Frequently Asked Questions For Importation and Transportation Of Organisms and Vectors (OV)

Frequently Asked Questions For Importation and Transportation Of Organisms and Vectors (OV)

The 9 CFR, §122.2 mandates that "no organisms or vectors shall be imported into the United States or transported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit".

The USDA APHIS Veterinary Services Organisms and Vectors (OV) unit of the Agricultural Select Agent Services (AgSAS) staff regulates the importation and transportation of livestock- and poultry-pathogenic organisms and vectors.

USDA APHIS Plant Protection and Quarantine regulates importation of plant pests.

CDC Import Permit program regulates importation of human infectious disease organisms and vectors.

A VS Form 16-3 "Application for Permit to: Import or Transport Controlled Materials or Organisms or Vectors" is the application form which is submitted to apply for a permit (VS form 16-6A) for Organisms or Vectors. It is also the same application used to apply for a permit (VS form 16-6A) for Animal Products and By-Products. A VS Form 16-6A "United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors" (usually referred to simply as a VS 16-6) is the actual permit that is issued to the permittee for import or transport of the regulated material.

OV issues VS 16-6 permits to the recipient ("The Permittee") but not to the sender ("The Shipper").

OV regulates all cultures or collections of organisms which may introduce or disseminate any contagious or infectious disease of livestock and poultry and their derivatives (DNA/RNA, recombinants, inactivated/attenuated). These pathogens include bacteria, viruses, fungi, protozoa, transmissible spongiform encephalopathy (TSE) agents, and their extracted nucleic acids.

OV regulates arthropods (e.g. insects, flies, fly larva, ticks, worms, mosquitoes, mites) that can effectively serve as the carriers of pathogens. Cultures and specimens of all animals (including laboratory animals and pets) are also considered as "vectors" if infected or likely exposed to pathogens

Controlled materials that require a VS 16-6 import permit include microorganisms (e.g. bacteria, viruses, fungi, protozoa, and TSE agents) that are pathogenic to livestock or poultry, their extracted nucleic acids, inactivated and killed products, and vectors of livestock or poultry pathogens. Importation of non-pathogenic microorganisms that have not been exposed to components derived from animal sources do not require a VS permit.

Controlled materials that require a VS 16-6 interstate transport permit include live microorganisms (e.g. bacteria, viruses, fungi, protozoa, and TSE agents) that are pathogenic to livestock or poultry, their extracted nucleic acids, inactivated and killed products, and vectors of livestock or poultry pathogens. Transportation of non-pathogenic microorganisms do not require a VS permit.

Examples of organisms and vectors that require VS permit for importation or transportation:

  1. Pathogens that can initiate or disseminate disease in livestock and poultry
  2. Vectors that can serve as the carrier of or have been exposed to an infectious disease of livestock or poultry
  3. Animal specimens including tissue, fluids, or blood collected from animals infected with pathogens or exposed to pathogens or vectors
  4. Cell cultures exposed to organisms that cause disease in livestock or poultry
  5. Human viruses and human vaccines intended for research use in livestock or poultry.
  6. Attenuated live viruses and vaccine strains
  7. Fish pathogens: infectious salmon anemia virus, and spring viremia of carp virus

Review the "Animal Products that Do Not Require an Import Permit (Guidelines)" posted on the APHIS website (USDA Import Guidelines). These guidelines describe materials that DO NOT require a permit, and describe documentation to include with your materials that will facilitate their import or transport.

Yes. Import and transport permit applications are both processed through ePermits and approved permits populate on the same form (VS 16-6). However, import permit applications require more information than transport permit applications. This is because APHIS classifies countries according to their animal disease status, and prohibits or restricts importation of certain materials from countries based on their disease status.

Examples of the information we need for import permits include:

  • A full description of the organism. This includes the genus and species for bacteria and the full name of the virus.

  • For bacteria, the applicant must verify that the organism was subcultured for isolation at least four times prior to import.

  • The country of origin of the materials. This allows us to determine if there are diseases endemic to that country that we might be concerned about in the imported material.

  • A description of any animal or animal-origin nutrients or media that importing materials might have been exposed of.

  • The method of inactivation should be provided if the material or components are high risk or if the material comes from a country endemic for select agents.

No. OV only regulates organisms that introduce or disseminate disease in livestock, poultry and certain diseases of aquaculture. Not included under OV restrictions are pathogens of pet animals or laboratory animals such as non-human primates, bats, mice, or rats (unless they have been exposed to an infectious disease of livestock or poultry).

No. Plant pathogens and vectors of plant pathogens that do not introduce or disseminate disease in livestock or poultry are not regulated by OV. For importation of plant pathogens and vectors of plant pathogens, please contact USDA Plant Protection and Quarantine (PPQ).

