Benefits sharing occurs when NPS receives monetary or non-monetary benefits from the commercial use of a discovery or invention resulting from research originating under an NPS Scientific Research and Collecting Permit, or other permit or authorization. The National Parks Omnibus Management Act of 1998 (16 USC 5935(d)) authorizes NPS benefits sharing. Additional authorities, including authorities on technology transfer and innovation, enable implementation. Yellowstone National Park took the lead in preparing a Final Environmental Impact Statement following which, in March 2010, NPS issued a Record of Decision to implement benefits sharing Servicewide. Benefits sharing is a new activity for parks. In 2013, NPS issued policy and procedures for benefits sharing and the related topic of technology transfer.
Director's Order #77-10: NPS Benefits Sharing, issued December 2013, defines NPS benefits sharing, lists fundamental benefits-sharing principles, describes basic benefits-sharing procedures, addresses related ethics and confidentiality, assigns responsibilities for administering benefits sharing, and outlines reporting requirements.
In 1995, Yellowstone National Park began exploring benefit sharing as a park option. Park managers concluded that Cooperative Research and Development Agreements (CRADAs) under the Federal Technology Transfer Act (FTTA) would be a legal and appropriate way for Yellowstone to implement benefits sharing and enhance resource conservation. Through use of a CRADA, Yellowstone would obtain a commitment by a non-federal scientist or company to share reasonable benefits with the park if the research results led to a commercial application. Benefits could be monetary or non-monetary, for example, providing scientific information vital to the understanding and protection of park resources.
In 1997, Yellowstone National Park entered into a Cooperative Research and Development Agreement (CRADA) with the biotechnology firm Diversa Corporation. Subsequently, Congress enacted the National Parks Omnibus Management Act of 1998, including the authorization for NPS to enter into equitable and efficient benefits-sharing arrangements with the research community and private industry.
In 1998, Edmonds Institute filed suit in federal court alleging that the Yellowstone/Diversa CRADA violated the FTTA, the NPS Organic Act of 1916, the Yellowstone National Park Organic Act, the National Environmental Policy Act (NEPA), the "so-called public trust doctrine," and the Administrative Procedure Act. In an initial ruling, Judge Royce Lamberth ordered NPS to complete the review mandated by NEPA, including but not limited to an environmental assessment. In his final judgment, Judge Lamberth dismissed the case with prejudice, ruling that benefits-sharing agreements are consistent with the NPS Organic Act and the Yellowstone National Park Organic Act; and that Yellowstone facilities qualify as a laboratory under the FTTA and, as such, may use the authorities accorded federal laboratories under the FTTA. The court also found that legislation enacted subsequent to the Yellowstone/Diversa CRADA reinforces the conclusion that application of the FTTA to the CRADA is consistent with Congressional intent regarding such agreements within units of the National Park System. The National Parks Omnibus Management Act of 1998 provides clear legal authority to conduct scientific study in the parks, use the information gathered for management purposes, encourage use of the parks for scientific study by Federal and non-Federal public and private entities, and enter into benefits-sharing arrangements.
For further background on the history of benefits sharing in Yellowstone National Park, see the park's Greater Yellowstone Ecosystem document. A key point in this history is that Yellowstone is the source of the extremophile bacterium, Thermus aquaticus, discovery of which led to research to improve the functionality of the polymerase chain reaction (PCR). Improving PCR was essential to developing the ability to efficiently analyze DNA. Today, PCR is the basis of a multimillion dollar industry with applications ranging from the rapid diagnosis of disease to forensic medicine. NPS did not have benefits-sharing authority when this discovery occurred and received no benefits from its commercial application.
All studies conducted in parks provide the NPS with some type of benefit. Scientific studies support the NPS mission by providing the Service, the scientific community, and the public with an understanding of park resources, processes, and values. Benefits sharing occurs when NPS receives monetary or other benefits from a discovery or invention with a commercial application resulting from research originating under an NPS Scientific Research and Collecting Permit, or other permit or authorization. Benefits sharing may result in improved conservation of resources and enhances the public benefits arising from research that occurs in parks. The entity with a proposed commercial use enters into an agreement with NPS, prior to commercialization, wherein NPS accepts benefits or declines benefits.
The commercial use or sale of collected specimens themselves is prohibited by 36 CFR 2.1 and NPS Management Policies 2006, 4.2.4.
