Presented at The Northeast Center to Advance Food Safety (NECAFS) Annual Meeting January 10, 2017 Boston, MA

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1 State and Territory Cooperative Agreement to Enhance Produce Safety in Preparation of Implementation of FDA's Rule: Standards for the Growing, Harvesting, Packing, & Holding of Produce for Human Consumption Presented at The Northeast Center to Advance Food Safety (NECAFS) Annual Meeting January 10, 2017 Boston, MA 1

2 CAP Start date (1 st budget cycle) Sept. 5, 2016 o State Produce Implementation Cooperative Agreement Program (CAP) homepage portunities/grantscoopagrmts/ucm htm 2

3 Kick Off Call Oct. 18, 2016 o Presentation can be viewed on the FDA Produce Safety Cooperative Agreement Programs FoodShield Workgroup page at: Highlights: Roles of OAGS, Office of Partnerships Project Officers, and NASDA Overview of funding restrictions and prior approval activities Programmatic overview Produce Safety Network overview 3

4 IT Farm Inventory webinar Nov. 30, 2016 o Recording can be viewed on the FDA Produce Safety Cooperative Agreement Programs FoodShield Workgroup page at: ordings Highlights: Grantee roles in developing farm inventory/it development Assess existing resources and capabilities and determine data sources, mechanisms and systems the state will utilize to establish and maintain a produce farm inventory FDA plans to assist in farm inventory/it development Exploring purchase of data by Summer main groups of data elements developed by FDA-NASDA Farm Inventory Subgroup; draft data elements shared in FoodShield FDA s IT system development is long term goal; short term, states to maintain and share inventory data in excel format or states current system (xml, csv) States could choose to modify their existing system Data security is per record owning agency s access controls 4

5 Strategic Planning webinar Dec. 14, 2016 o Recording can be viewed on the FDA Produce Safety Cooperative Agreement Programs FoodShield Workgroup page at: cordings Highlights: FDA provided recommended template for consistency in the format of state plans (Instructions and recommended template shared on FoodShield) NASDA is soliciting States to serve as subgroup leads and members; subgroup objectives and deliverables will align with Cooperative Agreement objectives and the NASDA Produce Safety Implementation Framework Collaborative FoodShield page announced For this Cooperative Agreement only, mid-year reports will be waived for this budget cycle only Annual reports due by May 1,

6 Programmatic Administrative (OP/CGS) Project Officer Contact Info Alicia Schroder, Lead Project Officer Denise Beuttenmuller, Project Officer Graham Giesen, Project Officer Doreen Gubbay, Project Officer

7 Awardees & Project Officer Assignments Aw ardee PSN Region OP Project Officer AK Western Graham Giesen AL Southern Denise Beuttenmuller AR Southern Denise Beuttenmuller AZ Western Graham Giesen CA Western Graham Giesen CO Western Graham Giesen CT Northeast Doreen Gubbay DE Northeast Doreen Gubbay FL Southern Denise Beuttenmuller GA Southern Denise Beuttenmuller HI Western Non-Grantee State IA North Central Alicia Schroder ID Western Graham Giesen IL North Central Non-Grantee State IN North Central Alicia Schroder KS North Central Alicia Schroder KY Southern Non-Grantee State Aw ardee PSN Region OP Project Officer LA Southern Denise Beuttenmuller MA Northeast Doreen Gubbay MD Northeast Doreen Gubbay ME Northeast Doreen Gubbay MI North Central Alicia Schroder MN North Central Alicia Schroder MO North Central Non-Grantee State MS Southern Non-Grantee State MT Western Graham Giesen NC Southern Denise Beuttenmuller ND North Central Non-Grantee State NE North Central Alicia Schroder NH Northeast Doreen Gubbay NJ Northeast Doreen Gubbay NM Western Graham Giesen NV Western Graham Giesen NY Northeast Doreen Gubbay Aw ardee PSN Region OP Project Officer OH North Central Alicia Schroder OK Southern Denise Beuttenmuller OR Western Graham Giesen PA Northeast Doreen Gubbay Puerto Rico Southern Non-Grantee State RI Northeast Doreen Gubbay SC Southern Denise Beuttenmuller SD North Central Non-Grantee State TN Southern Denise Beuttenmuller TX Southern Denise Beuttenmuller UT Western Graham Giesen VA Southern Denise Beuttenmuller VT Northeast Doreen Gubbay WA Western Graham Giesen WI North Central Alicia Schroder WV Northeast Doreen Gubbay WY Western Non-Grantee State

8

9 NASDA's Role in Assisting with the State Produce Safety Cooperative Agreements Continue working with States to plan/develop/implement all 11 focus areas outlined in the Model Produce Safety Implementation Framework Play a leadership role in the National Consortium for Produce Safety Program Development Work with States and FDA to build State Produce Safety Programs that are nationally aligned and consistent Support States and Extensions as they develop and deliver On-Farm Advisory Review tools and resources, with the goal of offering proactive assistance to farmers as they plan for implementation of the Produce Safety Rule 9

