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 FDAand 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