FEDERAL GOVERNMENT CLEARANCES FOR RECEIPT OF INTERNATIONAL SHIPMENT OF HUMAN 
EMBRYONIC STEM CELLS

Release Date:  November 16, 2001

NOTICE:  NOT-OD-02-013

National Institutes of Health

Many of the sources of human embryonic stem cells are located in countries 
other than the United States.  For investigators wishing to conduct federal 
research using human embryonic stem cells, permission may be required for 
their importation.  Several U.S. federal government agencies have policies in 
place for the importation of biological specimens.  This document explains 
them and provides agency contacts and additional information.  Some countries 
may have additional requirements for exportation, but NIH does not know of 
specific cases at the present time.  Therefore, this issue is not addressed in 
this document.

The primary concern about importation of human embryonic stem cells pertains 
to their potential infectious properties, such as bovine spongiform 
encephalopathy (BSE) i.e., mad cow disease.  All of the sources of human 
embryonic stem cells known to the NIH are aware of the Federal government 
needs for permits for importation.  Specific requirements pertain to the use 
of bovine serum albumin products that were used in human embryonic stem cell 
research in foreign countries that may have BSE.  Federal agencies require 
information about the certified sources of bovine serum albumin that originate 
from sources in countries that may have BSE.

All investigators receiving human embryonic stem cells from international 
sources should consider obtaining the following:

o  United States Department of Agriculture (USDA) Permits to Import or 
   Transport Controlled Material or Organisms or Vectors (Forms 16-3 and 
   16-7).

o  Background information regarding importation requirements, forms, and 
   fees can be obtained at the following website: 
   http://www.aphis.usda.gov/ncie/.  On-line applications can be completed 
   at this site or the forms can be downloaded from this site (both form
   16-3 and the supplemental form16-7 are required.
   http://www.aphis.usda.gov/forms/vs16-3.pdf  
   http://www.aphis.usda.gov/forms/vs16-7s.pdf

o  Additional information can be obtained by contacting Dr. Linda Kahn, 
   NCIE-Import Products Veterinary Services, National Center for Import and 
   Export, 4700 River Road, Unit 40, Riverdale, MD 20737-1232.  Tel: (301) 
   734-3277, fax (301) 723-8226.

Some investigators receiving human embryonic stem cells from international 
sources may wish to apply for additional permits for the receipt of cells and 
tissues that may harbor agents or vectors of human disease.  

o  The Centers for Disease Control and Prevention has a separate policy and 
   permit process for importation of biologic products that may harbor 
   etiologic agents that cause human disease.  Information about this process 
   may be obtained from the Office of Health and Safety Information (Ohasis) 
   http://www.cdc.gov/od/ohs/   

   The CDC application for permit for import or transport of agents or 
   vectors of human disease is document #101000 and can be found at 
   http://www.cdc.gov/od/ohs/biosfty/imprtper.htm 

   Additional information can be obtained by contacting Dr. Jonathan Y. 
   Richmond at the Centers for Disease Control and Prevention, Office of 
   Health and Safety, 1600 Clifton Road, N.E., Mail Stop F05 Atlanta, GA 
   30333. 

o  The U.S. Food and Drug Administration (FDA) does not issue importation 
   permits for cell lines.  However, for clinical research applications 
   that involve the use of human embryonic stem cells, the agency 
   recommends that sponsors contact the FDA regarding policies for the 
   manufacture of biological products.  Contact information about these 
   policies can be obtained from:

   FDA Office of Regulatory Affairs, Associate Commissioner for Regulatory 
   Affairs, tel: (301) 827-3101 or http://www.fda.gov/ora , Joyce Frey-
   Vasconsells, Ph.D., Deputy Director, Center for Biologics Evaluation and 
   Research/FDA, tel: (301) 827-5102 or email: [email protected], or 
   Eda Bloom, Ph.D., Coordinator, Xenotransplantation Working Group, 
   Division of Cell and Gene Therapy, Center for Biologics Evaluation and 
   Research/FDA, tel: (301) 827-0452 or email: [email protected].

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