Difference between revisions of "Permitting"

Latest revision as of 18:10, 8 April 2022

Statement of Purpose

This page is for information on scientific permitting, as well as revenant laws and regulations, associated with the collection, transport, and use of natural history specimens.

Contributors

Major editor: Breda Zimkus. An outline for this content was first generated during The American Society of Ichthyologists and Herpetologists (ASIH) Annual Joint Meeting - 2016, during an iDigBio sponsored workshop with contributions from the following individuals participating in the "Field to Database" Group: Cesar Aguilar, Ben Frable, Meredith Mahoney, Zachary Randall, David Wernecke, and Breda Zimkus. The Categories of Legal/Compliance Documentation was first generated by GGBN with a number of additions made by participants of a BCoN-funded workshop "Addressing Legal Issues Involved in Digitized Collections: The Nagoya Protocol as a Test Case" (NSF grant DBI #1441785) held at Harvard University in March 2018.

Introduction

Proper planning for collection of natural history specimens includes researching the permits needed to conduct research, collect, export and import scientific specimens in the specific country. The process of applying for and receiving permission to conduct research and collect specimens may take months or more. Requirements vary greatly from country to country, and project proposals or permit applications may be needed in the local language. In addition to national permits, additional permission and documentation may be needed to research and/or collect particular species or in specific regions (i.e., protected lands). See Field Preparation for additional information regarding how to prepare for fieldwork that includes collecting specimens. Natural history museums should track all legal and compliance documentation (e.g., agreements, certificates, permits) associated with the specimens and may need to obtain additional documentation to transport, export, or re-import specimens as loans, gifts, or exchanges.

Many countries have national legislation and regulations in regard to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. The Nagoya Protocol establishes a legal framework for access to genetic resources (any biological material of plant, animal, microbial or other origin ‘containing functional units of heredity’, which includes specimens and their derivatives) and benefit-sharing (ABS): it requires countries to clarify access procedures, to share benefits that arise from utilization of genetic resources, and to ensure that users comply with provider country ABS laws. Users or collectors of biological material may be required to obtain:

1. Obtain Prior Informed Consent (PIC) from the country providing the resource (the country of origin) regarding their proposed utilization of the genetic resources. PIC may be part of a National Permit (e.g., collection permit) or included in another agreement.
2. Establish Mutually Agreed Terms (MAT) between provider and user, including terms for sharing benefits arising from the utilization (if national access laws call for MAT to be established). MAT may be part of a National Permit (e.g., collection permit) or included in another agreement.

For more detailed information, see Access and Benefit-Sharing (Nagoya Protocol and the CBD) and consult the Access and Benefit-sharing Clearing-House (ABSCH), a web-based platform for information exchange associated with the implementation of the Nagoya Protocol.

Permitting Checklist for Researchers

When Preparing for a Collection Trip

• Ensure that all animal protocols have been approved by institutional authorities (e.g., IACUC, IRB). See Ethical Collection.
• Consult the Access and Benefit-Sharing Clearing House to determine if information is available regarding Prior Informed Consent and Mutually Agreed Terms for the specific country. See Access and Benefit-Sharing (Nagoya Protocol and the CBD).
• Determine if a Memorandum of Cooperation/Understanding (MOU, MOC) or Material Transfer Agreement (MTA) is required between an in-country organization (e.g., local collaborating institution) and your home institution.
• Apply for permits needed to conduct research and collect specimens in the country, state/region, or protected area. See Collecting Permit or Research Permit.
• Determine if any species require additional permits for species protected by an International Agreement or Federal Laws.
• Contact Collection Managers at the museums where the specimens/samples will be accessioned to determine if any additional documentation is needed (e.g., Transfer of Ownership ).

