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29 August 2007
[Federal Register: August 28, 2007 (Volume 72, Number 166)]
[Proposed Rules]
[Page 49231-49236]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au07-40]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
[[Page 49231]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS-2007-0033]
RIN 0579-AC53
Agricultural Bioterrorism Protection Act of 2002; Biennial Review
and Republication of the Select Agent and Toxin List
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Agricultural Bioterrorism Protection
Act of 2002, we are proposing to amend and republish the list of select
agents and toxins that have the potential to pose a severe threat to
animal or plant health, or to animal or plant products. The Act
requires the biennial review and republication of the list of select
agents and toxins and the revision of the list as necessary. This
action would implement the findings of the second biennial review of
the list.
DATES: We will consider all comments that we receive on or before
October 29, 2007.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
, select ``Animal and Plant Health Inspection
Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2007-0033 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instructions for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2007-0033, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS-2007-0033.
Reading Room: 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For information concerning the
regulations in 7 CFR part 331, contact Ms. Gwendolyn Burnett, Select
Agent Program Compliance Manager, PPQ, APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737-1231, (301) 734-5960.
For information concerning the regulations in 9 CFR part 121,
contact Dr. Frederick D. Doddy, Veterinary Medical Officer, Animals,
Organisms and Vectors, and Select Agents, VS, APHIS, 4700 River Road
Unit 2, Riverdale, MD 20737-1231, (301) 734-5960.
SUPPLEMENTARY INFORMATION:
Background
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 provides for the regulation of certain biological
agents and toxins that 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. The Animal and Plant Health Inspection
Service (APHIS) has the primary responsibility for implementing the
provisions of the Act within the Department of Agriculture (USDA).
Veterinary Services (VS) select agents and toxins are those that have
been determined to have the potential to pose a severe threat to animal
health or animal products. Plant Protection and Quarantine (PPQ) select
agents and toxins are those that have been determined to have the
potential to pose a severe threat to plant health or plant products.
Overlap select agents and toxins are those that have been determined to
pose a severe threat to both human and animal health or animal
products. Overlap select agents are subject to regulation by both APHIS
and the Centers for Disease Control and Prevention (CDC), which has the
primary responsibility for implementing the provisions of the Act for
the Department of Health and Human Services (HHS).
Subtitle B (which is cited as the ``Agricultural Bioterrorism
Protection Act of 2002'' and 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 the Secretary determines has the potential to pose
a severe threat to animal or plant health, or to animal or plant
products. Paragraph (a)(2) of section 212 requires the Secretary to
review and republish the list every 2 years and to revise the list as
necessary. In this document, we are proposing to amend and republish
the list of select agents and toxins based on the findings of our
second biennial review of the list.
In determining whether to include an agent or toxin in the list,
the Act requires that the following criteria be considered:
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 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.
We use the term ``select agent and/or toxin'' throughout the
preamble of this proposed rule. Unless otherwise specified, the term
``select agent and/or toxin'' will refer to all agents or toxins listed
by APHIS. When it is necessary to
[[Page 49232]]
specify the type of select agent or toxin, we will use the following
terms: ``PPQ select agent and/or toxin'' (for the plant agents and
toxins listed in 7 CFR 331.3), ``VS select agent and/or toxin'' (for
the animal agents and toxins listed in 9 CFR 121.3), or ``overlap
select agent and/or toxin'' (for the agents and toxins listed in both 9
CFR 121.4 and 42 CFR 73.4).
PPQ Select Agents and Toxins
APHIS's Plant Protection and Quarantine (PPQ) program convened an
interagency working group to review the list of PPQ select agents and
toxins and develop recommendations regarding possible changes to that
list. Using the four criteria for listing found in the Act, the working
group revisited the currently listed PPQ select agents and toxins and
evaluated a number of plant pathogens for inclusion on the list. Based
on this review, APHIS is proposing several amendments to the list of
PPQ select agents and toxins listed in 7 CFR 331.3.
