Permits - USDA and CDC

PERMIT REQUIREMENT FOR BIOLOGICAL MATERIALS 

Import, interstate movement, and export of infectious agents and/or biological materials that are suspected to contain such agents, are tightly regulated by Federal agencies and may require permits. These permits minimize the risk of inadvertent release and inappropriate use of such materials. Compliance with multiple regulatory agencies may be required in some cases, depending on the nature of the material to be transported, the point of origin, etc.

If a permit is required, the recipient of the regulated material must obtain the permit prior to transport. If you are the shipper, a copy of the permit must be obtained from the recipient and included in the shipped package. It is important to remember that most permits are issued to the individual, and not to the institution; hence, the PI or the recipient is responsible for finding out about the permit requirements from the relevant agencies, applying for the permit, and obtaining it prior to transport. The permit application process may take several weeks and sufficient processing time must be allowed before the materials are needed.

Failure to comply with regulations when transporting regulated biological materials may result in shipment delays or destruction at the port of entry, refusal of the shipment by carriers, and be subject to fines and/or criminal penalties.

Please note that the information in this document is not applicable to the transport of select agents and toxins. Contact Haley Sinn, 335-9553, or Nyree Mortensen, 353-5679, if your shipment involves a select agent or toxin.

PERMIT INFORMATION

Centers for Disease Control and Prevention (CDC) Etiologic Agent Import or Transport Permits

CDC Import Permit regulations regulate the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States.

A CDC Import permit is required prior to importing the following into the US:

  • Infectious biological agent (e.g., bacteria, viruses, fungi, prion, etc.)
  • Infectious substance or any material that may potentially contain an infectious biological agent
  • Vector – Any arthropod or other animal host or vector of human diseases, or any non-infectious self-replicating system capable of transferring an infectious biological agent to a human
  • Animals, Arthropods, Snails, Bats
  • Non-human primate material (all non-human primate material, unless it has been specifically treated and rendered non-infectious, in which case documentation of the treatment method may need to be provided)

A CDC import permit may not be required in certain cases (e.g. healthy human specimens, a diagnostic specimen that does not contain an infectious biological agent, a biological agent that has been rendered non-infectious, nucleic acids that cannot produce infectious forms of any infectious biological agent). However, in cases where it is determined that an import permit is not required, a certification statement should accompany the shipment. This statement must include a detailed description of the material and a statement detailing how the person making the certification knows that the specimen does not contain an infectious biological agent, including a description of how the material was rendered non-infectious, if applicable. Please refer to the CDC IPP website for more information on what to include in the certification statement.

Permit Application

There is no fee associated with obtaining a CDC import permit.

Before importing an infectious biological agent, infectious substance, or vector into the US, the recipient must:

  • Determine if the shipment requires a permit. CDC’s e-Tool is a helpful tool in determining whether an import permit is required. Also, visit the CDC Website at https://www.cdc.gov/phpr/ipp/index.htm, or call 404-718-2077.
  • If the shipment requires a permit, visit the CDC Import Permit Program (IPP) website at https://www.cdc.gov/phpr/ipp/applications/index.htm to complete the permit application.
  • After the permit is issued, ensure that a copy of the permit is retained by the shipper and receiver, and that the shipment is accompanied by the applicable permit.
  • Ensure that the shipper is in compliance with all legal requirements including all packaging and labeling requirements.
  • Ensure that adequate biosafety measures are in place for storage and use of the regulated agent.
  • Ensure compliance with all permit requirements and conditions as long as you are in possession of the imported material.
  • It is advisable to maintain all shipping records as long as you are in possession of the imported material.

In some cases, a site inspection may be required prior to approving the permit. If a site inspection is required, CDC will provide an initial notice of inspection and coordinate the visit with the permittee. The purpose of these inspections is to verify the implementation of adequate biosafety measures and may include (but not limited to) evaluation of documentation, safety equipment, practices and procedures that are in place, and the structure and features of the facility. If no further information is required after the inspection, an inspection report will be provided and the permit will be processed and approved.

