[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Rules and Regulations]
[Pages 52173-52189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20852]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 71, 83, and 93

[Docket No. APHIS-2007-0038]
RIN 0579-AC74


Viral Hemorrhagic Septicemia; Interstate Movement and Import 
Restrictions on Certain Live Fish

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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

SUMMARY: We are establishing regulations to restrict the interstate 
movement and importation into the United States of live fish that are 
susceptible to viral hemorrhagic septicemia, a highly contagious 
disease of certain fresh and saltwater fish. In 2005 and 2006, viral 
hemorrhagic septicemia was detected in freshwater fish in several of 
the Great Lakes and related tributaries. The disease has been 
responsible for several large-scale die-offs of wild fish in the Great 
Lakes region. This action is necessary to prevent further introductions 
into, and dissemination within, the United States of viral hemorrhagic 
septicemia.

DATES: Effective date: This interim rule is effective November 10, 
2008.
    Comment dates: Comments on the interim rule are due on or before 
November 10, 2008. Comments on the environmental assessment are due on 
or before October 9, 2008.

ADDRESSES: You may submit comments by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0038 to submit or view comments and 
to view supporting and related materials available electronically.
    <bullet> Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2007-0038, 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-2007-0038.
    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: Dr. P. Gary Egrie, Senior Staff 
Veterinary Medical Officer, National Center for Animal Health Programs, 
VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737-1231; (301) 
734-0695; or Dr. Peter L. Merrill, Senior Staff Veterinarian, National 
Center for Import and Export, VS, APHIS, 4700 River Road Unit 39, 
Riverdale, MD 20737-1231; (301) 734-8364.

SUPPLEMENTARY INFORMATION:

[[Page 52174]]

Background

    Viral hemorrhagic septicemia (VHS) is a highly contagious disease 
of certain fresh and saltwater fish, caused by a rhabdovirus. It is 
listed as a notifiable disease by the World Organization for Animal 
Health (OIE). The pathogen produces variable clinical signs in fish 
including lethargy, skin darkening, exophthalmia, pale gills, a 
distended abdomen, and external and internal hemorrhaging. The 
development of the disease in infected fish can result in substantial 
mortality. Other infected fish may not show any clinical signs or die, 
but may be lifelong carriers and shed the virus.
    Four genotypes of VHS virus have been identified, and appear to be 
distributed geographically. Genotypes I, II, and III are mainly found 
in Europe or Asia and are highly pathogenic to rainbow trout. The 
fourth genotype, referred to as North American type IV, has been found 
in wild fish from the East and West coasts of North America 
periodically since 1988. This genotype is less virulent to commercially 
important fish stocks than the European/Asian VHS virus genotypes 
because it results in less morbidity and mortality than those 
genotypes.
    In 2005 and 2006, VHS outbreaks were reported in wild fish from the 
Great Lakes in both Canada and the United States. The mortality 
associated with numerous individual outbreaks ranged from just a few 
fish to many thousands per outbreak.
    The 2005 and 2006 VHS outbreaks were the first freshwater 
isolations of VHS virus in the United States. The strain of VHS virus 
isolated from all of these outbreaks, while similar to North American 
type IV found in saltwater, has been shown to be genetically distinct 
from other known strains of VHS virus, and is apparently capable of 
causing substantial morbidity and mortality in many native species of 
fish. It is currently believed that the saltwater-adapted type IV 
strain mutated into a strain that is affecting new host fish species in 
new environments in both Canada and the United States. The extent of 
VHS viral distribution is not yet known; however, reported epizootics 
attributable to VHS since 2005 have been limited to wild fish from the 
Great Lakes watershed.
    The emerging strain (tentatively called North American type IV(b) 
to differentiate it from what will likely be renamed type IV(a)) has 
caused a number of mass mortalities in wild fish populations, ranging 
up to many thousands of fish. Some outbreaks were reported to occur at 
temperatures that had not been previously associated with the 
development of VHS disease. Virus growth is generally inhibited when 
water temperatures are above 15 [deg]C; however, this VHS virus appears 
to have a much wider temperature range. According to research conducted 
at the U.S. Geological Survey, type IV(b), in vitro, grows best at 15 
[deg]C and up to 20 [deg]C where growth begins to decline. Type IV(b) 
viral growth was inhibited at 25 [deg]C. Additionally, all the species 
of fish in the 2005 and 2006 North American outbreaks had not 
previously been known to be susceptible to VHS infection and/or 
disease. The list of fish species susceptible to VHS, as determined by 
the Animal and Plant Health Inspection Service (APHIS), currently 
includes 28 separate species. These species include baitfish, 
recreationally important fish, and food fish such as salmonids and 
catfish.

Federal Order

    The Animal Health Protection Act (AHPA) authorizes the Secretary of 
Agriculture to prohibit or restrict the importation or movement in 
interstate commerce of any animal, article, or means of conveyance if 
the Secretary determines that the prohibition or restriction is 
necessary to prevent the introduction or dissemination of any pest or 
disease of livestock into or within the United States.
    In response to recent outbreaks of VHS in wild fish populations in 
the Great Lakes, the Administrator determined that it was necessary, in 
order to prevent the spread of VHS into aquaculture facilities, to 
prohibit or restrict the interstate movement and importation of VHS-
regulated species of live fish. Accordingly, on October 24, 2006, APHIS 
issued a Federal Order prohibiting the importation of VHS-susceptible 
species of live fish from two Canadian provinces (Ontario and Quebec) 
into the United States and the interstate movement of the same species 
of live fish from the eight States bordering the Great Lakes (Illinois, 
Indiana, Michigan, Minnesota, New York, Ohio, Pennsylvania, and 
Wisconsin).
    At the time the Federal Order was issued, only three States 
(Michigan, New York, and Ohio) had been affected by VHS within the 
jurisdictional borders of their States. Epidemiologic considerations 
such as the commonality of the Great Lakes watershed influenced APHIS' 
decision to include all of the States within the Great Lakes watershed 
as ``affected'' or ``at-risk.''
    In October 2006, APHIS held a 2-day meeting with Federal, State, 
Tribal, and industry representatives to discuss VHS and the Federal 
Order, and to obtain information regarding State regulations and 
diagnostic testing programs related to VHS. During this meeting, APHIS 
received several recommendations from participants regarding 
modifications to the Federal Order that could be made to alleviate 
impacts on industry and related businesses in the Great Lakes region 
while still protecting against the spread of VHS.
    APHIS also met with the Department of Fisheries and Oceans Canada 
(DFO) and the Canadian Food Inspection Agency (CFIA) in November 2006. 
At that time, Canada provided APHIS with information about its VHS 
testing program and requested that APHIS amend the Federal Order to 
allow the importation of fish that Canada certifies as VHS-free.
    Based on the information gathered at these meetings, on November 
14, 2006, APHIS modified the Federal Order to allow VHS-susceptible 
species of live salmonid fish from the affected Canadian provinces to 
be imported into the United States if the shipment meets the 
regulations of the U.S. Fish and Wildlife Service (FWS) in 50 CFR 
16.13(a)(3) and 16.13(b). The FWS regulations in 50 CFR 16.13(a)(3) 
provide that live or dead uneviscerated salmonid fish are prohibited 
entry into the United States for any purpose except by direct shipment 
accompanied by a certification that: (1) The fish lots from which the 
shipments originated have been sampled; (2) viral assays have been 
conducted on the samples according to methods specified in the 
regulations; and (3) certain pathogens, including the virus causing 
VHS, have not been detected in the fish stocks from which the samples 
were taken. The FWS regulations further provide that live salmonid fish 
can be imported into the United States only with the written approval 
of the Director of FWS. The regulations in 50 CFR 16.13(b) set out the 
information that must be included in the certification statement 
required in Sec.  16.13(a)(3).
    The modified Federal Order also established conditions under which 
VHS-susceptible species of live fish could be moved from the eight 
States bordering the Great Lakes. Specifically, the Order provided that 
VHS-susceptible live fish may be moved interstate for slaughter if the 
fish are: (1) Intended for human consumption; (2) transported to a 
State-inspected slaughter facility that discharges waste water into a 
municipal sewage system that includes waste water disinfection, or 
disposes of waste water in a non-discharging settling pond or a 
settling pond that disinfects according to State

[[Page 52175]]

and Federal requirements, and renders or composts offal, including 
carcasses; and (3) accompanied by a valid VS Form 1-27 issued by an 
APHIS area office if not tested for VHS.
    The Order also provided that VHS-susceptible fish may be moved 
interstate to research and diagnostic laboratories provided the fish 
are: (1) Accompanied by a valid VS Form 1-27 issued by an APHIS area 
office stating that the fish are destined for a research or diagnostic 
laboratory that has been approved by a State, Tribal, or Federal 
competent authority for aquatic animal health and (2) received at a 
laboratory where waste fluids and carcasses are considered medical 
waste and disposed of according to State and Federal requirements. 
Finally, the Order provided that VHS-susceptible fish may be moved 
interstate for purposes other than slaughter, research, or diagnostics 
provided the fish are transported with documentation from the 
appropriate State, Tribal, or Federal competent authority for aquatic 
animal health stating that the fish have tested negative for VHS virus 
under specific national and international standards.
    In January 2007, APHIS hosted public meetings in Lakewood, CO; 
Memphis, TN; Romulus, MI; and Coraopolis, PA. The purpose of the 
meetings was to present current information about the outbreaks of VHS 
and actions taken to prevent its spread, and to give interested 
stakeholders an opportunity to present data and views concerning the 
possible regulation of VHS by the Agency.
    On May 4, 2007, APHIS modified the Federal Order to allow for the 
catch-and-release of VHS-susceptible regulated fish in waters that 
cross State and international boundaries. These activities include 
recreational fishing, tournaments, competitions, fishing derbies, or 
other types of contests where individuals catch, compare, and release 
live VHS-susceptible fish. However, catch-and-release fishing 
activities do not include the movement of VHS-susceptible fish intended 
to be used as live bait. Catch and release fishing activities are 
considered low risk for spreading VHS virus because fish are caught and 
released within the same body of water and within a limited geographic 
area over a limited time period. In contrast, the use of live bait is 
considered high risk for spreading VHS virus because the bait is used 
for fishing in multiple bodies of water over a broader geographic area.
    On November 8, 2007, APHIS modified the Federal Order by revising 
the list of VHS-susceptible species. We removed 12 species and added 2 
new freshwater fish species that are susceptible to VHS. We also 
clarified the scientific names of several species. Currently, there are 
28 separate species of fish listed.
    The original October 2006 Federal Order listed 37 species of VHS-
susceptible fish, including all species listed by the OIE as 
susceptible to all known strains of VHS. The updated list includes only 
those species found in freshwater environments in the United States and 
Canada that have been infected by VHS under natural (i.e., 
nonexperimental) conditions of exposure and from which VHS virus has 
been isolated by cell culture, with confirmation of strain identity 
through molecular detection. Anadromous fish species \1\ that have 
migrated into freshwater and from which VHS strain type IV(a) is 
isolated are excluded.
---------------------------------------------------------------------------

    \1\ We define anadromous fish as fish that are born and spawn in 
freshwater, but which spend part of their lifecycle in saltwater.
---------------------------------------------------------------------------

