EPA, FDA, and USDA Have Taken Steps to Regulate GE Crops, but USDA Has Not Updated Its Regulations to Oversee GE Crops Derived from Alternative Technologies

EPA, FDA, and USDA, generally have taken steps to regulate GE crops,  including those derived from alternative technologies, but USDA has not  updated its regulations to oversee all GE crops. EPA and FDA officials  said that they apply the same legal authorities and oversight processes to  regulate GE crops from alternative technologies that they do for other GE  and non-GE crops, regardless of how they are derived. Conversely,  USDA’s regulations pertaining to GE crops address only GE crops for  which the donor, vector, or recipient of genetic material is a plant pest. In 1995, FDA established a voluntary premarket consultation process,  through which companies are encouraged to notify the agency before  marketing a food produced from a GE crop and voluntarily submit a  summary of the developer-performed safety assessment that, among  other things, (1) identifies distinguishing attributes of new genetic traits,  such as the source and function of the genetic material, the purpose of  the modification, and the estimated concentration of the new material in  food derived from the GE crop; (2) provides information regarding  whether any new material in food made from the GE crop is known or  suspected to be a toxin or allergenic, and the basis for concluding that the  GE-derived food can be safely consumed; and (3) compares the  composition or characteristics of GE-derived food to that of its non-GE  counterpart with special emphasis on important nutrients and toxins that  occur naturally in the food. However, USDA officials said that they do not have a  timeline for finalizing a new rule. Nonetheless, USDA  has taken some steps to address unintended mixing of GE and non-GE  crops. USDA Has Limited Data on the Unintended Mixing of GE and Non-GE Crops, Making It Difficult to Know the Extent and Economic Impact of Such Mixing

According to USDA officials and several stakeholders, USDA has limited  data on the unintended mixing of GE and non-GE crops from production  to market, making it difficult to know the extent of such mixing and the  associated economic losses experienced by farmers. USDA officials said that the National Agricultural Statistics Service  (NASS) and the Economic Research Service (ERS) have generally not  collected information on unintended mixing between GE and non-GE  crops in past farmer surveys because no specific request had been made  by other USDA agencies to obtain this information. In 2014, USDA’s Organic Survey, administered by NASS, and partly in  response to the AC21 recommendation to fund or conduct research on  the quantification of economic losses incurred by farmers as a result of  unintended GE presence, included a question asking organic farmers if  they had experienced an economic loss because of unintended GE  presence in their crops offered for sale, and if so, to quantify their three  most recent losses. Further,  these officials said that while they lack information on the number of  nonorganic producers seeking to market their non-GE crop as identity- preserved (i.e., crops of a specific genetic variety, which might bring a  higher price), the acreage planted with identity-preserved corn and  soybeans is significantly greater than the acreage planted with organic  versions of these crops. However, USDA currently has no efforts under way to survey these  identity-preserved producers on this issue. Without including producers  growing identity-preserved crops, in addition to producers growing  organic crops, in its survey efforts, USDA lacks statistically-valid data  needed to understand the full scope of the potential economic impacts  from unintended GE presence. USDA, EPA, and FDA Provide Varying Degrees of Information to the Public about Oversight of GE Crops

USDA, EPA, and FDA provide varying degrees of information to the  public about their oversight of GE crops. In addition, USDA regularly  provides information and updates on actions and meetings on its website  relating to its oversight of GE crops and other GE organisms, and offers  opportunities for public input. On its  website, EPA provides updates on actions related to oversight of GE  crops, including pesticide registrations such as those intended for use  with GE crops. Publishing a notice of intent, programmatic environmental  impact statement, and proposed rule in the coming months are good first  steps, but without setting a timeline, with milestones and interim steps, for  updating its GE crop regulations, it will be difficult for the agency to set  priorities, use resources efficiently, measure progress, and provide  management a means to monitor the agency’s progress in promulgating a  new rule. In addition, until a rule is finalized, USDA will continue to lack  regulatory authority to fully assess the potential risks, if any, to plant and  environmental health posed by GE crops created with alternative  technologies, in particular those that either do not use plant pests or use  plant pests but do not result in plant pest DNA in the crop developed. Our objectives were to examine (1) the steps the U.S.  Department of Agriculture (USDA), Environmental Protection Agency  (EPA), and Food and Drug Administration (FDA) have taken to regulate  GE crops, including those derived from alternative technologies; (2) what  data USDA has on the extent of unintended mixing of GE and non-GE  crops, and what steps, if any, have been taken to prevent such mixing;  and (3) the extent to which USDA, EPA, and FDA provide information to  the public on GE crops they oversee.
Why GAO Did This Study

