Spring Viremia of Carp; Import Restrictions on Certain Live Fish, Fertilized Eggs, and Gametes, 51429-51437 [E6-14478]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 71, Number 168 (Wednesday, August 30, 2006)]
[Rules and Regulations]
[Pages 51429-51437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14478]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 93

[Docket No. APHIS-2006-0107]


Spring Viremia of Carp; Import Restrictions on Certain Live Fish, 
Fertilized Eggs, and Gametes

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 importation 
into the United States of live fish, fertilized eggs, and gametes of 
fish species that are susceptible to spring viremia of carp, a serious 
contagious viral disease of carp. Cases of spring viremia of carp 
confirmed in the United States in 2002 and 2004, and since eradicated, 
have been linked to the unregulated importation of fish infected with 
the virus. This action is necessary to prevent further introductions of 
spring viremia of carp into the United States.

DATES: This interim rule is effective September 29, 2006. We will 
consider all comments that we receive on or before October 30, 2006.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov and, in the lower ``Search Regulations and Federal 
Actions'' box, select ``Animal and Plant Health Inspection Service'' 
from the agency drop-down menu, then click on ``Submit.'' In the Docket 
ID column, select APHIS-2006-0107 to submit or view public comments and 
to view supporting and related materials available electronically. 
Information on using Regulations.gov, including instructions for 
accessing documents, submitting comments, and viewing the docket after 
the close of the comment period, is available through the site's ``User 
Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0107, 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-2006-0107.
    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. Peter L. Merrill, Aquaculture 
Specialist, National Center for Import and Export, VS, APHIS, 4700 
River Road Unit 39, Riverdale, MD 20737-1231; (301) 734-0649; or Dr. 
Jill B. Rolland, Fishery Biologist, National Center for Animal Health 
Programs, VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737-1231; 
(301) 734-7727.

SUPPLEMENTARY INFORMATION:

Background

    Spring viremia of carp (SVC) is a disease of certain species of 
finfish, caused by an eponymous rhabdovirus. The following species are 
considered susceptible to SVC: Common carp, including koi (Cyprinus 
carpio), grass carp (Ctenopharyngodon idellus), silver carp 
(Hypophthalmichthys molitrix), bighead carp (Aristichthys nobilis), 
Crucian carp (Carassius carassius), goldfish (Carassius auratus), tench 
(Tinca tinca), and sheatfish (Silurus glanis). SVC was first reported 
in Yugoslavia in 1969 and has since spread to other European countries 
as well as Asia. SVC is considered extremely contagious, and there are 
currently no U.S.-approved vaccines or treatments for the virus.
    In the United States, SVC is not known to exist in farm-raised 
fish. The disease is considered a foreign animal disease and is 
reportable to the Animal and Plant Health Inspection Service (APHIS). 
SVC is also a listed as a notifiable disease by the World Organization 
for Animal Health (OIE). Characteristics of OIE-notifiable aquatic 
animal diseases such as SVC include the following:
    1. The disease has been shown to cause significant production 
losses due to morbidity or mortality at a national or multinational 
level where it occurs;
    2. The disease has been shown to, or is strongly suspected to, 
negatively affect wild aquatic animal populations that are shown to be 
an asset worth protecting; or
    3. The disease has the potential for international spread, 
including via live animals, their bodily fluids and waste, and 
inanimate objects.

[[Page 51430]]

