(Last Updated October
2020)
This Guideline applies to:
Human pharmaceuticals, approved active pharmaceutical ingredients*, over- the-counter (OTC) drug monographs, human vaccines, human medical devices (including 510k and empty blood collecting tubes) veterinary pharmaceuticals, and veterinary medical devices (including 510k and empty blood collecting tubes) approved by the Food and Drug Administration (FDA) containing animal derived components.
* FDA approved Active pharmaceutical ingredients (API) only derived from or containing gelatin and/or lactose.
FOR VETERINARY MEDICAL DEVICES such as but not limited to; empty blood collecting tubes and 510k medical devices:
FDA has regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated. It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled prior to importation to the United States. The labels of all veterinary devices should clearly indicate that they are for animal use only.
Information pertaining to veterinary devices may be accessed at the following FDA websites:
To learn more about the importation process, you may reference the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions
This Guideline does NOT apply to:
Non FDA Veterinary vaccines or veterinary diagnostic test kits, Anti-venom, dietary supplements, non-empty veterinary blood collecting tubes, nutraceuticals, FDA approved test kits, test kit reagents, test kit components, in vitro reagents including but not limited to bovine serum, monoclonal antibodies, cell lines, media, transport media, and non- FDA approved bulk pharmaceutical and vaccine active ingredients.
INTRODUCTION:
Material derived from any animal is potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agriculture Specialists/Inspectors at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, human pharmaceuticals, human medical devices, approved active pharmaceutical ingredients (usually shipped in bulk), vaccines, veterinary pharmaceuticals and veterinary regulated medical devices, containing animal derived ingredients and approved by the Food and Drug Administration (FDA) may enter the United States without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.
The U.S. Food and Drug Administration and U.S. Public Health Service, both may have primary jurisdiction over human pharmaceuticals, approved active pharmaceutical ingredient (usually shipped in bulk), human vaccines, veterinary pharmaceuticals and medical devices. They should be contacted for their importation requirements at the following locations:
U.S. Food and
Drug Administration
Division of Import Operations and Policy
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Website address http://www.fda.gov
U.S. Public
Health Service
Centers for Disease Control, Office of Biosafety
1600 Clifton Road Atlanta, GA 30329-4027 USA
800-CDC-INFO (800-232-4636), TTY: 888-232-6348
FDA has authority over “devices,” as defined in the FD&C Act, for animal use.
The USDA, Veterinary Biologics, Evaluation and Licensing (CVB, PEL), may have primary jurisdiction over veterinary biologics, including vaccines, veterinary medical devices imported for any purpose. For additional information, see the CVB web site https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/ct_vb_import_export_products , email cvb@aphis.usda.gov and/or call (515) 337-6100.
PROCEDURES:
A USDA APHIS VS import permit (VS Form 16-6), will not be required for FDA approved human pharmaceuticals, approved active pharmaceutical ingredient (usually shipped in bulk), over- the-counter (OTC) drug monographs, human vaccines, human medical devices, veterinary pharmaceuticals, and FDA regulated veterinary in bulk and/or packaged and ready for use.
In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation or information accompanies each shipment and be presented for review by the Department of Homeland Security, Customs and Border Protection (CBP) Agriculture Specialist/Officers at the U.S. port of arrival. For FDA approved human and/or veterinary pharmaceuticals, human and/or veterinary vaccines and human and/or veterinary medical devices:
USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, USDA, APHIS, VS further recommends that the documentation accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agriculture Specialists/Inspectors at the U.S. port of arrival. We do not recommend that the foreign producer/shipper place this document inside the shipping containers. We further recommend that you provide a copy of this guideline to your producer/shipper.
For FDA regulated Veterinary Medical Devices:
FDA has regulatory oversight over veterinary devices such as 510k medical devices and/or empty blood collecting tubes. The FDA can take appropriate regulatory action if a veterinary medical device is misbranded or adulterated. Imported FDA regulated products are expected to comply with all applicable regulations at the time of entry.
The labels of all veterinary devices should clearly indicate that they are for animal use only.
