Abstract
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Critics point to a number of perceived deficiencies in the current regulatory regime. The division of regulatory authority between three agencies could result in gaps in coverage, for example, particularly with respect to next-generation products engineered using recently developed GE technologies that do not involve the introduction of genetic material derived from a plant pest. First-generation GE crops generally fell under the regulatory authority of at least one, and often all three agencies, particularly if the GE plant produced a food crop (corn or soybean) engineered through the use of a pathogen-derived transformation vector (Agrobacterium-mediated transformation) to produce a pesticide (Bacillus thuringiensis, or BT). 5 However, GE plants engineered using newer technologies that do not involve genetic material derived from any plant pest, and that do not result in the production of anything that might be characterized as a pesticide, arguably fall outside the jurisdiction of USDA and EPA, at least under current interpretation of agency regulations. Even FDA's voluntary review process would be inapplicable if the GE plant is not a source of food or feed (a biofuel feedstock, for example).
In July 2015, the Obama administration issued a memorandum to the heads of FDA, USDA, and EPA that initiates a process for reviewing and updating the regulatory system as it applies to biotechnology products, including GE crops. 6 This process is intended to “ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.” 7 In response, the three agencies have commissioned the National Academies of Sciences, Engineering, and Medicine (NAS) to conduct a study that will, among other things, “identify the kinds of products that may be produced with biotechnology in the next 10 years, [and] provide advice on the scientific capabilities, tools, and expertise that may be necessary to regulate those forthcoming products.” 8 The NAS expects to release a report on the outcome of its study at the end of 2016. 9 This report will likely include recommendations for improving the regulation of GE crops, which could potentially involve consolidation of regulatory authority in a single agency.
In the meantime, two reports critical of USDA's current regulatory approach to regulating GE crops were published by the USDA's Office of Inspector General (OIG) and the U.S. Government Accountability Office (GAO), in September 2015 and March 2016, respectively. The remainder of this article briefly summarizes some of the more significant findings and recommendations of these two federal audit reports.
The USDA's Office of Inspector General Audit Report
The first report to be discussed, entitled Controls over APHIS’ Introduction of Genetically Engineered Organisms (the “OIG Report”), is based on the results of an audit conducted for the stated purpose of determining whether APHIS adequately controls the introduction of GE organisms into the environment. 10 This audit included an assessment of the extent to which APHIS had addressed recommendations made by the OIG in a 2005 audit report—this earlier audit had identified weaknesses in APHIS’ regulations and internal management controls which increased the risk that regulated GE organisms would inadvertently persist in the environment before those GE organisms were deemed safe to grow without regulation. 11 As discussed below, the OIG Report released last year concludes that APHIS needs to take additional steps to tighten its control and oversight over the release of GE organisms into the environment, and provides 13 specific recommendations for achieving this result. 12
The OIG Report begins by faulting APHIS for not having implemented corrective actions for three of the 28 recommendations made in the 2005 report, as well as for its failure to develop a timeline for resolving these recommendations, which involved consolidating regulations for minimizing inadvertent release of GE material, regulating the movement of GE seeds, and incorporating additional authority to control noxious weeds into its regulations. 13 The OIG Report further found that three recommendations from 2005 relating to control over field tests had been only partially addressed by APHIS, but that further action needed to be taken in order to better protect against unintended release of GE organisms into the environment. 14
The OIG Report acknowledged that APHIS's task of complying with recommendations from the 2005 report had been made more difficult by the range and variety of public comments made in response to the agency's publication of proposed regulations intended to address the OIG's recommendations—more than 5,500 responses, containing more than 88,000 signatures, were submitted by a diverse array of stakeholders. 15 Nonetheless, the OIG insists that APHIS must develop a reasonable timeline for implementing corrective actions to adequately address the remaining recommendations from the 2005 report. In response, APHIS has agreed to work diligently to propose changes to current regulations that address all of the recommendations in both the 2005 report and the OIG Report, and to have a draft proposed regulation ready for departmental review by September 30, 2016.
One of the more significant deficiencies identified in the 2005 report was the lack of consolidated, comprehensive guidance for managing field releases of GE organisms and conducting field tests. 16 In the course of the 2015 audit, APHIS told OIG auditors that its policies and procedures regarding field trials had been consolidated internally, but acknowledged that this internal consolidation had not met “the spirit of the recommendation from the 2005 audit report,” and that these requirements had yet to be consolidated into a comprehensive regulation. The OIG Report found that this lack of regulatory guidance had resulted in inconsistent treatment of incidents of potential non-compliance by entities conducting field trials involving regulated organisms.
