SOW WIC Food Packages Scientific Review FINAL.pdf

USDA Food and Nutrition Administration (FNA) WIC Food Packages Scientific Review

STATEMENT OF WORK

I. INTRODUCTION

Consistent with the requirements set forth in the Child Nutrition Act of 1966,1 the U.S.

Department of Agriculture (USDA) Food and Nutrition Administration (FNA) is seeking a contractor to conduct a comprehensive scientific review of the supplemental foods available under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program, updating the 2017 review conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM). 2 The primary aims of this review will be to:

1) Review and assess the food and nutritional status and needs of the WIC-eligible population

2) Provide specific scientifically-based recommendations based on this review and the preponderance of scientific evidence including the most recently available science; and

3) Ensure that the recommendations would result in WIC food packages that:

i. Are consistent with the most recently available nutrition science,

ii. Address the health and dietary patterns of the WIC participant population, and

iii. Can be efficiently operationalized and effectively administered across the

Nation.

II. BACKGROUND

WIC is a major component of America’s commitment to adequate nutrition for low-income households. WIC was established in 1972 to provide nutritious supplemental foods, nutrition education, and referrals to related health and social services to low-income pregnant, breastfeeding and non-breastfeeding and postpartum women, infants and children up to age 5 who are at nutritional risk. WIC participants receive a monthly benefit from one of seven science-based food packages, according to their life stage nutritional needs. Participants then use their WIC electronic benefit transfer (EBT) card to buy the food and beverages in their package.

The WIC food packages provide supplemental foods designed to meet the special nutritional needs of participants. Combined with breastfeeding support and promotion and nutrition education, the WIC food packages, are the primary ways by which WIC impacts the dietary quality, habits, and feeding practices of participants.

The Child Nutrition Act of 1966 directs the Secretary of Agriculture to, at least every 10 years:

“(i) conduct a scientific review of the supplemental foods available under the program;

and (ii) amend the supplemental foods available, as necessary, to reflect nutrition science, public health concerns, and cultural eating patterns.”

1 Section 17 of the Child Nutrition Act of 1966 (as amended through P.L. 107-249, October 23, 2002.)

2 National Academies of Sciences, Engineering, and Medicine. 2017. Review of WIC Food Packages: Improving Balance and Choice: Final Report. Washington, DC: The National Academies Press.

DOI: https://doi.org/10.17226/23655.

https://doi.org/10.17226/23655

To-date two scientific reviews of the WIC food packages have been commissioned by the USDA Food and Nutrition Administration through the National Academies of Science, Engineering, and Medicine’s (NASEM) Food and Nutrition Board (formerly the Institute of Medicine). The first review began in 2003 with recommendations published in a 2006 report entitled “WIC Food Packages: Time for a Change.”3 The second review began in 2014 with recommendations published in a 2017 report entitled “Review of WIC Food Packages: Improving Balance and Choice: Final Report.”2 In response to the 2017 report recommendations, FNA published a proposed rule to revise the WIC food packages in November 2022 and a final rule in April 2024.

While dates for implementation vary based on the type of food package change, States agencies were required to make most changes by April 2026.4

FNA is seeking a qualified contractor to conduct the third comprehensive scientific review of the WIC food packages, building upon the scientific evidence in the previous two reports and the current food packages as codified in regulation.

III. DEFINITIONS

DGA: Dietary Guidelines for Americans DRI: Dietary Reference Intake EBT: Electronic Benefit Transfer FNB: Full Nutrition Benefit FNA: Food and Nutrition Administration MMA: Maximum Monthly Allowance NASEM: National Academies of Science, Engineering, and Medicine USDA: U.S. Department of Agriculture WIC: Special Supplemental Nutrition Program for Women, Infants, and Children

IV. SCOPE

The project is expected to be conducted in two phases. During Phase I, the contractor shall review all relevant scientific literature to ensure that the WIC food packages are scientifically based; assess current science on the nutritional needs of the WIC target population; review information on the dietary intake of WIC participants; and examine public health concerns and issues surrounding different types of eating patterns.

