Genetically Engineered Crops: USDA Needs to Enhance Oversight and Better Understand Impacts of Unintended Mixing with Other Crops
Published: 2016-03-15T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: Many large-scale commercial crops grown in the United States are  predominantly genetically engineered (GE) varieties, that is, their genetic  makeup has been modified through the use of modern biotechnology.  The U.S. Department of Agriculture (USDA) and industry groups estimate  that over 90 percent of the corn, soybeans, and cotton and a substantial  percentage of canola and sugar beets planted in the United States are  GE varieties. Authoritative scientific bodies, such as the National  Academy of Sciences, have issued reports stating that foods and food  ingredients derived from GE crops pose no greater food safety risk than  their non-GE counterparts. Proponents of GE crops have cited a number  of benefits, including a less labor-intensive process to control weeds,  increased crop productivity to feed growing populations, and greater crop  resistance to pests. Proponents also have said such crops contribute to  more environmentally friendly food production by requiring less tilling of  the soil, meaning less erosion and water use, and a reduced carbon  footprint. Opponents have cited the lack of consensus on the potential  impacts of GE crops on agriculture, the environment, trade, and human  health. Among their concerns are the potential for insects and weeds to  develop greater resistance to pesticides that are used in conjunction with  a GE crop, the spread of GE pollen to non-GE crops and seed supplies,  economic impacts from the potential disruption of domestic and  international markets for non-GE crops and related foods, and possible  human health risks associated with consuming foods derived from GE  crops and the pesticides applied to them.
Furthermore, as demand for foods derived from organic and non-GE  ingredients has increased, so have concerns about the mixing of GE and  non-GE crops and the unintended spread of genetic traits into the  environment that might have unanticipated consequences for plants and  animals. Some consumer groups have advocated for mandatory labeling  of all foods containing ingredients derived from GE crops to allow  consumers to know what is in their food. Opponents of labeling have said  that such mandatory labeling would cause confusion among consumers  and suggest a food safety risk that does not exist. Legislation has been  introduced at both the federal and state levels relating to labeling of foods  derived from GE ingredients. A number of bills have been introduced in  the 114th Congress related to labeling foods containing ingredients  derived from GE crops, and, according to the National Conference of  State Legislatures, lawmakers in more than 30 states have introduced  legislation on GE labeling as of July 2015.
Three federal agencies have primary responsibility for regulating GE  crops and food in the United States: USDA, the Environmental Protection  Agency (EPA), and the Department of Health and Human Services’s  Food and Drug Administration (FDA). USDA is responsible for assessing  whether GE crops pose a risk as “plant pests” that could directly or  indirectly harm plants. To accomplish this, under the statutory authority of  the Plant Protection Act, USDA regulates to detect, control, and prevent  spread of plant pests including preventing the unintended release of  regulated GE crops into the environment; such a release could occur  when a developer tests the crop in a field trial. USDA may, upon finding  that a crop does not pose a potential plant pest risk, grant a petition to  deregulate the crop, meaning that it can be moved or released without  agency oversight. EPA is responsible for regulating all pesticides,  including those produced by plants that have been genetically modified to  protect themselves from insects, bacteria, and viruses. USDA and, to a  lesser extent, EPA exercise oversight of the thousands of field trials in  which developers have tested new varieties of GE plants since 1987.  FDA is responsible for ensuring the safety of most of the nation’s food  supply. With respect to GE crops, FDA encourages companies to  voluntarily submit safety data on new food or feed derived from GE crops  before it is marketed.
Given the continued debate concerning the nature and extent of  agricultural and environmental benefits and challenges of GE crops, as  well as the related food safety assessment issues, you asked us to review  the oversight of and information on GE crops. This report examines (1)  the steps EPA, FDA, and USDA have taken to regulate GE crops,  including those derived from alternative technologies; (2) the data USDA  has on the extent and impact 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. In this report, we define alternative  technologies as those in which the GE crop developed contains no DNA  of a plant pest, such as a bacterium or virus. This includes technologies in  which a plant pest may have been used initially as part of the GE crop  development process. It also includes technologies that do not use plant  pests at all.
To determine how federal agencies have regulated GE crops derived  from alternative technologies, we interviewed officials from USDA, EPA,  and FDA, as well as representatives from 35 external stakeholder groups,  using a standard set of questions. Stakeholders represented  biotechnology, food industry, consumer, environmental, farm, and  commodity producer groups and academia. They were identified during  the course of our work and through the “snowball sampling” technique.  We selected these stakeholders to ensure that we captured a broad  spectrum of views. We did not evaluate the underlying science, including  the inherent safety or efficiency, of alternative GE technologies.
To examine what data, if any, exist on unintended mixing of GE and non- GE crops, we obtained USDA’s strategic plans and reports, including  USDA’s 2012 Advisory Committee on Biotechnology and 21st Century  Agriculture report with recommendations addressing the mixing of GE  and non-GE crops. We also conducted a literature search and review to  identify studies on the actual or potential impacts of GE crops on other  crops. We interviewed USDA officials who regulate, oversee, or set  standards for cultivation, shipping, handling, and packing of major  commodity crops, to determine the extent of USDA’s role, if any, with  respect to addressing the unintended mixing of GE and non-GE crops.  We also interviewed stakeholders identified in our first objective to  determine non-governmental roles in preventing the unintended mixing of  GE and non-GE crops in the supply chain, from production to market,  including the storage and shipping infrastructure. We did not review GE  crops regulated under USDA’s permit and notification field trial processes,  or the extent to which these crops are affecting the supply chain, as  USDA’s Inspector General was reviewing these subjects at the time of  our work. Instead, the focus of our report is on those GE crops that have  been deregulated and are available for commercialization. To determine  the extent to which USDA, EPA, and FDA are providing the public with  information on GE crops, we examined the extent to which that  information is disseminated publicly in agency documents and on agency  websites, interviewed agency officials, and examined any requirements  and agency efforts to be transparent about how the agencies reached  regulatory or policy decisions related to GE crops.
We conducted this performance audit from August 2014 to March 2016 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: Genetic engineering refers to a modern set of tools that can be used for  precisely modifying the genetic makeup of crops, animals, or  microorganisms in order to introduce, remove, or rearrange specific  genetic material conferring desired traits. Genetic engineering techniques  allow for faster development of new crop varieties, since the gene or  genes for a given trait of interest can be readily incorporated into a plant  or animal species to produce a new variety. GE varieties have been  developed for many crops, plants, trees, and flowers. As of October 2015,  USDA had deregulated 118 GE plants, with corn, soybeans, and cotton  being the most prevalent. Common classes of traits engineered into crops  include insect resistance, herbicide tolerance, resistance to viruses, and  other changes to enhance product quality. A number of different  techniques can be used to modify organisms. To date, genetic  engineering has relied extensively on the use of a particular bacterium to  introduce traits into plants. To do this, developers remove the elements of  the bacterium harmful to the plant, for example, and use the disarmed  bacteria to insert new genetic material to facilitate the desired genetic  change. The bacterium used to introduce genes is not the only plant pest  involved in genetic engineering. Small segments of DNA from plant  viruses are sometimes inserted into GE crops to control the expression of  genes of interest. Some of the bacteria and viruses used in genetic  engineering to transfer genetic material into crops are defined as plant  pests under USDA’s regulations, meaning that they can directly or  indirectly injure or cause disease or damage to plants.
In addition to bacterial transformation, it is possible to introduce genes  with physical technologies.  These technologies include particle  bombardment (e.g., gene gun, or biolistics, where particles are coated  with DNA containing the desired traits and shot into the target cells), and  electroporation (the application of an electric current to a cell membrane  in order to open a channel through which DNA may pass). Developers  have also found many genetic sequences from plants that perform the  same function as the aforementioned plant virus genes, that is, they  control the expression of the introduced genes of interest. Thus, it is  possible to produce genetically engineered plants that do not contain  plant pest genetic sequences, according to USDA officials.
Alternative technologies, in particular genome editing technologies, have  come into more widespread use. In many cases, crops produced using  some of these alternative technologies cannot be distinguished from their  non-GE counterparts. These alternative technologies tend to be more  precise and efficient. These technologies are distinguished by the use of  artificial versions of nucleases, or “molecular scissors,” that cut DNA at  specific locations, which is a cornerstone of the newer genetic  engineering technologies. Genome editing can be used to create  deletions, substitutions, and gene insertions. These technologies also do  not necessarily require use of a plant pest to introduce genetic changes.
subsections: section_title: GE and Non-GE Crops in the Supply Chain
paragraphs: GE crops may become unintentionally mixed with non-GE crops at  various points in the supply chain, from production to market. Cross- pollination is a natural process that some crops depend on for  reproduction that can result in unintended mixing at the farm level when  pollen from one crop fertilizes plants in a nearby field. For example, GE  pollen may drift to a nearby non-GE field and fertilize those crops, and the  resultant seeds and associated crops may have unintended GE traits  when planted. This is especially true for cross-pollinated crops, such as  corn, but much less true for a crop like soybeans that is primarily self- pollinated. But since corn pollen can move relatively long distances, and  since corn plants naturally cross-pollinate, non-GE corn may be pollinated  by GE corn if these crops are planted close enough to each other.  Commingling is unintended mixing that occurs after crops are harvested,  when GE crops or their residue accidentally come into contact with non- GE crops during transport, storage, handling, or processing. For example,  if a railcar transports GE grains one day and then non-GE grains the next  day, there is a chance that residual traces of the GE crop shipment could  end up in the non-GE shipment. Since GE and non-GE crops are  generally indistinguishable in appearance, it is difficult to prevent  commingling without segregation methods. For purposes of this report,  we are referring to both cross-pollination and commingling as unintended  mixing.
The Advisory Committee on Biotechnology and 21st Century Agriculture  (AC21) was originally established in 2003 and was charged with providing  guidance to USDA on issues, identified by the Office of the Secretary,  including examining the long-term impacts of biotechnology on the U.S.  food and agriculture system and recommending how USDA might  address those impacts. In 2011, the Secretary of Agriculture revived  AC21 to address, among other things, what types of compensation  mechanisms, if any, would be appropriate to address economic losses by  farmers in which the value of their crops is reduced by unintended GE  presence (unintended mixing of GE and non-GE materials), and what  would be necessary to implement such mechanisms. Unintended mixing  may result in economic losses by farmers, for instance, if pollen from a  field of GE corn drifts and pollinates non-GE corn in a neighboring field  and the resulting grain is harvested. In this case the non-GE farmer may  receive a lower price for the crop or the shipment may be rejected by a  buyer if the shipment exceeds a predetermined level of GE content. AC21  comprises of representatives from a cross-section of the agricultural  community, including farmers, seed companies, food manufacturers,  organic farming organizations, state government, biotechnology  companies, and medical professionals.