While on a Collection Trip

• Obtain original copies of all required permits (e.g., Collecting Permit, Export Permit, Research Permit) and make multiple copies of each
• Have private landowners sign a Landowner's Permission to Collect letter that demonstrates permission to conduct research and collection activities, remove material or parts, and transfer the ownership of the collected material in perpetuity
• Submit import forms (e.g., U.S. Fish & Wildlife Service 3-177) for clearance before shipment or transport of specimens in checked baggage if required by importing country
• Schedule wildlife inspections at first port of entry (e.g., airport) if required by importing country
• Pack specimens according to institutional EH&S classification; use correct packing instructions, label based on classification, and document properly; retain waybills if needed for import

After the Conclusion of a Collecting Trip

• Transfer specimens/samples to museum with copies of all permits and any additional legal or compliance documentation

Tracking Permits Associated with Specimens

A museum specimen is part of many activities that begin from the point of being acquired/collected in the wild, and is continuous throughout the research life cycle of that specimen. From a museum’s perspective of responsibility, this research life exists for as long as the specimen can be utilized, which is assumed to be in perpetuity. All activities involving that specimen (documented as transactions for research, exhibition and teaching) comprise legal compliance issues that include permits, permissions, certificates and agreements required to allow those activities. Implementation of the Nagoya Protocol requires museums to take on new responsibilities associated with tracking and implementing current and historical regulations associated with the acquisition and/or subsequent activities associated with specimens. Museums should consider finding digital solutions for tracking permits and other documentation for easy retrieval in addition to physical documentation, including:

• Keeping digital records of all compliance documentation (e.g., permits, certificates, agreements)
• Keeping digital records of all transactions (e.g., accessions, loans, borrows, gifts, exchanges)
• Keeping digital records of byproducts of use (e.g., publications, sequence accessions)

Categories of Legal/Compliance Documentation

The Categories of Legal/Compliance Documentation was first generated by GGBN with definitions and additions made by participants of a BCoN-funded workshop "Addressing Legal Issues Involved in Digitized Collections: The Nagoya Protocol as a Test Case" (NSF grant DBI #1441785) held at Harvard University in March 2018. Click on individual categories to obtain more information.

• Access and Benefit-Sharing Agreement: serves as evidence that a genetic resource has been accessed in accordance with Prior Informed Consent and that Mutually Agreed Terms have been established
• Authorization to Possess: authorization to possess specimens under certain conditions
• Collecting Permit: authorizes the collection of specimens; note: salvage may be included or may require a specialized permit
• Contract: formal and legally binding agreement between parties
• CITES: allows for the handling of specimens that are included on the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) list
• Copyright: provides the creator of an original work exclusive rights, usually for a limited time
• Data Use: used for the transfer of non-public data that is subject to some restrictions on its use
• Exemption Permit: authorizes that an action does not require specific permits or documentation
• Export Permit: authorizes exporting specimens abroad
• Ethical Collection: approved protocols associated with the research that includes vertebrate animals (e.g., IACUC) and human subjects (e.g., IRB)
• Genetically Modified Organism: indicates that specimens are (or are not) genetically engineered; may include specific indication and/or authorization to release
• Hunt/Fish/Trap License: license to hunt, fish, or trap animals, usually recreational but can be required for collecting
• Human Pathogens: indicates that specimens are in accordance with any domestic regulations regarding human pathogens
• Import Permit: authorizes importing specimens into a country from abroad
• Intellectual Property Rights: rights given to persons over the creations of their minds
• Material Transfer Agreement: governs the transfer of tangible materials between two organizations
• Memorandum of Cooperation: outlines the terms and details of cooperation between parties
• Memorandum of Understanding: outlines the terms and details of an understanding between parties
• Patent: right granted to an inventor
• Phytosanitary: indicates that plant and plant products are free from regulated pests
• Quarantine Agreement: agreement that establishes quarantine requirements
• Receiving Permit: authorization to receive specimen under certain conditions
• Research Permit : authorizes researcher to engage in scientific activity; may specify type of activity or place that it will occur
• Salvage Permit: authorizes the collection of dead animals or animal parts from the wild
• Transport Permit: authorizes the transfer of specimens within a given country
• Veterinary Certificate: indicates that specimens are in accordance with any domestic regulations regarding animal health

Access and Benefit-Sharing Agreement

Under the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, Parties are to issue a permit or its equivalent at the time of access as evidence that access to genetic resources was based on Prior Informed Consent (PIC) and that Mutually Agreed Terms (MAT) were established. Parties are required by the Nagoya Protocol to make information on the permit or its equivalent, available to the ABS Clearing-House for the constitution of an Internationally Recognized Certificate of Compliance (IRCC). For more detailed information, see Access and Benefit-Sharing (Nagoya Protocol and the CBD).

Authorization to Possess

In some cases, specific documentation may be needed to certify that permission has been given to possess specimens under certain conditions. For example, museums may receive permission to accession material that has been confiscated from wildlife agencies.

