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APHIS Factsheet

Biotechnology Regulatory Services May 2013

Questions and

Answers:USDA InvestigatingDetection ofPositive GeneticallyEngineered (GE)Glyphosate-

Resistant Wheat inOregonQ: Why were the initial samples referred to the

Oregon State University (OSU) scientist?A: An Oregon farmer noticed some volunteers, orplants that had germinated and developed in a placewhere they were not intentionally planted, in hiswheat eld, were resistant to glyphosate and sentthe samples to the OSU scientist. She receivedthe samples on April 30, 2013, and conducted testson the samples. Based on her preliminary tests,

the samples she received tested positive for theglyphosate trait and the farmer was informed of thetesting results.

Q: What did USDA do after being notied by theOregon State University scientist?

A: APHIS was contacted by the Oregon StateUniversity scientist on May 3, 2013, after her testresults from an Oregon farms volunteer plantsindicated the possible presence of the transgenethat conveys resistance to the commonly-usedherbicide glyphosate. APHIS immediately began a

formal investigation into this situation that included,among other things, dispatching investigatorsonsite to investigate how this situation occurred andcollecting additional samples from the farm. Thistesting is extremely complicated and time consuming.APHIS made the public announcement about thisdetection as soon as USDA laboratories had absoluteconrmation regarding the specic GE glyphosate-resistant wheat variety.

Q: Has APHIS ever authorized eld testing of GEwheat in Oregon?

A: APHIS last approved eld trials of glyphosate-resistant GE wheat in Oregon in 2001. There are noAPHIS-authorized glyphosate-resistant GE wheat eldtrials being conducted in Oregon or any neighboringstates at this time.

Q: Are there other states where APHIS has

approved the eld testing of this same glyphosate-resistant GE wheat variety detected in Oregon?Where and when?

A: Yes. APHIS authorized over 100 eld tests withthis specic glyphosate-resistant wheat variety inyears spanning from 1998 through 2005. Field tests

were conducted in Arizona, California, Colorado,Florida, Hawaii, Idaho, Illinois, Kansas, Minnesota,Montana, Nebraska, North Dakota, Oregon, SouthDakota, Washington, and Wyoming.

Q. Has FDA completed an assessment to ensure

the safety of Monsantos GE glyphosate-resistantwheat?

A. Yes. The FDA completed a voluntary consultationon the safety of food and feed derived from this wheatvariety in 2004. For the consultation, the developerprovided information to FDA to support the safetyof this wheat variety. FDA completed the voluntary

consultation with no further questions concerning thesafety of grain and forage derived from this wheat,meaning that this variety of wheat is as safe for foodand feed use as non GE-wheat varieties now on themarket.

FDAs consultation summary, which includes thedevelopers conclusion that this wheat variety is notmaterially different in composition, safety, or any otherrelevant parameter from wheat now grown, marketed,and consumed, can be found here: http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm155777.htm

FDAs 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 byindustry?

A: To our knowledge, GE wheat is not currentlyauthorized for commercial sale or planting in anycountry. We understand that there have been,over the past decade or so, ongoing discussions

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among wheat industry representatives, technologydevelopers, and major users of wheat both in the UnitedStates and overseas about when GE wheat varietiesmight be commercially introduced into the worldwidemarketplace.

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, Oregonproduces predominately soft white wheat and exports90 percent of its wheat production.

Q: Is this GE wheat present in commerce?

A: At this time, we have no information that thisGE glyphosate-resistant wheat variety has enteredcommerce. There is no public health concern. Ourfocus is on our ongoing investigation.

Q: What do you think the worldwide impact of thisnding will be?

A: We dont wish to speculate on market reaction. Asboth a leading producer and consumer of wheat, theUnited States is directly aware of the concerns thatan event like this could raise in the food/feed supplychain, from seed producers and farmers to retailers andconsumers. We are working hard to reassure domesticand global wheat consumers that this development,although unwelcome, does not pose a risk to foodsafety.

Q: Might GE wheat be in U.S. food aid shipments?A: Foods exported commercially or as food aid bythe United States are the same foods consumedby Americans every day. This is the case with allcommodities, including wheat. This development doesnot 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 498,000tons of wheat as food aid with an estimated valuebetween $180 -$200 million.

Q: What does APHIS investigative process entail?

