WORLD TRADE
ORGANIZATIONIP/C/W/393
28 January 2003
(03-0577)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
ACCESS TO GENETIC RESOURCES REGIME OF THE
UNITED STATES NATIONAL PARKS
Communication from the United States
The following communication, dated 27 November 2002, has been received from the
Permanent Mission of the United States with the request that it be circulated to Members.
_______________
I. INTRODUCTION
In June of 2001, the United States introduced a paper (IP/C/W/257) that described in detail
the provisions of the Convention on Biological Diversity (the CBD) that might have some
implications for the TRIPS Agreement,1 and explained in some detail how those obligations might be
implemented through the use of an access regime for genetic resources based upon contracts.  Thepaper suggested that, inter alia , contracts authorizing collection of genetic materials include
provisions requiring reporting and benefit sharing and that parties to such access agreements be
obliged to notify the appropriate authorities in the event an invention was developed using genetic
materials collected under the contract.  The paper also advocated including a contractual obligation on
the party being granted access to identify the contract and the source of the genetic resources in any
patent application claiming that invention filed anywhere in the world.
In March of this year, we submitted another paper (IP/C/W/341) describing in considerable
detail, the procedures used by the US National Cancer Institute (NCI) in collecting genetic materials
for screening for potential therapeutic uses related to cancer.  Copies of a model letter of collection
and a model memorandum of understanding were appended, along with lists of the countries and
organizations with which NCI has negotiated such agreements.  Both the letter of collection and thememorandum of understanding contain provisions providing for benefit sharing.
The purpose of this paper is to describe the regime for access to genetic materials in US
national parks.
II. BACKGROUND
The collection of biological specimens for scientific research in US national parks is not new.
The first research permit in the national park system, which authorized collection of microbial
specimens from hot springs at Yellowstone National Park,
2 was issued over a century ago.  In 1916,
legislation was enacted creating the US National Park Service to administer US national parks, inparticular to "conserve the scenery and the national and historic objects and the wild life therein and
                                                     
1 Specifically, Articles 8(j), 15, 16 and 19.
2 Established on 1 March 1872, Yellowstone National Park is the first and oldest national park in the
world.IP/C/W/393
Page 2
to provide for the enjoyment of the same in such manner and by such means as will leave them
unimpaired for the enjoyment of future generations."
Over the years, research permits have continued to be granted authorizing collection of
specimens from the parks.  The National Park Servi ce's current regulations governing the collection of
specimens for scientific research were put in place in 1983.3  A single case study should suffice to
demonstrate the public benefits of permitting access to genetic resources.  In 1966, Thomas Brock
was studying microorganisms living in Yellowstone's hot spring pools.  In the laboratory, he named
one of the curious organisms he had discovered Thermus aquaticus  and submitted a living sample for
safekeeping to the American Type Culture Collection, an organization that collects and maintains
microorganisms.4
Two decades after Dr. Brock's academic work in Yellowstone, his discoveries produced a
practical application that he had never imagined.  In  1985, a biotechnology company named Cetus
Corporation was seeking to develop a new way to duplicate genetic material.  At the time,
chromosomes were very difficult to study because they are made of genes and genes are composed of
DNA, but DNA was too small to study effectively.  Dr. Kary Mullis, a Cetus scientist, invented auseful method for DNA duplication, called Polymerase Chain Reaction (PCR),
5 but, unfortunately,
the high temperatures required by PCR destroye d the polymerase enzymes, requiring laboratory
technicians to add fresh enzymes throughout the PCR process, making that process tedious and
resource intensive.
Other scientists at Cetus added to PCR an enzyme, named Taq polymerase, isolated from a
sample of Thermus aquaticus  obtained from the American Type Culture Collection.  Taq polymerase
had the unusual ability to keep working even at high temperatures.  The scientists learned to
reproduce the enzyme in the laboratory so that it would not be necessary to use original samples.
PCR using Taq polymerase was so effective that a whole new scientific field flourished as scientistsfinally had a convenient way to reproduce and study DNA.
Today, the DNA copying process, made practical because of the study of a Yellowstone
microorganism, has become a major part of DNA studies around the world.  Taq polymerase helps
permit the uses of DNA that are so familiar today – from matching DNA in criminal investigations, to
medical diagnoses or cures, bioremediation of toxic wastes, and research into the basic building
blocks of life.
