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

Mon Dec 14 10:15:09 EST 2015

All:

As far as I am aware, barley is not affected. The reason for the changed status of wheat is that there have been two recent incidents where "wild" wheat transgenics were found. In the attached document, these incidents are described and also there is discussion of how dormancy in wheat may have contributed to these incidents. This discussion suggests to me that APHIS is considering wheat to be different in this respect than barley or other cereals.

HOWEVER, all it will take is one case of a transgenic barley escape to change this situation. All of us working with transgenics must be diligent not only with field releases but with our greenhouse and seed lab and storage facilities with respect to having established, robust procedures for preventing accidental releases into the environment.

I have not looked into the changes in field release conditions that will be part of the permitting process for wheat, but given the focus on dormancy and the potential for volunteers over a longer period of time, I suspect that there may be aspects of the monitoring process that could significantly impact rotations and land use where transgenic wheat has been grown.

Phil Bregitzer
USDA-ARS
National Small Grains Germplasm Research Facility
1691 S. 2700 W.
Aberdeen, ID 83210
208-397-4162 ext. 116

From: fhb-bounces at scabusa.org [mailto:fhb-bounces at scabusa.org] On Behalf Of Sue Canty, USWBSI-NFO
Sent: Monday, December 14, 2015 6:14 AM
To: fhb at scabusa.org
Subject: [FHB] Changes to USDA-APHIS Biotechnology Regulatory Services (BRS) approvals for the environmental release of transgenic wheat.

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<https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology/sa_permits_notifications_and_petitions/ct_submissions_home/%21ut/p/a1/vZJLc4IwFIV_SxcsMdcoAt35aH23znQchQ0DIUAcSDCJtf77Rrrr-Oqm2d3cc5KbLweFaItCHn-yPNZM8Lg812Evmr1PcHsAeDoevwxg-va6WLnzGQbsGEFwQzB3HvMPx_1J110AQNfDMB0NJiPXXwJMe4_54crqwz3_BoUoJFzXukBBXBdMRURwTbmOSpbIWJ4sUHEkDjLKBDkoCxImNCUFF6XIf5o1lRXTKuJCs4yRhp2KYp6ajmZNZQHRkTokFVOq6Raiouera8JSFHSxD37iYNslPra7xKW25_jETlOPum2SpbSH0ewBFlguh8vcHBvrwmY8E2j72IBoe2lAcyLb7fdh3zA6U_nSaPvfkJofupOxRnArRI3gRkoM27wUSZP4oM-TjmcgSppRSWXrIM12oXWtni2w4Hg8tnIh8pK2iKguGQqhDKhfusAk1b36CjPkxx_zUFfr9bryOk65O3WAraqNpz04Pn0DRjZR6g%21%21/?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fbiotechnology%2Fsa_permits_notifications_and_petitions%2Fsa_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<https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology/sa_permits_notifications_and_petitions/ct_submissions_home/%21ut/p/a1/vZJLc4IwFIV_SxcsMdcoAt35aH23znQchQ0DIUAcSDCJtf77Rrrr-Oqm2d3cc5KbLweFaItCHn-yPNZM8Lg812Evmr1PcHsAeDoevwxg-va6WLnzGQbsGEFwQzB3HvMPx_1J110AQNfDMB0NJiPXXwJMe4_54crqwz3_BoUoJFzXukBBXBdMRURwTbmOSpbIWJ4sUHEkDjLKBDkoCxImNCUFF6XIf5o1lRXTKuJCs4yRhp2KYp6ajmZNZQHRkTokFVOq6Raiouera8JSFHSxD37iYNslPra7xKW25_jETlOPum2SpbSH0ewBFlguh8vcHBvrwmY8E2j72IBoe2lAcyLb7fdh3zA6U_nSaPvfkJofupOxRnArRI3gRkoM27wUSZP4oM-TjmcgSppRSWXrIM12oXWtni2w4Hg8tnIh8pK2iKguGQqhDKhfusAk1b36CjPkxx_zUFfr9bryOk65O3WAraqNpz04Pn0DRjZR6g%21%21/?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fbiotechnology%2Fsa_permits_notifications_and_petitions%2Fsa_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<http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUxMjExLjUyNjM0NDIxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MTIxMS41MjYzNDQyMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NTQ0ODY3JmVtYWlsaWQ9cnV0aGRtQHVtbi5lZHUmdXNlcmlkPXJ1dGhkbUB1bW4uZWR1JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&102&&&https://www.aphis.usda.gov/biotechnology/downloads/wheat_permit_change.pdf>.

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