If all requirements are met, some import permit applications are granted expedited status by CDC and may be approved within 24 hours. Expedited status is typically given if the request is for emerging agents or in response to outbreaks (e.g. Zika virus, materials suspected to contain Ebola virus, MERS-CoV)

Permit holders must be aware of all permit conditions in the issued document. A separate CDC authorization or permit may be required for the subsequent transfer or distribution of agents within the US, if noted as a condition of the issued permit.

United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Transport permits

USDA APHIS issues permits to ensure the safe import and transport of materials containing plant or animal material that may potentially harm US agricultural products including livestock, poultry and crops. These permits outline the controls necessary for the import, export, interstate transport and release of these regulated products.

The Veterinary Services branch of USDA APHIS issues the Veterinary Services (VS) Import, Export or Transport permits and the Plant Protection and Quarantine (PPQ) branch of APHIS issues the PPQ permit. APHIS also regulates the movement of certain genetically engineered organisms through its Biotechnology Regulatory Services (BRS).

Animal Health permits

A Veterinary services (VS) permit is required for the importation and/or transport of:

  • Certain live animals and animal products
  • Specimens from animals infected with pathogens or exposed to pathogens or vectors
  • Livestock and poultry pathogens
  • Cell cultures exposed to organisms that cause disease in livestock or poultry
  • Vectors that can serve as the carrier of or have been exposed to an infectious disease of livestock or poultry
  • Human viruses and human vaccines intended for research use in livestock or poultry
  • Attenuated live viruses and vaccine strains

A VS permit may be required for importation of certain organisms even though they are not livestock or poultry pathogens if the medium associated with the culture of an organism is of animal of origin.

For example, a VS permit is not required for the importation of Zika virus. However, if the Zika virus cultures were exposed to animal products such as FBS (fetal bovine serum) or nutrient supplements, a VS permit is required for importation.

Note:
  -  Importation of live or killed mosquito vectors of Zika do require a VS permit. 
  -  Importation of human serum infected with Zika is regulated by the CDC.

Examples of animal related permits include:

VS 16-3: Application for Permit to Import Controlled Material or Transport Organisms or Vectors
VS 16-7: Application for Permit to Import Cell Cultures and their Products
VS 17-129: Application for Import or In-transit permit (for Live Animals, Semen or Embryos)
APHIS 2005: Application for US Veterinary Biological Product Permit

Contact information for USDA APHIS Animal Health Permits

Plant and Plant Products Permits

A Plant Protection and Quarantine (PPQ) Permit is required for the importation and movement of:

  • Regulated plants and plant products for consumption or propagation
  • Plantings such as nursery stock, small lots of seed, and postentry quarantine
  • Plant products such as fruits and vegetables, timber, cotton, and cut flowers
  • Protected plants and plant products such as orchids and threatened and endangered plant species
  • Prohibited plant materials for research

Please note that a PPQ permit is required to transport Drosophila from foreign sources, and for movement to and from Hawaii and the Territories. Although the organism itself presents minimal risk as a plant pest, shipment labels indicating ‘fruit flies’ raise agricultural and environmental concerns, due to the similarity of the common name to other plant pests such as the Mediterranean and Oriental fruit flies. Thus, to ensure that Drosophila shipments are properly routed to PPQ inspection stations for confirmation of identity, a plant pest permit (PPQ Form 526) is required for import.

Examples of some plant related permit applications include:

PPQ 526: Application for Permit to Move Live Plant Pests or Noxious Weeds
PPQ 586: Application for Permit to Transit Plants and/or Plant Products, Plant Pests and/or associated soil through the US
PPQ 587: Application for Permit to Import Plants or Plant Products
PPQ 588: Application to import plants or plant products for experimental, therapeutic or developmental purposes

Contact Information for USDA APHIS Plant Health Permits

Biotechnology Regulatory Services (BRS) permit

A BRS permit may be required for the importation, interstate movement and environmental release of certain genetically engineered organisms that may pose a plant pest risk, including plant insects or microbes.