Collecting Permit

Various types permits legally allow a researcher to collect possess specimens from the wild. Most institutions require copies of collection permits as evidence that all specimens were obtained legally. Permits may be issued at the federal, state, or local level (e.g., indigenous lands and peoples); depending on the country and region, multiple permits may be needed. Most permits specify the taxon/taxa and number that may be collected. Specific activities may be stipulated via the permit type (e.g., collection, capture, salvage, incidental take). Similar permits may also be needed to handle animals, even if the specimens are not collected. See also, Scientific Collecting Licenses. Note: a specific permit may be needed to salvage specimen (see also Salvage Permits (US)), or collecting permits may not be issued, and rather a Hunt/Fish/Trap License obtained (see below).

Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)

International agreements may regulate the transport of particular specimens, and specific permits may be required to collect, import, or export specimens. The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) is an international agreement between governments. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival. CITES works by subjecting international trade in specimens of selected species to certain controls. All import, export, re-export and introduction from the sea of species covered by the Convention has to be authorized through a licensing system. Each Party to the Convention must designate one or more Management Authorities in charge of administering that licensing system and one or more Scientific Authorities to advise them on the effects of trade on the status of the species. The species covered by CITES are listed in three Appendices, according to the degree of protection they need. (For additional information on the number and type of species covered by the Convention, see [How CITES Works].)

Certificate of Scientific Exchange (COSE)

A Certificate of Scientific Exchange (COSE) authorizes the non-commercial loan, donation or exchange of CITES-listed specimens (i.e., preserved, dried or embedded specimens, herbarium specimens, live plant material) between scientists or scientific institutions. Registered scientific institutions can be found on the CITES website. If specimens are protected by other U.S. laws and/or treaties, you are required to obtain additional authorizations prior to any export or re-import of those specimens. Note: a COSE cannot be used with specimens collected by field researchers unless such specimens are first accessioned into the collection of a registered facility in the state of origin. For the import or export of specimens that are not part of your museum collection, have not yet been collected, or accessioned into your collect, a separate CITES collection permit is likely needed.

Contract

Museum acquisitions can occur through collection, purchases, donations, and bequests, as well as transfer or exchange of objects from individuals, private companies, other museums, or research institutions outside the Museum. Museums should track any contracts associated with the collection or transfer of ownership of specimens.

Landowner's Permission to Collect

It is best practice to obtain a signed document that indicates that a researcher has authorization to enter the property and remove specimens. This contract should include:

• Name of researcher with full contact information
• Name of landowner with full contact information
• Property address
• Activities to be conducted
• Transfer of ownership of material collected
• Signature of researcher with date signed
• Signature of landowner with date signed

Transfer of Ownership

Museums should document the transfer of ownership of specimens using either a Deed of Gift or Deed of Transfer form. Details regarding the type of information that should be included in each form can be found below.

Deed of Gift

• Name of donor with full contact information
• Name of museum with full contact information
• Description of materials offered
• Statement that the donor owns the objects and has the authority to gift
• Statement that the gift is without restrictions, or specific restrictions
• Statement that the donor relinquishes all rights he/she may have had
• Signature of donor with date signed
• Signature of museum representative with date signed

Deed of Transfer

• Name of originating museum with contact information
• Name of accessioning museum with contact information; if printed on the museum’s letterhead, this information will already be on the form and doesn’t need to be duplicated
• Description of materials offered
• Statement that donor institution owns the object and has authority to transfer
• Statement that the gift is without restrictions (or exactly what the restrictions are) and that donor institution relinquishes all rights it may have had
• Signature of donor institution representative with date signed
• Signature of receiving museum representative with date signed

Data Use

A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed by nonprofit, government or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use. A DUA us similar to a confidentiality agreement in that it restricts the use and disclosure of the data set. Institutions will want to ensure that DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with institutional policies, applicable laws and regulations, and federal requirements.

Exemption Permit

An exemption permit or certificate authorizes documents that specimens, products, or derivatives, or the particular actions taken to acquire the specimens are exempt from the normal procedures (e.g., do not require legal documentation normally required). For example, permitting exemptions may be made if specimens are:

• In transit
• Collected prior to a specific date associated with the ratification or implementation of a law or regulation
• Captive-bred or artificially propagated

Export Permit

Permission to remove specimens from their country of origin is generally obtained with an export permit. Most export documentation requires a list of the species (scientific and possibly common names) and the total number of specimens per species. For details about exports from the U.S., see U.S. Fish & Wildlife Service (USFWS). Note: some protected or regulated species may require additional export permits; consult U.S. Agencies Regulating Import, Export, and Transport and U.S. Conservation Laws and Protected Species for more information.

