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 regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and "Docket No.
02-082-1" 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
