[FHB] Changes to USDA-APHIS Biotechnology Regulatory Services (BRS) approvals for the environmental release of transgenic wheat.

Mon Dec 14 08:13:51 EST 2015

USWBSI researchers working with wheat transformation should be aware that
the approval process for the environmental release (field planting) of
transgenic wheat have recently changed.

We understand that notifications** will no longer be accepted by BRS and
that a permit* will be required.

As the permitting process will take more time USWBSI members should plan
accordingly for the 2016 field season.

While we know this change applies to wheat, researchers working with barley
are advised to check with BRS in case the regulations for barley have also
changed.

*Permits
APHIS issues permits for the introduction of GE organisms that pose a plant
pest risk, including plants, insects, or microbes.  All regulated GE
organisms are eligible for the permitting procedure.  Applicants include
scientific information for APHIS to review before APHIS issues the permit.

**Notifications
Notification is an administratively-streamlined alternative to a permit.
The GE plant must meet specified eligibility criteria, and the introduction
must meet certain pre-defined performance standards.

Begin forwarded message:

From: "APHIS Biotechnology Regulatory Services"
<APHISBRS at subscribers.usda.gov <mailto:APHISBRS at subscribers.usda.gov> >

Subject: USDA Decision on GE Wheat Trials

Date: December 11, 2015 at 1:01:50 PM CST

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Dear BRS Stakeholder, 

On September 25, 2015, the U.S. Department of Agriculture's (USDA) Animal
and Plant Health Inspection Service (APHIS) published in the Federal
Register a notice of request for comments on changes to requirements for
field testing genetically engineered (GE) wheat. The comment period closed
on October 26, 2015. USDA is announcing today its decision to require
developers to apply for a permit for field trials involving GE wheat,
beginning with GE wheat planted on or after January 1, 2016.

The decision to require growers to plant GE wheat under the more stringent
permit process rather than the notification process employed in the past,
will provide added protection that GE wheat will not persist in the
environment after field trials are concluded, and will remain confined
during the trials. APHIS regulations at 7 CFR part 340 specify that in order
to be eligible for notification, a field trial must be conducted so the
regulated article does not persist in the environment and no offspring are
produced that could persist in the environment. In addition, when the field
trial ends, no viable material shall remain which is likely to volunteer
(grow following the harvest of a crop) in subsequent seasons. Bringing GE
wheat under permit enables APHIS to create and enforce permit conditions
that minimize the likelihood that the regulated GE wheat will spread or
persist in the environment. APHIS already requires permits for many GE
organisms, including all trees, perennial grasses and sorghum. 

This action also strengthens the United States wheat export system. The
permit reporting requirements help prevent possible unintended mixing with
non-GE wheat that can have negative effects on trade, and reassures
international trading partners that the U.S. is committed to being the
world's reliable supplier of grain. 

More information regarding this decision is available at the following URL:
https://www.aphis.usda.gov/biotechnology/downloads/wheat_permit_change.pdf
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