RiskAssessPoultCoopAgreeAnn - UPDATED.pdf

Solicitation No.: FSIS-02152022 Issuance Date: 15 April 2022 Closing Date/Time: 16 May 2022 at 2pm (EST)

SUBJECT: Solicitation for Applications for funding: Salmonella Risk Assessment - FSIS

Department of Agriculture’s Food Safety and Inspection Service

Ladies/Gentlemen:

The United States Government, represented by the USDA’s Food Safety and Inspection Service, is issuing Amendment One for solicitation: FSIS-02152022. Amendment One includes the following updates:

• The solicitation has been updated to provide greater details of the Government’s requirements.

• Terms and conditions have been incorporated

• Non-disclosure and Conflict of Interest forms have been incorporated.

• A question-and-answer period has been incorporated

The question-and-answer period has been incorporated to provide potential Cooperators the opportunity to ask clarifying questions regarding the solicitation and the Government’s requirements. Additionally, general questions can be submitted; it is the Government’s intent to respond to all questions. The questions and answers to all questions will be posted publicly after removing all identifiable information.

All questions must be submitted via email to George Baptist III at George.baptist@usda.gov on or before 2pm (EST) on 25 April 2022. All submission shall have the title “FSIS-02152022 Questions” in the subject line.

The Government anticipates posting responses to the questions via a second amendment on 04 May 2022.

Additionally, all applications for funding must be submitted via Grants.gov by 2pm (EST) on 16 May 2022.

Thank you in advance for your participation, the Government looks forward to receiving your applications.

Sincerely, George D. Baptist III Senior Contracting Officer, USDA, FSIS mailto:George.baptist@usda.gov

United States Department of Agriculture

Food Safety and Inspection Service

FSIS Salmonella Risk Assessment Cooperative Agreement Announcement

FSIS-02152022 FSIS

Application Due Date: 05/16/2022

V3 - 04/15/2022

OVERVIEW

United States Department of Agriculture (USDA)

Food Safety and Inspection Service and Office of Public Health Science

(FSIS, OPHS)

FSIS Salmonella Risk Assessment Cooperative Agreement Announcement

Research Related - Cooperative Agreements

New Renewal

FSIS-02152022 FSIS

Health

To support development of novel production to consumption risk models to estimate reductions in foodborne illness through the control of Salmonella.

Publication Date: To receive notification of any changes to FSIS-02152022 FSIS return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Salmonella Risk Assessment Cooperative Agreement Announcement: 03/2/2022

Deadline for Submission of Proposals: 05/16/2022

Preliminary Notification of Selected Proposals: 05/31/2022

Estimated Start Date: 06/17/2022

Expiration Date: 04/14/2023

Due Dates for E.O. 12372: E.O. 12372 does not apply to this program

Components of Participating Organizations

Notice of Funding Opportunity (NOFO) Title

Agency Notice of Funding Opportunity Number

Category of Funding Activity:

Participating Organization(s)

Activity

Notice of Funding Opportunity Type

NOFO Purpose

Key Dates https://www.grants.gov/ https://www.grants.gov/

Table of Contents

A. PROGRAM DESCRIPTION

B. FEDERAL AWARD INFORMATION

C. ELIGIBILITY INFORMATION

D. APPLICATION AND SUBMISSION INFORMATION

E. APPLICATION REVIEW INFORMATION

F. FEDERAL AWARD ADMINISTRATION INFORMATION

G. FEDERAL AWARDING AGENCY CONTACT

GENERAL TERMS AND CONDITIONS …………………………………………….…18

ATTACHMENT A - NON-DISCLOSURE AGREEMENT …………………….……….41

ATTACHMENT B - CONFLICT OF INTEREST FORM ……………...…………….….43

ATTACHMENT C – TECHNICAL EVALUATION CRITERIA ……………………

A. PROGRAM DESCRIPTION

The Food Safety and Inspection Service (FSIS) is the public health agency in the United States Department of Agriculture (USDA) responsible for ensuring the safety of meat, poultry, and egg products.

The Office of Public Health Science (OPHS)—one of many program areas supporting FSIS’ mission—brings public health leadership to FSIS to assure the establishment and support of scientifically sound food safety programs. The OPHS Risk Assessment and Analytics Staff (RAAS) conducts scientific risk assessments and develops new analytic methods for assessing risks of biological and chemical hazards in meat, poultry and egg products that inform risk management decisions and risk communication activities. RAAS’ scientific and technical analyses guide, support and enhance FSIS public health goals as they relate to regulatory initiatives, internal policymaking, data collection, research priorities, and the FSIS food safety goals.

Authorizing Statues/Regulations FSIS has the legal authority to regulate meat, poultry and egg products, based on the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA) which were enacted by Congress.

• Federal Meat Inspection Act (FMIA) (21 USC 601 et seq.) (1906)

• Poultry Products Inspection Act (PPIA) (21 USC 451 et seq.) (1957)

• Egg Products Inspection Act (EPIA) (21 USC 1031 et seq.) (1970)

Each of these Acts are intended to protect the health and welfare of the consuming public by preventing the introduction of adulterated or misbranded meat, poultry or egg products into commerce.

