Volume:35·Issue:06·2003·December·Page: Journal of Nutrition Education and Behavior 319 VIEWPOINT Application of Modern Biotechnology to Food and Agriculture:Food Systems Perspective Christine MeCullum,PhD,RD:;!Charles Benbrook,PhD;2 Lori Knowles,LLB,BCL,MA,LLM:3 Susan Roberts,JD,MS,RD,LD;4 Tamara Schryver,MS,RD5 1 Center for Health Promotion and Prevention Research,School of Public Health,University of Texas- Houston,Health Science Center,Houston,Texas,2 Benbrook Consulting Services,Sandpoint,Idaho;3 The Hastings Center,Garrison,New York;4 Agricultural Law Center,Drake University Law School, Des Moines,Iowa;5 Food Science and Nutrition Department,University of Minnesota,St.Paul, Minnesota ABSTRACT The purpose of this article is to provide nutrition educators with an introduction to a range of considerations and forces that are driving the application of modern biotechnology in the food and fiber sector based on a food systems perspective.In doing so,the following issues are critically assessed:(1) the global debate on how to regulate genetically engineered(GE)foods and crops,(2)cultural differences in public perceptions of GE foods,and(3)evaluation of selected GE traits against the principles of social,economic,and ecological sustainability,including the potential of modern agricultural biotechnology to enhance global food security.Where appropriate,we also review other agricultural technologies and the broader political,social,and economic contexts in which these technologies have been introduced.Finally,we offer recommendations for how multiple stakeholder groups,including policy makers,biotechnology advocates,and nutrition educators,can move toward a more informed dialogue and debate on this issue. KEYWORDS modern biotechnology,food and agriculture,food systems perspective INTRODUCTION The Convention on Biological Diversity(CBD)has defined biotechnology as "any technological application that uses biological systems,living organisms,or derivatives thereof,to make or modify products or processes for specific use."Interpreted in this broad sense,biotechnology covers many contemporary agricultural and food manufacturing tools.However,when biotechnology is used in a more narrow sense,it refers only to new deoxyribonucleic acid(DNA)techniques,molecular biology, and reproductive technological applications ranging from gene transfer to DNA typing to cloning of plants and animals.Whereas there is little controversy about many aspects of biotechnology and its application,there has been considerable controversy about the use of modern biotechnology in food and agriculture,particularly the use of genetic engineering and genetically engineered organisms(GEOs). Genetically engineered(GE)crops were first introduced for commercial production in 1996.Since then, their use has increased rapidly.In 2002,GE crops were planted on 145 million acres worldwide.The earliest applications of genetic engineering to agriculture have focused primarily on simplifying pest management in widely planted crops.Technology targets have been chosen by the private sector based
VIEWPOINT Application of Modern Biotechnology to Food and Agriculture: Food Systems Perspective Christine McCullum, PhD, RD;; 1 Charles Benbrook, PhD; 2 Lori Knowles, LLB, BCL, MA, LLM; 3 Susan Roberts, JD, MS, RD, LD; 4 Tamara Schryver, MS, RD 5 1 Center for Health Promotion and Prevention Research, School of Public Health, University of TexasHouston, Health Science Center, Houston, Texas; 2 Benbrook Consulting Services, Sandpoint, Idaho; 3 The Hastings Center, Garrison, New York; 4 Agricultural Law Center, Drake University Law School, Des Moines, Iowa; 5 Food Science and Nutrition Department, University of Minnesota, St. Paul, Minnesota The purpose of this article is to provide nutrition educators with an introduction to a range of considerations and forces that are driving the application of modern biotechnology in the food and fiber sector based on a food systems perspective. In doing so, the following issues are critically assessed: (1) the global debate on how to regulate genetically engineered (GE) foods and crops, (2) cultural differences in public perceptions of GE foods, and (3) evaluation of selected GE traits against the principles of social, economic, and ecological sustainability, including the potential of modern agricultural biotechnology to enhance global food security. Where appropriate, we also review other agricultural technologies and the broader political, social, and economic contexts in which these technologies have been introduced. Finally, we offer recommendations for how multiple stakeholder groups, including policy makers, biotechnology advocates, and nutrition educators, can move toward a more informed dialogue and debate on this issue. modern biotechnology, food and agriculture, food systems perspective INTRODUCTION The Convention on Biological Diversity (CBD) has defined biotechnology as "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use." Interpreted in this broad sense, biotechnology covers many contemporary agricultural and food manufacturing tools. However, when biotechnology is used in a more narrow sense, it refers only to new deoxyribonucleic acid (DNA) techniques, molecular biology, and reproductive technological applications ranging from gene transfer to DNA typing to cloning of plants and animals. Whereas there is little controversy about many aspects of biotechnology and its application, there has been considerable controversy about the use of modern biotechnology in food and agriculture, particularly the use of genetic engineering and genetically engineered organisms (GEOs). Genetically engineered (GE) crops were first introduced for commercial production in 1996. Since then, their use has increased rapidly. In 2002, GE crops were planted on 145 million acres worldwide. The earliest applications of genetic engineering to agriculture have focused primarily on simplifying pest management in widely planted crops. Technology targets have been chosen by the private sector based Journal of Nutrition Education and Behavior Volume: 35 • Issue: 06 • 2003 • December • Page: 319 ABSTRACT KEYWORDS
