Chapter 26

BIOSAFETY

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Appendix I. Import, Export, and Transfer Restrictions

I.1 Introduction and Scope 

                            

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 (biosafety@lbl.gov) 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:

 

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.

 

http://scrapetv.com/News/News%20Pages/usa/Images/department-of-homeland-security-logo.jpg  CDFA Logo   http://upload.wikimedia.org/wikipedia/commons/thumb/a/ac/APHIS.svg/535px-APHIS.svg.png  http://www.sagalradio.org/Images/CDClogo.png  Official Web 
page of the U S Fish and Wildlife Service FDA logo


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:

Text Box:
USDA-APHIS label for shipping soil samples under a soil permit.
Source: Berkeley Lab EHS.

 

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    

 

symbol_biosecurity_low_res_white_backgroundSelect 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        

 

http://www.clker.com/cliparts/b/8/d/3/1195422905133983312leaf_piotr_katarzyna_mor_01.svg.thumb.pngThe 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:

 

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   

http://www.clker.com/cliparts/d/8/9/8/11949852501611787715mucca.svg.hi.pngThe 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:

 

I.2.2.3  APHIS Genetically Engineered Organisms Permits  

 

http://upload.wikimedia.org/wikipedia/commons/9/97/DNA_Double_Helix.pngAPHIS 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.

 

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.

 

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

  • African elephant ivory
  • Animals
  • Artificially propagated plants
  • Asian elephant ivory
  • Biological samples
  • Captive-born export
  • Circuses/traveling animal exhibitions
  • Goldenseal
  • Ginseng
  • Marine mammals
  • Museum specimens
  • Personal pet
  • Plants
  • Raptors
  • Trophies by taxidermist
  • Wildlife

 

  • African elephant
  • African elephant ivory
  • African leopard
  • Argali
  • Asian elephant ivory
  • Biological samples
  • Birds
  • Bontebok
  • Circuses/traveling animal exhibitions
  • Marine mammals
  • Museum specimens
  • Personal pet
  • Plants
  • Polar bears
  • Scientific and zoological breeding or display
  • Sport hunted trophy
  • White rhinoceros
  • Wildlife

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:

 

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:

 

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

 

Bacteria

  • Bacillus anthracis
  • Brucella abortus
  • Brucella melitensis
  • Brucella suis
  • Burkholderia mallei (Pseudomonas mallei)
  • Burkholderia pseudomallei (Pseudomonas pseudomallei)
  • Chlamydophila psittaci (formerly known as Chlamydia psittaci)
  • Clostridium argentinense (formerly known as Clostridium botulinum Type G) botulinum neurotoxin producing strains
  • Clostridium baratii, botulinum neurotoxin producing strains
  • Clostridium botulinum
  • Clostridium butyricum, botulinum neurotoxin producing strains
  • Clostridium perfringens, epsilon toxin producing types
  • Coxiella burnetii
  • Francisella tularensis
  • Rickettsia prowazekii
  • Salmonella typhi
  • Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups.  Note: STEC E. coli is also known as enterohaemorrhagic E. coli (EHEC) or verocytotoxin producing E. coli (VTEC).
  • Shigella dysenteriae
  • Vibrio cholerae
  • Yersinia pestis

 

Viruses

  • Andes virus
  • Chapare virus
  • Chikungunya virus
  • Choclo virus
  • Congo-Crimean haemorrhagic fever virus
  • Dengue fever virus
  • Dobrava-Belgrade virus

 

 

Viruses (contined)

  • Eastern equine encephalitis virus
  • Ebola virus
  • Guanarito virus
  • Hantaan virus
  • Hendra virus (Equine morbillivirus)
  • Japanese encephalitis virus
  • Junin virus
  • Kyasanur Forest virus
  • Laguna Negra virus
  • Lassa fever virus
  • Louping ill virus
  • Lujo virus
  • Lymphocytic choriomeningitis virus
  • Machupo virus
  • Marburg virus
  • Monkey pox virus
  • Murray Valley encephalitis virus
  • Nipah virus
  • Omsk haemorrhagic fever virus
  • Oropouche virus
  • Powassan virus
  • Rift Valley fever virus
  • Rocio virus
  • Sabia virus
  • SARS-associated coronavirus (SARS-CoV)
  • Seoul virus
  • Sin nobre virus
  • St. Louis encephalitis virus
  • Tick-borne encephalitis virus (Far Eastern subtype formerly known as Russian Spring-Summer encephalitis virus, and Siberian subtype formerly known as West Siberian virus)
  • Variola virus
  • Venezuelan equine encephalitis virus
  • Western equine encephalitis virus
  • White pox
  • Yellow fever virus
  • 1918 pandemic influenza virus, reconstructed replication competent forms containing any portion of the coding regions of all eight gene segements.