AC21’s recent focus has been to strengthen coexistence, meaning the  ability of the agriculture sector to maintain different production systems.  Coexistence specifically involves the concurrent cultivation of non-GE  crops (e.g., conventional, organic, and identity-preserved) and GE crops.  AC21 defined identity-preserved crops as those of an assured quality in  which the identity of the material is maintained from the germplasm or  breeding stock to the processed food product on a retail shelf.  Coexistence issues arise when the production-related activities of one  farmer affect another farmer, potentially resulting in costs for the other  farmer. Farmers could adopt measures to prevent mixing of GE and non- GE crops, such as using buffer zones between different crop types, which  may result in smaller yields and additional costs because of the acreage  taken out of production to create the buffer zone.
section_title: Key Statutes and Responsible Agencies Overseeing GE Crops
paragraphs: Three federal agencies share responsibility for overseeing GE crops— USDA, EPA, and FDA. Each agency has specific responsibilities for  certain activities with GE crops, but not all of the agencies are necessarily  involved in overseeing each activity or use of a GE crop. The agencies  apply their general authorities under statutes that are relevant to each  agency’s responsibilities for overseeing GE crops specifically, as shown  in table 1.
Under the Plant Protection Act (PPA), USDA is responsible for preventing  the importation or dissemination of plant pests and noxious weeds into or  within the United States. A noxious weed is any plant or plant product that  can injure or cause damage to crops, livestock, interests of agriculture,  public health, or the environment, among other things. USDA may prohibit  or restrict the importation, entry, export, or movement in interstate  commerce of, among other things, GE crops that might introduce or  disseminate a plant pest or noxious weed. Under its regulations, USDA  allows individuals, including GE crop developers, to petition the agency to  determine deregulated status for a GE crop if enough evidence has been  collected showing that it poses no more of a plant pest risk than the  equivalent non-GE crop, and it is not designated as a noxious weed. If  USDA deregulates a GE crop, it is no longer subject to the restrictions of  the plant pest provisions of the regulations relating to GE crops. However,  USDA could later find the GE crop to be a plant pest or noxious weed on  the basis of new data or analysis, and place restrictions on the  importation, entry, export, or movement of the GE plant.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),  EPA is responsible for regulating the genetic materials engineered into a  crop to produce pesticides that ward off insects, bacteria, and viruses, as  well as the pesticidal substance that the crop ultimately produces.  These are known as plant-incorporated protectants. As with  conventional chemical or biological pesticides, EPA regulates the sale,  distribution, and use of GE pesticides, and they must be registered before  they are distributed or sold. In addition, EPA regulates the sale,  distribution, and use of pesticides used in conjunction with GE crops  engineered to be tolerant to those pesticides.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA  regulates to ensure the safety of most of the food supply, while USDA,  under its authority, is responsible for the safety of meat, poultry,  processed egg products, and catfish. FDA regulates to ensure the safety  of foods and food products from plant sources, including food from GE  crops, which must meet the same requirements as foods from non-GE  crops. FDA also has in place a voluntary premarket consultation program  and encourages developers of GE crops to consult with the agency  before marketing their products.
section_title: 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
paragraphs: 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.  Although USDA proposed revising its regulations pertaining to the  importation, interstate movement, and environmental release of certain  genetically engineered organisms in 2008 to bring the regulations into  alignment with the PPA and update the regulations in response to  advances in genetic science and technology, it later withdrew its  proposed rule. However, according to USDA officials, the agency needs  to update its regulations to also subject GE crops that either do not use  plants pests or use plant pests but do not result in plant pest DNA in the  GE crop developed to the same restrictions and requirements as GE  crops for which the donor, vector, or recipient of genetic material is a  plant pest.
subsections: section_title: EPA and FDA Apply the Same Legal Authorities to Oversee GE Crops Derived from Alternative Technologies as They Do for Non-GE Crops and GE Crops from Other Technologies
paragraphs: EPA officials said that they regulate all pesticides, including those  engineered into crops (GE pesticides) using the same legal authorities  regardless of how they are derived, and FDA officials said that they apply  the same legal authority to regulate GE crops from alternative  technologies that they do for non-GE crops. Accordingly, EPA uses the  same oversight process to regulate GE pesticides engineered into crops  using alternative technologies that it does for GE pesticides engineered  into crops using other technologies. FDA’s program to voluntarily work  with companies to consider food safety issues is followed for any type of  GE crop brought to FDA for consideration, regardless of the technology  used to develop it, according to FDA officials.
EPA regulates a GE pesticide in a crop when it meets the definition of a  pesticide under FIFRA and is intended for such use, regardless of how  the pesticide was created or the technology used to develop it. EPA  officials stated that as new GE technologies are developed, many will  eventually make their way to EPA for analysis and consideration as part  of the pesticide registration process. For example, in May 2010 EPA  registered a GE pesticide based on the plum pox virus. This pesticide  was engineered into varieties of the European plum tree to give the tree  the ability to resist the virus, which affects the quality of fruits and can  leave infected trees unable to produce fruit. This GE pesticide was  developed based on ribonucleic acid interference. According to EPA  officials, EPA considers this a pesticide because it was designed to  defeat a virus, and therefore it mitigates a pest. EPA officials said they  will evaluate GE pesticides using alternative GE technologies on a case- by-case basis as they are brought to EPA for pesticide registration.
Before EPA can register a pesticide, a company must provide data  demonstrating that the pesticide will not pose unreasonable risks to  human health or the environment when used in accordance with  widespread and commonly recognized practice. According to EPA  documents and officials, when assessing the potential risks of  pesticides—including those that are GE pesticides—EPA requires studies  from applicants examining factors such as potential risks to human  health, environmental fate and effects (e.g., potential for gene flow to non- GE crops), and the need for management plans to mitigate the potential  development of pest (e.g., insect or weed) resistance in the field. EPA  officials stated that they follow the process outlined in an internationally  accepted guideline issued by the Codex Alimentarius Commission for risk  assessment when examining new genetic material that has been  introduced into a plant.
FDA regulates to ensure the safety of foods, including foods derived from  GE crops, under the FFDCA and its implementing regulations. Foods  derived from plant varieties developed through genetic engineering are  subject to the same safety requirements as foods derived from non-GE  crops. In May 1992, FDA established its policy regarding the review of GE  foods in its Statement of Policy: Foods Derived from New Plant Varieties.  This policy describes the kinds of assessments FDA recommends that  companies perform to ensure that foods and feeds from new plant  varieties are as safe as comparable foods and feeds already on the  market, and otherwise do not raise regulatory concerns. In its 1992 policy,  FDA stated that it was not aware of any information that showed foods  from GE crops, as a class, were different from comparable foods in a  meaningful or uniform way or that they have a different or greater safety  concern than foods developed by non-GE plant breeding. FDA officials  said that the basic principle as expressed in the agency’s 1992 policy is  that the traits and characteristics of foods should be the focus of safety  assessments for new varieties of food crops, not the technologies used to  develop them. In addition, FDA has the authority under the FFDCA to  seek an order to remove any food—including any foods derived from GE  crops—from the market if the food is unsafe, or adulterated, under the  law. FDA can also seek sanctions against those marketing such a food.  According to documentation available on FDA’s website, FDA’s priority is  to ensure that all foods, including those derived from GE crops, are safe  and otherwise in compliance with the FFDCA and applicable regulations.
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. FDA scientists then evaluate this safety  assessment, which includes tests done by the developer, to determine  whether it contains sufficient information to conclude that the developer  has addressed all matters relevant to the safety and regulatory status of  the GE food. FDA officials said that such testing provides a way to  detect undesirable traits at the developmental stage and defer marketing  until any concerns are resolved. When FDA’s team of scientists is  satisfied with the developer’s submission and has no further questions  regarding safety or other regulatory issues based on the developer’s  information, the consultation is considered complete, and FDA provides a  letter to the developer stating that it has no further questions. Although  the consultation process is voluntary, according to FDA documentation  and agency officials, it is the agency’s experience that companies  developing foods and feeds do not commercially market food or feed from  their GE crops until they have received this letter or have satisfied any  other agency requirement, if applicable. As of November 2015, 108  voluntary premarket consultations had been completed representing more  than 150 different crop varieties, according to FDA’s website and FDA  officials, and FDA officials said they are not aware of any GE product  intended for marketing that has not first gone through FDA’s voluntary  consultation process—that is, developers expected to consult with FDA  prior to marketing have been doing so.
section_title: USDA’s Regulations Do Not Allow for Assessment of GE Crops Derived from Alternative Technologies
paragraphs: According to USDA officials, USDA needs to update its regulations to  assess certain potential plant and environmental health risks associated  with GE crops derived from alternative technologies. According to USDA  officials, USDA’s regulations for GE crops do not capture the full authority  to protect plant and environmental health provided by the PPA, and are  not broad enough to allow USDA to restrict all GE crops that may pose a  risk to plant health.
Under current regulations, USDA, through its Animal and Plant Health  Inspection Service (APHIS), restricts the introduction and dissemination  of GE crops for which the donor, vector, or recipient of genetic material is  a plant pest, such as a bacterium or virus, until the agency assesses  certain potential plant and environmental health risks and determines the  regulated article does not pose a potential plant pest risk. For example,  a gene that confers resistance to the herbicide glyphosate that was  sequenced from a bacterium has been used extensively to transform  varieties of corn, soybean, and alfalfa crops, according to USDA officials.  USDA also regulates any plant pests that have been genetically  engineered. For example, USDA regulates the diamondback moth that  has been engineered with genes that disrupt reproduction in this pest.  This moth and its larvae are known pests for crops such as cauliflower,  cabbage, and broccoli.
USDA regulates new GE crop varieties in field trials. During field trials,  developers that are issued authorizations to release GE crop varieties  through field trials must follow specific controls outlined in those  authorizations to avoid unauthorized release or unintended mixing of GE  and non-GE crops, among other things. For example, if a developer  inserted a trait that confers glyphosate tolerance into a type of grass  using a plant pest, the developer would be required to submit a request  for authorization to move or conduct outdoor plantings of this GE plant.  Developers may petition USDA to deregulate their GE crops if they can  demonstrate that these crops do not represent a plant pest risk.  Commercialization of GE crops may follow deregulation. In contrast, if the  developer engineered the grass conferring the same glyphosate  tolerance, but did so by using a GE technology that did not involve a plant  pest or did not result in plant pest DNA in the grass developed, the  developer would not require an authorization, unless USDA later finds the  GE crop to be a plant pest on the basis of new data or analysis. The  reason, USDA officials said, is that the GE technology used to insert the  desired trait did not involve use of a plant pest and no plant pests were  otherwise used or inserted. Although developers sometimes request  authorization to conduct field trials of GE crops that do not meet the  definition of a regulated article (e.g., because a plant pest was not used  or a plant pest was used but no plant pest DNA was in the GE crop  developed), USDA’s regulations requiring an authorization are limited to  situations where a plant pest was involved in the genetic engineering as a  donor, vector, or recipient of genetic material, rather than on the potential  risk to plant and environmental health associated with the plant and the  introduced trait, as shown in figure 1.
