Meeting August 26-27, 1999 - National Genetic Resources Advisory Council (NGRAC)

Executive Summary
Ninth Meeting August 26-27, 1999

1. The ninth meeting of the National Genetic Resources Advisory Council (NGRAC) was held August 26-27, 1999, in USDA's Jamie L. Whitten Federal Building at Washington, D.C. In attendance from the Council were seven appointed and four ex-officio members/designates. USDA Research, Education, and Economics (REE) Science Advisor, Dr. Philip Schwab, represented the Under Secretary's office. NGRAC Chair, Richard Lower, conducted the meeting that focused on the status of the germplasm and genome activities of the Department, implementation of the NGRAC's previous recommendations to improve the National Genetic Resources Program (NGRP), invasive species, intellectual property issues in germplasm exchange, and the international germplasm negotiations at FAO and Convention on Biological Diversity (CBD).

2. The Council received an update from Dr. Schwab on the status of the FY2000 budgets for genetic resources of agencies in REE, the USDA biotechnology policy presented by the Secretary at the National Press Club in July and the announced advisory committee on agricultural biotechnology (ACAB). Since the committee will advise the USDA on biotechnology policy including future USDA research (such as that involved in the Technology Protection System patent) and on genetically modified organisms (GMOs) in respect to labeling of food content, the NGRAC expressed great interest to be closely linked with the ACAB's activities in genetic resources. The NGRAC believes there are many issues in common and expressed great interest to be closely linked with the ACAB's activities in genetic resources.

3. National Program Leaders for the Agricultural Research Service (ARS) and the Cooperative States Research, Education, and Extension Service (CSREES) reported on the plant, microbial and animal components of the National Genetic Resources Program. An initiative of the American Soybean Association for pathogen collections that attracted the support of the American Seed Trade Association's initiative was described by its coordinator, Kellye Eversole, to increase funding to the National Plant Germplasm System (NPGS) by $5 million in FY2000, by $20 million in FY2001 and to $50 million total by FY2002. Advances in cryopreservation techniques for storage of animal embryos and semen led to an ARS decision to shift funding for the operational coordination of a long-term animal germplasm repository to the Fort Collins National Seed Storage Laboratory where cryopreservation research is conducted. NGRAC members repeated their concern from meetings past about the need for a strategic plan or roadmap of all USDA germplasm and genome programs. The NGRAC noted that forthcoming ARS program workshops for animal germplasm and genome programs need to consider the possible role of on-farm conservation of domestic farm animal diversity.

4. The Council was briefed on the new White House interagency initiative on invasive species (Executive Order 13112, February 3, 1999 ). Actions take the form of prevention, detection, control, monitoring and restoration involving USDA (APHIS, ARS, CSREES, FS, FSA and NRCS), EPA, Corps of Engineers, Transportation and Treasury (Customs). Most work will be at state and local levels through invasive species management teams and off-shore study and interdiction. A new advisory committee is expected to shape a complete plan by August 2000 and there will be an inter-agency cross-cut budget in FY2001. The NGRAC recognized its mutual interest in the issue and expressed a strong desire to work closely with the new advisory committee.

5. The NGRAC discussed its previous concerns about the USDA patent on the Technology Protection System (TPS) resulting from a Cooperative Research and Development Agreement (CRADA) with Delta and Pine Land Company (DP&L). The NGRAC suggested that the "FACT SHEET" developed by ARS to respond to issues on TPS (web site: http://www.ars.usda.gov/other) be kept up-to-date and take into account more of the benefits of the technology. The NGRAC continues to see the issue as one of continuing interest, particularly for its possible impact on small farmers who save planting seeds from their crops.

6. U.S. Patent and Trademark Office (USPTO) representative, Ms. Alice Zalik, reviewed current issues involving patent policy (especially Article 27, paragraph 3 (b)1 of the TRIPS Agreement about patents on living organisms) and the upcoming meeting of the World Trade Organization and its Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council. The phase-in time for implementing TRIPS provisions in most countries is January 1, 2000 with the least developed of the developing countries having until 2006. The NGRAC suggested that there could be a harmful shift to trade secret approaches if patents are not allowed and that would make new technologies less transparent and available.