While the results of such research on materials collected from national parks flowed to the
world, however, there was no provision for ensuring that benefits flowed back to the parks that
supplied the original materials.  The National Parks Omnibus Management Act of 1998 expressly
authorizes "negotiations with the research commun ity and private industry for equitable, efficient
benefits-sharing arrangements" in connection with research conducted in national parks.  The Act also
mandates increased scientific research in the national parks and the use of science in park
management decisions.  The law encourages the national parks to be places for scientific study by
public as well as private sector researchers, and mandates long-term inventory and monitoring
programs that provide baseline information, and document trends relating to the condition of parkresources.
A lawsuit in 1998 challenged the legality of a cooperative research and development
agreement (CRADA) negotiated between the Yellow stone National Park (Yellowstone) and Diversa
                                                     
3 These regulations can be found in the US Code of Federal Regulations, Title 36, section 2.5, which
can be accessed at http://www.access.gpo.gov/nara/cfr/waisidx_01/36cfrv1_01.html.
4 The ATCC is also an international depository authority under the WIPO Budapest Treaty on the
International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.
5 Dr. Mullis was awarded a Nobel Prize for his invention.IP/C/W/393
Page 3
Corporation (Diversa), a biotechnology company that develops new technologies for discovering and
modifying genes.  The judge dismissed the case with  prejudice to the plaintiff, ruling that benefits-
sharing CRADAs are consistent with the National Park Service Organic Act and the Yellowstone
National Park enabling act.
As an example of benefit sharing under the CRADA between Diversa and Yellowstone,
Diversa, in 1999, at no charge to the federal government, developed a DNA pedigree for the
endangered Yellowstone wolves, the first such pedigree ever established.  This pedigree, which the
Yellowstone National Park could not have afforded to pay for, helps in understanding the dynamics of
the wolf population, assessing the genetic health of the park's wolf population, identifying wolves that
are killed illegally, detecting when wolves from other areas immigrate to Greater Yellowstone, and
documenting breeding in the wild.  This knowledge is used by Yellowstone staff in carrying out theircharge to conserve the wild life in the park so that it can be enjoyed by this and future generations.
III. GENERAL RULES FOR DOING RESEARCH IN US NATIONAL PARKS
The National Park Services has separate requirements for collecting research materials from
parks, depending on the use to which the research is to be put.  For collections aimed solely at basicresearch and education, the superintendent of each national park has authority to issue research
permits addressing the resources and needs of the park the superintendent oversees.  A Scientific
Research and Collecting Permit is required for most scientific activities involving fieldwork or
specimen collection, particularly if the research ha s the potential to disturb resources or visitors.  In
some instances, other federal or state agency permits or approvals also might be required to besubmitted with the application for a Scientific Research and Collecting Permit before the
superintendent of the national park will consider the application.  For example, research proposals
involving threatened or endangered species must be accompanied by a permit from the US Fish and
Wildlife Service and the National Marine Fisheries Service.  Application materials, including
Guidelines to Researchers for Study Proposals , can be obtained from the Internet ( www.nps.gov ) or
by contacting the park in which the proposed research is to take place.  Specimen collection for
scientific research will be authorized only if the collection is necessary for the stated scientific goals
included in the written research proposal.  The research proposal must detail the activities that will
occur in the park together with th e analyses that will occur elsewhere, such as in the scientists'
laboratory or office.
Each proposal is reviewed to ensure complian ce with the National Environmental Policy Act
and other relevant laws, regulations and policies.  Depending on the complexity and sensitivity of the
proposal, the superintendent might also require a review by relevant scientific experts, internal or
external.  Permits may be issued only if the proposed research will not have an adverse impact on
public health and safety, environmental or scenic values, natural or cultural resources, other scientific
research, management responsibilities, allocation and use of facilities, and visitor activities.
Researchers granted permits to work in National Park System areas must complete an
Investigator's Annual Report on the required form for each year of the permit, including the final year.
This can be done on paper or over the Internet.  The reports themselves document the
accomplishments of research conducted in the parks.  The principal researchers are accountable forthe accuracy and content of their reports.  In addition to the reports, park research coordinators can
request copies of field notes, data, reports, publications and other documents and materials related to
studies conducted in the National Park System Areas.  The General Conditions for Scientific Research
and Collecting Permit  is attached.
As noted above, specimens and components of specimens  collected under permit are to be
used for scientific or educational purposes only;  specimens collected in parks may be loaned by the
NPS for scientific purposes but may not be sold fo r any purpose;  research results derived from NPSIP/C/W/393
Page 4
specimens  may not be used for commercial or other revenue-generating purposes without further
permission.