FSIS recently announced it will develop a stronger and more comprehensive food safety framework for the control of Salmonella in poultry. Several initiatives are underway to incorporate the latest science, data and laboratory technology into FSIS’s decision-making to identify ways to control Salmonella in poultry and reduce foodborne illness.

FSIS is developing two separate risk assessment models, in chicken and in turkey. These production-to-consumption risk models will estimate reductions in foodborne illness attributed to chicken and to turkey resulting from control of Salmonella. Specifically, the models will predict the impact of:

• controlling Salmonella prevalence, levels (enumeration), and subtypes of public health concern pre-harvest and post-harvest,

• implementing preharvest controls, post-harvest controls, and combined pre- and post-harvest controls, and

• establishing criteria limiting Salmonella prevalence, levels and/or subtypes, or requiring a specified reduction in a relevant indicator organism.

Inputs will include prevalence, levels, and subtypes of Salmonella at various points in the production-to-consumption chain, along with pre-harvest and post-harvest production practices.

FSIS will be able to use FSIS-generated data for some of the model inputs. Other inputs may be informed by published scientific studies, or expert elicitations. Outputs will include prevalence and levels of Salmonella, and Salmonella subtypes, at other points in the chain and the corresponding predicted public health impact, i.e., reduction in foodborne illnesses, of Salmonella control strategies. In this way, the risk assessment models enable FSIS to assess risk management options.

The purpose of this announcement is to advertise opportunities to parties who are interested in partnering with OPHS to provide research services to address the key objectives and focus areas in FSIS’ goal to build a stronger framework for the control of Salmonella in poultry.

Before any information is released to the public or disseminated to individuals beyond authorized users under the cooperative agreement, the Cooperator must submit to FSIS draft copies of all papers, publications and/or products to be reviewed, strictly for confidentiality purposes. In addition, FSIS will review draft papers, publications and/or products to ensure consistency with the scope of the purposes described above. We encourage applications from multi-disciplinary teams, to ensure we have the broad expertise needed. Applications from minority serving institutions are encouraged.

FSIS seeks a collaboration in the following areas:

1) Existing Industry Data. FSIS is seeking to collaborate with researchers who can gather and analyze data from the chicken and turkey industries. This would include data considered proprietary in nature. Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C.

§794d) must be adhered to throughout the life of the agreement. FSIS considers data generated by producers and processors of poultry potentially useful in developing these production-to-consumption risk models. For FSIS to effectively evaluate risk management options, it is essential to learn more about current prevalence and levels of Salmonella and Salmonella subtypes across the industry, the types of industry practices and food safety controls that are currently being used, and effects of these practices and controls. The following are examples of the types of data that could be useful in developing a production-to-consumption process simulation risk assessment model to assess the effects of FSIS risk management options:

1. Preharvest

1. Proportion and effectiveness of preharvest controls being used and whether these controls have different effects on different Salmonella subtypes:

(1) vaccination

(2) biosecurity

(3) feed

(4) water treatments

(5) probiotics/prebiotics

(6) bird density

(7) bedding management

(8) waste management

(9) other specific Salmonella control strategies on the farm

2. Proportion and types of pre-harvest testing and the results of such testing.

2. Postharvest

1. Effectiveness of postharvest controls and whether these controls vary based on differences in subtypes:

(1) staging slaughter of more highly contaminated flocks

(2) chemical interventions, high-pressure pasteurization, irradiation, ozone, or other treatments (refer to the FSIS Guideline for Controlling Salmonella in Raw Poultry: FSIS-GD-2021-0005 (usda.gov) for additional guidance)

2. Types and results of testing (pathogens, indicator organisms):

(1) products

(2) frequency

(3) serotyping

(4) concentrations/levels

(5) whole genome sequencing

3. Average monthly volume

4. Line speeds

5. Incoming product specifications

(1) Aerobic Plate Count (APC) load

(2) Salmonella prevalence

(3) Salmonella subtype

6. Type of laboratory support (e.g., data from accredited lab or whether AOAC-approved methods were used).

7. Process control indicators – results and consequences of testing for:

(1) APC

(2) generic E. coli

(3) Salmonella

(4) other https://www.fsis.usda.gov/sites/default/files/media_file/2021-07/FSIS-GD-2021-0005.pdf https://www.fsis.usda.gov/sites/default/files/media_file/2021-07/FSIS-GD-2021-0005.pdf

8. Hazard Analysis and Critical Control Point (HACCP) validation and verification.

9. Lotting practices

10. Bird characteristics (e.g., age, weight, genotypic resistance to Salmonella enteric colonization)

Because controls of levels and/or subtypes of Salmonella are possible risk management options, data related to levels or subtypes of Salmonella are especially important. Cooperators should describe what and how much data they will analyze and how they will summarize the data in a form suitable for use as inputs to the risk assessment models. Data sets should be complete.

FSIS encourages submissions from applicants who can provide data that are representative of the industry both geographically and seasonally. Ideally data sets would represent large, small and very small establishments.

