Authorizations to Transport Biomaterials
Contact Hubert B. Olipares, MSPH, SLS (ASCP) for assistance
olipares@hawaii.edu
(808) 956-3197
Import, Export and Movement of Biological Materials (Biomaterials) in 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 on this page.
*Biological Materials include but are not limited to plants, animals, arthropods, invertebrates, insects, bacteria, viruses, parasites, fungi, oomycetes, mycoplasmas, RNA, recombinant DNA, prions, proteins, GMOs, cell lines [specify if transformed, immortalized], tissues (e.g., blood, lung), human specimens (sputum, urine, feces, tissue, swabs), non-human animal specimens, fetal calf serum, algae, protoclones and nematodes, weeds, biological control agents (including those not presently discovered or known to exist in Hawai‘i) and “new” microorganisms identified as those “combining genetic material from organisms in different genera.
University Authorization to Import Biological Materials
An authorization from the University of Hawaiʻi is required for any biological materials regulated by state and federal agencies. Please follow these steps to obtain University authorization:
Step 1: Complete & Submit the BSP2 Authorization Request
What Requires a BSP-2 Permit from UH Biosafety?
- Importing/Exporting Biomaterials Into or Out of the State
- Moving Biomaterials Within the State, Inter-Island
- Moving Biomaterials Within the Same Island (on public roadways) (some exclusions apply below)
- Moving Biomaterials On Campus, Between Buildings (some exclusions apply below)
- Moving Biomaterials Within the Same Building (some exclusions apply below)
- Transfer of Biomaterials Between PIs
- Complete Destruction of Any Biomaterials
- Native (endemic) plant propagation
- Intention of biological material use has changed (i.e. research to teaching)
- Animals and Plants under CITES permit
*Live Vertebrate Animals to/from a Centralized AVS Vivarium requires a T-1 form rather than a BSP-2
What Does Not Require a BSP-2 Permit from UH Biosafety?
Importation/Exportation/Movement/Destruction of:
- Biological Material that has been neutralized/deactivated or preserved and no longer poses a human or animal health risk or risk to the environment (exceptions include prions and nervious tissue)
- Preserved animals, plants or tissues (chemical preservative)
- Local Environmental samples that are not suspected to contain a pathogen or infectious substance and only moving within one island, campus or building
- Indigenous plants/plant parts that are not suspected to contain a pathogen or infectious substance and only moving within the same building
- Diagnostic Specimens that are not suspected to contain a pathogen or infectious substance and only moving within the same building
- Animals that are not suspected to contain a pathogen or infectious substance and only moving within the same building
- Recombinant Materials, Genomic Materials, Cells/Tissue Cultures/Organs that are not suspected to contain a pathogen or infectious substance, Fetal Bovine Serum, Fetal Calf Serum, Micro-particles (bacteriophages, plasmids, and other DNA/RNA particles), Serum and like products (from bovine, calf, sheep, and other animals), Quality control kits (i.e., biological indicators for autoclaves), Reference strains only moving within the same building
Step 2: Include with your BSP2 Authorization Request
-
- Date of Annual Biosafety Training
- Shipping and Receiving Training is required for anyone who transports Infectious and Biological Materials.
- 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 biological materials
Calendar Year BSP2 Approval
Non-living, non-regulated biological materials that do not require a permit from HDOA, USDA, CDC, Customs, or NFWS, can be placed on a “calendar year BSP2” form. Approvals are valid for a calendar year (January 1 – December 31). These must be renewed annually. Applicable materials include but are not limited to proteins, antibodies, antigens, nucleotides, genomic material, and other non -regulated materials. Components of the biological materials cannot be infectious, diseased or derived from agriculture animals.
*Calendar approval cannot be used for foreign vendors or shippers (outside of the US) or those that have Federal US import requirements. Contact biosafe@hawaii.edu for more information.
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 materials 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 Materials Requiring an HDOA Permit:
- Conditionally-approved Animals
- Restricted Animals
- Restricted Microorganisms Part A
- Restricted Microorganisms Part B
Biological Materials Requiring an HDOA Letter of Authorization:
- Non-restricted Microorganisms
- American Type Tissue Culture (ATCC) requests
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 uhpermit@hawaii.edu, 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
- Microorganism Advisory Subcommittee Memo Template
Official Press Releases from Hawaiʻi Department of Agriculture:
- New State Plant and Animal Import Permit Fees June 30, 2010
- Notice: Fee Schedule July 1, 2010
- Current HDOA Inspection fee is $25.00 for laboratory or site.
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), but may require additional approval. Please read through the following exceptions carefully.
ATCC/BEI Request
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 uhpermit@hawaii.edu 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 uhpermit@hawaii.edu for additional information.
Inter-state Transport
When you are collecting samples on a neighbor island, contact the Hawaiʻi Department of Agriculture (HDOA) Plant Quarantine Branch(PQ) for that specific island (see below) in advance to give them notice of your permit and samples for interstate (inter-island) transport. A permit for transport may need to be sought prior to shipment, 2-3 months in advance. An appointment prior to shipment may be necessary. Provide the PQ office a copy of the advance permit and the conditions for their review. This aids the inspector on how to issue the interisland certificate sticker for regulated samples inspected prior to transporting to Honolulu. If you are collecting samples on Lanai and Molokai, please contact the Manager of the Branch or the Maui PQ Supervisor for guidance. There are no PQ offices on Lanai and Molokai. At the end of the year, an annual report is due by January 31st of the following year.
Hawaiʻi Island
16E Lanikaula Street
Hilo, Hawaiʻi 96720-4302
Phone: (808) 974-4141 FAX: (808) 974-4148
Keahole Airport, Kailua-Kona
Phone: (808) 326-1077, FAX: (808) 326-2126
Maui (Molokai and Lanai) Islands
635 Mua Street
Kahului, Hawaiʻi 96732-2322
Phone: (808) 873-3962, FAX: (808) 873-3586
Kauaʻi Islands
4398A Pua Loke Street
Lihue, Hawaiʻi 96766-5671
Phone: (808) 241-7135, FAX: (808) 241-7137
Do not ship samples directly to the Agriculture Diagnostic Service Center. All samples must be submitted through a CTAHR Extension Office. (Animal diagnostic specimens are exempt from permit, unless it is potentially infectious).
New plant diseases or insects must be notified directly to HDOA. An HDOA collection permit may be needed. Restricted shipment of diseased plant pests and insects are prohibited.
HDOH and DLNR may be required. A Scientific Collection permit must be specific to the location of collection and specify transport back to the laboratory.
Live animal transport will require IATA/DOT training that the University does not conduct. Contact your courier for specific information.
Chemicals and chemical preserved materials are not under the purview of UH Biosafety Program. Training is not conducted at the University. Contact your campus Environmental Health & Safety Office on hazardous material shipments.
Federal permits (CDC-Intrastate transport, USDA-APHIS, PPQ, VS, and BRS, NFWS/CITES and Custom and Border Protection) may apply. Check with the Federal Agencies directly.
All UH personnel who ship, transport, or move material into the University or export outside of the University/State must be trained and notify the Biosafety Program Office via a BSP2 form.
Exporting Biological Materials
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 BSP2 are no longer accepted. Include a copy of any required permits and licenses and submit to uhpermit@hawaii.edu 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.