IV. COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
According to National Park Service policy, any party that submits an application for a
Scientific Research and Collecting Permit proposing to use the results of research for commercial or
revenue-generating purposes must enter into a CRADA or other approved benefit-sharing agreement
with the NPS.  Under a CRADA, the National Park Service makes a clear distinction between sale or
other transfer to third parties of collected research specimens or materials and the sale or other
transfer of the results of research based upon the collected research specimens or materials.  The sale
or other transfer to third parties of collected specimens or components thereof is strictly prohibited.
The party to the CRADA, however, may make commercial or other revenue-generating use of theresults of its research, with benefit-sharing to the National Park Service as provided for in the
CRADA.
The scientific research and collecting permit is sued by the National Park Service to the other
party spells out the terms and conditions under which that party will be permitted to collect researchspecimens or other materials from the park and the purposes to which such specimens or other
materials may be put.  The CRADA or other benefit-sharing agreement would identify the allocation
of ownership in any inventions made, and the other rights and obligations of the parties, including
reporting requirements and the manner in which any disputes will be handled.  Some contracts might
provide for express damages in the event of a breach of any of the provisions of the agreement by the
party seeking to collect research specimens or othe r materials.  Reporting requirements might include
notification of the development of any invention based upon research using research specimens
collected in the parks and identification of the contract in any patent application claiming an invention
developed as a result of the research on collected specimens or other materials.
Only one CRADA has been negotiated by the NPS to date.  The litigation in 1998 imposed a
requirement to comply with National Environmental Policy Act and the NPS is currently developing
an environmental impact statement to consider the effects of benefits-sharing within the National Park
System .
V. CONCLUSION
We believe that a similar system, adapted to the legal systems and government structures of
other countries, would work well in promoting the sustainable use of genetic resources  and in
ensuring that benefits resulting from any research using those resources are shared with the source of
the resources.  Such benefits could include training for scientists, direct application of the research
results (as in the example of the genetic pedigree of the endangered Yellowstone wolves), or
monetary remuneration.  We are working to develop a model law that might be adapted to serve as thebasis of domestic legislation for countries that are seeking to establish a practical means to regulate
access to the resources in their country and ensure benefit sharing.IP/C/W/393
Page 5
GENERAL CONDITIONS
FOR SCIENTIFIC RESEARCH AND COLLECTING PERMIT
United States Department of the Interior National Park Service
1. Authority  – The permittee is granted privileges covered under this permit subject to the
supervision of the superintendent or a design ee, and shall comply with all applicable laws
and regulations of the National Park System area and other federal and state laws.  A
National Park Service (NPS) representative may accompany the permittee in the field to
ensure compliance with regulations.
2. Responsibility  – The permittee is responsible for ensuring that all persons working on the
project adhere to permit conditions and applicable NPS regulations.
3. False information  – The permittee is prohibited from giving false information that is
used to issue this permit.  To do so will be considered a breach of conditions and begrounds for revocation of this permit and other applicable penalties.
4. Assignment  – This permit may not be transferred or assigned.  Additional investigators
and field assistants are to be coordinated by the person(s) named in the permit and should
carry a copy of the permit while they are working in the park.  The principal investigatorshall notify the park's Research and Collecting Permit Office when there are desired
changes in the approved study protocols or methods, changes in the affiliation or status of
the principal investigator, or modification of the name of any project member.
5. Revocation  – This permit may be terminated for breach of any condition.  The permittee
may consult with the appropriate NPS Regional Science Advisor to clarify issues
resulting in a revoked permit and the potential for reinstatement by the park
superintendent or a designee.
6. Collection of specimens (including materials)  – No specimens (including materials)
may be collected unless authorized on the Scientific Research and Collecting permit.
The general conditions for specimen collections are:
• Collection of archeological materials without a valid Federal Archeology Permit is
prohibited.
• Collection of federally listed threatened or endangered species without a valid US Fish
and Wildlife Service endangered species permit is prohibited.
• Collection methods shall not attract undue attention or cause unapproved damage,
depletion, or disturbance to the environment and other park resources, such as historic
sites.
• New specimens must be reported to the NPS annually or more frequently if required by
the park issuing the permit.  Minimum information for annual reporting includes
specimen classification, number of specimens collected, location collected, specimen
status ( e.g. herbarium sheet, preserved in alcohol/formalin, tanned and mounted, dried
and boxed, etc.), and current location.IP/C/W/393
Page 6
• Collected specimens that are not consumed in analysis or discarded after scientific
analysis remain federal property.  The NPS reserves the right to designate the repositoriesof all specimens removed from the park and to approve or restrict reassignment of
specimens from one repository to another.  Because specimens are Federal property, they
shall not be destroyed or discarded without prior NPS authorization.