    Finally, on April 2, 2008, APHIS modified the Federal Order to 
allow VHS-susceptible species of live non-salmonid fish from affected 
Canadian provinces to be imported into the United States for direct 
slaughter if accompanied by an APHIS permit.
    The Federal Order was issued in response to the rapid spread of VHS 
in the Great Lakes region and was designed to prevent the introduction 
of VHS into aquaculture facilities by controlling the movement of VHS-
susceptible fish species while APHIS gathered more information about 
the disease and developed a regulatory program that would allow the 
interstate movement and importation of VHS-susceptible fish under 
certain conditions. Taking into consideration the information provided 
by States, Tribes, and other interested stakeholders, APHIS has now 
developed a regulatory framework for the interstate movement and 
importation of VHS-susceptible fish species.
    In the Federal Order, we used the terms ``VHS-susceptible species'' 
and ``VHS-affected or at-risk States or regions;'' however, for the 
purposes of these regulations we will use the terms ``VHS-regulated 
species'' and ``VHS-regulated areas or regions.''
    Accordingly, we are amending the interstate movement regulations in 
title 9, subchapter C, by adding a new part 83, ``Viral Hemorrhagic 
Septicemia'' (Sec. Sec.  83.1 through 83.7). We are also amending 9 CFR 
part 71 to provide that fish affected with VHS may be moved interstate 
in accordance with part 83. Finally, we are amending the animal import 
regulations in 9 CFR part 93, subpart I, ``Aquatic Animal Species'' 
(Sec. Sec.  93.900 through 93.916). The new interstate movement and 
importation requirements are discussed in detail below.
    As stated previously in this document, the AHPA authorizes the 
Secretary of Agriculture to prohibit or restrict the importation or 
movement in interstate commerce of any animal, article, or means of 
conveyance if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction or dissemination 
of any pest or disease of livestock into or within the United States. 
Ballast water (i.e., water with its suspended matter taken on board a 
ship to control trim, list, draught, stability, or stresses of a ship) 
can be taken onto a ship in its port of origin and discharged into the 
water body of the ship's destination port, making it a potential 
pathway for VHS virus. APHIS has neither the regulatory authority nor 
the technical expertise to safely regulate ballast water discharge. 
Therefore, we do not address ballast water in this interim rule. APHIS 
will assist the U.S. Coast Guard, which has clear regulatory authority 
for ballast water, in their development of ballast water discharge 
standards.

Definitions (Sec. Sec.  83.1 and 93.900)

    In Sec. Sec.  83.1 and 93.900, we define the terms used in the 
regulations. In Sec.  83.1, we set out the following standard terms and 
definitions, which are found throughout title 9, subchapter C: 
Accredited veterinarian, Administrator, Animal and Plant Health 
Inspection Service (APHIS), APHIS representative, Department, 
interstate, moved (movement), person, State, and State animal health 
official. These terms and their definitions are set out in the 
regulatory text at the end of this document.
    In both Sec. Sec.  83.1 and 93.900, we define terms that are 
specific to VHS and aquatic animals. These terms are anadromous fish, 
catch-and-release fishing, cultured fish, secure water source, VHS 
virus, and viral hemorrhagic septicemia (VHS). These terms are defined 
as follows:
    Anadromous fish. Fish that are born and spawn in freshwater, but 
which spend part of their lifecycle in saltwater.
    Catch-and-release fishing. Fishing for pleasure or for recreational 
purposes, including tournaments, organized fishing competitions, 
fishing derbies, or other types of contests where individuals catch, 
compare, and release live VHS-regulated fish. This term excludes VHS-
regulated fish used, or intended to be used, as live bait.
    Cultured fish. Fish of the same species and age class, originating 
from the same

[[Page 52176]]

broodstock and on the same water supply, whose care is partly or 
totally managed from the first life stage onwards.
    Secure water source. A biosecure water supply that does not contain 
pathogens or has not had the opportunity to be contaminated with 
pathogens. Biosecure water supplies include well, spring, or borehole 
water; surface water that does not contain fish populations; or water 
that has been treated to eliminate aquatic animal pathogens.
    VHS virus. Any North American (type IV) strain of VHS virus, a 
rhabdovirus of fish.
    Viral hemorrhagic septicemia (VHS). A disease caused by infection 
with VHS virus.
    Due to slight differences in terminology and program requirements, 
some VHS-specific terms are defined differently in Sec. Sec.  83.1 and 
93.900. These terms are approved laboratory, competent authority, VHS-
regulated area, VHS-regulated region, and VHS-regulated fish.
    In Sec.  83.1, approved laboratory is defined as a laboratory 
authorized by a State, Tribal, or Federal competent authority for 
aquatic animal health to perform assays for the detection of VHS virus 
while, in Sec.  93.900, approved laboratory is defined as a laboratory 
authorized by the competent authority of a country for aquatic animal 
health to perform assays for the detection of VHS virus.
    In Sec.  83.1, we define competent authority as the State, Tribal, 
or Federal entity with the legal responsibility for ensuring or 
supervising the implementation of aquatic animal health measures. This 
definition is similar to the current definition for competent authority 
in Sec.  93.900, which refers to the national veterinary services or 
other authority of a country responsible for aquatic animal health.
    In Sec.  83.1, VHS-regulated area is defined as any State or 
portion of a State listed in accordance with Sec.  83.4. Section 93.900 
defines VHS-regulated region as any region listed in accordance with 
Sec.  93.910.
    In Sec.  83.1, we define VHS-regulated fish as any fish species 
listed in accordance with Sec.  83.4 while, in Sec.  93.900, we define 
VHS-regulated fish as any fish species listed in accordance with Sec.  
93.910.
    Finally, in Sec.  83.1, we define the term Interstate Certificate 
of Inspection (ICI). This term is specific to the interstate movement 
requirements in part 83 and is defined as an official document issued 
by an accredited veterinarian or a State, Tribal, or Federal competent 
authority in the originating State that certifies that the fish being 
moved interstate originated from a facility that has been found free of 
VHS virus.

Interstate Movement

General Restrictions; Conditions of Movement (Sec. Sec.  83.2 and 83.3)

    Section 83.2 provides that live VHS-regulated fish may not be moved 
interstate from a VHS-regulated area except in compliance with part 83. 
Section 83.3 sets forth the conditions under which live VHS-regulated 
fish may be moved interstate.
    Paragraph (a) of Sec.  83.3 provides that, apart from the 
exceptions provided in paragraphs (b) through (e) of that section, live 
VHS-regulated fish, including fish moved to live fish markets, may only 
be moved interstate from a VHS-regulated area if the fish originated 
from a facility that has been found free of the VHS virus in accordance 
with Sec.  83.6 and the fish are accompanied by an Interstate 
Certificate of Inspection (ICI) issued by an accredited veterinarian or 
a State, Tribal, or Federal competent authority for aquatic animal 
health.
    Paragraph (b) of Sec.  83.3 provides that live VHS-regulated fish 
may be moved interstate directly to a slaughtering establishment 
provided the fish are transported in a sealed conveyance and 
accompanied by a VS Form 1-27. The VS Form 1-27 is available through 
APHIS' Veterinary Services offices, and can be issued by a State, 
Tribal, Federal, or accredited veterinarian. The fish must be moved to 
a slaughtering establishment that discharges its waste water to a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus, or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus. In addition, any water used to transport the 
fish must be disposed of to a municipal sewage system that includes 
waste water disinfection sufficient to neutralize any VHS virus, or to 
either a non-discharging settling pond or a settling pond that 
disinfects, according to all applicable local, State, and Federal 
regulations, sufficiently to neutralize any VHS virus. These 
requirements are necessary to ensure that water waste discharged to the 
environment (or to a public waterway) does not contain any viable VHS 
virus. Offal, including carcasses, from the slaughtering establishment 
must be either rendered or composted.
    Paragraph (c) of this section extends these same provisions to fish 
moved for research or diagnostic purposes. Paragraph (d) specifies that 
live VHS-regulated fish may be moved interstate during catch-and-
release fishing.
    Finally, paragraph (e) provides that the Administrator may, on a 
case-by-case basis, permit the interstate movement of fish whose 
movement is not otherwise provided for in part 83, under such 
conditions as the Administrator may prescribe in each case to prevent 
the introduction and dissemination of VHS.

VHS-Regulated Fish and VHS-Regulated Areas (Sec.  83.4)

    Paragraph (a) of Sec.  83.4 provides that APHIS will list as a VHS-
regulated fish any fish species found in freshwater to be susceptible 
to the North American (type IV) strain of VHS virus under natural 
(i.e., non-controlled) conditions of exposure and from which VHS virus 
has been isolated in cell culture or other assay determined by the 
Administrator to be adequate to detect VHS virus, with confirmation of 
strain identity through genetic sequencing. Anadromous fish that have 
migrated into freshwater and from which VHS strain type IV(a) has been 
isolated will not be considered VHS-regulated fish under this rule 
because this strain appears to be less pathogenic than type IV(b). Type 
IV(a) has been in the United States since at least 1988 and has not 
resulted in large-scale fish mortalities across a broad range of 
species such as those that were associated with the outbreaks of type 
IV(b) in the Great Lakes.
    Paragraph (a) further provides that, when APHIS determines that a 
species meets the criteria of this paragraph and should be added to the 
list of VHS-regulated fish, APHIS will publish a notice in the Federal 
Register announcing that determination.
    Paragraph (b) of this section provides that APHIS will list as a 
VHS-regulated area each State or portion of a State from which VHS 
virus has been detected in any VHS-regulated fish species (with or 
without clinical signs of disease) in a water source that is not a 
secure water source, or which the Administrator determines to be at 
risk of having VHS based on criteria such as inadequate surveillance or 
movement requirements, or other epidemiologic information.
    Paragraph (b) further provides that, if the Administrator 
determines that a State or portion of a State meets the criteria for a 
VHS-regulated area, APHIS will publish a notice of its decision in the 
Federal Register and take comments from the public. The designation as 
a VHS-regulated area will become

[[Page 52177]]

effective upon publication of this notice. After reviewing the 
comments, APHIS will issue a second notice in the Federal Register 
announcing its decision on whether or not the designation as a VHS-
regulated area will remain in effect.
    Paragraph (c) provides that these lists of VHS-regulated fish and 
VHS-regulated areas will be maintained on the APHIS aquaculture Web 
site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/aquaculture. The purpose of maintaining the lists on the Web site is to 
maintain the most accurate, up-to-date list possible in a location 
where affected parties can easily view recent changes. The Web site 
list should be particularly useful when a new area is added to the 
list, which occurs immediately after APHIS receives and confirms 
reports of a new outbreak. Changes to lists maintained in the 
regulations typically take several weeks, so maintaining the lists on 
the Web site will allow APHIS to communicate new developments and take 
prompt action as soon as it confirms an outbreak or identifies a new 
species of fish affected by VHS.
    Paragraph (c) also includes an address from which the lists of VHS-
regulated fish and VHS-regulated areas may be obtained from APHIS.
    As of this rule's effective date, the following fish species and 
areas are regulated because of VHS:

VHS-Regulated Areas

    Illinois, Indiana, Michigan, Minnesota, New York, Ohio, 
Pennsylvania, Wisconsin.