    If SVC is discovered in an OIE member country, the affected country 
must report the discovery to OIE, which will notify the other member 
countries.
    Transmission of SVC virus (SVCV) \1\ may occur through water 
contaminated with feces, urine, or mucus from infected fish and by 
parasites such as leeches. SVCV can survive for long periods of time in 
water and mud, increasing the possibility of transmission between sites 
by contaminated equipment. In addition, piscivorous birds that prey on 
SVC-susceptible species often travel over very large areas and can 
transmit the disease between sites. The presence of SVCV in ovarian 
fluid also suggests that the disease may be transmitted from parent to 
offspring. Morbidity and mortality vary considerably by several factors 
including temperature, fish species, and other factors, but may be 
substantial. Some fish that recover from SVC can become non-clinical 
carriers of the virus. Non-clinical carriers of the virus can transmit 
the virus to other susceptible species, but do not show signs of SVC.
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    \1\ SVC refers to actual clinical expression of the disease in 
susceptible species caused by the pathogen. SVCV refers to the 
actual pathogen regardless of its expression in the host species.
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    Although other factors, such as age, can determine how severely the 
disease will affect a population, the temperature at which fish become 
infected, temperature fluctuations during the infective period, and the 
ability of the fish to mount a timely immune response seem to be the 
most important components for SVC. Generally, the disease flourishes in 
the spring as water temperatures increase, but maximum mortality occurs 
when temperatures are below 64 [deg]F. As temperatures rise, disease 
expression varies as the immune resistance of carp also rises. 
Temperatures at or above 68 [deg]F are optimal for immune function of 
susceptible species, where fish may not exhibit symptoms of the 
disease. Once the disease is detected in host species, total 
depopulation of exposed susceptible species is necessary given the 
contagious nature of the pathogen and the possibility of non-clinical 
carriers that may not exhibit symptoms.
    Clinical signs of SVC may be nonspecific and include darkening of 
the skin, exophthalmia (pop-eye), ascites (dropsy), pale gills, 
hemorrhages in the gills, skin, and eyes, and a protruding vent with a 
thick mucoid fecal cast. Pinpoint hemorrhages may occur in many organs 
and are considered an important indicator for SVC. Other internal signs 
include edema, inflammation of the intestine, and enlargement of the 
spleen. Concurrent infections often occur and may complicate the 
diagnosis. Mortality can be up to 70 percent in yearlings, while older 
age groups generally experience lower mortality rates. As stated 
previously, SVC does not exist in farm-raised fish populations in the 
United States. During two routine tests of wild fish populations in 
1989 and 1993, test results showed that some fish had been exposed to 
the European strain of SVCV. Because of the low number of positive 
tests compared with all of the tests that were conducted, we consider 
the European strain of SVC to exist at very low prevalence levels in 
wild fish populations in the United States.
    In April 2002, a koi farm in North Carolina experienced an outbreak 
of SVC. The outbreak occurred shortly after the facility spawned koi 
that had been imported from a production facility in an Asian country 
where the SVC-status is unconfirmed. At the North Carolina farm, 
incoming fish had not been pre-screened for SVC and, apart from new 
stock importation, the U.S. farm did not have any known risks for SVCV 
exposure. The farm sent a sample of the diseased koi to the Fish 
Disease Diagnostic Laboratories of the University of Arkansas at Pine 
Bluff, an APHIS-approved diagnostic laboratory. After a tentative 
positive diagnosis for SVC, the Arkansas laboratory forwarded the 
sample to the OIE reference laboratory for SVC in Weymouth, England. 
The OIE laboratory confirmed the tentative diagnosis of SVC on June 25, 
2002. The confirmed case was reported to APHIS on July 3, 2002. The 
affected koi farm operated sites for hatching and resale in North 
Carolina and Virginia. Due to multiple transfers of fish between sites, 
both of the farm's sites were considered exposed to SVCV.
    Two additional cases of SVC were confirmed in the summer of 2004, 
in Missouri and Washington. In the Missouri outbreak, a shipment of 
fish to the facility preceded the SVC outbreak by 2 weeks. These fish 
came from a U.S. facility where a disease with symptoms similar to SVC 
had been previously encountered in the spring of each of the 2 prior 
years. This U.S. facility where the fish originated had also imported 
fish from Asian countries prior to the onset of its disease problems, 
but had ceased importations afterwards. In the Washington outbreak, a 
hobbyist had acquired fish from a U.S. distributor who had obtained 
SVC-susceptible fish from a pet store supplied by Asian sources. In 
both situations, the imported fish had not been screened for SVC prior 
to importation.
    An APHIS review of the details in both of these cases concluded 
that domestic U.S. populations of SVC-susceptible fish were not 
considered to have been at prior risk from SVCV exposure other than 
from fish of direct or indirect Asian origin brought onto their 
premises. After SVC outbreaks were reported, the site in Washington, 
owned by a backyard hobbyist, and the site in Missouri, a commercial 
operation, were completely depopulated, cleaned and disinfected, and 
restocked with SVC-negative fish.
    Tracebacks conducted at the affected facilities in North Carolina, 
Washington, and Missouri indicated that all three of the outbreaks in 
commercial facilities followed the introduction of imported fish from 
countries where SVC was known to exist or where the SVC status is 
unconfirmed. Furthermore, subsequent genetic identification of the 
viral strain involved in all U.S. farmed fish outbreaks of SVC 
determined that the virus was of Asian, rather than European, genotype, 
which is the only genotype of SVC that has been identified in previous 
testing of wild fish populations in the United States. As the Asian 
strain of SVC had not been previously detected or reported in the 
United States, or in the Western hemisphere, APHIS concluded that the 
SVC outbreaks in U.S. farmed fish were linked to the importation of 
SVC-infected fish.
    Currently, there are no Federal regulations that restrict the 
importation of SVC-susceptible species of fish to prevent the 
introduction of SVC. Based on our review of the 2002 and 2004 cases of 
SVC in the United States, we have determined it is necessary to 
restrict the importation of live fish, fertilized eggs, and gametes of 
SVC-susceptible species to ensure they are free of SVC.
    Accordingly, we are amending the animal import regulations in 9 CFR 
part 93 by adding a new subpart I, ``Aquatic Animal Species'' 
(Sec. Sec.  93.900 through 93.907, referred to below as the 
regulations). The regulations will restrict the importation of live 
fish, fertilized eggs, and gametes of SVC-susceptible species. In 
addition, the importation of live cultures of SVCV, preserved SVCV 
viral RNA or DNA, tissue samples containing viable SVCV, or other 
specimens intended for diagnostic or research purposes and which 
contain viable SVCV may be imported only under permit in accordance 
with 9 CFR part 122, ``Organisms and Vectors.''
    The regulations in new subpart I are explained below, by section.

[[Page 51431]]

Definitions (Sec.  93.900)

    Section 93.900 contains definitions of the following terms: 
Administrator, Animal and Plant Health Inspection Service, APHIS 
representative, certifying official, communicable disease, competent 
authority, container, Department, fertilized egg, gamete, inspector, 
person, port veterinarian, region, spring viremia of carp (SVC), SVC-
susceptible species, and United States.
    The following definitions are standard and found throughout part 
93: Administrator, Animal and Plant Health Inspection Service, APHIS 
representative, communicable disease, Department, inspector, person, 
port veterinarian, region, and United States. These terms and their 
definitions are set out in the regulatory text at the end of this 
document.
    Some additional terms that are being added to the regulations will 
be new to part 93 and their applicability is specific to aquatic animal 
species. Also, some of the terms have not been discussed previously in 
this document. These terms are certifying official, competent 
authority, and container. These terms will be defined as follows:
    Certifying official. An individual authorized by the competent 
authority of a country to sign health certificates for aquatic animals.
    Competent authority. The national veterinary services or other 
authority of a country, having the responsibility and competence for 
ensuring or supervising the implementation of aquatic animal health 
measures.
    Container. A transport receptacle that is specially constructed to 
facilitate transportation of aquatic animals or aquatic animal products 
by one or several means of transport.