First, we are proposing to remove Candidatus Liberobacter
asiaticus, a bacterium causing Huanglongbing or citrus greening
disease, from the list. Citrus greening disease has been introduced
into the United States and now C. Liberobacter asiaticus would have
virtually no impact if used as a weapon of terrorism. The bacterium
itself is not harmful to humans but the disease has harmed trees in
Asia, Africa, the Arabian Peninsula, and Brazil. The Asian strain of
the disease, C. Liberibacter asiaticus, was found in south Miami-Dade
County Florida in early September, 2005. Since that time, this plant
pathogen has spread through much of Southern Florida. The disease is
primarily spread by the Asian citrus psyllid and the African citrus
psyllid as they feed. The Asian citrus pysllid, Diaphorina citri, has
been present in Florida since 1998. The exact pathway responsible for
introducing citrus greening and the Asian citrus psyllid into the
United States is still unknown. Once infected, there is no cure for a
tree with citrus greening disease. In areas of the world where citrus
greening is endemic, citrus trees decline and die within a few years.
In order to protect the U.S. citrus industry, there is an urgent need
to facilitate timely research on effective means to manage the disease
in the United States. For these reasons, we are removing C.
Liberobacter asiaticus from list of PPQ select agents and toxins.
We are proposing to regulate all pathovars of Xanthomonas oryzae.
Currently, Xanthomonas oryzae pv. oryzicola is listed. However, both
pathovars (oryzicola and oryzae) represent a significant risk to U.S.
rice production. By removing the pathovar designation (pv. oryzicola)
from the currently listed organism, both pathovars would be covered by
the regulations. Originally, we included the pathovar designation
because scientific reports indicated the presence of Xanthomonas oryzae
pv. oryzae in the United States. However, current scientific
information indicates that this pathovar does not occur in the United
States. Entities that currently have possession of Xanthomonas oryzae
pv. oryzae would become regulated as a result of this proposed change
to the regulations.
We are also proposing to add Peronosclerospora sacchari as a
synonym of the listed organism Peronosclerospora philippinensis because
recent scientific research has shown that these two organisms are the
same. Entities that currently have possession of Peronosclerospora
sacchari would become regulated as a result of this proposed amendment
to the regulations.
In addition to the proposed changes to the existing list, the
following pathogens would be added to the list:
Candidatus Liberibacter americanus. This bacterial species
also causes citrus greening disease and has only been reported in Sao
Paulo State, Brazil, where it has been detected in 26 municipalities of
Sao Paulo State since its discovery in 2004. The citrus greening
disease management plan in place for C. Liberobacter asiaticus
mentioned above is specific to that one pathogen--not all three. C.
Liberobacter africanus, which is currently listed, and C. Liberobacter
asiaticus have different biological characteristics than C.
Liberibacter americanus, and each of the pathogens has a potential to
cause different detrimental effects on citrus production in the United
States. There have been no reports of this Liberibacter species in the
United States although the psyllid insect vector (Diaphorina citri) has
been reported in both Florida and Texas. Polymerase chain reaction
(PCR) assays can distinguish this species from C. Liberobacter
africanus and C. Liberobacter asiaticus. While we use the spelling
``Liberobacter'' in the proposed regulations, some sources use the
spelling ``Liberibacter.'' APHIS considers both spellings to be
identical for regulatory purposes.
Phoma glycinicola (formerly Pyrenochaeta glycines). This
fungus causes red leaf blotch of soybean and has been described as very
aggressive, having resulted in yield losses up to 75 percent in
Ethiopia due to defoliation of some soybean cultivars. The fungus
survives in soil for long periods, and the disease may be spread widely
through movement of contaminated seed, soil, or other means. This
pathogen is not present in the United States, but it has the potential
to be a major foliar disease of soybean if introduced.
Phytophthora kernoviae. This fungus-like organism is a
newly reported pathogen of forest trees and shrubs and has only been
reported in England, Wales, and New Zealand. The extent of host damage
and speed with which disease symptoms arose in rhododendron, beech, and
oak prompted England's Department for Environment, Food and Rural
Affairs to identify this pathogen as a serious threat to its woodland
areas. Nursery stock shipped to the United States from the European
Union must be tested for this pathogen. Pathogen spores are easily
spread through airborne mist droplets, rain, wind, or movement of
contaminated plant material or soil. P. kernoviae is considered more
virulent or aggressive in rhododendron than is P. ramorum, which causes
sudden oak death syndrome. This pathogen could be a highly destructive
disease in many common trees and shrubs in the United States if
introduced.
