Intellectual Property Rights and Biodiversity

Intellectual Property Rights and Biodiversity<br><br>
  1. Intellectual Property Rights and Biodiversity

  2. IPR INFO SHEET GATT & 3rd World Pharmaceutical

  3. Pirates of Diversity: The Global Threat to the Earth's Seeds

  4. rBGH, Monsanto and Corporate Agriculture

  5. A Primer on Agricultural Biotechnology

  6. Patenting Of Life and Its Implications For Indigenous Peoples

  7. The Human Genome Diversity Project and Its Implications For Indigenous Peoples

  8. Genetic Engineering

  9. Releases of Genetically Engineered Plants and Their Impacts on Less

  10. International Policy on Plant Genetic Engineering

  11. GATT and Retail Food Cooperatives

  12. Patent Nonsense: On the Patenting of Life by Dr. Phil Bereano
  13. Towards A Biosafety Protocol

  14. Genetic Engineering Regulations by Michelle Thom Institute for

  15. RUPANTAR - a simple e-mail-to-html converter.

IPR  Intellectual Property Rights & Biodiversity

IPR Intellectual Property Rights & Biodiversity


1.Intellectual Property Rights and Biodiversity

2.IPR INFO SHEET GATT & 3rd World Pharmaceutical GATT and Third World Pharmaceuticals

3.Pirates of Diversity: The Global Threat to the Earth's Seeds

4.rBGH, Monsanto and Corporate Agriculture

5.A Primer on Agricultural Biotechnology

6.The Human Genome Diversity Project and Its Implications For Indigenous Peoples

7. Patenting Of Life and Its Implications For Indigenous Peoples

8. Genetic Engineering

9.Releases of Genetically Engineered Plants and Their Impacts on Less Developed Countries

10.GATT and Retail Food Cooperatives

11.International Policy on Plant Genetic Engineering

12. Genetic Engineering Regulations by Michelle Thom Institute for Agriculture and Trade Policy

13.Patent Nonsense: On the Patenting of Life by Dr. Phil Bereano

14. Towards A Biosafety Protocol


Subject: Intellectual Property Rights and Biodiversity


by Kr istin Dawkins, Michelle Thom and Carolyn Carr Institute for Agriculture and Trade Policy

Intellectual property rights (IPRs) are rights to make, use, and sell a new product or technology that are granted, usually for a period of 17-20 years, solely to the inventor or the corporation which files a claim on the inventor's behalf. They generally take the form of patents, trademarks, or copyrights and have traditionally fallen under the domain of national law. Different countries have produced different IPR laws, each one a balance between industry's desire to capitalize on its investments in technological development and the rights of society to benefit from the knowledge and resources of its country.


Under the new rules of the General Agreement on Tariffs and Trade (GATT)[1] which took effect January 1, 1995, all member countries must bring their national IPR laws into conformity with certain provisions of the new agreement on Trade-Related Intellectual Property Rights (TRIPs). This agreement obliges member governments to provide for "the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof." (Sui generis is a Latin phrase meaning "of their own kind.") Simultaneously, governments are given the option to exclude from patentability "plants and animals other than micro-organisms" and the "essentially biological processes for the production of plants or animals other than non-biological and microbiological processes." These provisions [2] were so controversial during the GATT negotiations that the final agreement states that they "shall be reviewed four years after the date of entry into force" -- in other words, in 1999.

Patenting enables the company to monopolize the market for new plant varieties deriving from the original plant for the term of the patent. Agrecetus, for example, a subsidiary of W.R. Grace, has sought exclusive rights to all genetically engineered varieties of cotton and soybeans in what is known as a "sweeping patent."[3] The cotton patent was granted by the U.S Patents and Trademarks Office (PTO) in 1992 and the soybean patent was granted by the European Patent Convention in 1994. Since then, the sweeping cotton patent was tentatively reversed in January by the PTO after a challenge was issued by the U.S. Department of Agriculture and an anonymous party. The European patent has also been challenged on grounds that genetically engineered plants are neither "novel" inventions nor "non-obvious" innovations, according to the criteria of European patent law.[4]

For pharmaceutical, food and seed companies, and the biotechnology firms behind them, the ability to patent the world's biological diversity brings promise of great new sources of revenue. Monsanto, for example, expects to earn an additional $150 million annually if it is able to patent and bring to market one of its new products: a variety of soybean that is designed to withstand intensive applications of the herbicide which Monsanto itself markets most widely: Round-Up.[5]


In developing new products, scientists take plant samples from the field to the laboratory, where the simple act of moving a single gene from one spot to another within a cell -- whether or not it causes an actual variation in the next generation, creates a "plant variety" deemed sufficiently "new" to qualify as a patentable invention. In most cases, such genetic engineering experiments produce nothing worthwhile. In a few cases, the variations have desireable traits that can be reproduced and marketed.

The emphasis on finding and isolating plants with the most marketable traits leads to the decline of other plant species, as only those required to create the new techno-varieties are cultivated. In the U.S. alone, the focus on commercial varieties has already led to the loss of many varieties of plants in seed bank storage. A survey of U.S. seed banks showed that some varieties of non-commercial crops such as chufas, martynia and rampion have been lost entirely.[6]

In addition, the privatization of genetic resources that have been engineered and patented accelerates the trend toward monocultural cropping. Just as a mere handful of varieties of patented hybrid corn now cover millions of acres of the midwestern U.S. corn belt, where prairies once hosted thousands of varieties of grasses supporting birds and butterflies, bees and other life, so too will the biodiversity of other lands shrink as patented crops take over.

In India, for example, peasant producers now cultivate some 50,000 varieties of rice[7] , developed through traditional practices over the millennia. This astonishing variety arose from subtle differences in soil and climatic conditions through mutation, evolution, and the deliberate application of cultural preferences. The GATT-TRIPs rules would prohibit these farmers from harvesting and reusing the seed of any rice variety that has been patented. (Unlike hybrid species cultivated by plant breeders, genetically engineered plants do produce viable seed.) Lack of access to seed stocks will cause the abandonment of much of India's biologically diverse agriculture, which in turn sustains healthy diversity in surrounding ecosystems.

Patent-holding companies are likely to use the GATT-TRIPs rules to ensure their monopoly rights are upheld. In the U.S., the Asgrow seed company, a subsidiary of the Upjohn company, sued Iowa farmers Denny and Becky Winterboer for harvesting and selling a variety of seed that had sexually reproduced in their field. The company was ruled against and the decision was upheld by a Federal Circuit Court of Appeals. Asgrow has since appealed and the case is about to be heard by the Supreme Court.[8]

Furthermore, an engineered organism may produce unanticipated harmful impacts on other species in its new environment. A group of scientists at Oregon State University, for example, engineered a variety of Klebsiella planticola, a bacteria known to reside in the soil and contribute to the decomposition of plant material. Their goal was to engineer a product that would efficiently convert agricultural wastes to ethanol fuel. Although the project was successful in meeting this goal, the scientists discovered in late stages of testing that the new product also destroyed much of a beneficial mycorrhizal fungus essential to the recycling of nitrogen through plant roots -- which could lead to desertification throughout the range of the product.[9]


The GATT-TRIPs rules prohibit member countries from discriminating, in granting patents, "as to the place of invention" and the "field of technology." These criteria will constrain countries in their use of IPRs as tools for development. The TRIPs agreement provides a 5-year grace period for countries making the transition from centrally-planned to market economies and a 10-year grace period for the least developed countries, which may not be sufficient to accommodate their development needs.

Many countries have allowed patents on processes but not products, and obligated patent-holders through "compulsory licensing" laws to make socially useful products available in the domestic marketplace. These policies have ensured that domestic firms can develop and market products of social value, including medicines and seeds, through reverse engineering. While they may not copy the formula of a patented product, they may create their own formula that produces an identical result. And they may not withold these products from the public.

India, Argentina, and Brazil are countries where these policies have paid off, and where, as a result, strong national opposition to the TRIPs rules has emerged. Historically, India has denied patents altogether in the fields of pharmaceutical and agricultural products, on grounds that these products are essential to the public's welfare. Recently, the Indian Parliament refused to pass legislation that would bring its national IPR laws into conformity with TRIPs.[10] The Argentines have used their IPR laws to develop a strong pharmaceutical sector that has contributed extensively to its national economy and become a powerful competitor in the global marketplace.[11] The Brazilians are seeking to do the same. In both Argentina and Brazil, their Congresses have also fought against altering their national IPR laws to conform with TRIPs.[12]

In the U.S., consumers will pay an additional $1.2 billion in 1996 and 1997 alone for over-the-counter and prescription drugs, as patents are extended from 17 to 20 years in what the Clinton Administration claims is a response to the new GATT-TRIPs rules.[13]

Besides limiting national economic and social development strategies, the GATT-TRIPs agreement will enable biotechnology companies to compete in the world marketplace with commodity exports that form the backbone of many national economies. Biologically-engineered synthetic substitutes for sugar, cocoa and plant oils are already taking over huge segments of the global markets for these commodities, upon which many impoverished African and Latin American nations depend.[14]

The quest for new plants to create new products has resulted in a new "gold rush" known as bioprospecting. Ethnobotanists go to indigenous communities, sometimes offering compensation in the form of gifts or shares in any royalties that may be earned, once a product is patented and marketed. Like gold diggers everywhere, these explorers inadvertently disrupt the indigenous communities. And once disrupted, it may be difficult or impossible for that human community to restore the traditional balance between itself and the ecosystem which has sustained it while being sustained by it. In 1994, FAO Assistant Director-General Obaidullah Khana referred to such bioprospecting as "biopiracy."[15]


In June 1992, more than 150 countries of the world (except the U.S.) signed the U.N. Convention on Biological Diversity, stating their commitment to "the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources."[16] One of the methods to reach these goals is by ensuring "appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding." However, this emphasis on rights is placed in perspective: parties to the Convention are "to ensure that such rights [IPRs] are supportive of and do not run counter to its objectives."

The Clinton Administration sought approval from biotechnology industry representatives before signing the Convention in June 1994. At that time, the Administration published an Intrepretive Statement[17] that redefines the IPR provisions of the Convention in the following ways:

* It declares U.S. patent law provisions an adequate and effective protection of IPRs; the U.S. will not recognize patent laws which restrict patenting nor allow compulsory licensing arrangements.

* It defines "fair and equitable sharing of benefits" very narrowly, requiring that any technology transfer system "take fully into account exclusive rights to technology that a party may possess, and ... that Parties [to the Convention] must ensure that access to and transfer of technology recognize and are consistent with adequate and effective protection of intellectual property rights."

* It warns that the U.S. will "strongly resist any actions taken by Parties to the Convention that lead to inadequate levels of protection of intellectual property rights, and will continue to pursue a vigorous policy with respect to the adequate and effective protection of intellectual property rights in negotiations on bilateral and multilateral trade agreements."

In other words, the U.S. will demand that IPR protection under the Convention on Biological Diversity is consistent with the GATT.


The Convention on Biological Diversity establishes important principles regarding the protection of biodiversity while recognizing the vast commercial value of the planet's store of germplasm. However, the recent expansion of international trade agreements establishing a global regime of intellectual property rights creates incentives that may destroy biodiversity, while undercutting social and economic development opportunities as well as cultural diversity. Countries are now under pressure to change their IPR laws to conform with the TRIPS agreement of the GATT. These rules will supersede national laws and allow privatization of the world's knowledge and resources. The ability of companies to gain monopolies over what were formerly freely available community resources -- seeds, plants and even micro-organisms -- will have devastating effects on both human communities and the protection of biodiversity.

1 Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations. Marrakesh, 15 April 1994.

2 Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 27, 3(b), Annex 1C to the Final Act, cited above.

3 "Plant Patent Dispute Reaches Standoff." AGWEEK. December 12, 1994.

5 Burstiner, Marcy. "A Seedy Business." Multinational Monitor. March 1988.
6 Fowler, C. and P. Mooney. Shattering: Food, Politics and the Loss of Genetic Diversity. University of Arizona Press. 1990.

7 Navdanya. Cultivating Diversity. Research Foundation for Science, Technology and Natural Resource Policy. Delhi, India. 1993.

8 Asgrow Seed Company v. Denny Winterboer and Becky Winterboer. Brief Amici Curiae of Rural Advancement Foundation International, Friends of the Earth, Seed Savers Exchange, et al. October 1994.

9 Hill, Richard L. "OSU study finds genetic altering of bacterium upsets natural order." The Oregonian. August 8, 1994.

10 Hazarika, Sanjoy. India Presses U.S. to Pass Biotic Treaty. The New York Times. April 23, 1995.

11 Challu, Pablo M. "The consequences of pharmaceutical product patenting." World Competition. December 1991.

12 "Argentine Patent Measure Heads for Veto by Menem." Journal of Commerce. April 12, 1995 and "Vote on Patent Law Further Delayed in Brazil." Journal of Commerce. April 28, 1995.

13 Schondelmeyer, Stephen W. The Prime Insitute.

14 Abugre, Charles. "Understanding the Commodity Problem in the Context of the Changing Order." Third World Network. August 1991.

15 "FAO Official Blasts Western Biopiracy." Reuter. June 6, 1994.

16 Convention on Biological Diversity. United Nations. June 1992.

17 Statement from the President of the United States transmitting the Convention on Biological Diversity. 103rd Congress, 1st Session. Treaty Document 103-20. USGPO, Washington DC. 1993.


