GENET archive


9-Misc: USDA Office of Inspector General reveals weaknesses in oversight about GE field tests

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SOURCE: ISB News, USA, by Phillip B. C. Jones
        file attached: mar0604-1.jpg
DATE:   Mar 2006

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Twenty years ago, the U.S. Department of Agriculture assumed
responsibility for regulating field tests of new genetically modified
(GM) plants and for ensuring that regulated GM plants, GM pollen, and GM
seeds do not persist in the environment. Since then, the agency has
approved over 10,000 applications for more than 49,000 field sites of GM

The USDA's Office of Inspector General had doubts about whether the
Animal and Plant Health Inspection Service's efforts to regulate GM
plants have kept pace with the ever-increasing number of approved field
test applications. To evaluate oversight of releases and movements of
regulated GM plants, the OIG visited 91 planted or harvested field test
sites in 22 states between May 2003 and April 2005.

On December 22, 2005, the Inspector General issued an audit report on the
office's findings. The OIG concluded that weaknesses in APHIS'
regulations and internal management controls increase the risk that
regulated GM organisms will inadvertently enter the environment before
the agency considers them sufficiently harmless to merit unregulated
status. The Inspector General offered recommendations to improve three
broad aspects of APHIS' oversight: in the accountability for GM plants;
in the agency's inspections and enforcement of rules; and in guidance for
containing GM plants and seeds.

Shoring up Accountability for GM Crops APHIS uses two mechanisms to
authorize field tests: permits and notifications. The agency considers
certain GM crops to pose a high risk, such as plants engineered to
produce pharmaceutical and industrial compounds, or plants engineered
with human genes. Field tests of these GM plants require the issuance of
permits. Based on its experience, APHIS deems that certain GM plants do
not present novel plant pest risks. To field test a low-risk GM plant,
applicants can use a streamlined notification process.

APHIS requires permit applicants to submit written protocols for review.
In contrast, the agency does not require notification applicants to
submit written containment protocols that describe how they plan to meet
performance standards for preventing the escape of GM test plants into
the environment. Rather, APHIS allows notification holders to supply
protocols verbally if APHIS selects their field test sites for
inspection. Since notifications comprise the vast majority of field test
authorizations, OIG argues, this policy undermines both the field test
approval and inspection processes.

The Inspector General also sees deficiencies in APHIS' monitoring of
concluded field tests. At the end of a field test, APHIS does not require
permit holders to report on the final disposition of GM plants that
produce pharmaceuticals or industrial chemicals. The OIG discovered two
harvests of GM pharmaceutical crops that had been stored at field test
sites for over a year without APHIS' knowledge or approval of the storage

APHIS sometimes lacked information about the precise locations of GM
field test sites. The OIG found that, after authorizing a field test,
APHIS did not consistently follow up with permit and notification holders
to find out exactly where they had planted their GM crops or even if they
had planted them. In the OIG's view, APHIS cannot effectively monitor
permit and notification holders' compliance with field test requirements
without knowing the locations of planted field test sites, including
global positioning system coordinates.

To ensure accountability for regulated GM crops, OIG recommended that
APHIS should require applicants to provide more information before and
during a field test, including global positioning system coordinates of
all planted field test sites. APHIS should also require all applicants to
file copies of scientific protocols for conducting field tests.

Bolstering Inspections and Enforcement of Rules

The OIG found room for improvement in APHIS' procedures for inspecting
test fields. The audit report describes a lack of coordination between
the two APHIS units responsible for the inspection program: Biotechnology
Regulatory Services (BRS), responsible for overall management of the
program; and Plant Protection and Quarantine (PPQ), which performs most
of the inspections of GM field test sites. According to the Inspector
General, BRS lacks a formal, risk-based process for selecting individual
sites for inspection, while PPQ officers do not complete all of the
inspections BRS requests, including inspections of high-risk
pharmaceutical and industrial crops.

In addition, neither BRS nor PPQ kept track of the total number of
completed inspections and their outcomes. The OIG found 11 violations
unrecorded in BRS' compliance infractions database at the time of the
audit, even though the violations had been reported to BRS or could have
been identified from available information.

To strengthen monitoring of field test sites, the OIG recommended that
APHIS formalize its inspection process and coordinate the
responsibilities of BRS and PPQ. APHIS also needs to develop a
comprehensive management information system to track the receipt and to
review of all information associated with release permits and notifications.

Neutralizing Terminated Test Fields

The Inspector General office found weaknesses in APHIS' guidance for
preventing the persistence of GM crops outside the field test zone. The
OIG discovered, for example, that APHIS did not specify when GM crops
must be destroyed after a field test. As a result, harvested crops can
remain in a field test site for months (Fig. 1).

The OIG recommended that APHIS should obtain reports on the final
disposition of high-risk pharmaceutical and industrial harvests. The
office also suggested that APHIS should draft guidance on deadlines for
destruction of test crops.

APHIS Concurs and Counters In a letter dated November 2, 2005, W. Ron
DeHaven, APHIS' administrator, stated that the Biotechnology Regulatory
Services has completed, or has begun implementing, 23 of the 28
recommendations. APHIS disagreed with most of the remaining recommendations.

OIG's suggestions for modifying the notification process created the most
noteworthy cause of disagreement. The OIG insists that APHIS should
obtain copies of notification applicants' scientific protocols for
conducting field tests and allow the agency's biotechnologists to review
the protocols to ensure that they meet performance standards. Otherwise,
APHIS relinquishes its regulatory responsibility in favor of a system in
which notification applicants merely certify that they will meet the
performance standards.

"While we do evaluate written protocols for permits," DeHaven argued, "we
believe that the current system of performance-based regulatory standards
for notifications is effective at protecting American agriculture."
DeHaven emphasized APHIS' familiarity with crops eligible for
notification, an expertise that justifies the agency's decision to omit a
review of written protocols prior to approval. "The intent of the
notification procedure," he said, "is to provide an administratively-
streamlined process for trials of crop-trait combinations with which
APHIS already has a great deal of experience and familiarity."

A copy of the audit report, "Animal and Plant Health Inspection Service
Controls Over Issuance of Genetically Engineered Organism Release
Permits," is available at the OIG website (

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