General Restrictions; Exceptions (Sec.  93.901)

    Paragraph (a) of Sec.  93.901 provides that no live fish, 
fertilized eggs, or gametes of SVC-susceptible species may be imported 
into the United States except in accordance with subpart I. This 
paragraph further provides that no such live fish, fertilized eggs, or 
gametes may be moved from the port of entry after arrival until 
released by the port veterinarian. In addition, this paragraph 
specifies that the Administrator may, upon request in specific cases, 
allow the importation of SVC-susceptible live fish, fertilized eggs, or 
gametes into the United States under conditions other than those 
specifically set forth in this subpart when he or she determines that 
such movement will not result in the introduction of SVC into the 
United States.
    Paragraph (b) of this section provides that other provisions of 
part 93 relating to the importation of live fish, fertilized eggs, and 
gametes shall not apply to shipments of live fish, fertilized eggs, or 
gametes in transit through the United States if an import permit has 
been obtained under Sec.  93.903 and all conditions of the permit are 
observed, and if the live fish, fertilized eggs, and gametes 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
     They are unloaded, in the course of such transit, into 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.
     They are moved in accordance with any additional 
conditions prescribed in the permit and determined by the Administrator 
to be necessary to ensure that the live fish, fertilized eggs, or 
gametes do not introduce SVC 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, fertilized eggs, 
or gametes it contains with any other SVC-susceptible 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, 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, fertilized 
eggs, or gametes 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 may be imposed by the Administrator for a particular 
shipment if necessary to prevent the dissemination of disease.

Ports Designated for the Importation of Live Fish, Fertilized Eggs, and 
Gametes (Sec.  93.902)

    Section 93.902 designates ports through which live fish, fertilized 
eggs, and gametes of SVC-susceptible species may be imported into the 
United States. We consider these ports to have adequate facilities and 
inspectors to perform the necessary inspections of shipments of live 
fish, fertilized eggs, and gametes.
    Air and ocean ports listed are Los Angeles and San Francisco, CA; 
Miami and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; Boston, 
MA; Newark, NJ; New York, NY; Portland, OR; Dallas-Ft. Worth, TX; and 
San Juan, PR. Land border ports listed are Detroit, MI; Buffalo-
Niagara, NY; Seattle and Sumas, WA; and Otay Mesa, CA.
    This section also provides for other ports to be designated by the 
Administrator in special instances with the concurrence of the 
Secretary of the Department of Homeland Security.

Import Permits for Live Fish, Fertilized Eggs, and Gametes (Sec.  
93.903)

    Paragraph (a) of Sec.  93.903 requires that live fish, fertilized 
eggs, or gametes of SVC-susceptible species 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.
    Paragraph (b) of this section provides the address 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 fish, 
fertilized eggs, and gametes of SVC-susceptible species.
    Paragraph (c) 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; 
the name and address of the importer; the species and number of live 
fish, fertilized eggs, or gametes to be imported into the United 
States; the purpose of the importation; the ports of embarkation; the 
mode of transportation (airplane, boat, car, etc.) to be used to ship 
the live fish, fertilized eggs, or gametes to the United States; the 
route of travel, including all carrier stops en route; the port of 
entry; the proposed date of arrival; and the name and address of the 
person to whom the shipment of live fish, fertilized eggs, or gametes 
will be delivered in the United States. APHIS

[[Page 51432]]

needs this information to determine whether the live fish, fertilized 
eggs, or gametes 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.
    Paragraph (d) explains what happens after we receive and review the 
application for an import permit. This paragraph provides that if, 
following our review, we determine that the live fish, fertilized eggs, 
or gametes are eligible to be imported, we will issue an import permit. 
This paragraph also specifies that an import permit does not guarantee 
that any live fish, fertilized eggs, or gametes will be allowed entry 
into the United States; the fish, fertilized eggs, or gametes will be 
allowed to enter the United States only if they meet all applicable 
requirements of the regulations.

Health Certificate for Live Fish, Fertilized Eggs, and Gametes (Sec.  
93.904)