• Each specimen (or groups of specimens labele d as a group) that is retained permanently
must bear NPS labels and must be accessioned and cataloged in the NPS National
Catalog.  Unless exempted by additional park-specific stipulations, the permittee will
complete the labels and catalog records and will provide accession information.  It is the
permittee's responsibility to contact the pa rk for cataloging instructions and specimen
labels as well as instructions on repository designation for the specimens.  Collected
specimens may be used for scientific or educational purposes only, and shall be dedicated
to public benefit and be accessible to the public in accordance with NPS policies and
procedures.
• Any specimens collected under this permit, any components of any specimens (including
but not limited to natural organisms, enzymes or other bioactive molecules, geneticmaterials, or seeds), and research results derived from collected specimens are to be used
for scientific or educational purposes only, and may not be used for commercial or other
revenue-generating purposes unless the permittee has entered into a cooperative Research
and Development Agreement (CRADA) or other approved benefit-sharing agreementwith the NPS.  The sale of collected resear ch specimens or other unauthorized transfers to
third parties is prohibited.  Furthermore, if the permittee sells or otherwise transfers
collected specimens, any components thereof, or any products or research results
developed from such specimens or their components without a CRADA or other
approved benefit-sharing agreement with the NPS, permittee will pay the NPS a royaltyrate of twenty percent (20%) of gross revenue from such sales or other revenues.  In
addition to such royalty, the NPS may seek other damages to which the NPS may be
entitled, including but not limited to injunctive relief against the permittee.
7. Reports  – The permittee is required to submit an Investigator's Annual Report and copies
of final reports, publications and other materials resulting from the study.  Instructions for
how and when to submit an annual report will be provided by NPS staff.  Park research
coordinators will analyze study proposals to determine whether copies of field notes,
databases, maps, photos, and/or other materials may also be requested.  The permittee is
responsible for the content of reports and data provided to the National Park Service.
8. Confidentiality  – The permittee agrees to keep the specific location of sensitive park
resources confidential.  Sensitive resources include threatened species, endangered
species, and rare species, archeological sites, caves, fossil sites, minerals, commercially
valuable resources, and sacred ceremonial sites.
9. Methods of travel  – Travel within the park is restricted to only those methods that are
available to the general public unless otherwise specified in additional stipulations
associated with this permit.
10. Other permits  – The permittee must obtain all other required permit(s) to conduct the
specified project.
11. Insurance  – If liability insurance is required by the NPS for this project, then
documentation must be provided that it has been obtained and is current in all respects
before this permit is considered valid.IP/C/W/393
Page 7
12. Mechanized equipment  – No use of mechanized equipment in designated, proposed, or
potential wilderness areas is allowed unless authorized by the superintendent or a
designee in additional specific conditions associated with this permit.
13. NPS participation  – The permittee should not anticipate assistance from the NPS unless
specific arrangements are made and documented in either an additional stipulation
attached to this permit or in other separate written agreements.
14. Permanent markers and field equipment  – The permittee is required to remove all
markers or equipment from the field after th e completion of the study or prior to the
expiration date of this permit.  The superintendent or a designee may modify thisrequirement through additional park specific conditions that may be attached to this
permit.  Additional conditions regarding the positioning and identification of markers and
field equipment may be issued by staff at individual parks.
15. Access to park and restricted areas  – Approval for any activity is contingent on the
park being open and staffed for required operations.  No entry into restricted areas is
allowed unless authorized in additional park sp ecific stipulations attached to this permit.
16. Notification  – The permittee is required to contact the park's Research and Collecting
Permit Office (or other offices if indicated in the stipulations associated with this permit)prior to initiating any fieldwork authorized by  this permit.  Ideally this contact should
occur at least one week prior to the initial visit to the park.
17. Expiration date  – Permits expire on the date listed.  Nothing in this permit shall be
construed as granting any exclusive research privileges or automatic right to continue,extend, or renew this or any other line of research under new permit(s).
18. Other stipulations  – This permit includes by reference all stipulations listed in the
application materials or in additional attachments to this permit provided by the
superintendent or a designee.  Breach of any of the terms of this permit will be grounds
for revocation of this permit and denial of future permits.
__________