Information for U.S. Government Funded Researchers Collecting In Situ Genetic Resources Outside the United States

Bureau of Oceans and International Environmental and Scientific Affairs
Washington, DC
November 5, 2003

I. Introduction

In many countries, providers of genetic resources are implementing new rules governing access to such resources and requiring the sharing of monetary and non-monetary benefits derived from those resources. It is important for U.S. researchers to be aware of these new rules when collecting genetic resources in the field (in situ)¹. This document is intended to provide important information about these rules that will help researchers:

• properly navigate the new and often confusing regulatory environment governing the in situ collection of plant, animal and microbial genetic resources in countries outside of the United States;
• promote the conservation of genetic resources and demonstrate respect for local and indigenous cultures, values, legalities and customs; and
• enhance prospects for success in accessing genetic resources and minimize the chances of encountering obstacles and delays.

The U.S. Government wants to help U.S. researchers avoid mistakes in complying with foreign access and benefit-sharing rules, which might lead to embarrassment, disruption of research efforts or, in the worst case, detention.

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¹ These new rules do not generally apply to genetic resources obtained from genebanks or existing collections, which are referred to as ex situ sources. 

II. Background

Until recently, genetic resources in situ were freely available because it was widely considered that they constituted a part of the “common heritage of mankind.” The new rules on access replaced that principle with two others. First, the researcher needs to obtain prior written approval for collecting the genetic resources from the provider. This is commonly referred to as obtaining “prior informed consent.” Second, the researcher and the provider should have an understanding as to what non-monetary benefits the researcher will extend to the provider and how any monetary benefits resulting from the commercialization of a product derived from the genetic resources will be shared. This concept is often called “benefit-sharing based on mutually agreed terms.”

The Convention on Biological Diversity (CBD), which entered into force in 1993, sets as one of its objectives “fairly and equitably sharing benefits deriving from the use of genetic resources.” With regard to prior informed consent, the convention states, “access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.” On benefit-sharing, it calls for parties to “take legislative, administrative or policy measures, as appropriate… with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party.…”

Although the U.S. has not ratified the CBD, most countries around the world are parties and many have implemented, or are working on, national legislation and policies on access and benefit-sharing. In 2002 parties to the CBD adopted as guidance for providers and collectors the voluntary “Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization.” The information below provides practical guidance for the researcher operating in countries that are party to the CBD. The guidance is consistent with best practices under the CBD and the advice in the Bonn Guidelines. (see www.biodiv.org for information on the CBD and list of parties).

III. Prior Informed Consent

Under the CBD provisions for access and benefit sharing, as adopted by many governments, a collector, either directly or indirectly through local partners or advisors, is expected to obtain written prior informed consent to collect genetic resources from the appropriate host country authorities. At a minimum, prior informed consent should be obtained from the agency identified by the “national focal point” or contact person designated by the government. In many instances, the national environmental authorities will play a central role in deciding whether to grant prior informed consent.

The prior informed consent of the national focal point or the agency it designates, by itself, may not be sufficient to authorize access. Additional consent agreements may be needed from other authorities (e.g., state, provincial, local governments, or indigenous communities), non-governmental entities (e.g., land owners) or individuals (e.g., research, including surveys, on human subjects).

In some cases, an U.S. researcher may ask a local partner (a scientist or institution) or agent to obtain all the necessary permits, including the prior informed consent for access to genetic resources. In those cases, the researcher ought to verify that the local partner has contacted in writing the CBD national focal point or the national environmental authorities and complied with the national rules on access and benefit-sharing.

CAUTION:  Local partners or advisors may not be aware of the national focal point for the CBD or of the current rules on access and benefit sharing in their country. In many cases, access rules are new or not yet in place. Due to unfamiliarity with current rules or in the absence of clear rules, local partners may provide a collector with erroneous assurances that all necessary permits on access have been obtained, when this is not the case. A collector should make a good faith effort to verify that the local partner or advisor has contacted the National focal point for CBD or another designated authority to request access. Be prudent and attempt to verify any statement by a local partner that it has the authority to grant access to genetic resources on its own. Permission from Universities or research institutions with which a collector is collaborating may not be sufficient.

Prior informed consent ought to:

a.  Be in writing;

b.  Be sought in advance of beginning collection activities;

c.  Describe, to the extent possible and recognizing there might be unexpected discoveries, the genetic resources sought and their expected use once collected;

d.  List, as far as is known, host, foreign, and U.S. collaborators with whom the genetic resources and associated knowledge will be shared (collectors should consider including host country scientists in the planning process);

e.  Notify the host country of the kind of assistance, if any, that may be requested to carry out the collection activities;

f.  Include a work plan (see Section IV for possible elements of a work plan).

NOTE: National focal points are listed on the CBD web page: http://www.biodiv.org/world/map.asp. For further information contact the CBD Executive Secretariat in Montreal, Canada, the Office of Ecology and Terrestrial Conservation at the U.S. Department of State or the U.S. Embassy located in the host country.

Convention on Biological Diversity
Executive Secretariat
393 rue Saint-Jacques, suite 300
Montréal, Québec, Canada H2Y 1N9
Telephone: +1-514-288-2220
Fax: +1-514-288-6588
E-mail: secretariat@biodiv.org

Office of Ecology and Terrestrial Conservation
U.S. Department of State
2201 C Street NW, Room 4333
OES/ETC – Room 4333
Washington, D.C. 20520
Telephone: +1-202-647-4268
Fax: +1-202-736-7351
E-mail: inforesearch@state.gov

IV. Mutually Agreed Terms

Under CBD provisions for access and benefit sharing, genetic resources should be collected under conditions understood and mutually agreed to by the provider and the collector. The mutually agreed terms should address the sharing of benefits, whether non-monetary or monetary. In some cases a simple permit or document will suffice; in others a more formal contract or material transfer agreement may be required.