Rathayibacter toxicus. This bacterium causes gumming
disease in ryegrass and is transported into seed heads by species of
Anguina, a genus of nematodes widely present in the United States.
Additionally, if consumed, a neurotoxin produced by this plant pathogen
causes illness or death in mammals. Disease management has been
expensive and difficult in areas affected by this pathogen, with heavy
reliance on use of herbicides on affected grasses.
VS Select Agents and Toxins
APHIS' Veterinary Services (VS) program also convened an
interagency working group to review the list of VS select agents and
toxins and the list of overlap agents and toxins in 9 CFR part 121 in
order to update and revise the lists as necessary.
We are proposing to remove 10 of the 20 overlap select agents and
toxins from the list set out in Sec. 121.4(b). Specifically, we would
remove the following bacteria: Botulinum neurotoxin producing species
of Clostridium, Coxiella burnetii, and Francisella tularensis; the
fungus Coccidioides immitis; Eastern equine encephalitis virus; and the
following toxins: Botulinum neurotoxins, Clostridium perfringens
epsilon toxin, shigatoxin, staphylococcal enterotoxin, and T-2 toxin.
[[Page 49233]]
The interagency working group considered each of the overlap
pathogens with respect to the four criteria for listing found in the
Act (as listed above, under ``Background''), and based on the group's
analysis, APHIS has determined that the 10 overlap select agents and
toxins should be removed from the list because they are naturally found
in the United States, do not pose a significant impact to animal
health, and are not likely candidates for use in an agroterrorism event
directed toward animal health. While any one of these considerations
alone would not likely be grounds for removing an agent or toxin from
the list, the group concluded that all three considerations mentioned
above apply to each of the 10 overlap select agents and toxins
identified.
Botulinum neurotoxin producing species of Clostridium (i.e., C.
botulinum, C. butyricum and C. baratii) are widely distributed in soil,
sediments of lakes and ponds, and decaying vegetation. The species may
be found in any region of the world and some species may occasionally
colonize the intestinal tract of birds and mammals under natural
conditions. The neurotoxins produced by these agents produce the
infectious toxicosis of botulism. There is a well known and established
history of infection and toxicosis in agricultural species associated
with C. botulinum in the United States, and we have concluded that
Botulinum neurotoxin producing species do not pose a serious threat to
American agriculture.
Coccidioides immitis is found naturally and predominantly in the
hot, dry regions of the southwestern United States, where winters are
relatively mild and the soil is alkaline. The introduction of
Coccidioides immitis may result in inapparent infection or
Coccidioidomycosis. Coccidioidomycosis, however, is not a contagious
disease, nor is it a disease of major agricultural concern. While
infections do occur in agricultural species, they appear to be limited.
Coxiella burnetii is a ubiquitous organism that occurs commonly in
animal reservoirs that include mammals, birds, and arthropods
throughout the United States. Infection in ruminants may result in
reproductive failures. Inapparent infection or mild illness does occur,
but abortion is the most significant clinical presentation.
Eastern equine encephalitis virus has been recognized as an
important veterinary pathogen that infects equines and birds during
sporadic outbreaks. Infection results in central nervous system
dysfunction and may result in moderate to high morbidity and mortality.
The virus is maintained naturally in nature in marshes and swamps in an
enzootic bird-mosquito-bird cycle, and is endemic in the United States
along the Atlantic and Gulf coasts. Eastern equine encephalitis virus
does not play a major role in agricultural species of concern, and
equine species are considered a dead-end host of the virus.
Additionally, the working group concluded that because the
following overlap select agents and toxins are naturally found in the
United States, do not pose a significant impact to animal health, and
are not likely candidates for use in an agroterrorism event directed
toward animal health, these select agents and toxins would have a
limited socio-economic impact on American agriculture, and thus should
be removed from the list: Botulinum neurotoxin producing species of
Clostridium, Clostridium perfringens epsilon toxin, Francisella
tularensis, staphylococcal enterotoxin, shigatoxin, and T-2 toxin.
These select agents and toxins would still be regulated by the CDC
under 42 CFR part 73. However, because these select agents and toxins
would no longer be subject to regulation under 9 CFR 121.4, they would
no longer be overlap select agents and toxins. CDC has initiated
rulemaking to revise its regulations to reclassify these select agents
and toxins as HHS select agents and toxins.
