E6-14478. 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.

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 http://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 [phone] before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Peter L. Merrill, Aquaculture Specialist, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; [phone]; or Dr. Jill B. Rolland, Fishery Biologist, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737-1231; [phone].

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.

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.

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 °F. As temperatures rise, disease expression varies as the immune resistance of carp also rises. Temperatures at or above 68 °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” (§§ 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.

Definitions (§ 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 (§ 93.901)

Paragraph (a) of § 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 § 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 (§ 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 (§ 93.903)

Paragraph (a) of § 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 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 (§ 93.904)

Paragraph (a) of § 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 § 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 °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 (§ 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 (§ 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 § 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 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 § 130.4. User fees for inspection at the port of entry and laboratory and facility inspections are the hourly fees set forth in § 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.

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.

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, 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.

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 §§ 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 41/2 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]

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.

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 [phone].

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 [phone].

List of Subjects in 9 CFR Part 93

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

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

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.

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

3. Part 93 is amended by adding a new Subpart I—Aquatic Animal Species, §§ 93.900 through 93.907, to read as follows:

Subpart I—Aquatic Animal Species

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

§ 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);

(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.

§ 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.

(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 § 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.

(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)

§ 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.

§ 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 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)

§ 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° 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)

§ 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)

§ 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 § 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, Animal and Plant Health Inspection Service.

Footnotes

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.

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.

4.  Global Trade Atlas, 1998.

5.  Global Trade Atlas, 2003.

6.  Global Trade Atlas, 2003.

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.

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.

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