No. Human pathogens that do not introduce or disseminate disease in livestock or poultry are not regulated by OV except if they are to be imported and have been exposed to animal materials or animals. For importation of pathogens that are concern of human and non-human primates, please contact Centers for Disease Control (CDC).

No. The regulation for VS 16-6 permit for a microorganism or vector?of veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective is done by APHIS' Center for Veterinary Biologics (CVB) and is centered around enforcement of the Virus Serum Toxin Act (PDF 17KB).

Yes. Receipt of zoonotic pathogens of livestock or poultry also requires a permit from VS irrespective of whether a CDC permit was obtained or not.

Yes. The expiration date listed on the USDA VS 16-6 permit is the last date on which the permittee is allowed to import or transport agents listed on the permit. VS permit 16-6 renewal instructions

Yes. You must amend your existing permit if your details change. Make requests for a change in name, address, laboratory information, or material description through the VS 16-3 application form or using VS permit 16-6 amendment instructions.

Yes. Renewal of permit is not required for possession of previously imported materials. However, the permittee is responsible for all materials until possession ends. Permit restrictions remain in effect until the material is used up, destroyed, or discarded following appropriate methods.

APHIS inspection is required prior to obtaining importation and transportation permits for any BSL-3 pathogens. Additionally, inspection is required for selected BSL-2 pathogens.

Please email your questions to: ov@aphis.usda.gov ; call 301-851-3300, option 3; or fax your inquiry to: 301-851-2239. For additional information please visit our website at: www.aphis.usda.gov/animal-health/organisms-vectors

VS 16-3 permit applications may be obtained:

  1. On-line at http://www.aphis.usda.gov/animal_health/permits/
  2. By writing to:
    USDA, APHIS, VS
    National Import Export Services
    4700 River Road, Unit 2
    Riverdale, MD 20737
    Telephone: 301-851-3300, Option 3
    Fax: 301-851-2239

    For faster processing, please submit your application using the online permitting system "ePermits"

Instructions for eauthentication can be found in ePermits Frequently asked Questions under “How do I obtain a level 2 account?”

OV recommends the following best practices:

  1. Apply through ePermits using form VS 16-3. Electronic submissions allow OV to provide you the most efficient service and reduce the time needed to process your application.
  2. Review the "Is a VS 16-6 permit required?" flowchart and  USDA Guidelines for no import permit required. These guidelines describe materials that DO NOT require a permit, and describe documentation to include with your materials that will facilitate their import or transport. It is always a good practice to include the printed guideline with the shipping documents.
  3. State whether the permit requested is an import permit or a transport permit. An import permit is for movement of materials into the U.S. Transport permits are for interstate transport within the United States.
  4. The restrictions are more stringent for import permits. See Q9 for best practices for import permit applications.
  1. Select Agents are prohibited from movement under a VS 16-6 permit. A Form 2 transfer issued through the Federal Select Agent Program is required.

  2. Importation of tissues and samples suspected of containing Select Agents is prohibited. Confirmation that the material does not contain Select Agents must be verified at one of the two Veterinary Services Diagnostic Laboratories by safety testing, safety treatment or both. A safety testing /treatment permit to one of the Veterinary Diagnostic Laboratories are generated with the initial application.
  1. Inactivated or excluded select agents can be received using a VS 16-6 permit. For importation, the inactivation method should be supplied.

  2. Avian influenza is considered highly pathogenic (a Select Agent) until proven to be low pathogenic avian influenza. This means a request for exclusion of the virus from the Federal Select Agent Program must be submitted (AgSAS@aphis.usda.gov). If the virus has already been excluded, OV may require the exclusion letter is submitted before a issuing a permit.
  1. Materials that have been exposed to animals or animal products from certain countries could act as vectors for certain organisms of concern for U.S agriculture. As examples, organisms such as Highly Pathogenic Avian Influenza could be found in eggs used to grow influenza viruses. Foot and Mouth disease virus or viral RNA (both select agents) could be transmitted through exposure to fetal bovine serum.

  2. In many cases, the materials can be treated prior to importation and may not require safety testing/treatment. For example, non-pathogenic bacterial cultures grown in standard autoclaved sterile media will not require a VS permit to import.

No, toxins are not regulated by OV. Some toxins are regulated by the Federal Select Agent Program.

OV regulates two aquatic pathogens: infectious salmon anemia virus and spring viremia of carp

Do I need an interstate transport permit for receipt of livestock or poultry specimens or by-products not known or suspected to be infected with livestock or poultry pathogens? No. The recipient is not required to obtain an interstate transport permit for surveillance specimens originated from healthy animals not known or suspected to be infected with livestock or poultry pathogens. An interstate transport permit is required for movement of materials that are known or suspected to contain communicable or contagious livestock or poultry disease agents such as diagnostic samples from sick animals and surveillance samples from outbreak situations.

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