The United States Department of Agriculture (“USDA”) and its Animal and Plant Health Inspection Service (“APHIS”), which oversees biotechnology regulation, was heavily criticized by its own Inspector General (OIG) 2005 audit report.1 The OIG concluded that weaknesses in APHIS’ internal management controls undermine its ability to oversee successfully the safe development of genetically engineered organisms.2 In a sentence, the OIG found that APHIS often failed to follow its own mandates.
USDA’s historic regulatory failures, as discussed below, raise significant questions regarding the agency’s ability to effectively regulate GMOs.
a) Failures in Accountability3
The OIG found that APHIS often lacks basic information about the field test site that it approves and is responsible for monitoring, including information about where the crops are being grown and what becomes of them at the end of the field test. Interestingly, APHIS does not follow up with all permit and notification holders to find out exactly where the fields have been planted or if they have been planted at all. In some cases, the OIG found that APHIS may only be aware of the State and county where an applicant plans to conduct a field test. Without knowing the locations of all planted field test sites, including their global positioning system (GPS) coordinates, the OIG concluded, APHIS cannot effectively monitor permit and notification holders’ compliance with field test requirements.
The OIG also found that before approving field tests, APHIS does not review notification applicants’ containment protocols, which describe how the applicant plans to contain the GM crop within the field test site and prevent it from persisting in the environment. Instead, APHIS allows notification holders to provide the protocols verbally if their field test sites are selected for inspection. Since notifications comprise the vast majority of field test authorizations, the OIG concluded that this policy undermines both the field test approval and inspection processes.
Additionally, the OIG found that at the conclusion of the field test, APHIS does not require permit holders to report on the final disposition of GM pharmaceutical and industrial harvests, which are modified for nonfood purposes and may pose a threat to the food supply if unintentionally released. For example, during the OIG inspection, the auditors found that two large harvests of GM pharmaceutical crops remained in storage at the field test sites for over a year without APHIS’ knowledge or approval of the storage facility.
If you previously believed that the USDA’s regulatory role is nothing more than a paper-pushing-applications-filed-and-signed approval process, you would be surprised to find that even that function was apparently too much for APHIS. The OIG found that APHIS does not thoroughly document its reviews of applications in the official files. Specifically, APHIS biotechnologists do not sufficiently document their review process and scientific basis for approving initial field test applications. APHIS also does not effectively track information required during the field tests, including approved applicants’ progress reports, which should contain the results of field tests, including any harmful effects on the environment. Although the OIG found that that many permit and notification holders submit these required progress reports late or not at all, APHIS does not always follow up to obtain the information.
Since the major thrust of APHIS oversight is that it requires applicants to follow procedures that will minimize the chance of inadvertent introduction of material from these unapproved genetically engineered crops to food crops, agriculture, the environment, and the food supply, these weaknesses cut to the very heart of the regulatory process and bring its legitimacy and competence into question.4
b) Inspection and Enforcement Weaknesses5
The OIG found that APHIS lacks a formal, risk-based process for selecting individual sites for inspection, and that it does not complete all of the inspections of the field test sites, including inspections of pharmaceutical and industrial crops. For example, while APHIS announced that during 2003 growing season it was going to inspect all pharmaceutical and industrial field test sites five times, the OIG found that APHIS did not. APHIS has also stated publicly that pharmaceutical and industrial field test sites would be inspected twice during the post-harvest period, or the year following the end of the field test, during which the field must be monitored for regrowth of the GM crop. The OIG found that APHIS did not perform all those promised inspections either.
Since APHIS trumpets a low infraction rate as evidence that its monitoring program is effective, the lack of inspection is particularly troubling.6 In fact, OIG found 11 violations that were not recorded in the Agency’s compliance infractions database at the time of its audit, even though they were reported to the Agency or could have been identified from information Agency already had. APHIS took administrative action on only 1 of those 11 violations.