                       VHS-Regulated Fish Species
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Black crappie.........................  Pomoxis nigromaculatus.
Bluegill..............................  Lepomis macrochirus.
Bluntnose minnow......................  Pimephales notatus.
Brown bullhead........................  Ameiurus nebulosus.
Brown trout...........................  Salmo trutta.
Burbot................................  Lota lota.
Channel catfish.......................  Ictalurus punctatus.
Chinook salmon........................  Oncorhynchus tshawytscha.
Emerald shiner........................  Notropis atherinoides.
Freshwater drum.......................  Aplodinotus grunniens.
Gizzard shad..........................  Dorosoma cepedianum.
Lake whitefish........................  Coregonus clupeaformis.
Largemouth bass.......................  Micropterus salmoides.
Muskellunge...........................  Esox masquinongy.
Northern pike.........................  Esox lucius.
Pumpkinseed...........................  Lepomis gibbosus.
Rainbow trout.........................  Oncorhynchus mykiss.
Rock bass.............................  Ambloplites rupestris.
Round goby............................  Neogobius melanostomus.
Shorthead redhorse....................  Moxostoma macrolepidotum.
Silver redhorse.......................  Moxostoma anisurum.
Smallmouth bass.......................  Micropterus dolomieu.
Spottail shiner.......................  Notropis hudsonius.
Trout-Perch...........................  Percopsis omiscomaycus.
Walleye...............................  Sander vitreus.
White bass............................  Morone chrysops.
White perch...........................  Morone americana.
Yellow perch..........................  Perca flavescens.
------------------------------------------------------------------------


    This interim rule does not provide a process by which APHIS will 
remove areas from the list of VHS-regulated areas if the area petitions 
APHIS for a reassessment of its disease status. As discussed in more 
detail below under the heading ``Related Issues on Which APHIS is 
Seeking Comment,'' we particularly invite comments on which specific 
factors APHIS should consider before removing an area from the list of 
VHS-regulated areas.

Interstate Certificate of Inspection (ICI) (Sec.  83.5)

    Paragraph (a) of Sec.  83.5 requires that live VHS-regulated fish 
moved interstate in accordance with Sec.  83.3(a) be accompanied by an 
ICI issued by an accredited veterinarian or a State, Tribal, or Federal 
competent authority for aquatic animal health. This paragraph further 
provides that an ICI will be valid for 30 days from the date of 
issuance.
    Paragraph (b) of this section requires that the ICI state that: (1) 
The live fish were inspected by the accredited veterinarian or a State, 
Tribal, or Federal competent authority for aquatic animal health within 
72 hours prior to shipment and found to be free of any clinical signs 
of disease consistent with VHS, and (2) the live fish covered by the 
ICI originated in an area or facility that has demonstrated freedom 
from VHS in accordance with Sec.  83.6.
    In addition, the section specifies that the ICI must contain the 
following information:
    <bullet> The name, address, and phone number of the owner or 
owner's agent.
    <bullet> The name, address, and phone number of the facility in 
which the fish originated.
    <bullet> The name, address, and phone number of the person or 
facility who will receive the fish; or the State or other regulatory 
authority responsible for oversight of the environment in which the 
fish will be introduced.
    <bullet> The name, address, and phone number of the shipping or 
transportation company.
    <bullet> The species and number of the fish.
    <bullet> The lot (or other) identification of the shipment.
    <bullet> The name, address, and phone number of the approved 
laboratory that performed the testing required by Sec.  83.6 and the 
number of fish tested, the assay(s) used for testing, and the test 
results.
    <bullet> The date the certificate was issued.
    <bullet> The type of water source according to Sec.  83.6(c).
    Requiring the issuance of an ICI will ensure that appropriate 
testing procedures were applied as well as allow for traceback should 
an inspector encounter a problem with or have questions about a 
shipment.

Testing Requirements (Sec.  83.6)

    Paragraph (a) of Sec.  83.6 provides that a facility can 
demonstrate freedom from VHS through negative testing results provided 
by an approved laboratory. Paragraph (a) also specifies that such 
testing must:
    <bullet> Be conducted with a testing sample size that provides for 
a 95 percent confidence level of detecting a 2 percent prevalence of 
infection in the facility.
    <bullet> Include virus isolation or other assay authorized by the 
Administrator, using appropriate cell lines to detect VHS virus, if 
present. All suspect VHS cytopathic effects must be positively 
identified as VHS through molecular assays and/or genetic sequencing.
    <bullet> Use proportional numbers of each VHS-regulated fish 
species which might be present in the facility.
    <bullet> Be conducted at water temperatures between 50 and 72 
[deg]F, or at other times or under environmental conditions when VHS is 
most likely to be detected, if present.
    Facilities with a history of negative testing results for VHS are 
assumed to have a lower risk of spreading VHS; therefore, we will 
decrease the number of fish required to be tested for such facilities. 
Specifically, paragraph (a)(1) of Sec.  83.6 also provides that 
facilities with cultured fish of VHS-regulated species which can 
document a 2-year history of negative testing for VHS virus can conduct 
testing at a sampling level to provide for a 95 percent confidence 
level of detecting a 5 percent prevalence of infection in the facility. 
Facilities with cultured fish of VHS-regulated species which can 
document a 4-year history of negative testing for VHS virus can conduct 
testing at a sampling level to provide a 95 percent confidence level of 
detecting a 10 percent prevalence of infection in the fish facility. 
Such facilities must be on a secure water source, and testing must be 
conducted twice a year, with at least 3 months between tests. These 
facilities must also document that any VHS-regulated species in the 
facility that originated in VHS-regulated States or Canadian

[[Page 52178]]

provinces originate from facilities of the same or higher health 
status.
    Because this is an emerging disease, APHIS may update the list of 
VHS-regulated fish species as our knowledge of species susceptibility 
increases. Paragraph (b) explains how facilities can maintain VHS-free 
status when new species are added to the list of VHS-regulated fish 
species. Specifically, paragraph (b) provides that, when a new species 
is added to the list of VHS-regulated fish, a facility that has been 
determined to be free of VHS must conduct additional testing on the 
newly listed species, if present in the facility, and the fish must be 
free of VHS virus in order for the facility to retain its free status. 
Paragraph (b) further provides that VHS testing must be conducted on 
each newly listed species with a sample size that provides for a 95 
percent confidence level of detecting a 2 percent prevalence of 
infection in the fish facility in order to return the facility to the 
same health status that existed prior to the new listing of the VHS-
regulated species.
    Paragraph (c) of this section specifies that the test results for 
fish maintained on a secure water source will be valid for 6 months 
from the date of sample collection provided no fish of a lesser or 
unknown health status are introduced into the facility. Test results 
for fish held on a water source that is not a secure water source will 
be valid for 30 days from the date of sample collection. This will help 
to ensure that fish qualified to move interstate by virtue of a health 
certification program retain that qualification for a reasonable length 
of time while not compromising the health status of those fish through 
the introduction of additional fish of unknown or lesser VHS status, or 
introduction of VHS virus through the water source.

Shipping Containers; Cleaning and Disinfection (Sec.  83.7)

    Paragraph (a) of Sec.  83.7 requires that all live VHS-regulated 
fish that are to be moved interstate in accordance with Sec.  83.3(a) 
must be moved in new containers or containers that have been cleaned 
and disinfected to neutralize any VHS virus to which the shipping 
containers may have been exposed. Cleaning and disinfection must be 
monitored by the accredited veterinarian or State, Tribal, or Federal 
competent authority for aquatic animal health who issues the ICI. The 
cleaning and disinfection protocols used must be referenced in the ICI 
or in a separate cleaning and disinfection certificate accompanying the 
shipment.

Import Restrictions

General Restrictions; Exceptions (Sec.  93.910)

    As previously discussed, the Federal Order, as amended, allows VHS-
susceptible species of live salmonid fish from the affected Canadian 
provinces to be imported into the United States if the shipment meets 
the FWS regulations in 50 CFR 16.13(a)(3) and 16.13(b). This interim 
rule will continue to allow live salmonid VHS-regulated fish to be 
imported into the United States from VHS-regulated regions in 
accordance with the FWS regulations. In addition, this rule establishes 
conditions under which live non-salmonid VHS-regulated fish species may 
be imported into the United States from VHS-regulated regions.
    Specifically, paragraph (a) of Sec.  93.910 provides that no live 
VHS-regulated species of fish may be imported into the United States 
from VHS-regulated regions except in accordance with subpart I or the 
regulations of the FWS in 50 CFR 16.13(a)(3) and 16.13(b). This 
paragraph further provides that no such live VHS-regulated fish may be 
moved from the port of entry after arrival until released by an APHIS 
representative or FWS official. In addition, this paragraph specifies 
that the Administrator may, upon request in specific cases, allow the 
importation of live VHS-regulated fish into the United States under 
conditions other than those specifically set forth in the subpart when 
the Administrator determines that such movement will not result in the 
further introduction of VHS into the United States.
    Paragraph (b) of Sec.  93.910 provides that APHIS will list as a 
VHS-regulated fish any fish species found in freshwater to be 
susceptible to the North American (type IV) strain of VHS virus under 
natural (i.e., non-controlled) conditions of exposure and from which 
VHS virus has been isolated in cell culture or other assay determined 
by the competent authority to be adequate to detect VHS virus, with 
confirmation of strain identity through genetic sequencing. As stated 
previously, anadromous fish that have migrated into freshwater and from 
which VHS strain type IV(a) has been isolated are not considered VHS-
regulated fish under this rule. Paragraph (b) further provides that, 
when APHIS determines that a species meets the criteria of this 
paragraph and should be added to the list of VHS-regulated fish, APHIS 
will publish a notice in the Federal Register announcing that 
determination.
    Paragraph (c) of this section provides that APHIS will list as a 
VHS-regulated region any region in which VHS virus has been officially 
reported to the OIE by the country's competent authority for aquatic 
animal health from any fish species in a water source that is not a 
secure water source, or which the Administrator determines to be at 
risk of having VHS based on criteria such as inadequate surveillance, 
less restrictive import requirements, or other epidemiologic 
information.
    Paragraph (c) further provides that, if the Administrator 
determines that a region meets the criteria for a VHS-regulated region, 
APHIS will publish a notice of its decision in the Federal Register and 
take comments from the public. The designation as a VHS-regulated 
region will become effective upon publication of this notice. After 
reviewing the comments, APHIS will issue a second notice in the Federal 
Register announcing its decision on whether or not the designation as a 
VHS-regulated region will remain in effect.
    Paragraph (d) provides that these lists will be maintained on the 
APHIS aquaculture Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/aquaculture. This paragraph further provides an 
address from which the lists of VHS-regulated fish and VHS-regulated 
regions may be obtained from APHIS.
    As of this rule's effective date, only two Canadian Provinces 
(Ontario and Quebec) are listed as VHS-regulated regions. The current 
list of VHS-regulated fish species is set out above under the heading 
``VHS-regulated fish and VHS-regulated areas (Sec.  83.4).''
    This interim rule does not provide a process by which APHIS will 
remove regions from the list of VHS-regulated regions if the area 
petitions APHIS for a reassessment of its disease status. As discussed 
in more detail below under the heading ``Related Issues on Which APHIS 
Is Seeking Comment,'' we particularly invite comments on which specific 
factors APHIS should consider before removing an area from the list of 
VHS-regulated regions.
    Paragraph (e) of Sec.  93.910 provides that other provisions of 
part 93 relating to the importation of live VHS-regulated fish shall 
not apply to shipments of such fish imported from VHS-regulated regions 
if they are imported in accordance with the FWS regulations in 50 CFR 
16.13. As previously discussed, the FWS regulations pertain to live 
salmonid fish species to be imported into the United States. This 
paragraph makes it clear that live salmonid VHS-regulated fish to be 
imported into the United States from VHS-regulated regions will be 
exempt from the other provisions in part 93 provided that the

