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
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:
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.
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.
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:
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
Office of Ecology and Terrestrial Conservation
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 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:
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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