Web Content Viewer (JSR 286)

Cell Cultures/Lines, Recombinant Cell Cultures/Lines, and Their Products (for in vitro use)

GUIDELINES FOR IMPORTATION #1120

Including
:
monoclonal antibodies, cell culture supernatants, ascitic fluid, cell extracts, hybridomas, cell cultures/lines which are not derived from livestock* or avian species.
 

Not including:
cell lines of livestock* or avian species origin and their products, microbial cultures and their products.

Introduction:

Materials derived from all animals are potentially subject to U.S.Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulations and must becleared by USDA inspectors at the port of arrival before entry into theUnited States is authorized.  A USDA, APHIS, VS permit is required formaterial derived from animals that may pose a risk of introducing livestockor avian diseases exotic to the United States.

Cell lines and other products of cell lines, including monoclonal antibodies, which:

  1. Are not derived from livestock or avian species;
  2. Are for in vitro use;
  3. Have not been exposed to livestock or avian disease agents exotic to the United States; and
  4. Do not produce antigens or contain genes of livestock or avian disease agents or do not produce monoclonal antibodies directed against livestock or avian disease agents.

May be imported without a USDA permit.

In addition, monoclonal antibodies intended for in vivo human use do not require a permit.

However, (1) cell lines derived from livestock or avian species, (2) cell lines derived from any species which will be used for in vivo use, and (3) cell lines of any species which may have been exposed to exotic livestock or avian disease agents will require a USDA, VS import permit.

Procedures:

A USDA, VS import permit will NOT be required for cell lines other products of cell lines, including monoclonal antibodies if the shipment is accompanied by:

A statement from the shipper/producer which clearly states or identifies:

a.  the material as a cell line or another product of a cell line (including monoclonal antibodies);
b.  the immunogen (what the monoclonal antibody is directed against), as applicable;
c.  the material is for in vitro use OR the material is for in vivo human use;
d.  the material does not come from a facility where work with exotic viruses affecting livestock and avian species is conducted; and
e.  the material is not recombinant OR the material is recombinant but contains no genes and expresses no products of exotic livestock or poultry disease agents.

This information must be supplied as statements and made available for review by the USDA Inspector at the port of arrival.  Do not put the documents INSIDE the shipping container.

Please instruct your shippers to provide this information.

If the above information is not supplied, the shipment will be subject to delays.  If the material cannot meet these criteria, a USDA import permit may be required.

Permit applications may be obtained several ways:

  1. On-line at: http://www.aphis.usda.gov/animal_health/permits/
     
  2. By writing to:
    USDA, APHIS, VS
    National Center for Import and Export
    4700 River Road, Unit 40
    Riverdale, MD 20737
    (301) 851-3300 telephone
    (301) 734-6402 fax

*The term, livestock, includes any bovine, ovine, caprine, porcine, and equine animal.

 



Additional Information