    Paragraph (a) of Sec.  93.904 requires that SVC-susceptible species 
of live fish, fertilized eggs, and gametes that are imported into the 
United States from any part of the world be accompanied to the port of 
entry in the United States 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 region, or issued by a certifying official 
and endorsed by the competent authority of the exporting region. 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 and found to be free of any clinical signs of disease 
consistent with SVC within 72 hours prior to the shipment being 
exported from the region of origin and that the live fish, fertilized 
eggs, or gametes covered by the health certificate meet the 
requirements of paragraph (b) of this section.
    Paragraph (b) of this section requires the live fish, fertilized 
eggs, or gametes to meet the following conditions to be eligible for 
importation into the United States:
     The live fish, fertilized eggs, or gametes must be under 
the supervision of the competent authority and must participate in a 
health surveillance program for SVC.
     The region or establishment from which the live fish, 
fertilized eggs, or gametes originate must demonstrate freedom from SVC 
through a minimum of 2-years' continuous health history, supported by 
laboratory testing by a pathogen detection facility approved for SVC 
viral assays by the competent authority.
     SVC-susceptible fish populations in the region or 
establishment must be tested at least twice annually, with at least 3 
months between the tests and at times or under environmental conditions 
that would facilitate the detection of SVCV if it were present. 
Sampling procedures must utilize an assumed pathogen prevalence of 2 
percent, with a corresponding confidence level of 95 percent. Samples 
must be collected and submitted by a certifying official or 
veterinarian recognized by the competent authority. The standard 
screening method for SVC must include isolation of SVCV in cell 
culture, using either the epithelioma papulosum cyprini (EPC) or 
fathead minnow (FHM) cell lines. However, the Administrator may 
authorize other assays for SVCV detection in lieu of virus isolation 
through cell culture, if the Administrator determines that such assays 
are robust enough to provide equal assurances of the SVC status of an 
exporting region or establishment. All viral testing results must be 
negative.
    These requirements will ensure that SVC-susceptible species of live 
fish, fertilized eggs, or gametes imported into the United States are 
not infected with SVCV.
    Paragraph (c) of Sec.  93.904 requires that the live fish, 
fertilized eggs, or gametes be shipped to the United States in new 
containers or containers that have been cleaned and disinfected to 
neutralize any SVCV to which the shipping containers may have been 
exposed. Cleaning and disinfection must take place under the 
supervision of the official who issues the health certificate.
    Acceptable disinfection procedures include individual or 
combination treatments with: Solutions having a pH of 12 or higher or 3 
or lower with a contact time of at least 10 minutes; heat at or above 
56 [deg]C for at least 15 minutes; chlorine solutions having a 
concentration of at least 500 ppm with a contact time of at least 10 
minutes; iodine solutions having a concentration of at least 100 ppm 
with a contact time of at least 10 min; ultraviolet exposure (254 nm; 
minimum exposure of 10,000 microwatt seconds/cm2); or other 
disinfectants such as Virkon used according to the manufacturer's 
directions. Other procedures may be used if determined adequate by the 
Administrator to neutralize the SVCV. Cleaning and disinfection 
protocols must be referenced in the health certificate or in a separate 
cleaning and disinfection certificate accompanying the shipment.
    The requirements described above are consistent with OIE's 
guidelines for trade in SVC-susceptible live fish, fertilized eggs, and 
gametes (Article 2.1.4.6 of the OIE Aquatic Code).

Declaration and Other Documents for Live Fish, Fertilized Eggs, and 
Gametes (Sec.  93.905)

    Section 93.905 requires the importer or his or her agent to submit 
the following documents to the collector of customs for use by the port 
veterinarians:
     All permits, certificates, or other documentation required 
by this part; 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, fertilized eggs, or gametes; 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.

Inspection at the Port of Entry (Sec.  93.906)

    Section 93.906 sets forth requirements for port of entry 
inspections of shipments of SVC-susceptible species of live fish, 
fertilized eggs, or gametes. Paragraph (a) provides that the shipments 
must be presented for inspection at a port of entry designated under 
Sec.  93.902. This paragraph also requires that the port veterinarian 
be notified at least 72 hours in advance of the arrival of the shipment 
in the United States. It also provides that any shipment of live SVC-
susceptible fish species that the port veterinarian determines to 
exhibit clinical signs consistent with SVCV infection or disease, or 
any shipments of live fish, fertilized eggs, and gametes of SVC-
susceptible species that otherwise do not meet the requirements of this 
subpart will be refused entry.
    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 will be disposed of as the Administrator may direct.

User Fees

    APHIS user fees for processing permit applications and for 
inspecting animals at the port of entry will apply. The user

[[Page 51433]]

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 
fees set forth in Sec.  130.30.

Processed Products of SVC-Susceptible Species

    Currently, we do not know the extent of imports to the United 
States of products of SVC-susceptible species. Such products could 
include muscle fillets (imported whole or for further processing), 
fresh or frozen whole uneviscerated fish, or tissues of SVC-susceptible 
species intended for use as bait, or other materials. Available 
scientific literature indicates that there is a perceived low risk of 
SVC transmission associated with products of SVC-susceptible species 
intended for human consumption or for further processing. Also, the 
importation of products from SVC-susceptible species has not been 
linked to outbreaks of SVC in the United States. Therefore, we are not 
restricting the importation of such products at this time. Fresh or 
frozen whole uneviscerated fish or tissues of SVC-susceptible species 
for use as bait may be determined to present additional risks. We will 
continue to seek more information regarding those risks and may impose 
restrictions on such materials at a later date. We welcome comment on 
this issue as well as on any aspect of this rule.

Immediate Action

    Immediate action is necessary to prevent further introductions of 
SVC into the United States. SVC is not currently present in farm-raised 
populations of fish in the United States. Each time SVC has been 
discovered in commercial fish sites, the disease has been eradicated. 
Tracebacks conducted at the affected facilities in North Carolina, 
Washington, and Missouri indicated that all three of the outbreaks in 
commercial facilities followed the introduction of imported fish from 
countries where SVC was known to exist or where the SVC status was 
unknown, and genetic identification of the viral strain involved in all 
U.S. farmed fish outbreaks of SVC determined that the virus was of 
Asian, rather than European, genotype, which is the only genotype of 
SVC that has been identified in previous testing of wild fish 
populations in the United States. The facilities did not have any known 
risks of SVCV exposure other than through such imports. Despite its 
current SVC-free status, the United States remains unprotected from 
continuing introductions of infected fish, since there are a number of 
known or suspected SVC-positive countries that export fish to the 
United States, and pre-testing of imported SVC-susceptible fish is not 
currently required. Therefore, it is necessary to implement regulations 
that will restrict such imports in as timely a manner as possible.
    Under these circumstances, the Administrator has found that notice 
and public procedures with respect to this action are contrary to the 
public interest and that there is good cause under 5 U.S.C. 553 for 
issuing this rule as an interim rule, rather than publishing a proposed 
rule.
    This rule will take effect 30 days after the date of publication to 
prevent detrimental effects to live fish, fertilized eggs, and gametes 
that were in transit to the United States prior to the publication 
date.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule.

