Chapter 26
BIOSAFETY
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Appendix I. Import, Export, and Transfer Restrictions
Materials being transferred (i.e., imported, exported, or transferred) from one location or person to another may be subject to regulatory restrictions or permit requirements. United States (U.S.), state, and foreign government agencies restrict and permit the movement of certain biological materials across borders to prevent threats to public health, agriculture, environment, and national security.
This appendix provides an outline of U.S.-based regulatory restrictions, permits, and lists related to the transfer (i.e., import, export, or transfer) of biological and related materials. This outline provides LBNL personnel with a starting point for determining whether such materials are potentially regulated by U.S. agencies, and whether there are restrictions or permits applicable to transfer of the material or equipment. Contact the LBNL Biosafety Office ([email protected]) for additional advice.
This appendix does not provide comprehensive information about restricted materials, or transfer or shipping requirements. Additional LBNL policy information may be found in the following documents:
- Web links and references to external agencies provided in this appendix
- Appendix H of this manual for transportation and shipping requirements
- The Berkeley Lab Export Control Manual for general LBNL export control requirements
The supervisor, work lead, person transferring the biological material, person requesting transfer of the biological material, and permit holder all have LBNL or legal responsibilities for complying with transfer requirements, obtaining any required permits, and following the conditions of the permit. Regulatory requirements, permits, and permit conditions related to the transfer of biological materials should also be included in the Biosafety Work Authorization. The LBNL Biosafety Office and Institutional Biosafety Committee (IBC) will review the researcher’s assessment and documentation of transfer requirements during the work authorization review process.
I.2 Importing or Transfer into the U.S. and California
There may be restrictions or permits required for the transfer of biological material between collaborators, or for importing material into the U.S. from foreign countries or in some cases into California or the San Francisco Bay Area.
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Shipments and persons entering the U.S. are processed by the U.S. Customs and Border Protection (CBP), which is a branch of the Department of Homeland Security. The CBP checks materials transported by travelers and shipments for proper import permits, packaging, and labeling. This check may include opening and inspecting the package. Noted concerns may be reported to other U.S. agencies. In addition, the California Department of Food and Agriculture (CDFA) and the U.S. Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS) do not allow the import of certain materials that may be infested with invasive species identified as pests by the state. CDFA also has border protection stations that inspect vehicles for commodities that may be infested with pests. The person importing the material (the importer) should therefore:
USDA-APHIS label for shipping soil samples under a soil permit.
Source: Berkeley Lab EHS.
- Obtain an import permit from the appropriate government organization prior to shipment, if required
- Package and label the material according to permit and shipping requirements
- Consider including a courtesy letter (e.g., a letter that describes the contents in detail and any hazards, concerns, permit requirements, or lack thereof) with the shipment
Prior to shipment of the material, the person importing the material (the importer) should contact the appropriate government organization to determine its transfer requirements. The importer is legally responsible for ensuring that personnel package, label, and ship regulated material from the foreign country according to the regulating agency’s requirements and shipping regulations. Shipping labels are often also issued to the importer with the permit. The importer must send the labels and one or more copies of the permit to the shipper. The permit and labels inform CBP and other agencies of the package contents.
I.2.1 CDC and APHIS Select Agent and Toxin Restrictions
Select agents and toxins are specific pathogenic agents
and toxins that pose a severe threat to human, animal, and plant health because
of their potential for use as biological weapons. They are therefore
regulated by the Department of Health and Human Services – Centers for Disease
Control and Prevention (HHS-CDC) and USDA-APHIS. See Work Process B.3.d.v of
this program for additional information; and Appendix B, Section
B.2 and Section
B.3, for a list of
select agents and toxins. Consult the most recent online list at www.selectagents.gov.
Only facilities registered with and individuals approved by CDC or APHIS are allowed to possess, have access to, or transfer the specific agents and strains or toxins for which they are approved. Transfers of select agents or toxins must be conducted with the approval and involvement of the LBNL EHS Biosafety Office.
I.2.2 APHIS Agricultural Permits
The USDA-APHIS defends America’s animal and plant resources from agricultural pests and diseases by regulating materials, organisms, or agents that may harm domestic or native animals or plants, or natural resources. These materials, organisms, or agents may cause harm directly (e.g., predator or pathogen) or indirectly (e.g., vector). Generally, APHIS requires a permit or another document issued to an individual to import, export, or store regulated materials from or to locations outside the continental U.S. or between U.S. states.
Work Process B.3.e, USDA-Regulated Materials, Organisms, and Agents, of this program provides an overview of APHIS agency branches along with categories and examples of regulated materials, organisms, and agents. The following sections provide additional agency details, requirements, and Web links for more information.
