Full_Announcement_PAR-27-010.pdf

Department of Health and Human Services Part 1. Overview Information

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE: The policies, guidelines, terms, and conditions stated in this No-tice of Funding Opportunity (NOFO) may differ from those used by the NIH. Where this NOFO provides specific written guidance that may dif-fer from the general guidance provided in the grant application form, please follow the instructions given in this NOFO.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Human Foods Program (HFP)

Funding Opportunity Title

National Produce Safety Partnership Program

Activity Code

UF4

Announcement Type

New

Related Notices

None

Number (FON)

PAR-27-010

Companion Funding Opportunity

None http://www.fda.gov/ https://www.fda.gov/about-fda/fda-organization/human-foods-program

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.103

Purpose

This funding opportunity aims to improve the safety of fresh produce and prevent produce-related illnesses.

Goals

The goal of this funding opportunity is to assist state and territory Pro-duce Safety Programs with building and maintaining produce regula-tory programs as part of a national Integrated Food Safety System (IFSS) focused on quality and national consistency, outreach and edu-cation to industry, and coordination across government agencies.

Key Dates Posted Date

November 4, 2026

Open Date (Earliest Submission Date)

November 4, 2026

Letter of Intent Due Date(s)

December 18, 2026, for January 19, 2027, application due date.

January 3, 2028, for March 1, 2028, application due date.

January 2, 2029, for March 1, 2029, application due date.

Application Due Date(s)

January 19, 2027

March 1, 2028

March 1, 2029

All applications are due by 11:59 PM local time of applicant organiza-tion. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Earliest Start Date

July 1, 2027

Late Applications

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the sub-mission process by the due date.

No late applications will be accepted for this Notice of Funding Oppor-tunity (NOFO).

Expiration Date

March 02, 2029

Due Dates for E.O.

12372

Not Applicable

Required Application Instructions Conformance to all requirements, both in the Application Instruction Guide and in the NOFO, is required and strictly enforced. When the program-specific instructions deviate from those in the Application In-struction Guide, follow the program-specific instructions.

Applications that do not comply with these instructions will not be accepted for review.

Table of Contents Part 1. Overview Information

Key Dates Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description

Background FDA’s National Produce Safety Partnership Program advances implementation of the nation's Food Safety Modernization Act (FSMA)’s Produce Safety Rule (PSR) codified at 21 CFR Part 112. The PSR out-lines science-based minimum standards for the safe growing, harvesting, packing, and holding of fresh produce grown for human consumption. These standards are designed to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce and provide a path-way for federal, state, and local agencies to work together to achieve our public health goals.

FDA began supporting state and territory agencies PSR implementation in 2016, providing awardees with funding and technical assistance to develop produce safety programs as part of a national Integrated Food Safety System (IFSS). In support of Executive Order 14212, recipients of funding under this Notice of Funding Opportunity will collaborate to protect a key component of healthy diets by enhancing the safety of fresh produce.

Program Structure Recipient agencies of this cooperative agreement program will maintain a produce safety program within their jurisdiction with the overarching purpose to enhance produce safety and achieve high rates of com-pliance with the FDA’s Produce Safety Rule. The objectives of this Cooperative Agreement Program (CAP) are holistically intended to support recipient produce safety programs and are focused on quality and na-tional consistency.

This program is structured to allow applicants to select from defined TRACKS, PATHS, and data submis-sion OPTIONS. All applicants are required to select:

• One Program TRACK, which identifies the foundational framework used to operate their produce safety program.

• One Program PATH, which identifies the regulatory authority under which produce safety inspec-tions are or will be conducted; and

• One data submission OPTION, which identifies the method by which required data is submitted to FDA as outlined in Objective 4.

All applicants must choose only one Program TRACK (1 or 2)

TRACK 1: Recipients will enroll in Produce Regulatory Program Standards (PRPS) (see Appendix G) as the foundation of their produce safety regulatory program and will complete applicable program objectives (Objectives 1-6).

TRACK 2: Recipients will develop and maintain their own foundational framework (i.e., will not enroll in PRPS) for their produce safety regulatory program and will complete applicable program objectives (Objectives 2-6).

All applicants must choose only one Program PATH (B or C)

PATH B: Jurisdictions will conduct produce safety inspections under FDA’s authority.

PATH C: Jurisdictions will conduct produce safety inspections under their own authority.

Note: PATH A, as included under PAR-21-174, is not an option under this cooperative agreement.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-112 https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/ https://grants.nih.gov/grants/guide/pa-files/PAR-21-174.html

All applicants must choose only one data submission OPTION (A or D)

OPTION A (Aggregated Data Submission): Recipients will submit inventory, inspection, and compli-ance data in an aggregated form.

OPTION D (Disaggregated Data Submission): Recipients will submit inventory, inspection, and com-pliance data in a disaggregated form without farm identifying information.

Objective 1: Produce Regulatory Program Standards (PRPS) Enrollment This objective is applicable to TRACK 1 recipients only.