One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. To receive a complete listing, send email to: ipr-info@iatp.or

  Dale Wiehoff
  Communications Director
  Institute for Agriculture and Trade Policy (IATP)
  1313 5th St.,SE, Suite 303
  Minneapolis, MN 55414-1546 USA
  Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: IPR INFO SHEET GATT & 3rd World Pharmaceutical GATT and Third World Pharmaceuticals
by Azra Talat Sayeed
July 1994

The Uruguay Round of General Agreement on Tariffs and Trade (GATT) will hinder the Third World from attaining self sufficiency in pharmaceutical production. Low-income consumers will be saddled with higher prices when they attempt to buy essential medicines. They will also discover that many life saving medicines are simply not available. This will happen because Third World drug manufacturers will be discouraged from entering production, or forced out of business altogether, by pharmaceutical transnational corporations (TNCs).

Negotiators of GATT addressed Trade Related Intellectual Property Rights (TRIPS) agreements in great detail, but little attention was paid to the needs of the people of the Third World. The need for local firms to develop home-based expertise and capital was ignored. The Uruguay Round also shifted legal protections further in the favor of TNCs.

Burden of Proof

One of the most potent powers granted to TNCs in the Uruguay Round is the placing of the burden of proof in patent disputes on Third World manufacturers. Article 34 states: "... if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process." This places Third World firms at great risk for patent suits by TNCs because they do not have the resources to defend themselves. The accused manufacturer must demonstrate that it has not violated process patents TRIPS.

The TRIPs agreement protects a product patent for 20 years from the date of filing and then extends another 20 years protection to the manufacturing process if the process is new. Once a product patent has expired, other manufacturers can also manufacture a given product. However, if the manufacturing process is still under protection, the new entrant needs to develop an alternative production process. The burden of proof is on the secondary manufacturer to show that their new process is in fact unique.
BR> Small firms may not be willing to enter the market for fear of legal action. If such producers stay out of the market, monopolies already present will become more powerful in the Third World drug trade. This lack of competition will increase prices and lower customer service. To make Article 34 fair, the burden of proof should rest on the accuser and not the accused.

High Prices

The present placement of the burden of proof on the accused will severely limit the capacity of the indigenous pharmaceutical industry to compete with TNCs. Already, the pharmaceutical industry requires huge capital investments and expensive product promotions, so little place is available for indigenous industries to create market share for themselves. Pharmaceutical TNCs will be able to create monopolies resulting in extremely high prices of medicines in the Third World.

Argentina offers a powerful example. Nearly all pharmaceuticals marketed by Argentinean drug firms are now sold at a prices ranging from 15-80 % lower than global corporation prices.1 This is the opposite of 15 years ago, when the Argentinean industry was just getting a foothold.2 With local market loyalties and efficient production, these firms can now provide low cost pharmaceuticals to the public. In addition, Argentina has a small export market for pharmaceuticals. The Argentinean pharmaceutical industry built a strong presence by locally producing and marketing drugs to the public at prices much lower than those of the TNCs. They were able to do so by defying and ignoring international patent systems created and promoted by the European nations and the United States. This allowed the Argentineans to compete with transnational pharmaceutical firms and also forced the transnational corporations to provide their products at competitive prices. Following are some price differentials in pharmaceutical products between the Argentinean and US markets3 :

Active Ingredient    US Market (US$)   Argentinean Market      (US$)
                      Brand Name      Foreign or Licences      Domestic

Ciprofloxacin           106.82                  14.20           13.15
Ketoconazole            240.05                  36.10           26.65
Ranitidine               84.23                  21.95           11.76

A similar experience can be seen in the case of India. India, using its compulsory licensing clause, allowed for the development of a national pharmaceutical industry. The indigenous industry has been capable of producing many essential drugs for its people at affordable prices. This would no longer be possible under the Uruguay Round. In fact, the independence of the Indian pharmaceutical industry has already been seriously undermined through unilateral trade measures taken by the United States4; a thrust which was largely brought about by the intervention of the US pharmaceutical industry. India has now changed its patent laws to conform with most of the US demands. Consequently, Indian manufacturers will no longer be able to provide affordable drugs to Indian consumers. Compare what India was able to do for its people with its domestic patent laws through a price comparison between products available in the Indian and Pakistani markets5:

Drug           India (Indian Rs.)      Pakistan (Indian Rs.)   US (Indian Rs

Ciprofloxacin           51.00                   234.63              305.21
Ketoconazole            43.00                   221.96              673.67
Ranitidine              29.30                   260.40              744.65
The Burden of Costs

The Third World has already paid a price to comply with U.S. patent protections in many ways. The following problems need to be addressed.

Non-use of a patent: In many cases, TNCs will apply for a patent in a particular country but will not actually set up manufacturing facilities. This means the drug itself is imported, but not the production process. As a result of the patent protection local firms cannot enter into production. These imported patented products are more expensive and negatively impact the balance of trade of a developing country. Article 27 of the TRIPS agreement will further extend this very leeway to corporate business. The wording of the article is as follows: ". . . patent shall be available and patent rights enjoyable without discrimination . . . whether products are imported or locally produced."
BR> It is imperative that the above clause be reevaluated due to its immense negative impact on the balance of trade of Third World countries. By producing products within the territories of a Third World country, the process would not only transfer technology (the basic premise for awarding patent protection), it also would provide a job market for the local population.

Licensing and Process Agreements: When TNCs do license their production processes to Third World manufacturers, they often do not allow their licensees to export products to other countries. Such agreements are not considered "barriers to trade" under GATT, though they certainly serve to restrict access of pharmaceuticals to many markets. Moreover, if employees at a Third World plant improve the product to bring about an innovative product, they usually are required to grant all patent rights back to the parent company6 so legal benefits stay in the hands of First World corporate owners. Further, many process agreements ban the establishment of research and development facilities by the licensee, charge excessive royalties, or force the Third World firm to buy inputs from the patent holder.7 Each of these limits the opportunity to develop indigenous industries and transfers wealth out of the Third World.

Transfer Pricing: Pharmaceutical TNCs will sell products (patented and otherwise) to their subsidiaries at prices that are 87-2,900% higher than found in open markets.8 This allows subsidiaries to show a net loss on their accounts thereby evading taxes in host countries. At the same time, subsidiaries will buy ingredients such as sugar from the parent company at excessive prices. Such manipulation of these prices has a negative impact on the balance of trade for Third World countries. If patents were abolished, then indigenous firms would be free to purchase all products from open markets, and hence not suffer such severe price manipulation.
< R> Without the patent protection of the TRIPs agreement, TNCs would be willing to set up joint ventures with indigenous firms as they want access to markets even at the expense of sharing profits. This would allow indigenous firms to gain access to more sophisticated technologies and products which might not be available otherwise.

In short, it can be seen that patents in general benefit the TNCs and stifle the growth of industry in the Third World. Patent protection has never been able to provide the transfer of technology, especially for the Third World. The GATT agreement on TRIPs creates a far more stifling arrangement. There is no reason to believe that it will generate any benefits to the developing world.


1 Pablo M. Challu. The consequences of pharmaceutical product patenting. World Competition, December 1991, Vol. 15 No. 2.

2 Daniel Chudnovsky. The challenge by domestic enterprises to the transnational corporations' domination: A case study of the Argentine pharmaceutical industry. World Development, Vol. 7, pp. 45-58, 1979.

3. Pablo M. Challu. The consequences of pharmaceutical product patenting. World Competition, December 1991, Vol. 15 N0. 2., p. 107.

4 The unilateral trade measure is taken through The Omnibus Trade and Competitiveness Act of 1988. The act's Super 301 provisions allow the United States Trade Representative to undertake trade investigations and identify nations that enact trade practices against the US which are 'unreasonable' or 'unjustifiable.' The identified countries are obliged to alter those practices or suffer a loss of trade with the US.

5 B.K. Keayla & Biswajitt Dhar. Indian Pharmaceutical Industry and Patent Regime for Drug Security, in Patent regime in TRIPs. National Working Group on Patent Laws. September 1993, pp. 14-16.

6 Owen T. Adikibi. The multinational corporation and monopoly of patents in Nigeria. World Development. Vol. 16, No. 4, pp. 511-526, 1988.

7A rman S. Kirim. Reconsidering patents and economic development: A case study of the Turkish pharmaceutical industry. World Development Vol. 13, No. 2, pp. 219-236, 1985.

8 Gary Gereffi. The phamaceutical industry and dependency in the Third World. Princeton University Press, 1983.

For further information please contact:
Azra Talat Sayeed
7-115 HSUF
Graduate Studies in Social and Administrative Pharmacy
University of Minnesota
308 Harvard Street S.E.
Minneapolis, MN 55455
Phone No.: (612) 624-1198
Fax No. : (612) 625-9931

One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing send email to:


    Dale Wiehoff
    Communications Director
    Institute for Agriculture and Trade Policy (IATP)
    1313 5th St.,SE, Suite 303
    Minneapolis, MN 55414-1546 USA
    Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: Pirates of Diversity: The Global Threat to the Earth's Seeds
by Karen Lehman
Institute for Agriculture and Trade Policy
July 1994

Each spring, seeds push through the furrowed earth like ships bearing the cargo of millenia. What they carry within is both an antique and a promise, the treasure trove of the earth's genetic diversity. Today, these awesome vessels of power are threatened by a new form of piracy, one which can destroy diversity itself in the blind rush to capture its fruits.

For centuries, seeds moved freely across the continents on the wind, in birds' bellies, in traders' caravans, conquerors' pockets, and imigrants' knapsacks. They were available to all, the sole property of none, the common heritage of the planet earth.

The common misunderstanding about the world's seeds is that they were naturally occurring. But behind every food crop seed there was a long line of farmers who literally created them through a process the Mende people of Sierra Leone call "hungoo," meaning innovation or invention. Just as the yucca moth and the yucca cactus have evolved together, so have the world's people and its grains.

Early on, the forerunners of agribusinesses transplanted bananas and sugarcane from Asia and coffee from Africa to Latin America and produced them in heavily policed plantations for export to European countries. The French outlawed the export of indigo seed from Antigua and the Dutch destroyed all of the nutmeg and clove trees in the Molucca Islands after they had established their own plantations. By separating the seed from its cultural root, the colonizers changed it forever from the living symbol of a community's history into a commodity.

The United States is known as the breadbasket of the world-yet of the food and industrial crops so abundantly harvested each fall, only one, the sunflower, is native to this continent. All 15 U.S. food crops worth $1 billion or more depend on genetic material from other countries: corn, potatoes, tomatoes and cotton from Latin America; rice and sugar cane from Indochina; soybeans and oranges from China; wheat, barley, grapes and apples from West Central Asia.

In the early 1960 s, the United States passed a law granting plant breeders the rights to patent seeds, thus preventing others from selling the same variety. Having made billions of dollars on seeds developed by farmers in other lands, seed companies are now taking the final step to ensure a neverending source of revenue. They are trying to force all countries to recognize patents on seeds through a set of trade accords called the General Agreement on Tariffs and Trade. If they succeed, farmers will be forced to pay royalties to companies who hold patents on the genetic material they or their ancestors helped to shape.

This new form of genetic piracy has an interesting name, "intellectual property rights," which are defined as the rights to protection of innovation. Intellectual property rights would only be recognized when they generated profit, which occurs when a worker pulls a gene out of a seed in a Boston laboratory, but not when a Mende farmer saves some seeds and rejects others. Intellectual property rights are also only respected when the innovation is capable of industrial application. Pioneer Hi-Bred can be protected when it mass produces seed varieties, but the Indian farmer who collects and saves seeds for next year's planting cannot.

This means that innovation that took place in communities over centuries, or even inovation in plant varieties that takes place in the present in a communal fashion, is not eligible for protection. As more power is concentrated in the hands to the corporate gene manipulators, the genetic diversity that has been tended by farmers in millions of fields around the world is lost.

On October 2, 1993, 500,000 Indian farmers demonstrated against passage of the General Agreement on Tariffs and Trade and vowed to protect their right to produce and protect their own seeds. They created a charter of farmers' rights, especially the right to conserve, reproduce, and modify seed and plant material. They speak for the rest of the farmers of the world who want to continue their partnership of hungoo with the vegetable kingdom. Resistance to the piracy of the earth's diversity could ensure that for future generations, seeds will continue to be the fruit of our common heritage and not the exclusive property of the gene splicers.

This is a condensed version of an article originally published in The Heart of the Beast Puppet Theatre 20th Annual May Day Parade Commerative Booklet, May 1994, Minneapolis, MN.

------------------------------------------------------------------------ One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing send email to:

   Dale Wiehoff
   Communications Director
   Institute for Agriculture and Trade Policy (IATP)
   1313 5th St.,SE, Suite 303
   Minneapolis, MN 55414-1546 USA
   Tel: (612) 379-5980 Fax: (612) 379-5982



Subject: rBGH, Monsanto and Corporate Agriculture


by Michelle Thom
Institute for Agriculture and Trade Policy
August 1994


In the early 1980s, four chemical/pharmaceutical companies, with the help of university scientists, began researching a new technology they believed would revolutionize the dairy industry. Through genetic engineering, researchers created recombinant bovine growth hormone (rBGH) to increase milk production in dairy cows by 10 to 25 percent.

The four companies promoting the research are Monsanto, Upjohn, Eli Lilly and American Cyanamid. Only the Upjohn version of the drug is identical to the naturally occurring hormone, bovine somatotropin (BST), responsible for lactation in dairy cows. The other three drugs differ in their chemical composition.