Moreover, some GE crops developed using genetic engineering  technologies that do not involve the use of a plant pest, or use a plant  pest but do not result in plant pest DNA in the crop developed, could pose  weediness risks, according to USDA officials. Specifically, there could be  unintended cross breeding with a related wild plant species that could  make the new plant a noxious weed. For example, if a drought tolerance  gene unintentionally moved from GE sorghum to Johnsongrass, a wild  relative of sorghum, the resultant Johnsongrass could become a more  aggressive or noxious weed in dry environments. According to USDA  officials, a GE crop could be regulated using USDA’s noxious weed  authority under the PPA, but to date USDA has not done so. This is  because USDA’s existing noxious weed regulations were not designed for  crops, according to USDA officials.
As of November 2015, USDA had received 44 letters of inquiry from GE  crop developers asking whether their GE crops are subject to USDA  regulations. As of that date, according to agency officials and USDA’s  website, USDA had determined that 30 of these GE crops are not subject  to USDA regulations and 1 GE crop is subject to USDA regulations; the  agency’s responses to the remaining 13 letters were pending. Most of  these inquiries were for GE crops developed using technologies that did  not involve a plant pest, or did involve the use of a plant pest but did not  result in plant pest DNA in the crop developed, putting them beyond the  scope of USDA’s regulations. USDA officials said they expect the  number of GE crops developed with alternative technologies that do not  use a plant pest, or that use a plant pest but do not result in plant pest  DNA in the crop developed, to increase in the future because these  technologies are generally more efficient and precise than technologies  using plant pests. For example, USDA officials observed that the plant  science community is excited about what can be accomplished with the  newest gene editing technologies, noting that such technologies can  provide for GE crop development at greater speeds and lower costs.
In responding to the letters of inquiry from GE crop developers, USDA  officials said that they consider information provided by the developer on  the GE technology used, recipient crop, and introduced trait. If the inquiry  is the first of its kind, USDA will work with various APHIS programs to  ensure that they do not have plant health concerns for which other  authorities could be used to protect plant health. While USDA may  consider potential risks associated with the GE crop variety, its final  response to the developer is solely focused on whether the GE crop is  regulated and generally does not include information on the potential  risks.
section_title: USDA Attempted to Update Its Regulations in 2008 and Is Considering Proposing Updated Regulations
paragraphs: In 2008, in part to respond to advances in genetic science and technology  and address potential risks, if any, posed by GE crops developed through  alternative technologies, USDA proposed a rule that included the  possibility of using the noxious weed provisions of the PPA. These  provisions would have expanded USDA’s review to apply to new GE crop  varieties that represent a potential noxious weed risk. According to USDA  officials, the proposed rule was somewhat ambiguous with regard to what  would be regulated and that created confusion for stakeholders.  According to the proposed rule and USDA officials, a developer would  talk to USDA if there was any doubt about whether the variety needed to  be regulated. Although USDA took steps to update its regulations to  capture any GE crop that may pose a risk to plant health, USDA  ultimately withdrew the proposed rule in February 2015 because of issues  raised by the public and industry, including a lack of clarity in several key  aspects of the rule, according to USDA officials. For example, many of  the public comments said that the proposed rule was not clear about what  was to be included or excluded in USDA’s regulatory scope and that  USDA had not been sufficiently clear about how it would implement the  proposed changes. In addition, according to USDA officials, commenters  said they were unsure whether this was a voluntary process and did not  know under what circumstances USDA would require regulation. In  withdrawing the proposed rule, USDA decided that an updated proposed  rule was needed, noting it wanted to engage stakeholders anew.
In February 2015, USDA officials said they were considering updating the  regulations to address shortcomings in USDA’s existing regulations and  to take advantage of 28 years of experience regulating products of  biotechnology to focus the program on those products that present a plant  health risk, regardless of which technologies were used in their  development. Executive Order 13563 states, among other things, that to  facilitate the periodic review of existing regulations, agencies shall  consider how best to promote retrospective analysis of rules that may be  outmoded, ineffective, and insufficient, and to modify, streamline, expand,  or repeal them in accordance with what has been learned. In addition,  an Office of Management and Budget (OMB) memorandum on this  executive order states that agencies should explore how best to evaluate  regulations in order to expand on those that work and to modify, improve,  or repeal those that do not. Candidates for reconsideration include rules  that new technologies or unanticipated circumstances have overtaken,  according to this memorandum. Furthermore, a July 2015 Memorandum  from the Executive Office of the President stated that advances in science  and technology have dramatically altered the biotechnology landscape,  referenced new technologies, and called on USDA, EPA, and FDA to, in  part, formulate a long-term strategy to ensure that the Federal regulatory  system is equipped to efficiently assess the risks, if any, associated with  future products of biotechnology.
USDA is currently in the early stages of the process of considering  updating its regulations. In May 2015, USDA hosted a series of webinars  and began providing opportunities for the public to provide initial feedback  on how the regulations might be improved. USDA also created a website  devoted to stakeholder engagement regarding USDA’s regulation of GE  crops. According to this website, the agency’s intention is to use an  open and robust policy dialogue to drive the development of a forward- looking rule that will provide a foundation for its future regulatory  activities. As of June 2015, USDA had received comments from over  221,000 individuals from its stakeholder engagement efforts, according to  USDA officials. Withdrawing the 2008 proposed rule allows USDA to  discuss regulatory issues in ways that were not possible previously.  USDA officials said that they expect to publish a notice of intent and do a  programmatic environmental impact statement in early 2016 to consider a  number of alternatives for an updated proposed rule. The officials also  said that USDA intends to publish a proposed rule no later than  September 2016. However, USDA officials said that they do not have a  timeline for finalizing a new rule.
Our body of work has shown that by setting implementation goals and a  timeline, an organization builds momentum and can show progress from  day one, thereby helping ensure an initiative’s successful completion. In  addition, our body of work has shown that timelines with milestones and  interim steps can be used to show progress toward implementing efforts  or to make adjustments to those efforts when necessary, and that without  defined tasks and milestones, it is difficult for an agency to set priorities,  use resources efficiently, measure progress, and provide management a  means to monitor this progress.
USDA officials noted that the process for finalizing a rule is challenging  and would be difficult to do in the remaining time under the current  administration. Although publishing the Notice, impact statement, and  proposed rule in the coming months are good first steps, 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 not be able to fully assess the potential  risks to plant and environmental health posed by GE crops created with  alternative technologies. Completing a new rule to update USDA’s  regulations is particularly important given that the number of GE crops  developed with alternative technologies is expected to grow.
section_title: USDA Has Limited Data on the Extent and Impact of Unintended Mixing of GE and Non-GE Crops, but Some Steps Have Been Taken to Address Such Mixing
paragraphs: USDA has limited data on the extent and impact of unintended mixing of  GE and non-GE crops from production to market. Nonetheless, USDA  has taken some steps to address unintended mixing of GE and non-GE  crops. In addition, farmers and the agribusiness industry (i.e., industries  associated with agricultural production and services, such as shipping  and processing) have taken steps to address unintended mixing.
subsections: section_title: 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
paragraphs: 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. According to USDA  officials, because GE crops on the market have been determined to be as  safe as non-GE crops, are legal for farmers to cultivate, and are often  destined for commingled commodity supplies, pollen movement between  GE and non-GE crops on the market has been neither regulated nor  tracked. In its 2012 report on enhancing coexistence, AC21  recommended that USDA fund or conduct research in a number of areas  relevant to the promotion of coexistence in American agriculture,  including quantification of actual economic losses incurred by farmers as  a result of unintended GE presence (unintended mixing) and occurrences  of these losses over time and in different geographic regions. Such  research would enable USDA to gather more information on the extent  and economic impact of the unintended mixing of GE and non-GE crops.
USDA officials identified two primary ways that the presence of GE crops  can have an economic impact on farmers producing non-GE crops  because of incurring additional costs: (1) by necessitating measures by  farmers to prevent unintended mixing before harvest; and (2) through lost  value on shipments rejected by grain-handling companies for exceeding  contract specifications for allowable GE presence in a shipment after  harvest. Measures farmers can take to prevent unintended mixing  include using buffer zones, such as extra rows of alternative crops or  empty space, intended to serve as a physical barrier between GE and  non-GE crops, or planting crops at different times than neighboring crops  to stagger the periods when each crop is pollinating. However, according  to USDA officials and some stakeholders, these measures can result in  decreased yields because of reduced acreage for production or a shorter  growing season. USDA officials said assigning dollar values to preventive  measures taken by farmers can be difficult and must consider geography,  climate, or weather, which can differ substantially between areas.  According to USDA officials, the cost of such preventive measures is  generally factored into the contractual price for the non-GE crop as these  measures may be required by the buyer.
In addition, USDA has limited data on the number of times crop  shipments have been rejected because they have exceeded a specified  level of unintended GE presence. Further, according to USDA officials  and the AC21 report, data on the extent to which GE and non-GE crops  are commingled within the supply chain are not available, in part,  because these data are considered proprietary by grain-handling  companies. Furthermore, there is limited public data on the contracted  prices for non-GE crop supplies, further challenging efforts to develop  economic loss information.
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. NASS and ERS are  the USDA agencies principally responsible for conducting farmer surveys.  The NASS and ERS missions are, in part, to provide timely, accurate, and  useful statistics in service to U.S. agriculture and to inform and enhance  public and private decision making on economic and policy issues,  respectively. Further, according to NASS’s strategic plan, NASS provides  key statistical information and basic research essential for making  informed policy decisions. As part of an effort to obtain some  information on unintended GE presence in non-GE crops, ERS included a  related question in the 2010 Agricultural Resource Management Survey.  The results of this survey indicated that approximately 2.5 percent of  organic corn farmers responding had shipments rejected by a buyer  because of the presence of GE material. However, the survey did not ask  these respondents to quantify all economic losses or indicate when such  losses were incurred, and the survey asked only about corn crops.
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. The NASS survey data were released in September  2015, and showed the existence of economic losses because of  unintended GE presence in non-GE crops, although at very small levels.  According to USDA officials, the survey data estimate $6.1 million in  economic losses because of unintended GE presence for organic farmers  from 2011 to 2014, in comparison to billions of dollars in sales for organic  farmers during this period. In addition, of the estimated 14,093 organic  farms, only an estimated 92 farms, or less than 1 percent, reported GE- related losses.