To reflect recent changes in scientific nomenclature, we would
amend the list of VS select agents and toxins in Sec. 121.3(b) by
replacing Cowdria ruminantium with Ehrlichia ruminantium; replacing
Mycoplasma mycoides mycoides with Mycoplasma mycoides subspecies
mycoides small colony (MmmSC); and replacing Mycoplasma capricolum/M.
F38/M. mycoides capri with Mycoplasma capricolum subsp.
capripneumoniae.
The World Organization for Animal Health (OIE) defines reportable
Newcastle disease as an infection of birds caused by an avian
paramyxovirus 1 virus possessing certain in vivo and/or molecular
characteristics. To be consistent with OIE's guideline for reporting an
outbreak of Newcastle disease, we would change how we refer to
Newcastle disease in the regulations. Specifically, we would replace
references to ``Newcastle disease virus (velogenic)'' in the list in
Sec. 121.3(b) and in the text of Sec. Sec. 121.3(f)(3)(i),
121.5(a)(3)(i), and 121.9(c)(1) with references to ``virulent Newcastle
disease virus.'' Additionally, we would add a footnote to the entry for
virulent Newcastle disease virus in Sec. 121.3(b). In the footnote we
would define a virulent Newcastle disease virus as either having an
intracerebral pathogenicity index in day-old chicks (Gallus gallus) of
0.7 or greater, or as having an amino acid sequence at the fusion (F)
protein cleavage site that is consistent with virulent strains of
Newcastle disease virus.
In Sec. 121.4(d)(3), we list five overlap toxins that cannot
exceed a specified amount while under the control of a principal
investigator, treating physician or veterinarian, or commercial
manufacturer or distributor. However, because we are proposing to
remove from the overlap select agent list the five overlap toxins
listed in this paragraph--specifically, botulinum neurotoxins,
Clostridium perfringens epsilon toxin, shigatoxin, staphylococcal
enterotoxins, and T-2 toxin--the paragraph would no longer be
necessary. Therefore, we would remove Sec. 121.4(d)(3) in its
entirety.
Section 121.6 deals with the exemptions for overlap select agents
and toxins. Two of the overlap select agents and toxins listed in Sec.
121.6(a)(3)(i) are botulinum neurotoxins and Francisella tularensis. To
reflect our proposed removal of those two select agents and toxins from
our list of overlap select agents and toxins, we would also amend Sec.
121.6 by removing botulinum neurotoxins and Francisella tularensis from
paragraph (a)(3)(i).
Similarly, botulinum neurotoxins and Francisella tularensis are
included in Sec. 121.9(c)(1), which sets out the reporting
requirements for the identification and final disposition of overlap
select agents or toxins contained in a specimen presented for diagnosis
or verification. We would amend Sec. 121.9 by removing botulinum
neurotoxins and Francisella tularensis from paragraph (c)(1).
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
In accordance with the Agricultural Bioterrorism Protection Act of
2002, we are proposing to amend and republish the list of select agents
and toxins that have the potential to pose a severe threat to both
human and animal health, to animal or plant health, or to animal or
plant products. The Act requires the biennial review and republication
of the list of select agents and toxins and the revision of the list as
necessary. This
[[Page 49234]]
action would implement the findings of the second biennial review of
the list.
Certain pathogens or toxins produced by biological organisms that
are released intentionally or accidentally can result in disease, wide-
ranging and devastating impacts on the economy, disruption to society,
diminished confidence in public and private institutions, and large-
scale loss of life. People or livestock can be exposed to these agents
from inhalation, through the skin, or by the ingestion of contaminated
food, feed, or water. Similarly, crops can be exposed to biological
pathogens in several ways--at the seed stage, in the field, or after
harvest.