[[Page 52179]]

fish are imported in accordance with the FWS regulations.
    Paragraph (f) of this section provides that other provisions of 
part 93 relating to the importation of live VHS-regulated fish shall 
not apply to shipments of such fish in transit through the United 
States, if an import permit has been obtained under Sec.  93.912 and 
all conditions of the permit are observed, and if the live VHS-
regulated fish species are handled as follows:
    <bullet> They are maintained under continuous confinement while in 
transit through the United States aboard an aircraft, ocean vessel, or 
other means of conveyance; or if they are unloaded in the course of 
such transit, they are placed in a holding facility that is provided by 
the carrier or its agent and has been approved by the Administrator as 
adequate to prevent the spread within the United States of any finfish 
pathogen; they are maintained there under continuous confinement until 
loaded aboard a means of conveyance for transportation from the United 
States; and they are maintained under continuous confinement aboard 
such means of conveyance until it leaves the United States.
    <bullet> They are moved in accordance with any additional 
conditions prescribed in the permit that the Administrator has 
determined to be necessary to ensure that the fish do not introduce VHS 
into the United States.
    For a holding facility to be approved by the Administrator, the 
following conditions must be met:
    <bullet> The holding facility must be sufficiently isolated to 
prevent direct or indirect contact of the live fish it contains with 
any other live VHS-regulated fish species in the United States.
    <bullet> The holding facility must be constructed to provide 
adequate protection against environmental conditions and so that it can 
be adequately cleaned, washed, and disinfected.
    <bullet> Provision must be made for disposal of fish carcasses, 
shipping water, effluent, waste, and any associated shipping materials 
in a manner that will prevent dissemination of disease.
    <bullet> Provision must be made for adequate sources of feed and 
water and for attendants for the care and feeding of fish in the 
facility.
    <bullet> The holding facility must comply with all applicable 
local, State, and Federal requirements for environmental quality.
    <bullet> The holding facility must comply with any additional 
requirements that the Administrator may impose on a particular shipment 
in order to prevent the dissemination of VHS virus.
    Paragraph (g) provides that the provisions of the subpart relating 
to the importation of live VHS-regulated fish shall not apply to fish 
moved into the United States from VHS-regulated regions during catch-
and-release fishing.

Ports Designated for the Importation of Live VHS-Regulated Fish Species 
(Sec.  93.911)

    Section 93.911 designates ports through which live VHS-regulated 
fish from VHS-regulated regions may be imported into the United States 
without an import permit. To relieve some of the paperwork burden 
associated with import permits, we will allow VHS-regulated fish 
species that have been tested in accordance with Sec.  93.913(b) and 
found to be free of VHS virus to be imported through certain Canadian 
border ports without an import permit. We consider those ports to have 
adequate facilities and inspectors to perform the necessary inspections 
of shipments of live fish without advance notification of the arrival 
of a shipment that is associated with the application for and issuance 
of an import permit. As described later in this document in the section 
titled ``Declaration and other documents (Sec.  93.914),'' all 
importers must submit a declaration to Customs. The information 
included in the declaration will parallel the information required in 
an import permit, except that importers must indicate the route of 
travel in an import permit. APHIS asks for notice of a shipment's route 
of travel in order to prevent transits of animals through countries 
subject to import restrictions because of certain animal disease risks. 
We typically do not require this information for shipments coming 
through land border ports because it is unlikely that a shipment 
entering the United States at a land border port would have traveled 
through any other countries.
    Paragraph (a) provides that VHS-regulated fish species may be 
imported into the following Canadian border ports without an import 
permit: Eastport, ID; Houlton and Jackman, ME; Detroit, Port Huron, and 
Sault Ste. Marie, MI; Baudette, MN; Opheim, Raymond, and Sweetgrass, 
MT; Alexandria Bay, Buffalo, and Champlain, NY; Dunseith, Pembina, and 
Portal, ND; Derby Line and Highgate Springs, VT; and Oroville and 
Sumas, WA.
    Paragraph (b) provides that live VHS-regulated fish may be imported 
into the United States with an import permit through the following 
ports: Anchorage, AK; Los Angeles and San Francisco, CA; Miami and 
Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; Boston, MA; Newark, 
NJ; Jamaica and Newburgh, NY; Portland, OR; Memphis, TN, Dallas-Ft. 
Worth, TX; Seattle, WA; and San Juan, PR.
    Paragraph (c) of this section also provides for other ports to be 
designated by the Administrator in specific cases with the concurrence 
of the Secretary of the Department of Homeland Security.

Import Permits (Sec.  93.912)

    Paragraph (a) of Sec.  93.912 requires that live VHS-regulated fish 
imported from VHS-regulated regions through a limited port listed in 
Sec.  93.911(b) be accompanied by an import permit issued by APHIS and 
must be imported within 30 days of the proposed arrival date stated in 
the import permit.
    Paragraph (b) provides the address and APHIS Web site from which 
prospective importers may request import permit applications and to 
which completed applications should be sent. An application for an 
import permit must be submitted for each shipment of live VHS-regulated 
fish.
    Paragraph (c) of this section specifies the information that must 
be included on an import permit application. It states that the 
application must include the name and address of the exporter; the 
proposed date of shipment to the United States; the name and address of 
the importer; the species and number of live VHS-regulated fish to be 
imported into the United States; the purpose of the importation; the 
port of embarkation; the mode of transportation; the route of travel, 
including all carrier stops en route; the port of entry in the United 
States; the proposed date of arrival in the United States; and the name 
and address of the person to whom the live VHS-regulated fish will be 
delivered in the United States.
    APHIS needs this information to determine whether the live fish are 
eligible for importation, to respond to an applicant, to identify the 
shipment at the port of entry, to ensure that inspectors and facilities 
are available for inspection in the United States, and to contact 
appropriate persons if any questions arise concerning the importation.
    Finally, paragraph (d) explains what happens after we receive and 
review the permit application. This paragraph provides that, if 
following our review, we determine that the live VHS-regulated fish are 
eligible for importation, we will issue an import permit. This 
paragraph also specifies that an import permit does not guarantee that 
any live fish will be

[[Page 52180]]

allowed entry into the United States; the VHS-regulated fish will be 
allowed to enter the United States only if they meet all applicable 
requirements of the regulations.

Health Certificate (Sec.  93.913)

    Paragraph (a) of Sec.  93.913 requires that all live VHS-regulated 
fish that are imported from VHS-regulated regions for other than 
immediate slaughter or research or laboratory use be accompanied by a 
health certificate. The health certificate must be in English or 
contain an English translation and must be issued by a full-time 
salaried veterinarian of the national government of the exporting 
country, or issued by a certifying official and endorsed by the 
competent authority of that country. The health certificate will be 
valid for 30 days from the date of issuance.
    In addition, the health certificate must state that the shipment 
was inspected by the veterinarian or certifying official who issued the 
certificate within 72 hours prior to shipment, and found to be free of 
any clinical signs of disease consistent with VHS; and the live fish 
covered by the health certificate originated in a region or facility 
that has demonstrated freedom from VHS through testing in accordance 
with paragraphs (b) and (c) of Sec.  93.913.
    Paragraph (b) provides that a facility can demonstrate freedom from 
VHS through negative testing results by a pathogen detection laboratory 
approved for VHS viral assays by the competent authority. All viral 
testing must meet the following conditions:
    <bullet> Be conducted with a testing sample size that provides for 
a 95 percent confidence level of detecting a 2 percent prevalence of 
infection in the facility.
    <bullet> Include virus isolation or other assays authorized by the 
competent authority, using appropriate cell lines to detect VHS virus, 
if present. All suspect VHS cytopathic effects must be positively 
identified as VHS through molecular assays and/or genetic sequencing.
    <bullet> Test proportional numbers of each VHS-regulated fish 
species which might be present in a shipment, if applicable.
    <bullet> Be conducted at water temperatures between 50 and 72 
[deg]F, or at other times or under environmental conditions when VHS 
virus is most likely to be detected, if present.
    As stated previously in this document, facilities with a history of 
negative testing results for VHS are assumed to have a lower risk of 
spreading VHS; therefore, we will decrease the number of fish that are 
required to be tested for such facilities. Specifically, paragraph (b) 
of this section also allows facilities with cultured fish of VHS-
regulated species which can document a 2-year negative testing history 
for VHS virus to conduct testing at a sampling level to provide a 95 
percent confidence level of detecting a 5 percent prevalence of 
infection in the facility and facilities with cultured fish of VHS-
regulated species which can document a 4-year negative testing history 
for VHS virus to conduct testing at a sampling level to provide a 95 
percent confidence level of detecting a 10 percent prevalence of 
infection in the fish facility. Such facilities must be on a secure 
water source, and testing must be conducted twice a year, with at least 
3 months between tests. The facilities must also document that any VHS-
regulated species in the facility that originated in VHS-regulated 
States or Canadian provinces originate from facilities of the same or 
higher health status.
    Paragraph (c) explains how facilities can maintain VHS-free status 
when new species are added to the list of VHS-regulated fish species. 
Specifically, paragraph (c) provides that when a new species is added 
to the list of VHS-regulated fish, a facility that has been determined 
to be free of VHS must conduct additional testing on fish of the newly 
listed species, if present in the facility, and the fish must be free 
of VHS virus in order for the facility to retain its free status. 
Paragraph (c) further provides that VHS testing must be conducted on 
each newly listed species with a sample size that provides for a 95 
percent confidence level of detecting a 2 percent prevalence of 
infection in the fish facility.
    Paragraph (d) of this section requires that, except as provided in 
Sec.  93.910(e) through (g), all live fish be shipped in new containers 
or containers that have been cleaned and disinfected to neutralize any 
VHS virus to which the shipping containers may have been exposed. 
Cleaning and disinfection of shipping containers must take place under 
the supervision of the veterinarian or certifying official who issues 
the health certificate, and be sufficient to neutralize any VHS virus 
to which shipping containers may have been exposed. Cleaning and 
disinfection protocols must be referenced in the health certificate or 
in a separate cleaning and disinfection certificate accompanying the 
shipment to the U.S. port of entry.

Declaration and Other Documents (Sec.  93.914)

    Section Sec.  93.914 requires the importer or his or her agent to 
submit the following documents to the appropriate Customs and Border 
Protection officer for use by the port veterinarians:
    <bullet> All permits, certificates, or other documentation required 
under Sec. Sec. Sec.  93.912 and 93.913; and
    <bullet> Two copies of a declaration that lists the port of entry; 
the name and address of the importer; the name and address of the 
broker; the origin of the live fish; the number, species, and the 
purpose of the importation; the name of the person to whom the fish 
will be delivered; and the location of the place to which such delivery 
will be made. This information will allow for the traceback of 
shipments should any problems occur subsequent to entry into the United 
States.

Inspection at the Port of Entry (Sec.  93.915)

    Section 93.915 sets forth requirements for port of entry 
inspections of shipments of live fish. Paragraph (a) provides that the 
shipments of live VHS-regulated fish must be presented for inspection 
at a port of entry designated under Sec.  93.911. This paragraph also 
provides that the port veterinarian must be notified at least 72 hours 
in advance of the arrival of the shipment in the United States for live 
fish of VHS-regulated species being imported through a limited port 
listed in Sec.  93.911(c). It also provides that any shipment that does 
not meet the requirements of this subpart will be refused entry (e.g., 
lacking appropriate permits, declarations, and/or health certificates 
or exhibiting clinical signs consistent with VHS).
    Paragraph (b) states that shipments refused entry must be exported 
within a time fixed in each case by the Administrator, and in 
accordance with other provisions he or she may require in each case for 
their handling, or the shipment will be disposed of as the 
Administrator may direct.