The 2005 report had also recommended clarification of guidelines regarding the transportation of GE seeds. 17 Federal regulations require double metal containers for shipment of regulated GE materials, but the 2005 audit found that APHIS often allowed shipment of seeds in non-metal containers, “in violation of its own requirements.” Although the regulations do allow shippers to request a variance from the metal container requirement, if the shipper can justify the request, the auditors found that in practice APHIS was not requiring shippers to obtain a formal variance in order to use non-metal containers. The OIG Report reiterates that APHIS needs to revise its shipping containment regulations to guard against further such non-compliances.
The 2005 report also recommended that APHIS update its regulations to incorporate provisions of the Plant Protection Act of 2000 (PPA), a statute intended to expand USDA's regulatory authority, including increased authority for controlling noxious weeds. 18 As of 2015, the agency has not done so, and the OIG Report faults USDA for having failed to do so after more than a decade. According to the OIG, APHIS currently does not even have a timeline for implementing this recommendation. The OIG Report acknowledges the difficulty APHIS has encountered in addressing the concerns of divergent stakeholders, but reiterates that “APHIS must develop a reasonable timeline for implementing agreed upon corrective actions” for this and other recommendations made in 2005. 19
The OIG Report further found that APHIS is currently failing to adequately monitor ongoing field trials, and that this has resulted in an unacceptable risk that a GE organism might be inadvertently released into the environment. 20 In particular, the report found that APHIS cannot account for all approved and planted GE crop locations, has insufficient ability to require entities to comply with reporting requirements, and lacks adequate processes for reviewing progress reports that are received.
APHIS does not inspect all field trials, so it is important to have some process in place for prioritizing inspection of sites that pose a higher risk of release of GE material into the environment. The OIG Report found that APHIS's current policy does not provide a detailed explanation of risk factors that the agency uses to make this determination, nor does it explain how risk factors are evaluated, how often the selection process will be performed, who is responsible for performing and reviewing the selection(s), or how the selection will be documented. 21 In response to this criticism, APHIS has agreed to develop a formal policy that identifies the risk factors that will be considered and provides details as to how these factors will be evaluated.
The OIG Report further found that APHIS could improve its processes by considering an organization's compliance history in determining whether to issue that organization a permit to conduct future field trials. 22 OIG auditors identified eight organizations that have continued to receive permits even after they collectively had 260 incidents reported over the past two years, involving unauthorized environmental releases and other failures to comply with the requirements. Currently, the APHIS biotechnologists who approve these permits are not required to review the applicant's compliance history. The OIG Report recommends that APHIS incorporate compliance reporting and tracking of all incidents in the Information Management System currently under development at USDA, so as to make this information available to biotechnologists involved in permit approval, and APHIS has agreed to do so.
Finally, the OIG Report found that APHIS does not maintain sufficient records documenting its process for reviewing petitions for non-regulated status of GE organisms. 23 In particular, OIG found that APHIS does not have an effective system for maintaining petition process documents, and thus cannot assure that petitioners complete each step of the review process. The report recommends that APHIS develop and implement specific policies and procedures for the retention and maintenance of all documents at each step of the petition process, i.e., not just the “major steps” currently being monitored by APHIS. In its response to the OIG Report, APHIS agreed with this recommendation and stated that documents generated during the review of a petition will be stored in an electronic Petition Tracking System, which will track when and by whom each document is created, revised, and approved. This system is slated for implementation by May 31, 2016.
The U.S. Government Accountability Office Report
In March 2016, the GAO issued a report entitled Genetically Engineered Crops: USDA Needs to Enhance Oversight and Better Understand Impacts of Unintended Mixing with Other Crops (the “GAO Report”). 24 This report is based on a performance audit conducted by the GAO from August 2014 to March 2016 at the request of Congress, in order to review agency oversight and information on GE crops. In particular, the audit examined: (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.