Additionally, Cooperators should describe their relationships with the poultry industry (both chicken and turkey), their previous experience collecting and analyzing data, and how they will ensure that data they collect remain confidential. Specifically, the Cooperator may include excerpts of information in its research results for the USDA and/or for disclosure in USDA publications, BUT MAY NOT, under any circumstances: (i) identify any retailer or manufacturer, (ii) disclose any retailer-identifiable or manufacturer-identifiable information, including specific brands or product names and/or (iii) disclose any market share data at the retailer, brand, or item level in any market.

FSIS understands that the data may be proprietary or viewed as confidential business information. Pursuant to USDA's Freedom of Information Act (FOIA) regulations (7 CFR 1.1 et seq.), FSIS is responsible for making the determination with regard to the disclosure or nondisclosure of information in agency records that has been submitted by a Cooperator. When, in the course of responding to a FOIA request, FSIS cannot readily determine whether the information obtained from a person is confidential business information, the Agency will seek to obtain and carefully consider the views of the submitter of the information and provide the submitter an opportunity to object to any decision to disclose the information. FSIS will protect Cooperators’ confidential business information from public disclosure to the extent authorized under FOIA and in conformity with USDA's FOIA regulations.

2) Dose Response: An important part of the risk assessment models described above is how the dose of Salmonella to which people are exposed affects the probability of their becoming ill.

In the past, FSIS has used the dose-response relationship developed by the World Health Organization1 to predict human illnesses. This dose-response relationship, however, is based on combined information for all Salmonella subtypes, with no information on any subtype-specific dose-response. In order to evaluate risk management options that consider the public health impact of controlling one or more specific Salmonella subtypes in poultry, FSIS seeks

1 Ad Hoc Expert Consultations on Risk Assessment of Microbiological Hazards in Foods, Report of the Joint FAO/WHO Expert Consultation on Risk Assessment of Microbiological Hazards in Foods, FAO Headquarters, Rome, Italy, 17 - 21 July 2000 Report of the Joint FAO/WHO Expert Consultation on Risk Assessment of Microbiological Hazards in Foods https://www.fao.org/fileadmin/templates/agns/pdf/jemra/SL00_en.pdf https://www.fao.org/fileadmin/templates/agns/pdf/jemra/SL00_en.pdf assistance developing a dose-response methodology that considers differences in virulence among Salmonella subtypes. Applicants should describe their experience in developing dose-response relationships and describe one or more approaches that account for differences in subtype. The Cooperator will be expected to develop one or more methodologies for relating risk of illness to subtype- specific doses of Salmonella, and to work with FSIS to incorporate the dose-response relationships into the models.

B. FEDERAL AWARD INFORMATION

Available Funding

Total funding for this program is $295,000, including direct and indirect costs.

Start Dates

June 17, 2022

Performance Periods

The anticipated period of performance is from June 17, 2022, to April 14, 2023 (9 months) with the possibility of a no-cost extension for up to 3 months

Number of Awards:

Type of Award

This award is a cooperative agreement with substantial involvement of the awarding Agency.

The Awardee should expect to have a project officer assigned to them for regular discussions and to have subject matter experts (scientists, risk assessors, statisticians) from FSIS assist, guide, and/or coordinate project activities to meet FSIS risk assessment goals.

Procurement Contracts The Agency does not expect to award procurement contracts associated with this NOFO.

Eligibility of Renewal or Supplemental Project Applications

Applications for renewal or supplementation of existing projects are eligible to compete with applications for new Federal awards. An application for renewal means an application submitted to continue an existing agreement that meets the objectives and requirements of this NOFO. An application for supplementation of an existing project means an application to add components to an existing agreement so that it would meet the objectives and requirements in this NOFO.

Substantial Involvement

• Initial meeting between FSIS and Cooperator to launch the Cooperation – within 30 days of award date.

• Q4 FY22 – Q2 FY23 This period will comprise the majority of the work to be done:

o Cooperator gathers, cleans/formats, and analyzes available industry data (industry practices and microbiological data for flocks and poultry) and provides relevant summary statistics and supporting contextual information, working closely with FSIS as an integral part of the project team to incorporate this information into the exposure models. The Cooperator and identified partners under the cooperative agreement will have substantial involvement with FSIS in the conduct of both quantitative risk assessments – one for Salmonella in chicken and one for Salmonella in turkey.

o Cooperator considers the available scientific data and develops a Salmonella dose-response relationship that takes into consideration differences in strain virulence, working closely with FSIS as an integral part of the project team to discuss, evaluate and consider the supporting evidence (strengths and limitations), characterize the uncertainty in the dose-response relationship, and develop options to ensure the dose-response relationship is “fit-for-purpose”.

o FSIS also encourages the Cooperator to be an integral part of the FSIS-led project team developing these risk assessments. This includes:

participating in consideration of the current science, identify and evaluate modeling approach and mathematics, and/or supporting model simulation (scenario analyses, uncertainty analyses, sensitivity analyses).

Information Dissemination and Disclosures

Note that the risk assessments, including model mathematics and/or source code, data analyses, and/or preliminary draft reports, and all other products of the cooperative agreement, developed under this cooperative agreement are considered by the Office of Management and Budget (OMB) to be highly influential (i.e., they inform major U.S. food safety policies). In compliance with OMB requirements, FSIS must ensure those involved in the cooperative agreement do not disseminate, discuss, make public or use any part or portion of the risk assessments, internal deliberations or confidential data prior to clearance of these risk assessments by OMB to inform FSIS’ proposed policies. The Cooperator will have to ensure that stakeholders who partner with them (e.g. U.S.

chicken or turkey industries or consumer advocacy group in food safety) do not have access to any part or portion of the risk assessments, deliberations on these risk assessments, or enable access to them or the deliberations on them or by others who those affiliated with them (e.g., through other funding or partnerships) until they are cleared by OMB.