The Produce Regulatory Program Standards (PRPS) support the development of risk-based produce regu-latory programs by establishing a uniform basis for measuring and improving the performance of these programs in the United States. By achieving and sustaining conformance of these program standards, federal and state produce regulatory programs can better direct their regulatory activities toward reduc-ing risk and produce-related incidents.

The PRPS comprise ten standards which establish foundations for the critical elements that serve as an objective framework to evaluate and improve components of a produce regulatory program. These ele-ments cover the produce program's regulatory foundation, training, inspection program, auditing, pro-duce-related illness, outbreak and emergency response, enforcement program, outreach activities, pro-gram resources, program assessment, and laboratory support. Achieving and sustaining conformance with the PRPS will require comprehensive self-assessment on the part of a program and will encourage continuous improvement and innovation.

a. All applicants must demonstrate their program has the necessary management support and access to internal and external resources to achieve full conformance with the PRPS.

b. All enrolled produce regulatory programs will be expected to implement strategic improvement plans to ensure continuous improvement and demonstrate that they are moving towards full conformance of the PRPS. All produce regulatory programs receiving funding under this cooperative agreement for PRPS activities will be expected to achieve the following:

i. By the end of 5 years of funded PRPS enrollment, programs are expected to achieve full conform-ance with all 10 standards, utilizing the following prioritization:

• During the first 3 years of PRPS enrollment, programs should prioritize conformance with Stand-ards 1, 3, 7, and 10, and prioritize implementation of Standards 2, 8, and 9. For this funding op-portunity, “implementation” means a program has a particular element, system, program, and documentation as required in the PRPS, and “conformance” means fulfillment of a requirement;

specifically, a program is using and can demonstrate the use of a particular element, system, or program listed in the PRPS.

ii. The FDA recognizes that the time required for achieving full conformance with the PRPS will vary between programs. The program must have a detailed strategic improvement plan on how to achieve conformance with the remaining PRPS elements and documentation of requirements not yet met in accordance with PRPS Standard 9.

Goals and Activities

Year 1 of enrollment:

1. Attendance and participation of key produce program managers and staff in an annual face-to-face or virtual national PRPS meeting, active participation in any required PRPS training and com-mittee meetings, participation in the PRPS Alliance, and other initiatives supporting national and program specific conformance of the PRPS.

2. Conduct a comprehensive baseline self-assessment, including completion of all applicable ap-pendices, worksheets, and other documents (or equivalent documents), as described in Standard 9.

3. Following the baseline self-assessment, develop a strategic improvement plan that will result in conformance with the PRPS. Documentation related to the self-assessment and strategic im-provement plan must be maintained. Strategic improvement plan(s) must include, at a minimum, all elements specified in Standard 9.

4. If applicable based upon assessment intervals, participation in in-person or virtual site visit(s) consisting of key state produce regulatory program and FDA personnel to discuss the conform-ance of program elements of the PRPS to prepare for assessment by the FDA /Human Foods Program/Office of Quality Assessment and Management/Quality Assessment Staff (Quality As-sessment Staff). Participation includes providing meeting space for in-person activities; accessi-bility of key produce regulatory program management and staff; and access to records, data-bases, and other materials supporting PRPS conformance.

Years 2 to 5 of enrollment:

1. Participation in assessments conducted by the Quality Assessment Staff based upon regular as-sessment intervals determined by the FDA. Assessments evaluate accuracy of self-assessments, document the progress towards implementation and conformance, and determine whether mile-stones identified in the strategic improvement plan are met. Participation includes providing meeting space for any in-person activities; accessibility of key state produce program manage-ment and staff; and access to records, databases, and other materials supporting PRPS conform-ance.

2. Participation in in-person or virtual site visit(s) consisting of key state produce regulatory pro-gram and FDA personnel to discuss the conformance of program elements of the PRPS at inter-vals consistent with preparing for assessment by the Quality Assessment Staff. Participation in-cludes providing meeting space for in-person activities, accessibility of key produce regulatory program management and staff, and access to records, databases, and other materials support-ing PRPS conformance.

3. Attendance and participation of key produce program managers and staff in an annual face-to-face or virtual national PRPS meeting, active participation in any required PRPS training and com-mittee meetings, participation in the PRPS Alliance, and other initiatives supporting national and program specific conformance of the PRPS.

4. Implementation of the strategic improvement plan. The strategic improvement plan should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance of the PRPS. Progress achieved should indicate that implementation and conformance of PRPS requirements can be expected by the timelines as outlined above in Objective 1(b)(i).

5. Review and update strategic improvement plan on an annual basis in accordance with Standard 9.

Documentation related to the evaluation and strategic improvement plan must be maintained. The strategic improvement plan must include, at a minimum, all elements specified in Standard 9.

Objective 2: Program Administration This objective includes elements of program administration needed to support the recipient’s project. Un-less specified otherwise, the goals and requirements under this objective are applicable to all recipients.