Special Provisions (Sec.  93.916)

    Section 93.916 sets forth requirements for importation for 
slaughter or for research or laboratory purposes.
    Paragraph (a) provides that live VHS-regulated fish from VHS-
regulated regions may be imported directly for slaughter under the 
following conditions:
    <bullet> An import permit has been obtained under Sec.  93.912 and 
all conditions of the permit are observed.
    <bullet> An APHIS representative at the port seals the means of 
conveyance with official seals.
    <bullet> The shipment is moved directly from the port of entry to a 
slaughtering establishment that discharges its waste water to a 
municipal sewage system that includes waste water disinfection

[[Page 52181]]

sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus. Offal, including carcasses, from the 
slaughtering establishment is either rendered or composted.
    <bullet> An APHIS representative unseals the vehicle upon arrival 
at the slaughtering establishment.
    <bullet> Any water used to transport the fish is disposed to a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus. Paragraph (b) of this section provides that 
live non-salmonid VHS-regulated fish may be imported from a VHS-
regulated region for research or laboratory use under the following 
conditions:
    <bullet> An import permit has been obtained under Sec.  93.912 and 
all conditions of the permit are observed.
    <bullet> The laboratory or research facility disposes of effluent 
to a municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus.
    <bullet> Carcasses must be rendered or composted.
    <bullet> Any water used to transport the fish is disposed to a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus.
    These measures will ensure that VHS virus that may be present in 
such fish is effectively neutralized or that the fish are rendered 
incapable of infecting fish in other waters of the United States.

Related Issues on Which APHIS Is Seeking Comment

    There are two additional issues related to VHS for which we are 
seeking public comment. This interim rule does not make any of the 
possible changes discussed below, because there are no immediate risks 
associated with them that would justify immediate action. However, we 
believe the following changes would improve the effectiveness of our 
programs to prevent the introduction of VHS and other fish pathogens 
and may include such changes in a subsequent rulemaking.
    As discussed above, the new lists of VHS-regulated areas and VHS-
regulated regions will be maintained on the APHIS Web site, not in the 
regulations. We do not however, provide criteria for removing an area 
or region from those lists. At present, VHS occurs only in wild fish 
populations in the United States and Canada, making the disease 
difficult to contain and eradicate. For that reason, we do not believe 
any areas or regions that are currently on the lists of VHS-regulated 
areas or VHS-regulated regions will be eligible for removal from those 
lists in the immediate future. Further, APHIS is still considering what 
information we would use in reassessing an area's or region's disease 
status and would find public input valuable. Specifically, APHIS seeks 
comments on what factors should be considered when removing areas and 
regions from the lists of VHS-regulated areas and VHS-regulated 
regions.
    We recognize that gametes are a potential pathway for the spread of 
VHS due to the ability of the virus to survive in ovarian fluid. While 
the disinfection of salmonid eggs is common practice, no standardized 
protocols exist for disinfecting non-salmonid eggs. Further, there is 
not sufficient documented scientific evidence to support regulated egg 
treatment protocols for non-salmonid eggs. APHIS seeks comment on what 
types of egg disinfection protocols, if any, should be considered for 
VHS-regulated non-salmonid species.

User Fees

    APHIS user fees for processing permit applications and for 
inspecting animals at the port of entry will apply. The user fees are 
set forth in 9 CFR part 130. User fees for processing applications for 
permits to import certain animals and animal products are listed in the 
table in Sec.  130.4. User fees for inspection at the port of entry and 
laboratory and facility inspections are the hourly rates set forth in 
Sec.  130.30.

Emergency Action

    The Administrator of the Animal and Plant Health Inspection Service 
has determined that there is good cause for publishing this interim 
rule without prior opportunity for public comment. Immediate action is 
necessary to prevent the introduction of VHS into aquaculture 
facilities by controlling the movement of live fish at risk of 
harboring VHS virus. Despite its current VHS-free status for farmed 
fish, the United States remains unprotected from continuing 
introductions of VHS-infected non-salmonid fish imported from Canada, 
since there are a number of exporters of VHS-regulated fish species in 
VHS-regulated areas in Canada, and pretesting of these fish is not 
currently required. Additionally, although VHS outbreaks have so far 
been limited to States within the Great Lakes watershed, there are no 
standardized restrictions in place other than those specified in the 
FWS regulations in title 50 and the existing APHIS Federal Order to 
prevent the further spread of VHS into new watersheds or areas by the 
transfer of live salmonid or non-salmonid VHS-regulated species. 
Therefore, it is necessary to implement regulations that will restrict 
such movements in as timely a manner as possible.
    We will consider comments we receive during the comment periods for 
this interim rule and the environmental assessment (see DATES above). 
After the comment period closes, we will publish another document in 
the Federal Register to notify the public of our decision regarding the 
environmental assessment. We will also publish a document in the 
Federal Register that will include a discussion of any comments we 
receive and any amendments we are making to the rule.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    We have prepared an economic analysis for this interim rule. It 
provides an initial regulatory flexibility analysis, which considers 
the potential economic effects of this proposed rule on small entities, 
as required by the Regulatory Flexibility Act, as well as a cost-
benefit analysis. The economic analysis is summarized below. The full 
economic analysis may be viewed on the Regulations.gov Web site (see 
ADDRESSES at the beginning of this document for instructions for 
accessing Regulations.gov). You may request paper copies of the 
economic analysis by calling or writing to the person listed under FOR 
FURTHER INFORMATION CONTACT. Please refer to Docket No. APHIS-2007-0038 
when requesting copies. The economic analysis is also available for 
review in our reading room (information on the location and hours of 
the reading room is listed under the heading ADDRESSES at the beginning 
of this document).

[[Page 52182]]

    Based upon available data and expected effects, we believe that the 
benefits of the interim rule, in terms of disease prevention, will 
justify the costs associated with restricting the movement of live 
fish. Costs associated with the interim rule will likely be difficult 
to distinguish from those already imposed by the amended Federal Order. 
Also, several of the States that will be regulated by the interim rule 
have regulations in place that compare closely with the interim rule. 
Net impacts of the interim rule therefore may be relatively small.
    We first consider potential costs of the rule for producers, allied 
industries, and State, Federal, and Tribal authorities. Possible 
benefits of the rule in terms of preventing the spread of VHS virus are 
then examined. Third, alternatives to the rule are presented. Lastly, 
we address expected impacts for small entities.

Summary of Cost-Benefit Analysis

    The interim rule will place restrictions on the importation and 
interstate movement of live VHS-regulated fish species from States 
within the Great Lakes Region where this disease has been confirmed. 
The potential impacts of the interim rule are not known, given the lack 
of information on aquaculture operations and commercial fisheries in 
the regulated areas. Additionally, little is known about the potential 
impacts on allied fishing industries and on hatcheries operating under 
Federal, State, or Tribal authority.
    Benefits of the rule will accrue from preventing the spread of an 
emerging strain of VHS virus to aquaculture facilities beyond the 
regulated States. Five of these States have comprehensive regulations 
in place to curb the spread of the virus. Impacts of the interim rule 
are likely to be largely already realized because of the amended 
Federal Order, and may be additionally diminished in the five States 
that have adopted movement restrictions consistent with the interim 
rule.

Expected Costs of the Interim Rule

    One industry that may be impacted is the wild-caught segment of the 
baitfish industry, to the extent that the requirements of the interim 
rule are more restrictive than the amended Federal Order and the 
regulations of the various States. However, we foresee any incremental 
changes to be minimal. A testing and certification protocol by which 
movement will be allowed under the rule is unlikely to be feasible for 
this segment of the industry. In addition to aquaculture and commercial 
fisheries, allied fishing industries such as bait shops and marinas may 
also be affected by the interim rule. Bait shops that sell VHS-
regulated species may face tighter supplies on top of the certification 
requirement for sales to unregulated States.
    State, Federal, and Tribal authorities may also be affected by the 
interim rule. Within the 8 regulated States, there are 7 Federal, 69 
State, and at least 13 Tribal hatcheries. These hatcheries produce and 
stock fish in streams, rivers, and lakes throughout the eight States 
and possibly in surrounding States. The interim rule may limit 
production and stocking by the agencies, and therefore the availability 
of broodstock in the regulated States and possibly other States, 
depending on the species stocked. Affected States may also face a 
decline in the number of fishing licenses sold due to reduced stocking 
and a limited availability of bait.
    Overall, regulated aquaculture facilities and commercial fisheries 
will bear the costs of testing, cleaning, and disinfection of 
containers, and fees associated with inspections and the issuance of 
permits. However, given the regulatory response to VHS to date by five 
of the eight regulated States, the impact of the interim rule may be 
muted. Many of the regulations in place in Michigan, New York, Ohio, 
Pennsylvania, and Wisconsin are closely aligned with the requirements 
in the interim rule and in some cases may be even more restrictive. In 
some instances, effects of the interim rule are already realized 
because of rules implemented at the State level. Additionally, the rule 
will codify restrictions and procedures already in place under the 
amended Federal Order. Net impacts of the interim rule are expected to 
be small because of the existing State regulations and the Federal 
Order.

Expected Benefits of the Interim Rule

    The interim rule is expected to benefit aquaculture facilities. The 
rule is intended to curtail the introduction of the VHS virus into 
areas outside of the Great Lakes Region. Mississippi dominates catfish 
farming in the United States. Alabama and Arkansas also have fairly 
large sales of cultured catfish. Additionally, Arkansas boasts the 
largest sales of cultured baitfish, accounting for 53 percent of 
baitfish aquaculture according to the 2005 Census of Aquaculture. 
Preventing VHS from spreading to these areas will help preserve the 
catfish and baitfish industries, valued at almost $440 million.

Alternatives to the Interim Rule

    APHIS considered three alternatives for the interim rule. The first 
alternative considered by the Agency would entail regulations much 
broader in scope than the provisions of the May 4, 2007, amended 
Federal Order. This alternative would restrict interstate movement of 
VHS-regulated species for all States where any VHS virus strain is 
detected, and would restrict importation of VHS-regulated species from 
all VHS-regulated countries, including countries in Europe, and also 
would regulate additional commodities. APHIS determined the interim 
rule will be less costly and provide the same level of protection as 
this alternative, based on current knowledge of the status of the two 
strains of VHS virus, type IV(a) and type IV(b), in the United States 
and Canada. VHS virus strain type IV(a) is not known to exist anywhere 
other than in marine environments and, thus, is unlikely to be found in 
the Great Lakes Region.
    A second alternative considered by the Agency would be to regulate 
areas based on Hydrologic Unit Code (HUC) level 2, or regional, 
definitions. APHIS determined that regulating areas known to have VHS 
virus type IV(b) based on the HUC 2 definition could pose an undue 
burden on entities within these areas far removed from the specific 
location of the VHS virus type IV(b) confirmation.
    Finally, APHIS considered a ``no action'' alternative. In this 
instance, APHIS would not implement regulations covering the interstate 
movement of VHS-regulated fish from VHS-regulated areas or the 
importation of VHS-regulated fish from VHS-regulated regions. Under 
this alternative, State agencies and Federal agencies other than APHIS 
would assume responsibility for preventing the spread of the VHS virus. 
Compliance with the various regulations could be burdensome for 
aquaculture producers and others who move fish interstate or 
internationally.