on two factors:what the tools of genetic engineering could feasibly accomplish and potential market size and profitability.One major category includes crops engineered for disease and insect resistance to prevent crop losses (eg,insect-resistant corn and cotton),and the second category encompasses herbicide-tolerant(HT)crops(eg,glyphosate-resistant,or Roundup Ready [RR]soybeans [Monsanto Co,St.Louis,MO]),which allow farmers to spray broad-spectrum herbicides over growing crops. During the period from 1996 until 2002,the dominant trait used has been herbicide tolerance,which now occupies 75%of the total acres planted globally.Bacillus thuringiensis Bt crops (engineered for insect resistance)occupy 17%of the total acres planted globally.In 2002,3 countries accounted for 95% of the total area(total number of acres)of GE crops planted globally:the United States(66%), Argentina(23%),and Canada(6%).The principal GE crops grown were soybeans,corn,and cotton The purpose of this commentary is to provide nutrition educators with an introduction to a range of considerations and forces driving the evolution of the application of modern biotechnology in the food and fiber sector based on a food systems perspective.The Figure Figure.Conceptualization of the interrelated components of local food systems. depicts the interrelated components of local food systems,which include the production,processing, distribution,access,use,and recycling/composting of food.These interrelated components are influenced by (1)natural resource allocation,(2)use of technological systems,and (3)society and culture (eg,values and beliefs,cultural norms,food practices),which are,in turn,influenced by broader forces,including governing institutions and public policies.Here we critically assess the following issues from a food systems perspective:(1)the global debate on how to regulate GE foods and crops,(2) cultural differences in public perceptions of GE foods,and(3)an evaluation of selected GE traits against the principles of social,economic,and ecological sustainability,including the potential of GE crops and modern biotechnology to enhance global food security.Where appropriate,we review other agricultural technologies and the broader contexts in which these technologies have been introduced.Finally,we offer recommendations for how policy makers,biotechnology advocates,and nutrition educators can move toward a more informed dialogue on this issue. GLOBAL DEBATE:HOW TO REGULATE GE FOODS AND CROPS In the United States,three federal agencies regulate different aspects of GE foods:the Environmental Protection Agency (EPA),the Food and Drug Administration(FDA),and the Department of Agriculture (USDA).These agencies operate under separate statutes and are overseen by different committees of Congress.They coordinate their efforts under the 1986 Coordinated Biotechnology Framework.The Table Table.US and Selected International Agencies with Legal Authority in Regulating Genetically Engineered(GE)Plants and GE Organisms* Agency Authority Specific Regulations Responsibility White House Executive 1986 Coordinated Coordination of federal Framework activities US Department Plant Protection Act 7CFR 340 New pests,environmental impact of Agriculture US Environmental Federal Food,Drug,and FFDCA rules,FIFRA rules Plant incorporated protectants
on two factors: what the tools of genetic engineering could feasibly accomplish and potential market size and profitability. One major category includes crops engineered for disease and insect resistance to prevent crop losses (eg, insect-resistant corn and cotton), and the second category encompasses herbicide-tolerant (HT) crops (eg, glyphosate-resistant, or Roundup Ready [RR] soybeans [Monsanto Co, St. Louis, MO]), which allow farmers to spray broad-spectrum herbicides over growing crops. During the period from 1996 until 2002, the dominant trait used has been herbicide tolerance, which now occupies 75% of the total acres planted globally. Bacillus thuringiensis ( Bt ) crops (engineered for insect resistance) occupy 17% of the total acres planted globally. In 2002, 3 countries accounted for 95% of the total area (total number of acres) of GE crops planted globally: the United States (66%), Argentina (23%), and Canada (6%). The principal GE crops grown were soybeans, corn, and cotton. The purpose of this commentary is to provide nutrition educators with an introduction to a range of considerations and forces driving the evolution of the application of modern biotechnology in the food and fiber sector based on a food systems perspective. The Figure Figure. Conceptualization of the interrelated components of local food systems. depicts the interrelated components of local food systems, which include the production, processing, distribution, access, use, and recycling/ composting of food. These interrelated components are