10 Proposed NASDA Plan for Coordination and Sharing of Work Between States Working subgroups will be established for each of the six broad objectives outlined in PAR Each state will be a lead and/or a participant in a minimum of 2 and up to 5 of the subgroups Each subgroup will develop a charge to guide their work, with objectives/deliverables and due dates, to be approved by Consortium leadership. Work products from each subgroup will be shared with all other states/territories via a secure website or share drive. The NASDA Model Produce Safety Implementation Framework will serve as a guide for the work done by each subgroup 10

11 FoodShield Overview The FDA Produce Safety Cooperative Agreement Program (CAP) FoodSHIELD Workgroup was developed and is administratively hosted by the FDA Office of Partnerships (OP) Produce Safety Team Developed to support collaboration of work between the two Produce Safety Cooperative Agreements (State CAP & NASDA CAP) Provides a central location for all relevant parties to collaborate, host meetings, share documents and other important information Within the main page, there are several Teams (private workgroups) Teams provide workspaces for select members of the parent workgroup to collaborate on specific projects (ie NASDA subgroups) 11

12 Question Will there be flexibility on the 10% re-budgeting Q&A Sharing Answer The 10% is not flexible. However, we understand the need for revisions and changes. Approval of requests is expected, not assumed. Due to the 10 month budget period for year one, is the FDA expecting carry Yes, carry over is expected in year one; however, we would not expect a large amount of states to have carry over in year two over from states Can a subawardee subaward funds? It can be done, however, it is not recommended due to the loss of control over the funds by the grantee. Additionally, we support a competitive bidding process for subawards. Is the PSA Grower training appropriate for the State grantee and/or regulator It would be appropriate for a grantee and/or regulator to attend a PSA Grower Training. Attendance may help grantees understand audience at this point in the State Produce Cooperative Agreement? the scope of the Produce Safety Rule, which may be helpful as they undertake the objectives in the Cooperative Agreement Program, such as outreach to industry stakeholders. However, there are two things to note: The PSA Grower Training is focused on industry stakeholders, but is currently slated to be a pre-requisite for the produce regulator curriculum that is under development. Regulator training is a Year 2 objective for Competition B and ORA/DHRD has not completed development of the Produce Safety Regulator curriculum. What data and fields will be needed for the Farm Inventory and when will that be available? Do state regulators require specific training courses? Is FDA certifying growers subject to PSR? A draft of the data elements were discussed on the IT Webinar 11/30/2016. The document can be found on FoodShield in "Documents" Yes. Specfics are still being developed. See FSMA Training Strategy FDA is not providing a certification that growers are subject to the rule; the Agency outlines those who are subject to the rule in Subpart A of the Final Rule 21 CFR Part 112. If a grower is self-certifying and will subsequesntly be incorporated into the farm inventory, you are required to verify and update farm inventory information, prioritizing farms covered by the regulation. Can a grantee can rent a truck rather than lease a car? The type of vehicle does not matter, as long as it is justified. Can a grantee use existing facility to house additional personnel rather than Once budget changes reach 10%, a formal budget change must be requested. leasing a facility as originally planned and budgeted? What paperwork is required for this? We included leasing office space in our grant proposal but have found some Operational expenses fall under indirect costs. space in one of our currently operated buildings. Can we use grant funds to pay for operational expenses for the space used (e.g., electricity, water, phone, etc.)? Our State does not have the capability of leasing all-terrain vehicles (ATV) leasing or renting vehicles is allowable; ATV is a vehicle, and vehicle purchase is not an allowable cost. However, if another and trailers, only to purchase. Is there a way to use grant funds to purchase Agency, or even a grower, has ATVs, then you can use CAP funds to reimburse for vehicle use; vehicle repair. Fuel and this equipment? Which would the following fall under: 1) fuels, 2) vehicle maintenance are considered supplies (allowable); expenses related to tracking driving habits seems to benefit the Dept. as a repair & maintenance 3)tool to track vehicle location and driving habits? whole, does not appear to be needed to complete the goals of the grant, would not approve as a cost. Are there specific forms or a specific template for issuing sub-awards? Is an Extension able to directly apply for the FDA grant for Competition A without going through our State Department of Agriculture? Do contractors under the grantee have to register in SAM? There is not a specific form or template required by FDA for awarding sub-awards. In general, the only eligible entities are state/territory government food agencies with actual or potential regulatory oversight and responsibility over their respective jurisdiction s commodities regulated in the Produce Rule. Registration with SAM is always appropriate. A formal subaward should register in SAM. 12

13 Thank you! 13

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