Summary of the Initial Regulatory Flexibility Analysis

    In accordance with the Regulatory Flexibility Act, we examined the 
potential economic effects the interim rule will have on small 
entities. The interim rule may affect aquaculture facilities, 
commercial harvesters, marinas, and other allied fishing industries in 
Illinois, Indiana, Michigan, Minnesota, New York, Ohio, Pennsylvania, 
and Wisconsin. Although information concerning many of these industries 
is sparse, it is likely that most

[[Page 52183]]

of the entities within these industries are small as defined by the 
Small Business Administration (SBA) guidelines.
    While it is likely that the majority of firms affected by the 
interim rule will be small, the magnitude of the impacts is unclear 
given the lack of data. Aquaculture facilities in States not regulated 
for VHS will benefit from the interim rule because the likelihood that 
fish in these facilities will be exposed to this disease will be 
reduced. Facilities located in Illinois, Indiana, Michigan, Minnesota, 
New York, Ohio, Pennsylvania, and Wisconsin will face costs related to 
testing if they raise VHS-regulated species for interstate movement. In 
States that have enacted their own regulations to prevent the potential 
spread of VHS, impacts on aquaculture facilities and commercial fishing 
operations as a result of this interim rule are likely to be dampened.
    The interim rule will impose some additional reporting, 
recordkeeping, and other compliance requirements. Live VHS-regulated 
species of fish may be imported and moved live from regulated Provinces 
and States. Movement requires testing and certification as described in 
the interim rule. Firms wishing to move live fish will be responsible 
for ensuring that the fish originate from a facility that has been 
tested and found to be free of VHS virus. Additionally, these firms 
will also be responsible for obtaining the permits needed to transport 
fish interstate, as well as paying the user fees associated with 
inspection of shipments.

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 in conflict 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.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with this 
interim rule, we have prepared an environmental assessment. The 
environmental assessment was prepared in accordance with: (1) The 
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 
4321 et seq.), (2) regulations of the Council on Environmental Quality 
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372). The environmental 
assessment provides a basis for our determination that implementation 
of this interim rule will not have a significant impact on the quality 
of the human environment.
    We will accept comments on the environmental assessment for 30 
days. To comment, follow the instructions under ADDRESSES at the 
beginning of this document. The environmental assessment may be viewed 
on the Regulations.gov Web site or in our reading room. (Instructions 
for accessing Regulations.gov and information on the location and hours 
of the reading room are provided under the heading ADDRESSES at the 
beginning of this interim rule.) In addition, copies may be obtained by 
writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

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 number 0579-0340 to the information 
collection and recordkeeping requirements.
    We plan to request continuation of that approval for 3 years. 
Please send written comments on the 3-year approval request to the 
following addresses: (1) Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) 
Docket No. APHIS-2007-0038, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238. Please state that your comments refer to Docket No. APHIS-2007-
0038 and send your comments within 60 days of publication of this rule.
    This interim rule establishes regulations to restrict the 
interstate movement and importation into the United States of live fish 
that are susceptible to VHS. In order to be moved interstate, live VHS-
regulated fish must originate from a facility that has been found free 
of VHS virus through testing specified in the regulations and be 
accompanied by an ICI issued by an accredited veterinarian or a State, 
Tribal, or Federal competent authority for aquatic animal health.
    Live VHS-regulated fish to be imported into the United States may 
need to be accompanied by a permit and must be accompanied by a 
declaration and by a health certificate that states that the live fish 
originated in a region or facility that has demonstrated freedom from 
VHS through testing in accordance with the regulations. The fish must 
be shipped in new containers or containers that have been cleaned and 
disinfected to neutralize any VHS virus to which the shipping 
containers may have been exposed. The cleaning and disinfection 
protocols must be referenced in the health certificate or in a separate 
cleaning and disinfection certificate accompanying the shipment to the 
U.S. port of entry. Finally, live fish imported for slaughter or for 
research or diagnostic purposes must, among other things, be 
accompanied by a VS Form I-27, which will be issued by the port 
veterinarian.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our information collection and recordkeeping 
requirements. These comments will help us:
    (1) Evaluate whether the information collection is necessary for 
the proper performance of our agency's functions, including whether the 
information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
information collection, including the validity of the methodology and 
assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.2681871 hours per response.
    Respondents: Accredited veterinarians, importers and exporters of 
VHS-regulated live fish, shippers moving VHS-regulated live fish 
interstate, and States.
    Estimated annual number of respondents: 515.
    Estimated annual number of responses per respondent: 16.601941.

[[Page 52184]]

    Estimated annual number of responses: 8,550.
    Estimated total annual burden on respondents: 2,293. (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) 
851-2908.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this interim rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects

9 CFR Part 71

    Animal diseases, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 83

    Animal diseases, Livestock, Quarantine, Reporting and recordkeeping 
requirements, Transportation.

9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.

0
Accordingly, we are amending 9 CFR chapter I as follows:

PART 71--GENERAL PROVISIONS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
2. Section 71.3 is amended as follows:
0
a. In paragraph (a), in the list of diseases which are endemic to the 
United States, by adding the words ``viral hemorrhagic septicemia,'' 
after ``chlamydiosis,''.
0
b. By adding a new paragraph (c)(5) to read as set forth below.


Sec.  71.3  Interstate movement of diseased animals and poultry 
generally prohibited.

* * * * *
    (c)(5) Fish affected with viral hemorrhagic septicemia may be moved 
interstate in accordance with part 83 of this subchapter.
* * * * *

0
3. A new part 83 is added to read as follows:

PART 83--VIRAL HEMORRHAGIC SEPTICEMIA

Sec.
83.1 Definitions.
83.2 General restrictions.
83.3 Interstate movement of live VHS-regulated fish species from 
VHS-regulated areas.
83.4 VHS-regulated fish and VHS-regulated areas.
83.5 Interstate Certificate of Inspection (ICI).
83.6 Testing requirements.
83.7 Shipping containers; cleaning and disinfection.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


Sec.  83.1  Definitions.

    Accredited veterinarian. A veterinarian who is approved by the 
Administrator, in accordance with part 161 of this chapter, to perform 
official animal health work of the Animal and Plant Health Inspection 
Service specified in subchapters A, B, C, and D of this chapter; and to 
perform work required by cooperative State-Federal disease control and 
eradication programs.
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Anadromous fish. Fish that are born and spawn in freshwater, but 
which spend part of their lifecycle in saltwater.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    APHIS representative. A veterinarian or other individual employed 
by APHIS who is authorized to perform the services required by this 
part.
    Approved laboratory. A laboratory authorized by a State, Tribal, or 
Federal competent authority for aquatic animal health to perform assays 
for the detection of VHS virus.
    Catch-and-release fishing. Fishing for pleasure or for recreational 
purposes, including tournaments, organized fishing competitions, 
fishing derbies, or other types of contests where individuals catch, 
compare, and release live VHS-regulated fish. This term excludes VHS-
regulated fish used, or intended to be used, as live bait.
    Competent authority. The State, Tribal, or Federal entity with the 
legal responsibility for ensuring or supervising the implementation of 
aquatic animal health measures.
    Cultured fish. Fish of the same species and age class, originating 
from the same broodstock and on the same water supply, whose care is 
partly or totally managed from the first life stage onwards.
    Department. The United States Department of Agriculture (USDA).
    Interstate. From one State into or through any other State.
    Interstate Certificate of Inspection (ICI). An official document 
issued by an accredited veterinarian or a State, Tribal, or Federal 
competent authority in the originating State that certifies that the 
fish being moved interstate originated from a facility that has been 
found free of VHS virus.
    Moved (movement). Shipped, transported, delivered, or otherwise 
aided, induced, or caused to be moved.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other legal entity.
    Secure water source. A biosecure water supply that does not contain 
pathogens or has not had the opportunity to be contaminated with 
pathogens. Biosecure water supplies include well, spring, or borehole 
water; surface water that does not contain fish populations; or water 
that has been treated to eliminate aquatic animal pathogens.
    State. Any of the 50 States, the Commonwealth of Puerto Rico, the 
Commonwealth of the Northern Mariana Islands, the District of Columbia, 
and any territories and possessions of the United States.
    State animal health official. The State official responsible for 
livestock, disease control, and eradication programs.
    VHS-regulated area. Any State or portion of a State listed in 
accordance with Sec.  83.4.
    VHS-regulated fish. Any fish species listed in accordance with 
Sec.  83.4.
    VHS virus. Any North American (type IV) strain of viral hemorrhagic 
septicemia (VHS) virus, a rhabdovirus of fish.
    Viral hemorrhagic septicemia (VHS). A disease caused by infection 
with VHS virus.


Sec.  83.2  General restrictions.

    Live VHS-regulated fish may not be moved interstate from a VHS-
regulated area except in compliance with this part.

[[Page 52185]]

Sec.  83.3  Interstate movement of live VHS-regulated fish species from 
VHS-regulated areas.

    (a) Except as provided in paragraphs (b) through (e) of this 
section, live VHS-regulated fish, including fish moved to live fish 
markets, may only be moved interstate from a VHS-regulated area if the 
fish originated from a facility that has been found free of the VHS 
virus in accordance with Sec.  83.6 and the fish are accompanied by an 
Interstate Certificate of Inspection (ICI) issued by an accredited 
veterinarian or a State, Tribal, or Federal competent authority for 
aquatic animal health.
    (b) Live VHS-regulated fish may be moved interstate directly to a 
slaughtering establishment provided that:
    (1) The fish are accompanied by a VS Form 1-27;
    (2) The fish are transported in sealed conveyances;
    (3) The slaughtering establishment meets the following conditions:
    (i) The slaughtering establishment discharges its waste water to a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus.
    (ii) Offal, including carcasses, from the slaughtering 
establishment is either rendered or composted.
    (4) Any water used to transport the fish is disposed of in a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus.
    (c) Live VHS-regulated fish may be moved interstate for research or 
diagnostic purposes provided that:
    (1) The fish are accompanied by a VS Form 1-27;
    (2) The fish are transported in sealed conveyances;
    (3) The facility that receives the fish meets the following 
conditions:
    (i) The facility discharges its waste water to a municipal sewage 
system that includes waste water disinfection sufficient to neutralize 
any VHS virus or to either a non-discharging settling pond or a 
settling pond that disinfects, according to all applicable local, 
State, and Federal regulations, sufficiently to neutralize any VHS 
virus.
    (ii) Offal, including carcasses, from the facility is either 
rendered or composted.
    (4) Any water used to transport the fish is disposed to a municipal 
sewage system that includes waste water disinfection sufficient to 
neutralize any VHS virus or to either a non-discharging settling pond 
or a settling pond that disinfects, according to all applicable local, 
State, and Federal regulations, sufficiently to neutralize any VHS 
virus.
    (d) Live VHS-regulated fish may be moved interstate during catch-
and-release fishing.
    (e) The Administrator may, on a case-by-case basis, permit the 
interstate movement of fish not otherwise provided for in this part, 
under such conditions as the Administrator may prescribe in each case 
to prevent the introduction and dissemination of VHS.

(Approved by the Office of Management and Budget under control 
number 0579-0340)


Sec.  83.4  VHS-regulated fish and VHS-regulated areas.