The overall basis for NPS negotiating benefits sharing is the NPS role in preserving and providing access to the research site and the opportunity to collect, study and use the resources therein. This NPS contribution often represents decades of work. In some cases, NPS also makes available research data, conclusions, or other assistance that informs and supports the research permittee's, or other authorized researcher's, efforts.
What kinds of research can lead to benefits sharing? While any scientific research could lead to a potential commercial application, in most cases, scientific research that specifically looks in parks for a useful application, process, or product that may result in a commercial application for the research results is most likely to lead to benefits sharing.
The search for useful applications of natural resources is an ancient quest in every human culture. Cultural traditions reflect accumulated experience and knowledge, such as information about which plants are nutritious, make good dyes, and are good medicine. This knowledge is revealed not only by living cultural traditions but also by archeological investigation of past cultures. Today, scientists continue to find useful applications for compounds from nature, but the search methods have changed. Biochemists chemically analyze plants, microorganisms, and other living things, resulting in discoveries not even visible under a microscope, such as enzymes (biological molecules) that act as catalysts for chemical reactions.
Sometimes, the only way to obtain a useful organic compound is to extract it from a naturally-occurring organism that contains it. But, thanks to improvements in science, useful compounds first discovered in nature can now often be chemically manufactured in a laboratory or factory, and sometimes they can be made by genetic engineering. An example is insulin, a hormone vital to human utilization of carbohydrates and fats. Many people with diabetes must take insulin as a medicine. Pharmaceutical manufacturers use genetic engineering techniques to produce insulin from microbial cultures of bacteria specially bred for producing insulin at a commercial scale. In other examples, manufacturers make compounds by applying the findings of molecular biologists who identify in wild organisms genes that control production of a desired compound, copy the compound-producing gene, and insert the gene copy into laboratory bacteria. Manufacturers apply these findings by growing the altered bacteria to produce more of the compound, which humans can then use.
Sometimes scientists identify a need for a certain chemical and look for it in nature. Just as often, however, a scientist may unexpectedly discover in research results a valuable application that is unrelated to the original intent of the research. For example, a researcher may accidentally discover new kinds of antibiotics while studying how frogs survive in the wild. Another scientist may be trying to determine how microorganisms live and accidentally discover a biochemical process that proves useful to humans for protecting themselves from a particular infection. Archeologists documenting ancient cultures may discover an ancient domesticated plant variety that is more disease-resistant than related contemporary varieties.
Current research in U.S. national parks most likely to result in benefits sharing is related to the study of microorganisms. Microorganisms are highly adaptable and can live almost anywhere, including the bottom of the ocean in Dry Tortugas National Park, in glacial ice in Glacier Bay National Park and Preserve, and in thermal pools in Yellowstone National Park. Any scientist who wants to collect or study in national parks must get a Scientific Research and Collecting Permit, or other applicable permit. Parks issue Scientific Research and Collecting Permits for the conduct of research that will advance science and education while not impairing the parks. Federal regulations prohibit sale or commercial use of any natural product from national parks; hence harvesting of park resources directly for commercial purposes is prohibited. Under a Scientific Research and Collecting Permit, scientists are authorized to take only limited quantities of research samples out of a park, and they are not allowed to sell or otherwise commercialize those research samples. If a scientist makes a practical or useful invention or discovery during research, the research results may be commercialized after entering into an agreement with NPS wherein NPS agrees to share benefits or declines to share benefits, but the sample collected from the national park unit may not be sold or otherwise used for commercial purposes. If a scientist proposes a commercial application for research results, the scientist must contact the park that issued the permit to negotiate benefits sharing.
In 1966, Thomas Brock, a microbiologist at Indiana University, was studying microorganisms living in Yellowstone National Park's thermal pools. He named one of the organisms—a bacterium, that he discovered in a sample from a thermal pool—Thermus aquaticus. This microorganism lives and thrives in water so hot that it would kill an ordinary plant or animal. Dr. Brock learned how to grow Thermus aquaticus in the laboratory and deposited a living sample at the American Type Culture Collection (a repository that maintains living cultures of microorganisms) for safekeeping and distribution to other researchers, upon request.