The Cooperator is welcome to utilize the risk assessments (e.g., source code/models) once they are public and the Cooperator can develop subsequent publications on this science in the literature. Any work that was done under the cooperative agreement in partnership with FSIS should be acknowledged and government cooperators be given authorship. If used in subsequent works, any models developed under the cooperative agreement should be cited and acknowledged as completed under the cooperative agreement with appropriate attribution to all authors, including federal ones.

• Q1 FY23 – Q2 FY23

o Actively contribute to sections of the risk assessment reports, to specifically include documentation of industry data collection and analyses and documentation of the dose-response model used in the risk assessment (relevant data and science, mathematics, and validation and/or calibration)

• Q2 FY23 – Q3 FY23

o In partnership with FSIS, respond to internal and independent external peer review comments and make changes to the risk assessments and models as needed based on reviews; resulting in final risk assessment models and documentation of revisions to the risk assessment/risk models in a Response to Peer Review Comment document.

C. ELIGIBILITY INFORMATION

Eligible Applicants Academic institutions, relevant non-government organizations, independent consultants specialized in microbial risk assessments for food safety, and/or multi-disciplinary groups that bridge the areas of expertise and responsibilities are sought as a Cooperator on this work.

Awardee must be a U.S. organization. Applications received by the deadline missing either a section or required document will not be reviewed.

Cost Sharing or Matching Cost sharing is not expected and will not be used as a factor during the merit review of any application hereunder.

D. APPLICATION AND SUBMISSION INFORMATION

Instructions for Proposal Submission The documents listed below must be submitted for a complete application. All proposals should be submitted electronically to the FSIS mailbox: George.baptist@usda.gov.

Page Limitations There is a 20-page limit for the Project Description section.

Supplemental materials (e.g., CVs, publications, etc.) should not exceed 30 pages for a total of limit of a proposal of 50 pages, not including the required forms under Section D.4.

Format Paper Size - 8 ½ by 11 inch Margin - 0.75 inch Font - Calibri or Times New Roman, 11-point or greater Spacing – single-spaced

Required Proposal Forms Submitted proposals should include the following sections and required forms listed in this announcement. The required forms are available on Grants.gov. However, all applications must be submitted electronically to the FSIS mailbox: George.baptist@usda.gov.

If an Applicant does not have access to the internet, the Applicant can request a hardcopy of the full NOFO by calling (202) 309-9141 between 9:00 A.M. and 5:00 P.M. EST or by contacting OPHS in writing at:

Joanna Zablotsky Kufel, Director 1400 Independence Ave, SW Room 341-E, J.L. Whitten Building Washington, DC 20250

All forms must have signatures from the proper officials at the submitting location. All proposals must be submitted as a PDF.

Application Package

This NOFO constitutes the full application package.

1) Abstract

• May not exceed 300 words.

2) Project description Proposals should describe:

• Data that will be provided, which is representative of the chicken and turkey industries and describe how it may be used in risk assessment models.

• Dose-response methodology that considers differences in virulence among Salmonella subtypes.

o See 1) and 2) in the Program Description for additional details of FSIS needs.

3) Budget explanation

• Narrative of the allocation of funds

4) Forms

• SF424 Application for Federal Assistance

• SF424A Budget Information for Non-Construction Programs

• SF424B Assurances for Non-Construction Programs

• Senior/Key Personnel Profile (Research & Related (R&R) Form) http://www.grants.gov/ o Include information, including resumes, on the Project Director/Principal Investigator and from those personnel most directly involved in the project activities.

• ATTACHMENT A Non-Disclosure Agreement

• ATTACHMENT B Conflict of Interest Form

• USDA AD-1047 Certification Regarding Debarment, Suspension, and Other

Responsibility Matters

• USDA AD-1049 Certification Regarding Drug-Free Workplace Requirements

• Grants.gov (GG) Lobbying Form Certification Regarding Lobbying

• Standard Form LLL (SFLLL) Disclosure of Lobbying Activities (if required)

Unique entity identifier and System for Award Management (SAM) Each applicant (unless excepted) is required to be registered in the SAM (System for Award Management) before submitting its application. The application must include a valid unique entity identifier and the applicant must continue to maintain an active SAM registration with current information at all times during the award period. The status of an applicant’s SAM registration may be used in the determination of an award. FSIS will not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and SAM requirements.

Submission Dates and Times Application Due Date: All proposals are to be submitted electronically to the FSIS mailbox George.baptist@usda.gov and must be received and be complete by 11:59 PM Eastern Standard Time, May 16, 2022.

Intergovernmental Review This initiative is not subject to intergovernmental review.

Funding Restrictions

• No construction costs are allowed.

• No pre-Federal award costs allowed.

• No travel costs should be included in the proposal.