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 are amending the regulations to establish restrictions on the 
importation into the United States of live fish, fertilized eggs, and 
gametes of fish species that are susceptible to SVC. We are also 
restricting the importation of diagnostic specimens and research 
materials containing viable SVCV. These actions are necessary to 
prevent the introduction of SVC into the United States.
    In accordance with 5 U.S.C. 603, we have performed an initial 
regulatory flexibility analysis, which is set out below, regarding the 
economic effects of this rule on small entities.
    The total value of SVC-susceptible species in the United States 
industry was approximately $23.2 million in 1998.\2\ The small business 
size standards for animal aquaculture, as identified by the Small 
Business Administration (SBA), based upon the North American Industry 
Classification System (NAICS) code 112511, is $750,000 or less in 
annual receipts. While the available data do not provide the number of 
U.S. farms producing SVC-susceptible species according to size, it is 
reasonable to assume that the majority of the operations are small 
businesses by SBA standards because of the value of sales compared to 
the total number of farms.\3\ In 1998, a total of 76 carp farms 
accounted for approximately $3.2 million in farm sales; 34 feeder 
goldfish farms accounted for approximately $9.3 million in sales; 115 
koi farms accounted for approximately $3.9 million in sales; and 65 
ornamental goldfish farms accounted for approximately $6.7 million in 
sales. The data above do not reveal the number of separate U.S. farms 
that produced the susceptible species in 1998, since some farms 
produced more than one species. APHIS welcomes information that would 
enable us to more precisely identify the number of small entities that 
may be affected by this rule.
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    \2\ NASS/USDA, 1998 Census of Aquaculture. Note: 1998 is the 
most recent year in which census data for aquaculture are available.
    \3\ Based upon 2002 Census of Agriculture--State Data.
---------------------------------------------------------------------------

    Existing data suggest that domestic producers of SVC-susceptible 
ornamental fish species (i.e., koi, Crucian carp, and goldfish) will 
benefit from this interim rule. The United States is a net importer of 
live ornamental fish. In 1998, the United States imported $45.1 million 
in live ornamental fish, with approximately 57 percent of that arriving 
primarily from Asia. In that same year, U.S. exports of live ornamental 
fish were $10.6 million, less than one-fourth the value of imports.\4\ 
This rule will ensure SVC-susceptible live fish, fertilized eggs, and 
gametes imported by these producers are free of SVC.
---------------------------------------------------------------------------

    \4\ Global Trade Atlas, 1998.
---------------------------------------------------------------------------

    The United States is a net exporter of live carp (i.e., common carp 
(excluding koi), grass carp, silver carp, bighead carp, tench, and 
sheatfish). In 1998, the United States exported approximately $1.7 
million in live carp, while importing roughly $0.2 million. 
Approximately 98 percent of U.S. exports of live carp are sent to 
Canada. U.S. producers who export live carp will also benefit from this 
interim rule because it will help to provide continued assurance of the 
SVC-free status of U.S. exports.
    U.S. imports of live carp come primarily from Japan, Hong Kong, and 
Israel,\5\ which are considered to be potential sources of SVCV-
infected fish. Japan accounted for 87 percent of the U.S. live carp 
import market in 2003,

[[Page 51434]]

and Hong Kong and Israel accounted for about 7 and 6 percent, 
respectively.\6\ SVC-susceptible fish imported from these and other 
regions of the world will have to be certified as being from a region 
or establishment determined to be free of SVC.
---------------------------------------------------------------------------

    \5\ Global Trade Atlas, 2003.
    \6\ Global Trade Atlas, 2003.
---------------------------------------------------------------------------

    Importers of SVC-susceptible species will be affected by the user 
fees that will be charged for processing applications for import 
permits and for conducting inspections at the port of entry under 
APHIS' regulations in Sec. Sec.  130.4 (processing import permit 
applications) and 130.30 (hourly rates for services). The user fee for 
processing an initial import permit application is $94. In the 
beginning, import compliance assistance ($70) might be necessary, which 
would raise the cost to $164 for each shipment, but we estimate that 
most importers will not need import compliance assistance. The user fee 
rate is $84 per hour ($21 per quarter hour) for inspection services, 
including travel time, during normal business hours. At other times, 
the user fees are $100 per hour ($25 per quarter hour) Monday through 
Saturday and on holidays. The user fees are $112 per hour ($28 per 
quarter hour) on Sundays.
    According to APHIS' Veterinary Services, the average inspection 
takes an estimated 4\1/2\ hours, including inspectors' travel time to 
the port. Therefore, the total cost of inspecting a shipment can range 
from $378 to $504, depending on whether the inspection is done during 
normal business hours.\7\ The projected average cost of inspection to 
an importer with four or more shipments annually is between $2700 and 
$3650.\8\ The average cost of import permits, based upon an average of 
7 shipments per annum per importer, will be $685.\9\ A small number of 
entities currently import more than 40 shipments of SVC-susceptible 
species annually. Permit and inspection costs for these importers are 
expected to range between $15,000 and $20,000. The projected total 
annual cost to importers of live SVC-susceptible species is between 
$237,384 and $316,512 for inspections, and about $59,032 for import 
permits.\10\
---------------------------------------------------------------------------