In 1985, Cetus Corporation, a biotechnology company, was working on developing a new way to duplicate genetic material to facilitate genetic studies—individual molecules of DNA are too small to study effectively. The key to working with DNA was to replicate the DNA molecules in order to get enough to study. A scientist at Cetus, Dr. Kary Mullis, had previously invented a way to duplicate DNA for which he received a Nobel Prize. This new process was called the Polymerase Chain Reaction (PCR). But, PCR required high temperatures, which destroyed the polymerase enzymes in the method being used at the time, requiring laboratory technicians to tediously add fresh enzymes throughout the PCR process.
Then, Dr. Mullis's colleagues at Cetus added an enzyme to PCR that had the unusual ability to keep working at high temperatures. Using a previously published process, they isolated that enzyme—Taq polymerase—from the Yellowstone Thermus aquaticus, which they had gotten from the American Type Culture Collection. PCR using Taq polymerase was so effective that a whole new scientific field has flourished as scientists finally had a convenient way to study DNA. Dr. Brock's academic work in Yellowstone had a practical application that he never imagined during his studies twenty-five years previously.
Today, the DNA copying process, made practical because of a series of studies using a Yellowstone microorganism, is widely used. Taq polymerase has led to 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.
At the time of this research, NPS did not have a benefits-sharing policy; however, this case study is a good example of the kind of research that could lead to benefits sharing.
The National Parks Omnibus Management Act authorizes the Secretary of the Interior to "enter into negotiations with the research community and private industry for equitable, efficient benefits-sharing arrangements" (16 USC 5935(d)). Because the Act does not provide detail on implementation, such as the type of arrangements that NPS should use or the authority to directly retain monetary benefits (rather than conveying them to the U.S. Treasury), NPS relies on the following additional authorities to implement benefits sharing:
Federal Technology Transfer Act of 1986 (FTTA) and related legislation (15 USC 3710), which focuses on technology transfer and enables federal laboratories, and therefore park units designated as federal laboratories, to enter into Cooperative Research and Development Agreements (CRADAs) under which a federal agency has numerous authorities including the ability to 1) negotiate licenses for patented inventions made at federal laboratories; 2) grant and waive rights to federal laboratory inventions and intellectual property; and 3) accept, retain, and use funds, personnel, services, and property from a collaborating party and provide personnel, services, and property to a collaborating party.
Omnibus Consolidated Appropriations Act of 1997, Section 203 of the National Parks Omnibus Management Act of 1998, and Section 818 of the Omnibus Parks and Public Lands Management Act of 1996 (16 USC 1g for park programs, 16 USC 5933 for cooperative studies units, and 16 USC 1a-2[j] for park research), and the National Park Service Organic Act (16 USC 1 through 4) and other authorities cited in Director's Order #20: Agreements, which collectively authorize NPS to receive and transfer money, property, services, or anything else of value with state, local, and tribal governments, other public entities, educational institutions, and private non-profit organizations to fulfill research, training, information dissemination, and other missions of the NPS.
Parks may receive non-monetary and/or monetary benefits. Parks must use these benefits to enhance NPS resource conservation, although some of the benefits may also be used to offset administrative costs associated with the benefits-sharing program.
Example of a monetary benefit: A biopharmaceutical company working on developing a vaccine using an enzyme that originated with a specimen collected in a park agrees in a Cooperative Research and Development Agreement (CRADA) to make specific payments at the conclusion of each development phase as described in a development plan.
Example of a non-monetary benefit: A company that made an invention based on study of toxins from ants collected in a park agrees to participate in the park's ongoing inventory of insects for six years.
In 1999, as part of a benefits-sharing agreement, Diversa Corporation, a biotechnology company, used its expertise in DNA analysis to develop a pedigree for the endangered Yellowstone wolves at no charge to the Federal government. This pedigree was the first ever established for a wild wolf population.
The pedigree helps park managers better understand the dynamics of the wolf population. It allows biologists to accurately assess the genetic health of the park's wolf population and enables identification of any individual wolves that are illegally killed. In addition, the pedigree facilitates detection of wolves from other areas, such as Idaho or northwest Montana, when they immigrate to Greater Yellowstone.
No. Once NPS learns about research results that potentially have commercially valuable applications, NPS will evaluate on a case-by-case basis whether to negotiate benefits or decline to negotiate benefits. Based on that evaluation, the NPS will enter into an agreement to share or decline benefits with the institution that has a proposed commercial use. The agreement will state the NPS decision on benefits and other terms and conditions.
NPS will negotiate benefits with the other party when, based on best available information about the possible commercial use of the research, potential benefits would have some value to NPS resource management and to the general public.