APHIS Factsheet

Biotechnology Regulatory Services May 2013

Questions and 

Answers:

USDA Investigating 

Detection of 

Positive Genetically 

Engineered (GE) 

GlyphosateResistant Wheat in 

Oregon

Q: Why were the initial samples referred to the 

Oregon State University (OSU) scientist?

A: An Oregon farmer noticed some volunteers, or 

plants that had germinated and developed in a place 

where they were not intentionally planted, in his 

wheat field, were resistant to glyphosate and sent 

the samples to the OSU scientist. She received 

the samples on April 30, 2013, and conducted tests 

on the samples. Based on her preliminary tests, 

the samples she received tested positive for the 

glyphosate trait and the farmer was informed of the 

testing results.

Q: What did USDA do after being notified by the 

Oregon State University scientist? 

A: APHIS was contacted by the Oregon State 

University scientist on May 3, 2013, after her test 

results from an Oregon farm’s volunteer plants 

indicated the possible presence of the transgene 

that conveys resistance to the commonly-used 

herbicide glyphosate. APHIS immediately began a 

formal investigation into this situation that included, 

among other things, dispatching investigators 

onsite to investigate how this situation occurred and 

collecting additional samples from the farm. This 

testing is extremely complicated and time consuming. 

APHIS made the public announcement about this 

detection as soon as USDA laboratories had absolute 

confirmation regarding the specific GE glyphosateresistant wheat variety. 

Q: Has APHIS ever authorized field testing of GE 

wheat in Oregon?

A: APHIS last approved field trials of glyphosateresistant GE wheat in Oregon in 2001. There are no 

APHIS-authorized glyphosate-resistant GE wheat field 

trials being conducted in Oregon or any neighboring 

states at this time. 

Q: Are there other states where APHIS has 

approved the field testing of this same glyphosateresistant GE wheat variety detected in Oregon? 

Where and when?

A: Yes. APHIS authorized over 100 field tests with 

this specific glyphosate-resistant wheat variety in 

years spanning from 1998 through 2005. Field tests 

were conducted in Arizona, California, Colorado, 

Florida, Hawaii, Idaho, Illinois, Kansas, Minnesota, 

Montana, Nebraska, North Dakota, Oregon, South 

Dakota, Washington, and Wyoming.

Q. Has FDA completed an assessment to ensure 

the safety of Monsanto’s GE glyphosate-resistant 

wheat?

A. Yes. The FDA completed a voluntary consultation 

on the safety of food and feed derived from this wheat 

variety in 2004. For the consultation, the developer 

provided information to FDA to support the safety 

of this wheat variety. FDA completed the voluntary 

consultation with no further questions concerning the 

safety of grain and forage derived from this wheat, 

meaning that this variety of wheat is as safe for food 

and feed use as non GE-wheat varieties now on the 

market.

 FDA’s consultation summary, which includes the 

developer’s conclusion that “this wheat variety is not 

materially different in composition, safety, or any other 

relevant parameter from wheat now grown, marketed, 

and consumed,” can be found here: http://www.fda.

gov/Food/FoodScienceResearch/Biotechnology/

Submissions/ucm155777.htm 

 FDA’s letter to the developer can be seen at: 

http://www.fda.gov/Food/FoodScienceResearch/

Biotechnology/Submissions/ucm155752.htm

Q. What is the status of GE wheat production by 

industry?

A: To our knowledge, GE wheat is not currently 

authorized for commercial sale or planting in any 

country. We understand that there have been, over 
the past decade or so, ongoing discussions among 

wheat industry representatives, technology developers, 

and major users of wheat both in the United States 

and overseas about when GE wheat varieties might 

be commercially introduced into the worldwide 

marketplace. 

Q: Does the U.S. export wheat from Oregon? 

A: Yes. According to Oregon Wheat Commission, 

Oregon exports 90 percent of its wheat production. 

Q: What type of wheat is exported from Oregon?

