Agriculture Reference
In-Depth Information
(beginning in 1985 and ending in September 2013) of releases for field testing
increased from 10,700 in 2005 to more than 17,000 in 2013. Field releases
approved for corn increased from close to 5,000 in 2005 to 7,800 in 2013.
Approved releases for GE varieties with herbicide tolerance traits increased
from 3,587 in 2005 to 6,772 in 2013, insect resistance from 3,141 to 4,909,
and product quality such as flavor or nutrition from 2,314 to 4,896.
R
EGULATORY
O
VERSIGHT
Before commercial introduction, genetically engineered (GE) crops
must conform to standards set by State and Federal statutes (Fernandez-
Cornejo and Caswell, 2006; USDA/APHIS, 2013). Under the Coordinated
Framework for the Regulation of Biotechnology, Federal oversight is
shared by the U.S. Department of Agriculture (USDA), the U.S.
Environmental Protection Agency (EPA), and the U.S. Food and Drug
Administration (FDA).
USDA's Animal and Plant Health Inspection Service (APHIS) plays a
central role in regulating field testing of agricultural biotechnology
products. Through either a notification or permit procedure, such
products—which include certain genetically engineered plants,
microorganisms, and invertebrates—are considered “regulated articles.”
APHIS issues authorizations for field releases of those GE organisms
(mostly GE plants) that are categorized as “regulated articles” under its
regulations, to allow technology providers to pursue field testing. GE
plants that meet six specific criteria described in the regulations undergo an
administratively streamlined process, known as a
notification
. Under a
notification
, applicants provide information on the nature of the plant and
introduced genes, descriptions of genetic modifications, size of the
introduction, and origin and destinations for movement or the location of a
field test. For GE plants that do not meet the criteria for a
notification
, an
APHIS
permit
is required. This process involves a more comprehensive
review. In addition to the data required for notification, permit applicants
must describe how they will perform the test, including specific measures
to reduce the risk of harm to other plants, so the tested organisms remain
confined and do not persist after completion of the field test.
After years of field tests, an applicant may petition APHIS for a
determination
of
nonregulated
status
in
order
to
facilitate
commercialization of the product.