Guidance pertaining to veterinary devices may be accessed at the following FDA websites:
If the pharmaceutical, medical device or vaccine to be imported cannot meet these criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:
IMPORT PERMIT
The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at http://www.aphis.usda.gov/animal_health/permits/.
The current permit processing fee is $150 and permit duration is one year.
Applications can be submitted by any of the following ways:
USDA, APHIS, VS
Animal Products Export Import (APIE)
Strategy and Policy Division-Import Animal Products
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300, Option 4
Tissues, blood/blood fractions, proteins, DNA, enzymes, feces, fluids, hormones, peptides, RNA, semen, urine, extracts, etc.
• Cell cultures, tissues in culture, hybridomas, and their products – refer to Guideline #1120
• Human specimens - the regulation of imported human specimens is deferred to the Centers for Disease Control (CDC)
U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) has jurisdiction over animal origin material. Material derived from any animal is potentially subject to USDA, APHIS, VS regulations and must be cleared at the U.S. port of arrival by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agricultural Specialists before entry into the United States is authorized. If the imported non-human primate material has not been inoculated with or exposed to any livestock or poultry foreign animal disease agent, then a VS import permit will not be required and the shipment should be deferred to CDC. The CDC can be contacted by telephoning: (404) 639-3311.
A USDA, APHIS, VS import permit will not be required for the importation of material derived from non-human primates, provided the material has not been inoculated with or exposed to any livestock or poultry foreign animal disease agent. DHS, CBP Agricultural Specialists/inspectors must be provided documentation to determine this, which may include: manifests, invoices, foreign producer/shipper statements on letterhead, or other shipping documents which provide the following information:
VS recommends that this information is available for review by the DHS, CBP Agricultural Specialists upon arrival of the shipment at the U.S. port of arrival. We do not recommend that it be placed inside the shipping container.
We further recommend that you provide a copy of this guideline to your foreign producer/shipper.
If the non-human primate material to be imported cannot meet these criteria, then a USDA import permit may be required.
An import permit issued by USDA, APHIS, VS is required for non-human primate material if the material has been inoculated with or exposed to any livestock or poultry foreign animal disease agent.
Permit applications may be obtained several ways:
1. On-line at: /animal_health/permits/
2. By writing to:
Semen for research purposes, blood, tissues, serum, feces, extracts, fluids.
*The term livestock includes any bovine, ovine, caprine, porcine, equine, cervid, fish, or shellfish.
Transgenic/knock-out mice and rats, hamsters, gerbils, guinea pigs, rabbits, ferrets, and their blood, tissue, DNA, extracts, antibodies, feces, sera, and antisera for research purposes. (blood, sera, antibodies, and antisera is limited to less than 1 liter)
Primates, dogs, cats, livestock*, poultry, hedgehogs, tenrecs, minipigs, monoclonal antibodies, hybridomas, cell lines, and material for commercial purposes. (Refer to Guideline #1120 for cell/tissue cultures and their products)
Material derived from any animal is potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protect (DHS, CBP) Agricultural Specialists at the port of arrival before entry into the United States is authorized. However, the USDA does not have regulatory authority over the importation of live laboratory animals or laboratory mammal material that have not been inoculated with or exposed to any livestock or poultry disease agents exotic to the United States.
The Centers for Disease Control and Prevention (CDC) has jurisdiction over live laboratory mammals and their material that may be infectious. Contact the Division of Select Agents and Toxins Importation Permit Program at 404-718-2077 or importpermit@cdc.gov regarding any documentation or other import requirements CDC may have.
USDA, Animal and Plant Health Inspection Service (APHIS), Plant Protection and Quarantine (PPQ) regulates the importation of plants and other vegetable matter. If the transport cage contains any plant or vegetable matter, including but not limited to potatoes, carrots, stray or hay, the importer must contact the PPQ Permit Unit at (301) 734-8758 to determine if it can be allowed entry. PROHIBITED VEGETABLE MATTER MUST BE REMOVED FROM THE CAGE AT THE PORT OF ARRIVAL BY A DHS, CBP AGRICULTURAL SPECIALIST.