Ethical Collection

Studies involving animals or human subjects should be conducted according to internationally-accepted standards. Prior approval or research protocols must be obtained if research involves vertebrate animals (e.g., IACUC) or human subjects (e.g., IRB). Note: journals are increasingly requiring that the name of the relevant ethics committees, as well as relevant permit numbers, must be provided at submission; therefore, this information has become important for museums to track.

Institutional Animal Care and Use Committee (IACUC)

Scientific procedures carried out on animals should minimize adverse effects and maximize the scientific benefit gained. These legal and ethical requirement are included under the laws and regulations of numerous countries worldwide, including the U.S. Animal Welfare Act (United States Code, Title 7, Chapter 54, Sections 2131-2159), the U.K. Animals (Scientific Procedures) Act 1986, the U.K. Animal Welfare Act 2006, the Animal Health and Welfare Strategy for Great Britain, Animal Welfare Strategy, Canadian Council on Animal Care in Science, among others. Researchers should be aware of laws and regulations associated with their home country and possibly the country of origin of the specimens collected.

Within the U.S., Institutional Animal Care and Use Committees (IACUCs) ensure that all projects involving the use of live vertebrates animals comply with federal regulations and guidelines. An institutional animal care and use committee (IACUC) is required by federal regulations for most institutions that use animals in research, teaching, and testing. The IACUC has a key oversight role, including the review and approval of animal use activities, and inspection of animal facilities. Federal regulations and guidelines dealing with animal welfare focus mainly on biomedical and behavioral research, teaching, and testing that takes place in the laboratory. The U.S. Department of Agriculture (USDA) Animal Welfare Act (AWA) regulations exempt field study ("any study done on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals") from IACUC review. However, if the animals are confined, an invasive procedure is involved, or the behavior of the animal is harmed or materially altered, then the study must comply with federal regulations and standards. Since field studies often cannot satisfy the USDA definition, and the IACUC is also answerable to Public Health Service (PHS) Guidelines, researchers should have protocols reviewed by Institutional Animal Care and Use Committees (IACUCs) before specimens are collected. In addition, some funding agencies may require proposed projects involving use of any vertebrate animal for research or education be approved by the submitting organization's Institutional Animal Care and Use Committee (IACUC) before an award can be made.

IACUC review of such studies would be necessary and would focus on, but not necessarily be restricted to, such issues as:

1. Number of animals to be used in the study, and the stability of the population from which the animals are to be taken
2. Appropriateness of the methods used for capturing, immobilizing, and euthanizing animals
3. Training and supervision of the personnel involved with the study

Institutional Review Board (IRB)

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established National, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.

Genetically Modified Organism

Import, export, or transport of Genetically Modified Organisms is often highly regulated and may require specialized permits, documentation or package labeling.

Human Pathogens

Documentation may be required to certify that specimens are in accordance with any domestic regulations regarding human pathogens.

Hunt/Fish/Trap License

In lieu of a Collecting Permit, a license to hunt, fish, or trap animals may be issued for the collection of specimens if a permit to collect scientific specimens is not needed or available. Consult the regional or local authorities to determine wither this type of license or a permit that authorize species-specific or research-related activities is needed.

Import Permit

Permission to import specimens into a country from abroad is generally required. Most import documentation requires a list of the species (scientific and possibly common names) and the total number of specimens per species. For details about imports into the U.S., see U.S. Fish & Wildlife Service (USFWS). Note: some protected or regulated species may require additional import permits; consult U.S. Agencies Regulating Import, Export, and Transport and U.S. Conservation Laws and Protected Species for more information.

Intellectual Property Rights

Intellectual property (IP) is a category of property that includes intangible creations of the human intellect, and primarily encompasses copyrights, patents, and trademarks. It also includes other types of rights, such as trade secrets, publicity rights, moral rights, and rights against unfair competition. Artistic works like music and literature, as well as some discoveries, inventions, words, phrases, symbols, and designs, can all be protected as intellectual property. In addition, plant variety rights are the rights to commercially use a new variety of a plant. The variety must amongst others be novel and distinct and for registration the evaluation of propagating material of the variety is considered.

