Viral Hemorrhagic Septicemia; Interstate Movement and Import Restrictions on Certain Live Fish, 52173-52189 [E8-20852]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

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


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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.

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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:
     Federal eRulemaking Portal: Go to https://
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.
     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 https://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.
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    \1\ We define anadromous fish as fish that are born and spawn in 
freshwater, but which spend part of their lifecycle in saltwater.
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    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 https://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
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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:
     The name, address, and phone number of the owner or 
owner's agent.
     The name, address, and phone number of the facility in 
which the fish originated.
     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.
     The name, address, and phone number of the shipping or 
transportation company.
     The species and number of the fish.
     The lot (or other) identification of the shipment.
     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.
     The date the certificate was issued.
     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:
     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.
     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.
     Use proportional numbers of each VHS-regulated fish 
species which might be present in the facility.
     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 https://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:
     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.
     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:
     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.
     The holding facility must be constructed to provide 
adequate protection against environmental conditions and so that it can 
be adequately cleaned, washed, and disinfected.
     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.
     Provision must be made for adequate sources of feed and 
water and for attendants for the care and feeding of fish in the 
facility.
     The holding facility must comply with all applicable 
local, State, and Federal requirements for environmental quality.
     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:
     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.
     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.
     Test proportional numbers of each VHS-regulated fish 
species which might be present in a shipment, if applicable.
     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:
     All permits, certificates, or other documentation required 
under Sec. Sec. Sec.  93.912 and 93.913; and
     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:
     An import permit has been obtained under Sec.  93.912 and 
all conditions of the permit are observed.
     An APHIS representative at the port seals the means of 
conveyance with official seals.
     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.
     An APHIS representative unseals the vehicle upon arrival 
at the slaughtering establishment.
     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:
     An import permit has been obtained under Sec.  93.912 and 
all conditions of the permit are observed.
     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.
     Carcasses must be rendered or composted.
     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 th