Source: INFINITE EVERSOLE-SPECIALTY CROP SERVICES, LLC submitted to NRP
SPECIALTY CROP REGULATORY ASSISTANCE WORKSHOP: NUTS AND BOLTS OF U.S. REGULATORY DOSSIERS FOR GENETICALLY ENGINEERED CROPS
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
ACTIVE
Funding Source
OTHER GRANTS
Reporting Frequency
Annual
Accession No.
1033242
Grant No.
2024-33522-43693
Cumulative Award Amt.
$23,800.00
Proposal No.
2024-03786
Multistate No.
(N/A)
Project Start Date
Sep 1, 2024
Project End Date
Aug 31, 2026
Grant Year
2024
Program Code
[HX]- Biotechnology Risk Assessment
Recipient Organization
INFINITE EVERSOLE-SPECIALTY CROP SERVICES, LLC
826 SHERWOOD OAKS LN
JONESBORO,AR 72404
Performing Department
(N/A)
Non Technical Summary
The Specialty Crop Regulatory Assistance (SCRA) initiative is a collaborative program aimed at assisting public and privatesector developers of biotechnology-derived or Genetically Engineered speacialty crops in their efforts to complete the U.S.regulatory process for commercialization. A two-day virtual conference/workshop will be held to focus on practical aspects ofenhancing knowledge of the regulatory process for developing dossiers for submission to U.S. regulatory agencies.
Animal Health Component
(N/A)
Research Effort Categories
Basic
(N/A)
Applied
(N/A)
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
90324103030100%
Knowledge Area
903 - Communication, Education, and Information Delivery;

Subject Of Investigation
2410 - Cross-commodity research--multiple crops;

Field Of Science
3030 - Information and communication;
Goals / Objectives
The main goal of the workshop is to enhance understanding among participants about the U.S. regulatory system to facilitate timely, efficient, and effective regulatory filings by small, GE crop developers.
Project Methods
In addition to the Project Director and Co-Project Director, the steering committee of the workshop will include Kellye Eversole (Chief Science and Technology Officer for IE-SCS and Executive Director of the SCRA), Subray Hegde (USDA-APHIS), Mike Mendelsohn (US-EPA), Jason Dietz (US-FDA), and Chris Dardick (USDA-ARS). The steering committee will work together to plan a two-day virtual conference/workshop focused on the practical aspects of the regulatory process for preparing dossiers on GE specialty crops for submission to U.S. regulatory agencies. This workshop is designed to simplify and demystify data requirements and regulatory dossier development for small companies, academics, and other potential developers.This committee will identify the Case Study topics to be presented by the appropriate person identified by the crop or trait developer. The invited speakers giving the regulatory responses will be the working U.S. regulatory officials who specialize in the subject matter presented and conduct the review of submissions seeking approvals in advance of prospective commercial release and developers of GE crops. Each of the three regulatory agencies and ARS will support us again for the SCRA workshop VI. Other workshop topics will include: case studies on multiple edit events, non-agronomic traits, GE microbes, and genome edited plants; Presentations on any new exemption rules and more on international regulations. Speakers for these sessions will be experts in their respective field and invited by members of the steering committee.

Progress 09/01/25 to 02/28/26

Outputs
Target Audience:Once the Organizing committee was confirmed the target audience moved to potential case studies and speakers. All case study speakers were issued invites via email. Six months following the initial invites, we secured speakers to fill the agenda. We also working withthe 3 regulatory agencies to identify the appropriate representative to provide agency responses to the case studies. Changes/Problems:Two weeks before the scheduled tech checks, the government shutdown and the Steering Committee recommended that we temporarily postpone the conference. Communication with the U.S. regulatory agencies were very limited durining this time and they were uable to participate or communicate. The agency official's participation in the workshop is critical, so we have worked with them to ensure they are available. At their request, we are considering late March or late April 2026 for the rescheduled dates. We have submitted a formal request for the grant to be extended at no cost. What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?We will continue to work toward a finalized agenda and confirm session moderators. These will be members of the Steering Committee.Once finalized the focus will turn to promotion to increase registration. In the six weeks leading up to the planned workshop, we averaged approximately 1-2 registrations per week. We will also begin scheduling tech checks with all session chairs and speakers.

Impacts
What was accomplished under these goals? The Organizing Committee held several calls during this reporting perod for the purpose of identifying case studies and other topics to be presented at the workshop. Three case studies were identified for invitations and all three have been confirmed to date. Several other subject matter speakers were invited/accepted.

Publications


    Progress 09/01/24 to 08/31/25

    Outputs
    Target Audience:The Target Audience for this workshop is public and private sector developeers of biotechnology-derived or Genetically Engineered specialty crops. This includes small companies, academia, and other potential developers. During the initial reporting period, the main audience reached is that of the U.S. regulatory agencies. Each agency is represented on the workshop organizing committee. We've held one call with this committee to begin planning the workshop and to get ideas from the regulators. August 1 - report Once the Organizing committee was confirmed the target audience moved to potential case studies and speakers. Two of three case studies and several other speakers are confirmed to date. We are getting close to a final agenda. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?Based on the input received from the organizing committe, we will begin to put a draft agenda together. August update: the next reporting period will focus on confirming all speakers, finalizing the agenda, and lots of promotion to support registrations. We are getting aobut 1-2 registrations per week. We will also schedule tech checks will all sessions chairs and speakers.

    Impacts
    What was accomplished under these goals? We have held one virtual call with the organizing committee of the workshop to begin discussing ideas for possible topics, case studies, and speakers. August 2025 update: We have held two additional organizing committee meetings with the main focus of identifying and inviting case study presenters and other speakers. We have confirmed 2 of the 3 case studies and invitations have been issued to all other submect matter speakers. We are only a few speaker confirmations away from having a final agenda.

    Publications