Goals and Activities

a. Recipients must develop and maintain a Program Workbook, utilizing a standardized template provided by the FDA (see Appendix I), to outline program objectives, annual goals and planned activities, track pro-gress, and provide periodic progress reports as described in Section VI.

b. Recipients must maintain program staff and partners to accomplish the implementation, oversight, monitoring, and reporting of program objectives.

i. Recipients must develop a succession plan that supports a seamless transition if staff were to leave the program. Elements of this plan should include program standard operating procedures, training plans for each position, and existing agency succession planning strategies. TRACK 1 recipi-ents may accomplish this through their work under Objective 1.

c. Recipients must provide program personnel with appropriate training and resources commensurate with work duties.

i. The training curriculum for inspectors must be commensurate with the published FDA compliance program (CPGM 7303.080 Produce Safety Inspections, see Appendix E) or other applicable direction from the FDA.

d. Recipients must provide for key program personnel to attend and participate in the Annual National Consortium for Produce Safety and other initiatives supporting program implementation. These initiatives must be directly tied to CAP objectives.

e. Recipients must establish and maintain the capability to submit data to the FDA through electronic data exchange systems (e.g., FDA's Food Safety Data Exchange (FSDX) portal, see Appendix F).

f. Recipient agencies must establish and maintain 21 CFR 20.88 information sharing agreements with the

FDA.

g. PATH B recipients must maintain FDA pocket credentials (with produce endorsement) for staff con-ducting Produce Safety Rule inspections.

h. PATH C recipients must follow their agency’s credentialing and identification procedures for staff con-ducting Produce Safety Rule inspections.

i. PATH C recipients must adopt all Subparts of the Produce Safety Rule (21 CFR Part 112) in their en-tirety, by statute or administrative regulation; with exceptions as follows: recipients may omit any, or all, of the following:

i. Subpart M (Sprouts)

ii. Subpart P (Variances)

iii. Subpart Q (Compliance and Enforcement), provided the grantee agency has compliance and en-forcement authority, or such authority will be obtained before conducting inspections

iv. Subpart R (Withdrawal of Qualified Exemption), provided that the state recognizes when FDA has withdrawn qualified exemption status

Additionally, PATH C recipients are responsible for ensuring that their statute and/or administrative regulation is updated to reflect applicable changes to the Produce Safety Rule resulting from FDA rule-making. Changes resulting from FDA rule-making must be incorporated into the grantee’s statute or administrative regulation no later than the earliest compliance date that is applicable to the rule-making.

j. New applicants, and recipients previously funded through PAR-21-174 as PATH A (non-regulatory pro-grams), must establish a mutually agreed-upon new applicant or transition plan with the FDA to include timelines, key milestones, and responsible parties. This plan must be established within the first 3 months of the recipient’s first year and clearly document any alternate timelines required under Objec-tives 2-6 as a new regulatory program.

k. TRACK 1 recipients will ensure that program elements developed under Objectives 2-6 are in conform-ance with the associated PRPS standards.

l. TRACK 2 recipients will develop and maintain a foundational framework for their produce safety pro-gram. Written procedures must be established by the end of the recipient’s first year, unless otherwise noted, to include the following:

i. Regulatory Foundation: recipients must evaluate the scope of their legal authority and regulatory provisions to ensure the protection of produce within their jurisdiction. The evaluation includes a de-termination of how the recipient’s legal authority and regulatory provisions correspond to the applica-ble sections of the Federal Food, Drug, and Cosmetic Act (FD&C) and Code of Federal Regulations

(CFR).

ii. Training Program: recipients must establish and maintain a written training plan that promotes staff development and demonstrates that all staff complete coursework, field training, and continu-ing education to adequately perform their work.

iii. Outreach and Technical Assistance Program: recipients must establish and maintain a written out-reach and technical assistance plan, and include the elements outlined in Objective 3.

iv. Inspection Program: recipients must establish and maintain written inventory and inspection pro-cedures appropriate to their chosen program PATH, and include the elements outlined in Objective 4.

v. Compliance and Enforcement Program: recipients must establish and maintain written compliance and enforcement procedures appropriate to their chosen program PATH, and include the elements outlined in Objective 5.

vi. Response Activities: recipients should utilize PRPS Standard 5 (see Appendix G), and must include the elements outlined in Objective 6, as the framework for their incident response activities and writ-ten procedures, to be established by June 30, 2032.

Objective 3: Outreach and Technical Assistance Program This objective is intended to provide opportunities for outreach and technical assistance on the Produce Safety Rule and the jurisdiction’s produce regulatory program to produce farms, prioritizing PSR covered farms. Outreach and technical assistance activities under this cooperative agreement provide an oppor-tunity to promote safe farming practices that minimize human pathogens and protect a key component of healthy diets by enhancing the safety of fresh produce. Unless specified otherwise, the goals and re-quirements under this objective are applicable to all recipients.