Material derived from rodents and other small mammals which: (a) have not been inoculated with, or exposed to any exotic livestock or poultry disease agents, and (b) do not originate from facilities where work with exotic disease agents affecting livestock or avian species is conducted, may be imported without USDA, APHIS, Veterinary Services (VS) restrictions.
A USDA permit will not be required for the importation of live laboratory mammals provided the mammals have not been inoculated with, or exposed to any exotic livestock or poultry disease agents, and do not originate from facilities where work with exotic disease agents affecting livestock or avian species is conducted. In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS , VS recommends that the following documentation accompany each shipment:
A USDA permit will not be required for the importation of laboratory mammal material provided the material is obtained from laboratory mammals that have not been inoculated with, or exposed to any exotic livestock or poultry disease agents, and do not originate from facilities where work with exotic disease agents affecting livestock or avian species is conducted. In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS , VS recommends that the following documentation accompany each shipment:
USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, with the letterhead containing the physical address of the foreign producer/shipper. USDA, APHIS, VS further recommends that the document, written in a clear and concise manner, accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agricultural Specialist at the U.S. port of arrival. We do not recommend that the foreign producer/shipper place this document inside the shipping containers.
We further recommend that you provide a copy of this guidance to your foreign producer/shipper.
If the live laboratory mammals or laboratory mammal material to be imported cannot meet these criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:
Amphibians, fish, reptiles, shellfish, aquatic species and/or their materials such as: blood, chondroitin, collagen, emulsions, extracts, feces, fluids, gelatin, glucosamine, oils, tissues, serum, urine, and venom, from these species.
This Guideline does not apply to: Bloodworms, antivenom, hydrosylates, meals (e.g. fish meal), monoclonal antibodies, hybridomas, cell lines (Refer to Guideline #1120 for cell/tissue cultures and their products), and live fish species susceptible to Spring Viremia of Carp (SVC) from all countries. For the list of regulated SVC species and import requirements (including permit application) please visit the following web site: Import Live Animals
Materials derived from all animals are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security Customs and Border Protection (CBP) Agricultural Specialists/Inspectors at the port of arrival before entry into the United States is authorized. A USDA, APHIS, Veterinary Services (VS) Import Permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, material from the above listed animals that have not been inoculated with or exposed to any livestock or poultry disease agents or antigens may enter the United States without USDA restrictions.
NOTE: The U.S. Fish and Wildlife Service has jurisdiction over the importation of Convention on International Endangered Species of Wild Fauna and Flora (CITES) listed animals. Please contact their Office of Management Authority at 800-358-2104. The National Oceanic and Atmospheric Administration (NOAA) provides information regarding import of both marine mammals and seafood at https://www.fisheries.noaa.gov/topic/international-affairs.
A USDA VS Import Permit will not be required for these types of animal products if DHS, CBP Agricultural Specialists/Inspectors are provided documentation which may include: manifests, invoices, foreign producer/shipper statements on letterhead, or other shipping documents which provide the following information:
VS recommends that this information is available for review by the DHS, CBP Agricultural Specialists/Inspectors upon arrival of the shipment at the U.S. port of arrival. We do not recommend that it be placed inside the shipping container.
We further recommend that you provide a copy of this guideline to your foreign producer/shipper.
If the amphibians, fish, reptiles, shellfish, aquatic species and/or their materials cannot meet these criteria, then a USDA import permit may be required.
IMPORT PERMIT FOR PRODUCTS AND BYPRODUCTS (For live animal applications, please visit the website listed above)
The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at http://www.aphis.usda.gov/animal_health/permits/.
The current permit processing fee is $150 and permit duration is one year.
Applications can be submitted by any of the following ways:
Animal Product Import and Export (APIE)
APHIS, Veterinary Services
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300, Option 1
biochemicals, materials not containing or derived from animal products including cell culture derived products.