Copyright

A number of documents associated with copyright may be tracked by museums, including:

• Copyright License: allows creators to designate whether the copy, distribution, and editing of their work is allowed; see Creative Commons copyright licenses for more information
• Transfer of Copyright: a legal document containing provisions for the conveyance of full or partial copyright from the rights owner to another party.
• Public Domain Dedication: allows for unrestricted used of a work that is in the public domain; Creative Commons public domain tools allows copyright holders to place works in the public domain using CC0 (occasionally written as CC Zero).

Patent

A patent is a form of right granted by the government to an inventor, giving the owner the right to exclude others from making, using, selling, offering to sell, and importing an invention for a limited period of time, in exchange for the public disclosure of the invention. An invention is a solution to a specific technological problem, which may be a product or a process and generally has to fulfill three main requirements: it has to be new, not obvious and there needs to be an industrial applicability.

Material Transfer Agreement

A Material Transfer Agreement (MTA) is a contract that governs the transfer of research materials between two institutions. Some countries may require that researcher's enter into cooperation with a local institution and sign an MTA to specify the rights, obligations, and restrictions of both the providing and receiving parties with respect to issues such as ownership, publication, intellectual property and permitted use and liability. To encourage the process of sharing research tools between scientists, the National Institutes of Health and the Association of University Technology Managers developed standard language to simplify material transfers, issued as the Uniform Biological Material Transfer Agreement (UBMTA).

Memorandum of Cooperation/Understanding

When two or more parties wish to engage in a collaborative effort in research, education or other activities, a Memoranda of Understanding (MOU) or Memoranda of Cooperation (MOC) may be needed. MOUs are legal agreements defining the roles and responsibilities. MoUs generally do not include terms and conditions for funding, exchange of materials, non-disclosure of proprietary information, licensing or future licensing of intellectual property, or specific research activities. MoUs may, however, describe how agreements for such activities will be negotiated and establish a timeline for doing so. Some countries may require collaboration with a local institutions or the inclusion of a local researcher on the project or collection team. Specific agreements between institutions may be required before collection permits are issued. Note: institutions may have a designated representative to sign such agreements.

Phytosanitary

Phytosanitary certificates are issued to indicate that consignments of plants, plant products or other regulated articles meet specified phytosanitary import requirements, and most often indicate that plant and/or plant products are free from regulated pests.

Quarantine Agreement

The main purpose of animal quarantine inspection certificate is to prevent the ingress of dangerous exotic diseases into the country through imported animals and animal products.

Receiving Permit

A receiving permit authorizes the acceptance of specimens under certain conditions. For example, a "Permit to Receive Soil" issued by the USDA APHIS may authorize the importation of soil from foreign sources (except countries with sanctions or embargoes by U.S. State Department), and interstate/ domestic movement of soil for chemical/ physical analysis in a controlled laboratory environment at the named facility on the permit.

Research Permit

Research permits may be required to engage in scientific activity; permits may specify the type of activity or place that it will occur. Permits may be required to conduct research in specific areas (e.g., protected lands). Privately owned land trusts and preserves (e.g., The Nature Conservancy, Audubon Society) also act as independent preserves and may have an independent process for obtaining permits.

• Federally Protected Lands

- National Forests

- National Monuments and Recreation Areas

- National Parks

- National Wildlife Refuge

• State Protected Lands

- Nature Preserves

- State Parks

Salvage Permit

A salvage permit may be needed specifically for the possession, transport, or receipt of dead animals or animal parts from the wild. Note: a specialized salvage permit may also be needed to possess wildlife killed in a vehicular collision. See also, Salvage Permits (US).

Transport Permit

Permits may be required to transport specimens across state boundaries within a given country. Note: some protected or regulated species may require specific transport permits; consult U.S. Agencies Regulating Import, Export, and Transport and U.S. Conservation Laws and Protected Species for more information.

Veterinary Certificate

Certificates of Veterinary Inspection (also referred to as Official Health Certificates or Health Certificates) may be required before import or transport to certify that specimens are in accordance with any domestic regulations regarding animal health.