These companies have collectively invested over $1 billion in the research and development of rBGH. Monsanto is the only company to receive approval from the Food and Drug Administration (FDA) to sell its rBGH product, Posilac, commercially. The other three companies' products remain in the FDA pipeline awaiting approval.

The FDA Approval Process

The FDA approved Monsanto's rBGH product, Posilac, for commercial use on November 5, 1993. A 90-day moratorium on the sale of rBGH ended on February 3, 1994. Posilac went on sale the following day.

In reviewing the safety and efficacy of rBGH, the FDA decided in 1985 that the drug posed no threat to human health. Studies indicate the use of rBGH increases the presence of the protein hormone Insulin-like Growth Factor-one (IGF-1) in milk. The FDA maintains that toxicity studies show IGF-1 is inactive when ingested by rats and is rendered obsolete under conditions used to process milk into infant formula.

Scientists such as Dr. Samuel Epstein of the University of Chicago's School of Public Health claim IGF-1 "induces the malignant transformation of normal human breast epithelial cells." And in recent testimony before the Minnesota Senate Agriculture Committee, Dr. Michael Hansen of the Consumer Policy Institute stated: "IGF-1 has been associated with the growth of numerous tumors, including colon, smooth muscle and breast."

Despite no long-term studies on the human health implications, the FDA concluded that "the use of recombinant bovine growth hormone in dairy cattle presents no increased health risk to consumers."

The FDA's Center for Veterinary Medicine (CVM) concluded rBGH was safe for animals in 1993. At issue was whether the use of rBGH increased the incidence of mastitis, or udder infections, in cows treated with the drug. At hearings last spring, former CVM Director Gerald Guest testified that rBGH does not cause or increase the severity of mastitis in treated cows. A spokesperson for Monsanto told the panel that the incidence of mastitis rises with increased milk production regardless of whether rBGH has been used.

Another researcher, Dr. Dale Bauman, who led a Monsanto-funded rBGH trial at Cornell University, claimed that the increase in mastitis in his study was not due to the use of rBGH, but to a higher presence of mastitis in the herd prior to treatment. The Cornell study concludes "animals were in good health throughout the study" and "no incidences of catastrophic health effects ... were observed." Bauman also stated in a 1987 letter on Cornell University stationery that he is a consultant for Monsanto and American Cyanamid.

A University of Vermont study, also funded by Monsanto, showed a four-fold increase in the number of cows that had to undergo antibiotic treatment for mastitis. Researchers involved in this study claimed that such a figure is inaccurate as the herd size in this particular study was very small - only 40 cows.

The FDA concluded in its own November 1993 Freedom of Information Summary that the increased risk of clinical mastitis to cows is 79% overall and 97% for first calf, or primiparous, heifers. Reviewing the data from the above-referenced Cornell University trial, Dr. Michael Hansen concluded the incidence of mastitis was 3.5 times higher among the treated herd than the control herd. Testifying at the CVM hearings, Hansen said, "We do not see how FDA can say a drug that causes disease is safe."

Yet the FDA accepted with little question industry-funded studies such as those performed by the University of Vermont and Cornell University upon which the agency based its final approval of Monsanto's Posilac product.
BR> The congressional watchdog General Accounting Office (GAO) also expressed concern about the mastitis issue for another reason. The GAO was concerned that the increased incidence of mastitis would lead to the use of antibiotics, which could end up as residues in the nation's milk supply. Unnecessary exposure to antibiotics can lead to a resistance to their intended effects by the bacterial or viral diseases they are supposed to fight off.

In approving rBGH, the FDA concluded that increased mastitis as the result of rBGH use did not pose a significant antibiotic residue risk to consumers. The FDA maintains that current tests detect antibiotic residues before they reach the consumer in fluid milk and dairy products. However, the FDA failed to acknowledge the conclusion of a 1992 GAO report entitled "FDA Strategy Needed to Address Animal Drug Residues in Milk." The GAO report concluded, "States are generally testing milk for only the same four animal drugs as they were in 1980, while up to 82 drugs that may leave residues in milk are known to be or are suspected of being used on dairy cows."

Despite over 100 studies on rBGH, too many contradictions exist to confidently believe these issues have been adequately addressed by the FDA.

Consumers Hate It, Farmers Don't Want It and the Cows Get Sick Thinking About It This became the phrase that characterized the reaction of farmers, consumers and public interest groups around the nation on February 4, 1994.

In reaction to approval of rBGH, coalitions of diverse interests began forming around the nation in an attempt to get rBGH off the market. The main reasons for rejecting the drug include:

* The FDA has not adequately studied the impacts of this product on human health. The FDA's conclusion that rBGH will have no adverse effects on humans was based on tests on human dwarves in the 1950s and a Monsanto test on rats in the 1980s.

* Monsanto admits in its own packaging that rBGH can increase mastitis, thereby creating the potential for increased use of antibiotics, which could end up in the milk supply. Other problems highlighted in the Posilac packaging include: "reduced pregnancy rates;" "an increased risk for clinical mastitis;" "increased frequency of medication;" "increased body temperature unrelated to illness;" "increase in digestive disorders;" "increased numbers of enlarged hocks and lesions," and the possibility of injection site reactions "that remain permanent but are not associated with animal health problems."

* A Minnesota farmer who participated in an American Cyanamid trial over two lactation periods said his herd experienced breeding problems; multiple births; deficient body condition; 100% failure to conceive after the second lactation; a 19% death rate; and a 15% "down cow" rate. Cyanamid refused to pick up the data from this trial and Dr. Brian Crooker, a University of Minnesota researcher, attributed "the farmer's results" to poor management. The farmer is a graduate of Penn State's College of Agriculture and a multiple winner of Holstein Breeder Association awards. To this day, the farmer remains under a Cyanamid "gag order."

* Dairy farmers are already suffering from an overloaded milk market and depressed dairy prices. With the approval of rBGH, production is up 8% in California; 8% in Texas; 10% in Idaho; 29% in New Mexico; and 20% in Arizona. In addition, the National Cheese Exchange fell 20% in recent weeks. A monthly survey of the Cheese Exchange prices sets the so-called Minnesota-Wisconsin (M-W) price for fluid milk, which is used as a benchmark price for other regions of the country. Thus, the price paid to farmers for their milk is also down 20%.

If prices continue to drop, more already-vulnerable family dairy farmers will be forced out of business. The Dairy Debate estimates that 40,000 dairies, or 30% of the nation's dairy industry, will be forced out of business if widespread adoption of rBGH occurs. Some estimates are that for every seven farms that fail, one rural business fails as well. The advent of rBGH represents "the probable acceleration of restructuring and concentration of production within the dairy industry."

Corporate Agriculture: The Monsanto Case

Prior to the approval of rBGH, the St. Louis-based Monsanto company earned the bulk of its income from two products - NutraSweet and Roundup.

NutraSweet is an artificial sweetener used in a number of products ranging from carbonated sodas to chewing gum. The European patent on NutraSweet recently expired, leaving part of Monsanto's revenue stream vulnerable.
< R> Roundup, one of the most popular herbicides on the market today, is packaged in a variety of forms to suit anyone from the farmer who works with hundreds of acres to the backyard gardening enthusiast. The patent on this product is set to expire before the turn of the century.

As a result of expiring patents, Monsanto is looking to other products of biotechnology to provide its future revenue sources. Products like Posilac are Monsanto's saviors. Its multi-million dollar investment in the development of rBGH is going to have to pay off if the company is to survive. The company is using threats of legal action to keep rBGH from being a commercial failure. Monsanto is suing Swiss Valley Farms of Davenport, IA and the Pure Milk and Ice Cream Company of Waco, TX for what it calls "false and misleading" labeling practices in an effort to stop companies from "defaming" its rBGH product.

Farmers and Consumers Respond

Meanwhile, farmers are struggling to reclaim agricultural production before it is entirely co-opted by the interests of companies like Monsanto. One strategy used by the National Farmers Union is a boycott of Monsanto products. NFU is asking farmers not to purchase Monsanto products for this year's growing season. In addition, they are asking consumers to avoid using Roundup in their gardens and to end their use of products containing NutraSweet.

In addition to the boycott, farmers are also uniting with consumers around the issue of rBGH and food safety. Minnesota Safe Food Link is one such organization which seeks to educate consumers and farmers about the mutual concerns of food safety and fair family farm policies.

Minnesota Safe Food Link is pursuing a variety of other avenues to educate the public about rBGH. Among the group's activities are:

* The passage of school board resolutions and city labeling ordinances;
< R> * Organized pressure on processors and grocers to provide and label rBGH-free milk; and

* State legislative initiatives for voluntary labeling of milk derived from cows not treated with rBGH.

This unification of farmers and consumers around the mutual interests of food safety and fair farm policies is integral to stopping corporate agriculture from controlling our food production system from the field to the table.

Works Consulted

Juskevich, J.C. and C.G. Guyer. "Bovine growth hormone: human food safety evaluation." Science. V. 249. August 1990.

Epstein, S. S. "Letter to FDA Commissioner David Kessler." February 14, 19 4.

Hansen, M.K. "Testimony Before the Committee on Agriculture and Rural Development of the Minnesota Senate on Voluntary Labeling of Products Not from rBGH-Treated Cows." March 21, 1994.

Kronfeld, D.S. "Health Management of dairy herds treated with bovine somatotropin." Journal of the American Veterinary Medical Association. V. 204(1). January 1, 1994.

Bauman, D.E., D.L. Hard and B.A. Crooker, et al. "Long-term evaluation of a prolonged release formulation of n-methionyl bovine somatotropin in lactating dairy cows." Journal of Dairy Science. V. 72(3), 1989.

"Farm Group Alleges Use of BGH Lowering Prices." The Times Argus. May 18, 19 4.

Liebhardt, William, ed. The Dairy Debate. Davis, CA: University of California, 1993.

Sunness, Sheldon. "Malice in Dairyland." Z Magazine. January 1990.

Monsanto Agricultural Group. Posilac Product Label. 1993.

Thom, Michelle. Biotechnology News Bulletin. April 6, 1993.

FDA Strategy Needed to Address Animal Drug Residues in Milk. General Accounting Office. August 1992.

One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing send email to: /a>

   Dale Wiehoff
   Communications Director
   Institute for Agriculture and Trade Policy (IATP)
   1313 5th St.,SE, Suite 303
   Minneapolis, MN 55414-1546 USA
   Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: A Primer on Agricultural Biotechnology

A Production of the Shiva Working Group on Global Sustainability* January 1995

Genetic engineering techniques are currently being used to produce a wide range of new products, which the biotechnology industry believes will benefit all citizens. Most research involves plants and animals although some effort is now being put on genetically engineered microbes, such as nitrogen fixing bacteria, frost suppressive bacteria, and some microbial soil amendments. Following is a sample of the rationales promoted by the industry for experimenting with agriculturally-related genetically engineered products.


* Herbicide tolerant plants won't die when sprayed with broad-spectrum herbicides, thereby allowing the herbicide to be used more.

* Insect and disease resistant plants contain toxins and other factors produced by other organisms, including bacteria, scorpions and other venomous organisms. The toxins enable the plant to resist pests.
* Delayed ripening allows food to be shipped farther. For example, genetic engineering allows the regulation of ripening in the trademarked FLAVR SAVR tomato.

* Environmental tolerance enables plants to become more drought resistant, freeze tolerant, and so on. This allows the geographic range of crops such as corn and soybeans to expand, potentially intensifying monoculture cropping and transforming local economies.

* "New commercial products" such as "pharm" plants that produce pharmaceuticals or modifications to canola and soy oils to enhance their use as industrial chemical inputs for the production of frivolous specialty soaps and cosmetics


* Essential nutrients may no longer be required in animal feed if animals are engineered to no longer need these nutrients. Will this result in new chemicals in the animal?

* Faster development may result from engineering animals that eat more or digest more efficiently so that they can grow larger and/or be slaughtered earlier. However, growing fast creates problems for the animal; some of these animals may be more prone to disease and stress.
BR> * Environmental tolerance is a factor being engineered in certain animals that currently cannot tolerate cold or heat or wet or dry. The animals would be able to withstand these environmental extremes so that they can be produced in now inhospitable areas--possibly leading to their escape and ability to out-compete wild species.

* "Quality modification" in animals that are engineered to produce characteristics humans find good to eat. The most well-known example is the genetically engineered lean but crippled pigs.

* "New commercial products" may "include "pharm" animals, similar to the concept of "pharm" plants. Examples would be cows or goats from which pharmaceuticals can be extracted from the milk.

* Bioinsecticides use genetically engineered viruses and bacteria to kill insects. Whether these microbes can escape and infect other organisms is not yet known.

* Artificial hormones stimulate faster growth, greater milk productions, and so on.. However, they also cause greater incidence of the disease mastitis, requiring the use of antibiotics which flow through the milk for human consumption.


The public must be kept informed about new developments in genetic engineering. The more informed we are, the more opportunities we will have to make informed decisions about these products. Labeling is one way to ensure the public can make an informed decision. Demanding that regulatory bodies such as the Food and Drug Administration put labels on genetically engineered foods can ensure the public's right-to-know about the latest events in genetic engineering.

In the U.S., only Minnesota and North Carolina have as yet regulated the development and use of genetic engineering. To find out what regulations may be under consideration in your area, contact your state legislators and local extension agents.