7. Department of State representative, Melinda Kimble, addressed the NGRAC on the status of international negotiation of the International Undertaking (IU) at the Food and Agriculture Organization (FAO) of the United Nations and the CBD's biosafety protocol. Ms. Kimble's report indicated that while progress was made on the matter of farmers' rights, the next struggle will likely be over benefit sharing and international collections in a multilateral system. Issues raised about access to international and foreign national collections, reciprocity parity and acceptance of protected materials into the NPGS had a full hearing by the NGRAC and public visitors to the meeting. The NGRAC continues to express its concerns and interests about the international issues involving ownership and access to genetic resources. It reaffirmed its belief that benefits accrue from open access and exchange. The Council recognized the important support of the State Department for genetic resources programs in the international germplasm arena and its unwavering support for the open and free access position of the USDA. The NGRAC believes the USDA should continue this policy unless international agreements and events force a reevaluation. It also supports the USDA to continue its general practice of accepting germplasm for subsequent release without restriction. The Council believes that uniform MTAs for germplasm exchanges with the IARC system are most desirable.

8. Mr. Richard Rominger, Deputy Secretary of Agriculture, joined the Council to hear its concerns and interests in topical issues and thanked the Council for its valuable contributions. He expressed interest in learning the Council's recommendations on what is being referred to as the "post genomics era". The NGRAC urged that the USDA be more aggressive about selling its unique abilities and capacity to conduct good genomic science.

9. Members suggested the venue for a future meeting be at the Fort Collins' long-term storage facility to help the Council better understand the operations of the NGRP.

10. The Ninth Session of the National Genetic Resources Advisory Council developed a single overarching resolution with embodied recommendations to the Department and NGRP.

Resolution 4/99 of the Ninth Meeting of the National Genetic Resources Advisory Council

The National Genetic Resources Council (NGRAC) reaffirms its previous recommendation to the USDA and the National Genetic Resources Program (NGRP) to develop a road map (more explicit in relevant content than the broad Agricultural Research Service Six-Year Plan) and strategic plan for its genetic resources and genomics programs. Additionally the Council believes that the plan should include but not be limited to the following important items, which are listed in a non-prioritized order:

• Include a mechanism to facilitate the coordination of the NGRAC with other Advisory Committees, in particular those that deal with genetic resources, such as the ones on Agricultural Biotechnology (ACAB) and Invasive Species. This will maximize, or realize, the value of the collective input of the other committees on items of common interest including cooperation in developing educational and information programs for school children, producers and the consumer public about important issues involving genetic resources.
• Build in interagency coordination and budget cross-cut so each agency can capitalize on interagency support and recognition of the USDA's unique capacities and resources. The value of a budget cross-cut is recognized by the White House invasive species initiative and substantiates the wisdom of the Council's previous unfulfilled recommendation that the Department develop a budget cross-cut for the NGRP.
• Develop plans for USDA participation in utilization of the results of current genome projects emphasizing "post-genomic" elucidation of gene function and regulation, particularly as they affect complex traits of agronomic and others of agricultural and environmental importance.
• Address the genomic research needs of other agriculturally important species when currently funded cDNA and complete sequencing projects are finished.
• Incorporate plans for development of physical and human resources required for germplasm conservation and utilization, including current germplasm resource centers for microbes, plants and animals, training of scientists in newer fields such as bioinformatics and genome technologies as well as in traditional fields in a changing disciplinary environment.
• Propose a broad education component to include not only the above-cited training in scientific specialties but also public education on facts, value, and challenges associated with genetic resources.
• Recognize through appropriate program activities that the maintenance of a highly diversified and openly accessible genetic resource collection held both in situ and ex situ is necessary for the future sustainability of our nation. Without diversity of knowledge and biological resources, present and future generations will be unable to respond to uncertain and changing conditions, which in the future will likely require a system that addresses production, natural ecosystem functioning, and diverse social needs such as recreation and culturally-relevant, quality food.
• Incorporate means to enhance current USDA efforts for small farms to remain viable and competitive in an increasingly global marketplace. The process for commitment to small farm development would include additional inputs from 1890 Land Grant universities and the more recently established 1994 tribal Land Grant colleges. 