influenced by (1) natural resource allocation, (2) use of technological systems, and (3) society and culture (eg, values and beliefs, cultural norms, food practices), which are, in turn, influenced by broader forces, including governing institutions and public policies. Here we critically assess the following issues from a food systems perspective: (1) the global debate on how to regulate GE foods and crops, (2) cultural differences in public perceptions of GE foods, and (3) an evaluation of selected GE traits against the principles of social, economic, and ecological sustainability, including the potential of GE crops and modern biotechnology to enhance global food security. Where appropriate, we review other agricultural technologies and the broader contexts in which these technologies have been introduced. Finally, we offer recommendations for how policy makers, biotechnology advocates, and nutrition educators can move toward a more informed dialogue on this issue. GLOBAL DEBATE: HOW TO REGULATE GE FOODS AND CROPS In the United States, three federal agencies regulate different aspects of GE foods: the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA). These agencies operate under separate statutes and are overseen by different committees of Congress. They coordinate their efforts under the 1986 Coordinated Biotechnology Framework. The Table Table. US and Selected International Agencies with Legal Authority in Regulating Genetically Engineered (GE) Plants and GE Organisms* Agency Authority Specific Regulations Responsibility White House Executive 1986 Coordinated Framework Coordination of federal activities US Department Plant Protection Act 7 CFR 340 New pests, environmental impact of Agriculture US Environmental Federal Food, Drug, and FFDCA rules, FIFRA rules Plant incorporated protectants
(health and environmental Protection Agency Cosmetic Act(FFDCA), risks) Federal Insecticide, Fungicide, Rodenticide Act(FIFRA) US Food and Drug FFDCA 1992 Statement of policy Whole foods,risk to human health Administration European Union European Community (EC) Directive 2001/18/EC Environmental risks treaty European Union EC treaty EC 258/97,EC 1139/98,Food risks and labeling EC49/2000,EC50/2000, Directive 2001/18/EC United Nations Convention on Biological Cartagena Protocol on Interboundary movement of Biosafety living modified organisms(LDMs) Biodiversity Codex Alimentarius Food and Agriculture In process Labeling,human health Commission Organization and World Health Organization *Adapted from BucchiniL,Goldman LR.12 In July 2003,the European Parliament approved legislation that will require strict labels for food and feed made with genetically engineered(GE) ingredients.Under the new rules,all GE products including animal feed,vegetable oils,seeds,and byproducts containing more than 0.9 percent GE material will have to be labeled.The legislation also ensures that GE foods are traced from their point of origin to the supermarket.The new laws are expected to take effect in early 2004. Living modified organisms(LMOs)is language that is used in this context to refer to genetically engineered organisms. highlights the US agencies and selected international entities with legal authority to regulate GE plants
*Adapted from Bucchini L, Goldman LR.12 †In July 2003, the European Parliament approved legislation that will require strict labels for food and feed made with genetically engineered (GE) ingredients. Under the new rules, all GE products including animal feed, vegetable oils, seeds, and byproducts containing more than 0.9 percent GE material will have to be labeled. The legislation also ensures that GE foods are traced from their point of origin to the supermarket. The new laws are expected to take effect in early 2004. ‡ Living modified organisms (LMOs) is language that is used in this context to refer to genetically engineered organisms. highlights the US agencies and selected international entities with legal authority to regulate GE plants Protection Agency Cosmetic Act (FFDCA), (health and environmental risks) Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) US Food and Drug FFDCA 1992 Statement of policy Whole foods, risk to human health Administration European Union European Community (EC) Directive 2001/18/EC Environmental risks treaty European Union EC treaty EC 258/97, EC 1139/98, Food risks and labeling† EC 49/2000, EC 50/2000, Directive 2001/18/EC United Nations Convention on Biological Cartagena Protocol on Biosafety Interboundary movement of living Biodiversity modified organisms (LDMs) ‡ Codex Alimentarius Food and Agriculture In process Labeling, human health Commission Organization and World Health Organization
and GEOs.In the United States,risk assessment requires the agency to analyze and interpret the scientific data and make informed predictions about the risks imposed by an activity.After assessing risk,risk management requires that the agency make legal and policy judgments about how to employ regulatory options that are available to the agency under its governing statute.Policy debates surrounding GE foods and crops are not only in the scientific and administrative communities but also increasingly with the public,which is showing a wariness of the technology.For example,focus groups commissioned by the FDA revealed that the majority of participants were surprised and outraged to learn that GE foods were on the market without their knowledge.The global debate on how to regulate GE foods,crops,and GEOs encompasses a multitude