Goals and Activities

a. Farms conducting PSR covered activities on PSR covered produce are eligible to receive outreach re-gardless of produce sales or exemption status; however, PSR covered farms must be prioritized.

i. Recipients are encouraged to provide outreach on produce safety and the Produce Safety Rule to produce farms supplying PSR covered produce directly to schools and/or other institutions serving vulnerable populations (e.g., hospitals and long-term care facilities).

ii. Produce farms located on Tribal lands or owned by Tribes or Tribal entities may receive outreach through this cooperative agreement, at their request. When federally recognized Tribes or farms on Tribal lands initiate contact with the recipient, the recipient must contact the FDA to discuss and co-ordinate the available Tribal outreach options. Additionally, recipients must communicate with the FDA when they receive requests for an On-Farm Readiness Review (OFRR) from a farm with Tribal affiliation to determine the appropriate entity to conduct the OFRR.

b. Outreach activities may include:

i. General outreach to industry such as one-time or short duration contact to provide information.

ii. Education utilizing existing curriculum and materials recognized by the FDA and training partners;

these may include but are not limited to curriculum and materials developed by the Produce Safety Alliance, Sprout Safety Alliance, and Regional Centers.

c. Technical assistance should be focused on PSR covered farms and may include individual assistance to interpret and apply the regulation to a specific situation, including on-farm (e.g., On-Farm Readiness Reviews) or off-farm/remote delivery (e.g., off-farm, in-person, or virtual technical assistance delivery).

TRACK 1 recipients should record OFRRs in PRPS Appendix 7.2.

d. Recipients may choose to distribute FSMA Food Traceability Rule (FTR) related educational and infor-mational materials during PSR inspections and/or any other in-person or virtual outreach activities. See Appendix H for FTR resources.

e. Recipients must develop and maintain an annual Outreach and Technical Assistance Plan as part of the required Program Workbook (see Appendix I), including annual targets for outreach and technical as-sistance activities based on their jurisdiction’s needs.

f. An Educational Needs Assessment (ENA) is required to be completed prior to the development of any new trainings and/or materials. The purpose of the ENA is to prevent duplicative efforts among recipi-ents, ensure material alignment with the PSR, and promote broader sharing of aligned materials.

Objective 4: Inspection Program This objective includes program elements for recipients to maintain an inspection program for produce farms under their jurisdiction. Unless specified otherwise, the goals and requirements under this objective are applicable to all recipients.

Goals and Activities

a. Recipients must maintain a verified inventory that captures at least the required data elements listed in Appendix C1 for all Produce Farms with Produce Sales. “Verified” refers to data collected directly from the farmer (e.g., collected through direct mailing, phone, informational visit, inspection, voluntary online registration, or other direct interaction with the farm).

i. All produce farms that are covered by the PSR, not covered due to produce sales under $25k (ad-justed for inflation), commercial processing exempt, grow only Rarely Consumed Raw (RCR) com-modities or commodities under Enforcement Discretion (ED), or eligible for a qualified exemption are to be re-verified at a minimum of every 5 years. This is to ensure that all PSR covered farms are con-sidered in work-planning, including those that may have previously been exempt.

ii. Recipients must establish procedures and timeframes for the identification and verification of new produce farms in their jurisdiction.

b. At a minimum, recipients must conduct routine inspections on 20% of their jurisdiction’s non-exempt covered farms annually. If the recipient chooses to do more inspections than 20% of their covered inven-tory annually, that is allowed but will not be considered for additional funding eligibility.

i. Each covered farm in inventory must receive a routine surveillance inspection at a frequency of no greater than every five years.

ii. Recipients, regardless of their authority, may periodically receive FDA issued inspection assign-ments. Recipients must follow the requirements and conditions set forth in the assignment. These inspections may be counted towards the annual routine inspection goal or non-routine inspections as appropriate.

c. Annual funding is also allocated for non-routine inspections, including Follow-up and For-cause inspec-tion types, estimated at 20% of all routine inspections conducted.

i. Recipients, regardless of their authority, may periodically receive FDA Follow-up or For-cause in-spection assignments. Recipients must follow the requirements/conditions set forth in the assign-ment. These inspections may be counted towards non-routine inspections.

d. Recipients conducting inspections under Subpart M of the Produce Safety Rule under this cooperative agreement, must conduct these inspections jointly with FDA, in coordination with the FDA, and at the dis-cretion of FDA.

i. Compliance and enforcement activities related to inspections under Subpart M of the Produce Safety Rule must be in coordination with the FDA.

ii. Personnel must complete FDA required training courses to conduct Subpart M inspection-related activities.

e. Recipients may implement and execute a produce safety inspection calibration program, in coordina-tion with FDA, to ensure the consistent understanding, application, and communication of Produce Safety Rule requirements during inspections.

f. When appropriate, the recipient must coordinate with the FDA and other state or local agencies on multi-jurisdiction farm inventory activities and/or inspections (e.g., farm mixed-type facilities, farms crossing state borders, and Tribal lands), according to the most current FDA CPGM 7303.080, Produce Safety Inspections (see Appendix E) or other applicable direction from the FDA.

g. Recipients must utilize an electronic system for maintaining inventory and inspection data and required data elements; the system should be capable of extracting data into an .xml file format and facilitate re-porting of required inventory, inspection, and compliance related data elements (see Appendix C and Ap-pendix D).

h. Recipients must select one of the following data submission OPTIONS (A or D), utilizing the associated reporting templates provided by the FDA (see Appendix I), to submit inventory and inspection data in the FDA's Food Safety Data Exchange Portal (see Appendix F) as outlined in Section VI, Additional Reporting Requirements.

i. Aggregated data submission OPTION A

• Recipients will submit data in aggregated form, using a format defined by FDA. See Appendix C2 and Appendix D1 for required data elements.

ii. Disaggregated data submission OPTION D

• Recipients will submit data in a disaggregated form, without farm identifying information, using a format defined by FDA. See Appendix C3 and Appendix D2 for required data elements.

