Permitting

Statement of Purpose

This page is for information on permits that may be needed to collect, import and/or export natural history specimens.

Contributors

Major author/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.

Institutional Animal Care and Use Committee (IACUC) Approval of Field Practices

Institutional Animal Care and Use Committees (IACUCs) ensure that all projects involving the use of live vertebrae 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. The appropriateness of the methods used for capturing, immobilizing, and euthanizing the animals
3. The training and supervision of the personnel involved with the study

http://ori.hhs.gov/education/products/ncstate/iacuc.htm

Access and Benefit-Sharing (Nagoya Protocol and the CBD)

Many countries have national legislation and regulations particularly with 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:

1. Obtain Prior Informed Consent (PIC) from the country providing the resource (the country of origin) regarding their proposed utilization of the genetic resources
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). Such agreements may be part of a National Permit (e.g., collection permit), included in a Material Transfer Agreement, or covered by a Memorandum of Understanding/Cooperation

The Access and Benefit-sharing Clearing-House (ABSCH) is a web-based platform for information exchange associated with the implementation of the Nagoya Protocol. This website should be the first and most relevant point of information when institutions or researchers plan to collect or access specimens or genetic resources or want to look up any country specific information. Data provided in the country profiles ideally include the following information:

• Checkpoints (i.e., national authorities and contacts associated with ABS)
• Competent National Authorities (CNAs; designated bodies responsible for granting access or issuing evidence that access requirements have been met)
• Contact information for National Focal Points (NFPs; designated body responsible for providing information on national legislation, rules, and procedures for access to genetic resources and ATK, and relevant authorities and stakeholders)
• Relevant legislative, administrative, and policy measures (e.g., act, decree, guidelines, regulations, rules associated with ABS)
• National websites or databases (e.g., guidance for foreign users seeking access to genetic resources, national Clearing-House mechanisms)

For more detailed information, see Access and Benefit-Sharing (Nagoya Protocol and the CBD).

Collection Permits

Collection permits legally permit a researcher to possess specimens from the wild. Collection permits may be issued at the federal, state, or local level and generally specify the taxon/taxa and number that may be collected.

Federal Permit

Federal permits to collect and remove animals may be MOU with local collaborators (e.g., university, researcher) may be required before federal permit is issued

Regional, State, Local Permits

(including Indigenous Lands and People, Landowner’s permission to collect, signed landowner permission may be required for some permits) [also, s

• A signed document showing private landowner permission to collect and remove animals may be required before a collection permit can be obtained.
• Note: Some private/indigenous groups stipulate protection of locality information in public databases (Note in Cataloging page).

Harassment Permit

e.g., loud noises, pyrotechnics, propane cannons, scarecrows, dogs, trained raptors)

Landowner's Permission to Collect

A signed document showing private landowner permission to collect and remove animals may be required before a collection permit can be obtained.

Digital/Media Permissions

e.g., photo, video, sound

Genetic Resource Permit

Permission to Take OR Permission to Export

Protected Regions and Species Permits

Protected Area Permit

e.g., National Park

Protected Species Permits

e.g., Threatened and Endangered)- includes collection and exportation?

CITES

(link to CITES page)

Importation Declaration

(link to U.S. 3-177 page)

Exportation Declaration

(link to U.S. 3-177 page) Export documents may require information on final deposition of specimens

Other Agreements

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 Understanding/Cooperation

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.

Permitting and Documentation Checklist

Before Conducting Fieldwork

• Apply for permits needed to conduct research and collect/export specimens in the country, state/region, or protected area
• Determine if any species require additional permits (e.g., CITES, ESA)
• Determine if a Material Transfer Agreement (MTA) is required between an in-country organization (e.g., local collaborating institution) and your home institution
• Ensure that all animal protocols have been approved by institutional authorities (e.g., IACUC)
• Contact Collection Managers at the museums where the specimens/samples will be accessioned to determine if any specific documentation is needed

While In Country

• Obtain original copies of all required permits (e.g., research permit, collecting permit, export permit) and make multiple copies of each
• Have private landowners sign a permission 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 EH&S classification; use correct packing instructions, label based on classification, and document properly; retain waybills if needed for importation

After Conclusion of Fieldwork

• Transfer specimens/samples to museum with copies of all permits and any additional documentation (e.g., deed of transfer, private landowner permission letter)