FSIS cooperative agreement funds may only be used for the purposes set forth in the award and must be consistent with the statutory authority for the award. Cooperative agreement funds and non–monetary support may not be used for matching contributions for other Federal grants or cooperative agreements, lobbying, or intervention in federal regulatory or adjudicatory proceedings. Federal funds may not be used to sue the Federal Government or any other government entity. If an Applicant is selected for an award, the Applicant must acknowledge that no pre–award or travel costs are included in this award.

Other Submission Requirements: None

E. APPLICATION REVIEW INFORMATION

Criteria The Review Board will evaluate complete proposals based on the selection factors in Attachment C.

Review Process

• Will be reviewed by FSIS personnel from multiple offices.

• Will be scored by individual reviewers based on the criteria in Attachment C and given an overall average score.

Simplified Acquisition Threshold The Federal awarding agency, prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently Federal Awardee Performance and Integrity Information System (FAPIIS)) (see 41 U.S.C. 2313);

An applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered and is currently in the designated integrity and performance system accessible through SAM; and

The Federal awarding agency will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in §200.205 Federal awarding agency review of risk posed by applicants.

Anticipated Announcement and Federal Award Dates

• Salmonella Risk Assessment Cooperative Agreement Announcement – March 2, 2022

• Deadline for Submission of Proposals – May 16, 2022

• Preliminary Notification of Selected Proposals – May 31, 2022

• Award Date – June 17, 2022

F. FEDERAL AWARD ADMINISTRATION INFORMATION

Federal Award Notices The official and binding notice of award signed by a representative of FSIS’ Administrative Services Division (ASD) will be provided after review of all proposals and selection of the awardee. As such, the selection notification is not an authorization to begin performance. Any pre-award costs incurred by the awardee will not be reimbursed. The Notice of Grant and Agreement Award (ADS-093) signed by the authorized agency official is the only authorizing document and will be provided electronically to the entity’s authorized official for signature.

Both successful and unsuccessful applicants will be notified of the award decision via letter.

Administrative and National Policy Requirements

This cooperative agreement will be administered under the guidance of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (OMB Uniform Guidance 2014, available at Grants.gov).

Below are listed some of the pertinent conditions that will be followed.

Cooperative Agreement Terms and Conditions of Award Program monitoring of the award recipient will be conducted on an ongoing basis. Written reports will be reviewed and evaluated quarterly by the FSIS project officer. Project coordination will occur bi-weekly, at a minimum, in the form of telephone conversations/virtual meetings between the project officer (PO)/grants management specialist and the project director/principal investigator.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism (rather than an “acquisition” mechanism), in which substantial FSIS programmatic involvement with the awardee is anticipated during the performance of the activities. Under the cooperative agreement, FSIS’ purpose is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

An FSIS PO will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance and reviewing progress reports.

Reporting

Performance reports

• Required to be submitted by the Cooperator electronically

• Required 30 days after the end of each quarter o Due Dates:

o July 30, 2022 o October 30, 2022 o January 30, 2023 o April 30, 2023

Financial status (SF-425)

• Required to be submitted by the Cooperator electronically

• Required 30 days after the end of each quarter o Due Dates:

o July 30, 2022 o October 30, 2022 o January 30, 2023 o April 30, 2023

Financial reports

• Required electronically through the Payment Management System (PMS)

• Final performance and financial report o Required within 120 days of the end of the award period Award Period: June 17, 2022 - April 14, 2023.

Final Performance/Financial Report Due: July 16, 2023

*Submissions should be sent to Joanna Zablotsky Kufel at Joanna.zablotsky-kufel@usda.gov.

Reports should include, at a minimum, the following information:

• Reporting period (e.g., Q1, FY2023)

• Status:

o Provide a brief summary of the progress made on the cooperative agreement, in relation to the objectives and goals, for the reporting period indicated. The progress on each task, as well as the project as a whole, should be approximated in percentage of completion.

• Progress in Reporting Period o Provide a list of each task or phase planned for the reporting period, along with a description of the work completed on each. If any tasks could not be completed as planned, an explanation of why the task could not be completed should be provided.

• Activities Planned for Next Reporting Period o Describe the proposed activity for each task or phase, as appropriate, for the next reporting period. Indicate if any barriers are anticipated in the next reporting period, and how, if possible, those barriers can be mitigated.

• Findings o Describe any significant technical information, findings, or implementation resulting from work conducted during the period or to date.

• Anticipated Problems/Course of Action o Describe any administrative or technical problems in the conduct of the project.

Explain the need for any anticipated or imminent changes in project scope, time, or cost.