• Additional funding may be available to recipients opting to provide data using the disaggregated data submission option to support IT development, IT system maintenance, and personnel to manage the data system (see Table 4).

i. PATH B recipients

i. Recipients must provide their farm inventory (see Appendix C1), with farm identifying information, to the FDA upon request.

ii. Recipients must conduct inspections according to the most current FDA CPGM 7303.080, Produce Safety Inspections (and attachments) (see Appendix E), and pertinent FDA guidance or operating in-structions for conducting produce safety inspections.

iii. Recipients must prioritize inspections considering criteria listed in the most current FDA CPGM 7303.080, under Part II- Implementation, Inspection Priorities.

• TRACK 1 recipients must include additional criteria as outlined in PRPS Standard 3.

• Recipients must demonstrate how they conduct their inspection work-planning and prioritization to FDA upon request.

iv. Recipients must submit all FDA 4056s with written observations, and full inspection reports for any potentially violative inspections. Refer to the most current FDA CPGM 7303.080, Produce Safety Inspections (see Appendix E), or other operating instructions provided by the FDA, for the required components and submission time frames of inspection reports by inspection classification.

• Inspection reports include, but are not limited to: Form FDA 4056, Produce Farm Inspection Re-port (PFIR) or PFIR Summary (PFIRS) (as appropriate), Attachments and Exhibits.

j. PATH C recipients

i. FDA will not routinely request a recipient’s farm inventory with farm identifying information. How-ever, recipients must provide farm inventory data with farm identifying information to the FDA upon request.

ii. Recipients are encouraged to conduct inspections according to the most current FDA CPGM 7303.080, Produce Safety Inspections (and attachments) (see Appendix E), and pertinent FDA guid-ance or operating instructions for conducting produce safety inspections.

iii. Recipients must use a risk-based prioritization model and are encouraged to prioritize inspections considering criteria listed in the FDA CPGM 7303.080, under Part II- Implementation, Inspection Priori-ties.

iv. FDA will not routinely request detailed inspection reports. However, recipients must provide de-tailed inspection reports to the FDA upon request, within 15 business days of the completion of the inspection or within 15 business days of the request.

• Inspection reports include, but are not limited to, the state equivalent of: Form FDA 4056, Produce Farm Inspection Report (PFIR) or PFIR Summary (PFIRS) (as appropriate), Attachments and Ex-hibits, and/or supporting evidence.

k. New applicants and recipients previously funded through PAR-21-174 as PATH A (non-regulatory pro-grams) must coordinate with the FDA on establishing an initial inventory of produce farms, and the devel-opment and implementation of an inspectional program, including initial work planning and participating in joint inspections. Additional requirements and timelines may be outlined and mutually agreed upon un-der Objective 2(j).

Objective 5: Compliance and Enforcement Program This objective includes program elements for recipients to maintain a compliance and enforcement pro-gram for produce farms under their jurisdiction. It is recommended that all programs coordinate with lo-cal/state/federal agencies to utilize the compliance and enforcement action(s) that will result in the greatest protection of public health. Unless specified otherwise, the goals and requirements under this objective are applicable to all recipients.

Goals and Activities

a. PATH B recipients

i. Recipients’ internal procedures on their preliminary review of inspection documentation must align with the FDA’s Investigation Operation Manual (IOM) and other pertinent FDA guidance or operating instructions.

ii. Recipients must submit their internal procedures on their preliminary review of inspection docu-mentation to the FDA for review by the end of their first year under this cooperative agreement, and as procedures are updated.

iii. Recipients must engage with the FDA on any compliance and enforcement activities according to the most current FDA CPGM 7303.080, Produce Safety Inspections (and attachments) (see Appendix E), and pertinent FDA guidance or operating instructions.

iv. In compliance cases, recipients must provide their inspection documentation to the FDA, and FDA will determine the compliance status and perform the enforcement action(s). Inspection documenta-tion may include previous inspection reports as determined by the FDA.

v. Recipients may need to conduct follow-up inspections as determined by the FDA.

b. PATH C recipients

i. Recipients’ written procedures for conducting compliance and enforcement activities should in-clude:

• A risk-based process to determine when a directed investigation, follow-up, or re-inspection is needed.

• A framework for compliance and enforcement progressive actions, utilizing the current compli-ance and enforcement guidance available.

ii. Recipients must submit biannual reporting on OAI inspections, including the submission of the fol-lowing data elements: inspection date(s), produce commodity/commodities observed, inspection type, full text of written observation(s) that led to OAI classification, enforcement action taken, farm’s corrective action, and recipient’s next steps (see Appendix I). This data submission requirement is not applicable to recipients submitting disaggregated data under OPTION D.