Summary of Ninth Meeting, August 26-27, 1999

1. The ninth meeting of the National Genetic Resources Advisory Council (NGRAC) was held August 26-27, 1999, in Room 104-A of the USDA's Jamie L. Whitten Federal Building at 1400 Independence Avenue, Washington, D.C. In attendance from the Council were seven appointed members (Lower, Hamilton, Berlyn, Hunter-Cevera, Panton, Rhoades, Sattler) and four ex-officio members/ designates (Tavares, DOE; Ramm, NIH; Schwab, REE; Shands, ARS). Dr. Philip Schwab, Science Advisor, represented the Research, Education, and Economics (REE) Under Secretary's office. NGRAC Chair Richard Lower conducted the meeting that focused on updates of the status of the germplasm and genome activities of the Department, implementation of the NGRAC's previous recommendations to improve the National Genetic Resources Program (NGRP), invasive species, intellectual property issues in germplasm exchange, and the ongoing international germplasm negotiations at FAO and Convention on Biological Diversity (CBD). Introductions of Members and approximately 15 guests were made and subsequent guests introduced themselves.

2. Dr. Schwab welcomed the NGRAC and provided an update about current events and issues of relevance and importance to the NGRAC, particularly the status of the FY2000 budgets for genetic resources of agencies in REE. He noted that no new money for genomics or the Fund for Rural America survived the House and Senate markups. The proposed increases to the National Research Initiative were cut in favor of special grant funds for projects at selected universities. In USDA events drawing considerable attention, he referred to Secretary Glickman's talk charting USDA biotechnology policy at the National Press Club, continued press attention on the Technology Protection System patent and genetically modified organisms (GMOs) in respect to labeling of food content. With the various seed and chemical company mergers, he noted that the Department has been quite concerned about the concentration in the seed and supply industries. The Secretary has taken a special interest in the newly created Advisory Committee on Agricultural Biotechnology (ACAB). Dr. Michael Schechtman (APHIS) will administer that Committee's activities. The NGRAC believes there are many issues in common and expressed great interest to be closely linked with the ACAB's activities in genetic resources.

3. The NGRAC heard update reports from Drs. Peter Bretting and Steve Kappes, National Program Leaders on the Agricultural Research Service (ARS) National Genetic Resources Program components. Dr. Marsha Stanton and Dr. Richard Frahm, National Program Leaders of the Cooperative State Research, Education and Extension Service (CSREES) provided that Agency's input. Dr. Bretting summarized the budget increases in germplasm that go to the House-Senate Conference Committee action, the schedule of workshops for strategic planning, issues of germplasm exchange involving current policies of restrictions and protected materials. He distributed a draft document by an interagency panel dealing with microbial germplasm and noted an initiative of the American Soybean Association for pathogen collections. Short term funding has been provided by the American Seed Trade Association and the United Soybean Board to plan the activity. Dr. Bretting asked the policy advice of the NGRAC regarding issues of managing selected types of intellectual property in the national program and the NGRAC agreed to discuss that later in the session. Council members repeated their concern from meetings past about the need for a strategic plan or roadmap of USDA germplasm and genome programs.