As soon as possible, governments, in cooperation with scientific experts and non-governmental organizations, should develop and adopt an international, legally binding protocol to control genetic engineering and the release of genetically engineered organisms to the environment.

The Shiva Working Group on Global Sustainability is a coalition of faculty, students and community leaders in Minnesota.


One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing send email to:

    Dale Wiehoff
    Communications Director
    Institute for Agriculture and Trade Policy (IATP)
    1313 5th St.,SE, Suite 303
    Minneapolis, MN 55414-1546 USA
    Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: Patenting Of Life and Its Implications For Indigenous Peoples
> by Debra Harry, Northern Paiute Nation, Nevada January 1995

Though it seems like science fiction in the minds of most people, genetic engineering is a current reality and is common practice in laboratories around the world. "With genetic engineering technology today, it is possible to manipulate the 'blueprints' of living isolate, splice, insert, rearrange, recombine and mass-reproduce genes."1

Scientists are capable of reprogramming the genetic codes of living things to suit societal or economic purposes. Transgenic experiments mix plant genome with that of animals, human genome with that of plants or animals. Does anyone have a right to own a life form or to commodify parts of the human body for profits? The ethical and legal questions raised by genetic engineering technology are numerous and unanswered. This area of biotechnology remains virtually unregulated.

Patent law is the primary vehicle which enables scientists to secure exclusive rights to the commercial benefits of their genetic research. Patent laws grant a limited property right to the patent holder, and exclude others from using the patented item for a specific period of time, usually for a 17-20 year period. Patents are usually granted for newly created inventions, as a means of recognizing the scientist's "intellectual property rights."

There has been a disturbing trend in patent law that extends patent protection to life forms since 1980 when the U.S. Supreme Court ruled that the creation of an oil-eating microbe is patentable.2 Since then, the U.S. Patent and Trademark Office (PTO) has granted numerous patents for newly created micro-organisms, living animals, and for human tissues and genes, breaking long-standing policy that animate life forms were not patentable.
In 1994, negotiators of the Uruguay Round agreement of the GATT established global rules requiring member nations to award bio-engineers exclusive rights to monopolize the development and commercialization of "plant varieties either by patents or by an effective sui generis system..."3 ("Sui generis" is a Latin phrase meaning "of like kind.") Governments that choose to ensure that the benefits of genetically-manipulated plants accrue to the public may be subject to challenge in the GATT's system of dispute resolution. This "TRIPs" chapter of the GATT -- which stands for "Trade-Related Intellectual Property Rights" -- must be reviewed in 1999.
Patenting Human Cell Lines

Putting questions of inventiveness aside, these trends have enabled scientists to hold patents for a wide variety of life forms, including almost 5% of the entire human genome. There is now a rush for control of the remaining 95% of the human genome.

In 1993, a patent claim was filed under the name of U.S. Secretary of Commerce Ron Brown, on the cell line of a 26 year old Guayami woman from Panama. Patent Claim WO 9208784 A1 was lodged for the Human T-Lymphotropic Virus Type 2, drawn from the "immortalized" DNA of the Guayami woman. Her cell line is of interest because some Guayami people carry a unique virus and whose antibodies may prove useful in AIDS and leukemia research. International protest and action by the Guaymi General Congress and others led to the withdrawal of the patent claim in November 1993.

On behalf of the U.S. Department of Commerce, Secretary Ron Brown filed patent claims on the human cell lines of indigenous people from the Solomon Islands.4 The Government of the Solomon Islands has demanded the withdrawal of the patent applications citing an invasion of sovereignty, lack of informed consent, and moral grounds as the reasons for protest. The Government of the Solomon Islands also demanded the repatriation of the genetic samples. However, in a response letter dated March 3, 1994 to the Ambassador of the Solomon Islands, Secretary Ron Brown states "there is no provision for considerations related to the source of the cells that may be the subject of a patent application." In other words, how the genetic samples were obtained is of no legal concern to him, in accordance with existing patent laws.


The Human Genome Diversity (HGD) Project is taking blood and tissue samples from indigenous peoples of 722 communities throughout the world for genetic studies.5 This raises troubling questions regarding the definition of genetic materials as "property", the ownership of the genetic samples themselves, and who stands to profit from the commercialization of products derived from the samples. The HGD Project puts the raw resource, that is, the human genes of indigenous people, in the hands of anyone who wants to experiment with them. In doing so, the HGD Project is opening the doorway for widespread commercialization and potential misuse of the samples and data. While the HGD Project does not plan to do genetic engineering, no safeguards exist to prevent others from doing so with the genetic samples collected.

It appears the colonizers, this time as well-funded and equipped "bio-prospectors", have their eyes on appropriating the natural resources of indigenous people to benefit those in the developed world. The HGD Project enables the staking of claims on the natural genetic resource base of indigenous peoples. Some of those claims will strike it rich, in the form of patentable genes. The research, manipulation and inevitable commercialization of the genetic data or samples will benefit those who can afford it, and the developers and investors who commercialize it. There will be minimal or no direct benefit to the people from which the natural resource is taken.

The HGD Project suggets that contract law is one way for indigenous peoples to protect their intellectual property rights, and to maintain control over the use of the genetic samples. Given the lack of any international policies or regulations governing the trade of human genetic materials, contracts may well afford the best legal protections and tool for defining the terms of exchange. However, indigenous peoples must be reminded that previous experience with contract law, treaties and other legal agreements have afforded negligible protection in the past, particularly on the domestic levels. International enforcement and monitoring of these agreements or contracts would most likely prove much more difficult.

The Case of John Moore

In 1984, John Moore filed a lawsuit claiming that his blood cells were misappropriated while he was undergoing treatment for leukemia at the University of California, Los Angeles Medical Center.6 During his treatment, Moore's doctor developed a cell line which proved valuable in fighting bacteria and cancer. The UCLA Board of Regents filed a patent claim on this cell line and commercially developed valuable antibacterial and cancer-fighting pharmaceuticals. Moore claimed that he was entitled to share in profits derived from commercial uses of these cells and any other products resulting from research on any of his biological materials.1 In a significant 1990 California Supreme Court decision, the court established that a donor does not have a "property right" in the tissues removed from his or her body.7 The court further reasoned that to favor John Moore's claim would "...hinder research by restricting access to the necessary raw materials," thereby interfering with the progress of science.8

Indigenous people must be aware that it may be extremely difficult or impossible to recover or repatriate the genetic samples, our blood, tissues, or body parts, once they are removed from our bodies and are out of our control.


Indigenous people must call for a world-wide moratorium on the collection, databasing, manipulation, and commercialization of human cell lines and their genetic resources.

Indigenous peoples need to determine the extent of existing international protections for genetic resources, and participate in the development of international policies which fully protect the resources of indigenous peoples from further theft, appropriation and exploitation.

Indigenous peoples must assert their sovereign right to manage and protect their peoples, resources and knowledge, as stewards of their territories and their people's future generations, and these rights must be respected and protected by non-indigenous peoples and nations as ethically, legally and morally correct.

Intellectual property rights represent Western notions that one can have "ownership and property right(s)" extended to all facets of the natural world. Western laws are paradoxical to Indigenous cosmologies which revere the sanctity of all life, and mandate human responsibility to serve as stewards, not owners, of the natural world. The infringement of Western law on indigenous peoples over the past few hundred years has created a complex political and legal framework of existence for indigenous peoples. However, it is important to remember that, most fundamentally, indigenous peoples inherently have full rights and authority to control and manage their own natural resources and internal affairs, free from external interference and control.


1 Kimbrell, Andrew, The Human Body Shop: The Marketing and Engineering of Life. San Francisco: Harper, 1994.

2 Diamond v. Chakrabarty, 477 U.S. 303 (1980).

3 Uruguay Round Final Act. Marrakesh, Morroocco. (April 15, 1994).

4 Publication Number WO-9215325-A, Priority Application No. US-052368 .

5 "Patents, Indigenous Peoples, and Human Genetic Diversity," RAFI Communique, Rural Advancement Foundation International, Ottawa, Canada. (May 1993).

6 New Developments in Biotechnology: Ownership of Human Tissues and Cells, Office of Technology Assessment, PB87-207536. (March 1987).

7 Moore v. Regents of the University of California et al., California Supreme Court. (1985).

8 Moore vs. Regents of the University of California, 793 P.2d 479, 271 Cal. Rptr. 146 (1990).

For More Information Contact:

    Debra Harry, Consultant and Trainer
    Current Kellogg Foundation National Fellow
    P.O. Box 72
    Nixon, NV 89424 USA
    Tel: 702-574-0309

    Jeannette Armstrong
    En'owkin Centre
    257 Brunswick Street
    Penticton, BC V2A 1P2 Canada
    Tel: 604-493-7181

    Rural Advancement Foundation International
    Suite 504-71 Bank Street,
    Ottawa, ONT K1P 5N2 Canada
    Tel: 613-567-6880
One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing, send email to:

    Dale Wiehoff
    Communications Director
    Institute for Agriculture and Trade Policy (IATP)
    1313 5th St.,SE, Suite 303
    Minneapolis, MN 55414-1546 USA
    Tel: (612) 379-5980 Fax: (612) 379-5982



Subject: The Human Genome Diversity Project and Its Implications For Indigenus Peoples

by Debra Harry, Northern Paiute Nation, Nevada January 1995

The Human Genome Diversity (HGD) Project is an international consortium of scientists, universities, governments and other interests in North America and Europe organized to take blood, tissue samples (cheek scrapings or saliva), and hair roots from hundreds of so called "endangered" indigenous communities around the world.

On the assumption that indigenous peoples are inevitably going to disappear and some populations are facing extinction sooner than later, scientists are gathering DNA samples from the living peoples before they disappear. The HGD Project refers to indigenous populations as "isolates of historic interest (IHIs)" and expresses a sense of urgency in collecting the DNA samples of indigenous peoples in order to "avoid the irreversible loss of precious genetic information" due to the danger of physical extinction.

The blood samples taken by the HGD Project will be "immortalized" for future study utilizing a technique of cell conservation which keeps certain cells of an organism alive and capable of multiplying, thus generating unlimited amounts of the organism's DNA. The immortalized cell lines will be stored at various gene banks, located mostly in the US.

Research teams are going into indigenous communities to collect samples from 50 persons from each of 722 identified populations. When asked about the scientific rationale for selecting 50 persons per group, Dr. Luca Cavalli-Sforza, a principal founder of the project, stated "One person can bleed 50 people and get on the airplane in one day." 1

  Indigenous Communities Targeted  for DNA     Collection

             Africa      165     South America   114
             Asia        212     North America   107
             Oceania     101     Europe           23
             TOTAL               722

Source: RAFI-Canada 2

Known in some places as the "Vampire Project," the HGD Project was formally adopted by the Human Genome Organization (HUGO) in January 1994. HUGO is a multi-national, multi-billion dollar initiative by scientists which seeks to sequence the DNA in the entire human genetic structure. The HGD Project seeks to map the variance, that is, the genetic differences of groups that differ from the monotype genome that will be identified by the HUGO effort.< R>
The HGD Project states that it will make the genetic samples available to "the public." This policy of open access will make the data and materials available to any one requesting it, in perpetuity. However, there will be minimal control of access to the genetic materials once they are stored in the gene banks. Scientists will need only to demonstrate the validity of their scientific research in order to gain access to the samples.

Prior Informed Consent and the Right to Refuse Anthropologists, linguists or other individuals trusted by the targeted group help provide entree to the targeted communities.

Although the HGD Project will seek the consent of the individuals and populations to be sampled, what constitutes "prior informed consent?" Who is authorized to give consent? Should consent be required only by the individual being sampled, or also include the governing body of that particular indigenous nation? Can consent be granted by government officials of the nation-state in which the indigenous nation is located? How will the project be explained in the local language? Will the full scope of the project and the short and long term implications and potential uses of the samples be fully disclosed? Will potential donors be fully informed of the potential for profits that may be made from their genetic samples? And finally, will a decision not to consent be respected in full?< R>
The HGD Project North American Committee has secured a grant from the J.D. and C.T. MacArthur Foundation to develop a model protocol (rules) for the collection of genetic samples from indigenous groups. Project organizers plan to meet with indigenous people to explain the project. This process will help project organizers to identify key concerns of indigenous people, but will primarily be used to seek their cooperation in the project.

Creation and Evolution

The HGD Project states that the research will help reconstruct the history of the world's populations, address questions about the history of human evolution and migration patterns, and identify the origins of existing populations.

While the HGD Project is looking for answers about human evolution, indigenous peoples already possess strong beliefs and knowledge regarding their creation and histories.

The cosmologies of indigenous people are environmentally and culturally specific and are not congruent with popular Western theories, such as the Bering Strait migration theory or Darwin's theory of evolution. The assumptions posed by the HGD Project that the origins and/or migrations of indigenous populations can be 'discovered' and scientifically 'answered' is insulting to groups who already have strong cultural beliefs regarding their origins. Questions arise concerning the impact of the findings on indigenous communities. For example, will theories of migration be used to challenge aboriginal territorial claims or rights to land?

Medical and Military Science

The project will also gather information of potential or actual medical interest, possibly leading to medical applications. In terms of reciprocal benefits to donor groups, the HGD Project will offer token benefits such as providing medicines, or treating easily diagnosable medical problems.

If indigenous people were interested in genetic research for a genetic question specific to their group, they do not need the HGD Project to do this work. The technology and expertise is widely available to groups interested in genetic research.