• Furthermore, if the recipient finds during an inspection that a farm has one or more conditions that have or could likely lead to produce contamination and there is impacted produce in the mar-ketplace, or it is unknown whether impacted produce is in the marketplace, the recipient must in-form the FDA, within 1 business day after the conditions are observed, and coordinate on any compliance and enforcement activities. In these situations, the recipient should continue to take the action they consider appropriate under their authority.

iii. New applicants and recipients previously funded through PAR-21-174 as PATH A (non-regulatory programs) must coordinate with the FDA on all compliance and enforcement activities until recipi-ents have fully established regulatory authority. Additional requirements and timelines may be out-lined and mutually agreed upon under Objective 2(j).

Objective 6: Response Activities Each jurisdiction should have the capability to systematically detect, investigate, mitigate, document, and analyze produce-related incidents to stop, control and prevent hazards that are likely to result in a pro-duce related illness, injury, or outbreak. Produce incidents include, but are not limited to, foodborne illness outbreaks, Laboratory Flexible Funding Model (LFFM) positive samples if the regulatory program is partic-ipating in an approved LFFM sampling plan, and significant weather events (e.g., flooding, wildfires).

These capabilities can reside and be funded by other offices or agencies in the jurisdiction or may be headed by the produce program funded under this cooperative agreement. The expectation is that there is coordination across multiple offices and departments within a jurisdiction and there is not duplication of efforts or redundant funding allocated for these capabilities. Unless specified otherwise, the goals and requirements under this objective are applicable to all recipients.

Goals and Activities

a. Recipients should engage and coordinate response with funded or voluntary Rapid Response Teams (RRT) in their jurisdictions, where applicable. TRACK 1 recipients must implement and conform with PRPS Standard 5 (see Appendix G).

b. In jurisdictions without a funded or voluntary RRT, TRACK 1 recipients must implement and conform with PRPS Standard 5, and TRACK 2 recipients should utilize PRPS Standard 5 as the framework for their incident response planning and field activities.

c. Recipients that plan on conducting produce response activities should ensure staff have the appropri-ate training (e.g., completion of ER220 Traceback Investigations course prior to conducting a traceback investigation).

d. If the recipient is part of the Laboratory Flexible Funding Model by signing on to an approved LFFM sampling plan, they will apply their Produce Safety Program response, enforcement, and regulatory frame-work, appropriate to their Program PATH, to conduct follow-up inspections, investigations (including traceback/forward) and enforcement actions (e.g., embargoes, holds, recalls, warning letters, closures, etc.) to positive samples identified as part of the LFFM cooperative agreement.

i. Recipients will commit to coordinating response and compliance follow-up on LFFM samples with the FDA in real-time, to include sharing findings and compliance actions or other follow-up activities discussing regulatory/compliance strategy with the FDA.

ii. If a potentially violative LFFM sample comes to a Produce Safety Program but is outside the Pro-duce Safety Program’s regulatory authority/jurisdiction, the program agrees to identify and notify the appropriate state/federal agencies with jurisdiction, and to notify the FDA.

iii. Potentially violative LFFM samples may come to the Produce Safety Program from any laboratory participating in the LFFM Human Food Product Testing track for microbiology. This includes samples collected by LFFM laboratories within the same state as the Produce Safety Program (may or may not be the primary servicing laboratory for the Produce Safety Program) and samples collected by other states/analyzed by other LFFM laboratories where the potentially violative product is traced back to the Produce Safety Program’s state.

iv. Recipients will collect samples in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed.

Appendices

Appendix A: Funding Band Descriptions and Determinations

Applicants will determine their eligible funding bands based on their actual verified farm inventory at the time of application. The following table describes the farm inventory numbers to include in each funding band determination.

Funding Band

Description Verified farm inventory for funding band de-terminations

Program Base and Regula-tory Fund-ing

(Table 1)

Includes program base funding applicable to all CAP objectives and additional fund-ing for regulatory work based on the appli-cant’s total number of verified non-exempt PSR covered farms in their jurisdiction.

# Non-exempt PSR covered farms

Farm In-ventory Funding

(Table 2)

Includes supplemental program funding for farm inventory work based on the ap-plicant’s total number of verified produce farms with produce sales (as detailed in Obj 4(a)) in their jurisdiction. This funding covers the maintenance and re-verification of existing farm inventory as well as the verification of new farms in their jurisdic-tion.

# Produce farms with produce sales: non-ex-empt PSR covered farms, farms not covered due to produce sales under $25k (adjusted for inflation), farms with commercial pro-cessing exemption, farms that grow only Rarely Consumed Raw (RCR) commodities or commodities under Enforcement Discretion (ED), and farms eligible for a qualified ex-emption

Outreach and Tech-nical As-sistance Funding

(Table 3)

Includes supplemental program funding for outreach and technical assistance ac-tivities based on the applicant’s total num-ber of verified farms eligible to receive out-reach and technical assistance (as de-tailed in Obj 3(a)) in their jurisdiction.