As part of this process, the contractor shall convene an expert committee and conduct no less than six expert committee meetings. In addition, the contractor shall conduct not less than two full day public forums to gather professional and public input. At the conclusion of Phase I, the contractor shall issue a Phase I Report that provides an assessment of the nutritional needs of the WIC population relative to current nutritional science, a discussion of how well the current WIC

3 Institute of Medicine. 2006. WIC Food Packages: Time for a Change. Washington, DC: The National Academies Press. DOI: https://doi.org/10.17226/11280.

4 USDA Food and Nutrition Service. 2025. Revisions to the WIC Food Package. Retrieved from:

https://www.FNA.usda.gov/wic/food-packages/background-revisions.

https://doi.org/10.17226/11280 https://www.fns.usda.gov/wic/food-packages/background-revisions food packages address these needs within the supplemental framework, modeling and analyses to be conducted in Phase II, and a preview of the Phase II recommendation development process.

Phase II will include a Phase II Report containing detailed documentation of all findings and specific recommendations for changes in the foods and amounts of food provided in the WIC food packages for each of the various types of WIC food packages. The recommendations for each of the packages should be supported by a discussion of the nutritional rationale (including but not limited to discussion of the latest nutritional science and other expert recommendations), a food group and subgroup and nutrient analysis, and estimated annual costs or savings compared to baseline of the individual food changes. In addition, the recommendations for all the packages should be presented as a recommendation supported by an estimate of the annual cost or savings and change from baseline. The recommendations may include options; however, the cost of each recommended set of changes shall be estimated separately for each food package.

V. RESEARCH QUESTIONS

All work performed under this contract shall address the research questions listed below while taking into account the following specific considerations:

• The WIC-eligible population’s nutritional needs and status considering life stage and population characteristics (such as, but not limited to, known risk conditions of the WIC-eligible population);

• The supplemental nature of the WIC Program;

• The role of the WIC food packages in achieving positive health outcomes;

• Costs;

• The economic role of WIC State agency contracts for infant formula rebates (in the case of recommendations to change the infant formula allowances);5

• Redemption rates of specific food categories;

• The role of the food packages on WIC participation and retention patterns;

• Public health concerns and eating patterns, as required in the statute;

• Nationwide marketplace availability of recommended foods and package sizes;6

• Implementation cost and feasibility for WIC State and local agencies;

• The scope of practice and time constraints of participant-facing WIC staff;

5 Nutritional adequacy of infant formulas is established and monitored by FDA. WIC formulas must meet FDA standards. Therefore, the contractor should review only maximum allowances of infant formulas in the context of the supplemental nature of WIC food packages rather than the nutritional adequacy of formulas.

6 The contractor shall consider foods that are: (1) easily apportioned into daily servings for an individual over a month's time; and (2) readily available in the marketplace. The contractor should not consider foods under development or recommend the development of foods not currently on the market.

• Burdens and incentives for WIC vendors, participants, potential participants, and their families; and,

• Comments received from the public.

Below is a list of research questions that shall guide this scientific review. When answering each of the research questions, the expert committee shall provide the rationale and recommendations for change.

Questions related to priority nutrients for the WIC-eligible population:

• Based on the current science and review of the WIC target population’s nutritional needs, what are the priority nutrients for inclusion in the WIC food packages? (WIC priority nutrients are those deemed critical for healthy growth and development that science and that research has demonstrated are lacking in the diets of WIC’s target population.)

• To what degree do the current food packages provide those priority nutrients?

• Given redemption data, are the food categories (and WIC-eligible foods in these categories) achieving the goal of delivering appropriate amounts of priority nutrients?

• What are the potential impacts of lowering amounts of or eliminating under-redeemed food items?

ο What, if any, are other foods to replace under-redeemed food items that would better meet the WIC population’s needs to deliver priority nutrients?

• Among the priority nutrients for inclusion in the WIC food packages, is there a hierarchy? If so, what is the hierarchy and how was that hierarchy determined?