Many in the indigenous communities are worried the research may identify genetic information that may be used against genetically distinct populations. The HGD Project raises the spectre of misuse of the genetic materials or data for racist purposes, and even raises the possibility of genocide by biological warfare.4 While scientists disagree on the feasibility of such uses, it is difficult to predict what will be technologically possible in ten years, or twenty. Biological warfare has been used on indigenous peoples in the past, a reminder of the potential threat presented by such scientific projects.

Conclusions and Recommendations

Genetic manipulation raises serious ethical and moral concerns with regard to the sanctity of life. For indigenous peoples, any violation of the natural law and the natural order of life is abhorrently wrong. Scientists are genetically manipulating existing life forms, altering the course of natural evolution, and creating new life forms. Genes are living organisms which reproduce, migrate and mutate. The full impact of genetically manipulated life forms cannot possibly be anticipated.

Indigenous people must engage in community education and discussion about the full scope of this project and the potential dangers of genetic manipulation. It is imperative that indigenous communities become fully aware of the implications of this project, and learn whether any genetic sampling is being conducted or is proposed to take place in their areas.
Every effort should be made to alert indigenous communities worldwide of the work of the Human Genome Organization and the Human Genome Diversity Project. The communities must be free to reject the taking of their genetic materials by such projects or by free-lance scientists. Groups from which any genetic materials have already been taken may wish to ensure the return to their possession of these materials.

Indigenous communities need to stand together and call upon the Human Genome Diversity Project and the Human Genome Organization to halt collection efforts. These organizations must work directly in consultation with indigenous people and organizations which reflect the diversity of the world's indigenous populations to develop appropriate domestic and international policies which protect the best interests of indigenous peoples.

Indigenous people must raise international awareness of these efforts and develop support among all people to prevent the further violation and assault of their human rights, further appropriation of their natural resources, and to protect the integrity of life.


1 "Glorification of the Genes?" Alan H. Goodman, Ph.D., presented at the SWISSAID/WWF International Symposium "Patents, Genes and Butterflies." Berne, Switzerland. (October 1994).

2 "Patents, Indigenous Peoples, and Human Genetic Diversity," RAFI Communique. Rural Advancement Foundation International, Ottawa, Canada. (May 1993).

3 Helland, Dag and Allan W. Hey, "A Short Review of Biotechnological Methods of Relevance to Modern Vaccine Development," Scandanavian Journal of Infectious Diseases 76, supplement (1990): 32-38.

4 Douglass, Joseph D., Jr., "The Challenges of Biological Warfare," Global Affairs. International Security Council, New York. (Winter 1988).

For More Information Contact:

   Debra Harry, Consultant and Trainer
   Current Kellogg Foundation National Fellow,
   P.O. Box 72, Nixon, Nevada 89424;  (702) 574-0309; 
   email: Debra_Harry@Together.or


Jeannette Armstrong, En'owkin Centre, 257 Brunswick Street, Penticton, BC V2A 1P2; (604) 493-7181

Rural Advancement Foundation International, Suite 504-71 Bank Street, Ottawa, Ontario K1P 5N2; (613) 567-6880

One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. To receive a complete listing, send email to:

   Dale Wiehoff
   Communications Director
   Institute for Agriculture and Trade Policy (IATP)
   1313 5th St.,SE, Suite 303
   Minneapolis, MN 55414-1546 USA
   Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: Genetic Engineering

A Production of the Shiva Working Group on Global Sustainability, University of Minnesota Ecology Department January 1995

What is genetic engineering? Sometimes called "biotechnology," genetic engineering is a high-tech process by which humans move specific genes from one organism into another organism. Conceivably, any gene from any organism can be moved into any other organism. These processes create some risks. Major areas of activity include:

*Agriculture - in which crops, livestock, and related micro-organisms are altered to increase production, influence disease patterns and environmental impacts, and so on;

* Medicine - with major efforts in pharmaceutical production using living organisms and human gene therapy;

* Pollution cleanup - using genetically engineered micro-organisms to degrade harmful chemicals, such as PCBs (relatively little work is going on in this area now);

* Mining - to develop genetically engineered micro-organisms that can concentrate rare metals and repressurize spent wells to revitalize depleted mines; and

* Biological weapons - adding to the arsenal of biological warfare agents, such as anthrax, by designing diseases to target selected populations of humans.


Ecological systems are extremely complex. Impacts at one level of the "food chain" can reverberate throughout the system. For example, changes in the invisible plankton in the sea can affect fish, and therefore affect humans. Likewise, the introduction of a genetically engineered organism in a particular ecosystem can have unforseen impacts on various species in that ecosystem Even when controlled experiments are concluded successfully, there is no guarantee that the novel organism will not create a problem in a different ecological setting.

Genetic engineering is unique among all of the major technologies that have been unleashed on society. Unlike the nuclear power industry or the pesticide industry, where major social problems occurred before the industries were regulated, there have been no disasters as yet from genetic engineering. However, the potential risks are so significant that efforts are emerging now to regulate the development and use of biotechnology at the international, national and state levels.


FOOD: The FLAVR SAVR tomato, trademarked by its designer, is genetically engineered to withstand longer storage without rotting. This delayed ripening also increases the transportability of food, allowing delivery of un-fresh foods to even farther destinations.

Genes for "antifreeze" proteins from Atlantic salmon have been transferred to Pacific salmon to enable this fish a wider range in aquaculture.

Fish genes have been also been moved into chickens. Pig and chicken genes have been moved into plants. Religious proscriptions may be violated, and food preferences, such as vegetarianism, may become difficult to follow.
BR> In addition to genes altering key features of the target organism, other genes that produce novel proteins are usually transferred as well so that the genetic engineer can know that a gene has been successfully transferred. These novel proteins may cause allergic reactions in unsuspecting people.

Most of these products are still in the experimental phase. Labeling is not now required on these products when they come to market.

ENVIRONMENT: Plant breeders can select genes which confer herbicide in new crop varieties. In theory, the new varieties allow the substitution of less toxic, less persistent and more "environmentally-friendly" herbicides for more problematic ones, such as 2,4-D. Recent analysis, however, suggests that the new crops are likely to increase herbicide use. Most herbicides are used before planting because they would harm the plant if applied later. Herbicide tolerance allows a person to apply herbicides both pre-planting and post-emergence. With increased herbicide use comes a greater risk of groundwater contamination.

The introduction of novel organisms can also affect the ecology of a field and its environs. For example, one microorganism engineered to better convert crop wastes to ethanol was found by its designers to also harm a beneficial fungi in the soil, reducing the capacity of nearby plants to absorb essential nitrogen.

HUMAN GENE THERAPY: Molecular biologists are defining an increasing number of human diseases as genetic. While some cures may be found through genetic engineering, it can also lead to indifference regarding prevention. For example, as the genetic causes of cancer are more fully understood, researchers may give less consideration to the impacts of carcinogens. What causes cancer? A molecular biologist will say, "Your genes!" Others would say, "Asbestos!" "Tobacco!" "Industrial wastes!" If a genetic disease can be treated with gene therapy, then the environmental components of disease and human difference can be ignored.

SUSTAINABLE AGRICULTURE: Corn that has been made resistant to the European corn borer is expected to increase corn yields in the U.S. central corn belt by 5%. This is expected to reduce corn prices, resulting in lower feed costs for pig and beef producers. While lower feed costs could be passed on to the meat eating consumer, lower corn prices will also increase government farm program payments. A recent economic analysis suggests that the potential benefits to the meat eating consumer are about the same size as the increased farm payments from the government. Thus, transgenic insect resistant corn would cause a transfer of wealth from the general public to the meat-eating public.

ANIMAL WELFARE: Animal biotechnology promises to transform farmyard animals as we know them. Recombinant bovine growth hormone (rBGH) increases the incidence of the disease mastitis in cows. Porcine growth hormone or "somatatropin" (PGH or PST) produces lean pork and crippled pigs. These products benefit larger producers with modern mechanized operations. Animals may be penned up permanently in overcrowded conditions subject to artificially rapid growth, poor health and early butchering.

FARMING AND RURAL LIFE: Many of these genetic engineering feats are meant to make farm production more "efficient," which will enable factory farms to grow larger and larger, concentrating the industry, encouraging vertical integration, and eliminating small family producers. Small towns will continue to decline. Overproduction of manure, increasing use of machinery and chemicals, and the introduction of novel genetic impacts will worsen environmental conditions in rural areas.


You have a right to know if your neighbors are producing genetically- engineered crops or animals. They may affect your health, the environment in which you live, and the future of your community. If you farm, they may affect your crops or the prices you can get for your animals or animal products.

In the U.S., only Minnesota and North Carolina have as yet regulated the development and use of genetic engineering. To find out what regulations may be under consideration in your area, contact your state legislators and local extension agents.

As soon as possible, governments, in cooperation with scientific experts and non-governmental organizations, should develop and adopt an international, legally binding protocol to control genetic engineering and the release of genetically engineered organisms to the environment.

Such a protocol must address the risks of genetically engineered organisms to the environment, human health and the economies of less developed countries, as the philosophy of sustainable development demands.

Until such strict regulations are in place covering the transfer, handling and use of genetically engineered organisms, there must be a worldwide moratorium on their release to the environment.

*The Shiva Working Group on Global Sustainability is a coalition of faculty, students and community leaders in Minnesota.

One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. To receive a complete listing, send email to:

   Dale Wiehoff
   Communications Director
   Institute for Agriculture and Trade Policy (IATP)
   1313 5th St.,SE, Suite 303
   Minneapolis, MN 55414-1546 USA
   Tel: (612) 379-5980 Fax: (612) 379-5982



Subject: Releases of Genetically Engineered Plants and Their Impacts on Less Developed Countries

Isabelle Meister and Dr. Sue Mayer Greenpeace International April 1995


Genetic engineering is being turned from a laboratory technique into a commercial process at an alarming speed. In this process genetic material can be transferred between unrelated species, an ability which has been seized upon by industry as a way of introducing new characteristics into plants, animals and micro-organisms. Many of these are intended for large scale commercial production leading to the release of enormous numbers of living 'designer' organisms into the environment.

There has already been scientific, socio-economic and ethical concerns expressed about the technology. For example, it is possible that new pests will be produced and, since they are living organisms, these will not be able to be recalled to the laboratory - a new form of 'genetic pollution' is looming. If northern crop plants are engineered to make products like cocoa or vanilla, the economies of some less-developed countries may be seriously compromised. The proponents of genetic engineering are anxious to reassure people that these concerns are misconceived and that genetic engineering will be used to help feed the world.


A study1 was undertaken to establish what is happening with genetic engineering of plants in the world today and the implications of those developments. The areas of focus were: what is taking place; who are the major stakeholders in the technology; and how the releases of such genetically engineered crop plants are regulated across the world. These areas were chosen as the major indicators of who will be the winners and losers as the biotechnology industry develops, whether the promised benefits are likely to be realised, and whether environmental safety is being properly taken into account. Plants were studied because they represent one of the fastest growing applications of genetic engineering with the possibility of causing serious environmental damage.

The research involved bringing together the available data on releases of genetically engineered plants worldwide, determining the financing of the technology, investigating the details of a selection of patents which have been granted on plants and establishing, where possible, what regulations exist. Because much of the information is commercially confidential, it has not been possible to make a fully comprehensive inventory; however we believe the results contained here provide an accurate picture of the progress and control of the technology today.

The emphasis of the study was to determine the implications for the environment and economies of less-developed countries and to make recommendations to the First Conference of Parties of the Convention on Biological Diversity in the Bahamas in November 1994 to ensure that the environment is properly protected.


* All of the world's major food crops have been genetically engineered, including maize, wheat and rice, which together form 50% of the world's food intake.

* Field trials with genetically engineered plants have taken place in at least 18 developed countries and have taken place or are expected to take place shortly in about 35 developing countries. At least 90 releases of genetically engineered plants have taken place in non-OECD countries and Mexico, at least a third of which were by northern-based multinational corporations such as the United States' companies Monsanto and Calgene and the Swiss company, Ciba-Geigy.

* Chemical industries now dominate research and development in plant genetic engineering. The spending of the top six companies in biotechnology research and development - Monsanto, Enimont, Du Pont, Sandoz, ICI and Ciba-Geigy - together accounted for 63% of the total spent by the top 15 companies in 1989.

* One of the most common developments is the production of herbicide resistant crop plants. Many agrochemical companies active in this area are engineering resistance to their own herbicides including Rhone Poulenc, Hoechst and Monsanto. Monsanto has tested their herbicide resistant cotton in Belize and Costa Rica. Calgene has tested cotton resistant to Rhone Poulenc's herbicide bromoxynil in Argentina and Bolivia.

* Other major areas of development involve altering characteristics which make crops either more suitable for northern markets (such as the production of tomatoes which rot more slowly than normal) or which make it possible to grow crops in a wider geographical range. Crops which have been restricted to hot conditions may in this way be grown in cooler climates.
* Patent protection for genetically engineered plants and the means of producing them is often obtained in countries that are not members of the Organization of Economic Cooperation and Development (non-OECD states) by transnational corporations which have their headquarters in OECD states - a form of genetic colonialism. Patent protection often covers crops which are particularly important in developing countries such as cotton, sorghum, cassava, millet, banana and rye. Such patents will ensure that northern countries can control and profit from their use and secure import monopolies by preventing local production.