USDA officials said that the results of the 2014 Organic Survey do not  provide complete information on the economic impacts of unintended GE  presence because, in part, the survey only included organic farmers, their  direct marketplace losses, and their three most recent losses. According  to USDA documentation, prior to fielding this survey, a number of USDA  officials, including APHIS, ARS, ERS, and Office of the Secretary officials,  as well as the Chair of USDA’s Organic Working Group, noted that it  would also be useful to collect information on other ancillary economic  costs, such as the costs of reshipping and re-storing rejected shipments,  as well as the costs associated with finding new buyers for rejected  shipments. However, for the 2014 Organic Survey, NASS officials said  that NASS and other stakeholders decided to limit the number of  questions on economic losses due to unintended GE presence given time  constraints on deploying the survey, and because of space restrictions.  In addition, NASS officials we interviewed noted the content of the  question was primarily directed by USDA’s Risk Management Agency in  light of AC21 discussions about the possibility of offering crop insurance  coverage for losses associated with unintended GE presence. NASS  officials said that adding additional questions on economic costs to future  organic surveys might be possible, but would need to be considered in  light of how a longer survey might affect farmer participation. They also  said any changes to future surveys would have to be approved by OMB.  Without more complete information on economic losses and other costs,  USDA is missing an opportunity to better understand the economic  impacts of unintended GE presence. As discussed, NASS’s mission is, in  part, to provide timely, accurate, and useful statistics in service to U.S.  agriculture. Further, OMB guidance directs federal agencies to (1)  periodically review information systems to determine how mission  requirements might have changed and whether the information continues  to fulfill ongoing and anticipated mission requirements, and (2) ensure the  information delivers the intended benefits to the agency and customers.  Although this guidance does not apply to USDA’s survey efforts, it serves  as an example of a best practice.
In addition to wanting more information on the losses sustained by  organic farmers because of unintended GE presence, USDA officials said  similar information is needed for non-organic producers who do not use  GE seed varieties and who take preventive measures, such as buffer  zones, to minimize the potential of GE crops affecting their crops. 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. For example, they noted that the former numbers  in the millions of acres, while the latter is in the hundreds of thousands of  acres. Thus, these officials said that the potential economic impacts of the  unintended presence of GE material in the crops of identity-preserved  producers may be even greater than the impacts on organic producers.  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. In turn, without these data on these  impacts, including the number of farmers and types of crops affected and  the nature and extent of the associated economic losses, USDA is  missing key information essential for making informed policy decisions on  ways to better promote coexistence as called for by AC21.
section_title: USDA Has Begun Taking Some Steps to Address the Unintended Mixing of GE and Non-GE Crops
paragraphs: USDA is not responsible for preventing the unintended mixing of GE  material in non-GE and organic crops during cultivation and after these  crops enter the supply chain, but has, nonetheless, taken some steps to  focus on this issue. For example, the Secretary of Agriculture has made  strengthening coexistence among different agricultural production  methods a priority. However, USDA officials said that while there are  many steps that USDA can take to help farmers produce crops that meet  their customers’ needs, segregating GE and non-GE crops is generally a  private sector function.
As discussed, in February 2011, the Secretary of Agriculture reactivated  AC21. In reactivating AC21, USDA announced that it would take further  steps to address the larger issue of coexistence between different types  of production methods in U.S. agriculture.
In November 2012, after a number of public meetings and the solicitation  of public comments, AC21 issued its report on enhancing coexistence,  which made five broad recommendations for strengthening coexistence  among different agricultural production methods, in particular between the  production of GE and non-GE crops. The recommendations were that  USDA should  fund or conduct research, such as the quantification of actual  economic losses incurred by farmers as a result of unintended GE  presence and occurrences of these losses over time and in different  geographies; fund education and outreach initiatives to strengthen understanding of  coexistence between diverse agricultural systems; develop mechanisms that foster crop stewardship and mitigate  potential economic risks derived from unintended gene flow between  crop varieties and promote and incentivize farmer adoption of  appropriate stewardship practices; develop a plan for ongoing evaluation of commercially available non- GE and organic seed varieties and identification of market needs for  producers serving GE-sensitive markets; and evaluate data gathered under the first recommendation regarding  actual economic losses and in considering loss data, if warranted,  implement a compensation mechanism to help address such losses.
Although NASS added the survey question on possible economic losses  to the 2014 Organic Survey in part because of an AC21 recommendation,  USDA officials stated that USDA may not have the authority to implement  some of the other recommendations in the AC21 report. For example,  these officials said that USDA currently does not have the authority to  compensate farmers who experience losses because of the unintended  presence of GE material in their non-GE crops. Some stakeholders we  interviewed said that non-GE farmers, including organic farmers, may not  be adequately compensated in the marketplace to cover losses resulting  from the unintended mixing of GE and non-GE crops. Other stakeholders,  however, said that these farmers chose to grow non-GE crops with the  knowledge of the potential for unintended mixing with GE crops,  balancing that risk against the higher prices they can get in the  marketplace for non-GE crops, particularly organic crops.
In March 2015, USDA held an invitation-only workshop for selected  farmer, nonprofit organization, academic, and other stakeholders,  available through a webcast for the public to view, to obtain additional  input on how to further advance understanding of agricultural  coexistence. After this workshop, USDA solicited public comments on  key ongoing USDA initiatives, as well as proposed initiatives, in response  to recommendations from AC21. Some of the ongoing initiatives include  improving new crop insurance options for farmers not growing commodity  crops, eliminating an insurance premium surcharge for organic farmers,  supporting an organic seed finder database to help better understand the  seed market and identify needs for increased sources of specific types of  organic seed, and outreaching to the public on how to foster  communication and collaboration to strengthen coexistence. Some of the  proposed initiatives include the following:
Developing a coexistence education and outreach strategy with the  goal of getting farmers to understand and accept responsibility for  both the biological and social consequences of their farming practices.
Developing updated procedures and a plan for handling and  prioritizing the evaluation of relevant germplasm stocks and  developing cost-effective approaches for assessing unintended GE  presence and mitigating that presence in those stocks.
Using USDA conservation programs, where applicable, to help  finance farmers’ measures to promote coexistence, such as creating  buffer zones.
USDA does not have a timetable for the implementation of the AC21  report recommendations or any newer coexistence activities but has  tracked the implementation of the ongoing initiatives closely, according to  USDA’s Office of the Secretary. USDA has begun implementation of  nearly all recommended activities that it currently has the authority to  implement. Some of the activities, for example, research  recommendations, are long-term projects. USDA has indicated that it will  be considering the 2014 Organic Survey data along with other economic  information on coexistence it is gathering in deciding on additional future  steps. USDA developed a document that describes its main coexistence  activities in December 2015 and posted it on the AC21 webpage.
section_title: Farmers and the Agribusiness Industry Have Taken Steps to Address Unintended Mixing
paragraphs: According to USDA officials and some stakeholders, farmers and the  agribusiness industry generally take measures to minimize unintended  presence of GE material in non-GE and organic crops through pollen flow  during cultivation or unintended mixing in storage, shipping, and  processing channels. Commodity group stakeholders described the  current crop commodity system as one that handles grains, oilseeds, and  other crops in bulk to keep the prices of food low. They said the  infrastructure was not built to address potential mixing of GE and non-GE  crops, so the crops may be unintentionally mixed at multiple points in the  supply chain. For example, GE and non-GE grain can be unintentionally  mixed in rail cars, in barges, or at grain elevators because there generally  is not a separate infrastructure for each type of grain. According to  industry stakeholders we spoke with, even with these challenges, farmers  and the agribusiness industry often take measures to keep GE and non- GE crops segregated to meet customer demand. These measures  include the following:
Physical separation of crops. Different crop types may be physically  separated by buffer zones, and seed producers may use “pinning  maps” to see the location of other reproductively similar seed crops  being grown in their area.
Temporal separation of crops. Farmers may plant their crops earlier  or later than surrounding farms to minimize pollination of their crops  by nearby GE crops. In transit and processing, a grain elevator or  other facility that handles both GE and non-GE crops might only  accept GE or non-GE crops on certain days of the week to avoid  unintended mixing.
Testing and inspection. Buyers may test or inspect arriving  shipments of non-GE crops to determine if there is GE material  present.
Tolerance levels and contract specifications. Buyers, such as  grain handlers, may have tolerance levels for GE content in non-GE  shipments that they are willing to accept (e.g., less than 0.9 percent  GE material). These tolerance levels are sometimes included in  contract specifications between buyers and farmers. Contracts may  also specify farm-level measures, including buffer zones, which are  required by buyers in the contracts with farmers.
Cleaning of shared equipment and storage. Farm-level, transit, and  handling equipment and storage infrastructure may be cleaned on a  regular schedule, or after its use for GE crops, to decrease the  likelihood of unintended mixing with non-GE crops.
Dedicated infrastructure. In some instances, growers, transporters,  and processors may use distinct equipment and facilities to process  non-GE crops separately from GE crops. Such infrastructure may  include dedicated silos; transportation systems, including rail cars or  containers; handling systems and grain elevators.
Figure 2 provides more information on measures to decrease unintended  mixing of GE and non-GE crops.
Some stakeholders said that many of the associated costs of these  measures are passed on to consumers or others in the supply chain. For  example, a grain handler would charge its customers a risk premium for a  non-GE crop shipment, and companies will determine risk premiums  based on the frequencies that crops are above the acceptable level of GE  material present and if a crop is sourced from a location where a lot of GE  crops are cultivated. Stakeholders said that companies would otherwise  not be able to absorb these costs unless the end-use consumers—for  example, those buying organic or non-GE foods—are willing to pay a  higher amount and take on the additional costs associated with these  measures.
Stakeholders disagree on who should be held responsible for any  financial losses caused by unintended mixing of GE and non-GE crops  and how to go about maintaining coexistence. Some stakeholders  suggest that non-GE crop farmers receive a premium price, which would  help to cover the higher production costs (e.g., costs of preventive  measures) and risks of unintended mixing. Others suggest that GE crop  farmers are responsible for the unintended presence of GE material in  neighboring non-GE and organic crops and should be liable for any  related financial losses on the neighboring farms. USDA officials and  some stakeholders have said that each production type has its associated  production costs and risks, and it is an individual farmer’s business  decision as to which production type to choose, taking into account these  factors.
section_title: USDA, EPA, and FDA Provide Varying Degrees of Information to the Public about Oversight of GE Crops
paragraphs: USDA, EPA, and FDA provide varying degrees of information to the  public about their oversight of GE crops. USDA and EPA generally  provide detailed information and updates on actions relating to their  oversight of GE crops through their websites, live forums, and other  means of communication, including Federal Register notices. FDA  provides information to the public on its voluntary premarket consultation  process for GE crops. (See app. II for more detail on the information that  the three agencies provide to the public about their oversight of GE  crops.) In addition, USDA and FDA have different roles and approaches  in labeling food that might contain GE ingredients. USDA certifies organic  products, which are intended to be non-GE. Companies also can hire  USDA to evaluate if their products are meeting company-specified non- GE standards. FDA maintains that there is no food safety reason to label  GE foods (see app. III on USDA and FDA labeling; app. IV provides  information on stakeholder perspectives and legislative actions on the  labeling of foods derived from GE ingredients).
subsections: section_title: All Three Agencies Provide Information to the Public about GE Crops
paragraphs: According to USDA’s APHIS strategic plan for fiscal years 2015 to 2019,  USDA will use traditional communication tools, including publications,  public service announcements, and newer technologies, to reach its  stakeholders, partners, and customers. 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. For example, APHIS’s Biotechnology  Regulatory Services (BRS), which is responsible for implementing USDA  regulations for certain GE crops that may pose a risk to plant health,  holds annual public stakeholder meetings that are open to all interested  parties to foster engagement in and ensure transparency of BRS’s  regulatory activities. USDA also routinely informs the public about its  actions related to oversight of GE crops through notices in the Federal  Register, and maintains a list of all open and previous relevant Federal  Register notices on its website. For example, USDA notified the public via  the Federal Register a month in advance of its 2-day workshop on  coexistence so that the public could listen in by telephone or webcast,  and USDA shared information on how listeners could provide comments  after the workshop. USDA also uses the Federal Register to alert the  public to the availability of preliminary determinations and related  assessments for new GE crops for which developers are seeking  nonregulated status to commercialize these crops. In addition, APHIS has  made educating the public about biotechnology an area of emphasis in its  strategic plan for fiscal years 2015 to 2019.