ο Outside of cost considerations, should amounts of one or more nutrients reflect a hierarchal need among the other priority nutrients?

ο Do cost considerations change the hierarchy?

Questions related to substitution options and tailoring food packages:

• What additional substitutes (and substitution amounts and ratios, as applicable) address various needs: public health concerns, eating patterns, special diets (such as, but not limited to those related to allergies, vegan and vegetarian dietary patterns), housing and living conditions (such as, but not limited to limited resources to prepare store or food), etc.?

• Should the fully breastfeeding infant food package have substitution options (vegetarian and non-vegetarian) for infant meats and if so, what would be the maximum monthly allowance (given package size availability vs the supplemental amount appropriate for an infant) and nutrient considerations (minimum requirements and nutrient specifications), as well as food safety issues and heavy metal concerns?

Special topics:

• How appropriate is the early introduction of allergy-containing foods through the WIC food packages, what would be the practical application of this practice, and how would it align with WIC’s legislative intent as a supplemental nutrition program designed to provide priority nutrients lacking in the diets of its target population?

• While protein has not been a priority nutrient for the WIC-eligible population for a significant amount of time, does the research indicate issues with the protein quality in (added to) plant-based milk, yogurt, and cheese alternatives?

• What specific adjustments, if any, should be made to the WIC food packages to support the nutritional needs of individuals who are pregnant with multiples while breastfeeding multiples?

Questions related to minimum requirements and nutrient specifications:

• What opportunities, if any, are there to reduce (or further reduce) nutrients the WIC target population should consume less of in the WIC food packages?

ο How would reducing these nutrients potentially affect participants’ acceptance of foods and, therefore, the goal of delivery priority nutrients to participants?

• Are there additives or other ingredients FNA should consider limiting in WIC-eligible foods based on the body of evidence for a particular ingredient? (e.g., additives found in WIC-eligible foods.)

Questions related to WIC formula:

• What does current science say about infant formula iron requirements and how does that compare to WIC’s requirement of 1.5 mg/100 kcal (10 mg/L)? What, if any, are the recommendations for revising this requirement?

• The definition of full nutrition benefit (FNB) of infant formula is based on reconstituted liquid concentrate. Does the committee recommend revising the FNB definition to use estimated energy needs for the formula fed infant as the underlying basis, and if so, what is a suggested revision?

• If the committee recommends a revised definition for FNB, what would be the recommended formula issuance amounts and infant feeding timeframes? Additionally, would the committee recommend changes to the maximum monthly allowance (MMA) amounts based on the redefined FNB?

• Among WIC infant participants receiving the partial breastfeeding or full formula food packages, is there still a need to establish FNB amounts for these breastfeeding infants, given that formula volumes are individually tailored to minimize supplementation and support breastfeeding?

• Within the WIC-eligible population, are there specific subgroups for whom liquid concentrate infant formula is nutritionally or medically necessary and the optimal physical form of formula?

• Given the variety of product types and physical forms of WIC formula products, how should these items be issued – reconstituted fluid ounce amount, protein needs, kilocalories, or some other method?

• What quantities of WIC formula should be available to medically fragile children and women participants (i.e., those receiving Food Package III)?

VI. PERIOD OF PERFORMANCE

The period of performance shall be four years (48 months) from the date of award.

VII. TASKS

Task 1: Kickoff Meeting

Within two weeks of the contract award date, the contractor shall meet with FNA staff to discuss considerations for the research questions, transfer of FNA data, and other information that would aid in the analyses. Following the meeting, the contractor shall submit a kickoff meeting summary of the discussion and key decisions made.

Task 2: Quarterly Progress Reports

The contractor shall submit progress reports on a quarterly basis to the Contracting Officer (CO) and Contracting Officer’s Representative (COR). Quarterly reports shall specify details regarding WIC site visits and food shopping experiences as well as details on the progress of each contract task. The site visits and shopping experience visits shall be conducted as follows:

WIC Site Visits Within six months of appointment to the expert committee, each member shall visit a local WIC site to observe how participants enroll and receive benefits and other WIC services including nutrition assessment, nutrition education, and benefit issuance.