I.2.2.1 APHIS Plant Health Permits
The Plant
Protection and Quarantine (PPQ) branch of APHIS safeguards agriculture and
natural resources from the risks associated with the entry, establishment, or
spread of animal and plant pests and noxious weeds to ensure an abundant,
high-quality, and varied food supply. PPQ provides the following resources:
- PPQ Permits Web page: Provides permit applications for soil, plant pests, plants, plant products, weeds, etc.
The PPQ
Soil Circular: Defines
what is and is not soil, and provides information about soil treatments and
permits. Soil is a mixture of inorganic and organic materials, when the
organic materials are unidentifiable plant and/or animal parts. This mixture
can support biological activity and therefore carry and introduce harmful pests
or diseases from one location to another.
The PPQ Plant Pest Program: Provides a list
of select insects, mollusks, nematodes, plant diseases, or noxious weeds that are
considered pests.- The PPQ Cooperative Agricultural Pest Survey Program: Provides lists of National Pests of Concern and State Pests of Concern.
- A list of fungal plant pathogens for each U.S. state is currently being developed by PPQ to help expedite the permit process for obtaining research isolates. The list will be based on the Widely Prevalent Fungi of the United States Web site.
Appendix B, Section B.4, of this manual also provides lists of bacterial, fungal, and viral plant pathogens that may be regulated by USDA.
I.2.2.2 APHIS Animal Health Permits
The Veterinary
Services (VS) branch of APHIS protects and improves the health, quality,
and marketability of our nation's animals, animal products, and veterinary
biologics by preventing, controlling, and/or eliminating animal diseases, and
monitoring and promoting animal health and productivity. VS provides the
following information on permits, types of materials, and diseases:
- VS animal health permits for importing controlled material, organisms, vectors, animal products, cell cultures and their products, live animals, semen, and embryos.
- Center for Import Export (NCIE) in APHIS VS regulates the import, export, and interstate movement of all animals and animal products (e.g., tissues, blood, and semen), including those that are genetically engineered.
- Center for Veterinary Biologics (CVB) in APHIS VS regulates and requires veterinary biologics permits for veterinary biologics. Examples of veterinary biologics include vaccines, antibodies, diagnostic kits, and certain immunomodulators, including those developed using genetically engineered organisms.
- Animal health – animal diseases information
- Animal diseases by animal species
I.2.2.3 APHIS Genetically Engineered Organisms Permits
APHIS uses the term biotechnology to mean the use of recombinant DNA technology, or genetic engineering
(GE) to modify living organisms. APHIS regulates certain GE organisms that may pose
a risk to plant or animal health. In addition, APHIS participates in programs
that use biotechnology to identify and control plant and animal pests. Below is
a list of the regulatory agency branches and requirements for genetically
engineered organisms and facilities.
- Biotechnology Regulatory Services (BRS) in APHIS uses permits, notifications, and petitions to regulate the importation, interstate movement, or environmental release of certain GE organisms, including plants, insects, or microbes that may be plant pests. When transgenic Drosophila developed for research need to be moved, BRS requires a Drosophila Courtesy Permit Application or an APHIS 2000 Form to confirm they are not plant pests and therefore do not need to be regulated.
- See NCIE and CVB in Section I.2.2.2 above.
I.2.3 CDC Agents or Vectors of Human Disease Permits
CDC requires a U.S. Public Health Service permit to import an etiologic agent, or material containing an etiologic agent, host, or vector of human disease. A permit is also required for interstate transfer if the original CDC import permit was issued on the condition that any subsequent transfer of the material would require a permit. According to the CDC Etiologic Agent Import Permit Program, the materials listed below require a permit.
- Etiologic
agents. Etiologic
agents that are microorganisms, infectious agents, and toxins that cause
disease in humans (e.g., bacteria, bacterial toxins, viruses, fungi,
rickettsiae, protozoans, and parasites) require a CDC permit. Etiologic agents
also include naturally occurring, bioengineered, or synthesized components of
an etiologic agent when the component causes human disease. Examples of
etiologic agents are listed in Appendix B, Section B.2 and Section B.3.
- Biological
materials. Biological materials that are known or suspected of containing an etiologic
agent also require a CDC permit. Examples include unsterilized specimens of
human and animal matter (e.g., tissue, blood, body discharges, fluids,
excretions or similar material) known or suspected of containing an etiologic
agent.
- Hosts and vectors
- Animals. Any animal known or suspected of being infected with an organism capable of causing disease that is transmissible to humans may require a CDC permit. See the CDC Animal Importation Web site for more information.
- Bats. All live bats require an import permit from the CDC and the U.S. Fish and Wildlife Services.
- Arthropods. Any living insect or other arthropod known for, or suspected of, containing an etiologic agent requires a CDC permit.
