal Industry" in the Act of 
March 4, 1913; 21 U.S.C. 151-159); or
    (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 131 et seq.).


Sec. 121.3  Notification requirements and procedures.

    (a) Any person or facility that possesses any biological agent or 
toxin listed in Sec. 121.2(b) must notify the Animal and Plant Health 
Inspection Service (APHIS) of such possession by October 11, 2002. Any 
person or facility that possesses any biological agent or toxin listed 
in Sec. 121.2(a) that is not exempt under Sec. 121.2(c) must notify 
APHIS of such possession by September 10, 2002. Notice must be provided 
using the form "Notification of Possession of Select Agents or High 
Consequence Livestock Pathogens and Toxins." A machine-readable 
version of the form may be obtained by calling (866) 567-4232. An 
alternate version of the form is available on the Internet at http://
www.aphis.usda.gov/vs/ncie.
    (b) Each facility should designate a responsible facility official 
to complete the form, and a single form that reflects all listed agents 
and toxins possessed by all persons within the facility should be 
submitted for each facility. The responsible facility official for each 
facility should consult with others in the facility (e.g., principal 
investigators) in order to obtain the information necessary to complete 
the notification form. The responsible facility official must review 
and sign the notification form and will be the individual contacted by 
APHIS if any questions arise concerning the facility's response.
    (c) Completed forms must be mailed to: Analytical Sciences, Inc., 
Attn: FSO P.O. Box 341809, Bethesda, MD 20827-1809.
    (d) Assistance in completing the form available on the Internet may 
be requested by calling (301) 734-3222. Assistance in completing the 
machine-readable form may be obtained by calling (866) 567-4232.

(Approved by the Office of Management and Budget under control 
number 0579-0201)

    Done in Washington, DC, this 7th day of August, 2002.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 02-20354 Filed 8-9-02; 8:45 am]
BILLING CODE 3410-34-P