A permit application providing details about the nature of the genetically engineered organism, along with conditions that will be used to prevent the spread of these organisms to the environment, must be submitted before transport. After careful review of these applications, a BRS permit is issued if the organism poses a plant pest risk. If the genetically engineered organism is not a plant pest, or does not carry sequences from plant pests, it is considered a non-regulated item. In such cases, BRS issues ‘courtesy permits’ for its movement. Though not required by the regulations, courtesy permits facilitate and expedite the movement of these non-regulated organisms, which may otherwise be hindered due to their similarity to a regulated organism. At UIowa, a majority of the BRS courtesy permits are issued for the transport of transgenic Drosophila. Although the organism itself is not considered to be a plant pest, and most transgenic Drosophila developed for research purposes do not contain genetic sequences from plant pests, a complete courtesy permit application (including details of the insert) is required. The application allows USDA APHIS to determine whether or not the transgenic Drosophila is a regulated article which requires a permit.

BRS permit applications

APHIS Form 2000: Application of permit or courtesy permit for movement or release of genetically engineered organisms
BRS Notification: Notification of Movement or Release of a Genetically Engineered Plant

Contact Information for USDA APHIS BRS

Products that do not require USDA import permit

Not all materials require a USDA import permit. However, these materials will be reviewed at the port of entry, and USDA provides guidance for importing such products.

  • The shipper is required to include a written statement on official letterhead along with the shipment.
  • Information to be included in this statement depends on the material that is being shipped and is listed under each category.

Permit Application

Before importing or transporting regulated animal, plant or genetically engineered material that may pose a risk to US agricultural products including livestock, poultry, or crops, the recipient must:

  • Determine whether a permit is required for the material you wish to transport by visiting:
    • The USDA APHIS National Center for Import and Export (NCIE) website, and the USDA APHIS Permits and Certifications website.
    • Additional resources to determine if a USDA permit is required for your shipment are listed at the end of this document
    • Although USDA does not provide a complete list of pathogens that require a permit due to its vast nature, a partial list is available.
  • The web-based USDA ePermits system is a convenient tool for researchers to submit and track permit applications and to apply for renewals and amendments.
  • For researchers who routinely need permits for the transport of regulated materials, it would be useful to establish an e-authentication account to expedite the application process, after which they can register to use the ePermits system. An e-authentication account with Level 2 access will be required for most types of permit applications (exceptions include APHIS form 2005, and some biotechnology ePermits and notifications).
    • The eAuthentication account for level 2 access can be created by submitting the online form. A confirmation email message will be sent from USDA regarding the customer profile you created. To confirm receipt, respond to the message as instructed.
    • After confirmation, you will need to present a government-issued picture ID at a Local Registration Authority (LRA) where a USDA employee will activate the account. Information on USDA service centers may be obtained from https://offices.sc.egov.usda.gov/locator/app?type=lra
    • The USDA service center closest to UIowa is:
          Iowa City Service Center
          
      51 Escort Ln SW
          Iowa City, IA 52240-8612
         (319) 354-1074; (855) 211-4011 fax
    • Once the account has been eAuthenticated, the researcher can log in and apply for a permit.
  • Unlike the CDC Import Permits, there is a fee associated with applying for certain USDA permits.
    • CFR 9, section 130 covers the user fees. Please visit the USDA APHIS VS Import/Export User Fees page for further information on applicable fees.
    • A fee may also be associated with certain site inspections. The need for a site inspection after an application is submitted is determined by several factors, including the risk level of the organism and how the agent is being used.
    • Additional information on permit application fees and contact information is available at the USDA APHIS businesses services website

Shippers must read and follow the guidance appropriately to prevent regulated materials from being held at the port of entry until the applicable permit is provided, to avoid delays and/or denial of entry.

