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Organisms and Vectors Guidance & Permitting

The Veterinary Services, Organisms and Vectors (OV) Permitting Unit regulates the importation into the United States, and interstate transportation, of organisms and vectors of pathogenic diseases of livestock and poultry.

The Code of Federal Regulations, in 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”.

VS Issues Guideline 1125 – Effective April 15, 2019

Veterinary Services will implement changes to permitting requirements based on Guideline 1125, effective April 15, 2019. The guideline describes allowances for non-regulated interstate movement of certain materials such as non-infectious materials and materials that have not been exposed to infectious agents. Scroll down to view Guideline 1125 in its entirety.


‘US-Origin Livestock and Poultry Pathogens’ Interstate
Transport Permit Changes – August 22, 2019

Organisms and Vectors Permitting made some changes to the organisms excluded from these permits.
Select FAQ 32 from the Frequently Asked Questions for Importation and Transportation of OV's tab below for information.


New Permit Condition – May 7, 2019 

A new permit condition will be added to import permits specifying a Customs entry may be required for materials that are not shipped by a commercial shipper. The importer is responsible for fulfilling this CBP requirement, if applicable. The restriction reads: “Imported article (including hand-carried material) may be subject to regulations enforced by US Customs and Border Protection (CBP). Please visit their website: https://help.cbp.gov/app/answers/detail/a_id/3681/kw/biologicals/


Organism and Vector Guidance

Effective Date: April 15, 2019

This Guideline Applies To:
Materials such as pathogenic microorganisms and vectors – including tissues and blood – which are infectious or contagious to livestock, poultry, or aquatic animals; or are treated, inoculated, or exposed to such pathogens. A partial list of the pathogens VS regulates, hereby referred to as the VS Pathogen List, is available here

These materials are regulated under alternate Guidelines or regulatory authorities: 

  • Agents and Toxins regulated by the Federal Select Agent Program. 
  • Materials imported from outside the United States.
  • Materials transported intrastate (within a State). 

Introduction:
The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), per Title 9, Code of Federal Regulations (CFR) Part 122, may require a permit for the interstate transport of certain organisms and vectors to protect American agriculture. VS issues such permits for the interstate transport of organisms, vectors, or derivatives thereof – including tissues and blood – which are infectious or contagious to livestock, poultry, or aquatic species or are treated, inoculated, or exposed to such pathogens. However, VS does not require an interstate transport permit for materials such as organism and vectors, and derivatives thereof, meeting the criteria described below (i.e., which are not infectious, contagious, or treated, inoculated or exposed to any livestock, poultry or aquatic pathogen). 

Whether VS requires a permit or not, the material may be regulated by other authorities, including local, State, or Federal regulatory agencies. The shipper and receiver are responsible for identifying and gaining approval from all applicable regulatory and oversight agencies. 

Materials and Conditions Where an Interstate Transport Permit is Not Required:
VS does not require an Organisms and Vectors permit (VS Form 16-6A, United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors) for the interstate transportation of: 

  1. Non-pathogenic microorganisms not able to spread communicable disease to livestock, poultry, or aquatic animals. 
     
  2. Biological agents (such as vaccines, bacterins, blood and blood components, allergenics, somatic cells, antibodies, gene therapy, tissues, and recombinant therapeutic proteins) not capable of introducing or disseminating infectious diseases to livestock, poultry, or aquatic animals. 
     
  3. Toxins or toxoids that are not infectious (able to multiply) or able to spread communicable disease to livestock, poultry, or aquatic animals. 
     
  4. Samples from animals or aquaculture systems not confirmed as infected by laboratory testing, not exposed to or suspected of illness caused by an infectious pathogen, and not experimentally infected with organisms or vectors. 
     
  5. Inactivated forms of pathogens. 
     
  6. Viable or dead insect vectors – excluding screwworms and other arthropods such as ticks – of livestock, poultry, or aquatic animal pathogens reared in a U.S. laboratory colony, not known to have been exposed to or to carry pathogens on the VS Pathogen List.  

Procedures:
Shipping Materials Without an Interstate Transport Permit
VS recommends shippers sending materials for which VS does not require an interstate transport permit provide the recipient a written statement describing the material, including genus and species (if applicable). The statement should also affirm the material is not a pathogen of livestock, poultry, or aquatic animals; and (if applicable) describe the inactivation or extraction method for any deactivated materials. 

Obtaining a Permit Application
If the material does not meet the above conditions, shippers may need a permit. Shippers may obtain an application for a permit (VS Form 16-3): 

  • Through the ePermits system.
  • Via email to ov@usda.gov
  • By writing to:
    Veterinary Services
    Strategy and Policy
    4700 River Road, Unit 2
    Riverdale, MD 20737 

Additional information on application submission and payment is available at the Organisms and Vectors web page.

Use these guidelines to import without a USDA permit. The guideline and required statements should be included with the shipping documentation. Read and follow the Guideline directions. If a Guideline is used inappropriately, the materials may be stopped at the port of entry.
Country Animal Disease Status

Find the USDA-recognized animal health status of particular countries and regions, organized by specific livestock or poultry diseases. 

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
Fish pathogens: infectious salmon anemia virus, and spring viremia of carp virus

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 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 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); Novel Swine Enteric Coronavirus disease (SECoV); Porcine delta coronavirus (PDCoV); 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)

The OV does not permit select agents, licensed veterinary biological products, non-infected animals or products, intrastate movement, or storage of biological materials. APHIS and other federal agencies regulate the movement of certain materials through alternate permitting programs. Please use the resources under the Related Links box to find out more about these program. 

Import Permits are issued to allow importation into the United States of:  organisms that may cause disease in livestock and poultry, vectors that could carry livestock and poultry pathogens, and/or organisms or vectors that were exposed to animal(s) or animal product(s) outside of the United States.  

Interstate transport permits are issued for the receipt of organisms that may cause disease in livestock and poultry, and/or vectors that could carry livestock and poultry pathogens across state or territory lines within the United States. 

Permit conditions and restrictions apply as long as the material is maintained.  However, permits do not need to be “renewed” for continued storage of material. 

New permit

Amended permit

Renewal permit

This is the initial application for an organisms and vectors permit.

An application to revise an existing permit, within the current permit period.  An amended permit does not extend the expiration date of the permit. 

 

An application to renew an existing permit for an additional time period.  Limited changes may be requested through the renewal application, such as address or contact information, or revisions relevant to the existing material description or its proposed use (e.g. different genotypes/mutations of a virus, or additional use restrictions, etc). 

$150.00

$75.00

$97.00

 *Always check with local and state authorities as additional laws or regulations may apply.  An OV permit does not supersede any other state or federal regulations. Permits from multiple state or federal agencies may be required.

To apply for an OV permit, please complete and submit a VS Form 16-3, “Application for Permit to Import or Transport Controlled Material or Organisms or Vectors”. The fastest way to submit a permit is through the online permitting system, ePermits click here.

Use of ePermits requires eAuthentication; to apply for eAuthentican, click here.

For a fillable pdf, please click here. You can submit the paper application via fax, email, or mail to:

USDA-APHIS-VS-AgSAS OV
4700 River Road, Unit 2
Riverdale, MD 20737
Phone: 301-851-3300, option 3
Fax: 301-851-2239
Email: OV@usda.gov

If your shipment has been placed under quarantine by the United States Department of Agriculture or Department of Homeland Security, follow the instructions in this link.

Contact Information

For questions please contact the organisms and vectors staff via email at OV@aphis.usda.gov or via phone at 301-851-3300 option 3

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