• Contact Information o Name and title of the person preparing the report.

mailto:Joanna.zablotsky-kufel@usda.gov

G. FEDERAL AWARDING AGENCY CONTACT(S)

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

• Science-related questions:

Joanna Zablotsky Kufel, Director, Risk Assessment and Analytics Staff (RAAS), FSIS Email: Joanna.zablotsky-kufel@usda.gov

Phone: 202-309-9141

• Technical/administrative question related to the cooperative agreement:

George Baptist III, Branch Chief, Administrative Services Division, FSIS Email: George.baptist@usda.gov Phone: 202-604-6767

For more information about FSIS please visit: https://www.fsis.usda.gov/ mailto:Joanna.zablotsky-kufel@usda.gov http://www.fsis.usda.gov/

FY 2022 GENERAL GRANT AND COOPERATIVEAGREEMENT

TERMS AND CONDITIONS

By accepting funds under this award from USDA’s Food Safety and Inspection Service (FSIS) the recipient agrees to comply with, and include in all awards and subawards, these General Terms and Conditions, the program-specific terms and conditions, all applicable Federal statutes, regulations and guidelines, and any amendments thereto. The recipient agrees to operate the funded program in accordance with the approved application and budget, supporting documents, and other representations made in support of the approved application. The term recipient is used to connote either recipient or subrecipient, as appropriate, throughout these General Terms and Conditions.

TABLE OF

CONTENTS

II. Governing Authorities

II.A. Legislative and Regulatory Authority II.B. Other Applicable Terms and Conditions II.C. Order of Precedence III. General Terms and Conditions III.A. Responsibilities Under Award Administration Legislative and Regulatory

Authority

III.B. Financial Management Standards III.C. Changes in Budget or Key Personnel

III.D. Bankruptcy III.E. Prohibited Program Activities

III.F. National Service Criminal History Check Requirements III.G. The Office of Inspector General III.H. Recognition of FSISFSIS Support

III.I. Reporting of Fraud, Waste, and Abuse III.J. Whistleblower Protection III.K. Liability and Safety Issues

III.M. Non-Discrimination Public Notice and Records Compliance

III.N. Identification of Funding III.O. Award Products

III.P. Suspension or Termination of Award III.Q. Grantee Procurement III.R. Trafficking in Persons

III.S. System of Award Management (SAM) and Universal Identifier Requirements (Required Provision Under 2 CFR § 25.220)

III.T. Transparency Act Requirements (For Grants and Cooperative Agreements of $30,000 or more)

III.U. Conflict of Interest III.V. Award Term and Condition for Recipient Integrity and Performance

Matters (Required Provision under 2 CFR § 200.210(b)(iii) for Grants and Cooperative Agreements of $500,000 or more)

III.W. Breaches of Personally Identifiable Information (PII)

IV. Attachment

I. GOVERNING AUTHORITIES

A. LEGISLATIVE AND REGULATORY AUTHORITY

This award is authorized by and subject to The National and Community Service Act of 1990, as amended, (42 U.S.C. 12501 et seq.) (NCSA) and/or the Domestic Volunteer Service Act of 1973, as amended, (42 U.S.C. 4950 et seq.)

(DVSA), the Federal Grant and Cooperative Agreement Act (FGCAA), 31 U.S.C. §§6301-6308, and FSISFSIS’ implementing regulations in 45 CFR Chapter XII and/or XXV. Recipients must comply with the requirements of the NCSA and/or DVSA and FSIS’ implementing regulations, as applicable.

B. OTHER APPLICABLE TERMS AND CONDITIONS

This award is subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards located at 2 CFR Part 200 and the agency’s implementing regulation at 2 CFR Part 2205 (hereinafter, the Uniform Guidance). Award recipients must read, understand, and implement these federal regulations. 2 CFR Part 200 was amended on August 2020. Please refer to Section III.O below.

The recipient must comply with all other applicable statutes, executive orders, regulations, and policies governing the award, including, but not limited to, those included in 2 CFR Chapter I, as well as those cited in these General Terms and Conditions and Program Specific Terms and Conditions, and the Assurances and Certifications. Some of these requirements are discussed in these General Terms and Conditions to provide emphasis or additional explanations to recipients. Other provisions are included in these FSIS’ General Terms and Conditions because they are required by specific laws or regulations.

In addition to the applicable statutes and regulations referred to above, the recipient must comply with and perform its award consistent with the requirements stated in:

1. The Notice of Grant Award and Signature Page;

2. These General Terms and Conditions;

3. The Program Specific Terms and Conditions;

4. The Notice of Funding Availability;

5. The recipient’s approved application (including the final approved budget, attachments, and pre-award negotiations); and

6. Grant Certification and Assurances.

C. ORDER OF PRECEDENCE

Any inconsistency in the authorities governing the Award shall be resolved by giving precedence in the following order: (a) applicable Federal statutes, (b) applicable Federal regulations, (c) Notice of Grant Award and Signature Page;

(d) FSIS Program Specific Terms and Conditions, (e) FSIS General Terms and Conditions, (f) the Notice of Funding Opportunity, and (g) the approved Award Application including all assurances, certifications, attachments, and pre-award negotiations.

II. GENERAL TERMS AND CONDITIONS

A. RESPONSIBILITIES UNDER AWARD ADMINISTRATION

1. Accountability of the Recipient. The recipient has full fiscal and programmatic responsibility for managing all aspects of the award and award-supported activities, subject to the oversight of FSIS. The recipient is accountable to FSIS for its operation of the program and the use of FSIS award funds. The recipient must expend award funds in a manner consistent with the cost principles in 2 CFR and in a reasonable manner, and it must record accurately the service activities and outcomes achieved under the award. Although recipients are encouraged to seek the advice and opinion of FSIS on special problems that may arise, such advice does not diminish the recipient’s responsibility for making sound judgments and does not shift the responsibility for operating decisions to FSIS.