WIC Food Shopping Experience To the extent practicable, within the first eight months following contract award, each committee member shall conduct at least one retail purchase using WIC EBT, including but not limited to the fruit and vegetable cash-value benefit and other WIC foods besides infant formula. All food obtained shall be donated to a local food bank, pantry, or soup kitchen.

Task 3: Public Forums and Open Meetings

Public Forums Consistent with previous scientific reviews of the WIC food packages, the expert committee shall conduct at least two public forums to hear public testimony. Each forum shall be at least one full business day. The dates/times and location of the forums shall be determined in collaboration with FNA. The public shall be notified about the scheduled forum at least 60 days prior to the scheduled date. The contractor shall provide USDA with unedited verbatim transcripts of each forum within 60 days and maintain an ongoing method of collecting comments and any supporting materials submitted for the record via online portal or in a format FNA finds agreeable.

Open Meetings In addition to the public forums, the expert committee shall invite FNA to speak at no fewer than two open meetings of the committee, including (1) the first open meeting following establishment of the committee and (2) the first open meeting following publication of the Phase I Report. The contractor shall deliver a summary of the open meeting to FNA within two weeks of the meeting being held.

Task 4: Phase I Report

The contractor shall produce a Phase I Report that includes, but is not limited to, a set of principles that will guide the subsequent work of the committee and detailed plans for completing the scientific reviews and data analyses, modeling, and impact assessment that will inform the Phase II Report recommendations. The Phase I Report shall also include a dietary analysis and nutrient profiles of current and revised WIC food packages (described in more detail below). The contractor shall deliver the Phase I Report to FNA and publish the report to the web for free public access and easy download.

Dietary Analysis:

The Phase I Report shall include a detailed nutrient, food group and subgroup, and food expenditure analysis of the most recently available data for the WIC population. The findings shall be presented for each of the WIC categories and by DRI age and lifecycle group.

Nutrient Profiles of Current and Revised WIC Food Packages:

The Phase I Report shall include detailed analyses of the nutrient content of the current and recommendations for revised WIC food packages. The contractor shall use the analyses to compare nutrient content between the current and recommendations for revised food packages and shall include a discussion of the changes with a rationale for each. The analyses and resulting data shall be presented in the same way prior WIC food packages reviews included them.

The Phase I Report shall also include the following specific components:

1) The data sources to be used in Phase II;

2) How the concepts in the DRI assessment and planning reports were applied;

3) How the sensitivity analysis will be incorporated into the Phase II work on food groups, priority nutrients, and costs;

4) How cost implications and market effects will be addressed in Phase II; and

5) How the regulatory impact analysis will be conducted, including an outline for the structure of these components of the final report.

Task 5: Phase II Report

The contractor shall produce a Phase II Report that includes an update of information from the Phase I Report, as needed, to provide a single comprehensive report on the subject in the Phase II Report and a review of the scientific information, methods, and assumptions underlying all recommendations in the report. The Phase II Report and recommendations shall reflect the most recent nutrition science, public health concerns, and eating patterns (as required by statute) and give full consideration to expert reports including, but not limited to, the Dietary Reference Intakes (DRIs), reports and policy statements of the American Academy of Pediatrics, and nationwide scientific reports on obesity, food security, food safety, nutrition during pregnancy, the postpartum period, infancy, and early childhood.

The final Phase II report must include the following:

• A dedicated section or chapter, describing all the recommended changes to the food packages, including food types, amounts, nutrient specifications, and substitutions. This section shall describe the science-based rationale for all recommendations in plain language.

• Clear statement(s) of priority nutrients and rationales, including why the priority nutrients identified for the WIC population may be different from nutrients of public health concern for the general population.

• Draft food package tables that reflect the committee’s recommended changes (i.e., tables that appear in regulations at 7 CFR 246.10(e)(9), (10), and (11)).