- Snails. Snail species capable of transmitting a human pathogen require a CDC permit.
I.2.4 Food and Drug Administration Import Program
With the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation are subject to examination by the U.S. Food and Drug Administration (FDA) when they are being imported or offered for import into the U.S. Most meat and poultry products are regulated by USDA. FDA requires various notifications or approvals prior to importing. See the FDA Import Program Web site for more information.
I.2.5 Fish and Wildlife Service Permits
The import, export, or re-export of a wildlife or plant specimen may be regulated by a conservation law or treaty (e.g., Endangered Species Act) implemented by the U.S. Fish & Wildlife Service (FWS). These laws are part of domestic and international conservation efforts to protect wildlife and plants subject to international trade. Wildlife is any living or dead wild animal, its parts, and products made from the animal. Wildlife not only includes mammals, birds, reptiles, amphibians, and fish, but also invertebrates such as insects, crustaceans, arthropods, mollusks, and coelenterates. The FWS Permits Web site should be used to determine whether a wildlife or plant specimen requires a permit and how to obtain a permit. Table I-1 below provides examples of wildlife or plant specimens that may require a permit to export or import.
Table I-1. Wildlife or Plant Specimens That May Require an FWS Permit
Export |
Import |
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Source: adapted from the UNH Shipment
of Biological Materials Manual,
University of New Hampshire,
March 30, 2007.
I.3 Exporting or Transfer from the U.S.
Controls for exporting from LBNL are outlined in the Berkeley Lab Export Control Manual. These export controls are designed to protect items and information that are important to the U.S. The controls are based on government rules and regulations that govern the transfer of the following items to non-U.S. entities or individuals, regardless of where or how the transfer takes place:
- Goods (systems, components, equipment, or materials)
- Technologies (technical data, information, or assistance)
- Software/codes (commercial or custom)
The Berkeley Lab Export Control Manual should be consulted for general export control requirements. This section of the Biosafety Manual only outlines U.S.-based regulatory restrictions and lists related to the export of biological materials.
Depending on the nature of the biological material, there may be restrictions or U.S. export permits required for the transfer of material to foreign countries. The country to which the material is being transferred may also require an import permit. If the material requires an export permit, the permit must be obtained from the appropriate government agency prior to transfer or shipment.
When leaving the U.S., travelers may be questioned or packages may be opened and inspected by any inspection service provided by other countries. The person exporting the material should therefore:
- Obtain an export permit from the appropriate government organization prior to shipment, if required
- Package and label the material according to permit and shipping requirements
- Consider including a courtesy letter (e.g., a letter that describes the contents in detail and any hazards, concerns, permit requirements or lack thereof) with the shipment
Several agencies and export control lists outlined in the next sections are involved in controlling exports of biological agents that may be used as biological weapons. Since LBNL is not a Department of Energy (DOE) Defense Programs laboratory, the export controls of most relevance at LBNL are those administered by the Department of Commerce, Bureau of Industry and Security, under the Commerce Control List (see Section I.3.1 of this program).
I.3.1 Commerce Control List
The Department of Commerce controls the export of all goods, technologies, and software not regulated by another government agency. Because LBNL is not a DOE Defense Programs laboratory, the most relevant export controls are those administered by the Department of Commerce – Bureau of Industry and Security (BIS), which maintains the Export Administration Regulations (EAR) Database. An important component of EAR is the Commerce Control List (CCL), a section of the regulations that lists specific goods, technologies, and software, the countries to which those items may or may not be exported, and any special restrictions or exceptions that may apply.
A permit may be required from the Commerce Department when exporting biological agents such as human, animal, and plant pathogens or toxins; genetic elements and genetically modified organisms; and products that might be used for culturing large amounts of agents. See Table I-2 for an example list of biological agents on the CCL. Consult the most recent online list in CCL Supplement No. 1 to Part 774 Category 1. Consult the BIS CCL Web site and Berkeley Lab Export Control Manual for additional information.
Table I-2. Commerce Control List of Biological Agents
Human Pathogens and Toxins |
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Bacteria
Viruses
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Viruses (contined)
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Table I-2. Commerce Control List of Biological Agents (Continued)
Human Pathogens and Toxins |
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Fungi
Toxins
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Toxins (continued)
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Animal Pathogens and Toxins |
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Bacteria
Viruses
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Viruses (continued)
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Table I-2. Commerce Control List of Biological Agents (Continued)
Plant Pathogens |
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Bacteria
Viruses
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Fungi
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Table I-2. Commerce Control List of Biological Agents* (Continued)
Genetic Elements and Genetically Modified Organisms |
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Technical Notes:
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Technical Notes (continued):
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Note: Table is current as of July 2013. Source: adapted from CCL Supplement No. 1 to Part 774 Category 1, pages 58 to 63 (July 16, 2013); and UNH Shipment of Biological Materials Manual (March 30, 2007). |
I.3.2 U.S. Munitions List
It is unlikely that agents and substances on this munitions list would be used or exported from LBNL, but this section is provided so that personnel can understand what is covered by this list. The U.S. Department of State controls the export of "defense articles and defense services" under the International Traffic in Arms Regulations (ITAR). Items in this category to be export-controlled are placed on the U.S. Munitions List (USML), a section of ITAR (Part 121) maintained by the U.S. State Department in conjunction with the U.S. Department of Defense.