2. Subawards. If authorized by law and permitted by FSIS, a recipient may make subawards in accordance with the requirements set forth in the

Uniform Guidance. The recipient must have and implement a plan for oversight and monitoring that complies with the requirements applicable to pass through entities identified at 2 CFR § 200.331 to ensure that each subrecipient has agreed to comply, and is complying, with award requirements.

A recipient of a Federal award that is a pass-through entity has certain obligations to its subrecipients. Those requirements are located at 2 CFR § 200.331, §200.207, § 200.338, and 2 CFR Part 200 Subpart F.

3. Notice to FSIS. The recipient will notify the appropriate FSIS Program

Manager immediately of any developments or delays that have a significant impact on funded activities, any significant problems relating to the administrative or financial aspects of the award, or any suspected misconduct or malfeasance related to the award or recipient. The recipient will inform the FSIS Program Manager about the corrective action taken or contemplated by the recipient and any assistance needed to resolve the situation. Recipients should also ensure that they comply with the mandatory reporting requirements for suspected criminal activity or fraud, waste or abuse as specified in section III. H.

B. FINANCIAL MANAGEMENT STANDARDS

1. General. The recipient must maintain financial management systems that comply with 2 CFR§ 200.302(b). The recipient’s financial management systems must be capable of distinguishing expenditures attributable to this award from expenditures not attributable to this award. The systems must be able to identify costs by program year and by budget category, and to differentiate between direct and indirect costs. For all recipient’s financial management requirements and responsibilities, refer to Subparts D and E of 2 CFR Part 200.

2. Allowability of Costs. To be allowable under an award, costs must meet the criteria of 2 CFR§ 200.403, which provides that costs must be necessary and reasonable for the performance of the award, must conform to limitations in the award or 2 CFR Part 200 as to types or amounts of cost items, must be consistent with policies and procedures that apply uniformly to both Federally financed and other activities of the recipient, must be adequately documented, and must not be included as a cost or used to meet cost share or matching requirements of any other Federally financed program. Furthermore, the costs must be accorded consistent treatment in like circumstances as either direct or indirect costs in order to avoid the double-charging of Federal awards (see 2 CFR § 200.403(d) and § 200.412).

3. Cost Reporting. Recipients will be reporting their Federal cash disbursements quarterly through the Payment Management System (PMS) at the Department of Health and Human Services and their Federal share of grant program expenditures (including indirect costs) semi- annually through FSIS’ eGrants system. Recipient’s financial management systems must be able to routinely produce reports which support and reconcile to the amounts reported to PMS and eGrants. Recipients must also ensure that the financial management systems of any subrecipients can routinely produce the same reports. As part of its ongoing fiscal oversight of recipients, FSIS will be requesting randomly selected recipients to provide reports supporting their Federal cash disbursements reported to PMS (including supporting information for cash disbursements made by subrecipients). FSIS expects recipients’ and subrecipients’ financial management systems to be able to produce those supporting reports on a routine basis.

4. Audits. Recipient organizations that expend $750,000 or more in total

Federal awards in a fiscal year shall have a single or program-specific audit conducted for that year in accordance with the Single Audit Act, as amended, 31 U.S.C. 7501, et seq., and 2 CFR Part 200, Subpart F. If the recipient expends Federal awards under only one Federal program, it may elect to have a program specific audit, if it is otherwise eligible. A recipient that does not expend $750,000 in Federal awards is exempt from the audit requirements for that year. However, it must continue to conduct financial management reviews of its subrecipients, and its records and its subrecipients’ records must be available for review and audit in accordance with 2 CFR §§ 200.333-200.337 and §200.331(a)(5). Additionally, a recipient acting as a pass- through entity must issue management decisions for audit findings pertaining to the Federal award provided to the subrecipient as required by 2 CFR § 200.521 and ensure follow-up on audit findings in a timely manner to ensure that the subrecipient corrects any deficiencies identified in the audit.

C. CHANGES IN BUDGET OR KEY PERSONNEL

All budget and programmatic changes must comply with 2 CFR § 200.308 – Revision of budget and program plans. 2 CFR § 200.407 Prior written approval (prior approval) – provides an exhaustive list of those other items requiring FSIS’ advance approval.

D. BANKRUPTCY

The recipient must notify FSIS if, during the term of its award, the recipient or one of its subrecipients becomes insolvent or is unable to pay its debts as they mature, or files a voluntary petition in bankruptcy or is the subject of an involuntary petition that is neither stayed nor dismissed within 60 days after the petition is filed.

E. PROHIBITED PROGRAM ACTIVITIES

The recipient must comply with, and require all subrecipients to comply with, the prohibitions on use of FSIS funds applicable to their program as identified in sections 132A and 174 of the NCSA (42 U.S.C. §§ 12584a and 12634) and section 403 of the DVSA (42 U.S.C. § 5043), and provisions by Congress in annual appropriations acts. More specific guidance on these prohibitions will be provided in FSIS’ Program Specific Terms and Conditions and in other guidance.