• A cost for each recommended food package change while assuming cost neutrality for the overall changes.

• A cost-benefit sensitivity analysis of the specific recommendations made in the Phase II Report.

• Recommendations based on the nutritional needs of WIC’s target population and hierarchy of priority nutrients that would require additional funding beyond the relative cost of the current food packages.

Documentation of Findings and Recommendations The findings and recommendations in the Phase II Report shall be supported by a data analysis, review of all relevant (both supporting and detracting) scientific literature, modeling of the dietary impacts on the various categories of WIC participants, and consideration of the practical aspects of program implementation, infant and child feeding, participant education, benefit delivery, vendor impacts, and market impacts. The deliverables shall include electronic copies of all nonproprietary databases used in the analysis and modeling, spreadsheets, analytic code, and full documentation to enable complete replication and extension of the analyses by FNA and the public.

Impact Analysis At least one chapter in the Phase II Report shall provide a regulatory impact analysis similar to, or of broader scope, complexity, and detail than, the regulatory impact analyses published by

USDA in support of the proposed and final versions of the most recent comprehensive updates to the WIC food packages. The format shall meet all current requirements of the Office of Management and Budget for such documents.

Sensitivity Analysis Because changes to the WIC food packages can impose significant implementation and administrative burdens, the Phase II Report shall include a sensitivity analysis chapter evaluating alternatives for food inclusion, exclusion, and quantity changes. These analyses shall present findings for nutrient levels (quantities and percentage of WIC participants with inadequate intakes relative to DRIs), food groups and subgroups (e.g., percent meeting DGA recommendations), and cost. Analyses shall be conducted regarding individual items and combinations (e.g., cost neutral adjustments that increase the fruit and vegetable cash-value benefit while reducing other foods).

Cost Neutrality The primary recommendations for the WIC food packages in the Phase II Report shall, in aggregate, be cost neutral (defined as within ±$0.10 of the Program’s per participant average monthly food cost). For reference, the FY2025 per participant monthly average was $64.82.

Research Recommendations The Phase II Report shall include a prioritized list of recommended data collections, analyses, demonstrations, and studies that would support documenting the impacts of recommended changes. It shall also include a prioritized list of research needs for the next decennial scientific review of the WIC food packages.

Versions and Format No later than 24 months following completion of the Phase I report, the contractor shall deliver the complete pre-publication version of the Phase II Report to FNA. As soon as practicable following delivery of the pre-publication version (not no later than 6 months), the contractor shall deliver the publication version of the Phase II Report to FNA and publish this report to the web for free public access and easy download.

The contractor shall deliver a pre-publication and publication version of the Phase II Report in the following formats:

• Phase II Report (pre-publication version): The contractor shall deliver electronic files of the report in Microsoft Word and PDF formats.

• Phase II Report (publication version): The contractor shall deliver a bound book with full color gloss cover: 40 printed copies. The contractor shall also deliver electronic files of the report in Microsoft Word and PDF format. The version of the report shall be 508 compliant.

Data Files and Documentation With delivery of each version of the Phase II Report, the contractor shall submit electronic copies of all non-proprietary data files used in the analysis and modeling, including spreadsheets, analytic code, and full documentation to enable full replication and extension of the analyses by FNA and the public.

Task 6: Briefings

Following completion of the Phase I and II report, one or more expert committee members (preferably including the committee chair) and at least one member of the contractor’s staff shall provide the following briefings (online or in-person) to USDA officials and/or members of Congress:

• Two briefings on the Phase I Report: USDA policy officials and FNA managers and staff will be invited to these briefings, as appropriate.

• Four briefings on the pre-publication version of the Phase II Report: Two briefings will be for USDA policy officials and FNA managers and staff. Two briefings will be for members of Congress and/or their staff.

The briefings shall be presented using a slide deck, consistent with contemporary professional standards for presentations at professional meetings. Electronic copies of the slide deck shall be delivered to FNA by the day before the briefings. All briefings shall take place at a location agreeable to FNA.

