www.checkbiotech.org ; www.raupp.info ; www.czu.cz

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 plants, March 2006 by
Phillip B. C. Jones.

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 facilities.

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.

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
(http://www.usda.gov/oig/rptsaudits2005.htm).

------------------------------------------
Posted to Phorum via PhorumMail