U.S. Agencies Regulating Import, Export, and Transport

Import, interstate movement, and export of infectious agents and/or biological materials that are suspected to contain such agents, are tightly regulated by Federal agencies and may require permits. These permits minimize the risk of inadvertent release and inappropriate use of such materials. Compliance with multiple regulatory agencies may be required in some cases, depending on the nature of the material to be transported, the point of origin, etc.

U.S. Fish & Wildlife Service (USFWS)

All importation and exportation of specimens and associated products into and out of the United States must be done via a U.S. Fish and Wildlife Service Designated Port using the U.S. Fish & Wildlife Declaration for Importation or Exportation of Fish and Wildlife (3-177). Declarations can be submitted online via the Electronic Declarations (eDecs) webpage. You may import or export your shipment at an authorized border port only if the wildlife itself originally comes from the United States, Canada, or Mexico, and your shipment is being sent from and going to one of these countries. Under very limited circumstances, you may be authorized under permit to use a port that does not normally handle wildlife trade. You must show that using one of our authorized ports would result in substantial deterioration or loss of the wildlife, or would cause an undue economic hardship. Final approval to use a non-authorized port depends on the availability of inspection services.

Live oysters, clams, mussels, and scallops, and their eggs, larvae, or juvenile forms that are exported for propagation or research related to propagation are exempt from declaration requirements, provided they do not require a permit under 50 CFR 17 (endangered and threatened species) or 23 (CITES-protected species). You do not have to declare exports of live farm-raised fish eggs or live farm-raised fish unless they require a permit under 50 CFR 17 or 23.

For additional information regarding filing instructions, see U .S. Fish & Wildlife Declaration for Importation or Exportation of Fish and Wildlife (3-177).

Injurious Wildlife

The U.S. Fish & Wildlife Office of Law Enforcement is responsible for enforcing the injurious wildlife provisions of the Lacey Act. This law authorizes the Secretary of the Interior to list as “injurious” any wildlife deemed to be harmful “to human beings, to the interests of agriculture, horticulture, forestry, or to wildlife or the wildlife resources of the United States” and prohibits import and interstate transport of any live specimen of a listed species without a permit. Permits may be granted by the U.S. Fish and Wildlife Service for the importation or shipment of specimens of injurious wildlife and their offspring or eggs for scientific, medical, educational, or zoological purposes. For more information regarding species currently listed as Injurious, including freshwater species, salamanders and constrictor snakes, see U.S. Fish & Wildlife Office of Law Enforcement. See the permit application form for import of injurious wildlife or interstate shipment between the jurisdictions.

Centers for Disease Control and Prevention (CDC)

CDC Import Permit regulations regulate the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States.

A CDC Etiologic Agent Import permit is required prior to importing the following into the U.S.:

• Infectious biological agent (e.g., bacteria, viruses, fungi, prion, etc.)
• Infectious substance or any material that may potentially contain an infectious biological agent
• Vector – Any arthropod or other animal host or vector of human diseases, or any non-infectious self-replicating system capable of transferring an infectious biological agent to a human
• Arthropods, Snails, Bats
• Non-human primate material (all non-human primate material, unless it has been specifically treated and rendered non-infectious, in which case documentation of the treatment method may need to be provided)

The Division of Global Migration and Quarantine (DGMQ) handles importation of all viverrid species (civets and relatives) and African rodents. An authorization letter is needed to import materials of this nature.

U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS)

USDA APHIS issues permits to ensure the safe import and transport of materials containing plant or animal material that may potentially harm U.S. agricultural products including livestock, poultry and crops. These permits outline the controls necessary for the import, export, interstate transport and release of these regulated products. The Veterinary Services branch of USDA APHIS issues the Veterinary Services (VS) Import, Export or Transport permits and the Plant Protection and Quarantine (PPQ) branch of APHIS issues PPQ permits. APHIS also regulates the movement of certain genetically engineered organisms through its Biotechnology Regulatory Services (BRS).

USDA import permits are required for organisms that can cause disease in livestock/poultry or vectors carrying pathogens:

• Birds: from specific countries (associated with END and HPAI)
• Mammals: bovine, equine, swine, primates
• Bees
• Live Plant Pests, Noxious Weeds and Soil
• Restricted or Not Authorized Plant Material‬ (requiring Controlled Import Permit)

U.S. Conservation Laws and Protected Species

A list of U.S. federally protected species are included on The Environmental Conservation Online System (ECOS), a gateway web site that provides access to data systems in the U.S. Fish and Wildlife Service. Many states also have additional state protected species that are illegal to collect; each state’s wildlife department likely has a list that should be checked before collecting.