Dr. Kappes, recently appointed National Program Leader for animal germplasm and production, was previously the scientist responsible for the bovine linkage map and germplasm activities at the ARS Meat Animal Research Center at Clay Center, NE. He described the shift of funding for the operational coordination of a long-term animal germplasm repository from Beltsville to the Fort Collins National Seed Storage Laboratory where considerable cryopreservation research is conducted. Advances in techniques of cryopreservation storage of embryos and semen of many animal types led to the decision to put more emphasis there. The NGRAC previously supported the development of the ARS plan to have the long-term storage facility at Beltsville with a security back-up at Fort Collins. The NGRAC noted that ARS animal germplasm and genome program workshops need to consider the role of on-farm conservation of domestic animal diversity. All expenses are currently borne by the farmers and some funding support to help subsidize the activity was seen by the Council as being helpful to the conservation of valuable germplasm resources. Dr. Kappes indicated that the costs of conservation could be quite high for either on-farm or ex-situ and the benefits are often not clear. Relevant questions were raised about potential support to small producers for animal genetic resources from agencies supporting human health now that animals are being used for production of vaccines and other medicinal products. The small quantity of animals needed for these uses was not seen as having a significant potential for such support. Dr. Richard Frahm, National Program Leader for Animal Genetics for CSREES called attention to the national workshop on Preserving Animal Germplasm Diversity-A Call to Action, October 31-November 3, 1999 in Nashville, Indiana.

4. Kellye Eversole of Eversole Associates updated the NGRAC on the American Seed Trade Association's initiative to increase funding to the National Plant Germplasm System (NPGS) by $5 million in FY2000, by $20 million in FY2001 and reaching $50 million total by FY2002. Given the difficult budget situation described by Dr. Schwab, the expectations were tempered. Ms. Eversole noted that she was working closely with the USDA Administration to try to get the administration's support for the large FY2001 increase.

5. Keith Pitts, from the Office of the Secretary of Agriculture, briefed the Council on the new White House interagency initiative on invasive species. An advisory committee met in July to examine how it will approach the subject. He noted the linkage of the issues to the genetic resources conservation and biotechnology. He indicated the issue of non-native invasive species is not too visible at present but is one of a number of environmental issues of increasing concern. Working on Executive Order 13112 of February 3, 1999, the Office of Science and Technology Policy will provide guidance to the agencies. The current draft document will be provided to the NGRAC for information and comment. Actions take the form of prevention, detection, control, monitoring and restoration. Agencies involved include USDA (APHIS, ARS, CSREES, FS, FSA and NRCS), EPA, Corps of Engineers, Transportation and Treasury (Customs). Most work will be at state and local levels through invasive species management teams and off-shore study and interdiction. A new FACA committee is expected to shape a complete plan by August 2000 and there will be an inter-agency cross-cut budget in FY2001. A web site to be focused on invasive species is expected to be developed to help educate the public on the matter and assist in its help in dealing with the problem. The NGRAC recognized its mutual interest in the issue and expressed a strong desire to work closely with the new advisory committee.

6. Director of the ARS Office of Technology Transfer, Dr. Richard Parry, presented an overview of the debate at the fourth meeting of the CBD's Subsidiary Body on Science, Technology and Technological Advice (SBSTTA) in Montreal on the Technology Protection System (TPS) developed from a Cooperative Research and Development Agreement (CRADA) with Delta and Pine Land Company (DP&L). He reported that a panel led by Dr. Richard Jefferson, a molecular biologist from Australia, had prepared a reference paper on the broader subject on genetic use restriction technologies (GURTs) that helped bring the broader picture of control of seeds into focus. The SBSTTA passed a recommendation to the Conference of Parties to meet in Nairobi in May 2000, to permit countries to ban the use of such technologies as being prejudicial to small farmers. The SBSTTA will meet again in January and there may be more pressure to move this to a world-wide ban. The "FACT SHEET" developed by ARS to respond to issues on TPS is on the web site: http://www.ars.usda.gov/other under "Related Links, Plans and Reports." The Council suggested that there is a continual need for it to be updated to take into account more of the benefits of the technology. The Council also questioned Dr. Parry about how much realistic influence the USDA, as co-owner of the patent, has in managing licenses to the technology. He stated that the government can oversee the use of the technology by encouraging broad sub-licensing to the technology but that the new advisory committee on agricultural biotechnology is seen as important in helping set the policy for the Department. The Council discussed the relevance to the biological control of seeds implicit in hybrid technology and seedless crops (watermelon, grapes) which are seen to provide product benefits rather than simply control seed use. The NGRAC continues to see GURTS issues to be of continuing interest for its impact on small farmers.