* Regulation of releases of genetically engineered organisms is in place in OECD countries but many less developed countries do not have any controls. Apparently unregulated releases (where there was no scrutinization process to ensure environmental safety) have taken place in six countries - Belize, Dominican Republic, Guatemala, Pakistan, Puerto Rico and South Africa.
* Illegal releases of genetically engineered organisms have taken place in Argentina (a vaccinia-rabies virus in 1986); Kenya (3 illegal cases since 1989, one involving ornamental plants from Argentina); and India (80 different genetically engineered species of microbes were illegally imported from Japan and released into crop fields).


Despite the lack of controls to protect the environment in many countries, many northern companies appear to be using the less developed countries as testing grounds for crops designed to suit their home markets. It is of very great concern that a situation of 'double standards' is evolving where developed countries are taking measures to protect their own environments but allowing their corporations to threaten the more vulnerable environments of less developed countries.

Genetically engineering organisms (GEOs) are living, with the ability to reproduce. Once in the environment they will not be able to be recalled or collected. They present ecological threats that will magnify, not decay over time. The organisms will not respect national borders, and growing international travel and trade increases the chance of movement of organisms from one country to another.


Governments, in cooperation with scientific experts and non-governmental organizations should adopt an international, legally binding protocol to control genetic engineering and the release of genetically engineered organisms to the environment. Such a protocol must address the risks of genetically engineered organisms to the environment, human health and the economies of less developed countries, as the philosophy of sustainable development demands.

Abuses involving GEOs are already occurring. Although internationally binding regulations are no guarantee against the exploitation of developing countries and the enforcement of such regulation would be difficult, the framework for legal redress would be in place and nations would have a tool for defending themselves against transnational giants.

Until such strict regulations are in place covering the transfer, handling and use of genetically engineered organisms, there must be a worldwide moratorium on their release to the environment.

1"Genetically Engineered Plants: Releases and Impacts on Less Developed Countries." Meister, Isabelle and Dr. Sue Mayer, submitted to the First Conference of Parties of the Convention on Biological Diversity. Nassau, The Bahamas. (1994).

For further information, please contact:

   Isabelle Meister, Greenpeace Switzerland
   Muellerstrasse 37, Postfach 276
   8026 Zurich, Switzerland
   Phone: 41-1-241-3441; Fax: 41-1-241-3821

   Dr. Sue Mayer, Greenpeace UK
   Canonbury Villas, London N1 2PN  U.K.
   Phone: 44-71-354-5100; Fax: 44-71-696-0012

   The Institute for Agriculture and Trade Policy
   1313 5th St. SE, Suite 303, Minneapolis, MN  55414-1546
   (612) 379-5980 fax (612) 379-5982 
One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing, send email to

   Dale Wiehoff
   Communications Director
   Institute for Agriculture and Trade Policy (IATP)
   1313 5th St.,SE, Suite 303
   Minneapolis, MN 55414-1546 USA
   Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: International Policy on Plant Genetic Engineering

by Michelle Thom, Institute for Agriculture and Trade Policy May 1995

During the 1970s and 1980s, developing nations expressed concern about the free flow of plant genetic resource materials, or germplasm, from the South to the North. Why, they asked, were patented seeds of southern origin bringing tremendous profits to multinational seed companies without compensation for the developing world? 1 In the culmination of what was dubbed the Seed Wars of the 80s, Third World leaders managed to air their concerns in an international arena via the United Nations Food and Agriculture Organization (FAO).

In 1983 the FAO established the Global System for the Conservation and Utilization of Plant Genetic Resources. It includes a legally non-binding set of guidelines called the "International Undertaking on Plant Genetic Resources" (Undertaking) and an intergovernmental Commission on Plant Genetic Resources. The Commission was created to monitor the implementation of the Undertaking and more generally, to discuss the use, control and conservation of plant genetic resources. It operates on the principle of one country, one vote.

The purpose of the Undertaking2 is to "ensure that plant genetic resources of economic or social interest, particularly for agriculture, will be explored, preserved, evaluated and made available for plant breeding and for scientific purposes." The underlying notion is the common heritage principle - that "plant genetic resources are a heritage of mankind and consequently should be available without restriction." The principle is extended to include not only native plant materials, but also farmer-developed varieties and new products of biotechnology. This guarantee of access without restriction caused eight industrialized countries to register reservations; the U.S. and Canada still do not adhere to the Undertaking.


Two annexes to the Undertaking were adopted in 1989. A third was adopted in 1991. A fourth is presently being negotiated. One annex addressing Farmers' Rights recognizes the right of farmers to be compensated for developing and conserving plant genetic resources. It is well known, for instance, that over generations, Andean potato farmers developed frost-resistant varieties for growing in flat bottomlands where frost is common, and Chiapan farmers bred at least a dozen varieties of corn, which were heavily utilized by local farmers.

The notion of farmers' rights emerged in part as a mechanism for equitably sharing the benefits of utilizing plant genetic resources acquired by seed breeders in the North with the people from whom the resources were obtained. As such, farmers' rights are acknowledged in the Convention on Biological Diversity, which emerged during the 1992 Earth Summit in Rio de Janeiro, Brazil, and extended to include indigenous communities. The Biodiversity Convention states that contracting parties will:

"... Respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices."3

Despite such recognition in the Biodiversity Convention, the idea of farmers' rights is still considered a source of continued tension surrounding the use and control of plant genetic resources.4


The Plant Breeders' Rights annex acknowledges the significance of the contributions of plant breeders, such as those who work for private entities like Pioneer Hi-Bred and Northrup King, and their work in international agricultural research. Plant breeders were concerned that farmers' rights could represent a wholesale transfer of wealth from the North to the South. This annex acknowledges that the rights of plant breeders are not incompatible with farmers' rights and allows for legal protection of patented seed varieties. 5

Quantifying the South's contribution to seed development and how to collect and distribute compensation remains an issue. As a result, the idea of farmers' rights remains just that - an idea. With the exception of the Biodiversity Convention, farmers' rights have not achieved overt recognition in other international dealings, such as trade agreements like the General Agreement on Tariffs and Trade (GATT). Because the GATT strengthens the intellectual property rights of the plant breeding industry, many Southern nations have questioned the commitment of the North to the Undertaking.


The third annex, adopted in 1991, reaffirmed the concept of "common heritage" but made it subject to the sovereign rights of nations over their plant genetic resources. In other words, nation states have the right to determine how to preserve, protect and be compensated for innovations utilizing their native plant genetic resources as part of the world community. It recognizes that countries of origin have legal ownership of the plant genetic resources found within their borders and thus have the right to control the use of and access to these materials. This concept is also endorsed in the Biodiversity Convention, which in its preamble reaffirms that "States have sovereign rights over their own biological resources."6


A fourth revision to the Undertaking is now underway. It will take place in three stages. Stage I will integrate the annexes and harmonize the Undertaking with the Biodiversity Convention. Many developing countries have suggested that the Undertaking adhere strictly to the Biodiversity Convention. The U.S. has suggested that, while this would be beneficial, the North may not be able to guarantee compensation. At last November's First Extraordinary Session of the FAO Commission, U.S. spokesperson Henry Shands said, "The international community cannot be in a position to ensure benefits. We can support but cannot necessarily ensure benefits." 7

Thereafter, Stage II of the fourth revision will discuss the question of how to enforce farmers' rights and equitable access to plant genetic resources, while Stage III will consider making the Undertaking a legally binding agreement, such as a protocol to the Biodiversity Convention.

Because a great deal of germplasm utilized by plant breeders of the North originated in the South, developing nations have a key role to play in ensuring the fourth revision addresses their concerns about access to and control over their native plants. In the fourth revision, representatives of developing countries are asking for the following: the regulation of access to plant genetic resources through an international forum such as the Biodiversity Convention, a clarification and realization of farmers' rights, and technology transfer to enable the conservation and sustainable use of plant genetic resources for food and agriculture.8

Comments on the fourth revision from FAO delegates will be incorporated into a draft of the proposed revised Undertaking and submitted to the Secretariat as a paper in June 1995.


Because the undertaking relies on the "common heritage" principle, it is necessary to ensure that the Undertaking adequately addresses the rights of farmers and indigenous communities who have traditionally understood the value and utility of plant genetic resources. Specifically, these communities should in some way receive compensation for their knowledge of plant genetic properties, the conservation of biodiverse resources and the numerous products that have resulted from this knowledge, which are primarily therapeutic or medicinal, and have brought significant profit to multinational pharmaceutical companies located in the North.

The Undertaking and related events provide nongovernmental organizations (NGOs) with a unique opportunity to respond in a way that empowers citizens, indigenous communities, and farmers throughout the world. Many NGOs, including the Rural Advancement Foundation International (RAFI) and Genetic Resources Action International (GRAIN), have already taken part in past meetings with the FAO Commission.

The Keystone Symposia, for example, involved governmental, nongovernmental and academic participants in exploring the question of preserving the world's plant genetic resources prior to the 1992 Rio Earth Summit. The group of 41 individuals from 22 different countries concluded that the current situation calls for a Global Initiative for the Security and Sustainable Use of Plant Genetic Resources.9

Likewise, the Crucible Group, made up of intergovernmental officials, NGOs and industry representatives, is working to identify the trends, concerns and opportunities related to intellectual property issues relevant to plant breeding and plant genetic resources. This effort resulted in the publishing of the book People, Plants, and Patents.10

In June 1996, government officials and NGOs will meet in Leipzig, Germany for the Fourth International Technical Conference on Plant Genetic Resources. Up for discussion will be two major documents: the First Report on the State of the World's Plant Genetic Resources, and the Global Plan of Action (GPA).

The Report is expected to be a critical assessment of the status of the world's plant genetic resources and the multilateral institutional capacity to preserve and develop these resources.

The GPA is a combination of recommended programs, priorities and projects to conserve and develop plant genetic resources. Envisioned as a major component of the FAO's contribution to the implementation of the Biodiversity Convention, the GPA will also address means of compensating developing countries for their native germplasm.11

In order to facilitate NGO participation in this process, the FAO has established the International Conference and Programme for Plant Genetic Resources (ICPPGR), which will coordinate activities and develop a range of initiatives and agreements designed to generate consensus and commitment for the Leipzig conference.12


1 See Neil Hamilton, "Who Owns Dinner: Evolving Legal Mechanisms for Ownership of Plant Genetic Resources," Tulsa Law Journal 28 (1993) discussing Hope Shand, "There Is a Conflict Between Intellectual Property Rights and Rights of Farmers in Developing Countries," Journal of Agricultural & Environmental Ethics 133 (1991).

2 Report of the Conference of FAO, 22nd Session, Agenda Item 6, United Nations Document c/83/REP, 1983.

3 Convention on Biological Diversity, June 5, 1992.

4 Food and Agriculture Organization of the United Nations, Interpretation of the International Undertaking on Plant Genetic Resources, Rome, 25th Session, U.N. Doc. C 89/24, November 11-30, 1989.

5 Ibid.

6 Ibid.

7 "PGRs Undertaking Gets First Reading," South-NorthDevelopment Monitor, November 15, 1994.

8 Ibid.

9 Keystone International Dialogue Series on Plant Genetic Resources, Final Consensus Report: Global Initiative for the Security and Sustainable Use of Plant Genetic Resources, Third Plenary Session, Oslo, Norway, May 31-June 4, 1991.

10 See The Crucible Group, People Plants and Patents, International Development Research Centre, 1994.

11 Pesticide Action Network, "Preparations for Plant Genetic Resources Action Plan," PANUPS, May 8, 1995 or "Go Between #49, December 1994-January 1995; PGR, March 1995.

12 Ibid.

For more information on the Undertaking, contact:

    Institute for Agriculture and Trade Policy,
    1313 5th Street S.E., Suite
    303, Minneapolism, MN  55414;
    Telephone: (612) 379-5980; fax: (612) 379-5982; 

International Conference and Programme for Plant Genetic Resources, FAO, AGP Division, Viale delle Terme di Caracalla, 1-00100 Rome, Italy, Tel: (39-6) 5225 5871, fax: (39-6) 5225 5533, Email:

One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. To receive a complete listing, send email to: ipr-info@iatp.o g.

    Dale Wiehoff
    Communications Director
    Institute for Agriculture and Trade Policy (IATP)
    1313 5th St.,SE, Suite 303
    Minneapolis, MN 55414-1546 USA
    Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: GATT and Retail Food Cooperatives

by Jim Glassman Minnesota Food Association June 1994

Why should anyone involved with retail food cooperatives be concerned about GATT?

The General Agreement on Tariffs and Trade (GATT)is a multi-lateral agreement governing the conduct of international trade. Last December, the "Uruguay Round" of the GATT negotiations concluded with a call for the creation of a World Trade Organization (WTO) to govern global trade. Retail food cooperatives vary somewhat in their missions, but the trade regime which the WTO will oversee will have potentially great effects on activities of significance to all coops - ranging from effects on the viability of their efforts to guarantee the quality of foods they carry, to the effectiveness of their promotion of local and sustainable agriculture, to the potential of their attempts to encourage more democratic participation in basic affairs of society.

GATT and democracy

For some coops, one of the central purposes is to provide an opportunity for people to play a more active role in the basic decisions effecting their lives, in this case, decisions about the character of their working environment. Insofar as coops wish to extend their concern about participatory democracy to the world at large, they have good reason to consider GATT a serious threat. GATT represents a danger to any notion that citizens in general have a right to control the world around them.
< R> The WTO arbitration panels signify what this danger is about. The panels are composed of three trade representatives who are not elected and who are obliged to rule in favor of measures facilitating trade, with other issues being subordinate. There is no provision under arbitration provisions for introduction of alternative perspectives, such as amicus briefs from non-governmental organizations, which might raise concerns about environmental or labor conditions.