of issues:(1)food safety risks,(2)environmental risks,(3)use of the precautionary principle for dealing with scientific uncertainty,(4)who participates in risk analysis and risk decision making,and(5)labeling and consumer right to know issues,each of which is described below in more detail. Food Safety In 1992,the FDA adopted a regulatory policy that specified that foods produced through genetic engineering techniques or containing GE substances substantially similar in"structure,function,and composition"to substances already in the food supply (proteins,carbohydrates,fats,and oils)were to be considered "generally recognized as safe".This terminology was later changed to "substantially equivalent".Under current FDA regulatory policy,if foods produced through GE techniques are deemed generally recognized as safe or substantially equivalent,they are not required to undergo mandatory premarket approval or premarket testing.The 1992 policy was opposed by FDA's own scientists,as was shown in documents that were forced to be released during a 1998 lawsuit against the FDA charging failure to fulfill its regulatory duties.In January 2001,the FDA proposed modifications to its regulatory policy and called for a 120-day premarket notification for any bioengineered food that would be brought to market.However,to date,the previously proposed change in FDA regulatory policy has not yet been approved. In January 2003,the nonprofit Center for Science in the Public Interest(CSPI)released a report concluding that the FDA's safety review process for the regulation of GE crops and foods needs to be strengthened to improve the quality of the FDA's regulatory oversight and to improve public confidence in the safety of foods made from these crops.Through examination of 14 submissions obtained under the Freedom of Information Act,CSPI found that when the FDA requested additional information to conduct a complete and thorough safety assessment,companies refused the FDA's request for more information 50%of the time (3 of 6).According to the CSPI report,several biotechnology companies declined to provide requested scientific data to the FDA about strains of GE insect-resistant corn.The report revealed technical shortcomings in data provided by the companies and errors that the FDA failed to detect.It also was noted that inadequacies in the FDA's review process will be exacerbated when more complex changes are made in the metabolism of plants and a wider range of genes are used. To address the observed shortcomings in the FDA's current regulatory policy,CSPI recommended that Congress provide the FDA with legal authority for mandatory review and safety approval of GE crops, including the authority to require any data it deems necessary to conduct a thorough food safety assessment.CSPI also has recommended that the FDA(1)develop detailed safety standards and testing guidelines;(2)require developers to submit complete details about their testing methods and the actual data from safety tests,including statistical analyses of those data;(3)establish an approval process that is transparent and provides the public with an opportunity to comment on submissions;(4)perform and make available to the public detailed assessments of commercialized GE crops;(5)reassess the safety of commercialized GE crops if new safety concerns are recognized or new tests become available;and(6) ask developers of current GE crops to provide additional data to give greater assurance of safety than the summary data previously provided to the agency.Finally,CSPI has recommended that when the FDA
and GEOs. In the United States, risk assessment requires the agency to analyze and interpret the scientific data and make informed predictions about the risks imposed by an activity. After assessing risk, risk management requires that the agency make legal and policy judgments about how to employ regulatory options that are available to the agency under its governing statute. Policy debates surrounding GE foods and crops are not only in the scientific and administrative communities but also increasingly with the public, which is showing a wariness of the technology. For example, focus groups commissioned by the FDA revealed that the majority of participants were surprised and outraged to learn that GE foods were on the market without their knowledge. The global debate on how to regulate GE foods, crops, and GEOs encompasses a multitude of issues: (1) food safety risks, (2) environmental risks, (3) use of the precautionary principle for dealing with scientific uncertainty, (4) who participates in risk analysis and risk decision making, and (5) labeling and consumer right to know issues, each of which is described below in more detail. Food Safety In 1992, the FDA adopted a regulatory policy that specified that foods produced through genetic engineering techniques or containing GE substances substantially similar in "structure, function, and composition" to substances already in the food supply (proteins, carbohydrates, fats, and oils) were to be considered "generally recognized as safe". This terminology was later changed to "substantially equivalent". Under current FDA regulatory policy, if foods produced through GE techniques are deemed generally recognized as safe or substantially equivalent, they are not required to undergo mandatory premarket approval or premarket testing. The 1992 policy was opposed by FDA's own scientists, as was shown in documents that were forced to be released during a 1998 lawsuit