A: According to Oregon Wheat Commission, Oregon 

produces predominately soft white wheat and exports 

90 percent of its wheat production. 

Q: Is this GE wheat present in commerce?

A: At this time, we have no information that this 

GE glyphosate-resistant wheat variety has entered 

commerce. There is no public health concern. Our 

focus is on our ongoing investigation.

Q: What is USDA doing to assure foreign buyers?

A: As a leading producer and consumer of wheat, 

the United States is keenly aware of the concerns a 

development like this could raise among our trading 

partners and we are working to assure our partners of 

the safety of the product in question, the thoroughness 

of our ongoing investigation and respond to any 

question they may have. Once the GE plant tissue 

was confirmed, USDA officers overseas met directly 

with appropriate government officials in key markets 

to inform them of this issue. USDA will continue to 

update our trading partners on the progress of the 

investigation, and will continue to work closely with our 

trading partners to ensure continued market access for 

U.S wheat.

Q: What are the measures taken by USDA to make 

sure there was no GE wheat exported? 

A: At this time, we have no information that this wheat 

variety has entered commerce. A thorough investigation 

is ongoing to determine how this situation occurred. 

Currently, there is no commercially available rapid 

validated for wheat. USDA GIPSA is working toward 

making available appropriate and validated testing 

techniques to address market needs that may develop. 

Q: What actions have been taken by other countries 

since this announcement?

A: Japan is temporarily suspending import tenders for 

western white wheat for food and western wheat for 

feed. Korea announced that it will test upon arrival 

all wheat and wheat flour from the United States. EU 

advised its Member States to test consignments of US 

soft white wheat.

Q: What do you think the worldwide impact of this 

finding will be?

A: We don’t wish to speculate on market reaction. As 

both a leading producer and consumer of wheat, the 

United States is directly aware of the concerns that 

an event like this could raise in the food/feed supply 

chain, from seed producers and farmers to retailers and 

consumers. We are working hard to reassure domestic 

and global wheat consumers that this development, 

although unwelcome, does not pose a risk to food 

safety. 

Q: Might GE wheat be in U.S. food aid shipments?

A: Foods exported commercially or as food aid by 

the United States are the same foods consumed 

by Americans every day. This is the case with all 

commodities, including wheat. This development does 

not compromise our ability to provide recipients of U.S. 

food aid with healthy, wholesome, and nutritious foods. 

For the 2012/13 marketing year (June 2012-May2013), 

USDA and USAID have provided an estimated 498,000 

tons of wheat as food aid with an estimated value 

between $180 -$200 million. 

Q: What does APHIS’ investigative process entail?

A: APHIS may refer potential situations to its 

Investigative and Enforcement Services (IES) staff 

for further investigation. APHIS has done so in this 

instance and an onsite investigation has been initiated. 

APHIS also works closely with State Departments of 

Agriculture and other federal agencies, including the 

Food and Drug Administration, the Environmental 

Protection Agency and the Department of Justice, 

to ensure compliance with APHIS regulations. The 

Plant Protection Act provides for substantial penalties 

for serious infractions, including civil penalties up to 

$1,000,000 and the possibility of criminal prosecution. 

APHIS has a Memorandum of Understanding with 

USDA’s Agricultural Marketing Service and Grain 

Inspection, Packers and Stockyards Administration 

for those agencies to provide technical sampling and 

testing expertise, when needed to support an APHIS 

investigation. 

Q: What did USDA test as part of its investigation?

A: At this time, USDA has tested DNA extracted from 

tissue from wheat plants collected in the field by APHIS 

investigators; seeds or kernels of suspect wheat are not 

available at this time. 

Q: Are there plans to expand the testing for this 

event?

A: USDA is conducting the investigation in a step-wise 

approach. Any additional testing for the investigation 

will depend on the outcome of tests currently underway.
Q: What tests are available to detect this event? Are 

these commercially available?

