The receipt, import, export and/or transport of certain biological materials may require one or more permits, depending on the material(s) and details of transport. Please read below for more information on various permit requirements for biological materials.
The CDC Import Permit Program, or IPP, regulates the importation of infectious biological materials that could cause disease in humans in order to prevent their introduction and spread into the U.S. The program ensures that the importation of these agents is monitored and that facilities receiving permits have appropriate biosafety measures in place to work with the imported agents.
Source: https://www.cdc.gov/orr/ipp/index.htm
Any noninfectious biological agent or biological substance that is being imported must be accompanied by an Importer Certification Statement. The statement must confirm the material is not known to contain or suspected of containing an infectious biological agent or has been rendered non-infectious.
You can find additional information, including an Importer Certification Statement Form template, online HERE.
APHIS regulates the importation, interstate movement, or environmental release (i.e., outdoor field trials) of certain organisms developed using genetic engineering (including plants, insects, and microbes) that may pose a plant pest risk.
Permit applications, which are carefully reviewed by APHIS regulatory scientists, provide details about the nature of the organism and the conditions that will be used to prevent the spread and establishment of the organism in the environment. A permit may include additional conditions to help prevent unauthorized release into the environment.
Source: https://www.aphis.usda.gov/biotechnology-permits
Under the authority of the Plant Protection and Honeybee Acts, a Plant Protection and Quarantine (PPQ) 526 permit is required for the importation, interstate movement and environmental release of plant pests (plant feeding insects, mites, snails, slugs, and plant pathogenic bacteria, viruses, fungi, etc.), biological control organisms of plant pests and weeds, bees, parasitic plants, and Federally listed noxious weeds.
APHIS also requires a 526 permit for the importation and interstate movement of soil or other potentially infected host material for the purpose of isolating or culturing microorganisms from those materials. Those materials may include but are not necessarily restricted to; plant material, insects/arthropods, environmental samples such as water, dust, sediments, etc. If the organism is imported on/in host material, no separate permit is required for the host material if the host material is not intended for propagation.
APHIS is authorized to inspect shipments and/or facilities at any time to verify compliance with permit conditions. Receipt of a PPQ permit does not relieve the applicant from the obligation to comply with the regulations of other Federal, State, and local agencies (e.g., U.S. Fish and Wildlife Service or the Environmental Protection Agency).
The PPQ 526 permit is required for the importation, interstate movement, possession, and/or environmental release of the following:
APHIS offers both the online APHIS eFile system and a manual process for application submission. PPQ strongly recommends applicants submit permit applications online, via the APHIS eFile system because the online system efficiently provides applicants electronic access to their applications and permits. Select the following link to start the application process.
Source: https://www.aphis.usda.gov/organism-soil-imports
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”.
Source: https://www.aphis.usda.gov/animal-product-import/organisms-vectors
Please note that export control regulations cover a wide variety of materials, technologies and information other than biohazardous material. Most research activities will fall under fundamental research exclusion in the regulations, however, it is strongly recommended that you be aware of these regulations if your research involves any international shipment or collaboration. If you are collaborating with individuals located in or visiting from a country or if you are visiting a country which the United States currently has sanctions against or is considered a State Sponsor of Terrorism, it is recommended that the regulations be consulted to ensure no violations are occurring. For example, carrying certain personal electronic devices to certain countries or training foreign nationals (individuals in the USA without a green card) from certain countries in specific methods or on specific technologies may be prohibited. Information supplied to foreign nationals may also fall under the category of deemed exports.
Export Administration Regulation (EAR)
Office of Foreign Assets Control provides a list of countries with current sanctions
U.S. Department of State Directorate of Defense Trade Controls
State Sponsors of Terrorism
"'Fundamental research' means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons."
Source: National Security Decision Directive 189
The funding source of a project can change the applicability of the export control regulations. If there exists any clause in the agreement with the funding agency or sponsor that would prohibit the public dissemination of the research, such as sponsor review of data prior to publication or the maintenance of confidential business information, export control regulations may then be applicable.
Exports of materials are carefully controlled by the Department of Commerce. For shipments outside of the United States it is crucial to contact UK Biosafety to determine if an export license is required your material.
If a license is required, there is an online application process. There is no cost associated with the application, however the application process can be quite lengthy.
Commerce Control List (CCL)
For more information regarding export control laws and regulations, contact the UK Office of Sponsor Projects Administration export compliance official -
John Craddock859-253-8377john.craddock@uky.edu
https://www.research.uky.edu/office-sponsored-projects-administration/export-control-and-sponsored-research