Genetically Engineered Crops:

Agencies Are Proposing Changes to Improve Oversight, but Could Take Additional Steps to Enhance Coordination and Monitoring

GAO-09-60: Published: Nov 5, 2008. Publicly Released: Dec 5, 2008.

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Genetically engineered (GE) crops--including crops engineered to resist pests or tolerate herbicides--are widespread in the United States and around the world. Taking direction from the 1986 Coordinated Framework for Regulation of Biotechnology, the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) regulate GE crops to ensure that they are safe. The unauthorized mixing of some GE crops with non-GE crops has caused controversy and financial harm. GAO examined (1) unauthorized releases of GE crops, (2) coordination among the three agencies, and (3) additional actions they have proposed to improve oversight. GAO gathered data from agencies and stakeholders; used criteria from prior GAO work to assess coordination; and reviewed agency proposals.

Unauthorized releases of GE crops into food, animal feed, or the environment beyond farm fields have occurred, and it is likely that such incidents will occur again. While there is no evidence that the six known releases into the food or feed supply or into crops meant for the food or feed supply affected human or animal health, some resulted in lost trade opportunities. Moreover, the total number of unauthorized releases into the environment is unknown. USDA and EPA have the authority to inspect fields in which GE crops are tested, but crop developers have detected most violations. USDA and EPA have taken enforcement actions in response to violations, ranging from warning letters to significant penalties. The agencies have used lessons learned from unauthorized releases to make regulatory and policy changes. For example, USDA increased inspections of field trial sites for GE crops producing pharmaceutical compounds; EPA discontinued a policy under which a GE crop containing a pesticidal agent could be approved for animal feed, but not for food; and FDA established a voluntary early food safety evaluation program for certain GE crops intended for food use to help mitigate the impact should unauthorized releases occur during field trials, although it has not made these evaluations available to the public. USDA, EPA, and FDA routinely coordinate their oversight and regulation of GE crops in many respects, but could improve their efforts. Specifically, USDA and FDA do not have a formal method for sharing information that could enhance FDA's voluntary early food safety review for certain GE crops in the field trial stage and support USDA's oversight. Also, the three agencies do not have a coordinated program for monitoring the use of marketed GE crops to determine whether the spread of genetic traits is causing undesirable effects on the environment, non-GE segments of agriculture, or food safety, as recommended by the National Research Council and others. USDA, EPA, and FDA have proposed regulatory changes intended to improve their oversight of GE crops. In 2007, USDA assessed a wide array of regulatory alternatives that could redefine, on the basis of risk, which GE crops it regulates and how it will respond to unauthorized releases. USDA's fiscal year 2009 budget request also seeks funding for a voluntary system to help GE crop developers employ best management practices to reduce the risk of unauthorized releases. Furthermore, the 2008 Farm Bill required USDA to take actions on lessons learned from its investigation of an unauthorized release of GE rice. EPA has proposed several changes to its regulations for GE crops that produce pesticides, including one change that would distinguish between pesticidal agents produced in GE crops and those applied topically to crops. In 2001, FDA proposed to require that GE food developers notify the agency before marketing their products. However, as of July 2008, FDA had not taken action to finalize the proposed rule, believing its current approach calling for voluntary notice is sufficient.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To improve transparency and mitigate the impact of an unauthorized release into the food or feed supply of a regulated GE plant that has completed an early food safety evaluation, the FDA Commissioner should fulfill the agency's commitment to post the results of completed early food safety evaluations on its Web site and add the results of future evaluations within 120 days of receiving the submission from the plant developer.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA's biotechnology web site now includes an inventory of the early food safety evaluation submissions received by the agency, the name of the submitter, the date FDA received to submission, the name of the protein, and the date of FDA's response letter. The web site, at http://www.fda.gov/Food/Biotechnology/Submissions/ucm222595.htm, also provides links to the company's submission and to the agency's response letter.

    Recommendation: To reduce the risk and impact of unauthorized releases, the Secretary of Agriculture and the FDA Commissioner should develop a formal agreement to share information concerning GE crops with novel genetic traits that, if unintentionally released into the food or feed supply, present or are likely to present public health concerns and, as a result, also could have negative financial consequences for the food and agriculture industry. With information from USDA about permits or notifications for field trials of such GE crops, FDA could identify which GE crops might benefit from an early food safety evaluation and encourage the developers of those crops to participate in evaluations. With assistance from FDA, USDA could make meaningful and transparent use of the health evaluation data available through FDA's early food safety evaluations in its risk assessment of GE crops.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: USDA and FDA agreed with the recommendation that they develop a formal agreement. In 2011, FDA, USDA, and EPA completed a memorandum of understanding that will facilitate the sharing of certain non-public information between the agencies. The completion of the memorandum of understanding was announced in the Federal Register in February 2012. According to the agencies, the memorandum of understanding will support and encourage cooperation and communication between USDA, FDA, and EPA in the regulatory oversight of genetically engineered plants and the foods derived from such plants. Under the memorandum, USDA, FDA, and EPA agree to share with each other information about genetically-engineered plants and the foods derived from such plants, including non-public information exempt from public disclosure usually referred to as "confidential business information" and "trade secrets." And, according to an FDA official, the memorandum of understanding was developed with GAO's recommendation in mind.