A: The polymerase chain reaction (PCR) test, which 

detects the DNA of the GE event, is used to detect 

it. The PCR test is a highly sensitive test that must be 

conducted by a competent laboratory with a validated 

method. Currently, there are no commercially available 

rapid tests validated for detecting the glyphosateresistant trait in wheat. At APHIS’ request, GIPSA is 

currently evaluating whether rapid tests validated for 

detecting the trait in other grains can do so in wheat. 

Q: Will APHIS take any action against the Oregon 

farmer in this situation?

A: We have no reason to believe at this time that 

the farmer who reported the presence of glyphosateresistant GE wheat volunteers in his field has committed 

any infraction.

Q: If APHIS were to detect GE glyphosate-resistant 

wheat in commercial seed and grain, what would 

APHIS’ next steps be? 

A: In instances when there are detections of low levels 

of regulated GE plant material in commercial seeds and 

grain, APHIS will initiate an inquiry to determine the 

circumstances surrounding the release, evaluate the 

risk, and determine what regulatory actions including 

remedial and enforcement actions, are required. 

This is the basis for APHIS’ low level presence (LLP) 

policy, which APHIS clarified in March 2007. If APHIS 

determines that an incident involving regulated GE 

plant material could pose a risk to plant health or the 

environment, APHIS will take appropriate remedial steps 

using its authority under the Plant Protection Act. In 

cases in which APHIS determines that remedial action 

is not necessary to mitigate LLP of regulated GE plant 

material to protect plant health and the environment, 

APHIS is not precluded from taking enforcement action 

against a company or individual for violations of APHIS 

regulations. Based on the FDA consultation that was 

completed on this particular variety of wheat in 2004, 

APHIS would not take remedial steps to remove LLP of 

this variety from the food supply, as FDA concluded that 

there is no food safety concern. More information about 

APHIS’ LLP policy can be found at the following link 

http://www.aphis.usda.gov/publications/biotechnology/

content/printable_version/fs_llppolicy3-2007.pdf

Q: How does APHIS authorize the field testing of GE 

organisms?

A: APHIS has two methods that can be used: permit 

and notification.

USDA is an equal opportunity provider and employer.

United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture

•	 Permits - Permits can be used for any GE organism 

and are required for plants that do not meet the 

special requirements that would allow testing 

under the more-streamlined notification procedure. 

Permittees must follow permit conditions specified 

in the regulations plus additional conditions which 

are tailored specifically for their permit.

•	 Notifications - The notification procedure is an 

expedited authorization process that can be used 

only for GE plants which qualify based on criteria in 

APHIS’ regulations. Review and acknowledgement 

of a notification takes 30 days after receipt. The 

responsible party who signs the notification letter 

agrees to meet performance standards specified 

in the regulations designed to prevent spread and 

establishment of potential plant pests.

 

Q: Has APHIS conducted verification tests? 

A: Yes. APHIS collaborates with USDA’s Agricultural 

Marketing Service (AMS) and Grain Inspection, 

Packers and Stockyards Administration (GIPSA) to 

test samples to detect specific genetic sequences or 

a protein expressed by the plant. AMS and GIPSA 

have nationally and internationally recognized technical 

expertise in commodity sampling, handling and testing. 

Q. How are GE products regulated? 

A. USDA, along with the FDA and EPA, is part of the 

Coordinated Framework for Regulation of Biotechnology 

which describes the Federal system for regulating the 

safe use of genetically engineered organisms.

 FDA has primary responsibility for ensuring the 

safety of human food and animal feed, as well as safety 

of all plant-derived foods and feeds. EPA regulates 

pesticides, including plants with plant-incorporated 

protectants (pesticides intended to be produced and 

used in a living plant), to ensure public safety. That 

agency also regulates pesticide residue on food and 

animal feed. APHIS regulates the introduction of certain 

GE organisms that may pose a risk to plant health.