APHIS Factsheet

Biotechnology Regulatory Services September 2014

Questions and
Answers:
Genetically
Engineered Wheat
Investigation
The U.S. Department of Agricultures (USDA)
Animal and Plant Health Inspection Service (APHIS)
is sharing information about two separate incidents
involving the detection of genetically engineered
(GE) wheat in the United States. The frst detection
occurred last year on a farm in Oregon. The second
detection occurred in July of this year at a research
facility in Montana where research feld tests involving
GE wheat were conducted between 2000 and 2003
under APHIS regulatory approval.
APHIS has concluded a comprehensive
investigation into the detection in Oregon, which
found no evidence of GE wheat in commerce and
determined the incident appears to be an isolated
event.
APHIS has opened a new investigation into
potential regulatory compliance issues after the
detection in a Montana research facility.
Q. Are these two events related?
A. No. Testing of the GE wheat from Oregon and
Montana has confrmed that the wheat found in both
locations was genetically engineered by Monsanto for
resistance to the herbicide glyphosate, commercially
known as Roundup. However, genetic testing shows
that the varieties of wheat differ signifcantly from one
another. The GE wheat found in Oregon contained
genetic material from a number of different wheat
varieties. The GE wheat found in Montana is less
genetically diverse and more similar to known varieties
of wheat. This confrms that the GE wheat detected in
Oregon did not originate from the feld trials conducted
in Montana.
Q: Is GE wheat in commerce?
A: No. As part of its investigations to date, APHIS
has no evidence of GE wheat in commerce. Testing
conducted by several trading partners during the last
year also has not detected the presence of GE wheat
in any commercial shipment from the United States.
Q: Is GE wheat in use in the United States?
A: No. USDA has not deregulated any GE wheat
varieties; there are no GE wheat varieties for sale or in
commercial production in the United States at this time.
Q. Are there food safety concerns?
A. No. Although USDA has not deregulated GE wheat
in the United States, there are no food safety issues
associated with this wheat. In 2004, the Food and Drug
Administration determined such GE wheat to be safe for
food and feed.
Q: Are there any impacts to trade as a result of
these detections?
A: No. Currently, all markets are accepting U.S.
wheat and no trade restrictions are in place. Testing
conducted by several trading partners during the last
year has not detected the presence of GE wheat in any
commercial shipment.
Oregon
Q: What did USDA investigate and why?
A: APHIS has completed a thorough investigation into
the 2013 detection of genetically engineered (GE) wheat
in one feld of an Oregon farm. The investigation sought
to determine how GE wheat came to be in the feld and
to determine the extent of its presence.
Q: When did APHIS launch the investigation?
A: The investigation launched on May 3, 2013.
Q: What did investigators examine?
A: Investigators initially began by collecting and testing
the following:
Samples of plants from the feld that survived
glyphosate treatment;
Samples of volunteers in the same feld that had not
survived glyphosate treatment;
Samples of plants that appeared on the periphery
of a feld that was planted with the same certifed
seeds;
Samples of the three varieties of soft white wheat
seed planted on the farm since 2009;
Samples of grain harvested from the farm including
from the 2012 harvest; and
Samples from the business that sold the seed to
and purchased the harvested grain from the grower,
and other businesses that purchased seed from this
business.
In addition to testing samples, USDA officials
completed 291 interviews with wheat growers,
grain elevator operators, and crop consultants, as
well as interviews with feld test plot researchers
involved in the testing of the GE wheat. The 12,842
pages of documents made public today detail the
investigation. With one exception, none of the growers
had themselves experienced a glyphosate-based
herbicide failing to destroy volunteer wheat plants.
One grower reported an experience with glyphosate-
resistant wheat in 2007. APHIS collected samples
from the reported area, all of which tested negative.
Q: What did USDA fnd in its investigation?
A: The investigation indicates that this appears to be
an isolated occurrence and that there is no evidence
of any GE wheat in commerce.
The 12,842 pages investigation also found that
the GE wheat is not a commercial variety of wheat.
USDA scientists compared the GE wheat found on the
Oregon farm to over 200 known cultivars of wheat that
have been developed for growers and could not fnd a
match. The GE wheat found on the Oregon farm is a
hybrid that includes genetic material from other types
and varieties of wheat, along with a GE glyphosate-
resistant wheat trait developed by Monsanto that
confers resistance to Roundup herbicide. The genetic
characteristics of the GE wheat volunteers are
representative of a wheat breeding program.
Q: Why did the investigation take so long?
A: This was one of the most thorough and
scientifcally complicated investigations APHIS has
conducted into a possible violation of the Agencys
regulations. After exhausting all leads, APHIS worked
as quickly as possible to fnish the investigation
and prepare its report of investigation, fndings, and
evidence fle. At the outset of the investigation, APHIS
committed to making the results known publicly. In
order to do so, over the last several months APHIS
has carefully reviewed thousands of pages containing
confdential business information collected as part of
the investigation. APHIS then worked to appropriately
withhold personal information and confdential
business information from the 12,842 pages of the
report and evidence fle that is now available on the
APHIS website at http://www.aphis.usda.gov/foia/
efoia.php.
Q. How was the GE wheat discovered?
A. An Oregon farmer noticed some wheat plants
growing in his feld that were resistant to glyphosate
and sent the samples to an Oregon State University
scientist. The scientist received the samples on April
30, 2013, and conducted tests on the samples. Based
on the preliminary tests, the samples were positive
for the glyphosate-resistance trait and the farmer
was informed of the testing results. The scientist then
notifed USDA on May 3, 2013 and USDA immediately
launched a thorough investigation, which included
collecting samples where USDA maintained full chain of
custody, giving us additional confdence in our results.
Q: What other steps were taken in the
investigation?
A: APHIS reviewed each of the 158 approvals it issued
between 1994 and 2005 for feld testing in sixteen
states of GE wheat varieties with the trait for resistance
to Roundup.
Montana
Q. What is USDA investigating?
A. APHIS is investigating occurrence of genetically
engineered (GE) wheat that was discovered at a
location where authorized regulated feld trials for GE
wheat occurred from 2000-2003. Upon notifcation of
the incident, APHIS immediately began an investigation
into this potential regulatory compliance issue and
sampled wheat at the location. Testing of samples
by a USDA laboratory confrmed that the wheat is
genetically engineered to resist Roundup. USDA is now
working to determine why GE wheat was found growing
at the research center after the conclusion of the feld
trials. SARC is located in a primarily sugar beet and
barley production area, not a major wheat producing
region.
Q. When did APHIS launch its investigation?
A. The investigation was launched on July 14, 2014.
APHIS also took steps to prevent unauthorized
movement of all wheat from the location.
Q. Why did USDA wait to announce this
investigation?
A. APHIS will generally acknowledge an open
investigation when it will not impact the active
investigation, and we generally will not comment on
open investigation. In this case, APHIS frst worked
to confrm the presence of GE wheat in the samples.
APHIS then had additional genetic testing done to
determine whether the variety of GE wheat found
growing at the research facility in Montana was related
to the variety of GE wheat found growing last year on
a single farm in Oregon. Those test results showed
that the GE wheat detected in Oregon and Montana
are genetically quite different. This suggests that
the GE wheat detected in Oregon appears to be an
isolated incident and the situation in Montana is being
investigated as a separate compliance issue at a
feld trial location. For these reasons, APHIS did not
announce the situation but rather included information
on its investigation as part of its announcement
regarding the close of its investigation into the detection
of GE wheat in Oregon last year.