against the FDA charging failure to fulfill its regulatory duties. In January 2001, the FDA proposed modifications to its regulatory policy and called for a 120-day premarket notification for any bioengineered food that would be brought to market. However, to date, the previously proposed change in FDA regulatory policy has not yet been approved. In January 2003, the nonprofit Center for Science in the Public Interest (CSPI) released a report concluding that the FDA's safety review process for the regulation of GE crops and foods needs to be strengthened to improve the quality of the FDA's regulatory oversight and to improve public confidence in the safety of foods made from these crops. Through examination of 14 submissions obtained under the Freedom of Information Act, CSPI found that when the FDA requested additional information to conduct a complete and thorough safety assessment, companies refused the FDA's request for more information 50% of the time (3 of 6). According to the CSPI report, several biotechnology companies declined to provide requested scientific data to the FDA about strains of GE insect-resistant corn. The report revealed technical shortcomings in data provided by the companies and errors that the FDA failed to detect. It also was noted that inadequacies in the FDA's review process will be exacerbated when more complex changes are made in the metabolism of plants and a wider range of genes are used. To address the observed shortcomings in the FDA's current regulatory policy, CSPI recommended that Congress provide the FDA with legal authority for mandatory review and safety approval of GE crops, including the authority to require any data it deems necessary to conduct a thorough food safety assessment. CSPI also has recommended that the FDA (1) develop detailed safety standards and testing guidelines; (2) require developers to submit complete details about their testing methods and the actual data from safety tests, including statistical analyses of those data; (3) establish an approval process that is transparent and provides the public with an opportunity to comment on submissions; (4) perform and make available to the public detailed assessments of commercialized GE crops; (5) reassess the safety of commercialized GE crops if new safety concerns are recognized or new tests become available; and (6) ask developers of current GE crops to provide additional data to give greater assurance of safety than the summary data previously provided to the agency. Finally, CSPI has recommended that when the FDA
lacks the authority to implement some of these recommendations,Congress should pass new legislation. Significant progress toward a global consensus on how to regulate the safety of GE foods was made when the Codex Alimentarius Ad Hoc Task Force on Foods Derived from Biotechnology completed draft principles for the human health risk analysis for GE foods.The draft principles stated that all GE foods should include a premarket safety assessment on a case-by-case basis for both intended and unintended effects and that all countries should include risk management measures,including a system for postmarket monitoring for the purpose of facilitating withdrawal of products from the market when a risk to human health was identified.These guidelines were adopted by the Codex Alimentarius in July 2003.This is considered a critical development globally because the World Trade Organization (WTO) considers the standards of the Codex Alimentarius Commission to be the global science-based standard. and,thus,immune to international trade challenges. Environmental Risks The EPA is the federal agency that evaluates and licenses pesticides under the Federal Insecticide, Fungicide,and Rodenticide Act(FIFRA)and the Federal Food,Drug,and Cosmetic Act(FFDCA).For plant-incorporated protectants,for example,GE crops with insecticidal properties,the scrutiny of the EPA encompasses environmental risks and human health concerns,although it is limited to pesticidal substances(the inserted DNA and the protein it produces).The USDA,under the Plant Protection Act, regulates all GE plants that have pest potential(see Table).A report issued by The National Research Council (NRC)on the environmental effects of transgenic plants has concluded that the USDA needs to (1)more rigorously review GE crops before approving them for commercial issue,(2)more actively seek outside scientific peer review of crop applications and advice on changes in regulatory policy,(3) more actively solicit public comment,and(4)monitor transgenic crops more closely after their approval In another recent NRC report entitled Animal Biotechnology:Science-Based Concerns,it was noted that for some applications of transgenic (GE)animals,scientific uncertainty will be a particular concern owing to the novelty of the health and environmental questions posed and the lack of established scientific methods for answering them. At the international level,controversy has stemmed from whether the Cartagena Protocol on Biosafety, commissioned by article 19 of the 1992 CBD,is needed to regulate living modified organisms(LMOs that are introduced into the environment.This international treaty,which is based on the precautionary principle,gives countries the right to bar imports of GE seeds,microbes,animals,and crops seen as a threat to their environment.Under what is known as the Advance Informed Agreement(AIA)procedure, any Party shipping LMOs for intentional introduction into the environment for the