F. THE OFFICE OF INSPECTOR GENERAL

FSIS’ Office of Inspector General (OIG) conducts and supervises independent audits, evaluations, and investigations of FSIS’ programs and operations.

Based on the results of these audits, reviews, and investigations, the OIG recommends disallowing costs and also recommends amending or adding policies to promote economy and efficiency and to prevent and detect fraud, waste, and abuse in FSIS’ programs and operations.

The OIG conducts and supervises audits of FSIS recipients, as well as legally required audits and reviews. The legally required audits include evaluating FSIS’ compliance with the Improper Payments Elimination and Recovery Act (IPERIA) which may result in grantees being requested to produce responsive documentation. The OIG uses a risk-based approach, along with input received from FSIS management, to select recipients and awards for audit. The OIG hires independent audit firms to conduct some of its audits. The OIG audit staff is available to discuss any audit and can be reached at (202) 606-9390.

Recipients must cooperate fully with FSIS requests for documentation and OIG inquiries by timely disclosing complete and accurate information pertaining to matters under investigation, audit or review, and by not concealing information or obstructing audits, inspections, investigations, or other official inquiries.

G. RECOGNITION OF FSIS SUPPORT

1. General Statement. Recipients and subrecipients of federal agency

FSIS assistance or resources shall identify their programs, projects or initiatives as FSIS or FSIS Seniors programs or projects accordingly.

All agreements with subrecipients, operating sites, or service locations, related to FSIS programs and initiatives must explicitly state that the program is an FSIS or FSIS Seniors program.

Similarly, recipients and subrecipients shall identify all national service members or volunteers serving at their programs, projects or initiatives as either FSIS members, FSIS Seniors volunteers, Day of Service volunteers or where appropriate for Volunteer Generation Fund simply “volunteers.”

2. Visual Representations and Prominent Display. Recipients shall identify their programs, projects, or initiatives, and their members or volunteers, through the use of visual representations, including: logos;

insignias; written acknowledgements, publications and other written materials; websites and social media platforms; and service gear such as clothing. All visual representations must follow current FSIS branding guidelines, which include proper logo use and cobranding requirements.

Please contact your FSIS Program Manager for assistance.

All recipient and subrecipient websites and social media communications shall clearly state, as appropriate, that they are an FSIS recipient or funded by a grant from FSIS and shall prominently display the FSIS or FSIS logo.

Recipients and sub-recipients shall prominently display the FSIS, name and logo on all service gear and public materials, in accordance with FSIS’ requirements.

3. Acknowledgement and Disclaimer on Published Materials. The appropriate FSIS logo shall be included on publications related to an award of FSIS assistance or resources. An acknowledgement and disclaimer shall be displayed on all reports and other published materials based upon work supported by the award. The acknowledgement and disclaimer may contain language the same as or similar to:

This material is based upon work supported by FSIS under Grant No(s) [ ]. Opinions or points of view expressed in this document are those of the authors and do not necessarily reflect the official position of, or a position that is endorsed by, FSIS.”

4. Alteration of Brand Identities Prohibited Without FSIS Written Permission. Recipients may not alter the FSIS logo or other FSIS branding and must obtain written permission from FSIS before using the FSIS name or logo on materials that will be sold. Recipients must also obtain written permission from FSIS before permitting donors to use the FSIS name or logo, or the FSIS Seniors name or logo in promotional materials.

5. Prohibited Use or Display of Names and Logos for Certain

Activities. The recipient or subrecipient may not use or display the FSIS name or logo, or the FSIS Seniors name or logo in connection with any activity prohibited by statute or regulation, including any political activities.

I. REPORTING OF FRAUD, WASTE, AND ABUSE

Recipients must contact the OIG and their Project Manager without delay when they first suspect:

1. Any criminal activity or violations of law has occurred, such as:

• Fraud, theft, conversion, misappropriation, embezzlement, or misuse of funds or property by any person, including FSIS personnel, grantees, or contractors—even if no federal funds or property was involved;

• Submission of a false claim or a false statement by any person in connection with any FSIS program, activity, grant or operations;

• Concealment, forgery, falsification, or unauthorized destruction of government or program records;

• Corruption, bribery, kickbacks, acceptance of illegal gratuities, extortion, or conflicts of interest in connection with operations, programs, activities, contracts, or grants;

• Other misconduct in connection with operations, programs, activities, contracts, or grants; or

• Mismanagement, abuse of authority, or other misconduct by FSIS personnel.

2. Fraud, waste, or abuse.

• Fraud occurs when someone is intentionally dishonest or uses intentional misrepresentation or misleading omission to receive something of value or to deprive someone, including the government, of something of value.

• Waste occurs when taxpayers do not receive reasonable value for their money in connection with a government-funded activity due to an inappropriate act or omission by people with control over or access to government resources.

• Abuse is behavior that is deficient, objectively unreasonable, or improper under the circumstances. Abuse also includes the misuse of authority or position for personal financial gain or the gain of an immediate or close family member or business associate.

The OIG maintains a hotline to receive this information, which can be reached by telephone at (202) 720-8001. Upon request, OIG will take appropriate measures to protect the identity of any individual who reports misconduct, as authorized by the Inspector General Act of 1978, as amended. Reports to OIG may also be made anonymously.

The…