    Recommendation: To reduce the risk and impact of unauthorized releases, the Secretary of Agriculture and the FDA Commissioner should develop a formal agreement to share information concerning GE crops with novel genetic traits that, if unintentionally released into the food or feed supply, present or are likely to present public health concerns and, as a result, also could have negative financial consequences for the food and agriculture industry. With information from USDA about permits or notifications for field trials of such GE crops, FDA could identify which GE crops might benefit from an early food safety evaluation and encourage the developers of those crops to participate in evaluations. With assistance from FDA, USDA could make meaningful and transparent use of the health evaluation data available through FDA's early food safety evaluations in its risk assessment of GE crops.

    Agency Affected: Department of Agriculture

    Status: Closed - Implemented

    Comments: USDA and FDA agreed with the recommendation that they develop a formal agreement. In 2011, USDA, FDA, and EPA completed a memorandum of understanding that will facilitate the sharing of certain non-public information between the agencies. The completion of the memorandum of understanding was announced in the Federal Register in February 2012. According to the agencies, the memorandum of understanding will support and encourage cooperation and communication between the three agencies. Specifically, under the memorandum, USDA, FDA, and EPA agree to share with each other information about genetically-engineered plants and the foods derived from such plants, including information exempt from public disclosure usually referred to as "confidential business information" and "trade secrets." According to an FDA official, the memorandum of understanding was developed with GAO's recommendation in mind.

    Recommendation: To help ensure that unintended consequences arising from the marketing of GE crops are detected and minimized, the Secretary of Agriculture, the EPA Administrator, and the FDA Commissioner should develop a coordinated strategy for monitoring marketed GE crops and use the results to inform their oversight of these crops. Such a strategy should adopt a risk-based approach to identify the types of marketed GE crops that warrant monitoring, such as those with the greatest potential for affecting the environment or non-GE segments of agriculture, or those that might threaten food safety through the unintentional introduction of pharmaceutical or industrial compounds into the food supply. The strategy should also identify criteria for determining when monitoring is no longer needed. In developing a strategy, the agencies should draw upon the analysis and conclusions of the National Research Council and the National Science and Technology Council.

    Agency Affected: Department of Agriculture

    Status: Closed - Not Implemented

    Comments: The three agencies--USDA, EPA, and FDA--have not worked together to develop a coordinated strategy for monitoring marketed GE crops.

    Recommendation: To help ensure that unintended consequences arising from the marketing of GE crops are detected and minimized, the Secretary of Agriculture, the EPA Administrator, and the FDA Commissioner should develop a coordinated strategy for monitoring marketed GE crops and use the results to inform their oversight of these crops. Such a strategy should adopt a risk-based approach to identify the types of marketed GE crops that warrant monitoring, such as those with the greatest potential for affecting the environment or non-GE segments of agriculture, or those that might threaten food safety through the unintentional introduction of pharmaceutical or industrial compounds into the food supply. The strategy should also identify criteria for determining when monitoring is no longer needed. In developing a strategy, the agencies should draw upon the analysis and conclusions of the National Research Council and the National Science and Technology Council.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: The three agencies--USDA, EPA, and FDA--have not worked together to develop a coordinated strategy for monitoring marketed GE crops.

    Recommendation: To help ensure that unintended consequences arising from the marketing of GE crops are detected and minimized, the Secretary of Agriculture, the EPA Administrator, and the FDA Commissioner should develop a coordinated strategy for monitoring marketed GE crops and use the results to inform their oversight of these crops. Such a strategy should adopt a risk-based approach to identify the types of marketed GE crops that warrant monitoring, such as those with the greatest potential for affecting the environment or non-GE segments of agriculture, or those that might threaten food safety through the unintentional introduction of pharmaceutical or industrial compounds into the food supply. The strategy should also identify criteria for determining when monitoring is no longer needed. In developing a strategy, the agencies should draw upon the analysis and conclusions of the National Research Council and the National Science and Technology Council.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Not Implemented

    Comments: The three agencies--USDA, EPA, and FDA--have not worked together to develop a coordinated strategy for monitoring marketed GE crops.

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