Three agencies have primary responsibility for regulating GE crops and food in the United States: USDA, EPA, and FDA. USDA and industry groups estimate that at least 90 percent of many major commercial crops, such as corn and soybeans, are GE varieties. Proponents say GE crops offer greater pest resistance, use less labor-intensive processes to control weeds, and result in increased productivity to feed growing populations. Opponents cite a lack of consensus on impacts to agriculture, the environment, and human health.
GAO was asked to review oversight and information on GE crops. This report examines (1) steps EPA, FDA, and USDA have taken to regulate GE crops; (2) the data USDA has on the extent and impact of unintended mixing of GE and non-GE crops, and what steps have been taken to prevent such mixing; and (3) the extent to which USDA, EPA, and FDA provide information to the public on GE crops. GAO analyzed legislation, regulations, and agency policies and reports and interviewed agency officials and stakeholders, including representatives from the biotechnology and food industries and consumer, farm, environmental, and commodity groups.

What GAO Found

The Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA), have taken steps to regulate genetically-engineered (GE) crops (i.e., crops whose genetic makeup has been modified), but USDA has not updated its regulations to oversee GE crops derived from alternative technologies in which the GE crop developed contains no plant pest DNA. EPA regulates certain GE crops as part of its pesticide registration process. FDA, through its voluntary consultation process, works with companies that develop GE crops to consider food safety issues. EPA and FDA apply the same legal authorities and oversight processes to regulate GE and non-GE crops, regardless of how a GE crop was developed. Conversely, USDA's GE crop regulations pertain only to crops for which the donor, vector, or recipient of genetic material is a plant pest. In 2008, USDA took steps to update its regulations to capture GE crops developed with alternative technologies. However, in February 2015, USDA withdrew its proposed rule because, in part, the scope of this rule was not clear. USDA still intends to update its regulations, but has not established a timeline for doing so. GAO's body of work has shown that without milestones and interim steps it can be difficult for an agency to set priorities, measure progress, and provide management a means to monitor the agency's progress in promulgating a new rule. In addition, until a rule is finalized USDA will continue to lack regulatory authority to assess the potential risks, if any, posed by GE crops created with alternative technologies.
USDA has limited data on the extent and impact of unintended mixing of GE and non-GE crops, according to USDA officials and stakeholders. USDA officials said that the agency has generally not collected information on unintended mixing in past farmer surveys because no specific request had been made to obtain this information. In a 2012 report, the USDA Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) recommended that the agency fund or conduct research, including quantifying actual economic losses (e.g., loss of a premium price for an organic crop), incurred by farmers as a result of unintended mixing. In its 2014 Organic Survey, USDA surveyed organic farmers on economic losses from unintended GE presence in their crops offered for sale. The survey results indicated that economic losses caused by unintended GE material in organic crops offered for sale exist, although at very small levels. However, USDA does not have similar data for farmers using non-GE seed and marketing their crops as identity-preserved (i.e., a specific genetic variety of a crop). USDA officials said identity-preserved crop acreage is significantly greater than organic crop acreage. Without including farmers growing identity-preserved crops in addition to those growing organic crops in its survey efforts, USDA is missing key information on the potential economic impacts of unintended mixing. Nonetheless, USDA has taken some steps to address unintended mixing, such as reviving AC21, as have farmers and the agribusiness industry.
USDA, EPA, and FDA provide varying degrees of information about their oversight of GE crops to the public. USDA and EPA regularly provide information and updates on actions relating to their oversight of GE crops on their websites and use a number of mechanisms to obtain public input on their actions. FDA provides information on GE crops relating to its consultation process.

What GAO Recommends

GAO recommends, among other things, that USDA set a timeline for updating its regulations and include farmers growing identity-preserved crops in its survey efforts to better understand the impacts of unintended mixing. USDA generally agreed with these recommendations.