The document containing the mutually agreed terms may include some or all aspects of the prior informed consent, and ought, where appropriate, to include:

a.  To the extent known, and recognizing there might be unexpected discoveries, the type and quantity of genetic resources expected to be collected and the geographical/ecological area of activity;

b.  Limitations, if any, imposed by the provider on the possible uses of the genetic resources;

c.  Whether or not the genetic resources can be transferred to third parties and conditions to be imposed in such cases;

d.  Provisions regarding sharing of scientific information and non-monetary benefits arising from the utilization of the genetic resources;

e.  Identification of any capacity building activities to be provided by the collector;

f.  Provisions on the sharing of monetary benefits arising from the utilization of the genetic resources [Note: The parties may agree to monetary benefit sharing terms up front or may decide to negotiate them at a later time when actual benefits are clearer.];

g.  Provisions on claiming intellectual property rights [Note: Providers may request that the collector in an application claiming intellectual property rights disclose the contract under which the genetic resources were provided and/or disclose the source of origin of the genetic resources utilized in the claim.];

h.  A work plan, which may also be included in prior informed consent agreements, should be drafted prior to collection and may include the following sections:

• U.S. Participants;
• Contractors/ host country partners;
• Objectives and justification;
• Methodologies and strategies;
• Dates of collection and itinerary;
• U.S. import requirements (e.g. Animal and Plant Health Inspection Service regulations);
• Benefits to host country;
• Field collection plan (including detailed maps);
• Storage and expected use;
• Dispute resolution.

V. Collection

A U.S. genetic resource collector should be aware that he or she may be viewed by others in the host country as a representative of the United States. The collector should act accordingly and be mindful that his or her actions in foreign countries might affect other U.S. collectors seeking access to genetic resources in the future.

Thus, collectors are encouraged to consider:

a.  Making efforts to collaborate with local counterparts during collection;

b.  Working with minimal quantities of natural materials, and developing sustainable harvesting procedures;

c.  When photographing people or sites, the sensitivities of the human subject or associations with the site;

d.  Preparing documentation on genetic resources collected and, if requested, providing a copy of notes to a host institution; and

e.  Assisting with capacity-building for local people and researchers through education in collecting skills and collaboration on subsequent research projects, and offering to present guest lectures at host institutions.

f.  Being prepared to address widespread confusion about the relationship of basic to potentially commercial research and unrealistic expectations of the probability of commercial returns from research activities.

VI. Importing genetic resources to the U.S.

A. Plants, Plant Materials and Micro-organisms

When planning to ship genetic resources to the United States, collectors should abide by the export laws of the host country and relevant U.S. requirements for importation. Passport information should be provided for the samples collected and may include descriptions of the plant specimen collected, collection location, habitat, description of type of propagule (e.g., seeds, scions, pollen) and documentation collected (e.g. photographs, herbarium vouchers). Please be aware that when exporting plant material, obtaining prior consent or other collection documentation does not exempt collectors from having to obtain any required phytosanitary certificates.

Additional export permits may also be required if the collection species is listed on any of the appendices of the Convention on the International Trade in Endangered Species (CITES). Special permits may be needed if the genetic resources collected are from species protected by the host government.

B. Animals and Animal Materials

Appropriate IACUC (Institutional Animal Care and Utilization Committee) approval must be obtained for vertebrate animal samples. Additionally, proper export documentation must be obtained from the host country. In the case of any animal listed in Appendix I or II of CITES, a CITES permit is needed. This will require a listing of the species, the provenance (e.g. wild born, captive born) and the type of biomaterial for each individual. Keep in mind that CITES permits are valid for one export event only. Samples not included in this shipment, even if listed on the permit, will need a new permit at the time of exportation. Importation into the U.S. also requires a Fish and Wildlife Service Declaration of Intent to Import. Further information can be found at www.permits.fws.gov http://www.permits.fws.gov.

VII. Traditional Knowledge

Subject to national laws, if the use of traditional knowledge is necessary to complete genetic resource collection, collectors are advised to obtain the approval and involvement of the holders of such knowledge. Collectors ought to respect customs, traditions, values, and customary practices of indigenous and local communities. In many cases, it may not be clear who has the authority in the indigenous and local community to approve the use of traditional knowledge by the collector. These questions are often political in nature and may not have been fully settled in the host country. Approval to access genetic resources does not imply approval to use associated knowledge and vice versa.

Subject to national legislation, collectors may be encouraged to equitably share the benefits arising from the utilization of traditional knowledge, innovations and practices. Collectors should consult relevant local and indigenous people and other stakeholders prior to collection when determining access, negotiating mutually agreed terms, and sharing benefits. Further, collectors should, to the extent feasible, respond promptly to inquiries and provide information regarding scientific and legal advice to stakeholders to enable them to participate effectively.

Collecting traditional knowledge from individuals may, in some cases, require clearance by Human Subjects Institutional Review Boards of your institution and/or that of your local collaborator. Researchers should check with these boards before embarking on a project.

VIII. Related Policies of U.S. Government Funding Agencies

Be aware that the agency supporting your research may have additional policies related to data or sample collection, management and dissemination of results. Researchers should review the award guidelines and policies of their funding agencies for such matters prior to beginning collections.

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