22d.

2.2.3.

2.2.4.

2.2.5.

2.26.

Q2ch.

Samples were collected by an official veterinarian, or certifying
official, representing the Competent Authority, and tested per the
OIE OR a laboratory testing method reviewed and approved by the
USDA prior to export.

No OIE-listed disease(s) affecting tilapia was/were reported at the premises
of origin within sixty (60) days prior to export.

The tilapia originate in the exporting country OR were legally imported and
verified to be of equal health status before entering the population for
export.

The tilapia were inspected by an official veterinarian of the exporting
country’s Competent Authority within seventy-two (72) hours prior to
export, and showed no clinical signs of disease.

All shipping containers are new, OR have been properly cleaned and
disinfected prior to use to ensure removal of organic material and mitigation
of diseases of concern the species is susceptible to.

The shipment will ship directly to the United States with no stops en route
other than those provided for on the USDA import permit per 2.1.6 above.

After the animal inspection, the health certificate is valid for seventy-two
(72) hours prior to export.

3. ARRIVAL AND INSPECTION AT THE PORT OF ENTRY

3.1. All shipments must only enter the United States through the following designated
ports of entry where APHIS, Veterinary Services (VS) personnel are available to
process the shipments:

3,2,

3,1,1.
3.1.2.
3,143.
3.1.4.
3:15.
3.1.6.
31.7:
3.1.8.
3.1.9:
3.1.10.

California: Los Angeles, San Francisco
Florida: Miami, Tampa

Georgia: Atlanta

Hawaii: Honolulu

Illinois: Chicago

New Jersey: Newark

New York: New York

Puerto Rico: San Juan

Texas: Houston

Washington: Seattle

Upon arrival at the designated U.S. port of entry, the importer, or the
importer's agent, must present the original official health certificate and the
original USDA import permit for the live fish, fertilized eggs, and/or
gametes to an APHIS VS Port Official.


1.3. All imported live fish, fertilized eggs, and gametes from TiLV—susceptible species
must enter through, and undergo veterinary inspection at, one of the U.S. Ports listed in
3.1. below. User Fees will apply.

2. CERTIFICATION

2.1. The official health certificate must include the following information:

2.1.1. The name and address of the consignor.

2.1.2. The name and address of the consignee.

2.1.3. The country of origin.

2.1.4. The port of embarkation.

2.1.5. The means of transportation.

2.1.6. The route of travel (country of origin +/- country or countries of transit).

2.1.7. The designated U.S. port of entry.

2.1.8. The date of veterinary inspection in the country of origin.

2.1.9. The total quantity of animals.

2.1.10. The total number of packages/containers.

2.1.11. The intended use of the animals (i.e. breeding, culture/grow out, research,
human consumption)

2.2. The official veterinarian of the exporting country’s Competent Authority must
certify the following statements:

2.2.1, EITHER
2.2.1.1 Tilapia from this population to be exported tested negative for

OR

TiLV within thirty (30) days prior to export per the World
Organization for Animal Health (OIE) OR a laboratory testing
method reviewed and approved by the USDA prior to export.
Sampling procedures used an assumed pathogen prevalence of two
(2) percent, with a corresponding confidence level of ninety-five
(95) percent. AND

Samples were collected by an official veterinarian, or certifying
official, representing the Competent Authority

2.2.1.2 The facility of origin participates in an ongoing TiLV monitoring

program for species susceptible to TiLV, by testing negative twice
annually for a minimum of two (2) consecutive years, with at least
three (3) months between tests. AND

Populations were sampled using an assumed pathogen prevalence of
two (2) percent, with a corresponding confidence level of ninety-five
(95) percent, and found negative for TiLV. AND


3.2.1. The importer, or the importer’s agent, must notify the APHIS VS Port
Official seventy-two (72) hours in advance of the expected arrival of the
shipment, to ensure clearance procedures may be expedited in a timely

manner.

3.3. The shipping containers AND live fish, fertilized eggs, and/or gametes must
be made available for inspection at the designated U.S. port of entry, and
may not be removed until an APHIS VS Port Official determines that the
shipment meets import requirements and releases the shipment.

If live fish, fertilized eggs, and/or gametes from TiLV-—susceptible species attempt to
enter the United States through other, non-designated ports of entry, they will be
refused entry by U.S. Department of Homeland Security (DHS) personnel.

3.4.

For more information regarding this Federal Order you may contact Staff Veterinary Medical
Officer Alicia Marston at 301-851-3361, or via email at Alicia.R.Marston@usda.gov.


FOR INFORMATION AND ACTION
DA-2019-01

November 12, 2019

Subject: Federal Order for U.S. Imports of Live Fish, Fertilized Eggs, and Gametes from
Tilapia Lake Virus (TiLV) — Susceptible Species

To: State and Territory Agricultural Regulatory Officials

The Animal and Plant Health Inspection Service (APHIS), USDA, is issuing this Federal Order
to prevent the entry or introduction of Tilapia Lake Virus (TiLV) into the United States by
restricting import shipments of all live fish, fertilized eggs and gametes from Tilapia Lake Virus
(TiLV)-susceptible species This Federal Order, effective December 12, 2019, requires all live
fish, fertilized eggs, and gametes from Tilapia Lake Virus (TiLV)- susceptible species to meet
the U.S. import requirements outlined below, including accompaniment by a USDA import
permit, official health certificate, and veterinary inspection.