Materials derived from any animal, including those materials produced with animal products or extracts of microorganisms, are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DSH, CBP) Agricultural Specialists at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing exotic animal diseases into the United States. However, chemically synthesized biochemicals and chemically synthesized materials that do not contain and were not derived from animal products may enter the country without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.
A USDA import permit will not be required for chemically synthesized biochemicals, chemically synthesized materials that do not contain animal products, or chemically synthesized materials that were not derived from animal products. In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation accompany each shipment:
USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, with the letterhead containing the physical address of the foreign producer/shipper. USDA, APHIS, VS further recommends that the document, written in a clear and concise manner, accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agricultural Specialists at the U.S. port of arrival. We do not recommend that the foreign producer/shipper place this document inside the shipping containers.
We further recommend that you provide a copy of this guideline to your foreign producer/shipper.
If the chemically synthesized material to be imported cannot meet these criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:
Products for human and animal consumption including but not limited to pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, medical devices, placebos, and investigational pharmaceuticals that contain lactose (milk sugar) and the following lactose derivatives, galactose and lactulose, as the ONLY animal origin ingredient. This would include bulk amounts of lactose or galactose or lactulose.
Products that contain other animal origin ingredients besides lactose or galactose or lactulose
Material derived from any animal is potentially subject to U.S.Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agricultural Specialists/Officers at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, the USDA has assessed the risk of lactose (milk sugar) and the following lactose derivatives, galactose and lactulose, and determined that they are not a viable vectors for Foot and Mouth Disease (FMD), and the risk of entry of FMD via products containing lactose or galactose or lactulose is negligible. Therefore, products that contain lactose or galactose or lactulose as the ONLY animal origin ingredient may enter the United States without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.
The U.S. Food and Drug Administration have primary jurisdiction over these materials.
They should be contacted for their importation requirements at the following locations:
U.S. Food and Drug Administration (FDA)
Division of Import Operations and Policy, HFC-170
5600 Fishers Lane, Rockville, MD 20857
Tel. (301) 796-0356
A USDA, APHIS, VS import permit will not be required for pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, and products for human and animal consumption that contain lactose or galactose or lactulose as the ONLY animal derived ingredient. In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation or information accompanies each shipment, and be presented for review by the DHS, CBP Agricultural Specialists/Inspectors at the U.S. port of arrival.
We do not recommend that the foreign producer/shipper place this documentation inside the shipping containers. A copy of this Guideline for Importation should be provided for your producer/shipper.
If the pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, and products for human and animal consumption, etc. to be imported cannot meet the criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:
The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at http://www.aphis.usda.gov/animal_health/permits/
The current permit processing fee is $150 and permit duration is one year.
Applications can be submitted by either of the following ways:
• By e-mail: animalproducts.application@aphis.usda.gov
• By fax: 301-734-8226
• By writing to: USDA, APHIS, VS
Import Export Services (NIES)
4700 River Road, Unit 40
Riverdale, MD 20737
301-851-3300,Option 1
301-851-2239 fax
9 CFR 94.16
Microbially produced materials such as: enzymes, plasmids, proteins, hormones, extracts, phages and/or DNA.
Materials derived from any animal, or produced with animal products or extracts of microorganisms, are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agricultural Specialists/Inspectors at the port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, microbes (usually E. coli or yeasts) that do not express material of a foreign livestock and/or poultry disease agent may enter the United States without USDA restrictions.
A USDA VS Import Permit will not be required for microbially produced biochemicals if DHS, CBP Agricultural Specialists/Inspectors are provided documentation which may include: manifests, invoices, foreign producer/shipper statements on letterhead, or other shipping documents which provide the following information:
An accurate description of the material.
This information must be available for review by the DHS, CBP Agricultural Specialist/Inspector at the port of arrival.
IMPORT PERMIT:
Permit applications may be obtained several ways:
Microbes (bacteria, viruses, yeasts/fungi), proteins, hormones, extracts, plasmids, DNA, RNA.
Materials produced by cell culture techniques.