Endangered Species Act (ESA)

The purpose of the ESA is to protect and recover imperiled species and the ecosystems upon which they depend. It is administered by the U.S. Fish and Wildlife Service and the Commerce Department’s National Marine Fisheries Service (NMFS). The FWS has primary responsibility for terrestrial and freshwater organisms, while the responsibilities of NMFS are mainly marine wildlife. Under the ESA, species may be listed as either endangered or threatened. “Endangered” means a species is in danger of extinction throughout all or a significant portion of its range. “Threatened” means a species is likely to become endangered within the foreseeable future. All species of plants and animals, except pest insects, are eligible for listing as endangered or threatened. For the purposes of the ESA, Congress defined species to include subspecies, varieties, and, for vertebrates, distinct population segments. You can search for listed species on the [| U.S. Fish & Wildlife Endangered Species List] and find out more information about permits on the [| U.S. Fish & Wildlife ESA Permits Page].

Bald & Golden Eagle Protection Act

The Bald and Golden Eagle Protection Act (16 U.S.C. 668-668c)] prohibits anyone, without a permit issued by the Secretary of the Interior, from "taking" bald eagles, including their parts, nests, or eggs. The Act provides criminal penalties for persons who "take, possess, sell, purchase, barter, offer to sell, purchase or barter, transport, export or import, at any time or any manner, any bald eagle ... [or any golden eagle], alive or dead, or any part, nest, or egg thereof." The Act defines "take" as "pursue, shoot, shoot at, poison, wound, kill, capture, trap, collect, molest or disturb." Associated Bald and Golden Eagle Act Permits can be found on the [U.S. Fish & Wildlife] website.

Migratory Bird Treaty Act

[The Migratory Bird Treaty Act (MBTA)] makes it illegal for anyone to take, possess, import, export, transport, sell, purchase, barter, or offer for sale, purchase, or barter, any migratory bird, or the parts, nests, or eggs of such a bird except under the terms of a valid permit. The migratory bird species protected by the Act can be found on the [Migratory Bird Treaty Act Protected Species (10.13 List)]. See also USFWS Federal Migratory Bird Special Purpose Salvage Permits.

Marine Mammal Protection Act (MMPA)

The Marine Mammal Protection Act (MMPA) prohibits, with certain exceptions, harassing, hunting, capturing, or killing, or attempting to harass, hunt, capture, or kill any marine mammal in U.S. waters and by U.S. citizens on the high seas, and the importation of marine mammals and marine mammal products into the U.S.

Jurisdiction for MMPA is shared by U.S. Fish and Wildlife Service (Service) and the National Marine Fisheries Service (NMFS), and the U.S. Fish and Wildlife Service is responsible for issuing permits when exceptions are made to MMPA. In general, exceptions may be made for:

• Pre-MMPA specimens taken before December 21, 1972
• International Agreements entered into by the United States before December 21, 1972
• Alaska natives
• Scientific research, public display, enhancing the survival or recovery of a species, and incidental take in commercial fisheries
• Waivers granted by the U.S. Government

The Lacey Act

The Lacey Act [1] regulates the trade of wildlife and plants and creates penalties for a broad spectrum of violations. Under the Lacey Act, it is unlawful to import, export, sell, acquire, or purchase fish, wildlife or plants that are taken, possessed, transported, or sold: 1) in violation of U.S. or Indian law, or 2) in interstate or foreign commerce involving any fish, wildlife, or plants taken possessed or sold in violation of State or foreign law. The law covers all fish and wildlife and their parts or products, plants protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and those protected by State law. When the Lacey Act was passed in 1900, it became the first federal law protecting wildlife. It enforces civil and criminal penalties for the illegal trade of animals and plants. Today it regulates the import of any species protected by international or domestic law and prevents the spread of invasive, or non-native, species. See information above regarding Injurious Wildlife Provisions of the Lacey Act.

References

1. ↑ Renner, S.C, D. Neumann, M. Burkhart, U. Feir, P. Giere, A. Gröger, A. Paulsch, C. Paulsch, M. Sterz, and K. Vohland. 2012. Import and export of biological samples from tropical countries-considerations and guidelines for research teams. Org Divers Evol 12: 81-98.