Q. How is this detection different from the one in
Oregon?
A. Unlike the investigation into the GE wheat in Oregon,
which occurred on a single feld on a single farm, the
detection in Montana occurred at a research facility
where GE wheat was previously grown as part of
APHIS-approved feld trials. The GE wheat varieties
collected from the sites in Oregon and Montana are not
the same, although they do share the same GE wheat
trait. Genetic testing has shown that the varieties of
wheat differ signifcantly from one another. The GE
wheat found in Oregon contained genetic material
from a number of different wheat varieties. The GE
wheat found in Montana is less genetically diverse. This
confrms that the GE wheat detected in Oregon did not
originate from the feld trials conducted in Montana.

Q. How is this detection different from the one in
Oregon?
A. Unlike the investigation into the GE wheat in Oregon,
which occurred on a single feld on a single farm, the
detection in Montana occurred at a research facility
where GE wheat was previously grown as part of
APHIS-approved feld trials. The GE wheat varieties
collected from the sites in Oregon and Montana are not
the same, although they do share the same GE wheat
trait. Genetic testing has shown that the varieties of
wheat differ signifcantly from one another. The GE
wheat found in Oregon contained genetic material from
a number of different wheat varieties. The GE wheat
found in Montana is less genetically diverse and more
similar to known varieties of wheat. This confrms that
the GE wheat detected in Oregon did not originate from
the feld trials conducted in Montana.
Q. Has GE wheat from the facility in Montana
entered commerce?
A. No. GE wheat from the research facility has not
been allowed to enter commercial channels this year.
GE wheat that was grown as part of authorized feld
trials between 2000 and 2003 was not allowed to enter
commercial channels per APHIS requirements for the
feld trials. None of the research facilitys wheat is sold
as seed.
Q. Is APHIS taking any additional steps in response
to the detection of GE wheat in Montana?
A. Yes. As it continues its investigation in Montana,
APHIS is also taking several additional steps to ensure
that unintended GE wheat is not growing in other
locations in the United States where feld trials are
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taking place or have recently occurred. APHIS will
inspect all feld trials planted in 2014, and follow-up with
post-harvest inspections to ensure those conducting
the feld trials adhere to APHIS requirements to monitor
for, and remove, volunteer plants (plants that grow in a
feld following a previous harvest). It will also conduct
some post-harvest volunteer monitoring inspections
of GE wheat feld trials that were planted in 2012 and
2013. Beyond this, APHIS is assessing other measures
such as the requirements it puts in place for feld
tests involving GE wheat, as well as the frequency of its
inspections of feld test sites to minimize the potential
for any further incidents involving GE wheat.