According to EPA officials, the agency has made it a policy priority to  increase engagement with the public on GE technologies and their  applications using a variety of platforms. For example, EPA’s Office of  Pesticide Programs has an outreach program that is responsible for  communicating to the public—through trade publications, media, and an  EPA e-mail distribution list that has about 11,000 subscribers—all of  EPA’s actions on regulatory decision making regarding pesticides. 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. As part of these updates, EPA made its predecision  rationale for the registration of the pesticide Enlist Duo, an herbicide  intended for use on some herbicide-tolerant GE crops, available for public  comment. EPA officials also cited other ways the agency provides  information to the public with respect to its GE crops oversight. For  example, the agency maintains a list of pending pesticide registration  decisions that are open for public comment in a docket on its website with  links to the respective comment pages for these pesticides on  Regulations.gov.
FDA officials said that the agency has developed more consumer-friendly  information on foods derived from GE crops, which is made available on  FDA’s website, including a question-and-answer web page on foods  derived from GE crops and the text of FDA congressional testimonies on  its oversight of foods derived from GE crops. In addition, FDA maintains a  biotechnology web page that includes FDA’s 1992 policy statement and  makes recommendations about what kinds of assessments companies  can perform to help determine that GE plant varieties are just as safe as  their non-GE counterparts. The FDA web page also includes guidance  documents for industry, including consultation procedures under FDA’s  1992 policy statement, information on recommended premarket  notification concerning foods from GE plants, and guidance for industry  on voluntary labeling whether foods have or have not been derived from  GE plants. FDA officials stated that this information is generally targeted  to a more technical audience as opposed to the general public. FDA  officials also stated that the agency has developed more consumer- friendly information on biotechnology and GE plants on its website.
According to FDA officials, FDA does not post developer submissions,  including the safety and nutritional assessments of the GE crop submitted  and the supporting data, on its website. In addition, these officials said the  agency does not post information on consultations that were withdrawn  before finalization or the reasons they were withdrawn, including any FDA  concerns. However, FDA officials said that the safety and nutritional  assessments are available in accordance with FDA’s public information  regulations and administration policies, and that FDA proactively  publishes a summary of the consultation at the conclusion of each  consultation. FDA officials stated that interested parties are able to  obtain the developer submissions and related data that are not trade  secrets or confidential commercial information from the agency by  submitting Freedom of Information Act (FOIA) requests. Stakeholders  expressed varying perspectives on FDA’s voluntary premarket  consultation process. For example, some stakeholders noted the difficulty  of going through the FOIA process to access the underlying data, and the  lack of a public comment period or public notice prior to a consultation’s  completion. FDA provides information on the voluntary premarket  consultation process on its website, including submission date and  developer name; the type of GE crop submitted; the trait being genetically  engineered into the crop (e.g., insect resistance); the intended use (e.g.,  human food or animal feed); and whether the product required EPA  review (when a plant-incorporated protectant, i.e., pesticide, is produced).  Some stakeholders also said that FDA’s final response letters and related  notes to the file do not demonstrate what FDA has done to analyze the  companies’ claims; the agency posts on its website the date and text of  final response letters to the developers of GE crops marking the  completion of the consultations. FDA officials said that information on  the voluntary premarket consultation is often of a highly technical nature,  and if FDA were to post this information, the agency would have to  evaluate what information in the submission may lawfully be disclosed,  revise the electronic files to make them more accessible under section  508 of the Rehabilitation Act of 1973, and then review the material to  ensure its accuracy before posting, a process that would take  considerable staff time. For this reason, FDA officials said that providing  the underlying data and further detail on a voluntary consultation in  response to an occasional FOIA request is more efficient.
section_title: USDA and FDA Approaches to Labeling GE Food Ingredients
paragraphs: USDA and FDA have different roles in labeling food that might contain GE  ingredients. As a result, the agencies differ in their approach to providing  information to the public on GE food ingredients and the labeling of GE  food ingredients.
USDA currently provides information to the public about the GE content of  a food product through two programs: USDA’s National Organic Program  and its Process Verified Program. The Organic Foods Production Act of  1990 directs the Secretary of Agriculture to establish a national organic  certification program. Under the National Organic Program, a program  managed by USDA’s Agricultural Marketing Service, products can receive  a USDA organic seal if they meet specific national standards. USDA  develops the standards for organically produced agricultural products to  assure consumers that products with the USDA organic seal meet  consistent, uniform standards. According to USDA officials, the Process  Verified Program was started in 1999 and is conducted on a fee-for- service basis by USDA’s Agricultural Marketing Service. Exercising its  authority under the Agricultural Marketing Act of 1946, the Agricultural  Marketing Service serves as a third-party auditor, physically visits a site,  and verifies that a company’s processes meet standards that a company  sets for itself. Companies, such as grain handlers or poultry, pork, and  cattle producers and processors, submit their processes to USDA for  verification. According to USDA officials, the Process Verified Program  allows consumers to be assured that what they are buying adheres to the  company’s standards when they see USDA’s process verified seal on  packaging.
FDA regulates food labeling and enforces prohibitions against  misbranded foods. According to FDA documentation and agency officials,  FDA applies the same labeling principles to foods regardless of whether  they are derived from GE or non-GE sources. The agency maintains it  has no basis for concluding that foods derived from GE sources differ  from their non-GE counterparts in any meaningful or uniform way solely  based on their method of production, and therefore there is no basis for  requiring labeling that indicates a food was developed through GE  techniques.
FDA provides information on its website about why foods from GE plants  are not currently required to be labeled to inform consumers about how  the food was produced. The agency acknowledges on its website that  there is strong consumer interest in knowing whether foods were  produced using GE methods and that FDA supports voluntary labeling,  maintaining that such statements must be truthful and not misleading.  FDA finalized guidance to industry in November 2015 on voluntary  labeling indicating whether foods have or have not been derived from GE  plants. This guidance contains nonbinding recommendations, and  states that labeling by manufacturers on a wholly voluntary basis  regarding whether a food was or was not bioengineered is acceptable to  FDA, provided that such labeling is truthful and not misleading. In  addition, the guidance states that FDA encourages food manufacturers to  ensure that labeling terminology concerning the use of modern  biotechnology in the production of food or its ingredients be accurate and  consistent and that the integrity and meaning of scientific terminology be  preserved to help ensure clear communication in food labeling. The  guidance also states that a manufacturer that claims that a food product  or its ingredients, including foods such as raw agricultural commodities,  are GE or not GE should substantiate that the claim is truthful and not  misleading. The guidance provides methods a manufacturer may use to  substantiate the claim, including documentation of handling practices and  procedures (those with control over growing, harvesting, storing, and  distribution should consider appropriate recordkeeping to document  whether foods are or are not produced using genetic engineering  including segregation procedures).
section_title: Conclusions
paragraphs: GE crops make up more than 90 percent of major U.S. crops such as  corn, soybeans, and cotton. USDA, FDA, and EPA are responsible for  regulating GE crops in the United States, with USDA generally ensuring  that GE crops do not pose risks to plant and environmental health.  Historically, USDA oversight has focused on GE crops that were created  using plant pests, such as a bacterium or virus. In recent years, USDA  has received an increasing number of inquiries from GE crop developers  regarding whether their GE varieties—created using alternative  technologies that either did not involve the use of a plant pest or did  involve the use of a plant pest but did not result in plant pest DNA in the  crop developed—are subject to USDA regulations. USDA acknowledges  that its regulations overseeing GE crops have not kept pace with these  technological developments and do not cover all GE crops. In February  2015, USDA withdrew its 2008 proposed rule that sought to revise its  regulations regarding the importation, interstate movement, and  environmental release of certain genetically engineered organisms to  bring the regulations into alignment with the PPA and update the  regulations in response to advances in genetic science and technology.  USDA officials said that USDA intends to publish a proposed rule no later  than September 2016 but that they do not have a timeline for finalizing an  updated rule. 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.
Furthermore, USDA has limited data on unintended mixing of GE and  non-GE crops, making it difficult for USDA to identify the extent and  impact of the unintended mixing. The Secretary of Agriculture reactivated  AC21, which has prioritized the promotion of agricultural coexistence. In  its 2012 report on enhancing coexistence, AC21 recommended that  USDA should fund or conduct research that would enable USDA to  gather more information on the extent and economic impact of  unintended mixing. USDA’s 2014 Organic Survey was an important first  step to gather data on the economic losses experienced by non-GE  farmers, but the data collected do not provide complete information on  economic impacts caused by unintended mixing of GE and non-GE  crops. Without collecting additional information in future organic surveys,  such as the costs of reshipping and re-storing shipments rejected  because of unintended GE presence, as well as the costs associated with  finding new buyers for such shipments, USDA is missing an opportunity  to better understand the economic impacts of unintended GE presence.  In addition, USDA does not have data on economic losses because of  unintended GE presence for non-GE producers other than for organic  producers who seek to market their crops as identity-preserved. Without  collecting similar data from producers of identity-preserved crops, USDA  lacks statistically valid data needed to understand the full scope of  potential economic impacts from unintended GE presence. In turn,  without these data, including the number of farmers and types of crops  affected and the nature and extent of economic losses, USDA is missing  key information essential for making informed policy decisions on ways to  better promote coexistence as called for by AC21.
section_title: Recommendations for Executive Action
paragraphs: We are making three recommendations to the Secretary of Agriculture.
To improve USDA’s ability to oversee GE crops, we recommend that the  Secretary of Agriculture direct the Administrator of APHIS to develop a  timeline, with milestones and interim steps, for updating its existing  regulations to cover GE crops developed with alternative technologies  that either do not use plant pests or use plant pests but do not result in  plant pest DNA in the crop developed.