# Produce farms conducting PSR covered activities on PSR covered produce: non-ex-empt PSR covered farms, farms not covered due to produce sales under $25k (adjusted for inflation), and farms eligible for a quali-fied exemption

Appendix B: Key Timelines

The following table contains key timelines by program objective for reference. This is not an all-inclusive list of NOFO requirements and expectations. Key timelines for reporting are detailed under Section VI.

Program Objective

Key Timelines

Objective 1 Refer to Year 1 and Year 2-5 Goals and Activities as detailed under Objective 1.

Objective 2 2(a): Recipients must develop and maintain a Program Workbook, utilizing a standard-ized template provided by the FDA, to outline program objectives, annual goals and planned activities, and provide periodic progress reports as described in Section VI.

2(l): TRACK 2 recipients will develop and maintain a foundational framework for their produce safety program. Written procedures must be established by the end of the recip-ient’s first year, except for procedures for response activities which must be established by the end of the project period (June 30, 2032).

2(j): New applicants, and recipients previously funded through PAR-21-174 as PATH A (non-regulatory programs), must establish a mutually agreed-upon new applicant or tran-sition plan with the FDA to include timelines, key milestones, and responsible parties.

This plan must be established within the first 3 months of the recipient’s first year and clearly document any alternate timelines required under Objective 2-6 as a new regula-tory program.

Objective 3 3(e): Recipients must develop and maintain an annual Outreach Plan as part of the re-quired Program Workbook, including annual targets for outreach and technical assis-tance activities based on their jurisdiction’s needs.

Objective 4 4(a)(i): All produce farms that are covered, not covered due to produce sales under $25k (adjusted for inflation), commercial processing exempt, grow only Rarely Consumed Raw (RCR) commodities or commodities under Enforcement Discretion (ED), or eligible for a qualified exemption are to be re-verified at a minimum of every 5 years.

4(b): At a minimum, recipients must conduct routine inspections on 20% of their jurisdic-tion’s non-exempt covered farms annually.

Objective 5 5(a)(ii): PATH B recipients must submit their internal procedures on the preliminary re-view of inspection documentation to the FDA for review by the end of their first year un-der this cooperative agreement, and as procedures are updated.

Objective 6 See Objective 2(l)(vi) Response Activities: recipients should utilize PRPS Standard 5, and must include the elements outlined in Objective 6, as the framework for their incident re-sponse activities and written procedures, to be established by June 30, 2032.

Appendix C: Farm Inventory Data Elements

Elements are included as a reference and are subject to minor changes. The required reporting forms and associated instructions will contain additional information on the options and format for each reported data element (e.g., free text, standardized list of entry options, Y/N) (see Appendix I).

C1: Farm Inventory Required Data Elements to be maintained in recipient’s IT system

Unique Farm ID Date Verified Farm Name Business Address Line 1 Business Address City Business Address State Abbreviation Business Address Zip code Business Address County Phone Number Email Address Farm Size based on average produce sales Covered Produce (Y/N) Commodities Activities Farm Type Farm PSR Coverage Status Seasonal Growing Period Seasonal Harvest Period Point of Contact Role Point of Contact First Name Point of Contact Last Name Point of Contact Phone Number Additional data elements must be maintained (See Appendix C3) by recipients participating in the Disaggregated Data Submission OPTION D.

C2: Aggregated Farm Inventory Data Submission (OPTION A)

# Farms by Farm Size and Farm PSR Coverage Status # Farms conducting covered activities on national priority commodities as identified by FDA # Farms growing covered produce # Farms harvesting covered produce # Farms packing covered produce # Farms holding covered produce # Farms processing covered produce # Farms retailing covered produce # Farm Mixed-Type Facilities

C3: Disaggregated Farm Inventory Data Submission (OPTION D)

State Abbreviation Unique Farm ID Date Verified Covered Produce (Y/N) Farm Size based on average produce sales Farm Type Farm PSR Coverage Status Activities Commodities Production Method* Soil Amendments Utilized* Agricultural Water Source(s)* Agricultural Water Application Method(s)* Livestock on the farm* Livestock adjacent to the farm* Manure or compost operation adjacent to the farm* *applicable to PSR covered farms; not expected to be reported until the farm has received an in-spection.

Appendix D: Inspection and Compliance Data Elements

Elements are included as a reference and are subject to minor changes. The required reporting forms and associated instructions will contain additional information on the options and format for each reported data element (e.g., free text, standardized list of entry options, Y/N) (see Appendix I).

D1: Aggregated Inspection and Compliance Data Submission (OPTION A)

# Total farms inspected # Total inspections For reporting period:

# Inspections completed # Farms inspected # Inspections with observations on the FDA 4056 or state equivalent # Inspections at farms that handle priority commodities # Farms with improved inspection classification from previous inspection # Observations corrected during inspection Inspection classification for each inspection by inspection type and farm size # Farms having previous OFRRs/food safety audits/PSR training # Observations by Produce Safety Rule Citation # Inspections resulting in compliance actions # Farms inspected resulting in compliance actions and by compliance action taken # Recalls and volume of product recalled # Compliance follow-up inspections/#farms and by improved classification

D2: Disaggregated Inspection and Compliance Data Submission (OPTION D)

State Abbreviation Unique Farm ID Farm Size Farm PSR Coverage Status Inspection End Date Date of Last PSR Inspection Covered Activities Observed Commodities Observed Inspection Type Previous Inspection Classification Current Inspection Classification PSR Training Source On-Farm Readiness Review (OFRR) Conducted Previous Food Safety Audit Written Observation(s) text by Citation # Other Observation(s) Discussion Item(s) narrative text Did this inspection result in Compliance and Enforcement Action?