 

 

Table I-2. Commerce Control List of Biological Agents (Continued)

 

Human Pathogens and Toxins

 

Fungi

  • Coccidioides immitis
  • Coccidioides posadasii

 

Toxins

  • Abrin
  • Aflatoxins
  • Botulinum toxins
  • Cholera toxin
  • Clostridium peifringens toxins
  • Conotoxin
  • Diacetoxyscirpenol toxin
  • HT-2 toxin
  • Microcystin (Cyanginosin)
  • Modeccin toxin

 

 

Toxins (continued)

  • Ricin
  • Saxitoxin
  • Shiga toxin
  • Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphyloccus enterotoxin F)
  • T-2 toxin
  • Tetrodotoxin
  • Verotoxin and other shiga-like ribosome inactivating proteins
  • Viscum Album Lectin 1 (Viscumin)
  • Volkensin toxin

 

Animal Pathogens and Toxins

 

Bacteria

  • Mycoplasma mycoides as: Mycoplasma mycoides subspecies mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia); and Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)

 

Viruses

  • African horse sickness virus
  • African swine fever virus
  • Avian influenza (AI) viruses identified as highly pathogenic (HP) strains - see the EAR CCL
  • Bluetongue virus

 

 

Viruses (continued)

  • Foot and mouth disease virus
  • Goat pox virus
  • Lumpy skin disease virus
  • Lyssa virus (a.k.a Rabies)
  • Newcastle disease virus
  • Peste des petits ruminants virus
  • Porcine enterovirus type 9 (swine vesicular disease virus)
  • Porcine herpes virus (Aujeszky's disease)
  • Rinderpest virus
  • Sheep pox virus
  • Swine fever virus (Hog cholera virus)
  • Teschen disease virus
  • Vesicular stomatitis virus

 

 

Table I-2. Commerce Control List of Biological Agents (Continued)

 

Plant Pathogens

 

Bacteria

  • Xanthomonas aibliineans
  • Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv.citri A) (Xanthomonas campestris pv.citri)
  • Xanthomonas oryzae pv. oryzae (Pseudomonas campestris pv. oryzae)
  • Clavibacter michiganensis subspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
  • Ralstonia solanacearum race 3, biovar 2

 

Viruses

  • Andean potato latent tymovirus
  • Potato spindle tuber viroid

 

 

Fungi

  • Colletotrichum kahawae (Colletotrichum coffeanum var.virulans)
  • Cochliobo!us miyabeanus (Helminthosporium oryzae)
  • Magnaporthe oryzae (pyricularia oryzae)
  • Microcyclus u!ei (Dothidella u!ei)
  • Peronosclerospora philippinesis (Peronosclerospora sacchari)
  • Phoma glycinicola (formerly Pyrencochaeta glycines)
  • Puccinia graminis ssp. graminis var. graminis, Puccinia graminis ssp. graminis var. stakmani, (Puccinia graminis [syn. Puccinia graminis f. sp. tritici])
  • Puccinia striiformis (Puccinia g!umarum)
  • Sclerophthora rayssiae var zeae
  • Synchytrium endobioticum
  • Tilletia indica
  • Thecaphora solani

 

Table I-2. Commerce Control List of Biological Agents* (Continued)

 

Genetic Elements and Genetically Modified Organisms

 

  • Genetic elements that contain nucleic acid sequences associated with the pathogenicity of controlled microorganisms
  • Genetic elements that contain nucleic acid sequences coding for any controlled "toxins" or "sub-units of toxins"
  • Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of controlled microorganisms
  • Genetically modified organisms that contain nucleic acid sequences coding for any controlled “toxins” or “sub-units of toxins”

 

Technical Notes:

  1. Genetic elements include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified or chemically synthesized in whole or in part.
  2. This section does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing strains, except those nucleic acid sequences that contain coding for the verotoxin or its sub-units.

 

 

Technical Notes (continued):

  1. “Nucleic acid sequences associated with the pathogenicity of controlled microorganisms” means any sequence specific to the relevant controlled microorganism that:
    1. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
    2. Is known to enhance the ability of the controlled microorganism, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.
  2. “Genetically modified organisms” include organisms in which the genetic material (nucleic acid sequences) has been altered in a way that does not occur naturally by mating and/or natural recombination, and encompasses those produced artificially in whole or in part.

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:

 

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

 

Bacteria

  • Xylella fastidiosa

 

Viruses

  • Banana bunchy top virus

 

 

Fungi

  • Phoma tracheiphial (Deuterophoma tracheiphila)
  • Moniliophthora rorei (Monilia rorei)

 

Warning List 1

 

Bacteria

  • Clostridium tetani 2
  • Legionella pneumophila
  • Yersinia pseudotuberculosis
  • Other strains of Clostridium species that produce botulinum neurotoxin 3

 

 

Fungi

  • Fusarium sporotrichioides
  • Fusarium langsethiae

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:

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.

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.

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

 

 

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