Furthermore, GATT forces governments to amend laws and even rewrite their constitutions to ensure that they are in line with GATT principles. Paragraph 4 of Article XVI states: "Each member shall ensure the conformity of its laws, regulations and administrative procedures with its obligations as provided in the annexed Agreements." The North American Free Trade Agreement (NAFTA) provides a good example of the pressures this will create on governments and citizens. In anticipation of NAFTA, Mexican President Carlos Salinas de Gortari and his ruling Institutional Revolutionary Party (PRI) changed a provision in the Mexican constitution which protects collective farms (ejidos). The ejidos, though often functioning imperfectly, have been an important form of protection for small Mexican farmers confronted by the increasing industrialization of Mexican agriculture. With the repeal of the ejido law, it is now possible for Mexican or foreign investors to buy up the ejidos, thus potentially displacing millions of farmers.

It was in part in reaction to this that the Zapatista rebels in Chiapas. Mexico took over the town of San Cristobal de Las Casas last January. The Zapatistas called for renegotiation of NAFTA and focused the world's attention on the huge economic burdens faced by the victims of Mexico's neoliberal economic policies. A world ruled by GATT principles seems destined to produce more moves like those of the PRI and more reactions like those of the Zapatistas.

GATT principles may. not protect collective forms of property like ejidos, but they do protect international investors with stringent requirements for the maintenance of Intellectual Property Rights (IPRs). The insistence on IPRs forces governments to recognize patent claims on products developed by companies and individual inventors, even if the product is developed from materials created by local producers over generations. Thus, for example, a University of Wisconsin scientist took out a patent on the neem tree, used for generations in India, simply on the basis of having participated in the development of a mass production process for neem. Indians who process neem themselves and use it for myriad purposes can thus be required to pay royalties for use of neem products. No one in India receives royalties for the generations of work which have gone into finding the various uses of neem. Appropriately, some commentators have referred to this usurpation of traditional people's rights to use their own crops as "the second enclosure of the commons." Codifying this enclosure movement, and thus strengthening the position of transnational corporations at the expense of local groups, is one of the major purposes of GATT and the WTO.
Finally, it is worth noting that both the NAFTA and GATT negotiation and approval processes are in and of themselves tremendous affronts to the notion that average citizens are entitled to a say in affairs effecting their lives. NAFTA was negotiated by the Bush administration under advice from business leaders with virtually no input from labor or environmental groups. The Bush administration made sure that there would be little labor input by violating federal requirements and failing to present a draft of NAFTA to the US Labor Advisory Committee on NAFTA in timely fashion. NAFTA was approved under "fast-track" procedures which prevented the US Congress from attempting to change any of its provisions as a condition for its implementation. Thus, the public was prevented from participating in the creation of the trade accord. Even so, it required shameless vote-buying by the Clinton administration to push the agreement through Congress.

Food coops which consider themselves to be part of a citizens' movement for greater empowerment have good reason to be concerned that GATT represents the antithesis of their own efforts.

GATT and food safety

Under GATT, acceptable standards of food safety will be determined by the Codex Alimentarius, a United Nations organization which is heavily influenced by industry. Many of the food safety standards established by this body are weaker than existing US standards. Once the WTO is in place, countries which maintain standards more stringent than those of Codex will be subject to challenges from other governments for establishing barriers to trade. Under these circumstances, a WTO arbitration panel would decide how to rule in the dispute. If the panel decided against the country with tougher food safety standards than the Codex, that country would be forced to either change its standards or else face sanctions and retaliation.
In addition, the WTO could make it more difficult for food coops to maintain the confidence of their customers in the safety and quality of their products. It has been suggested, for example, that an existing Minnesota law regulating the field release of genetically engineered organisms could be ruled a trade barrier under GATT principles. Extending this claim, it seems reasonable to suspect that laws attempting to regulate the use of genetic engineering in food production might be found to inhibit trade. Given the concern of many consumers about potential allergic reactions to foods with unidentified additives, this should be a matter of interest to coops.

In principle, coops could deal with this concern by promoting labeling of foods that are genetically engineered or produced using genetic engineering. But recent challenges to the labeling of milk as not containing Bovine Growth Hormone (BGH) show that this approach could be treacherous. Furthermore, the possibility that GATT rules could be used to interpret labeling laws themselves as barriers to trade should not be ruled out at this point. Similar issues could be raised with regard to the viability, under GATT of attempts to promote organic agriculture and to certify foods as organically grown.

GATT, Local Agriculture and Sustainability

Many coops see their missions as not only involving the promotion of good food but also of locally-grown produce. GATT threatens this project by making it difficult for countries to maintain subsidies or forms of protection for local growers. Indeed, GATT requires that the United States import a minimum of 5 percent of domestic consumption for every crop consumed.

The potential impact of measures such as this has already been discussed extensively in the case of the NAFTA. NAFTA will force the Mexican government to abandon subsidies to small farmers producing corn. The likely impact of this on these farmers is that they will be driven out of business by cheaper imports of corn from the United States and Canada. In Minnesota, likely victims of NAFTA and GATT would include sugar beet producers, who currently benefit from subsidies and other measures that inhibit cheaper sugarcane imports. In addition, programs supporting local agriculture, such as "Minnesota Grown," could be challenged as trade barriers under NAFTA and GATT.

Sustainable agricultural practices will be threatened under GATT as well. Any attempts by states or countries to control imports on the basis of the process or method of production is referred to under GATT as a "technical barrier to trade" (TBT). Any attempts to insure that imported products are produced sustainably could be ruled a TBT by the WTO. In addition, attempts to promote local sustainable agriculture through subsidies or other measures would be a violation of GATT principles. Yet such subsidies to sustainable and organic producers may be necessary to offset the artificially cheap price of manyconventional products, which only cost as little as they do because the price of problems like soil erosion, ill health from pesticides, and fossil fuel pollution are not internalized but passed on to society in general. GATT would make it difficult to maintain programs that would level the playing field for sustainable and organic practices.

For all of these reasons, then, retail food cooperatives should be concerned about the potential passage of GATT. Passage is not a fait accompli, however, nor is GATT irreversible if it does gain US Congressional approval. By working with groups which are organizing in opposition to GATT, coops can play a role in preventing GATT from undermining the viability of attempts to insure availability of safe food, produced sustainably and on ways compatible with the development of a politically and economically democratic society.

For more information, contact:

Minnesota Safe Food Link, 1313 Fifth Street SE, Suite 303,
Minneapolis, MN. USA 55414. Telephone: (612)379-5980; fax: (612) 379-5982.< r>
Institute for Agriculture and Trade Policy, 1313 Fifth Street SE, Suite 303, Minneapolis. MN. USA 55414. Telephone: (612)379-5980; fax: (612) 379-5982.

One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. For a complete listing, send email to:

    Dale Wiehoff
    Communications Director
    Institute for Agriculture and Trade Policy (IATP)
    1313 5th St.,SE, Suite 303
    Minneapolis, MN 55414-1546 USA
    Tel: (612) 379-5980 Fax: (612) 379-5982



Subject: Patent Nonsense: On the Patenting of Life by Dr. Phil Bereano
> Council for Responsible Genetics
Washington Biotechnology Action Council
--who acknowledges the work of colleagues around the world.

In August of 1993, Pat Mooney of the Rural Advancement Foundation International (RAFI) was examining a patent database when he came across an application filed by the U.S. Secretary of Commerce on the cell line of a 26-year old Guaymi Indian woman from Panama.1 (A cell line is a group of cells taken from a human body that are capable of being sustained and grown in laboratory culture media, and are therefore said to be "immortal;" a line of cells contains the complete genetic code, the genome, of the individual from whom the cells were taken.)

Thus, for the first time, an applicant was attempting to establish monopoly ownership over the genome of a living person. These cells were believed to contain special anti-viral qualities. Although two individual men were listed in the application as "inventors," it is not clear that their actions in taking the woman's blood when she went to the hospital for treatment and the subsequent isolation of these cells amounts in any sense to what would be considered as "invention."

When contacted, the Guaymi had no idea they were candidates for monopolization and demanded that the U.S. withdraw its patent claim and return the cell line to the tribe. The Guaymi President reflected, "I never imagined people would patent plants and animals. It's fundamentally immoral, contrary to the Guaymi view of nature, and our place in it. To patent human material . . . to take human DNA and patent its products . .

Subject: Towards A Biosafety Protocol

by Kristin Dawkins Institute for Agriculture and Trade Policy

What are the Risks?

To date, biotechnology companies have released small numbers of more than
2,700 experimental genetically engineered organisms.1 Even when controlled experiments are concluded successfully, there is no guarantee that the engineered organism will not create a problem in a different ecological setting.

In one case, scientists in Germany designed genetically engineered bacteria that convert crop wastes into ethanol. Later, scientists at Oregon State University tested the organism under different conditions and discovered that the "designed" bacteria also reduced the amount of a beneficial fungus in the soil that is essential to plant development. "So if the bacterium had been released," said one of the scientists, "and spread widely, very likely we would be unable to grow crops without a control measure for this organism."2

Genetically-engineered fish and shellfish pose even greater ecological risks, since all aquatic organisms are undomesticated and have the capacity to survive in nature, moving easily from the controlled environment to the wild. For example, of 46 exotic fishes which have successfully invaded U.S. waters to date, 22 escaped from aquaculture facilities. No fish farmer can ensure sea pens are indestructible. A 1988 storm tore apart hundreds of sea nets and their moorings at a Norwegian facility, allowing a million farmed salmon to escape; catches in later years have shown that these animals spread very widely. A similar accident with transgenic fish, such as the Chinook salmon which grows 11 times faster than normal or the Atlantic salmon with an antifreeze gene from winter flounder, could lead to global
disruptions of salmon communities and their capacity to reproduce normally.3

Although scientists are developing techniques to sterilize genetically-engineered fish, there is as yet no guarantee of sterility in 100 percent of the cases. An accidental release, therefore, could lead to catastrophic impacts on a wild population. In some cases, a transgenic breed may be able to transfer the altered genes to wild relatives, diluting specialized adaptations that evolved in response to specific survival needs. In other cases, a transgenic breed might significantly strengthen a wild relative, enabling it to out-compete native species for food and breeding sites within a habitat. Even sterile transgenic fish could pair with fertile relatives, reducing the numbers of young produced by an already endangered species. Numerous examples of such ecological disruptions have already been documented where exotic species were released into a new environment.

Requirements of the Convention on Biological Diversity * Article 8(g) of the Convention on Biological Diversity, signed by 156 countries upon its publication in Rio de Janeiro in June 1992, commits the parties to "establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology..."

* Article 8(h) commits the parties to "prevent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or species."

* Article 19(3) commits the parties to "consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology..."

Debating the Need The U.S., not a party, has insisted that there is no need for a protocol on biosafety, despite a series of opinions to the contrary. The U.S. objected to the U.N. Environment Programme's 1993 Panel IV report on grounds that it was not a "consensus document;" the majority of this panel of experts had concluded that "the purpose of strengthened international cooperation in the field of biotechnology and biosafety is best served by the adoption of a legally binding instrument."4 And the vast majority of the parties attending the First Conference of the Parties (COP1) in the Bahamas last year spoke in favor of moving away from discussions of "need" and towards substantive discussion of the specific modalities.

As a result, COP1 established an "ad hoc open-ended group of experts nominated by governments" to reconsider the question in May 1995 in Cairo.

Noting that the COP1 had "expressed deep concern and interest about the need for the safe transfer, handling and use of all living modified organisms (LMOs) resulting from biotechnology," these experts concluded with some ambiguity that although "the potential risks posed by LMOs are often environment-dependent and ... an organism that is safe in one country is not necessary [sic] safe in another country," methodologies for "risk assessment are well defined and are not fundamentally different from those in other technologies." This panel emphasized the need for expert advice, capacity building at the national level, and an "appropriate international framework" with which to "address the movement of LMOs across national boundaries."5

A regionally-representative group of government delegations then met in Madrid in July 1995 to consider the Cairo experts' report in order to bring a formal recommendation to the Second Conference of the Parties (COP2.) All of these delegations noted "the urgent need to give attention to the issue of transboundary movement of LMOs resulting from modern biotechnology." The final report notes that the "large majority of delegations favored the development ... of a protocol under the Convention on Biological Diversity" although "those delegations who did not yet have a position on whether there is a need for a protocol or not" suggested COP2 consider four options: coordination and strengthening of existing arrangements; new voluntary international arrangements; a new legally binding instrument (protocol); or "a combination of some of the above."6 In Madrid, the U.S. publicly announced its continuing opposition to a protocol.7

The Jakarta Decision In Jakarta, Indonsia, the 2nd COP called for "a negotiation process to develop in the field of the safe transfer, handling and use of living modified organisms, a protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation, and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedure for advance informed agreement." This language is a compromise: Northern governments had argued that the scope of the agreement should reference "transboundary transfer of any" living modified organisms (LMOs); Southern governments preferred a protocol encompassing "the safe transfer, handling and use" of LMOs.

The COP2 agreed to establish an Open-Ended Ad Hoc Working Group to build upon the work of the Cairo and Madrid intersessional meetings of 1995, which should take into account the precautionary principle while seeking to minimize unnecessary negative impacts on biotechnology research and development and not hindering access to and transfer of technology.