Follow-up inspection planned?

Compliance and Enforcement Action(s) Completed Recalls Resulting from PSR Inspection

Appendix E: FDA Compliance Program 7303.080 Produce Safety Inspections

• FDA Website Appendix F: FDA Food Safety Data Exchange (FSDX) Portal

• FSDX Portal Appendix G: FDA Produce Regulatory Program Standards (PRPS)

• FDA Website Appendix H: FSMA Food Traceability Rule (FTR) resources

• FDA Website Appendix I: Required Program Reporting Forms

• FDA Website See Section VIII. Other Information for award authorities and regulations.

https://www.fda.gov/media/166413/download?attachment https://fsdx.fda.gov/webcenter/portal/FSDX https://www.fda.gov/food/regulatory-program-standards-food/produce-regulatory-program-standards-prps https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods https://www.fda.gov/food/funding-opportunities-provided-office-domestic-partnerships/grants-cooperative-agreements-food

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there is substantial Federal scientific or programmatic involvement. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New Only the application type(s) listed here are allowed for this NOFO.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropria-tions, availability of funding, and satisfactory awardee performance and workload.

FDA intends to fund an estimate of up to $34 million dollars for fiscal year (FY) 2027 in support of this cooperative agreement program. Fund-ing for FY2028, FY2029, FY2030, and FY2031 will be contingent upon an-nual appropriations and availability of funding.

It is anticipated that up to fifty-six (56) awards will be made, not to ex-ceed $12 million in total costs (direct plus indirect), per award.

Award Budget

Application budgets need to reflect the actual needs of the proposed pro-ject. Proposed budgets should not exceed the maximum eligible funding (including direct and indirect costs) determined by combining the funding associated with the applicant’s selected program TRACK, PATH, and ad-ditional optional funding as applicable (see Tables 1-5). Eligible First Time Applicants not previously funded under PAR-16-137 or PAR-21-174 should refer to Table 6 for the TOTAL maximum eligible funding for their initial year.

Funding Structure Each eligible applicant may apply for up to their maximum annual eligible funding, which is based on combining the maximum eligible funding from each funding band as outlined in Tables 1, 2, and 3, in addition to any applicable optional funding requested as outlined in Table 4. The ap-plicant should select the funding bands that correspond to their actual verified farm inventory at the time of application (See Appendix A). Fund-ing band determinations are based on the anticipated workload of each recipient. Additional one-time funding for applicants previously funded through PAR-21-174 as PATH A (non-regulatory programs) that will tran-sition to a regulatory program is outlined in Table 5.

Table 1: Program Base and Regulatory Funding: Outlines program base funding across all applicable CAP objectives and additional funding for regulatory work based on the applicant’s total number of verified non-ex-empt PSR covered farms in the recipient's jurisdiction.

Funding Band

Range of non-exempt PSR Covered

Farms

Maximum Eligi-ble Funding

Additional Funding for PATH C Compliance

Programs

A 1–100 $320,000 $16,000

B 101–200 $440,000 $22,000

C 201–400 $680,000 $34,000

D 401–600 $920,000 $46,000

E 601–800 $1,100,000 $55,000

F 801–1,000 $1,340,000 $67,000

G 1,001–1,500 $1,850,000 $92,000

H 1,501–2,000 $2,450,000 $122,000

I 2,001–3,000 $3,500,000 $175,000

J 3,001–4,000 $4,700,000 $235,000

K 4,001–6,000 $6,800,000 $340,000

L 6,001+ $8,000,000 $400,000

Note: Recipients may utilize CAP funds for produce response activities under Objective 6. If additional response related funding is needed, recip-ients should contact their FDA Program Official for available options.

Table 2: Farm Inventory Funding: Outlines supplemental program fund-ing for farm inventory work based on the applicant’s total number of veri-fied produce farms with produce sales (as detailed in Obj 4(a)) in the re-cipient’s jurisdiction. This funding covers the maintenance and re-verifi-cation of existing farm inventory as well as the verification of new farms in the recipient's jurisdiction.

Funding Band Range of Total Pro-duce Farms

Maximum Eligible Funding

A 1-1,000 $20,000

B 1,001-2,000 $46,000

C 2,001–3,000 $72,000

D 3,001–5,000 $104,000

E 5,001–7,000 $156,000

F 7,001–10,000 $215,000

G 10,001–12,000 $286,000

H 12,001–16,000 $364,000

I 16,001+ $442,000

Table 3: Outreach and Technical Assistance Funding: Outlines supple-mental program funding for outreach and technical…