The USML contains many categories of articles, including Category XIV (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment). Section (b) of this USML category states that biological materials include “Biological agents and biologically derived substances specifically developed, configured, adapted, or modified for the purpose of increasing their capability to produce casualties in humans or livestock, degrade equipment, or damage crops.” Such agents and substances are not typically used at LBNL, but the export of any item on the USML requires an export license issued by the U.S. State Department. Exports of all other products not covered by the USML are subject to the export jurisdiction of the U.S. Department of Commerce, BIS, as discussed in Section I.3.1 of this program.
I.3.3 Biological Weapons Convention Lists
The Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, commonly known as the Biological Weapons Convention (BWC), has been in force since 1975. The BWC is the first multilateral disarmament treaty banning an entire category of weapons. It effectively prohibits the development, production, acquisition, transfer, retention, stockpiling, and use of biological and toxin weapons. The BWC is also a key element in the international community’s efforts to address the proliferation of weapons of mass destruction. The U.S. and other countries participating in the Australia Group (AG)are States Parties to the BWC. The AG is an informal forum of countries that, through the harmonization of export controls, seeks to ensure that exports do not contribute to the development of chemical or biological weapons.
The AG maintains the following Common Control Lists of equipment and agents that require export control:
- Chemical weapons precursors
- Dual-use chemical manufacturing facilities and equipment and related technology and software
- Dual-use biological equipment and related technology and software
- Biological agents
- Plant pathogens
- Animal pathogens
U.S. export permits or licenses are not directly regulated by the AG nor covered by the BWC lists, since the BWC lists are related to international treaty and are not derived from U.S. regulations. It appears to the author of this section of the ESH Manual Biosafety Program that the Department of Commerce BIS and U.S. Department of State are the U.S. agencies that have primary responsibility for enforcing U.S. exports related to the BWC. Section I.3.1 and Section I.3.2 above should therefore be used to determine U.S. regulatory requirements related to the BWC lists.
The Core List of agents on the AG Common Control List appears to be the same or very similar to the agents on the BIS CCL presented above in Table I-2. Therefore, the Core List of agents on the BWC list is not relisted in this section of the Biosafety Program. However, the AG Common Control Lists also include a few additional agents that are not on the Core List. These additional agents are listed in Table I-3. It is not clear to the LBNL Biosafety Office, the author of this section, how or if these additional agents are regulated for U.S. export control.
Table I-3. BWC Agents Not On the Commerce Control List
Plant Pathogens – Items for Inclusion in Awareness-Raising Guidelines |
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Bacteria
Viruses
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Fungi
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Warning List 1 |
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Bacteria
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Fungi
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Note: Table is current as of July 2013. Source: The AG Common Control List of biological agents (March 2013), animal pathogens (July 2013), and plant pathogens (June 2012).
Table Footnotes: 1 Biological agents are controlled when they are an isolated live culture of a pathogen agent, a preparation of a toxin that has been isolated or extracted from any source, or material including living material that has been deliberately inoculated or contaminated with the agent. Isolated live cultures of a pathogen agent include live cultures in dormant form or in dried preparations, whether the agent is natural, enhanced, or modified. An agent is covered by this list except when it is in the form of a vaccine. A vaccine is a medicinal product in a pharmaceutical formulation licensed by, or having marketing or clinical trial authorization from, the regulatory authorities of either the country of manufacture or of use, which is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered. 2 AG recognizes that this organism is ubiquitous. However, since it has been acquired in the past as part of biological warfare programs, it is worthy of special caution. 3 It is the intent of Australia Group members to add to the control list strains of species of Clostridium identified as producing botulinum neurotoxin. |
I.4 References
- Berkeley Lab Export Control Manual
- Commerce Control List, Supplement No. 1 to Part 774 Category 1
- DOE Guidelines on Export Control and Nonproliferation, July 1999
- UNH Shipment of Biological Materials Manual, University of New Hampshire, updated March 30, 2007
- Web sites and Wikipedia articles of referenced government agencies and topics, accessed April 2010
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