7. U.S. Patent and Trademark Office (USPTO) representative, Ms. Alice Zalik, presented an overview of current issues involving patent policy and the upcoming meeting of the World Trade Organization and its Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council. She reviewed the Article 27, paragraph 3 (b)1 of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) treaty on the matter of patents on living organisms.

GATT TRIPS Article 27(3). Members may exclude from patentability: (b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this sub-paragraph shall be reviewed four years after the entry into force of the Agreement establishing the WTO.

One study has shown that the TRIPS provisions are not inconsistent with the CBD, an argument put forth by developing countries for negating the TRIPS provisions. She noted the phase-in in time for various provisions in different countries and that most will have to be in place by January 1, 2000. Developed countries generally do not support extensions of time, broadening of exceptions or creating mandatory exceptions since they were required to implement all provisions upon ratification while developing countries are focused on trying to get extensions due to their perceptions of negative impacts. The least developed of the developing countries have until 2006 to implement the provisions. She noted that the TRIPS Council has only recommending authority to the WTO ministers and cannot take action alone. The TRIPS Council is split down the line between industrialized and nonindustrialized nations on the patentability issue. The NGRAC noted that there could be a harmful shift to trade secret approaches if the patents are not allowed and that would not help make new technologies transparent and available. Ms. Zalik noted that all patents since 1979 are fully disclosed on the USPTO web site. The Council raised the issue about the use of prior art information from outside the U.S. by patent examiners. She noted that printed documents are relied on but they are not always readily available or cited. Some of the recent high visibility challenges to patents by India (the neem tree and tumeric natural product issues) have resulted from unavail- ability of information in a timely manner. Specifically, she noted that a number of inventors from India are patenting in the U.S. because they cannot patent in India. She suggested that other countries could develop means to protect indigenous information and knowledge and gain benefits for their own people.

8. Department of State's Melinda Kimble, now Deputy Assistant Secretary for International Finance and Development in the Economic and Business Affairs Bureau and former Acting Assistant Secretary for the Bureau of Oceans, Environment and International Science (OES), addressed the NGRAC on the status of international negotiations of the International Undertaking (IU) at the Food and Agriculture Organization (FAO) of the United Nations and the CBD's biosafety protocol. She noted that the State Department has continued to ask for Senate ratification of the CBD but prospects don't look good at present. Ms. Kimble's report indicated that while progress was made at FAO on the matter of farmers' rights, the next struggle in developing a multilateral system will be over benefit sharing and international collections. A contact group will meet in Uppsala, Sweden in early September to prepare for the next session scheduled for Rome, September 20-24, 1999. She speculated that the timing was very unfortunate since the same countries will be concluding the highly contentious biosafety protocol negotiations in Vienna on September 19 and the tone of that meeting would likely impact on the FAO meeting. She noted that years have been wasted in conducting surveys and inventories for the CBD and not much has happened to help countries. Now there is the potential for the "precautionary principle" to be invoked so broadly in the name of food safety that food security may be threatened for many of the world's poorest. She noted that people are dying of malnutrition and hunger while unreasonable regulations prevent food from reaching them. Council members noted that unrealistic benefit sharing expectations by some countries have forced some pharmaceutical companies to terminate or drastically change their programs to sample native biodiversity for natural products. In addition cancellations or diminution of interest due to bureaucratic problems encountered in getting permits or in collecting were seen to be a serious loss to the developing countries. Even in Australia, a collector was not permitted to sample a specimen of interest since it was not on the permit's list of species and there was no flexibility to adjust the list.

9. Discussions concerning international germplasm issues dominated much of the following sessions. Issues raised in the last NGRAC meeting on access to international and foreign national collections, reciprocity parity and acceptance of protected materials into the NPGS had a full hearing of views of the NGRAC and public visitors to the meeting. The Council continued to express its concerns and interests in the international issues involving ownership and access to genetic resources. It understands that the international negotiations are difficult and it reaffirms its belief in the benefits that accrue from a position of open access and exchange. The Council recognized the important linkage with and contributions of Melinda Kimble of the U.S. Department of State in supporting genetic resources programs and policies in the international germplasm arena and is pleased with the State Department's unwavering support for the open and free access position of the USDA. The Council supports the USDA to continue this policy unless international agreements and events force a reevaluation of such policy. The Council also supports the USDA to continue its general practice of accepting germplasm for subsequent release without restriction. The Council believes that germplasm exchanges with the IARC system should be dealt with in a uniform and transparent manner across the CGIAR centers and other international collections through the use of uniform MTAs that are visible and available on their web sites/home pages.