To improve USDA’s ability to better understand the economic impacts of  unintended mixing of GE and other crops, we recommend that the  Secretary of Agriculture take the following two actions:
Direct the Administrator of NASS to work with all relevant USDA  stakeholders, including APHIS and the Organic Working Group, to  determine what additional information should be sought in future  organic surveys, such as the costs of reshipping and re-storing  shipments rejected because of unintended GE presence, as well as  the costs associated with finding new buyers for such shipments.
Direct the Administrator of NASS to include producers, growing  identity-preserved crops, in addition to organic producers in USDA’s  survey efforts.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to USDA, EPA, and the Department of  Health and Human Services for review and comment. USDA provided  written comments, which are reproduced in appendix V. USDA said that it  generally agreed with the report’s recommendations. EPA and the  Department of Health and Human Services did not provide written  comments. USDA and the Department of Health and Human Services’s  FDA also provided technical comments that we incorporated as  appropriate.
Concerning our first recommendation in the draft report, to develop a  timeline, with milestones and interim steps, for updating its existing  regulations to cover GE crops developed with newer technologies that do  not depend on the use of plant pests, USDA said that it agreed, in part,  with the recommendation. Specifically, USDA said it had developed an  internal timeline for outlining key milestones and interim steps, all with  associated target dates, for updating the regulations that cover GE  organisms. While USDA may have such a timeline now, it did not provide  us with this timeline during the course of our work. In addition, USDA  stated USDA's proposed regulations are being developed to address  products of biotechnology, regardless of laboratory technique used to  create or modify the genome. Thus, the intention of the proposed rule  currently in development (as well as the 2008 proposed rule) is the overall  protection of plant health through regulation of GE organisms that may  pose a plant pest or noxious weed risk, with no relation to the technology  used to develop the GE organism. In response to USDA’s comments, we  modified our recommendation so that instead of discussing GE crops  developed with newer technologies that do not depend on the use of plant  pests, the recommendation discusses GE crops developed with  alternative technologies that either do not use plant pests or use plant  pests but do not result in plant pest DNA in the crop developed.
Concerning our second recommendation, that NASS work with all  relevant USDA stakeholders, including APHIS and the Organic Working  Group, to determine what additional information should be sought in  future organic surveys, such as the costs of reshipping and re-storing  shipments rejected because of unintended GE presence, as well as the  costs associated with finding new buyers for such shipments, USDA  stated that it agreed. Specifically, USDA stated that NASS works with all  relevant stakeholders to determine what information is needed for future  organic surveys. For example, USDA said that since the 2014 Organic  Survey, NASS has held a series of meetings with APHIS officials and the  Chair of USDA’s Organic Working Group to discuss the 2014 Organic  Survey results and how to move forward with future survey questions.  USDA stated that the most recent of these meetings was held in January  2016 and that at the conclusion of this meeting, NASS, APHIS, and the  chair of the working group vowed to keep meeting as well as to bring  more stakeholders into the discussions, which will ensure that future  organic surveys and related surveys involving GE related questions will  have the necessary attention to obtain data, such as the need to better  understand the economic impacts of unintended mixing of GE crops.  Such actions, if taken, would address our recommendation.
Concerning our third recommendation, that NASS include producers  growing identity-preserved crops, in addition to organic producers in  USDA’s survey efforts, USDA did not indicate whether it agreed or  disagreed. USDA stated that NASS’s overall survey programs currently  include identity-preserved crops and conventional and organic producers.  USDA described the sample design for its survey programs, specifically  that the design includes area and list frames, and their definitions.  However, the point of this recommendation is that NASS should survey  producers growing identity-preserved crops regarding their potential  economic losses from unintended GE presence, as is being done for  organic producers. As we noted in the report, U.S. acreage planted to  identity-preserved crops is significantly greater than that planted to  organic crops; yet, little is known about the economic costs to identity- preserved farmers of unintended mixing. Until NASS surveys producers  growing identity-preserved crops on these potential economic costs,  USDA will continue to lack statistically valid data needed to understand  the full scope of potential economic impacts from unintended GE  presence.
While USDA stated that it generally agrees with our recommendations, it  also stated that it takes issue with five themes that are repeated  throughout the report. Specifically, USDA states that it is concerned that  the intent of its current efforts to update the regulations is misstated; the  intent of the 2008 proposed rule is misstated; plant pest and newer  technologies are inappropriately conflated; newer technologies are  presented as inherently more risky; and the 'Am I Regulated?' inquiries  are presented as escaping regulation because they were developed using  newer technologies.
USDA further clarified its position on these five themes, stating first that  its current intention for updating its biotechnology regulations remains the  same as it was in 2008: to protect plant health from plant pests and  noxious weeds regardless of the method to transform the organism. In  this regard, USDA said that in several places in our report we incorrectly  state that that 2008 proposed rule was intended to capture newer  technologies. We do not say that the intent of the 2008 proposed rule or  USDA’s current efforts to update its biotechnology regulations is to  capture new technologies. However, we do say that underlying USDA’s  efforts to update its regulations is the goal of subjecting new GE crops  developed with newer (now alternative) technologies to a more  comprehensive assessment of potential risks before commercialization of  these new crops. As discussed, GE crops developed with the use of a  plant pest are subject to a comprehensive assessment of their potential  risks before the crops can be commercialized. Such assessments are not  required, under USDA’s biotechnology regulations, for GE crops  developed with alternative technologies. As a result, there is a gap in  USDA’s current regulatory coverage that the agency has been seeking to  close for more than 10 years, starting with the development of the 2008  proposed rule and continuing with its current efforts to update its  biotechnology regulations.
In addition, USDA stated that we used the phrase “newer technologies  that do not involve a plant pest" several times and that this phrase  incorrectly conflates the use of newer technologies with the use of a plant  pest component when there are older technologies (e.g., biolistics) that  do not involve a plant pest and newer technologies that do (e.g.,  TALENS). USDA stated that its statutory authority is to prevent the  introduction and dissemination of plant pests and noxious weeds in the  United States, and as such, it may regulate any GE organism which "the  Administrator determines is a plant pest or has reason to believe is a  plant pest" and may regulate, as necessary, any plant that poses a risk as  a noxious weed. We acknowledge that some newer technologies, such as  TALENS, involve the use of a plant pest, and some older technologies,  such as biolistics, do not. However, we note that while TALENS involves  the use of a plant pest in developing a new GE crop, no plant pest DNA  remains in the crop developed. Thus, that crop is not subject to USDA’s  biotechnology regulations unless USDA later learns, after the crop has  been commercialized, of a plant pest or noxious weed concern. It is that  distinction we were trying to draw with our use of “newer technologies,”  that is, those technologies that result in a new GE crop that is not subject  to USDA regulation under its biotechnology regulations. In this regard,  during our work USDA, EPA, and FDA officials told us that the field of  biotechnology is rapidly evolving with the introduction of new GE  organisms and new and emerging technologies that do not depend on the  use of a plant pest. In light of USDA’s comments, we have revised the  report to substitute the use of “alternative technologies” for “newer  technologies.” Further, we have revised the report to define alternative  technologies as those in which the GE crop developed contains no plant  pest DNA. This would include technologies such as TALENS that use a  plant pest, and those technologies that do not use a plant pest at all.
Moreover, USDA also stated that the draft report implies that some of the  newer technologies are inherently more risky and that USDA has no  reason to believe that newer technologies, such as gene editing, are  riskier or present any new risks, as compared to older technologies.  USDA stated that it concludes, as did the Office of Science and  Technology Policy in 1986 when it issued the Federal Coordinated  Framework for the Regulation of Biotechnology, that potential risk of a GE  organism is derived from the characteristics of the GE organism itself and  the environment in which it is introduced and not from the technology that  was used for the GE organism. We disagree that we have characterized  newer (now alternative) technologies as inherently more risky. Instead the  report discusses the potential risks of new GE crops developed with these  technologies that are not subject to USDA’s biotechnology regulations.  For example, these crops are not subject to USDA’s permit and  notification requirements, the conduct of confined field trials, or the  submission of detailed information for review by USDA scientists. Further,  under USDA’s regulations, developers of new GE crops developed using  alternative technologies do not need to petition USDA to “deregulate”  their product before commercializing it. However, in light of USDA’s  concern, we have revised the report to further qualify “potential risks” by  adding “if any” after this phrase. We also have revised the report to make  clear that we are focusing on those new GE crops in which the crop  contains no plant pest DNA, regardless of whether the technology  employed used a plant pest or not.
Finally, USDA said the report gives the incorrect impression that many of  the 'Am I Regulated?' inquiries from GE crop developers escape USDA  regulations because they were developed using newer (now alternative)  technologies. USDA stated that most inquiries to date concern GE plants  developed with biolistics, which is an older technology, and that for those  inquiries where it determined that the organism in question was not a  regulated article, it first concluded that there was no reason to believe the  organism presented a plant pest risk. As discussed, we have made  changes to the report defining alternative technologies as those in which  the GE crop developed contains no plant pest DNA. This includes  technologies where a plant pest may have been used initially as part of  the GE crop development process. It also includes technologies that do  not use plant pests at all in the development of a GE crop. Further, while  USDA may conclude there is no reason to believe the organism covered  by an inquiry presents a plant pest risk, that conclusion is not based on a  comprehensive assessment (e.g., the conduct of confined field trials and  the submission of detailed information for review by USDA scientists) of  the potential risks of that organism (i.e., a new GE crop). As discussed,  under USDA’s current biotechnology regulations, only those new GE crop  varieties developed with and containing plant pest DNA are subject to a  comprehensive USDA assessment of potential risks before  commercialization, and it is this regulatory gap, at least in part, that USDA  seeks to close in updating its biotechnology regulations. At present, only  after commercialization of a GE crop created with an alternative  technology, can USDA, if it becomes aware of a possible plant pest risk  or noxious weed risk, take regulatory action.
As agreed with your office, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies of this report to the  appropriate congressional committees, the Secretary of Agriculture, the  Secretary of Health and Human Services, the Commissioner of the Food  and Drug Administration, the Administrator of the Environmental  Protection Agency, the Director of the Office of Management and Budget,  and other interested parties. In addition, the report will be available at no  charge on GAO’s website at http://www.gao.gov.
If you or your staff have any questions concerning this report, please  contact me at (202) 512-3841 or morriss@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who make key contributions to this  report are listed in appendix VI.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: We reviewed federal oversight and information on genetically engineered  (GE) crops. 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. In this report, we define alternative  technologies as those in which the GE crop developed contains no DNA  of a plant pest, such as a bacterium or virus. This includes technologies in  which a plant pest may have been used initially as part of the GE crop  development process. It also includes technologies that do not use plant  pests at all.
