IU’s Biological Safety Program ensures the safe use of recombinant DNA (rDNA), pathogenic microorganisms, and other infectious agents and toxins in research. We strive not just to comply with federal regulations, but also to adhere to the highest ethical standards when it comes to protecting you and the environment from potential exposure to hazards.
Importation, interstate movement, domestic transport, and environmental release of infectious agents and other regulated biological materials are governed by U.S. federal regulations to protect public health, agriculture, and the environment. It is necessary to adhere to federal regulations before and during the import, transfer, shipping, or use of such materials at Indiana University.
Permits are issued to the individual importer or responsible party, not to the university as an institution, but Indiana University Environmental Health and Safety (IUEHS) Biosafety must be notified (bioprmt@iu.edu) prior to submission of a permit application per the Indiana University Biosafety Manual. IUEHS Biosafety is available to assist investigators throughout the permitting process.
CDC permits are required for importation or transfer of infectious biological agents, infectious substances, vectors of human disease, animals or materials known or suspected to contain infectious agents, and certain non-human primate materials.
Applications should be submitted at least 10 working days prior to shipment; complex or high-risk imports may require additional review time.
Certain materials rendered non-infectious or not reasonably expected to contain infectious agents may not require a permit but must be accompanied by appropriate certification documentation.
Use, possession, or transfer of select agents and toxins requires active federal registration through the Federal Select Agent Program. Possessing or using select agents without registration and prior approval is strictly prohibited.
USDA APHIS permits are required for importation or domestic movement of animal pathogens, livestock-related materials (including bovine-derived reagents), plant pests, and certain genetically engineered organisms.
Processing times vary depending on permit type and complexity. Environmental release or field test permits may require up to 120 days for review.
USFWS regulates the import, export, and interstate transport of wildlife, fauna, and products derived from either, under various wildlife laws and treaties, including, but not limited to, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and the U.S. Endangered Species Act (ESA). USFWS permits may apply when research activities involve the acquisition or transport of wildlife or fauna specimens or materials derived from either, including:
USFWS permitting requirements are separate from, but complementary to, import/export control regulations. Compliance with import/export controls does not replace the need for USFWS permits, and shipments of wildlife materials may require both import/export authorization and wildlife permits depending on the material and destination.
All biological materials entering the United States are subject to U.S. Customs and Border Protection requirements for proper documentation, packaging, labeling, and declaration. Failure to comply may result in delays, confiscation, or penalties.
Import of chemical substances, mixtures, or articles containing either, into the U.S., must comply with the Toxic Substances Control Act (TSCA).
If you have questions about specific material(s) or need guidance on the application process, please reach out to your campus Biosafety Officer. The Biosafety Office can also assist you with ensuring your facilities meet the provisions of your permit so you remain inspection-ready and compliant with regulations upon request. Remember, IUEHS Biosafety must be notified (bioprmt@iu.edu) prior to submission of a permit application per the Indiana University Biosafety Manual.
If your research requires an import permit and the materials involved may also require an Institutional Biosafety Committee (IBC) protocol, please contact the RSCO early in your planning process.
RSCO can help you determine required documentation, timelines, and compliance steps to ensure both import permit and IBC requirements are in place before materials arrive or are used on campus. Reaching out early helps prevent delays and supports safe, compliant research activities.
Contact the Research Safety and Compliance Office