    \7\ Total cost of an average inspection during normal business 
hours is derived as follows: ($84*4) + $42 = $378. Total cost of an 
average inspection on Sundays is derived as follows: ($112*4) + $56 
= $504.
    \8\ Based upon 2004 SVC-susceptible species import records of 
628 shipments from the Automated Target System Inbound Production 
Web Server.
    \9\ The estimated total average cost for import permits does not 
include the import compliance assistance fee of $70, which is only 
incurred until the application process becomes familiar to the 
importer.
    \10\ The projected total annual cost to importers for 
inspections during normal business hours is derived as follows: $378 
per inspection*628 shipments = $237,684 for inspections. The 
projected total annual cost to importers for inspections on Sundays 
is derived as follows: $504 per inspection*628 shipments = $316,512. 
The total annual cost for permits is derived as follows: $94 per 
permit*628 shipments = $59,032.
---------------------------------------------------------------------------

    Import permit and inspection expenditures by entities will be 
roughly proportional to the number of shipments imported. We do not 
have data on the average value of shipments of SVC-susceptible species 
by importers, or the range or distribution of shipment values. Imports 
of SVC-susceptible species are often a mixture of the less expensive 
ornamental fish and the more expensive koi. APHIS invites comment on 
the average revenues and operating costs, and average number of 
shipments per year, of small-entity importers that may be impacted by 
this interim rule.
    The user fees set forth in this interim rule are financial targets, 
with the goal of recovering the cost of agency operations. Profit 
margins of some importers could decline due to the user fees, depending 
upon the extent to which they are unable to pass these costs on to 
their buyers. One possible response of buyers of imported SVC-
susceptible species to price increases may be to shift to domestic 
sources for ornamental fish, and limit imports to the more expensive 
species, such as koi. Given their limited domestic availability, price 
changes that may occur because of the user fees incurred by importers 
should not have a large effect on the quantities imported. APHIS 
welcomes information from the public as to the domestic wholesale 
supply of the various SVC-susceptible species, compared to quantities 
imported. While it is anticipated that the permit and inspection costs 
may have a discernable impact on prices of SVC-susceptible species, we 
believe the benefits of preventing future introduction of SVC into the 
United States, in terms of forgone depopulation and cleaning and 
disinfecting expenditures, will exceed any negative price effects.
    APHIS considered several alternatives to the import requirements 
for SVC-susceptible species set forth in this final rule. One 
alternative was to list regions where SVC is known to exist in our 
regulations and to only impose import restrictions on SVC-susceptible 
species imported from those regions. This approach would allow for 
regions maintaining SVC-free status to export SVC-susceptible species 
without the added import permit and health certificate requirements. 
However, it was determined that due to the complex epidemiology of SVC, 
and the present inability of APHIS to monitor or assess the veterinary 
infrastructure of countries maintaining SVC freedom, that the 
establishment of a list of SVC-free regions could not be done with any 
reliable assurance of initial or ongoing validity.
    A second alternative APHIS considered was to exempt SVC-susceptible 
species intended to remain in private aquaria from the restrictions set 
forth in this rule; however, it was determined that we could not assure 
that allowing such an exemption would mitigate the risk of spreading 
the pathogen or disease via accidental or purposeful release into 
waterways with wild SVC-susceptible populations.
    APHIS also considered exempting a limited number of imported SVC-
susceptible fish brought into the United States as personal baggage, 
since many goldfish (Carassius auratus) and possibly other SVC-
susceptible species are brought into the United States in this fashion 
by international travelers. It was determined that we could not 
adequately ensure that such practices would not result in accidental or 
purposeful release into waterways where other populations of fish, 
including farmed fish species, could be affected.
    APHIS invites comment on any additional information that will 
enable us to better assess the financial burden that the rule may place 
on small-entity importers of SVC-susceptible species.
    This rule contains certain reporting and recordkeeping requirements 
(see ``Paperwork Reduction Act'' below).

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.

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 0579-0301 to the information 
collection and recordkeeping requirements.

[[Page 51435]]

    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-2006-0107, 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-2006-
0107 and send your comments within 60 days of publication of this rule.
    This interim rule establishes regulations to restrict the 
importation of live fish, fertilized eggs, and gametes of SVC-
susceptible species into the United States. It also restricts the 
importation of diagnostic specimens or research materials containing 
viable SVCV. Live fish, fertilized eggs, and gametes of SVC-susceptible 
species that are imported into the United States will have to be 
accompanied by a health certificate. Importers of SVC-susceptible 
species will be required to obtain an import permit, and provide a 
declaration at the port of entry. Importers of live cultures of SVCV, 
preserved SVC viral RNA or DNA, tissue samples containing viable SVCV, 
or other specimens for diagnostic or research purposes will also have 
to obtain an import permit.
    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 .40090834 hours per response.
    Respondents: Importers of SVC-susceptible live fish, fertilized 
eggs, and gametes, and cultures/diagnostic specimens containing SVCV.
    Estimated annual number of respondents: 12,010.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 36,010.
    Estimated total annual burden on respondents: 5,969 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

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) 734-7477.

List of Subjects in 9 CFR Part 93

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

0
Accordingly, we are amending 9 CFR part 93 as follows:

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
1. 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
2. The heading for part 93 is revised to read as set forth above.


0
3. Part 93 is amended by adding a new Subpart I--Aquatic Animal 
Species, Sec. Sec.  93.900 through 93.907, to read as follows:
Subpart I--Aquatic Animal Species
Sec.
93.900 Definitions.
93.901 General restrictions; exceptions.
93.902 Ports designated for the importation of live fish, fertilized 
eggs, and gametes.
93.903 Import permits for live fish, fertilized eggs, and gametes.
93.904 Health certificate for live fish, fertilized eggs, and 
gametes.
93.905 Declaration and other documents for live fish, fertilized 
eggs, and gametes.
93.906 Inspection at the port of entry.