GENERAL Permit Conditions and Amendments

  • Once a permit is granted, proper use, possession and disposal of the regulated material is the responsibility of the permittee.
  • It is recommended that a separate Standard Operating Protocol (SOP), detailing handling and work practices, is maintained for each regulated material. This SOP may be required by the regulatory agency during a site inspection. The SOP must list the physical containment and specific operational standards for the regulated material, include information on handling regulated waste, decontamination techniques including autoclaving (how and when the autoclave is tested to ensure adequate sterilization, how and where an autoclave activity log is maintained, how the material is transferred from one room to another if the autoclave is located in a different room), etc.
  • Permits are valid only through the time period indicated on the permit. Although certain permits may not need to be renewed for continued storage, permit conditions will remain in effect for all regulated material as long as the permittee is in possession of the material. Permit conditions will not expire until the regulated material is used up, appropriately disposed of, or destroyed.
    • If permit conditions state that a valid permit must be maintained so long as the regulated material is possessed, the permittee must renew the permit, even though the material may no longer require transport. It is recommended that the permittee start the renewal process at least 3 months in advance to allow adequate time for processing. If the material is no longer required, the lab should close out the permit.
  • Unless specifically mentioned under permit conditions, CDC and USDA Veterinary Services does not regulate the intrastate movement of most regulated material, though it may fall under state/local regulations. However, if regulated material is transferred to another researcher within the state or the institution, the permittee is still legally responsible for the material’s use, possession, and disposal. Hence, EHS recommends that each recipient obtain his or her own permit before any material is transferred.
  • If a permit indicates USDA/APHIS inspected the facility/rooms, it is required that all work be conducted in only those approved rooms.
  • An amendment to the existing permit is required if the permit details change (including name, address, laboratory information or the regulated material description).
  • USDA and CDC transport permits are issued to a specific individual and not to the laboratory or the institution. Hence, if the permittee leaves the University, it is important to close out the existing permit, and reapply for a new permit if the lab intends to continue working with the regulated material. For this reason, it is recommended that the Principal Investigator (PI) serve as the responsible party, even though the permit may be issued to any eligible lab personnel.
    • A new permit application must be submitted if the permittee leaves the University and wishes to transport the material to another institution.
  • Please note that permit close out is not the same as expiration of a permit. The permittee is still legally responsible for the use, possession and disposal of the regulated material as indicated in the permit conditions, even after a permit expires.
    • If a permit is closed out, the regulatory agency may conduct an inspection to ensure the lab adhered to all permitting conditions of the regulated material.
  • It is advisable to maintain a copy of the permit and document the method of destruction even after the regulated material has been disposed.

Other Relevant Regulatory Agencies

  • In addition to the applicable USDA APHIS VS permits, US Fish and wildlife CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) permits may also be required for certain live animals, including bats. Materials from certain endangered species that is CITES listed, such as Vero cells (established from Adult African Green Monkey kidney cells) also requires a CITES permit before it is imported into the US.
    • For example, a USDA APHIS VS permit is not required for the importation of Zika virus into the US (unless it has been exposed to animal products). However, if the virus is cultured in VERO cells, a CITES permit is required.
  • Federal export control regulations prohibit the export of certain biomaterials to foreign countries without an export license issued by the government. The Export Administration Regulations are administered by the US Department of Commerce. For more information, contact Pat Cone-Fisher, Export Control Coordinator, 319-335-3585 or visit the Export Controls and University Research website.

Contact EHS – Biosafety

If you have questions regarding whether a permit is required for your material or for assistance with permit applications, please contact Aswathy Sreedharan, 335-9547. If the permitting agency requests a site inspection prior to approving the permit, EHS staff can also assist with the inspection process.

Once a permit is obtained, please send a copy to the Biosafety Office, Attn: Aswathy Sreedharan, 100 EHS, or email it to Aswathy-sreedharan@uiowa.edu. Biosafety staff will review permitting conditions and assist permittees with tracking expiration dates.

For assistance with shipping regulations, contact Nyree Mortensen, 353-5679, or Haley Sinn, 335-9553.

Additional Resources