Organisms and Vectors Guidance & Permitting

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. For importation, OV also regulates those organisms 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 may be infected with or have been exposed to livestock or poultry 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 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 and/or transportation:

1. Pathogens that can initiate or disseminate disease in livestock and poultry
2. Vectors that are infected with 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

Review the Guidelines for animal products that do not need an import permit and Guideline 1125: Conditions under which Veterinary Services does not require a transport permit. These guidelines describe materials for which a permit IS NOT required, and describe documentation to include with your materials to facilitate their import or transport.

Yes. Import and transport permit applications are both processed through the APHIS eFile system 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).

OV regulates organisms pathogenic to livestock or poultry, even if the pathogen was isolated from a human.

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. OV does not regulate human diagnostic samples (human clinical samples expected to contain pathogen/s).

For importation on human and non-human primate pathogens, and for movement of human diagnostic samples, 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?”

For current fee structure please visit:  VS User Fees

OV recommends the following best practices:

1. Apply through APHIS eFile System (Veterinary Services Permitting Assistant-VSPA) 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 may be imported and received using a VS 16-6 import permit. The inactivation method should be supplied in the application.
   
   
2. Excluded select agents that are to be moved between U.S. states and territories also require a VS 16-6 interstate transport permit.
   
   
3. 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) and approved prior to permit issuance. If the virus has already been excluded, OV may require the exclusion letter before 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.

Organisms and Vectors does not issue commercial permits.

Carefully read and follow the instructions on the applicable guideline, as outlined below: IMPORT: Guidelines to be used for importation into the United States also require original written statements from the producer. INTERSTATE MOVEMENT: There is an interstate transport guideline that is to be used only for eligible items that are moved from one U.S. state or territory to another (not to be used for importation).

Do you seek interstate transport of US Origin Livestock and poultry pathogens? If so, Organisms and Vectors permitting has two US ORIGIN LIVESTOCK AND POULTRY PATHOGENS PERMITs that may work for you: 1) allows in-vitro work only on regulated materials received via interstate transport; and, 2) the other allows in-vitro and in-vivo work on regulated materials received via interstate transport. These permits are only applicable for interstate movement of U.S. origin organisms classified as Biosafety level 1 (BSL1) and biosafety level 2 (BSL2) materials that do not require a USDA VS laboratory inspection. The blanket permits are template permits and cannot be changed. If you need specific permit language, or if you seek organisms that require laboratory inspections, a separate application is required.

1. The US Origin Livestock and Poultry pathogens in-vitro only interstate transport permit allows receipt by interstate transport of all BSL1 and BSL2 US origin livestock and poultry pathogens except: Low Pathogenic Avian Influenza, Newcastle Disease virus (non-select agent strains, ICPI 0.07 or lower), and Pseudorabies (Aujesky’s disease) that will be propagated. Propagation of these organisms requires a separate permit in which the BSL2 labs are inspected and listed on the permit.

2. The US Origin Livestock and Poultry pathogen in-vitro and in-vivo interstate transport permit allows transport of all BSL1 And BSL2 US origin livestock and poultry pathogens except:

• • Organisms when used in ANY animal are excluded from the permit because lab inspections are required : Low Pathogenic Avian Influenza; Newcastle Disease virus (non-select agent strains, ICPI 0.07 or lower); Prion diseases- Scrapie Chronic Wasting Disease, Bovine Spongiform Encephalopathy; Pseudorabies (Aujesky's disease); Surra (Trypanosoma evansi); Trypanosomiasis (Trypanosoma congolense, T. vivax, T. brucei brucei, T. evansi) and
    
    
  • Organisms when used in LIVESTOCK OR POULTRY susceptible species are excluded from the permit because lab inspections are required: Contagious equine metritis (Taylorella equigenitalis); Cysticercosis (cysticercus cellulosae metacestode stage of Taenia solium); Dourine (Trypanosoma equiperadum); Equine Infectious Anemia virus; Equine piroplasmosis (Babesiosis)- Babesia caballi, Babesia equi/Theileria equi,Babesia bovis; Equine viral arteritis (EVA); Infectious salmon anemia; Japanese Encephalitis virus attenuated vaccine (JEV14-14-2) used in pigs; Porcine Reproductive and Respiratory Syndrome (PRRS); Spring viremia of carp; Theileria  (annulata, buffeli, equi, lestoquardi, lowenshuni, mutans, orientalis, parva, sergenti, uilenbergi; Vesicular stomatitis (VSV)