Materials derived from any animal or produced with animal products or extracts of microorganisms are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by USDA inspectors at the port of arrival before entry into the
A USDA veterinary import permit will not be required for recombinant microbes or their products if the following is provided in the shipping documents:
The above information should be supplied with each shipment in a clear and concise manner and be available for review by the USDA Inspector at the port of arrival. We recommend that a separate memorandum or letter be included with the shipping documents, such as U.S. Customs declaration and invoice.
Please instruct your shippers to provide this information.
If the above information is not supplied, the shipment will be subject to delays. If the material to be imported cannot meet these criteria, a USDA import permit may be required.
Permit applications may be obtained several ways:
*The term, livestock, includes any bovine, ovine, caprine, porcine, and equine animal
Environmental or water organisms, such as algae.
Microorganisms are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by CBP inspectors at the port of arrival before entry into the United States is authorized. A USDA permit is required for any microorganism that is known to cause infectious, contagious, or communicable diseases of livestock or poultry. However, non-pathogenic bacteria, viruses, algae, or yeast (fungi) may be imported into the country without USDA veterinary restrictions.
Import requirements for plant pathogens may be obtained by contacting Biological Assessment and Taxonomic Support
USDA, APHIS, PPQ
4700 River Road, Unit 133
Riverdale, MD 20737
Main: 301-851-2046
Fax: 301-734-8700.
A USDA veterinary import permit will not be required for specimens if the following is provided in the shipping documents:
This information should be supplied as statements on producer/shipper letterhead in a clear and concise manner and be available for review by the USDA Inspector at the Portof Arrival. We recommend that a separate memo or letter be included with the shipping documents, such as U.S. Customs declaration and invoice. Do not put documents INSIDE shipping containers.
Please instruct your shippers to provide this information.
If the above information is not supplied, the shipment may be subject to delays. If the material to be imported cannot meet these criteria, then a USDA import permit may be required.
How to obtain a Permit application:
USDA, APHIS, VS
National Center for Import and Export
4700 River Road, Unit 40
Riverdale, MD 20737
Main: 301-851-3300, option 3
Fax: 301-851-2239
Material derived from any animal is potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agricultural Specialists at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing foreign animal diseases into the United States.
Rawhide and antlers intended for use as pet chews/treats may be imported without a USDA VS Import Permit provided the conditions of this guideline are met.
Rawhide:
Plain rawhide intended for use as pet chews/treats (may be cut, molded, or in sheets) which has not been ground, flavored, basted, colored, or otherwise processed is allowed entry without a VS Import Permit. All shipments are subject to inspection by CBP personnel at the U.S. port of arrival.Antlers originating from a region affected by FMD and/or Antlers in Velvet must be accompanied by a VS Import Permit unless consigned to an approved establishment.
To view the USDA list of regions considered to be free of FMD please visit the USDA APHIS web site at; www.aphis.usda.gov scroll down and click on the “import animal or animal product” link, scroll down on the next page and click on “country animal disease status”, and then click on the “Countries/Regions Free of Foot-and-Mouth Disease” (FMD).
Permit applications may be obtained several ways:
1. On-line at: Animal Health Permits
2. By writing to:
USDA, APHIS, VS
National Import Export Services
4700 River Road, Unit 40
Riverdale, MD 20737
Phone: 301-851-3300 – option #1
Fax: 301-851-2239
Monoclonal antibodies, cell culture supernatants, ascitic fluid, cell extracts, hybridomas, cell cultures/lines which are not derived from livestock*.
Cell lines of livestock* and their products, microbial cultures and their products.
Materials derived from all animals are potentially subject to U.S.Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulations and must becleared by USDA inspectors at the port of arrival before entry into theUnited States is authorized. A USDA, APHIS, VS permit is required formaterial derived from animals that may pose a risk of introducing livestock diseases exotic to the United States.
Cell lines and other products of cell lines, including monoclonal antibodies, which:
May be imported without a USDA permit.
In addition, monoclonal antibodies intended for in vivo human use do not require a permit.
However, (1) cell lines derived from livestock or avian species, (2) cell lines derived from any species which will be used for in vivo use, and (3) cell lines of any species which may have been exposed to exotic livestock or avian disease agents will require a USDA, VS import permit.