One of the GAO Report's key findings was that USDA has failed to adequately update its regulations to account for advances in the technology used in genetically modifying plants. 25 According to the GAO, under current regulations, USDA only asserts authority to regulate GE crops in which the donor, vector, or recipient of genetic material is a plant pest. Traditionally, genetic modification of crops has involved the use of vectors and regulatory elements derived from plant pathogens, particularly Agrobacterium and plant viruses, and has generally resulted in a final product that incorporates some genetic material from the source pathogen. This residual DNA has provided the necessary jurisdictional hook for USDA to assert regulatory authority over GE crops made using these traditional technologies.
However, more recent advances in technology allow for the introduction of genetic material into a plant in such a way that there is no residual genetic material from a plant pathogen. 26 For example, genome-editing technologies employing modified nucleases can be used to create deletions, substitutions, and gene insertions without any involvement of genetic material from a plant pest, resulting in gene-edited crops that are essentially indistinguishable from crops created by means of conventional crossbreeding. 27 Significantly, in the absence of genetic material derived from a pathogen, the primary jurisdictional basis that has been used by USDA for assertion of regulatory authority over GE crops, appears to be lacking in these products. The GAO Report states that as of November 2015, USDA had on at least 16 occasions informed a GE crop developer that a GE crop under development was not subject to USDA regulation because a plant pest was not used to modify the plant's DNA. 28 USDA officials told auditors that a GE crop produced using a technology that does not involve the introduction of genetic material derived from a plant pest could be regulated pursuant to USDA's noxious weed authority provided under the PPA, but to date, the agency has not done so because USDA's existing noxious weed regulations were not designed to encompass crops. 29
According to the GAO Report, USDA does not appear to currently have the regulatory authority to assess the potential risks, if any, resulting from GE crops created using alternative transformation technologies. The report notes that in 2008, USDA initiated the process of proposing new regulations that would encompass GE crops developed using technologies that do not involve the use of genetic material derived from plant pests, but that in February 2015, USDA withdrew the proposed regulations, in part because of a lack of clarity as to the scope of the rule. 30 Although USDA has stated that it intends to reinitiate the rulemaking process, USDA has not created a timeline for the promulgation of new regulations encompassing these advanced technologies. The report recommends that USDA set a timeline, including milestones and interim steps, in order for the agency to better set priorities and monitor progress in the promulgation of a new rule.
The GAO Report also found that USDA has not done enough to address concerns associated with potential unintended mixing of GE and non-GE crops. 31 Because of consumer concerns associated with GE crops, farmers producing non-GE crops can demand a premium in the market. However, a common infrastructure used for the storage, transportation, and distribution of both GE and non-GE crops can cause some mixing to occur, which can potentially harm non-GE producers if the unintended presence of GE material causes buyers to refuse to pay the premium. The GAO recommends that USDA obtain more data to better understand the extent to which unintended mixing occurs, and its economic impact on producers of non-GE crops.
In 2014, USDA conducted an Organic Survey which queried organic farmers as to economic losses they might have experienced due to the unintended presence of GE material in crops offered for sale. 32 A relatively small number of the organic farmers surveyed reported some economic loss, but these losses were found to be relatively small compared to overall revenue generated by organic farming. However, there are a number of non-organic farmers who plant non-GE seeds and market their crops as “identity-preserved,” i.e., a specific genetic variety of a crop. USDA officials told the GAO that the total acreage of identity-preserved crops is significantly greater than organic crop acreage, but that these farmers were not included in the Organic Survey. The GAO Report recommends that USDA include non-organic farmers growing identity-preserved crops in a future survey to better understand the economic impact of unintended mixing on all non-GE farmers.
Finally, the GAO Report notes that although USDA is not responsible for preventing the unintended mixing of GE material with non-GE and organic crops, the agency has taken some steps to focus on this issue. 33 For example, the Secretary of Agriculture has placed a high priority on strengthening the ability of GE and non-GE agricultural production to coexist. Nonetheless, USDA officials maintain that segregating GE and non-GE crops is generally a private-sector function. 34 USDA officials reported that farmers and the agribusiness industry, in response to consumer demand, generally take measures to minimize unintended presence of GE material in non-GE and organic crops. These measures include the physical and temporal separation of GE and non-GE crops, testing and inspection of shipments of non-GE crops for the presence of GE material, the adoption of buyer-tolerance levels for acceptable levels of GE content in non-GE shipments, the cleaning of handling equipment and storage infrastructure after it has been used for GE crops, and, in some instances, dedicated infrastructure to process non-GE crops separately from GE crops. 35