Because of its size and complexity, the U.S. food and agriculture
system is vulnerable to deliberate attacks, particularly with foreign
diseases that do not now occur domestically. The U.S. livestock
industry, with revenues of approximately $150 billion annually, is
vulnerable to a host of highly infectious and often contagious
biological agents that have been eradicated from the United States, or
have never existed here. Many of these animal-targeted agents could
simply be point-introduced into herds. Given the increasing
concentration and specialization in the livestock industries, this
could cause the immediate halt of movement and export of vast
quantities of U.S. livestock and livestock products. Crops, too, are
vulnerable. They are grown over very large areas (more than 72 million
acres of soybeans were cultivated in the United States in 2003),
exacerbating difficulties in surveillance and monitoring.\1\
---------------------------------------------------------------------------
\1\ Making the Nation Safer: The Role of Science and Technology
in Countering Terrorism. Committee on Science and Technology for
Countering Terrorism, Division on Engineering and Physical Sciences,
National Research Council. National Academy Press (2002).
---------------------------------------------------------------------------
Preparedness for a biological attack against people, crops or
livestock is complicated by the large number of potential agents, the
long incubation periods of some agents, and the potential for secondary
transmission. All of these factors make it vital to prevent the misuse
of biological agents and toxins through registration, biosafety,
security and incident response measures.
This preliminary regulatory impact analysis addresses expected
economic effects of this rule. Expected benefits and costs are examined
in accordance with Executive Order 12866. Expected impacts for small
entities are also considered, as required by the Regulatory Flexibility
Act.
Benefits and Costs
This rule would update the select agents and toxins listed in 7 CFR
part 331 and 9 CFR part 121. Those parts of the CFR require
registration, biosafety, incident response and security measures for
the possession, use and transfer of the listed select agents and
toxins. These parts are intended to prevent the misuse of those select
agents and toxins, and therefore reduce the potential for harm to
humans, animals, animal products, plants or plant products in the
United States. Should any select agent or toxin be intentionally
introduced into the United States, the consequences could be
significant. Direct losses in agriculture could occur as a result of
the exposure, such as death or debility of affected production animals,
or yield loss in plants. Industry could also be affected through the
imposition of domestic and foreign quarantines and the resulting loss
of markets. The Federal and State governments would also incur costs
associated with eradication and quarantine enforcement to prevent
further spread, and, in the case of intentional introduction, law
enforcement. In addition, there is the potential for a disruption in
the domestic food supply, whether through contamination, consumer
perception, or both. Past food safety incidents have shown that
consumer perceptions (both domestic and international) about the safety
of an implicated food product and about the producing country or
sector's ability to produce safe food can be slow to recover and can
have a lasting influence on food demand and global trade.\2\ As such,
the benefits associated with the rule are the avoided losses to the
animals or plants that could be attacked by these organisms, and their
products and markets.
---------------------------------------------------------------------------
\2\ Buzby, J.C. Effects of food-safety perceptions on food
demand and global trade. Changing Structure of Global Food
Consumption and Trade/WRS-01-1. Economic Research Service/USDA.
---------------------------------------------------------------------------
The costs associated with outbreaks can be very high, as is
demonstrated by natural outbreaks associated with select agents. For
example, it has been estimated that the losses to agriculture and the
food chain from a recent foot-and-mouth disease (FMD) outbreak in the
United Kingdom, including the costs compensated by the government,
amounted to about [pound]3.1 billion ($4.7 billion). In 1999, it was
estimated that the potential impacts of an FMD outbreak in California
alone would be between $8.5 billion and $13.5 billion.\3\
---------------------------------------------------------------------------
\3\ 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.
---------------------------------------------------------------------------
The above-cited consequences relate to natural or accidental
introduction. Deliberate introduction greatly increases the probability
of a select 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.
Any entity that possesses, uses, or transfers listed select agents
or toxins is required to comply with the select agent regulations.
These entities include research and diagnostic facilities; Federal,
State and university laboratories; and private commercial and non-
profit enterprises. The regulations include requirements for
registering the possession, use, transfer or destruction of select
agents or toxins. In addition, the entity is also required to ensure
that the facility where the agent or toxin is housed has adequate
biosafety and containment measures; ensure that the physical security
of the premises are adequate; ensure that all individuals with access
to select agents or toxins have the appropriate education, training,
and/or experience to handle such agents or toxins; ensure that all
individuals with access to select agents or toxins have an approved
security risk assessment; and maintain complete records concerning
activities related to the select agents or toxins.