    (a)(1) APHIS will list as a VHS-regulated fish any fish species 
found in freshwater to be susceptible to the North American (type IV) 
strain of VHS virus under natural (i.e., non-controlled) conditions of 
exposure and from which VHS virus has been isolated in cell culture or 
other assay determined by the Administrator to be adequate to detect 
VHS virus, with confirmation of strain identity through genetic 
sequencing. Anadromous fish that have migrated into freshwater and from 
which VHS strain type IV(a) has been isolated will not be considered 
VHS-regulated fish.
    (2) If APHIS determines that, in accordance with the criteria in 
paragraph (a)(1) of this section, a species should be added to the list 
of VHS-regulated species, APHIS will publish a notice in the Federal 
Register announcing that determination.
    (b)(1) APHIS will list as a VHS-regulated area each State or 
portion of a State from which VHS virus has been detected in any VHS-
regulated fish species (with or without clinical signs of disease) in a 
water source that is not a secure water source, or which the 
Administrator determines should be regulated based on criteria such as 
inadequate surveillance or movement requirements, or other 
epidemiologic information.
    (2) If the Administrator determines that a State or portion of a 
State meets the criteria in paragraph (b)(1) of this section, APHIS 
will publish a notice of its decision in the Federal Register and take 
comments from the public. The designation as a VHS-regulated area will 
become effective upon publication of this notice. After reviewing the 
comments, APHIS will issue a second notice in the Federal Register 
announcing its decision on whether or not the designation as a VHS-
regulated area will remain in effect.
    (c) APHIS maintains the lists of VHS-regulated fish and VHS-
regulated areas on the APHIS aquaculture Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/aquaculture. The 
lists may be obtained from the Animal and Plant Health Inspection 
Service, Veterinary Services, National Aquaculture Program, 4700 River 
Road Unit 46, Riverdale, MD 20737-1231.


Sec.  83.5  Interstate Certificate of Inspection (ICI).

    (a) Live VHS-regulated fish moved interstate in accordance with 
Sec.  83.3(a) must be accompanied by an ICI issued by an accredited 
veterinarian or a State, Tribal, or Federal competent authority for 
aquatic animal health. An ICI will be valid for 30 days from the date 
of issuance.
    (b) The ICI must state that:
    (1) The live fish were inspected by the accredited veterinarian or 
a State, Tribal, or Federal competent authority for aquatic animal 
health within 72 hours prior to shipment, and were found to be free of 
any clinical signs of disease consistent with VHS.
    (2) The live fish covered by the ICI originated in an area or 
facility that has demonstrated freedom from VHS in accordance with 
Sec.  83.6.
    (c) The ICI must include the following information:
    (1) The name, address, and phone number of the owner or owner's 
agent.
    (2) The name, address, and phone number of the facility in which 
the fish originated.
    (3) The name, address, and phone number of the person or facility 
who will receive the fish; or the State or other regulatory authority 
responsible for oversight of the environment in which the fish will be 
introduced.
    (4) The name, address, and phone number of the shipping or 
transportation company.
    (5) The species and number of the fish.
    (6) The lot (or other) identification of the shipment.
    (7) The name, address, and phone number of the approved laboratory 
that performed the testing required by Sec.  83.6.
    (i) The number of fish tested;
    (ii) The assay(s) used for testing; and
    (iii) The test results.
    (8) The date the certificate was issued.
    (9) The type of water source according to Sec.  83.6(c).

(Approved by the Office of Management and Budget under control 
number 0579-0340)

[[Page 52186]]

Sec.  83.6  Testing requirements.

    (a) A facility can demonstrate freedom from VHS through negative 
testing results provided by an approved laboratory. Testing must meet 
the following conditions:
    (1) Be conducted with a sample size that provides for a 95 percent 
confidence level of detecting a 2 percent prevalence of infection in 
the facility.
    (i) Facilities with cultured fish of VHS-regulated species which 
can document a 2-year history of negative testing for VHS virus, can 
conduct testing at a sampling level to provide a 95 percent confidence 
level of detecting a 5 percent prevalence of infection in the facility. 
Such testing must be conducted twice a year, with at least 3 months 
between tests.
    (ii) Facilities with cultured fish of VHS-regulated species which 
can document a 4-year history of negative testing for VHS virus can 
conduct testing at a sampling level to provide a 95 percent confidence 
level of detecting a 10 percent prevalence of infection in the 
facility. Such testing must be conducted twice a year, with at least 3 
months between tests.
    (iii) Such facilities must be on a secure water source, and 
document that any VHS-regulated species in the facility that originated 
in VHS-regulated States or Canadian provinces originate from facilities 
of the same or higher health status.
    (2) Include virus isolation or other assays authorized by the 
Administrator, using appropriate cell lines to detect VHS virus, if 
present. All suspect VHS cytopathic effects must be positively 
identified as VHS through molecular assays and/or genetic sequencing.
    (3) Use proportional numbers of each VHS-regulated fish species 
which might be present in the facility.
    (4) Be conducted at water temperatures between 50 and 72 [deg]F, or 
at other times or under environmental conditions when VHS is most 
likely to be detected, if present.
    (b) When APHIS adds a new species to the list of VHS-regulated 
species after a facility has been determined to be free of VHS in 
accordance with paragraph (a) of this section, the facility must 
conduct additional testing on fish of the newly listed species, if 
present in the facility, and the fish must be free of VHS virus for the 
facility to retain its free status. VHS testing must be conducted on 
each newly listed species with a sample size that provides for a 95 
percent confidence level of detecting a 2 percent prevalence of 
infection in the facility.
    (c) For VHS-regulated fish maintained on a secure water source, 
test results will be valid for 6 months from the date of sample 
collection provided that no fish of a lesser or unknown health status 
are introduced into the facility. Test results for fish held on a water 
source that is not a secure water source will be valid for 30 days from 
the date of sample collection.


Sec.  83.7  Shipping containers; cleaning and disinfection.

    (a) All live fish that are to be moved interstate in accordance 
with Sec.  83.3(a) must be moved in new containers or in containers 
that have been cleaned and disinfected.
    (1) Cleaning and disinfection of shipping containers must be 
monitored by the accredited veterinarian or State, Tribal, or Federal 
competent authority for aquatic animal health who issues the ICI.
    (2) Cleaning and disinfection must be sufficient to neutralize any 
VHS virus to which shipping containers may have been exposed.
    (3) The cleaning and disinfection protocols used must be referenced 
in the ICI or in a separate cleaning and disinfection certificate 
accompanying the shipment.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control 
number 0579-0340)

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, 
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR 
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

0
4. The authority citation for part 93 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

0
5. Section 93.900 is amended by adding the following definitions in 
alphabetical order to read as set forth below.


Sec.  93.900  Definitions.

* * * * *
    Anadromous fish. Fish that are born and spawn in freshwater, but 
which spend part of their lifecycle in saltwater.
* * * * *
    Approved laboratory. A laboratory authorized by the competent 
authority of a country for aquatic animal health to perform assays for 
the detection of VHS virus.
    Catch-and-release fishing. Fishing for pleasure or for recreational 
purposes, including tournaments, organized fishing competitions, 
fishing derbies, or other types of contests where individuals catch, 
compare, and release live VHS-regulated fish. This term excludes VHS-
regulated fish used, or intended to be used, as live bait.
* * * * *
    Cultured fish. Fish of the same species and age class, originating 
from the same broodstock and on the same water supply, whose care is 
partly or totally managed from the first life stage onwards.
* * * * *
    Secure water source. A biosecure water supply that does not contain 
pathogens or has not had the opportunity to be contaminated with 
pathogens. Biosecure water supplies include well, spring, or borehole 
water; surface water that does not contain fish populations; or water 
that has been treated to eliminate aquatic animal pathogens.
* * * * *
    VHS-regulated fish. Any fish species listed in accordance with 
Sec.  93.910.
    VHS-regulated region. Any region listed in accordance with Sec.  
93.910.
    VHS virus. Any North American (type IV) strain of VHS virus, a 
rhabdovirus of fish.
    Viral hemorrhagic septicemia (VHS). A disease caused by infection 
with VHS virus.


Sec. Sec.  93.901 through 93.906  [Undesignated heading added]

0
6. Subpart I is amended by adding an undesignated center heading, 
``General Provisions for SVC-Regulated Fish Species'', preceding Sec.  
93.901.


Sec. Sec.  93.907 through 93.909  [Reserved]

0
7. Sections 93.907 through 93.909 are added and reserved.

0
8. An undesignated center heading and new Sec. Sec.  93.910 through 
93.916 are added to subpart I after the newly reserved Sec. Sec.  
93.907 through 93.909 to read as follows:

General Provisions for VHS-Regulated Fish Species


Sec.  93.910  General restrictions; exceptions.

    (a) No live VHS-regulated species of fish may be imported into the 
United States from VHS-regulated regions except in accordance with this 
subpart or the regulations of the U.S. Fish and Wildlife Service (FWS) 
in 50 CFR 16.13(a)(3) and 16.13(b), nor may such live VHS-regulated 
fish be moved from the port of entry after arrival until released by an 
APHIS representative or FWS official; Provided, that the Administrator 
may, upon request in specific cases, allow the importation of live VHS-
regulated fish into the United States under conditions other than those 
specifically set forth in this subpart

[[Page 52187]]

when the Administrator determines that such movement will not result in 
the further introduction of VHS into the United States.
    (b)(1) APHIS will list as a VHS-regulated fish any fish species 
found in freshwater to be susceptible to the North American (type IV) 
strain of VHS virus under natural (i.e., non-controlled) conditions of 
exposure and from which VHS virus has been isolated in cell culture or 
other assay determined by the competent authority to be adequate to 
detect VHS virus, with confirmation of strain identity through genetic 
sequencing. Anadromous fish species that have migrated into freshwater 
and from which VHS strain type IV(a) has been isolated will not be 
considered VHS-regulated fish.
    (2) If APHIS determines that, in accordance with the criteria in 
paragraph (b)(1) of this section, a species should be added to the list 
of VHS-regulated species, APHIS will publish a notice in the Federal 
Register announcing that determination.
    (c)(1) APHIS will list as a VHS-regulated region any region in 
which VHS virus has been officially reported to the World Health 
Organization for Animal Health by the country's competent authority for 
aquatic animal health from any fish species in a water source that is 
not a secure water source, or which the Administrator determines to be 
at risk of having VHS based on criteria such as inadequate 
surveillance, less restrictive import requirements, or other 
epidemiologic information.
    (2) If the Administrator determines that a region meets the 
criteria in paragraph (c)(1) of this section, APHIS will publish a 
notice of its decision in the Federal Register and take comments from 
the public. The designation as a VHS-regulated region will become 
effective upon publication of this notice. After reviewing the 
comments, APHIS will issue a second notice in the Federal Register 
announcing its decision on whether or not the designation as a VHS-
regulated region will remain in effect.
    (d) APHIS maintains the lists of VHS-regulated fish and VHS-
regulated regions on the APHIS aquaculture Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/aquaculture. The 
lists may be obtained from the Animal and Plant Health Inspection 
Service, Veterinary Services, National Aquaculture Program, 4700 River 
Road Unit 46, Riverdale, MD 20737-1231.
    (e) Other provisions of this subpart relating to the importation of 
live VHS-regulated fish shall not apply to shipments of such fish 
imported from VHS-regulated regions if they are imported in accordance 
with the FWS regulations in 50 CFR 16.13.
    (f) Other provisions of this subpart relating to the importation of 
live VHS-regulated fish shall not apply to shipments of such fish in 
transit through the United States, if an import permit has been 
obtained under Sec.  93.912 and all conditions of the permit are 
observed, and if the live VHS-regulated fish species are handled as 
follows:
    (1) They are maintained under continuous confinement while in 
transit through the United States aboard an aircraft, ocean vessel, or 
other means of conveyance; or, if they are unloaded in the course of 
such transit, they are placed in a holding facility that is provided by 
the carrier or its agent and has been approved by the Administrator as 
adequate to prevent the spread within the United States of any finfish 
disease; they are maintained there under continuous confinement until 
loaded aboard a means of conveyance for transportation from the United 
States; and they are maintained under continuous confinement aboard 
such means of conveyance until it leaves the United States.
    (2) They are moved in accordance with any additional conditions 
prescribed in the permit that the Administrator has determined to be 
necessary to ensure that the fish do not introduce VHS into the United 
States.
    (3) For a holding facility to be approved by the Administrator, the 
following conditions must be met:
    (i) The holding facility must be sufficiently isolated to prevent 
direct or indirect contact of the live fish it contains with any other 
live VHS-regulated fish species in the United States.
    (ii) The holding facility must be constructed to provide adequate 
protection against environmental conditions and so that it can be 
adequately cleaned, washed, and disinfected.
    (iii) Provision must be made for disposal of fish carcasses, 
shipping water, effluent, waste, and any associated shipping materials 
in a manner that will prevent dissemination of disease.
    (iv) Provision must be made for adequate sources of feed and water 
and for attendants for the care and feeding of fish in the facility.
    (v) The holding facility must comply with all applicable local, 
State, and Federal requirements for environmental quality.
    (vi) The holding facility must comply with any additional 
requirements that the Administrator may impose on a particular shipment 
in order to prevent the dissemination of disease.
    (g) Other provisions of this subpart relating to the importation of 
live VHS-regulated fish shall not apply to fish moved into the United 
States from VHS-regulated regions during catch-and-release fishing.