Despite these decisions, the U.S. stated in the closing Ministerial segment of the Jakarta conference that governments must still develop a framework for deciding whether the need for a protocol is established and how to proceed.7

U.S. Policy at Home Domestically, the U.S. is aware of the need for regulating the release of LMOs although there is a good deal of political pressure to weaken existing regulations. Three federal agencies now address genetically engineered organisms.

* The U.S. Department of Agriculture, for example, now requires permits for shipping genetically engineered organisms between states and for some releases into the field although releases involving corn, soybeans, tobacco, cotton, tomatoes and potatoes merely require the company to file a notice; a proposed rule change would exempt almost all transgenic plants from this permitting process, exempt most viral genes (including those not yet discovered) from risk assessment, and expedite the commercialization of crop varieties "closely related" to those already commercialized.

* The U.S. Environmental Protection Agency (EPA) regulates organisms containing altered DNA as "new" chemical substances and reviews and registers genetically engineered plant and microbial pesticides although it may soon exempt virus and herbicide-resistant plants. It is worth noting that some scientists at the EPA recently charged that the agency "lacks a sound process to assess the risks these organisms may pose to human health and North American ecosystems."

* The U.S. Food and Drug Administration's policy is to treat genetically-engineered products intended for human or animal consumption as traditional and safe, requiring no pre-market tests, notification or labeling - unless the producer itself declares that there may be some risk.8

NGOs and Scientists Demand Action Non-governmental organizations and scientists from around the world have joined many developing country delegations in arguing urgent movement towards specific rules and their adoption. Many agree that a legally binding protocol requires, at least: prior notification, locally-specific testing, comprehensive impact assessment, full public disclosure, and fully informed advanced agreement of affected nations and communities for every experimental and commercial release and transfer of a LMO or its products; * developing a comprehensive methodology for the case-by-case evaluation of each LMO or its product, addressing the purported need relative to existing alternatives as well as the socio-economic, human health, and ecological impacts of its full life cycle including disposal on environments other than that in which it was developed;

* establishing an international roster of independent personnel from the broadest possible range of disciplines which, at the request of a party, can be assembled as a team to assist with compliance as well as capacity-building at the national level;

* adherence to the precautionary principle, giving all nations and communities the right to determine what is an acceptable level of risk and the right to refuse any release or transfer of a LMO or its product;

* adherence to the polluter-pays principle, obligating the commercial developer and/or the commercial exporter of the LMO or its product to invest in implementation of the protocol and strict liability;

* on-going monitoring of LMO performance, impacts, and range of habitat after any release or transfer; * national reports, compliance reviews, mechanisms for enforcement and dispute resolution; and

* the full participation of all interested persons through transparent and accountable processes at the international, national, and community levels for every element of implementation including notification, impact assessment, consent and refusal, methodological evaluation, roster nominations, team selection, risk management, post-release performance monitoring, mitigation procedures, capacity-building, national reports, compliance reviews, and dispute resolution.

To join the effort, please consider joining the National Biosafety Council - a non-profit group whose members sign on to the following pledge:

"We commit ourselves as members of the National Biosafety Council (NBC) to support the adoption of an international biosafety protocol. We believe the protocol should be enforceable through standards that bind every country to comply with safeguards that are effectively managed. Release of genetically modified organisms in the absence of a biosafety protocol could have unpredictable, catastrophic consequence on the environment and health. If a protocol is not forthcoming or should its administration be inadequate, we will call upon all nations to adopt a moratorium on all release of genetically engineered organisms."

To sign on, as an individual or as an organization, please send your name, affiliation if any, address, telephone, fax and e-mail if any to: National Biosafety Council, c/o Institute for Agriculture and Trade Policy, 1313 Fifth Street SE, #303, Minneapolis, MN 55414 USA FAX: 612-379-5982.

    Dale Wiehoff
    Communications Director
    Institute for Agriculture and Trade Policy (IATP) 1313 5th Street SE, 
    Suite 303
    Minneapolis, MN 55414-1546 USA
    Tel: (612) 379-5980 Fax: (612) 379-5982


Subject: Genetic Engineering Regulations by Michelle Thom Institute for Agriculture and Trade Policy

MINNESOTA REGULATIONS The Minnesota Department of Agriculture (MDA) has proposed new rules for regulating the agricultural biotechnology industry in the state. These rules will determine how a company can commercialize genetic engineering: what will be sold and how it can be sold. This is the most critical decision that is made in the development of any technology into a salable product.

According to Minnesota's Genetic Engineering Law [Minnesota Statutes 116.91-.96], an agency's rules must protect the environment and humans. New rules would provide industry with a clear path to develop commercial products. They do not provide for effective public consultation and have minimal public notification requirements. In some cases, MDA would not even have to notify the public of its decisions at all.

Industrial commercialization proceeds through several stages: testing of potential products in the laboratory, selecting promising ones for outdoor testing (field releases), testing in the field with further selection and increasingly larger field tests, and preliminary market testing. At some point, the industry will decide that the product is so promising that they will want to sell it.. Given this developmental process, the regulations should require permitting first, notification second and commercial use exemption last - only after enough information has been collected to convince experts and the general public that a particular genetically engineered product is safe and beneficial.

The proposed MDA rules create one big loophole through which industry can slip: the commercial use exemption. The rules provide alternative regulatory systems, but obviously most industries would prefer an exemption. The three systems are:

* Commercial use exemption - Industry requests that MDA exempt them from any regulation. Industry provides MDA with specified information. MDA determines if the product is safe, and can approve, not approve, or add conditions to the industry request.

* Permit - Industry decides that it wants to conduct a field release, determining the size, location, and scope of the experiment. Industry provides MDA with specified information. MDA evaluates the potential effects of their proposed release on the environment and humans. MDA only evaluates that particular release, and can provide the industry with a permit to conduct the release.

* Notification - MDA requires that industry send written notice to MDA informing where, when and how industry will conduct a release. Industries keep MDA informed of any further field testing of allowed organisma. (Now, notification is allowed for only certain genetically engineered modifications of six crops: corn, tobacco, cotton, tomatoes, potatoes and soybeans.)

NORTH CAROLINA REGULATIONS 1 In 1989, North Carolina adopted the Genetically Engineered Organisms Act [NC General Statutes Chapter 106, Article 62], revising a 1987 policy which gave complete power over releases to the North Carolina Department of Agriculture (NCDA) and provided no opportunity for citizen input.

The 1989 Act requires a permit for the release or commercial use of genetically engineered organisms; public notice and comment; a state role that carries a minimum burden; and no "undue governmental interference with the progress and commercial development of biotechnology." In most cases, the law also requires that a review take place within the time frame established by federal agencies for reviewing companies' applications for releasing genetically engineered organisms.

The Act granted the NCDA sole authority for regulating the release of genetically engineered organisms. A Genetic Engineering Review Board (GERB) was also established under the law; it has tended to delegate most of its oversight authority to the NCDA and has had minimal representation by the public interest sector.

Although the public is entitled to review release applications with Confidential Business Information deleted, state bureaucrats wield enormous procedural power. Hearings, for example, are scheduled only when the agriculture "commissioner determines that significant public interest and justification exist."

The law contains a five-year sunset provision, which means it expires in September 1995. Reports indicate there is little organized support for continuing the Act and organized opposition by the biotechnology industry. Public interest groups that have historically played a role in the development and implementation of North Carolina's law are having trouble mustering support as the Act has fallen far short of expectations. They say NCDA has acted as a surrogate for the biotechnology industry. About the only thing the Act has accomplished, they say, is that it has enabled citizens to obtain information faster than through a federal Freedom of Information Act (FOIA) request.

NATIONAL REGULATIONS 2: USDA, FDA and EPA One of the primary reasons states like Minnesota and North Carolina pursued their own regulatory strategy is the fragmented and convoluted nature of federal oversight.. It is often unclear which agency is responsible for what. Furthermore, federal agencies take the burden of proof for safety off companies by requiring companies to notify the agency only when they think there may be a problem. Thus, consumers become the guinea pigs.

Under the federal system, three agencies are responsible for various aspects of regulating genetically engineered organisms: the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

USDA Within USDA, three departments handle oversight: the Animal and Plant Health Inspection Service (APHIS) oversees agricultural products; the Food Safety and Inspection Service (FSIS), oversees animal products; the Agricultural Biotechnology Research Advisory Committee (ABRAC) is a scientific advisory body.

Most of the regulatory activity occurs within APHIS. The main law granting authority for oversight to APHIS is the Plant Pest Act, which requires permits for genetically engineered organisms that are shipped interstate or used in the environment. As of 1992, companies are only required to notify the agency if they want to field test atypical modifications of six crops: corn, soybeans, tobacco, cotton, tomatoes and potatoes. Companies that want to field test other genetically engineered crops, such as squash and canola, are required to submit to a permitting process. FSIS regulates genetically engineered animals and animal products; however no such product has been commercialized yet and no formal policy has been adopted. ABRAC merely offers scientific guidance to APHIS and FSIS.

FDA FDA regulates the products of biotech intended for human and/or animal consumption. Authority to regulate genetically engineered products is granted by the Food Drug and Cosmetic Act (FDCA). Under this Act, FDA typically reviews each product on a case-by-case basis, but provides companies with a great deal of flexibility. For example, Calgene, which developed the genetically engineered delayed-ripening tomato Flavr Savr, was not required to undergo an FDA review prior to commercialization; the company did so on a voluntary basis in an attempt to allay the fears of consumers.

The agency's policy is that products of genetic engineering should be treated as traditional and safe, with emphasis on the end product, not the process by which the product was derived. The agency does not require pre-market safety tests, notification or labeling A 90-day pre-market notification policy is reportedly being discussed at FDA.

EPA The EPA also regulates genetically engineered agricultural products. Jurisdiction is granted by two laws: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). EPA typically uses existing FIFRA regulations to review and register genetically engineered plant pesticides and microbial pesticides. Proposed revisions in 1995 would exempt virus and herbicide-resistant plants from FIFRA oversight. Public interest groups object. Too little is known about virus-resistant plants they say, and thus, they should not be exempted until more data is available on their potential risks to the environment.
Under TSCA, EPA regulates organisms containing altered DNA as new chemical substances. TSCA's purpose is to regulate chemical substances not otherwise regulated as drugs; the Act applies to new genetically engineered microorganisms used in chemical manufacturing and the environment and to non-pesticidal organisms, such as nitrogen-fixing bacteria. TSCA may eventually apply to genetically engineered microorganisms used in pollution remediation when such things reach commercialization stage.

No federal agency requires consumer labeling, creating a problem for people of various religious persuasions, vegetarians, those with food allergies and those who simply do not want to purchase the products of biotechnology in support of more sustainable methods of food production.

INTERNATIONAL BIOSAFETY PROTOCOL The Convention on Biological Diversity, signed at the Earth Summit in Rio de Janeiro in June 1992 by more than 150 countries (except the U.S.), states that all "Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity." 3

In 1993, the U.N. Environment Programme convened a panel of experts with this exact mandate; a majority of the panel found that there was a need and defined the "scopes and confines" and the "modalities of and elements to be included" in a possible protocol.4 At the First Conference of the Parties to the Convention, in December 1994, the participating governments formed two additional panels: another experts panel with the same mandate which convened in Cairo in May 1995; and a panel of governmental officials which will meet in Madrid in July1995 to review this experts' panel report.5 These officials will forward their findings to the Second Conference of the Parties, convening in November 1995 in Istanbul.

Non-governmental organizations (NGOs) are circulating a worldwide call for a legally binding biosafety protocol:

"We the undersigned NGOs call upon the Conference of the Parties to the Convention on Biological Diversity to formulate and adopt a legally binding biosafety protocol. We believe that the lack of a legally binding protocol could result in a catastrophic release of genetically modified organisms.
Therefore, we further call for a worldwide moratorium on all releases of genetically modified organisms - and call upon all nations to adopt such a moratorium - until such a biosafety protocol has been achieved."

To endorse this petition or for more information on the regulation of genetic engineering, contact:

Community Nutrition Institute, 910 17th Street NW, Suite 413, Washington,
DC 20006; Telephone: 202-776-0595; Fax: 202-776-0599;


Edmonds Institute, 20319 92nd Avenue West, Edmonds, WA 98020; Telephone: (206) 775-5383; Email: BR>
SOURCES 1 Stark, Margo, Ed., In Our Backyard: State Action to Govern the Release of Genetically Engineered Organisms Into the Environment, Biotechnology Working Group. February 1993. 2 Food and Allied Service Trade (FAST), Biotechnology: A Report on the Future of Food -- Promise or Peril? Washington, DC, 1992. 3 Convention on Biological Diversity, Article 19.3.

United Nations. June 1992. 4 UNEP Expert Panels Established to Follow-Up on the Convention on Biological Diversity, Report of Panel IV. UNEP/Bio.Div./Panels/Inf.4 Nairobi, 28 April 1993. 5 Report of the Panel of Experts on Biosafety. Cairo, Egypt, 1-5 May 1995. CBD/Biosafety Panel/5/L.1.

----- One in a series of info sheets on Intellectual Property Rights available from the Institute for Agriculture and Trade Policy. To receive a complete listing, send email to:

   Dale Wiehoff
   Communications Director
   Institute for Agriculture and Trade Policy (IATP) 1313 5th Street SE, 
   Suite 303
   Minneapolis, MN 55414-1546 USA
   Tel: (612) 379-5980 Fax: (612) 379-5982

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