While any entity affected by the changes proposed in this rule may
incur costs in complying with the select agent regulations, the
proposed changes are expected to have minimal impacts. The proposed
changes to the PPQ select agent list include the addition of four
pathogens to the list, the removal of an organism from the list, and
technical changes to the names of organisms currently listed. These
changes should only affect a small number of entities. The plant pest
permit database maintained by APHIS indicates that very few entities
currently possess any of the agents that would be added to the list. In
addition, most of the entities that do possess these agents are already
registered due to their possession of other listed agents or toxins.
The few entities that would be affected by the removal of organisms
from the list would no longer be required to comply with the select
agent regulations with regard to those removed organisms.
The proposed changes to the VS select agent list include the
removal of agents, the redefinition of an agent, and technical changes
to the nomenclature used for some agents in the list to be
[[Page 49235]]
consistent with OIE definitions. The agents that are proposed for
removal are overlap agents regulated by both USDA and HHS. HHS would
continue to regulate these agents as HHS-only agents. Therefore, any
entity in possession of these agents would continue to be subject to
select agent regulations as administered by HHS. The redefinition of
Newcastle disease virus (velogenic) to virulent Newcastle disease virus
may lead to new registrants. It is possible that additional entities
may be in possession of a virulent strain of Newcastle disease virus
that does not fit the current definition. However, these strains have
not circulated in the United States since the 1970s. In addition,
entities most likely to be in possession of virulent Newcastle disease
virus are already in possession of Newcastle disease virus (velogenic)
and therefore already registered.
Alternatives Considered
The alternative to this rule would be to leave the regulations
unchanged. In this case, the lists of select agents in 7 CFR part 331
and 9 CFR part 121 would remain unchanged. However, APHIS has conducted
reviews of these lists and concluded that changes are necessary to
ensure that the lists contain those biological agents and toxins that
have the potential to pose a severe threat to both human and animal
health, to plant health, or to animal and plant products. These reviews
were conducted in accordance with the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, which requires a
biennial review and republication of the select biological agent and
toxin list, with revisions as appropriate. Therefore, this alternative
was rejected.
Conclusion
This proposed rule would update the PPQ, VS, and overlap select
agent and toxin lists. The regulation of select agents and toxins is
intended to prevent their misuse and thereby reduce the potential for
harm to animals, animal products, plants or plant products in the
United States. Should any select agent or toxin be intentionally
introduced into the United States, the consequences would be
significant. Consequences could include disruption of markets,
difficulties in sustaining an adequate food and fiber supply, and the
potential spread of disease infestations over large areas. In any
animal or plant disease outbreak, the government would incur the costs
of eradication or control. Industry would be affected through the
imposition of domestic and foreign quarantines and the resulting loss
of markets, and the destruction of infected or exposed animals or
plants, or animal products or plant products. Even though compensation
may be paid for the destroyed property, repopulating (flocks, herds,
fields, etc.) may be time-consuming, with additional losses from idle
capital and lost markets. In addition, there is the potential for a
disruption in the domestic food supply, whether through contamination,
consumer perception, or both. Such a disruption can have a lasting
influence on food demand and global trade.
Entities most likely to be affected by this rule are laboratories
and other institutions conducting research and related activities that
involve the use of the newly added select agents and toxins. The impact
of these changes is expected to be minimal, however. Indications are
that very few entities currently possess any of the agents or toxins
that would be added to the list of select agents and toxins. Entities
that would be affected by the removal of agents or toxins from the list
would no longer be required to comply with the regulations with regard
to those removed agents or toxins. Other changes proposed would not
affect what agents or toxins are listed but rather the nomenclature by
which those agents and toxins are identified, and therefore would have
no economic impact.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
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 proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
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 propose to amend 7 CFR part 331 and 9 CFR part 121
as follows:
TITLE 7--[AMENDED]
PART 331--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
1. The authority citation for part 331 continues to read as
follows:
Authority: 7 U.S.C. 8401; 7 U.S.C. 2.22, 2.80, and 371.3.