Sec.  93.911  Ports designated for the importation of live VHS-
regulated fish species.

    (a) Live VHS-regulated fish from VHS-regulated regions may be 
imported into the United States without an import permit through the 
following Canadian border ports: Eastport, ID; Houlton and Jackman, ME; 
Detroit, Port Huron, and Sault Ste. Marie, MI; Baudette, MN; Opheim, 
Raymond, and Sweetgrass, MT; Alexandria Bay, Buffalo, and Champlain, 
NY; Dunseith, Pembina, and Portal, ND; Derby Line and Highgate Springs, 
VT; and Oroville and Sumas, WA.
    (b) Live VHS-regulated fish may be imported into the United States 
with an import permit through the following ports: Anchorage, AK; Los 
Angeles and San Francisco, CA; Miami and Tampa, FL; Atlanta, GA; 
Honolulu, HI; Chicago, IL; Boston, MA; Newark, NJ; Jamaica and 
Newburgh, NY; Portland, OR; Memphis, TN; Dallas-Ft. Worth, TX; Seattle, 
WA; and San Juan, PR.
    (c) Designation of other ports. Other ports may be designated by 
the Administrator in specific cases with the concurrence of the 
Secretary of the Department of Homeland Security.


Sec.  93.912  Import permits.

    (a) Live VHS-regulated fish imported from VHS-regulated regions 
through a limited port as described in Sec.  93.911(b) must be 
accompanied by an import permit issued by APHIS and must be imported 
within 30 days of the proposed arrival date stated in the import 
permit.
    (b) An application for an import permit must be submitted for each 
shipment of live VHS-regulated fish to the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import and 
Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231. Application 
forms for import permits may be obtained from this address. 
Applications may also be obtained from the following APHIS Web site: 
http://www.aphis.usda.gov/vs/ncie/pdf/vs17-129.pdf.
    (c) A completed application must include the following information:
    (1) The name and address of the person intending to export live 
VHS-regulated fish to the United States;
    (2) The proposed date of shipment to the United States;

[[Page 52188]]

    (3) The name and address of the person intending to import live 
VHS-regulated fish into the United States;
    (4) The species and number of live VHS-regulated fish to be 
imported into the United States;
    (5) The purpose of the importation;
    (6) The port of embarkation;
    (7) The mode of transportation;
    (8) The route of travel, including all carrier stops en route;
    (9) The port of entry in the United States;
    (10) The proposed date of arrival in the United States; and
    (11) The name and address of the person to whom the live VHS-
regulated fish will be delivered in the United States.
    (d) If APHIS determines that the live VHS-regulated fish from VHS-
regulated regions are eligible for importation, APHIS will issue an 
import permit indicating the applicable conditions for importation. An 
import permit does not guarantee that any live VHS-regulated fish will 
be allowed entry into the United States; the VHS-regulated fish will be 
allowed to enter the United States only if they meet all applicable 
requirements of the permit and regulations.

(Approved by the Office of Management and Budget under control 
number 0579-0340)


Sec.  93.913  Health certificate.

    (a) General. All live VHS-regulated fish that are imported from 
VHS-regulated regions for other than immediate slaughter or research or 
laboratory use must be accompanied by a health certificate issued by a 
full-time salaried veterinarian of the national government of the 
exporting country, or issued by a certifying official and endorsed by 
the competent authority of that country. The health certificate must be 
written in English or contain an English translation. The health 
certificate will be valid for 30 days from the date of issuance. The 
health certificate for the live VHS-regulated fish must state that:
    (1) The live fish were inspected by the veterinarian or certifying 
official who issued the certificate within 72 hours prior to shipment, 
and were found to be free of any clinical signs of disease consistent 
with VHS; and
    (2) The live fish covered by the health certificate originated in a 
region or facility that has demonstrated freedom from VHS through 
testing in accordance with paragraphs (b) and (c) of this section.
    (b) Testing. A facility can demonstrate freedom from VHS through 
negative testing results by a pathogen detection laboratory approved 
for VHS viral assays by the competent authority of that country. 
Testing must meet the following conditions:
    (1) Testing must be conducted with a testing sample size that 
provides for a 95 percent confidence level of detecting a 2 percent 
prevalence of infection in the facility.
    (i) Facilities with cultured fish of VHS-regulated species which 
can document a 2-year history of negative testing for VHS virus can 
conduct testing at a sampling level to provide a 95 percent confidence 
level of detecting a 5 percent prevalence of infection in the facility. 
Such testing must be conducted twice a year, with at least 3 months 
between tests.
    (ii) Facilities with cultured fish of VHS-regulated species which 
can document a 4-year history of negative testing for VHS virus can 
conduct testing at a sampling level to provide a 95 percent confidence 
level of detecting a 10 percent prevalence of infection in the 
facility. Such testing must be conducted twice a year, with at least 3 
months between tests.
    (iii) Such facilities must be on a secure water source, and 
document that any VHS-regulated species in the facility that originated 
in VHS-regulated States or Canadian provinces originate from facilities 
of the same or higher health status.
    (2) Tests must include virus isolation or other assays authorized 
by the competent authority, using appropriate cell lines to detect VHS 
virus, if present. All suspect VHS cytopathic effects must be 
positively identified as VHS through molecular assays and/or genetic 
sequencing.
    (3) Proportional numbers of each VHS-regulated fish species which 
might be present in a shipment must be used for testing, if applicable.
    (4) Testing must be conducted at water temperatures between 50 and 
72 [deg]F, or at other times or under environmental conditions when VHS 
virus is most likely to be detected, if present.
    (c) When APHIS adds a new species to the list of VHS-regulated 
species after a facility has been determined to be free of VHS in 
accordance with paragraph (b) of this section, the facility must 
conduct additional testing on fish of the newly listed species, if 
present in the facility, and the fish must be free of VHS virus for the 
facility to retain its free status. VHS testing must be conducted on 
each newly listed species with a sample size that provides for a 95 
percent confidence level of detecting a 2 percent prevalence of 
infection in the fish facility.
    (d) Shipping containers. Except as provided in Sec.  93.910(e)-(g), 
all live fish that are to be shipped to the United States must be 
shipped in new containers or in containers that have been cleaned and 
disinfected.
    (1) Cleaning and disinfection of shipping containers must be 
monitored by the veterinarian or certifying official who issues the 
health certificate.
    (2) Cleaning and disinfection must be sufficient to neutralize any 
VHS virus to which shipping containers may have been exposed.
    (3) The cleaning and disinfection protocols used must be referenced 
in the health certificate or in a separate cleaning and disinfection 
certificate accompanying the shipment to the U.S. port of entry.

(Approved by the Office of Management and Budget under control 
number 0579-0340)


Sec.  93.914  Declaration and other documents.

    (a) For live VHS-regulated fish offered for importation under this 
subpart, the importer or his or her agent must submit the following 
documents to the appropriate Customs and Border Protection officer for 
use by the port veterinarians:
    (1) All permits, certificates, or other documentation required 
under Sec. Sec.  93.912 and 93.913; and
    (2) Two copies of a declaration that lists the port of entry; the 
name and address of the importer; the name and address of the broker; 
the origin of the live fish; the number, species, and the purpose of 
the importation; the name of the person to whom the fish will be 
delivered; and the location of the place to which such delivery will be 
made.

(Approved by the Office of Management and Budget under control 
number 0579-0340)


Sec.  93.915  Inspection at the port of entry.

    (a) Shipments of live VHS-regulated fish must be presented for 
inspection at a port of entry designated under Sec.  93.911. For live 
fish entering through a limited port listed in Sec.  93.911(c), the 
APHIS port veterinarian must be notified at least 72 hours in advance 
of the arrival in the United States of the shipment. Any shipment that 
does not meet the requirements of this subpart will be refused entry.
    (b) Shipments refused entry must be exported within a time fixed in 
each case by the Administrator, and in accordance with other provisions 
he or she may require in each case for their handling, or the shipment 
will be disposed of as the Administrator may direct.

(Approved by the Office of Management and Budget under control 
number 0579-0340)

[[Page 52189]]

Sec.  93.916  Special provisions.

    (a) Slaughter. Live VHS-regulated fish from VHS-regulated regions 
may be imported directly for slaughter under the following conditions:
    (1) An import permit has been obtained under Sec.  93.912 and all 
conditions of the permit are observed.
    (2) An APHIS representative at the port seals the means of 
conveyance with official seals.
    (3) The shipment is moved directly from the port of entry to a 
slaughtering establishment that meets the following conditions:
    (i) The slaughtering establishment discharges its waste water to a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus.
    (ii) Offal, including carcasses, from the slaughtering 
establishment is either rendered or composted.
    (4) An APHIS representative will unseal the vehicle upon arrival at 
the slaughtering establishment.
    (5) Any water used to transport the fish is disposed to a municipal 
sewage system that includes waste water disinfection sufficient to 
neutralize any VHS virus or to either a non-discharging settling pond 
or a settling pond that disinfects, according to all applicable local, 
State, and Federal regulations, sufficiently to neutralize any VHS 
virus.
    (b) Research or laboratory use. Live VHS-regulated fish may be 
imported from a VHS-regulated region for research or laboratory use 
under the following conditions:
    (1) An import permit has been obtained under Sec.  93.912 and all 
conditions of the permit are observed.
    (2) The laboratory or research facility disposes of effluent to a 
municipal sewage system that includes waste water disinfection 
sufficient to neutralize any VHS virus or to either a non-discharging 
settling pond or a settling pond that disinfects, according to all 
applicable local, State, and Federal regulations, sufficiently to 
neutralize any VHS virus.
    (3) Carcasses must be rendered or composted.
    (4) Any water used to transport the fish is disposed to a municipal 
sewage system that includes waste water disinfection sufficient to 
neutralize any VHS virus or to either a non-discharging settling pond 
or a settling pond that disinfects, according to all applicable local, 
State, and Federal regulations, sufficiently to neutralize any VHS 
virus.

    Done in Washington, DC, this 4th day of September 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-20852 Filed 9-8-08; 8:45 am]
BILLING CODE 3410-34-P