University of Hawai‘i
Contact Hubert B. Olipares, MSPH, SLS (ASCP) for assistance
To import microorganisms into the state of Hawai‘i requires authorization from the Office of Research Compliance and also may require permits or letters of authorization from state regulators (e.g., the Hawai‘i Department of Agriculture) and from federal regulators (e.g., CDC, USDA/APHIS, DOC). The procedures for obtaining each are described below:
University Authorization to Import Biological Materials
- Step 1: Complete & Submit the BSP2 Permit Application
- Step 2: Include with your BSP2 Permit application
- Date of Annual Biosafety Training
- Shipping and Receiving Training is required for anyone who transports Infectious and Biological Substances. Training is provided at the Laulima Worksite “ORC 103 Transportation of Biological Substances“
- Copy of your Federal and/or State Permit or License (HDOA, CDC, USDA, Department of Commerce). See below for information regarding obtaining a permit or letter of authorization.
- Step 3: See a step-by-step checklist for importing microorganisms
State of Hawai‘i Department of Agriculture (HDOA) Authorization to Import Biological Materials
Materials Requiring a State HDOA Permit or Letter of Authorization
Most biological commodities imported into the State of Hawaiʻi require at minimum a state permit or a letter of authorization. The lists below will tell you whether a biological material requires a permit or letter of authorization.
Biological Commodities Requiring an HDOA Permit:
- Conditionally-approved Animals
- Restricted Animals
- Restricted Microorganisms Part A
- Restricted Microorganisms Part B
Biological Commodities Requiring an HDOA Letter of Authorization:
How to Obtain a State HDOA Permit or Letter of Authorization
To obtain a Hawaiʻi Department of Agriculture (HDOA) permit to import biological commodities, complete an HDOA PQ-7 application form and submit it to email@example.com, or call Biosafety Compliance at 808-956-3197 for additional information and instructions. The State of Hawaiʻi permit process is lengthy, all applicants should consider submitting their permit applications to the Research Compliance Office at least one year prior to the date needed.
- HDOA PQ-7 application form
- HDOA PQ-7 application instructions
- UH Checklist for completing PQ7 application
- HDOA Permit Requirements
Official Press Releases from Hawaiʻi Department of Agriculture:
Federal Authorization to Import Biological Materials
Centers for Disease Control (CDC) Etiologic Agent Import Permit Program
A CDC import permit is generally required for any infectious agent known or suspected to cause disease in humans. Visit the Centers for Disease Control Etiologic Agent Import Permit Program for more information.
United States Department of Agriculture (USDA/APHIS)
A USDA permit may be required for:
- Imported veterinary biological products
- Importation, interstate movement, or release of a genetically-engineered organism (e.g., animal, plant, microorganism)
- Plant and plant products imported into the United States
- Transit through and interstate movement within the United States of:
- Plant pests (plant feeding insects, mite’s snails, slugs, and plant pathogens)
- Biological control organisms of plant pets and weeds, parasitic plants, and federally-listed noxious weeds under regulatory authorities
- Effective October 1, 2009 user fees associated with permit applications are as follows:
- New permit application: $137
- Renewal permit: $89
- Amended permit: $68
- FBS inspection: $469 (all fees are per application)
- Import compliance fee: $514 per shipment
Please visit the U.S. Department of Agriculture for more information.
Importation of Non-Regulated Biological Materials
Some biological materials are not regulated by state and federal agencies (Hawaiʻi Department of Agriculture, USDA, CDC) or require additional approval. Please read through the following exceptions carefully.
American Type Tissue Culture Collection/BEI Resources requires all individuals to obtain an approval/exception letter from Hawaiʻi Department of Agriculture prior to requesting any biological commodity from them. Please contact firstname.lastname@example.org for the proper procedures.
Other Items that May Require Authorization
- Biological toxins
- Fetal Bovine Serum, Fetal Calf Serum
- Micro-particles (bacteriophages, plasmids, and other DNA/RNA particles)
- Native plant propagation
- Plants and plant parts (cutting, grafts, scion, bud, seed, leaf, root, etc.)
- Serum and like products from bovine, calf, sheep)
- Soil samples
- Quality control kits (i.e., biological indicators for autoclaves)
- Reference strains
Email email@example.com for additional information.
Exporting Biological Commodities
All biological materials shipped out of the State of Hawaiʻi including inter-island transfers must comply with IATA, DOT shipping regulations. Individuals preparing the shipment must have current General Biosafety training and Transportation of Infectious and Biological Materials training.
Anyone who prepares a shipment containing a Category A, Infectious Substances and Select Agents and Toxins must receive approval from the Research Compliance office.
Complete the UH BSP2 application. Note: Any other versions of the BSP are no longer accepted. Include a copy of any required permits and licenses and submit to firstname.lastname@example.org or fax to 808-956-2265. We are not responsible for documentation submitted to other email addresses or fax numbers. Only the Research Compliance Officer or the Research Compliance Assistant may sign and approve any transportation of biological commodities documents at the University of Hawaiʻi.
The export of some biological materials, chemicals, microorganisms, and toxins require an export license from the federal government. To determine what laws and regulations apply to U.S. exports, contact the UH Office of Export Controls for advice.
You may also use this Flow Chart to guide you through the process and requirements for exportation.