A: APHIS may refer potential situations to itsInvestigative and Enforcement Services (IES) stafffor further investigation. APHIS has done so in thisinstance and an onsite investigation has been initiated.APHIS also works closely with State Departments ofAgriculture and other federal agencies, including theFood and Drug Administration, the EnvironmentalProtection Agency and the Department of Justice,

to ensure compliance with APHIS regulations. ThePlant Protection Act provides for substantial penaltiesfor serious infractions, including civil penalties up to$1,000,000 and the possibility of criminal prosecution.APHIS has a Memorandum of Understanding withUSDAs Agricultural Marketing Service and GrainInspection, Packers and Stockyards Administration

for those agencies to provide technical sampling andtesting expertise, when needed to support an APHISinvestigation.

Q: What did USDA test as part of its investigation?A: At this time, USDA has tested DNA extracted fromtissue from wheat plants collected in the eld by APHISinvestigators; seeds or kernels of suspect wheat are notavailable 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 investigationwill depend on the outcome of tests currently underway.

Q: What tests are available to detect this event? Arethese commercially available?

A: The polymerase chain reaction (PCR) test, whichdetects the DNA of the GE event, is used to detectit. The PCR test is a highly sensitive test that must beconducted by a competent laboratory with a validatedmethod. Currently, there are no commercially availablerapid tests validated for detecting the glyphosate-resistant trait in wheat. At APHIS request, GIPSA iscurrently 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 Oregonfarmer in this situation?

A: We have no reason to believe at this time thatthe farmer who reported the presence of glyphosate-resistant GE wheat volunteers in his eld has committedany infraction.

Q: If APHIS were to detect GE glyphosate-resistantwheat in commercial seed and grain, what would

APHIS next steps be?A: In instances when there are detections of low levelsof regulated GE plant material in commercial seeds andgrain, APHIS will initiate an inquiry to determine thecircumstances surrounding the release, evaluate therisk, and determine what regulatory actions includingremedial and enforcement actions, are required.This is the basis for APHIS low level presence (LLP)policy, which APHIS claried in March 2007. If APHISdetermines that an incident involving regulated GE

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plant material could pose a risk to plant health or theenvironment, APHIS will take appropriate remedial stepsusing its authority under the Plant Protection Act. Incases in which APHIS determines that remedial actionis not necessary to mitigate LLP of regulated GE plantmaterial to protect plant health and the environment,APHIS is not precluded from taking enforcement actionagainst a company or individual for violations of APHISregulations. Based on the FDA consultation that wascompleted on this particular variety of wheat in 2004,APHIS would not take remedial steps to remove LLP ofthis variety from the food supply, as FDA concluded thatthere is no food safety concern. More information aboutAPHIS LLP policy can be found at the following linkhttp://www.aphis.usda.gov/publications/biotechnology/content/printable_version/fs_llppolicy3-2007.pdf

Q: How does APHIS authorize the eld testing of GEorganisms?

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

and notication.

Permits - Permits can be used for any GE organismand are required for plants that do not meet thespecial requirements that would allow testingunder the more-streamlined notication procedure.Permittees must follow permit conditions speciedin the regulations plus additional conditions whichare tailored specically for their permit.

Notications - The notication procedure is anexpedited authorization process that can be usedonly for GE plants which qualify based on criteria in

APHIS regulations. Review and acknowledgementof a notication takes 30 days after receipt. Theresponsible party who signs the notication letteragrees to meet performance standards speciedin the regulations designed to prevent spread andestablishment of potential plant pests.

Q: Has APHIS conducted verication tests?A: Yes. APHIS collaborates with USDAs AgriculturalMarketing Service (AMS) and Grain Inspection,Packers and Stockyards Administration (GIPSA) totest samples to detect specic genetic sequences ora protein expressed by the plant. AMS and GIPSA

have nationally and internationally recognized technicalexpertise in commodity sampling, handling and testing.

Q. How are GE products regulated?A. USDA, along with the FDA and EPA, is part of theCoordinated Framework for Regulation of Biotechnologywhich describes the Federal system for regulating thesafe use of genetically engineered organisms.

USDA is an equal opportunity provider and employer.

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

FDA has primary responsibility for ensuring thesafety of human food and animal feed, as well as safetyof all plant-derived foods and feeds. EPA regulatespesticides, including plants with plant-incorporatedprotectants (pesticides intended to be produced andused in a living plant), to ensure public safety. Thatagency also regulates pesticide residue on food andanimal feed. APHIS regulates the introduction of certainGE organisms that may pose a risk to plant health.