In general, to achieve our objectives, we interviewed officials or obtained  documentation from USDA, EPA, and FDA. We also interviewed  nonfederal stakeholders, including biotechnology, food industry,  consumer, environmental, farm, and commodity group representatives,  and those from academia. Industry and commodity groups included the  Agricultural Retailers Association, American Seed Trade Association,  American Soybean Association, American Sugarbeet Growers  Association, Association of Official Seed Certifying Agencies,  Biotechnology Industry Organization, Cargill, Clarkson Grain, Grocery  Manufacturers Association, National Corn Growers Association, National  Grain and Feed Association, North American Export Grain Association,  and Organic Seed Growers and Trade Association. Consumer groups  included the Center for Food Safety, Center for Science in the Public  Interest, Institute for Responsible Technology, Consumers Union, and  Organic Consumers Association. In addition, we interviewed officials from  the American Association for the Advancement of Science, American  Farm Bureau Federation, Biology Fortified, Environmental Working  Group, Food & Water Watch, Genetic Literacy Project, National  Association of State Departments of Agriculture, National Conference of  State Legislatures, National Family Farm Coalition, National Organic  Coalition, and the Non-GMO Project, as well as six academics who are  agricultural economists studying the potential economic impacts of GE  crops. We identified the academics through a literature review, as well as  through the “snowball sampling” technique.
More specifically, to determine how federal agencies regulate GE crops  derived from alternative technologies, we interviewed agency officials  from USDA, EPA, and FDA, as well as representatives of 35 external,  nonfederal stakeholders, generally using a standard set of questions. We  took several steps to identify external, nonfederal stakeholders to  interview for our work. First, we considered those stakeholders  interviewed by GAO for our 2008 report related to GE crops and whether  they conduct work in the areas related to this engagement. Second, we  identified individuals through literature reviews. Third, we used the  snowball method—where each stakeholder was asked to propose or  recommend additional stakeholder groups for GAO to interview. We  selected the 35 stakeholders to ensure that we captured a broad  spectrum of views on GE crop issues. Findings from the interviews of this  sample of stakeholders cannot be generalized to those we did not speak  to. We additionally gathered information from the National Academy of  Sciences, including publicly available information from three public  meetings and 10 webinars associated with the academy’s ongoing study  on GE crops. We did not evaluate the underlying science behind  alternative GE technologies or the scientific basis of regulatory decisions  related to GE crops made by USDA, EPA, and FDA.
To examine what data, if any, exist on unintended mixing of GE crops and  non-GE crops, we obtained USDA’s strategic plans and reports, including  USDA’s Advisory Committee on Biotechnology and 21st Century  Agriculture reports with recommendations addressing options to minimize  the mixing of GE and non-GE crops. We also interviewed USDA officials  who regulate, oversee, or set standards for cultivation, shipping, handling,  and packing of major commodity crops, to determine the extent of  USDA’s role, if any, with respect to addressing the unintended mixing of  GE and non-GE crops. Further, we interviewed stakeholders identified in  our first objective to determine nongovernmental roles in preventing the  unintended mixing of GE and non-GE crops in the supply chain. We also  conducted a literature search to identify and review studies on the actual  or potential impact of GE crops on other crops. We did not review GE  crops regulated under USDA’s permit and notification field trial processes,  or the extent to which these crops are affecting the supply chain, as  USDA’s Inspector General was reviewing these subjects. The USDA  Inspector General issued this report in September 2015. Instead, the  focus of our report is those GE crops that have been deregulated and are  available for commercialization.
To determine the extent to which USDA, EPA, and FDA are providing the  public with information on GE crops, we interviewed agency officials and  reviewed agency documentation regarding how these agencies reached  regulatory or policy decisions related to GE crops, and examined the  extent to which that information is disseminated publicly, for example on  the agencies’ websites. We also interviewed stakeholders identified in our  first objective to determine their perspective on the adequacy of the  agencies’ provision of information on GE crops to the public. To examine  USDA and FDA approaches to labeling GE food ingredients, we reviewed  relevant laws and agency guidance and interviewed agency officials on  applicable programs. Specifically, at USDA, we reviewed documents and  interviewed officials with respect to USDA’s National Organic Program  and Process Verified Program. At FDA, we reviewed FDA documentation  and written statements from FDA officials on the agency’s labeling  principles. The documentation included FDA’s 1992 Statement of Policy:  Foods Derived from New Plant Varieties, and its 2015 guidance to  industry on voluntary labeling indicating whether foods have or have not  been derived from GE plants.
We conducted this performance audit from August 2014 to March 2016 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: Further Detail on USDA, EPA, and FDA Efforts to Provide Information to the Public on Their Oversight of GE Crops
paragraphs: This appendix discusses the efforts of three agencies—the U.S.  Department of Agriculture (USDA), the Environmental Protection Agency  (EPA), and the Food and Drug Administration (FDA)—to provide  information to the public on the oversight of genetically engineered (GE)  crops.
USDA’s Animal and Plant Health Inspection Service’s (APHIS) strategic  plan for fiscal years 2015 to 2019 includes education and outreach efforts  to ensure that GE organisms do not pose plant pest risks when released  into the environment and as an alternative to rulemaking. According to  the plan, USDA will use traditional communication tools, including  publications and public service announcements, in addition to newer  technologies to reach its stakeholders, partners, and customers, and  plans to expand its use of technology. Further, APHIS’s Biotechnology  Regulatory Services (BRS) 2015 to 2018 strategic plan states that USDA  will use high-quality analysis in decision making and will strengthen risk  assessment models to focus on GE organisms that pose a risk to plant  health. USDA will also seek to keep stakeholders aware of its regulatory  actions.
USDA regularly makes efforts to provide information relating to its  oversight of GE crops and to offer opportunities for public input. For  example:
APHIS’s BRS, which is responsible for implementing USDA  regulations for certain GE crops that may pose a risk to plant health,  holds annual public stakeholder meetings that are open to all  interested parties to foster engagement and transparency in BRS’s  regulatory activities.
BRS makes available on its website all letters of inquiry from GE crop  developers asking whether their GE crops are subject to USDA  regulations, as well as BRS’s response to each inquiry.
BRS makes available on its website a list of all pending and  completed petitions submitted by developers to receive a  determination on whether their new GE crops are likely to pose a  plant pest risk and therefore would be regulated and provides links to  supporting documentation, including guidance for submitting a  petition, the developer’s initial petition, BRS’s preliminary assessment,  and BRS’s final assessment and decision.
BRS has posted to its website an online video explaining how USDA  regulates biotechnology.
USDA sought public input through the Federal Register on how to  foster communication and collaboration between farmers to  strengthen coexistence following the release of the Advisory  Committee on Biotechnology and 21st Century Agriculture report in  2012.
EPA officials stated that the agency has a significant interest in being  transparent and assuring the public that the federal government is taking  all measures necessary to ensure human and environmental safety.  These officials said that EPA provides updates on its actions related to  GE crops, including making its predecision rationale for pesticide  registrations, available for public comment. For example:
During the registration process for the pesticide Enlist Duo, an  herbicide intended for use on some herbicide-tolerant GE crops,  EPA made its assessments of the pesticide and its rationale for  regulating the pesticide available for public comment for 30 days.  According to agency officials, EPA extended the comment period  on this pesticide for an additional 30 days and evaluated public  comments before making a final registration decision. EPA then  notified the public about which changes the agency had made in  response to public comments.
EPA occasionally convenes a Scientific Advisory Panel to provide  independent scientific advice on a wide range of health and safety  issues related to pesticides, including those related to GE crops,  and information such as archived transcripts from the panel’s  meetings are made publicly available on EPA’s website.
EPA’s Office of Pesticide Programs has an outreach program that  is responsible for communicating to the public all of EPA’s actions  on regulatory decision making regarding pesticides. Through this  program, EPA disseminates information through trade  publications, media, and an EPA e-mail distribution list that has  about 11,000 subscribers. According to EPA officials, the outreach  program also employs press releases and is increasing its use of  social media tools to engage the public on newer platforms.
FDA officials stated that the agency has developed more consumer- friendly information on foods derived from GE crops. This information,  made available on FDA’s website, includes a question-and-answer web  page on foods derived from GE crops, a 2013 statement on labeling of  foods from GE crops, a consumer update on FDA’s role in regulating the  safety of foods from GE crops, and the text of FDA congressional  testimonies on its oversight of foods derived from GE crops.
Information on FDA’s voluntary premarket consultation process available  on the agency’s website includes submission date and developer name;  the type of GE crop submitted; the trait being genetically engineered into the crop (e.g., insect  resistance); intended use (e.g., human food or animal feed); whether the product required EPA review (when a plant- incorporated protectant, i.e., pesticide, is produced);
FDA’s “note to the file” summarizing FDA’s evaluation of the  information submitted by the developer and the consultation’s  outcome; and the date and text of FDA’s final response letter, also called a “no  further questions” letter, to the developer, that marks the  completion of the consultation.
Additional information about voluntary premarket consultations that is not  otherwise trade secret or confidential commercial information may be  obtained through a Freedom of Information Act (FOIA) request, according  to FDA documentation and officials. From September 2002, the earliest  date for which FDA maintains digital internal records on FOIA requests,  through July 2015, FDA received at least one FOIA request for 22 (39  percent) of the 56 voluntary premarket consultations completed during  that time. FDA officials stated that although developers generally note  that their submissions typically do not contain very much trade secret or  confidential commercial information, some companies request that their  information not be published on the Internet. Further, FDA officials noted  that this information is often of a highly technical nature and if FDA were  to post this information, these officials said FDA would have to evaluate  what information in the submission may lawfully be disclosed, revise the  electronic files to make them more accessible under section 508 of the  Rehabilitation Act of 1973, and then review the material to ensure its  accuracy before posting, a process that would take considerable staff  time. Noting that their staff already face a number of competing priorities,  these officials questioned whether routinely preparing companies’  detailed data for posting on FDA’s website was a good use of staff time,  especially since these data can be obtained by FOIA request.
section_title: Appendix III: USDA and FDA Approaches to Labeling GE Food Ingredients
paragraphs: The U.S. Department of Agriculture (USDA) and Food and Drug  Administration (FDA) have different roles in the regulation of food  labeling, including the labeling of foods that might contain genetically  engineered (GE) ingredients, based on their respective statutory  authorities. As a result, the agencies differ in their approach to providing  information to the public on GE food ingredients and the labeling GE food  ingredients.
subsections: section_title: USDA’s National Organic Program and Process Verified Program
paragraphs: USDA currently provides information to the public about the GE content of  a food product through two programs: USDA’s National Organic Program  and its Process Verified Program.