The OIG also found that in 2005, APHIS has still not updated its regulations to reflect the Plant Protection Act of 2000, under which APHIS carries out its biotechnology oversight duties. As an interesting side note, an Office of the General Counsel official advised OIG that in 2005 APHIS did not have legislative authority to hold applicants financially responsible for costs incurred by USDA due to an unauthorized release of regulated GMOs. Because APHIS cannot require applicants to provide proof of financial responsibility before it authorizes field tests, USDA may have to bear the expense of removing GM material from the environment in the event of an unintentional release.
c) Inadequate Guidance for Containing GM Crops and Seeds7
Another troubling revelation was the finding that APHIS’ guidance is insufficient to prevent the persistence of GM crops outside the field test. For example, APHIS does not specify when GM crops must be destroyed, or “devitalized,” following the field test. Approved applicants sometimes allow harvested crops to lie in the field test site for months at a time, their seeds exposed to animals and the elements. Also, because APHIS has not specifically addressed the need to physically restrict edible GM crops from public access, the OIG found a regulated edible GM crop, which had not gone through the Food and Drug Administration’s regulatory process for approval for human consumption, growing where they could easily be taken and eaten by passersby.
The OIG concluded that APHIS’ current regulations, policies, and procedures do not go far enough to ensure the safe introduction of agricultural biotechnology and that APHIS “is relinquishing its regulatory responsibilities in favor of self-certification” by GMO applicants. Substantive review and oversight is replaced with blind acceptance of unverified industry promises to comply with performance standards.8
No Optimistic Outlook
Although the Audit report noted that APHIS has agreed to most of the OIG’s recommendation, it is questionable, given the agency’s history, whether and to what extent the recommendations have been implemented since the Audit has been issued.
In 1988, for example, in an early analysis conducted by the General Accounting Office (now the Government Accountability Office) (GAO), the GAO criticized the shortcomings in USDA’s oversight of GMOs, echoing calls by the scientific community that certain regulatory decisions were “scientifically indefensible.”91011 The 2005 OIG Audit Report found that despite the fact that APHIS agreed to improve its tracking of inspection reports following an Office of Inspector General (OIG) audit more than 10 years before, APHIS continued to lack an effective, comprehensive management information system to account for all inspections and their outcomes.12 Furthermore, in 2002, the Board on Agricultural and Environmental Resources noted that USDA has no systematic monitoring of GMOs, especially after they are released, further disputing APHIS’s self-congratulatory claims to effective and successful regulations because, frankly, without systematic monitoring, the lack of evidence of damage is not necessarily lack of damage.13 And then there are USDA/APHIS’ court battles played out in the last decade, involving, for example, GM alfalfa, sugar beets and sugar cane, exposing USDA’s failure to follow the law and casting an even further shadow of doubt about the regulatory competence of the USDA.
It also does not help that USDA suffers from a major case of the revolving door syndrome, where industry heads make smooth transitions between government posts and back, irrespective of which political party is in power. The undeniable and almost palpable conflict of interest further draws away from any claims that the USDA is effectively regulating GMOs. Andrew Kimbrell, the executive director of The Center for Food Safety, in discussing the USDA, remarked in 2007 that he has “never seen a government agency so openly and unashamedly defend the interests of a corporation and not represent the interests of farmers.”
Given its historic failures and its current pro-GMO leadership, it is doubtful that USDA has changed its ways since 2005.
- U.S. Department of Agriculture Office of Inspector General, Audit Report: Animal and Plant Health Inspection Service Controls Over Issuance of Genetically Engineered Organism Release Permits, (Dec. 2005), available at http://www.usda.gov/oig/webdocs/50601-08-TE.pdf (last visited on December 20, 2009) (“Audit Report” hereinafter); see also Rebecca Bratspies, Some Thoughts On the American Approach to Regulating Genetically Modified Organisms, 16 Kan.J.Law & Public Policy 393, 415-18 (2007).
- Bratspies, supra note 1 at 415.
- Unless specifically indicated otherwise, the information was obtained from the Audit Report, supra note 1.
- Bratspies, supra note 1 at 416.
- See supra note 3.
- Bratspies, supra note 1 at 415-16.
- See supra note 3.
- Bratspies, supra note 1 at 417
- Bratspies, supra note 1 at 405-07/
- Richard Caplan and Skip Spitzer, Regulation of Genetically Engineered Crops and Food in the United States, (2001), p. 8, available at http://www.pirg.org/ge/reports/GERegulations.pdf (last visited on November 9, 2009).
- Board on Agriculture and Natural Resources, Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation, p. 173-74 (2002), available at, http://www.nap.edu/openbook.php?record_id=10258&page=1 , (last visited on December 20, 2009).
- Audit Report, supra note 1 at iii.
- BANR, supra note 11 at p. 168.