Subpart I--Aquatic Animal Species


Sec.  93.900  Definitions.

    Wherever in this subpart the following terms are used, unless the 
context otherwise requires, they shall be construed, respectively, to 
mean:
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service of the United States Department of 
Agriculture (APHIS).
    APHIS representative. A veterinarian or other individual employed 
by the Animal and Plant Health Inspection Service, United States 
Department of Agriculture, who is authorized to perform the services 
required by this part.
    Certifying official. An individual authorized by the competent 
authority of a country to sign health certificates for aquatic animals.
    Competent authority. The national veterinary services or other 
authority of a country, having the responsibility and competence for 
ensuring or supervising the implementation of aquatic animal health 
measures.
    Container. A transport receptacle that is specially constructed to 
facilitate transportation of aquatic animals or aquatic animal products 
by one or several means of transport.
    Department. The United States Department of Agriculture (USDA).
    Fertilized egg. A viable fertilized ovum of an aquatic animal.
    Gamete. The sperm or unfertilized egg of aquatic animals that is 
held or transported separately.
     Inspector. An employee of the Animal and Plant Health Inspection 
Service authorized to perform duties required under this subpart.
    Person. Any individual, corporation, company, association, firm, 
partnership, society or joint stock company.
    Port veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this subpart 
at a port of entry.
    Region. Any defined geographic land area identifiable by 
geological, political, or surveyed boundaries. A region may consist of 
any of the following:
    (1) A national entity (country);

[[Page 51436]]

    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.);
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Spring viremia of carp (SVC). A disease caused by infection with 
spring viremia of carp virus, a rhabodivrus capable of infecting 
several carp species, in addition to some other cyprinid and ictalurid 
fish species.
    SVC-susceptible species. Common carp (Cyprinus carpio), grass carp 
(Ctenopharyngodon idellus), silver carp (Hypophthalmichthys molitrix), 
bighead carp (Aristichthys nobilis), Crucian carp (Carassius 
carassius), goldfish (Carassius auratus), tench (Tinca tinca), and 
sheatfish (Silurus glanis).
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other territories and possessions 
of the United States.


Sec.  93.901  General restrictions; exceptions.

    (a) No live fish, fertilized eggs, or gametes of SVC-susceptible 
species may be imported into the United States except in accordance 
with this subpart,\11\ nor shall any such live fish, fertilized eggs, 
or gametes be moved from the port of entry after arrival until released 
by the port veterinarian; provided that the Administrator may, upon 
request in specific cases, allow the importation of SVC-susceptible 
live fish, fertilized eggs, or gametes under conditions other than 
those set forth in this subpart when the Administrator determines that 
such movement will not result in the introduction of SVC into the 
United States.
---------------------------------------------------------------------------

    \11\ The importation of live cultures of SVC virus, preserved 
SVC virus viral RNA or DNA, tissue samples containing viable SVC 
virus, or other specimens intended for diagnostic or research 
purposes and which contain viable SVC virus may be imported only 
under permit in accordance with 9 CFR part 122.
---------------------------------------------------------------------------

    (b) Other provisions of this subpart relating to the importation of 
live fish, fertilized eggs, and gametes shall not apply to shipments of 
SVC-susceptible species of live fish, fertilized eggs, or gametes in 
transit through the United States if an import permit has been obtained 
under Sec.  93.903 and all conditions of the permit are observed; and 
if the live fish, fertilized eggs, and gametes 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
    (2) They are unloaded, in the course of such transit, into a 
holding facility \12\ that is provided by the carrier or its agent and 
has been approved by the Administrator in accordance with paragraph 
(b)(4) of this section 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 are maintained under 
continuous confinement aboard such means of conveyance until it leaves 
the United States.
---------------------------------------------------------------------------

    \12\ Requests for approval of such facilities should be made to 
the Animal and Plant Health Inspection Service at the address 
provided in Sec.  93.903 for permit applications.
---------------------------------------------------------------------------

    (3) They are moved in accordance with any additional conditions 
prescribed in the permit and determined by the Administrator to be 
necessary to ensure not introduce SVC into the United States.
    (4) For a holding facility to be approved by the Administrator:
    (i) The holding facility must be sufficiently isolated to prevent 
direct or indirect contact of the live fish, fertilized eggs, or 
gametes it contains with any other SVC-susceptible 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, 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 live fish, fertilized 
eggs, or gametes 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 may be imposed by the Administrator for a particular 
shipment if necessary to prevent the dissemination of disease.

(Approved by the Office of Management and Budget under control 
number 0579-0301)


Sec.  93.902  Ports designated for the importation of live fish, 
fertilized eggs, and gametes.

    (a) The following ports are designated as ports of entry for live 
fish, fertilized eggs, and gametes of SVC-susceptible species imported 
under this subpart:
    (1) Air and ocean ports. Los Angeles and San Francisco, CA; Miami 
and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; Boston, MA; 
Newark, NJ; New York, NY; Portland, OR; Dallas-Ft. Worth, TX; and San 
Juan, PR.
    (2) Canadian border ports. Detroit, MI; Buffalo-Niagara, NY; and 
Blaine and Seattle, WA.
    (3) Mexican border ports. Otay Mesa, CA.
    (b) 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.  93.903  Import permits for live fish, fertilized eggs, and 
gametes.