10. Mr. Richard Rominger, Deputy Secretary of Agriculture, joined the Council to hear its concerns and interests in topical issues. In doing so, he shared some views on the genomic databases and heard Council views on the importance and need for future USDA participation in the so-called genomic revolution. Noting that considerable funding for agricultural genomes had been put into the National Science Foundation budget and that USDA scientists were successful in sharing of the awards, the Council urged that the USDA be more aggressive about its abilities and capacity to conduct good genomic science. In doing so, the Council suggested that industry should be more forthcoming in forging partnerships to further and broaden the work. Mr. Rominger expressed interest in learning the Council's recommendations on what is being referred to as the "post genomics era" and thanked the Council for its valuable contributions.

11. Members suggested for a future venue that a meeting be held at the Fort Collins long-term storage facility to help the Council better understand the operations of the NGRP. Because of timing, it did not appear that combining a meeting with next spring's ARS National Program Staff Workshop on genetic resources would be feasible.

12. The Ninth Session of the National Genetic Resources Advisory Council developed a single overarching resolution with embodied recommendations to the Department and NGRP. Resolution 4/99 of the Ninth Meeting of the National Genetic Resources Advisory Council The National Genetic Resources Council (NGRAC) reaffirms its previous recommendation to the USDA and the National Genetic Resources Program (NGRP) to develop a road map (more explicit in relevant content than the broad Agricultural Research Service Six-Year Plan) and strategic plan for its genetic resources and genomics programs. Additionally the Council believes that the plan should include but not be limited to the following important items, which are listed in a non-prioritized order:

• Include a mechanism to facilitate the coordination of the NGRAC with other Advisory Committees, in particular those that deal with genetic resources, such as the ones on Agricultural Biotechnology (ACAB) and Invasive Species. This will maximize, or realize, the value of the collective input of the other committees on items of common interest including cooperation in developing educational and information programs for school children, producers and the consumer public about important issues involving genetic resources.
• Build in interagency coordination and budget cross-cut so each agency can capitalize on interagency support and recognition of the USDA's unique capacities and resources. The value of a budget cross-cut is recognized by the White House invasive species initiative and substantiates the wisdom of the Council's previous unfulfilled recommendation that the Department develop a budget cross-cut for the NGRP.
• Develop plans for USDA participation in utilization of the results of current genome projects emphasizing "post-genomic" elucidation of gene function and regulation, particularly as they affect complex traits of agronomic and others of agricultural and environmental importance.
• Address the genomic research needs of other agriculturally important species when currently funded cDNA and complete sequencing projects are finished.
• Incorporate plans for development of physical and human resources required for germplasm conservation and utilization, including current germplasm resource centers for microbes, plants and animals, training of scientists in newer fields such as bioinformatics and genome technologies as well as in traditional fields in a changing disciplinary environment.
• Propose a broad education component to include not only the above-cited training in scientific specialties but also public education on facts, value, and challenges associated with genetic resources.
• Recognize through appropriate program activities that the maintenance of a highly diversified and openly accessible genetic resource collection held both in situ and ex situ is necessary for the future sustainability of our nation. Without diversity of knowledge and biological resources, present and future generations will be unable to respond to uncertain and changing conditions, which in the future will likely require a system that addresses production, natural ecosystem functioning, and diverse social needs such as recreation and culturally-relevant, quality food.
• Incorporate means to enhance current USDA efforts for small farms to remain viable and competitive in an increasingly global marketplace. The process for commitment to small farm development would include additional inputs from 1890 Land Grant universities and the more recently established 1994 tribal Land Grant colleges.

Henry L. Shands
Executive Secretary
October 6, 1999
As edited by the Members

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