For more information regarding this Federal Order you may contact Staff Veterinary Medical
Officer Alicia Marston at 301-851-3361, or via email at Alicia.R.Marston@usda.gov.

Burke Healey
Deputy Administrator
Veterinary Services

Attachment: Federal Order


FEDERAL ORDER
Federal Order for U.S. Imports of Live Fish, Fertilized Eggs, and Gametes from Tilapia Lake
Virus (TiLV) — Susceptible Species
DA-2019-01
November 12, 2019

The Animal and Plant Health Inspection Service (APHIS), USDA, is issuing this Federal Order
to prevent the entry or introduction of Tilapia Lake Virus (TiLV) into the United States by
restricting United States import shipments from all countries of all live fish, fertilized eggs and
gametes from Tilapia Lake Virus (TiLV)-susceptible species. All shipments must now have a
USDA import permit, official health certificate and veterinary inspection. This Federal Order is
effective December 12, 2019.

This Federal Order is issued in accordance with the regulatory authority provided by the Animal
Health Protection Act, as amended, 7 U.S.C. § 8301 ef seg. Section 8303 authorizes the
Secretary of Agriculture to prohibit or restrict the importation or entry of any animal, article, or
means of conveyance, or use of any means of conveyance or facility, if the Secretary determines
that the prohibition or restriction is necessary to prevent the introduction into or dissemination
within the United States of any pest or disease of livestock.

APHIS has determined that the introduction and establishment of TiLV poses a serious threat to
U.S. agriculture. TiLV was first detected in the United States in March, 2019. The virus can
cause high mortality in susceptible fish. Restrictions to prevent the introduction and
establishment of TiLV are warranted to address the animal health and economic risks associated
with imports of live fish, fertilized eggs, and gametes from TiLV—susceptible species. The
TiLV-susceptible species are Nile tilapia (Oreochromis niloticus), commercial hybrid tilapia
(Oreochromis niloticus x Oreochromis aureus), red hybrid tilapia (Oreochromis spp.) and wild
tilapia (Sarotherodon galilaeus).

A Preliminary Risk Assessment for Tilapia Like Virus (TiLV) and an Analysis of U.S. Imports
and Exports of Live Tilapia, Eggs, and Milt conducted by APHIS in 2019 determined the risk
posed to relevant industries by the introduction of TiLV via imported tilapia fingerlings (young
fish) or the shipping water carrying them as “High,” and the likelihood that tilapia infected with
TiLV will be imported into the United States as “High,” especially due to the absence of import
regulations certifying tilapia are healthy and disease free. More than 15 countries are considered
to be “Affected” by TiLV, while many more are considered to be “At Risk.”

Currently, the major countries from which the United States imports tilapia are Ecuador, Israel,
Taiwan, and Thailand, all of which are considered to be TiLV-affected. While it is known that
the United States imports from TiLV-affected countries, tilapia are also imported from countries
with unknown TiLV health status; coupled with the insufficient global TiLV surveillance and
detection programs, the APHIS import requirements outlined below therefore apply uniformly to
all live fish, fertilized eggs, and gametes from Tilapia Lake Virus (TiLV)-susceptible species to
be imported into the United States from all countries.


Outbreaks of TiLV in the United States would not only harm domestic tilapia production, but
also jeopardize the potential for the U.S. tilapia industry to export. In general, if the United States
has import requirements, this provides trading partners that we export to additional assurance
they are receiving healthy animals. As no TiLV import controls are in place at this time, U.S.
exporters could be held to the most stringent export requirements, and export markets for tilapia
would likely be negatively affected (closed or restricted based on negotiated export protocols) by
another detection of TiLV in the United States.

Therefore, APHIS, with the support of industry, has concluded that the following import
requirements are necessary to protect the domestic U.S. tilapia industry and future U.S. tilapia
exports.

Import Requirements for Live Fish, Fertilized Eggs, and Gametes from Tilapia Lake Virus
(TiLV)-Susceptible Species

This Federal Order requires United States import shipments of live fish, fertilized eggs, and
gametes from TiLV—susceptible species to meet the following U.S. import requirements:

1. GENERAL REQUIREMENTS

1.1. The U.S. importer must obtain an USDA import permit for live fish, fertilized eggs, and
gametes from TiLV—susceptible species (see 1.2.1 — 1.2.4. below) from the:
U.S. Department of Agriculture (USDA),
Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS),
Strategy & Policy (S&P), Unit 39
4700 River Road, Riverdale, MD 20737-1231
Email: VS.Live.Animals.Import.Permits@usda.gov
Telephone: (301) 851-3300, Menu option 2.

1.1.1. The application (VS Form 17-129, Application for Import or In-Transit
Permit) may be obtained from the APHIS web site, or by emailing or
telephoning S&P:
https://www.aphis.usda.gov/aphis/resources/forms/ct_vs_forms

1.2. An official health certificate is required for all live fish, fertilized eggs, and gametes
from TiLV-—susceptible species (see 1.2.1 — 1.2.4. below). The official health certificate
must be issued (signed, dated) and endorsed by an official veterinarian of the exporting
country’s Competent Authority, and accompany the shipment to the port of entry
designated on the USDA import permit.

1.2.1. Nile tilapia (Oreochromis niloticus)
1.2.2. Commercial hybrid tilapia (Oreochromis niloticus x Oreochromis aureus)
1.2.3. Red hybrid tilapia (Oreochromis spp.)

1.2.4. Wild tilapia (Sarotherodon galilaeus)