    (a) Live fish, fertilized eggs, or gametes of SVC-susceptible 
species imported into the United States must be accompanied by an 
import permit issued by APHIS and must be imported within 30 days after 
the proposed date of arrival stated in the import permit.
    (b) An application for an import permit must be submitted for each 
shipment of live fish, fertilized eggs, or gametes of SVC-susceptible 
species 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.
    (c) A completed application shall include the following 
information:
    (1) The name and address of the person intending to export live 
fish, fertilized eggs, or gametes of SVC-susceptible species to the 
United States;
    (2) The proposed date of shipment to the United States;
    (3) The name and address of the person intending to import live 
fish, fertilized eggs, or gametes of SVC-susceptible species into the 
United States;
    (4) The species and number of live fish, fertilized eggs, or 
gametes of SVC-susceptible species 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 fish, 
fertilized eggs, or gametes of SVC-susceptible species will be 
delivered in the United States.
    (d) If APHIS determines that the live fish, fertilized eggs, or 
gametes are

[[Page 51437]]

eligible for importation, APHIS will issue an import permit indicating 
the applicable conditions for importation. An import permit does not 
guarantee that any live fish, fertilized eggs, or gametes will be 
allowed entry into the United States; the fish, fertilized eggs, or 
gametes 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 0579-0301)


Sec.  93.904  Health certificate for live fish, fertilized eggs, and 
gametes.

    (a) General. All live fish, fertilized eggs, and gametes of SVC-
susceptible species that are imported from any region of the world must 
be accompanied by a health certificate issued by a full-time salaried 
veterinarian of the national government of the exporting region, 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 fish, fertilized eggs, or gametes must state that:
    (1) The live fish, fertilized eggs, or gametes 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 SVC; and
    (2) The live fish, fertilized eggs, or gametes covered by the 
health certificate meet the requirements of this section.
    (b) Surveillance. The live fish, fertilized eggs, or gametes must 
meet the following conditions to be eligible for importation into the 
United States:
    (1) The live fish, fertilized eggs, or gametes must originate in a 
region or establishment which conducts a surveillance program for SVC 
under the supervision of the competent authority.
    (2) The region or establishment must demonstrate freedom from SVC 
through a minimum of 2-years' continuous health history, supported by 
laboratory testing by a pathogen detection facility approved for SVC 
viral assays by the competent authority.
    (3) SVC-susceptible fish populations in the region or establishment 
must be tested at least twice annually, with at least 3 months between 
the tests and at times or under environmental conditions that would 
facilitate the detection of SVCV if it were present. Sampling 
procedures must utilize an assumed pathogen prevalence of 2 percent, 
with a corresponding confidence level of 95 percent. Samples must be 
collected and submitted by a certifying official or veterinarian 
recognized by the competent authority. The standard screening method 
for SVC must include isolation of SVCV in cell culture, using either 
the epithelioma papulosum cyprini (EPC) or fathead minnow (FHM) cell 
lines. However, the Administrator may authorize other assays for SVCV 
detection in lieu of virus isolation through cell culture, if the 
Administrator determines that such assays provide equivalent assurance 
of the SVC status of an exporting region or establishment. All viral 
testing results must be negative.
    (c) Shipping containers. All live fish, fertilized eggs, and 
gametes must be shipped to the United States in new containers or in 
used containers that have been cleaned and disinfected in accordance 
with this section.
    (1) Cleaning and disinfection of shipping containers must take 
place under the supervision of the veterinarian or certifying official 
who issues the health certificate.
    (2) Cleaning and disinfection must be sufficient to neutralize any 
SVC virus to which shipping containers may have been exposed. 
Acceptable disinfection procedures include individual or combination 
treatments with: Solutions having a pH of 12 or higher or 3 or lower 
with a contact time of at least 10 minutes; heat at or above 56[deg] C 
for at least 15 minutes; chlorine solutions having a concentration of 
at least 500 ppm with a contact time of at least 10 minutes; iodine 
solutions having a concentration of at least 100 ppm with a contact 
time of at least 10 minutes; ultraviolet exposure (254 nm; min exposure 
of 10,000 microwatt seconds/cm2); or other disinfectants 
such as Virkon used according to the manufacturer's directions. The 
Administrator may authorize other procedures if the Administrator 
determines they are adequate to neutralize the SVC virus.
    (3) 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.

(Approved by the Office of Management and Budget under control 
number 0579-0301)


Sec.  93.905  Declaration and other documents for live fish, fertilized 
eggs, and gametes.

    (a) For all live fish, fertilized eggs, and gametes offered for 
importation under this subpart, the importer or his or her agent must 
submit the following documents to the collector of customs for use by 
the port veterinarian:
    (1) All permits, certificates, or other documentation required by 
this subpart; 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, fertilized eggs, or gametes, 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.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control 
number 0579-0301)


Sec.  93.906  Inspection at the port of entry.

    (a) All live fish, fertilized eggs, and gametes of SVC-susceptible 
species imported from any part of the world must be presented for 
inspection at a port of entry designated under Sec.  93.902. The APHIS 
port veterinarian must be notified at least 72 hours in advance of the 
arrival in the United States of a shipment of live fish, fertilized 
eggs, or gametes of SVC-susceptible species. Any shipment of live SVC-
susceptible fish species that the port veterinarian determines to 
exhibit clinical signs consistent with SVCV infection or disease, or 
any shipments of live fish, fertilized eggs, and gametes of SVC-
susceptible species that otherwise do not meet the requirements of this 
subpart, shall be refused entry.
    (b) Shipments refused entry, unless 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, shall be 
disposed of as the Administrator may direct.

(Approved by the Office of Management and Budget under control 
number 0579-0301)

    Done in Washington, DC, this 24th day of August 2006.
Kevin Shea,
Acting Administrator,