Task 7: Webinar

To facilitate dissemination of the information and recommendations in the reports, the contractor shall conduct a virtual public webinar on the Phase II Report intended for a broad array of WIC stakeholders, including but not limited to, State and local WIC managers and staff. Following the webinar, the contractor shall provide FNA with an electronic recording, transcript, and list of attendees of the webinar.

Key Deliverables by Task Task Task Name Deliverable(s) Due Date 1 Kick-off

Meeting Kick-off meeting

No later than 3 weeks after contract award

Kick-off meeting summary Within 2 weeks of the kick-off meeting

2 Quarterly Progress Reports

Quarterly progress reports End of each quarter until the contract expires

3 Public Forums and Open Meetings

Public forum transcripts Within 60 days of each forum Public comments Ongoing throughout the contract Open meeting summaries Within 2 weeks of the open meeting 4 Phase I Report Phase I report No later than 18 months from the date of contract award 5 Phase II Report Phase II report (pre-publication version) No later than 24 months from delivery of the Phase I report

Task Task Name Deliverable(s) Due Date Phase II report (pre-publication version) data files Phase II report (publication version; 508 compliant)

No later than 6 months from delivery of the Phase II pre-publication report Phase II report (publication version; 508 compliant) data files

6 Briefings Phase I report briefing slides

Within one month of submission of the corresponding report

Phase II report (pre-publication version) briefing slides

7 Webinar Webinar recording Within 20 business days of the released publication version of the Phase II Report

VIII. SPECIAL CONSIDERATIONS

Expert Committee Composition The expert panel for this project shall include no less than 12 or more than 24 individuals. The panel shall, at a minimum, include the following areas of expertise:

1. Public health nutrition

2. Pediatrics

3. Obstetrics

4. Breastfeeding

5. Food and nutrient analysis, including use of the Dietary Reference Intakes in assessment and planning

6. Childhood obesity prevention and treatment

7. Child food security

8. Epidemiology and statistics

9. Economics (agricultural or consumer)

10. Food cost data sets and analysis

11. Food processing, packaging, and marketing

12. Eating patterns of the WIC eligible population

13. Development of and dietary adaptations for food allergies in children

14. Inborn errors of metabolism

15. Medical foods

16. Vendor operations, including check-out efficiency and retail food management

17. WIC Program operations and management

18. Regulatory impact analysis

19. Health risk assessment and analysis

Report Contents The Phase I and Phase II Reports shall include but not be limited to the following sections:

• table of contents

• acknowledgements

• executive summary

• chapters with narrative discussion, tables, graphics and references

• appendices

• biographical sketches of committee members

• list of reviewers

• acronyms and abbreviations

• index

Recordings FNA reserves the right to electronically audio and/or video record and take photographs at the forums, open meetings, and briefings. FNA retains a permanent, irrevocable, nonexclusive right to publish, disseminate, and rebroadcast these recordings in whole or in part. FNA shall not alter the recorded versions of these presentations and discussions (except to enhance visual and audio clarity if needed, or to facilitate access by disabled individuals, e.g., closed captioning) but may disseminate them in whole or in part either alone or along with other materials. FNA shall not disseminate the recordings of the prepublication briefings and discussions at FNA outside of USDA until after publication of the related deliverable.

Publication Rights FNA reserves an irrevocable, nonexclusive right to publish, post to the web, and otherwise reproduce and disseminate copies of all deliverables under the contract. FNA shall not alter the report but may disseminate it in whole or in part, either alone or along with other materials.

IX. GOVERNMENT FURNISHED INFORMATION

FNA shall provide WIC administrative data and other contractor-developed deliverables, as needed, to support this effort. This Government-Furnished Information (GFI) may include pre-publication final reports, restricted data, and other deliverables from recent FNA WIC studies as well as WIC administrative data submitted by WIC State agencies. The Contractor is responsible for securing data from all non-FNA sources.