A USDA, VS import permit will NOT be required for cell lines other products of cell lines, including monoclonal antibodies if the shipment is accompanied by:
A statement from the shipper/producer which clearly states or identifies:
a. the material as a cell line or another product of a cell line (including monoclonal antibodies);
b. the immunogen (what the monoclonal antibody is directed against), as applicable;
c. the material is for in vitro use OR the material is for in vivo human use;
d. the material does not come from a facility where work with exotic viruses affecting livestock and avian species is conducted; and
e. the material is not recombinant OR the material is recombinant but contains no genes and expresses no products of exotic livestock or poultry disease agents.
This information must be supplied as statements and made available for review by the USDA Inspector at the port of arrival.
If the above information is not supplied, the shipment will be subject to delays. If the material cannot meet these criteria, a USDA import permit may be required.
Permit applications may be obtained several ways:
*The term, livestock, includes any avian/poultry, bovine, caprine, fish, ovine, porcine, and equine animal.
Test kits may contain small amounts of animal-derived components. Most test kits are consigned to universities, diagnostic laboratories, or pharmaceutical companies which dispose of them by autoclaving and/or incineration. Therefore, applicable imported test kits present a negligible risk of exposure of U.S. animal populations to exotic disease agents and do not require a USDA, Veterinary Services (VS) import permit.
Test Kits Not Requiring a USDA Import Permit:
A USDA Import Permit is not required for test kits if the shipment meets the following conditions and it is recommended that the shipment be accompanied by:
If the material to be imported cannot or does not meet the criteria outlined above on this Guideline, then a USDA, VS or USDA, CVB Import Permit is required.
Test Kits and material(s) that require a USDA, VS import permit:
USDA, VS Import Permit applications may be obtained several ways:
Test Kits that can diagnose infectious diseases of animals, imported for any purpose, or for any type of research require a Research and Evaluation Permit from USDA, VS, Center for Veterinary Biologics, Policy, Evaluation and Licensing (CVB, PEL).
Please include the information recommended/required by this Guideline along with the shipping documents for each shipment and ensure that it is available for review by USDA authorized inspectors at the port of entry. DO NOT put documents INSIDE the shipping container. If the above information is not available, the shipment may be subject to delays and import compliance fees.
The Food and Drug Administration and/or the Centers for Disease Control should be contacted for information regarding the import of kits that diagnose human disease.
1A self-contained test kit includes everything needed to use the kit assembled in a pre-packaged kit ready for final use.
Materials derived from animals, or produced with animal-origin ingredients, are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security (DHS) Customs and Border Protection (CBP) personnel at the port of arrival before entry into the United States is authorized.
Imported products containing plant materials may be subject to regulations enforced by:
Most commercially derived vitamins and minerals are synthetically produced from non-animal origin ingredients. Exceptions include vitamin D3, vitamin A, and dicalcium phosphate.
Articles containing dicalcium phosphate will be allowed entry without a USDA VS Import Permit only when the shipment is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so.
The certificate must state the name and BSE risk classification of the exporting region and:
If the material cannot meet the criteria outlined in this guideline, then a USDA, APHIS, VS import permit may be required.
The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at Animal Health Permits.
The current permit processing fee is $150 and permit duration is one year.
Applications can be submitted by any of the following ways:
This Guideline does not apply to histopathological slides or other fixed slides which contain Foot and Mouth Disease virus or Rinderpest virus.
Microorganisms are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared at the port of arrival before entry into the United States. A USDA permit is required for any microorganisms that are known to cause infectious, contagious, or communicable diseases of livestock or poultry.
However, specimen slides that are fixed with 10% formalin for a minimum of 24 hours; or BSE, Scrapie, or CWD prion agents fixed in 96% absolute formic acid solution for a minimum of 30 minutes, followed by emersion in fresh 10% formalin for a minimum of 45 hours, may be imported into the US without a USDA Veterinary permit.