first time shall have to give prior notification to the importing country that is a party to the Protocol and provide sufficient information to enable it to make an informed decision.LMOs intended for food,feed,and processing are subject to information sharing requirements through a central Biosafety Clearinghouse.Countries can also decide whether or not to import these commodities based on their own scientific risk assessment.Finally,exporters must ensure that all shipments are accompanied by appropriate documentation that is required under the Protocol.The Cartagena Protocol,which was approved by over 130 countries in January 2000,became legally binding to its signatories in September 2003,90 days after it was ratified by 50 countries.Although the United States has not ratified the protocol,it must adhere to its provisions when shipping GE products to countries that are signatories to the protocol. The Precautionary Principle as a Basis for Dealing with Scientific Uncertainty The precautionary principle has its origins in the German word Vorsorgeprinzip,which is freely translated as the obligation to "foresee and forstall"environmental harms.The precautionary principle was established as a concept of environmental law in the 1970s.Since that time,it has been invoked in
lacks the authority to implement some of these recommendations, Congress should pass new legislation. Significant progress toward a global consensus on how to regulate the safety of GE foods was made when the Codex Alimentarius Ad Hoc Task Force on Foods Derived from Biotechnology completed draft principles for the human health risk analysis for GE foods. The draft principles stated that all GE foods should include a premarket safety assessment on a case-by-case basis for both intended and unintended effects and that all countries should include risk management measures, including a system for postmarket monitoring for the purpose of facilitating withdrawal of products from the market when a risk to human health was identified. These guidelines were adopted by the Codex Alimentarius in July 2003. This is considered a critical development globally because the World Trade Organization (WTO) considers the standards of the Codex Alimentarius Commission to be the global science-based standard, and, thus, immune to international trade challenges. Environmental Risks The EPA is the federal agency that evaluates and licenses pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). For plant-incorporated protectants, for example, GE crops with insecticidal properties, the scrutiny of the EPA encompasses environmental risks and human health concerns, although it is limited to pesticidal substances (the inserted DNA and the protein it produces). The USDA, under the Plant Protection Act, regulates all GE plants that have pest potential (see Table). A report issued by The National Research Council (NRC) on the environmental effects of transgenic plants has concluded that the USDA needs to (1) more rigorously review GE crops before approving them for commercial issue, (2) more actively seek outside scientific peer review of crop applications and advice on changes in regulatory policy, (3) more actively solicit public comment, and (4) monitor transgenic crops more closely after their approval. In another recent NRC report entitled Animal Biotechnology: Science-Based Concerns , it was noted that for some applications of transgenic (GE) animals, scientific uncertainty will be a particular concern owing to the novelty of the health and environmental questions posed and the lack of established scientific methods for answering them. At the international level, controversy has stemmed from whether the Cartagena Protocol on Biosafety, commissioned by article 19 of the 1992 CBD, is needed to regulate living modified organisms (LMOs ) that are introduced into the environment. This international treaty, which is based on the precautionary principle, gives countries the right to bar imports of GE seeds, microbes, animals, and crops seen as a threat to their environment. Under what is known as the Advance Informed Agreement (AIA) procedure, any Party shipping LMOs for intentional introduction into the environment for the first time shall have to give prior notification to the importing country that is a party to the Protocol and provide sufficient information to enable it to make an informed decision. LMOs intended for food, feed, and processing are subject to information sharing requirements through a central Biosafety Clearinghouse. Countries can also decide whether or not to import these commodities based on their own scientific risk assessment. Finally, exporters must ensure that all shipments are accompanied by appropriate documentation that is required under the Protocol. The Cartagena Protocol, which was approved by over 130 countries in January 2000, became legally binding to its signatories in September 2003, 90 days after it was ratified by 50 countries. Although the United States has not ratified the protocol, it must adhere to its provisions when shipping GE products to countries that are signatories to the protocol. The Precautionary Principle as a Basis for Dealing with Scientific Uncertainty The precautionary principle has its origins in the German word Vorsorgeprinzip , which is freely translated as the obligation to "foresee and forstall" environmental harms. The precautionary principle was established as a concept of environmental law in the 1970s. Since that time, it has been invoked in