2. In Sec. 331.3, paragraph (b) is revised to read as follows:
Sec. 331.3 PPQ select agents and toxins
* * * * *
(b) PPQ select agents and toxins:
Candidatus Liberobacter africanus (Candidatus Liberibacter
africanus);
Candidatus Liberobacter americanus (Candidatus Liberibacter
americanus);
Peronosclerospora philippinensis (Peronosclerospora sacchari);
Phoma glycinicola (formerly Pyrenochaeta glycines);
Phytophthora kernoviae;
Ralstonia solanacearum, race 3, biovar 2;
Rathayibacter toxicus;
Sclerophthora rayssiae var. zeae;
Synchytrium endobioticum;
Xanthomonas oryzae;
Xylella fastidiosa (citrus variegated chlorosis strain).
* * * * *
TITLE 9--[AMENDED]
PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
3. The authority citation for part 121 continues to read as
follows:
Authority: 7 U.S.C. 8401; 7 U.S.C. 2.22, 2.80, and 371.4.
4. In Sec. 121.3, footnotes 1 and 2 are redesignated as footnotes
2 and 3, respectively, and paragraph (b) is revised to read as follows:
[[Page 49236]]
Sec. 121.3 VS select agents and toxins
* * * * *
(b) VS select 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;
Ehrlichia ruminantium (Heartwater);
Foot-and-mouth disease virus;
Goat pox virus;
Japanese encephalitis virus;
Lumpy skin disease virus;
Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1);
Menangle virus;
Mycoplasma capricolum subspecies capripneumoniae (contagious
caprine pleuropneumonia);
Mycoplasma mycoides subspecies mycoides small colony (MmmSC)
(contagious bovine pleuropneumonia);
Peste des petits ruminants virus;
Rinderpest virus; Sheep pox virus;
Swine vesicular disease virus;
Vesicular stomatitis virus (exotic).
Virulent Newcastle disease virus \4\
---------------------------------------------------------------------------
\4 \ A virulent Newcastle disease virus (avian paramyxovirus
serotype 1) has an intracerebral pathogenicity index in day-old
chicks (Gallus gallus) of 0.7 or greater or having an amino acid
sequence at the fusion (F) protein cleavage site that is consistent
with virulent strains of Newcastle disease virus.
---------------------------------------------------------------------------
* * * * *
5. Section 121.4 is amended as follows:
a. By revising paragraph (b) to read as set forth below.
b. In paragraphs (c) and (d), by redesignating footnotes 3 and 4 as
footnotes 4 and 5, respectively.
c. By removing paragraph(d)(3).
d. In paragraph (f)(3)(i), by removing the words ``Botulinum
neurotoxins,'' and ``Francisella tularensis,''.
Sec. 121.4 Overlap select agents and toxins.
* * * * *
(b) Overlap select agents and toxins:
Bacillus anthracis;
Brucella abortus;
Brucella melitensis;
Brucella suis;
Burkholderia mallei;
Burkholderia pseudomallei;
Hendra virus;
Nipah virus;
Rift Valley fever virus;
Venezuelan equine encephalitis virus.
* * * * *
Sec. 121.5 [Amended]
6. In Sec. 121.5, paragraph (a)(3)(i) is amended by removing the
words ``Newcastle disease virus (velogenic)'' and adding the words
``virulent Newcastle disease virus'' in their place.
Sec. 121.6 [Amended]
7. Section 121.6, paragraph (a)(3)(i) is amended by removing the
words ``Botulinum neurotoxins,'' and ``Francisella tularensis,''.
Sec. Sec. 121.7 and 121.8 [Amended]
8. Sections 121.7 and 121.8 are amended by redesignating footnotes
5, 6, and 7 as footnotes 6, 7, and 8, respectively.
Sec. 121.9 [Amended]
9. In Sec. 121.9, paragraph (c)(1) is amended by removing the
words ``Botulinum neurotoxins,'' and ``Francisella tularensis,'', and
by removing the words ``Newcastle disease virus (velogenic)'' and
adding the words ``virulent Newcastle disease virus'' in their place.
Sec. Sec. 121.12 through 121.16 [Amended]
10. Sections 121.12 through 121.16 are amended by redesignating
footnotes 8 through 13 as footnotes 9 through 14, respectively.
Sec. 121.20 [Amended]
11. Section 121.20 is amended by redesignating footnote 14 as
footnote 15.
Done in Washington, DC, this 22nd day of August 2007.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-17039 Filed 8-27-07; 8:45 am]
BILLING CODE 3410-34-P