The Organic Foods Production Act of 1990 directs the Secretary of  Agriculture to establish a national organic certification program. Under the  National Organic Program, a program managed by USDA’s Agricultural  Marketing Service, products can receive a USDA organic seal if they  meet specific national standards. USDA develops the standards for  organically produced agricultural products to assure consumers that  products with the USDA organic seal meet consistent, uniform standards.  Specifically, according to USDA’s policy and regulations, USDA’s  National Organic Program establishes standards for organic certification,  which forbids the use of GE methods, among other things, in the  production of organic crops. Products bearing the USDA organic seal  have received a process-based certification, in addition to other national  standardized factors set by USDA’s National Organic Program required to  attain organic status. USDA’s National Organic Program standards for  certified organic crops prohibit the use of sewage sludge, synthetic  fertilizers, synthetic pesticides, and genetic engineering. Meat and poultry  products that qualify as USDA organic may make a “Non-Genetically  Engineered” claim based on their organic certification. However, the  USDA organic seal itself does not bear the term non-GE. In addition, the  National Organic Program requires that certifying agents conduct residue  testing from a minimum of 5 percent of operations that they certify.
According to USDA officials, the Process Verified Program was started in  1999 and is conducted on a fee-for-service basis by USDA’s Agricultural  Marketing Service. Exercising its authority under the Agricultural  Marketing Act of 1946, the Agricultural Marketing Service serves as a  third-party auditor, physically visits a site, and verifies that a company’s  processes meet standards a company sets for itself. According to USDA  documentation and officials, these processes include, for example, how  crops are grown or how livestock are raised, and whether the products  are handled and processed according to specific guidelines. Companies,  such as grain handlers or poultry, pork, and cattle producers and  processors, submit their processes to USDA for verification. According to  USDA officials, the Process Verified Program allows consumers to be  assured that what they are buying adheres to the company’s standards  when they see USDA’s process verified seal on packaging. The USDA  website includes the process points for all companies for which the  Agricultural Marketing Service has completed process verifications and  displays what standards USDA used to audit the company’s process or  processes. For example, the Agricultural Marketing Service has done  process verifications to evaluate whether a company is feeding poultry a  vegetarian diet, is not treating its livestock with antibiotics, or is handling  grains in accordance with specific contract specifications (e.g., that they  are segregating the grains in a way that satisfies a contract).
USDA’s Agricultural Marketing Service completed its first process  verification for a non-GE process in May 2015. It allowed a company to  market its raw organic corn and soybeans by saying they were produced  using a process intended to result in a product with GE content below a  specific threshold. The company’s claim was that its non-GE process  results in corn and soybeans that do not exceed 0.9 percent GE content.  According to agency officials, USDA’s program verified the company’s  process for the crops, although it did not address the content of any final  products.
USDA officials stated that there has to be transparency if a food  processor is going to use the USDA Process Verified Program seal. For  example, the packaging of soy milk produced from non-GE process- verified soybeans would have to specify that it was made from non-GE  soybeans, but could not imply that the final product, which includes other  ingredients, had been produced in accordance with the same non-GE  standards, unless those were also process verified by USDA.
USDA officials stated that other companies have approached USDA  about potentially pursuing their own non-GE process verification. These  officials said that USDA will continue to operate the program by  evaluating companies’ processes against the companies’ own standards  because USDA officials do not have the statutory authority to define what  is a universal non-GE process standard. These officials stated that setting  a government standard for what constitutes a non-GE food or process  would probably require legislative action by Congress.
section_title: FDA Maintains There Is No Basis for Requiring GE Labeling
paragraphs: FDA regulates food labeling and enforces prohibitions against  misbranded foods. According to FDA documentation and agency officials,  FDA applies the same labeling principles to foods regardless of whether  they are derived from GE or non-GE sources. The agency maintains it  has no basis for concluding that foods derived from GE sources differ  from their non-GE counterparts in any meaningful or uniform way solely  based on their method of production, and therefore there is no basis for  requiring labeling that indicates a food was developed through GE  techniques. Further, according to its 1992 policy on GE foods, FDA  maintains that it has no basis to conclude that as a class, foods  developed with GE techniques present any different or greater safety  concern than foods developed by non-GE plant breeding. According to  FDA officials, scientific studies, information, and data FDA has reviewed  since it issued its 1992 policy, including data and information evaluated  through its voluntary premarket consultation process, reflect this same  conclusion.
FDA provides information on its website about why foods from GE plants  are not currently required to be labeled to inform consumers about how  the food was produced. The agency acknowledges on its website that  there is strong consumer interest in knowing whether foods were  produced using GE methods and that FDA supports voluntary labeling,  maintaining that such statements must be truthful and not misleading.  FDA finalized guidance to industry in November 2015 on voluntary  labeling indicating whether foods have or have not been derived from GE  plants. This guidance contains nonbinding recommendations and states  that labeling by manufacturers on a wholly voluntary basis regarding  whether a food was or was not bioengineered is acceptable to FDA,  provided that such labeling is truthful and not misleading. In addition, the  guidance states that FDA encourages food manufacturers to ensure that  labeling terminology concerning the use of modern biotechnology in the  production of food or its ingredients be accurate and consistent and that  the integrity and meaning of scientific terminology be preserved to help  ensure clear communication in food labeling. In addition, according to the  guidance  if a food derived from GE plants is significantly different from its  traditional counterpart such that the common or usual name or  existing statement of identity no longer adequately identifies or  describes the new food, the name of the new food must be changed  to a term that accurately identifies or describes the new food; if a GE food or one of its constituents differs from its traditional  counterpart regarding how the food is used or the consequences of its  use (for example, if the GE food behaves differently than its traditional  counterpart when used in a comparable way, such as in frying or  canning), a statement must be made on the label to describe the  difference(s) in use or the consequence(s) of its use; and if a food derived from GE plants contains an allergen that consumers  would not expect to be present in the food based on the name of the  food, the presence of that allergen must be disclosed on the label.
The guidance also states that a manufacturer that claims that a food  product or its ingredients, including foods such as raw agricultural  commodities, are GE or not GE should substantiate that the claim is  truthful and not misleading. The guidance provides methods a  manufacturer may use, including documentation of handling practices and  procedures (those with control over growing, harvesting, storing, and  distribution should consider appropriate recordkeeping to document  whether foods are or are not produced using genetic engineering,  including segregation procedures), use of certified organic food  (compliance with USDA’s requirements can be used to support food  labeling claims about the production of food without the use of genetic  engineering), and the use of validated test methods (to confirm the  presence of bioengineered material in food derived from GE plants).
section_title: Appendix IV: Stakeholder Perspectives and Legislative Actions on Labeling of Foods Derived from GE Ingredients
paragraphs: Stakeholders we interviewed have differing views with respect to labeling  of foods derived from genetically engineered (GE) ingredients.  Proponents of mandatory GE labeling, including some consumer rights  groups, argued that consumers have a right to know what is in their food.  They also said that mandatory GE labeling would allow members of the  public to make more informed decisions about what they purchase and  consume. In addition, some proponents said mandatory GE labeling  would be a low-cost way for companies to better inform consumers. For  example, an analysis requested by the Consumers Union in 2014  estimated the cost of introducing such a national standard, if passed on  to consumers through higher prices, would be less than $10 per family  each year. Some opponents of GE labeling suggested that labeling  foods containing GE ingredients—particularly without a demonstrated  food safety risk—would confuse or unnecessarily alarm consumers. They  estimated the costs of mandatory GE labeling could be as much as $400  to over $800 per family each year, as companies pass the costs on to  consumers of changing packaging or switching to non-GE suppliers to  avoid a label. However, some stakeholders said that a federal standard  for GE labeling would promote clarity for consumers and prevent  inconsistent policies. For example, one stakeholder said that if no national  standard is imposed, states may act on their own, resulting in a system  with policies that differ from state to state, creating confusion, negative  impacts on interstate commerce, and additional costs for consumers as  product packaging and labeling would have to be tailored to each  individual state.
A number of bills were introduced in the 114th Congress related to  labeling foods containing GE ingredients. A bill titled “Genetically  Engineered Food Right-to-Know Act” was introduced in the Senate and  House in February 2015, among other things, to establish a consistent  and enforceable standard for labeling of foods produced using genetic  engineering. A bill titled “Safe and Accurate Food Labeling Act of 2015”  was introduced in the House in March 2015 that would effectively prohibit  mandatory labeling of GE foods, including any state-level labeling  requirements. That legislation would make FDA’s voluntary premarket  consultation process mandatory, establish a USDA certification for non- GE foods similar to the current National Organic Program, and preempt  any state-level legislation requiring GE labeling.
As of July 2015, according to the National Conference of State  Legislatures, various bills were introduced in more than 30 states since  2011 to address GE labeling at the state level. Some bills proposed a  mandatory labeling system, under which a product containing any GE  ingredients must be labeled as such. Other proposals involved a  voluntary labeling system that would set labeling standards for products  that do not contain GE ingredients and, in some cases, implement a  system for verifying and labeling products as non-GE. As of July 2015,  three states had passed mandatory labeling laws for food products made  from GE ingredients. Vermont enacted legislation in May 2014, which  requires mandatory labeling of all GE foods beginning July 1, 2016. In  addition, Connecticut and Maine enacted legislation in June 2013 and  January 2014, respectively, on mandatory labeling of GE food products.  Connecticut’s law will go into effect when four other states adopt similar  legislation, including at least one state bordering Connecticut, and the  combined population of northeast states adopting such legislation must  exceed 20 million. Maine’s law requires five contiguous states, including  Maine, to pass a law requiring GE labeling before its law will go into  effect.
section_title: Appendix V: Comments from the U.S. Department of Agriculture
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, James R. Jones, Jr.  (Assistant Director), Cheryl Arvidson, Kevin S. Bray, Barbara El  Osta, Cindy Gilbert, Adrian Pavia, Caitlin Rice, Aaron Shiffrin, and  Kiki Theodoropoulos made key contributions to this report.
section_title: Related GAO Products
paragraphs: Genetically Engineered Crops: Agencies Are Proposing Changes to  Improve Oversight, but Could Take Additional Steps to Enhance  Coordination and Monitoring. GAO-09-60. Washington, D.C.: November  5, 2008.
Genetically Modified Foods: Experts View Regimen of Safety Tests as  Adequate, but FDA’s Evaluation Process Could Be Enhanced. GAO-02- 566. Washington, D.C.: May 23, 2002.
International Trade: Concerns over Biotechnology Challenge U.S.  Agricultural Exports. GAO-01-727. Washington, D.C.: June 15, 2001.
Intellectual Property: Deposits of Biological Materials in Support of  Certain Patent Applications. GAO-01-49. Washington, D.C.: October 16,  2000.
Biotechnology: Information on Prices of Genetically Modified Seeds in the  United States and Argentina. GAO/T-RCED/NSIAD-00-228. Washington,  D.C.: June 29, 2000.
Biotechnology: Information on Prices of Genetically Modified Seeds in the  United States and Argentina. GAO/RCED/NSIAD-00-55. Washington,  D.C.: January 21, 2000.