In the case of histopathological slides which contain Foot and Mouth Disease virus or Rinderpest virus, importers must apply for a USDA import permit and include the method of inactivation.
A USDA import permit will not be required for the importation of histopathological slides if the following is provided in the shipping documents:
A statement from the shipper/producer which clearly states:
USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, with the letterhead containing the physical address of the foreign producer/shipper. USDA, APHIS, VS further recommends that the documentation, written in a clear and concise manner, accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agricultural Specialists at the U.S. port of arrival. We do not recommend that the foreign producer/shipper place this document inside the shipping containers.
Please instruct your shipper to provide this information. We further recommend that you provide a copy of this guideline to your foreign producer/shipper.
If the above information is not supplied, the shipment may be delayed. If the material to be imported cannot meet these criteria, then a USDA permit may be required.
This Guideline applies to swine products and swine byproducts from Puerto Rico (PR) and the U.S. Virgin Islands (USVI) moving interstate to other parts of the United States, including other U.S. territories.
This Guideline does not apply to live swine and swine germplasm, transport of which will continue to be suspended from PR and USVI to other parts of the United States, including other U.S. territories.
On September 17, 2021, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) issued Federal Order DA-2021-0002 suspending the interstate movement of all live swine, swine germplasm, swine products, and swine byproducts from Puerto Rico (PR) and the U.S. Virgin Islands (USVI) to other parts of the United States, including other U.S. territories until sufficient mitigations could be established to authorize such movement. APHIS took this action out of an abundance of caution to further safeguard the U.S. swine herd and protect the interests and livelihoods of U.S. pork producers from African swine fever (ASF), which was confirmed in the Dominican Republic on July 28, 2021.
APHIS subsequently issued revised Federal Order DA-2021-0003 on December 2, 2021, outlining mitigations to allow certain commercially processed swine products and swine byproducts from PR and USVI to move to other parts of the United States, including other U.S. territories, while continuing to provide the necessary protections against ASF.
The September and December 2021 Federal Orders do not restrict the inter-island movement of cooked and raw swine products between PR and the USVI in both passenger baggage (travelers) and cargo (commercial).
For commercially processed swine products or swine byproducts from PR or USVI in passenger baggage: Only canned meat/meat products or baked goods that are commercially labeled and packaged, and shelf-stable without requiring refrigeration will be eligible for entry. The passenger must declare swine products and swine byproducts to the USDA inspector at the airport before leaving PR or to the U.S. Customs and Border Protection officer before leaving the USVI.
For commercially processed swine products or swine byproducts from PR or the USVI in cargo (including mail), a USDA Veterinary Services (VS) transport permit will be required unless the commodity has met the cooking and documentation requirements below.
A USDA VS transport permit will not be required if the processed swine products and swine byproducts are accompanied by supporting documentation confirming one of the following heat treatments:
Supporting documentation verifying the above requirements must include a signed producer statement on company letterhead. In addition, information on invoices, bills of lading, packing lists, or other verifying documents may also be required to verify compliance with the above requirements.
VS recommends that the supporting documentation of the above treatments accompany each shipment. VS does not recommend that the documentation be placed inside the shipping container and further recommends that a copy of this guideline be provided to the producer/shipper in PR and/or the USVI.
For fresh frozen/chilled pork/pork meat products from PR or the USVI in commercial cargo – VS transport permits will be required for all commercial cargo shipments of fresh frozen/chilled pork/pork meat products, and other swine products and swine byproducts not meeting the above requirements that are shipped directly from PR or the USVI to other parts of the United States, including other U.S. territories outside of the protection zone (PR and USVI). Please contact USDA APHIS directly at APIE@usda.gov for specific permitting procedures.
When applying for a USDA VS transport permit, provide documentation such as manifests, invoices, producer/shipper statements on official company letterhead, or other shipping documents which provide the following information:
The permit application and instructions, including information on the user fee and e-authentication, is available on the APHIS web site at http://www.aphis.usda.gov/animal_health/permits/.
The current permit processing fee is $150 and permit duration is one year.
Applications can be submitted by any of the following ways: