Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages

DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

7 CFR Part 246

[FNS-2022-0007]

RIN 0584-AE82

Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages

AGENCY:

Food and Nutrition Service (FNS), Department of Agriculture (USDA).

ACTION:

Final rule.

SUMMARY:

This final rule considers public comments submitted in response to the proposed rule revising the WIC food packages published on November 21, 2022. It revises regulations to align the WIC food packages with the current

Dietary Guidelines for Americans

and to reflect recommendations from the National Academies of Science, Engineering, and Medicine while promoting nutrition security and equity and considering program administration. The changes are intended to provide WIC participants with a wider variety of foods that align with the latest nutritional science; provide WIC State agencies with greater flexibility to prescribe and tailor food packages that accommodate participants' special dietary needs and personal and cultural food preferences; and address key nutritional needs to support healthy dietary patterns. This rule provides foods in amounts that are more consistent with the supplemental nature of the Program; encourages fruit and vegetable consumption; and strengthens support for individual breastfeeding goals to help establish long-term breastfeeding.

DATES:

Effective date:

This rule is effective June 17, 2024.

Implementation dates:

See section V of the

SUPPLEMENTARY INFORMATION

.

Compliance dates:

This rulemaking consists of multiple provisions. Compliance for each provision is referenced in the

SUPPLEMENTARY INFORMATION

section of this final rule and detailed in the section-by-section analysis.

•

Severability.

If any provision of such section promulgated through this final rule, “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages” (FNS-2022-0007; RIN 0854-AE82), is held to be invalid or unenforceable by its terms, or as applied to any person or circumstances, it shall be severable and not affect the remainder thereof.

FOR FURTHER INFORMATION CONTACT:

Allison Post, Chief, Administration, Benefits, and Certification Branch, Policy Division, Food and Nutrition Service, USDA, 1320 Braddock Place, Alexandria, Virginia, 22314, (703) 305-2746 OR

Allison.Post@usda.gov.

SUPPLEMENTARY INFORMATION:

Table of Abbreviations

APA—Administrative Procedure Act

APL—Authorized Products List

AAP—American Academy of Pediatrics

CVV—Cash-Value Voucher

DGA—Dietary Guidelines for Americans

EBT—Electronic Benefit Transfer

FDA—U.S. Food and Drug Administration

FNB—Full Nutrition Benefit

FNS—Food and Nutrition Service

kcal—Kilocalorie

MIS—Management Information Systems

MMA—Maximum Monthly Allowance

NASEM—National Academies of Sciences, Engineering, and Medicine

USDA—United States Department of Agriculture (also referred to as “the Department”)

WIC—Special Supplemental Nutrition Program for Women, Infants, and Children

I. Background

WIC is a powerful, evidence-based public health program, with a long history of improving health and developmental outcomes for children. Through the WIC food packages, nutrition and breastfeeding education, and referrals, WIC is uniquely positioned as an effective tool to help reduce disparities in maternal and child health outcomes.

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This final rule revises the WIC food packages to reflect the latest nutritional guidance in the 2020-2025 DGA and recommendations from NASEM while considering public comments to the proposed rule “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages” published on November 21, 2022 (87 FR 71090), hereafter referred to as “the 2022 proposed rule.”

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Informed by science-based recommendations, the updated food packages continue to strengthen WIC and build on its long history of improving participant health outcomes. The changes made in this rule promote nutrition security and equitable access to nutritious foods by:

1

Caulfield LE, Bennett WL, Gross SM, Hurley KM, Ogunwole SM, Venkataramani M, Lerman JL, Zhang A, Sharma R, Bass EB. Maternal and Child Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Comparative Effectiveness Review No. 253. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 75Q80120D00003.) AHRQ Publication No. 22-EHC019. Rockville, MD: Agency for Healthcare Research and Quality; April 2022. DOI:

https://doi.org/10.23970/AHRQEPCCER253.

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The authorizing legislation for WIC uses the word “women” in the Program title and thus it is used in the title for this rule. However, gender neutral language is used when possible throughout this final rule.

• Encouraging fruit and vegetable consumption.

• Addressing key nutritional needs to support healthy dietary patterns.

• Providing greater flexibility, variety, and choice to accommodate personal and cultural food preferences and special dietary needs.

• Strengthening support for individual breastfeeding goals to help establish long-term breastfeeding.

The Department is committed to advancing nutrition security and health equity through this final rule, ensuring mothers, babies, and young children have equitable access to the key nutrition they need during crucial stages of growth and development.

A. Purpose of the WIC Food Packages

The WIC food packages provide supplemental foods designed to address the specific nutritional needs of low-income pregnant, breastfeeding, and non-breastfeeding postpartum individuals, infants, and children up to five years of age who are at nutritional risk. Every WIC participant receives a monthly food benefit from one of seven science-based food packages, according to their participant category and nutritional needs.

Participant Categories

The seven food packages available in the following participant categories are:

(1)

Food Package I:

Infants birth through 5 months (Fully Breastfed, Partially Breastfed, and Fully Formula Fed)

(2)

Food Package II:

Infants ages 6 through 11 months (Fully Breastfed, Partially Breastfed, and Fully Formula Fed)

(3)

Food Package III:

Medically Fragile Women, Infants, and Children

(4)

Food Package IV:

Children ages 1 through 4 years

(5)

Food Package V:

Pregnant and Partially (Mostly) Breastfeeding Women up to 1 year postpartum

(6)

Food Package VI:

Postpartum Women (minimally or non-breastfeeding) up to 6 months postpartum

(7)

Food Package VII:

Fully Breastfeeding Women up to 1 year postpartum

Individual Nutrition Tailoring and Food Substitutions

As part of the WIC certification process, a comprehensive nutrition (and

breastfeeding, as applicable) assessment is conducted for each WIC participant. Through this process, food packages can be individually tailored—by making substitutions, reductions, and/or eliminations to the food type (

e.g.,

dry beans vs. peanut butter) and physical food forms (

e.g.,

fluid vs. dry milk)—to accommodate the participant's special dietary needs (

e.g.,

a food allergy or intolerance), cultural and personal preferences, and housing/living conditions (

e.g.,

limited resources to prepare food). During the nutrition assessment, WIC participants also receive instructions on how to redeem their WIC food benefits at retail vendors, including information about substitution options. Through nutrition tailoring and the issuance of Food Package III, WIC conforms with section 504 of the Rehabilitation Act by providing participants with special dietary needs with the supplemental foods that accommodate their medical needs.

Authorized Foods

Food categories and quantities, as well as minimum nutritional requirements, are established at the Federal level and outlined in WIC regulations at 7 CFR 246.10. Depending on the food package, the authorized food categories include infant formula, cereal, and foods; exempt infant formulas; WIC-eligible nutritionals; milk; cheese; breakfast cereal; juice; fruits and vegetables; whole wheat/whole grain bread; eggs; legumes and/or peanut butter; and canned fish.

The WIC Program is administered by 89 WIC State agencies, including the 50 states, 33 Indian Tribal Organizations (ITOs), the District of Columbia, and five U.S. Territories (the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands). In accordance with Federal WIC regulations, each WIC State agency determines which eligible foods, including brands and package sizes, will be made available to their participants. When creating their APL, WIC State agencies consider a variety of factors including participant acceptance and choice, product availability, and price. WIC State agencies may establish criteria in addition to the Federal minimum requirements (

e.g.,

allow only low-sodium canned vegetables), authorize substitution options specified in regulations (

e.g.,

yogurt as a substitute for milk), and/or implement administrative adjustments to manage food costs (

e.g.,

limiting brand types, specifying packaging methods) based on these factors.

Redeeming WIC Foods

Participants redeem their food benefits (

i.e.,

the foods included in their prescribed food package) at retail vendors the WIC State agency authorizes, and in some instances, through home delivery or direct distribution systems the WIC State agency operates. Nationwide there are approximately 40,000 WIC-authorized vendors.

B. Multi-Stage Scientific Approach To Revise the WIC Food Packages

This final rulemaking represents the third

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comprehensive revision to the WIC food packages since Congress established WIC as a permanent program in 1975. Consistent with this current rulemaking, prior revisions were based in nutritional science.

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In 1980, USDA reorganized the WIC food packages from three to six standardized packages marking the first comprehensive revision. In 2007, the USDA published an interim rule revising the WIC food packages marking the second comprehensive revision.

The most recent comprehensive revision to the WIC food packages was based on the Institute of Medicine's (now NASEM) 2006 report “WIC Food Packages: Time for a Change,” which cited the health and nutrition risks WIC's target population faced, including overweight and obesity; diets lacking in whole grains, fruits, and vegetables; and short duration of breastfeeding. USDA contracted with the Institute of Medicine to complete this review and recommend cost-neutral changes to the WIC food packages based on the nutritional needs of the WIC population. The report provided the scientific basis for the proposed rule to revise the WIC food packages published in August 2006 (71 FR 44784), which garnered broad support from public commenters, the majority of whom were Program participants.

Reflecting the comments received, USDA published an interim rule in December 2007 (72 FR 68966) that implemented revised WIC food packages. Due to the extent and comprehensive nature of the revisions, the Department provided an extended public comment period on the interim rule to obtain comments on the impacts of implementing the new WIC food packages. On March 4, 2014, USDA published the final rule “Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages” (79 FR 12274), hereafter referred to as “the 2014 final rule.” The revisions in the 2014 final rule aligned the WIC food packages with nutritional science current at the time, aimed to promote and support the establishment of successful long-term breastfeeding, provided participants with a wider variety of foods, and provided WIC State agencies with greater flexibility in prescribing WIC food packages to accommodate participants' cultural food preferences. Key changes implemented through the 2014 final rule and preceding interim final rule included:

Introduction of the CVV for the purchase of fruits and vegetables.

• Addition of whole grains (

e.g.,

bread, tortillas, brown rice, etc.).

• Addition of soy-based beverage, yogurt, and tofu as milk alternatives.

• Reductions in some foods (

e.g.,

milk, egg, and juice) to better align with the supplemental nature of WIC.

• Allowance for participants in Food Package III to receive all authorized WIC foods.

In 2014, USDA contracted with NASEM to conduct a second review of the WIC food packages, in accordance with the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, HHFKA), which requires USDA to conduct a scientific review of the WIC food packages at least every ten years. The Department charged NASEM with developing recommendations for revising the WIC food packages to be consistent with the DGA and that considered the health and cultural needs of WIC participants while ensuring WIC remained cost-neutral, efficient for nationwide distribution, and straightforward to administer. NASEM's process included a comprehensive review and analysis of available scientific evidence, including relevant published literature, National Health and Nutrition Examination Survey (NHANES) 2005-2012 data, WIC food benefit redemption data, the 2015-2020 DGA, and, for children under age 2 years, recommendations from expert authorities in the health of the WIC population including the AAP, the Academy of Nutrition and Dietetics (AND), and the World Health Organization. In 2017, NASEM published its recommendations in the report, “Review of WIC Food Packages: Improving Balance and Choice: Final Report,” which informed many of the revisions in the 2022 proposed rule.

Using a systematic process, NASEM developed recommendations aimed to ensure the WIC food packages:

• Provide a balanced supplement to the diets of women and children.

• Contribute to reduced prevalence of inadequate and excessive nutrient intake.

• Contribute to a dietary pattern that is consistent with the 2015-2020 DGA for individuals 2 years of age and older.

• Contribute to a diet that is consistent with established recommendations for infants and children less than 2 years of age, including encouragement of and support for breastfeeding.

• Include foods that are available in forms and amounts suitable for low-income persons who may have limited transportation options, storage, and cooking facilities.

• Include foods that are readily acceptable, commonly consumed, widely available, consider cultural eating patterns and food preferences, and provide incentives for families to participate in the WIC Program.

• Include foods that do not create an undue burden on WIC State agencies or vendors.

NASEM's review emphasized the supplemental nature of the food packages—meaning foods are provided as part of a balanced diet that meets but does not exceed recommended amounts of foods and nutrients to prevent overweight/obesity and/or displace other healthy and important food groups and nutrients. Accordingly, NASEM designed food packages that provide moderate proportions of individuals' nutrient requirements and food group amounts recommended as part of a healthy dietary pattern, and that prioritize nutrients that are under consumed and associated with health outcomes relevant to the WIC-eligible population. Finding that the current food packages provide varying proportions of priority nutrients

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(between 5 and 400 percent of the Dietary Reference Intake (DRI)) and recommended food group

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amounts (between 0 and 177 percent of DGA recommended intake amounts), NASEM recommended reducing foods provided in more-than-supplemental amounts and increasing foods needed to improve intake of priority nutrients and recommended food groups. NASEM provided recommendations for food packages that achieve cost neutrality as requested by the Department. However, also at the request of the Department, NASEM provided clear alternative nutrition-based recommendations for consideration if cost neutrality were not the prevailing principle in rulemaking. Since the goal of this final rule is to follow science-based recommendations that advance nutrition security and improve health equity, the Department has accepted NASEM's alternative recommendations in regard to certain food items such as the higher CVV.

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The 2017 NASEM Report discusses priority nutrients in Chapter 05; Table 5.1 (page 217) summarizes the criteria used to determine priority nutrients for the WIC-eligible population.

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Recommended food groups include fruits, vegetables, grains, protein foods, and dairy and alternatives, as established in the

Dietary Guidelines for Americans, 2020-2025

Healthy U.S.-Style Dietary Patterns at various calorie levels for the WIC-eligible population.

Following the 2017 NASEM report, on December 29, 2020, the USDA and the U.S. Department of Health and Human Services published the 2020-2025 DGA, which provides science-based recommendations for healthy dietary patterns by life stage and, for the first time since the 1985 edition, recommendations for infants, children up to 2 years of age, and pregnant and breastfeeding individuals. To ensure the changes to the WIC food packages aligned with the current dietary guidelines, USDA conducted a thorough review of the 2020-2025 DGA and incorporated relevant updates into the 2022 proposed rule.

The revisions to the food packages support WIC participants' nutritional needs, achieve a better balance of nutrients, and align with the supplemental nature of the Program. Nutrition security—meaning consistent and equitable access to healthy, safe, and affordable food essential to optimal health and well-being—is prioritized over cost neutrality while the supplemental nature of the WIC food packages remains central to the final revisions. The changes to the WIC food packages are designed to:

• Provide additional flexibility, variety, and choice for individuals with special dietary needs due to medical conditions, limited cooking and/or storage facilities, and cultural and personal preferences (including, but not limited to, vegan and vegetarian diets), while ensuring the delivery of priority nutrients to WIC participants.

• Consider marketplace availability of supplemental foods.

• Increase the actual and perceived value of the WIC food packages to eligible populations.

• Improve equitable access to nutritious foods.

• Promote and support breastfeeding of all durations and intensities.

• Provide foods in amounts that are more consistent with the supplemental nature of the Program.

• Align with DGA guidance to follow a healthy dietary pattern and meet, but not exceed, recommended food group and subgroup amounts and nutrients appropriate for an individual's life stage.

• Build on the 2014 changes to the WIC food packages and the positive impact those had on participant diet quality and reduced prevalence of obesity among children.

6 7 8

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Pan L, Blanck HM, Park S, Galuska DA, Freedman DS, Potter A, Petersen R. State-Specific Prevalence of Obesity Among Children Aged 2-4 Years Enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children—United States, 2010-2016. MMWR Morb Mortal Wkly Rep. 2019 Nov 22;68(46):1057-1061. doi: 10.15585/mmwr.mm6846a3. PMID: 31751324; PMCID: PMC6871901.

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Daepp MIG, Gortmaker SL, Wang YC, Long MW, Kenney EL. WIC Food Package Changes: Trends in Childhood Obesity Prevalence. Pediatrics. 2019 May;143(5):e20182841. doi: 10.1542/peds.2018-2841. Epub 2019 Apr 1. PMID: 30936251; PMCID: PMC6565338.

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Chiasson MA, Findley SE, Sekhobo JP, Scheinmann R, Edmunds LS, Faly AS, McLeod NJ. Changing WIC changes what children eat. Obesity (Silver Spring). 2013 Jul;21(7):1423-9. doi: 10.1002/oby.20295. Epub 2013 May 22. PMID: 23703806.

II. 2022 Proposed Rule Comment Summary

The 2022 proposed rule to revise regulations governing the WIC food packages was published in the

Federal Register

on November 21, 2022 (87 FR 71090), with a 90-day comment period. During this time USDA received 17,731 comments. Sixteen form letter campaigns comprised 15,863 submissions. All comments were considered without regard to whether they were provided by a single commenter or repeated by many. Importance was given to the substance or content of the comment, rather than the number of times a comment was submitted. There were 1,795 unique comments of which 993 were substantive. A total of 73 comments were either duplicates or not relevant or related to the rule. Comments that did not refer to the WIC food packages or changes in the proposed food rule were considered outside of scope for the revisions to the WIC food packages and are not addressed as part of this final rule. The comments came from a variety of sources, including WIC State and local agencies, professional organizations and associations, advocacy groups, health care professionals, universities, members of Congress, the food industry, farmers, participants, and private citizens.

USDA worked in collaboration with a data analysis company to code and analyze the public comments using a commercial web-based software product and obtained data showing support for or opposition to each proposed change. Over 12,000 commenters provided broad general support for revisions to the WIC food packages while approximately 20 commenters provided general comments in opposition to the 2022 proposed rule. The remaining

comments discuss specific provisions in the proposed food package rule and are further detailed and addressed throughout this final rule. The Final Summary of Public Comments report is available online at

www.regulations.gov

in docket FNS-2022-0007. The Final Summary of Public Comments includes the specific number of comments in support of or opposition to each provision in the 2022 proposed rule, with a detailed narrative describing the key points made by commenters. USDA used the Final Summary of Public Comments and a supplementary review of individual comments to finalize provisions within this final rule. USDA refers to the Final Summary of Public Comments for numbers of comments received on each provision, with general summaries of comments provided in the preamble of this final rule.

USDA appreciates the many comments expressing support for revisions to the WIC food packages and urging USDA to implement the science-based recommendations included in the 2022 proposed rule. USDA agrees the WIC food packages' benefits have an important role in supporting and improving the health of infants, children, and women who are at nutritional risk and, consequently, improving healthcare costs.

III. Discussion of the Final Rule

The following is a discussion of the provisions set forth in the 2022 proposed rule, a summary of the comments received that addressed these provisions, and the Department's rationale for changes in the final rule that either modify or retain the proposed revisions. Provisions not discussed in this preamble did not receive significant or substantial public comments and are retained in this final rule as proposed.

This preamble communicates the rationale for modifications to the 2022 proposed rule that are codified in this final rulemaking. The reasons for the proposed changes were carefully examined in consideration of comments received to determine their continued applicability, given the goals for this rulemaking and the foundation of current nutritional science. Unless otherwise stated in the preamble of this final rule, the rationales included in the preamble of the 2022 proposed rule are regarded as a basis for the final regulations. Therefore, a thorough understanding of the rationales for the final regulations may require reference to the preamble of the 2022 proposed rule (87 FR 71090).

The following chart provides a summary comparison of the proposed and final revisions to the WIC food packages.

Section

Summary of proposed revisions

Summary of final revisions based on public comment

A. Fruits and Vegetables

1. Increase the CVV maximum monthly allowances for child, pregnant, breastfeeding, and postpartum participants

Finalize as proposed.

2. Require WIC State agencies to authorize at least one other form of fruits and vegetables in addition to fresh

Finalize as proposed.

3. Require vendors to stock at least three varieties of vegetables

Finalize as proposed.

4. Expand what can be purchased with the CVV

Finalize as proposed.

B. Juice

1. Reduce or remove the maximum monthly allowance for juice

2. Allow CVV as a substitute for juice

Reduce juice amounts to 64 fluid ounces for child and all adult participants.

Finalize as proposed.

C. Milk and Milk Substitutions

1. Reduce maximum monthly allowances of milk

Finalize as proposed.

2. Require authorization of lactose-free milk

Finalize as proposed.

3. (a) Permit only unflavored milk, including lactose-free milk, and (b) reduce total sugars allowed in yogurt and plant-based milk substitutions

3a. Finalize as proposed.

3b. Establish an added sugars limit for yogurt and plant-based milk alternatives.

4. Add a (a) calcium specification for tofu [200 milligrams per 100 grams of tofu] and (b) vitamin D specification for yogurt [100 international units (IU) (2.5 micrograms) per 8 ounces of yogurt]

4a. Add a minimum calcium specification of 100 milligrams per 100 grams of tofu.

4b. Add a minimum vitamin D specification of 106 IU (2.67 micrograms) per 8 oz (1 cup) of yogurt and extend the implementation timeline.

5. Increase yogurt substitution amounts for milk

Finalize as proposed.

6. Add soy-based yogurts and soy-based cheeses as substitution options for milk

Allow plant-based yogurts and plant-based cheeses.

7. Update the FDA standard of identity citations for yogurt

Finalize as proposed.

8. Allow reduced-fat yogurts for 1-year-old children without restrictions

Finalize as proposed.

9. Remove cheese as a food category from the fully breastfeeding food package

Finalize as proposed.

D. Infant Foods

1. Reduce infant cereal, infant fruits and vegetables, and infant meat

Finalize as proposed.

2. Increase CVV substitution amounts for infant fruits and vegetables, allow forms other than fresh, and lower the minimum age for infants to receive a CVV

Finalize as proposed.

3. Prohibit added fats in infant foods

No change to current provision.

E. Add Infant Formula Flexibilities and Create a Separate Food Package for Partially (Mostly) Breastfeeding Participants

1. Increase formula amounts in the first month for partially (mostly) breastfed infants

Finalize as proposed

2. Allow all prescribed infant formula quantities to be considered “up to” amounts

Finalize as proposed.

3. Create a separate and enhanced food package for partially (mostly) breastfeeding participants

Finalize as proposed.

F. Breakfast Cereals

1. Change whole grain criteria for breakfast cereals

Finalize as proposed.

2. Require all breakfast cereals meet whole grain criteria

Require 75 percent of breakfast cereals meet whole grain criteria

Replace the total sugars limit for breakfast cereal with an added sugars limit of ≤21.2 g per 100 grams dry cereal (≤6 grams per dry ounce)

G. Whole Wheat Bread, Whole Grain Bread, and Whole Grain Options

1. Revise (reduce for children and increase for pregnant, postpartum, and breastfeeding participants) MMA for whole wheat and whole grain bread and other whole grain options

Finalize as proposed.

2. Change criteria for whole grain breads

Finalize as proposed.

3. Expand whole grain options

Add proposed whole grain options and allow for additional whole grain options that meet specifications.

H. Canned Fish

1. Add canned fish to food packages for children (2 through 4 years) and specify varieties

Add canned fish to food packages for children (1 through 4 years) and allow canned light tuna and chub mackerel for children

2. Add canned fish to food packages for pregnant, partially (mostly) breastfeeding, and postpartum participants not currently receiving canned fish, revise amounts for fully breastfeeding participants, and revise WIC-eligible varieties

Finalize as proposed.

I. Legumes and Eggs

1. Require WIC State agencies to authorize both dried and canned legumes

Finalize as proposed.

2. Require authorization of legumes and peanut butter as substitutes for eggs and allow WIC State agencies to choose to authorize tofu to substitute for eggs

Finalize as proposed.

3. Requested comment on nut and seed butters

Implement a provision to allow WIC State agencies the option to authorize nut and seed butters as a substitute for peanut butter.

J. Maximum Monthly Allowances

1. Allow WIC State agencies to authorize a greater variety of package sizes to increase variety and choice, while still providing participants with package sizes that ensure they can receive the full benefit amount (i.e., at least one package size, or a combination of sizes, must add up to the full MMA)

Finalize as proposed.

A. Fruits and Vegetables

The final rule increases the CVV amounts for child, pregnant, postpartum, and breastfeeding participants; requires the authorization of an additional form of fruits and vegetables beyond fresh, dependent on participant category; requires vendors to stock at least three varieties of vegetables; and expands what foods can be purchased with the CVV.

1. Increase CVV Maximum Monthly Allowances for Child, Pregnant, Breastfeeding, and Postpartum Participants (§ 246.10(e)(10) and (11), Tables 2 and 3)

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The change in terminology from “CVV” to cash-value benefit, or “CVB,” is not included in this final rule; however, USDA proposed this change in the rule titled: “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Online Ordering and Transactions and Food Delivery Revisions to Meet the Needs of a Modern, Data-Driven Program” (88 FR 11516). The proposal would update the definition of cash-value voucher to remove the clause, “cash-value voucher is also known as cash-value benefit, or CVB, in an EBT environment,” and create an independent definition of CVB as a type of electronic benefit that is a fixed-dollar amount used to obtain authorized fruits and vegetables.

This final rule codifies the increase in the CVV amounts for child, pregnant, breastfeeding, and postpartum participants as summarized in the 2022 proposed rule. The increase to the CVV is consistent with the temporary increase in the CVV that has been in place since October 1, 2021, as a result of appropriations legislation (the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022, Pub. L. 117-103; the Consolidated Appropriations Act, 2023, Pub. L. 117-328; and the Consolidated Appropriations Act, 2024, Pub. L. 118-42).

Commenters expressed broad support for the increase to the CVV amounts of $24 for child participants, $43 for pregnant and postpartum participants, and $47 for partially (mostly) and fully breastfeeding participants adjusted annually for inflation. In expressions of support, commenters cited that the increased CVV amounts: (1) allow participants to buy and consume more fruits and vegetables to support improved health; (2) have led to greater participant satisfaction and retention; (3) support retailers in low-income and rural areas stocking more fruits and vegetables because of the increased buying power, improving choice and access; and (4) support the economy, particularly produce farmers.

No comments opposed the increase in CVV amounts. Some commenters requested adjusting the value of the CVV for WIC State agencies administering WIC in high-cost areas, citing reduced purchasing power because of the likelihood of relatively higher food prices. Given that NASEM recommended further study to evaluate the feasibility of making such adjustments to the CVV, the Department is not making this change in the final rule and instead seeks to pursue future cross-program research to obtain data necessary to better understand variations in cost of living to inform potential future changes.

Some commenters suggested increasing CVV amounts beyond those proposed, with several requests for USDA to increase the amount for pregnant participants to match that of breastfeeding participants at $47. The CVV amounts in the 2022 proposed rule provide approximately half of the recommended daily amounts of fruits and vegetables for adults and children, which aligns with the goal of providing supplemental amounts of foods and nutrients in the WIC food packages. These increased CVV amounts are consistent with the DGA recommendation to increase consumption of fruits and vegetables and afford participants greater choice to select fruits and vegetables that accommodate their cultural and personal food preferences. For these reasons, the Department maintains the amounts as proposed. The following are the CVV amounts (using 2022 as the base year)

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for the purchase of fruits

and vegetables by participant category (monthly CVV amounts will be adjusted annually for inflation):

10

The base year used for calculating inflation adjustments will be 2022. Note that the temporary increase in the CVV for fiscal year 2023 was based on the proposed amounts (2022 base year amounts) and adjusted upward for inflation to provide $25 for child participants, $44 for pregnant and postpartum participants, and $49 for partially (mostly) and fully breastfeeding participants. The inflation adjustment made for FY 2023 was consistent with the approach required under 7 CFR 246.16(j)(4). Similarly, the temporary increase in the CVV for fiscal year 2024 is based on the proposed amounts (2022 base year amounts) and adjusted upward for inflation to provide $26 for child participants, $47 for pregnant

and postpartum participants, and $52 for partially (mostly) and fully breastfeeding participants. The inflation adjustment made for FY 2024 is consistent with the approach required under 7 CFR 246.16(j)(4). See WIC Policy Memo #2023-2: Consolidated Appropriations Act, 2023, Extending the Temporary Increase in the Cash-Value Voucher/Benefit for Fruit and Vegetable Purchases,

www.fns.usda.gov/wic/policy-memorandum-2023-2

and WIC Policy Memorandum #2024-1: FY 2024 Cash-Value Voucher Benefit Amounts.

www.fns.usda.gov/wic/2024cash-value-voucher-benefit-amounts.

Children 1 through 4 years:

$24.

Pregnant:

$43.

Postpartum:

$43.

Partially (mostly) breastfeeding:

$47.

Fully breastfeeding:

$47.

2. Require One Other Form of Fruits and Vegetables in Addition to Fresh (§ 246.10(e)(3)(v), (e)(4)(ii), (e)(5)(ii), (e)(6)(ii), (e)(7)(ii), and (e)(9) Through (11), Tables 1 Through 3)

This final rule codifies the requirement that WIC State agencies authorize fresh and at least one other form (frozen, canned, and/or dried) of both fruits and vegetables for the child, pregnant, postpartum, and breastfeeding food packages and requires fresh and at least one other form (frozen or canned) for the CVV substitution for infant (ages 6 through 11 months) food packages. Dried fruits and vegetables pose a choking hazard for infants and are not authorized.

Most commenters expressed support for requiring another form of fruits and vegetables in addition to fresh. Many WIC State agencies commented that they already allow for an additional form so there is no burden to implementing this provision. Commenters also highlighted that the provision would support the purchase of produce with a longer shelf life and expand participant choice, which could lead to increased redemption rates and mitigate food waste. The Department agrees with these comments and adds that in combination with the increase in the CVV, the provision will provide participants with greater flexibility to accommodate various storage or cooking conditions as well as special dietary needs (

e.g.,

allergy/intolerance to certain forms of fruits and vegetables) and cultural and personal preferences.

Some WIC State agencies requested clarification regarding frozen, canned, and dried options as well as pickled or fermented products and sugar in additional forms of fruits and vegetables. Several commenters expressed support for additional forms of fruits and vegetables with concern about the sodium, sugar, and additives in canned and frozen products. The Department clarifies that with this provision, canned or frozen fruit may not contain added sugars, fats, oils, or salt and, that canned or frozen vegetables may not contain added sugars, fats, or oils (§ 246.10(e)(12), Table 4). Regarding sodium, the Department acknowledges the sodium content of canned vegetables may be higher than other forms (

i.e.,

fresh, frozen, and dried), and that canned vegetables can be prepared in ways that reduce sodium content. The Department also clarifies that while sodium is not restricted in canned or frozen vegetables in Federal regulations, WIC State agencies may establish criteria in addition to the Federal minimum requirements.

The Department recognizes the potential for confusion among households with infant participants whose benefits are aggregated

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with children and women participants who may receive dried forms of fruits and vegetables and confirms that WIC State agencies should address this topic through nutrition education.

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Aggregation of WIC benefits: WIC State agencies may aggregate WIC supplemental food amounts for families or households with multiple participants receiving the same food with the same nutrient specification. This may be useful when benefits are issued via EBT.

3. Require Vendors To Stock at Least Three Varieties of Vegetables (§ 246.12(g)(3)(i))

This final rule codifies the provision to require vendors to stock at least three varieties of vegetables as summarized in the proposed rule.

Most commenters, including WIC State and local agencies, expressed support for this provision. Several suggested the requirement would not create additional burden as most retailers already stock more than two varieties of vegetables, noting this provision could reduce barriers and increase equitable access to vegetables. The Department agrees with these commenters and adds that increasing the minimum number of vegetables stocked will help reduce disparities in food access in communities where obtaining produce is difficult and provide participants with greater access to support establishing healthy dietary patterns during critical life stages.

Several commenters expressed concern that this provision could result in a potential loss of small vendors, and a few WIC State agencies cited the administrative burden of requiring additional varieties of vegetables. The Department recognizes that the requirement for vendors to stock at least three varieties of vegetables could potentially impact some small vendors. The ability to stock shelf stable forms of vegetables will ease this concern, as Federal regulations will not require small vendors to stock three forms of fresh vegetables. As suggested in several comments, the Department will develop resources and technical assistance for WIC State agencies to adapt and use in training WIC-authorized vendors on the new provisions and allowable flexibilities in this final rule.

4. Expand What Can Be Purchased With the CVV (§ 246.10(e)(12), Table 4)

This final rule expands what can be purchased with the CVV, including fresh cut herbs, white potatoes, and larger sizes of packaged fruits and vegetables.

a. Allow Fresh Herbs (§ 246.10(e)(12), Table 4)

This final rule codifies allowing participants to purchase fresh cut herbs with the CVV as summarized in the 2022 proposed rule.

Allowing fresh cut herbs to be purchased with the CVV increases participant choice, helps accommodate cultural eating patterns, and aligns with the DGA, which categorizes fresh herbs (

e.g.,

cilantro and basil) as dark green vegetables.

The few comments received specific to this proposal were supportive, with WIC State agencies noting that herbs can have health benefits by increasing flavor and decreasing the salt and sugar added during cooking. Commenters cited the potential of including fresh herbs to better meet recommended daily food group amounts for fruits and vegetables. The Department agrees with comments acknowledging that herbs can help enhance the flavor of foods as a strategy to reduce added sugars, saturated fat, and sodium in support of healthy dietary patterns.

Several commenters asked for clarification on this provision, specifically what is included as a fresh herb and whether dried herbs could also be considered in this provision. The Department agrees that clarification on the types of allowable herbs is important. The intent of this provision is to allow participants to purchase fresh herbs, cut at the root or with the root intact, that are in a consumable form. For consistency with the WIC Farmers' Market Nutrition Program and the DGA, the Department will not allow dried herbs to be purchased with the CVV. The Department will further address this through technical

assistance, such as guidance or training depending on need.

b. Codify That White Potatoes Are WIC Eligible (§ 246.10(e)(12), Table 4)

This final rule permanently removes white potatoes as an excluded vegetable, as summarized in the 2022 proposed rule. Doing so codifies the provision in the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) that precludes the exclusion or restriction of any variety of fresh, whole, or cut vegetables (except vegetables with added sugars, fats, or oils) in WIC. FNS issued WIC Policy Memorandum #2015-3:

Eligibility of White Potatoes for Purchase with the Cash-Value Voucher,

which has allowed for the purchase of white potatoes with the CVV through present day. No comments opposed to this provision were provided.

c. Allow Larger Sizes of Packaged Fresh Fruits and Vegetables (§ 246.10(e)(12), Table 4)

This final rule codifies allowing larger package sizes of fresh fruits and vegetables to be WIC-eligible as summarized in the 2022 proposed rule. Prior to this rulemaking, regulations prohibited larger package sizes of fresh cut produce, referred to as “party trays.” In accordance with current nutrient requirements, packages of fresh fruits and vegetables regardless of size may not contain added sugars, fats, or oils (which may appear in the form of dips, sauces, or glazes). The change will also allow participants with more than one family member participating in WIC to use aggregate benefits to purchase larger amounts of precut fruits and vegetables.

The Department received broad general support for this provision, with commenters noting the added flexibility of larger package sizes will better serve participants and support consumption of a variety of fruits and vegetables. WIC State agencies noted party trays commonly contain dips or sauces, which are not WIC-eligible and may cause confusion among participants, and that party trays are typically less cost effective and have a greater risk of food spoilage if not consumed quickly. The Department acknowledges these concerns, will continue to provide technical assistance to WIC State agencies to assist in implementing the provisions of this final rule, and encourages WIC State agencies to address package size considerations to minimize food spoilage through nutrition education.

B. Juice

This final rule codifies a reduction in juice from 128 to 64 ounces in the child food package and from 144 to 64 ounces in the pregnant and breastfeeding food package as proposed, and a reduction in juice from 96 ounces to 64 ounces in the postpartum food package, which modifies the proposed provision to eliminate juice. In addition, this rule allows substitution of a $3 CVV for the full juice amount across all food packages as originally proposed.

1. Reduce Maximum Monthly Allowance for Juice (§ 246.10(e)(10) and (11), Tables 2 and 3)

This final rule codifies the reduction of juice from:

• 128 ounces to 64 ounces in the child food package, as proposed,

• 144 ounces to 64 ounces in the pregnant and breastfeeding food packages, as proposed, and

• 96 ounces to 64 ounces in the postpartum food package. Based on public comment, the Department modified its proposal to eliminate juice in the postpartum food package.

Many commenters, including WIC State agencies, expressed support for the reduction in juice with several suggesting the Department eliminate juice from all WIC food packages. Commenters cited overconsumption, particularly among young children, as reason to reduce or eliminate juice, noting the lack of dietary fiber that may contribute to excess caloric intake. The Department agrees with the importance of limiting juice consumption as part of a healthy dietary pattern and notes the reduced quantities provide more appropriate supplemental amounts at approximately 27 to 53 percent of DGA-recommended limits for juice for most participants compared to 40 to 107 percent previous WIC food packages provided.

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The DGA emphasizes the consumption of whole forms of fruits and vegetables over juice. While the DGA includes 100 percent juice as part of the fruit and vegetable food groups, it emphasizes whole fruit and a variety of vegetables from all subgroups, and places limits on the amount of juice that contributes to a healthy dietary pattern. Juice is not a separate food subgroup (like dark-green vegetables) in the DGA recommended dietary patterns. Additionally, the DGA recognizes juice as lower in dietary fiber than whole fruits or vegetables. The DGA identifies dietary fiber as a dietary component of public health concern for the U.S. population due to underconsumption, and these low intakes are associated with health concerns.

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For children ages 12 to 23 months, the reduced juice quantity provides 53 percent of the upper DGA limit based on 4 ounces/day for 700-1000 kcal. For children 2 to 4 years, the reduced juice quantity provides 36-53 percent of the upper DGA limit based on 4-6 ounces/day for 1000-1600 kcals. For all pregnant and breastfeeding food packages, the reduced juice quantity provides 27 percent of the upper DGA limit based on 8 ounces/day for 2000-2400 kcals.

Comments in opposition cited juice as a convenient and cost-effective source of fruit, an under consumed food group among the WIC-eligible population. Some commenters expressed general concern with the reduced benefit level, believing this disincentivizes participation and may impede participant retention goals. Several commenters requested the Department reconsider eliminating juice from the postpartum food package, noting the benefits of juice are applicable to the entire WIC-eligible population and the elimination is not aligned with the Department's goal of improving equitable access to supplemental foods.

The Department agrees that juice, specifically 100 percent juice which the WIC food packages provide, is a convenient and cost-effective source of nutrients, particularly vitamin C. However, the Department also acknowledges that juice is lower in dietary fiber—a dietary component of public health concern—than whole fruits and vegetables, and that juice in the current WIC food packages provides a disproportionate amount of fruit and vegetable servings compared to servings from whole forms. The Department believes the overall improved variety, flexibility, and choice afforded through the WIC food packages will appeal to participants while also providing foods in appropriate supplemental amounts.

The Department appreciates comments citing the benefits of juice across life stages, including for postpartum individuals, and agrees with the importance of ensuring equitable access to nutrient-dense foods for all participant categories. Further, the Department acknowledges the recommended amounts of fruits and vegetables in the 2020-2025 DGA are equivalent across life stages; specifically, the DGA recommends 2 and 2.5 to 3 cup equivalents per day of fruits and vegetables, respectively, for pregnant, breastfeeding, and postpartum individuals. The provision of 64 fluid ounce provides approximately 27 percent of the upper limit of juice in the recommended fruit and vegetable category of the DGA for postpartum women, which aligns with the supplemental amounts provided for all pregnant and breastfeeding participant categories.

2. Allow CVV as a Substitute for Juice (§ 246.10(e)(10) and (11), Tables 2 and 3)

This final rule codifies the provision allowing participants to substitute a $3 CVV for the full juice amount (64 fluid ounces) through individual tailoring during benefits issuance, as summarized in the 2022 proposed rule. The dollar value of the CVV substitution for juice will be adjusted annually for inflation, consistent with fruit and vegetable CVV adjustments in § 246.16.

Most commenters expressed support for the CVV substitution option, citing the importance of participant choice and the benefits of whole fruits and vegetables in comparison to juice, namely dietary fiber. Commenters further suggested increasing the dollar amount of the CVV substitution to $4 or more, believing this higher amount to be reflective of the market value for juice, and that as a Federal requirement or WIC State agency option the CVV be the default with juice as the substitution upon participant request. The Department agrees with the importance of participant choice and clarifies that (a) WIC State agencies have the option to make the $3 CVV the default with juice substituted upon request and (b) the dollar value of the CVV substitution will be evaluated and adjusted annually for inflation to ensure it keeps pace with the market value of juice.

Comments in opposition noted substituting 64 ounces of juice with a $3 CVV results in fewer net servings of fruits and vegetables as whole forms of fruits and vegetables typically cost more than juice, with one suggestion to also allow substituting additional juice for the CVV. The Department notes that while juice in nutrient-dense forms can be included in healthy dietary patterns, the 2020-2025 DGA emphasizes fruits and vegetables in whole forms and sets limits on the amount of juice consumption. As noted above, juice in the current WIC food packages provides a disproportionate amount of fruit and vegetable servings compared to servings from whole forms. Further, the option to substitute a $3 CVV for the full juice amount (64 fluid ounces), supports the Department's goals of providing greater flexibility, variety, and choice to accommodate special dietary needs, cultural practices, and personal preferences.

C. Milk and Milk Substitutions

This final rule revises milk and milk substitutions as proposed with some modifications based on public comments and in consideration of providing greater flexibility, variety, and choice to WIC State agencies and participants. The changes include:

Reduce milk amounts provided in child, pregnant, and breastfeeding food packages.

Permit only unflavored milk and establish an added sugar limit for yogurts and plant-based milk alternatives.

• Allow plant-based

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substitution options for milk.

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To reflect the addition of plant-based milk alternatives to the currently allowed soy-based beverage as a WIC-eligible, the preamble refers to “plant-based milk alternatives,” a term consistent with that the FDA uses in their draft labeling recommendations and inclusive of soy-based beverage.

• Add a calcium specification for tofu and a vitamin D specification for yogurts.

• Allow reduced-fat yogurts for 1 year-old children without restrictions.

• Remove cheese as a separate food category from the fully breastfeeding food package.

• Require authorization of unflavored lactose-free milk.

• Increase yogurt substitution amounts.

• Remove the limitation that no more than a total of 4 quarts of milk (for participants in Food Packages IV-VI) or 6 quarts of milk (for participants in Food Package VII) may be substituted for a combination of cheese, yogurt, or tofu.

• Create separate food packages for children 12 through 23 months and children 2 through 4 years.

• Update the FDA standards of identity citations for yogurt.

1. Reduce Maximum Monthly Allowances of Milk (§ 246.1(e)(10) and (11), Tables 2 and 3)

As NASEM recommended, this final rule codifies the proposed reduction in milk amounts from:

• 16 quarts to 12 quarts for children ages 12 to 23 months in the child food package

• 16 quarts to 14 quarts for children ages 2 through 4 years in the child food package,

• 22 quarts to 16 quarts in the pregnant and partially breastfeeding food packages, and

• 24 quarts to 16 quarts in the fully breastfeeding package.

These changes provide appropriate supplemental quantities and improve the balance of foods in the food packages.

The provision to reduce milk amounts received mixed support. Many commenters, including several WIC State and local agencies, expressed support for the reduced milk amounts, with the primary rationales that participants report receiving too much milk, the changes are consistent with the supplemental nature of WIC even after the reductions to the dairy amounts, and the WIC food packages still provide most of the recommended dairy amounts. Some commenters also suggested alternatives to the provision as proposed, including retaining current amounts or reducing amounts to a lesser degree for various participant categories. However, there were also many commenters, including a few WIC State agencies, who opposed the reduced amounts. Comments in opposition stated that dairy provides important nutrients and should not be reduced in a program that serves at-risk participants; dairy foods are some of the most highly redeemed products in the WIC food packages and a reduction would be noticeable and impact WIC participants and retailers; reducing milk amounts conflicts with the DGA and runs counter to WIC's nutrition focus; and that the change, which is not needed as a cost-savings measure, will lead to participants increasing their consumption of less nutritious beverages, and will reduce participation in WIC. The Department also acknowledges, while legally non-binding, the report language from the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act (Pub. L. 118-42) requests that the Secretary not reduce the maximum monthly allowance with respect to milk when submitting this final rule.

The Department agrees that milk provides important nutrients, and WIC continues to support access to dairy products while rebalancing the foods and beverages currently provided in quantities that exceed recommended amounts. The current DGA recommends consuming amounts of foods to meet nutrient needs while not exceeding calorie requirements. The recommended amounts of dairy range from 1.66 to 3.00 cups per day across life stages. At current levels, the WIC food packages provide up to 128 percent of these amounts from milk alone. Recognizing the inconsistency with WIC's supplemental intent, NASEM recommended reducing the milk amounts to provide a more balanced supplement to participants' diets. Ultimately, the reduced milk quantities reflect NASEM's recommendations and will provide 71 to 96 percent of the dairy amounts the DGA recommends; help to rebalance the food packages to better align with DGA dietary patterns; and are more consistent with the

supplemental nature of WIC. The reduced quantities for children are also comparable to the amounts in the Child and Adult Care Food Program (CACFP) nutrition standards.

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Further, the Department believes the comprehensive set of changes made in this final rule align with nutrition science and consumer preferences and will result in more participants fully redeeming their food benefits.

14

Child Nutrition Programs: Revisions to Meal Patterns Consistent with the 2020 Dietary Guidelines for Americans (FNS-2022-0043) (

https://www.regulations.gov/document/FNS-2022-0043-0001

).

Regarding the concern that reduced milk quantities will disincentivize program participation, the Department believes that through flexibilities and additions made in this final rule, such as increasing the CVV, adding canned fish to more WIC food packages, and adding additional juice, dairy, and whole grain substitution flexibilities and food options to accommodate special dietary needs, cultural practices, and personal preferences, participants will continue to see the WIC food packages as a valuable benefit.

2. Permit Only Unflavored Milk and Establish an Added Sugar Limit for Yogurts and Plant-Based Milk Alternatives (§ 246.10(e)(12), Table 4)

This final rule permits only unflavored milk and establishes an added sugar limit for yogurts and plant-based milk alternatives.

a. Permit Only Unflavored Milk

This final rule codifies the provision to allow only unflavored milk as summarized in the 2022 proposed rule.

This provision received broad support, with commenters, including several WIC State agencies, stating that only a small number of WIC State agencies currently authorize flavored milk. The Department will provide targeted technical assistance to WIC State agencies currently authorizing flavored milk to support successful implementation of this change. Commenters in support of this provision also cited alignment with the DGA recommendation that nutrient-dense beverages include little to no added sugars. Commenters who opposed no longer allowing flavored milk, including a few WIC State agencies, stated that participants would not drink unflavored milk and that a healthy dietary pattern can include some added sugars, which would allow for added sugars in dairy. The Department clarifies the 2020-2025 DGA includes a limit on added sugars of less than 10 percent of calories per day and that nutrient-dense beverages include little, if any, sweeteners. The DGA further recommends that children 12 through 23 months of age avoid added sugars because their nutrient requirements are high relative to the amount of food consumed, providing virtually no room in their diets for added sugars. The Department clarifies that this provision also applies to lactose-free milk.

b. Establish an Added Sugars Limit for Yogurts and Plant-Based Milk Alternatives

This final rule replaces the current total sugars limits with an added sugars limit and codifies the following provisions for reducing sugars in yogurts and plant-based milk alternatives based on public comment as requested in the 2022 proposed rule:

• Plain or flavored yogurts (dairy and plant-based) must contain ≤16 grams of added sugars per 8 ounces (see

Vitamin D Fortification of Yogurts

for vitamin D requirement).

• Plant-based milk alternatives must contain ≤10 grams of added sugars per 8 fluid ounces (see

Plant-Based Milk Alternatives

for other nutrient requirements).

To maintain consistency across food categories that currently have total sugar limits, this final rule also codifies an added sugars limit for breakfast cereal (see section F. Breakfast Cereals).

The Department acknowledges the 2022 proposed rule requested comment on an added sugars limit for yogurt and soy-based beverages. As discussed below (see

Allow Plant-Based Alternatives that Meet Nutrient Specifications

), the Department is codifying changes to allow plant-based milk alternatives that meet the nutrient specifications for WIC-eligible soy beverages. Therefore, the Department considered comments regarding added sugars in soy-based beverages to apply to this broader category of plant-based milk alternatives, summarized below.

Commenters in support of using an added versus total sugars limit in yogurt and plant-based milk alternatives, including several WIC State agencies, highlighted that added sugars are not equivalent to natural sugars found in lactose or fruit, an added sugar limit is more consistent with DGA recommendations, and added sugars information is available on the Nutrition Facts label under FDA requirements. The Department agrees with the commenters and notes that using an added sugars limit instead of a total sugars limit increases consistency with proposed limits for Federally administered Child Nutrition Programs, which is of value to USDA and those who participate in such programs. At the time NASEM developed their WIC food packages recommendations, FDA's regulation to include added sugars on food labels was not yet implemented. Given the DGA recommendations on limiting added sugar, and that the FDA's labeling requirement for added sugars are in effect, this final rule includes an added sugar limit for yogurt and plant-based milk alternatives (as well as for breakfast cereal, see section F).

Comments in opposition stated that specific to yogurt, the varied fat levels of yogurts result in differing amounts of naturally occurring sugar from lactose. These commenters suggested the added sugars limits NASEM provided in Table 6.5 (page 303) of their 2017 report would be complex and create an administrative burden. Commenters further highlighted the lack of naturally occurring sugar in plant-based yogurts, noting these products require additional added sugars for palatability, and expressed concern regarding any proposed limit for total or added sugars. The Department agrees there would be substantial administrative burden associated with added sugars limits that differ based on the fat content of yogurt. The added sugars limit of ≤16 grams per 8 ounces of yogurt aligns with NASEM's suggested limits, which ranged from 11-18 grams of added sugars per 8 ounces depending on fat content, while easing administrative burden and aligning with proposed limits for Federally administered Child Nutrition Programs. The Department believes that a limit on the allowable added sugars content in plant-based yogurts is important for consistency with current dietary guidance and to support healthy dietary patterns.

3. Allow Plant-Based Alternatives That Meet Nutrient Specifications as Milk Substitution Options (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

This final rule adds plant-based milk alternatives, yogurts, and cheeses as milk substitution options.

a. Plant-Based Milk Alternatives

This final rule codifies allowing plant-based milk alternatives that meet the nutrient specification for WIC-eligible soy beverages in current WIC regulations (§ 246.10(e)(12), Table 4) as summarized in the 2022 proposed rule, with the addition of an added sugar limit codified in this final rule (see

Establish an Added Sugars Limit for Yogurts and Plant-Based Milk Alternatives,

above).

This final rule also codifies a technical correction to 7 CFR 246.10(e)(10) through (12) to reflect the

addition of plant-based milk alternatives to the currently allowed soy-based beverage as a WIC-eligible food by replacing “soy-based beverage” with “plant-based milk alternatives,” a term consistent with FDA draft labeling recommendations

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for these products. Additionally, the Department is clarifying that the current WIC State agency option to authorize plain or flavored (

e.g.,

vanilla, chocolate, etc.) soy-based beverage will apply to all plant-based milk alternatives, and such products will be required to meet added sugar requirements. The Department is also clarifying that Federal regulations will not require or allow for medical documentation to issue plant-based milk alternatives or other milk substitution options. Among the goals of this final rule are to accommodate special dietary needs and cultural and personal preferences and to provide more equitable access to the supplemental foods WIC provides. Requiring medical documentation to issue foods outside of Food Package III creates an unnecessary burden on participants and inequitable access if WIC State agencies' policies differ in how participants can obtain a milk substitution. Therefore, WIC State agencies that require medical documentation to provide a milk substitution option may no longer do so; rather, WIC State agencies must issue milk substitutions to participants when individually tailoring WIC food packages to accommodate special dietary needs and cultural and personal preferences.

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FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers

(

https://www.fda.gov/news-events/press-announcements/fda-provides-draft-labeling-recommendations-plant-based-milk-alternatives-inform-consumers#:~:text=The%20draft%20guidance%2C%20%E2%80%9CLabeling%20of%20Plant-based%20Milk%20Alternatives,and%20Nutrition%20Service%20fluid%20milk%20substitutes%20nutrient%20criteria

).

Most commenters, including WIC State agencies, supported offering other plant-based milk alternatives that meet nutrient specifications and discussed that many children who are allergic to milk are also allergic to soy, and so providing other plant-based milk alternatives provides a healthy beverage option for these participants. Commenters also discussed that providing additional plant-based milk alternatives provides more options for those with cultural preferences for non-dairy milks and urged the Department to allow a variety of plant-based milks beyond soy. Some commenters, including WIC State agencies, noted the limited availability of products that meet the current nutrient specifications and expressed concern for the relatively high cost of plant-based milks. The Department recognizes the limited availability of products that currently meet nutrient specifications and, given that dairy and soy are among the most common food allergens, is creating a pathway to allow WIC Stage agencies to authorize such products as they become available rather than waiting for a future rulemaking. Such a pathway provides WIC State agencies with greater flexibility to prescribe and tailor WIC food packages that accommodate participants' special dietary needs and personal and cultural food preferences, thus increasing equity. Additionally, USDA understands the cost concerns that some WIC State agencies expressed, and while the Department encourages WIC State agencies to offer as much flexibility, variety, and choice as possible for their participants, USDA also reminds WIC State agencies that they are not required to authorize all WIC-eligible foods. When deciding which types and brands of WIC foods to authorize, including when authorizing plant-based milk alternatives, WIC State agencies should consider factors such as package size, food prices, product availability across their jurisdiction, and program management costs along with participant preference and demand.

Some commenters also expressed a concern about the unit of measure since some products are available in 48-ounce containers. The current substitution ratio for soy-based beverages—an equal quart for quart substitution—will apply to plant-based milk alternatives, as will the ability for participants to substitute these products for the full milk allotment. Since milk and plant-based milk alternatives provide critical nutrients such as calcium and vitamin D, it is important that WIC participants have a way to redeem their full food benefit. For all foods authorized, WIC State agencies must authorize container sizes that equal or add up to the full MMA. However, this final rule also gives WIC State agencies the option to also authorize container sizes that may not equal or add up to the full MMA (see section J. Maximum Monthly Allowance (MMA)).

While the Department received broad support for this provision, several commenters expressed mixed views on the nutrient specifications for, or current nutrient content of, plant-based milk alternatives. One WIC State agency and one local WIC agency supported allowing plant-based milk alternatives but opposed the nutrient requirements, citing variety and flexibility as more important than matching the nutrient content of dairy milk. In contrast, some commenters expressed concern about the lack of equivalency in the nutrient content of plant-based milk alternatives relative to WIC-eligible dairy products, noting the important nutrients dairy-based products provide and citing the AAP, the AND, the American Academy of Pediatric Dentistry (AAPD), and the American Heart Association (AHA) as not recommending plant-based milk alternatives. A couple of commenters opposing this provision asserted the proposed authorization of lactose-free milk and flexibilities for substituting yogurt and cheese will ensure dairy's nutrients and health benefits are accessible to all WIC participants without a need to authorize plant-based milk alternatives.

USDA agrees cow's milk provides important nutrients, including calcium, vitamin D, and potassium—defined as nutrients of public health concern in the 2020-2025 DGA. As such, based on recommendations from NASEM, FNS proposed in 2006, implemented in 2007, and finalized in 2014 a provision to allow soy-based beverage that was fortified to contain nutrients in amounts similar to cow's milk. This was to ensure participants who substitute soy-based beverage for milk consume priority nutrients in similar amounts relative to dairy milk. Allowing other plant-based milk alternatives with the same nutrient specifications as soy-based beverage supports consumption of priority nutrients in similar amounts relative to dairy milk. It also creates consistency across eligible products and reduces administrative burden and the possibility of participant and vendor confusion.

USDA does not agree that lactose-free milk and dairy-based yogurt and cheese alone are sufficient alternatives for WIC participants. Individuals do not consume dairy for a variety of reasons, including special dietary needs such as an allergy, or cultural or personal preferences. While some individuals with lactose intolerance may tolerate dairy-based yogurt and cheese and soy-based beverages, dairy and soy are among the top food allergens, making these foods unavailable options as milk substitutions for WIC participants with these allergies.

The Department highlights the 2020-2025 DGA's recognition of beverages fortified with calcium, vitamin A, and vitamin D as included in the dairy group because of the similarity in nutrient composition when compared to cow's milk. While the nutritional content of many plant-based milk alternatives currently available in the retail marketplace is not similar to dairy

milk or soy-based beverages, the pathway the Department is creating through this rulemaking will allow for products to be added in the future. Additionally, USDA notes that in response to the 2022 proposed rule, the AAP commented, “Dairy-free alternatives to milk can be helpful for children with milk allergies or other dairy restrictions.” While noting that “many of these products lack the essential nutrients that dairy products contain,” they also stated that they would be “supportive of the addition of dairy-free alternatives to the WIC food package so long as their protein, vitamin D, and calcium amounts are similar to milk and that they do not contain significant added sugars.” Allowing WIC State agencies to authorize additional plant-based milk alternatives that meet the nutrient specifications for WIC-eligible soy beverage, as the marketplace allows, supports equitable access to supplemental foods consistent with the legislative intent of the WIC Program.

b. Add Plant-Based Yogurts and Plant-Based Cheeses

Based on public comment requested, this final rule codifies allowing plant-based yogurts and cheeses as substitution options for milk as summarized in the 2022 proposed rule with modification to the vitamin D specification and the use of an added versus a total sugar limit (see

Establish an Added Sugars Limit for Yogurts and Plant-Based Milk Alternatives

) for plant-based yogurt:

• Plant-based yogurts must contain ≤16 grams of added sugars and at least 250 milligrams of calcium, 6.5 grams of protein, and 106 IU (2.67 micrograms) of vitamin D per 8 ounces.

• Plant-based cheeses must contain at least 250 milligrams of calcium and 6.5 grams of protein per 1.5 ounces.

Several commenters, including WIC State agencies, supported allowing additional plant-based yogurts and cheeses (

i.e.,

not just soy-based) as milk substitution options to accommodate those with dairy and soy allergies and provide variety for those who follow vegetarian or vegan dietary patterns. As with plant-based milk alternatives, commenters likewise cited availability and cost concerns. As noted in the discussion for plant-based milk alternatives, while the availability of products that meet nutrient requirements for plant-based yogurts and cheeses are limited currently, creating a pathway for future inclusion eliminates a barrier to addressing special dietary needs and cultural and personal preferences. USDA also received a request for the vitamin D requirement to match the minimum optional vitamin D fortification amount outlined in the FDA's updated Standard of Identity (SOI) (see

Vitamin D Fortification of Yogurts

) for the discussion on vitamin D). Only a few commenters opposed adding plant-based yogurts and cheeses, with a concern expressed for participant confusion because plant-based milk alternatives are not allowed, and an assertion that dairy-based yogurt and cheese provide important nutrients. This final rule allows plant-based milk alternatives, thus there is consistency in allowing plant-based milk alternatives, yogurts, and cheeses. USDA agrees that WIC-eligible dairy-based foods provide important nutrients, including calcium and vitamin D. Likewise, allowing plant-based yogurts and plant-based cheeses that meet the nutrient specifications contained in this rule allows for greater access to these nutrients by participants with certain conditions or for those who follow vegetarian or vegan dietary patterns.

5. Add a Calcium Specification for Tofu and a Vitamin D Specification for Yogurt (§ 246.10(e)(12), Table 4)

This final rule adds a calcium specification for tofu and a vitamin D specification for yogurt.

a. Calcium Fortification of Tofu

This final rule codifies a calcium requirement for tofu as summarized in the 2022 proposed rule with modification to 100 milligrams of calcium per 100 grams of tofu.

Commenters, including WIC State agencies, expressed general support for requiring calcium fortification of tofu, stating this would be especially beneficial for participants with milk allergies. Many commenters expressed concerns about current marketplace availability of tofu products that meet the proposed specification (200 milligrams of calcium per 100 grams of tofu), stating that this requirement would remove or eliminate all tofu products currently eligible and noting the effect that adding calcium has on the texture of tofu.

Based on comments, USDA conducted additional marketplace analyses. Using USDA Agricultural Research Service's (ARS) Food Data Central Database, 27 out of 40 tofu products randomly selected across a variety of brands and textures were found to provide 100 milligrams or more of calcium per 100 grams of tofu. For the three WIC State agencies that provided information about products in their state, this calcium amount is consistent with the lower end of what they reported as being available: 100-153 milligrams of calcium per 100 grams of tofu. Calcium is a priority nutrient for the WIC target population, so adding a calcium specification for WIC-eligible tofu ensures those who substitute tofu for milk still obtain calcium. Lowering the minimum requirement from 200, as proposed, to 100 milligrams of calcium per 100 grams of tofu increases access to this priority nutrient in a manner that reflects current marketplace availability.

b. Vitamin D Fortification of Yogurts

This final rule codifies a vitamin D requirement for yogurts (dairy- and plant-based) as summarized in the 2022 proposed rule with modification to 106 IU (2.67 micrograms) of vitamin D per 8 ounces of yogurt. The Department is also extending the implementation date for this requirement to April 26, 2027, based on public comment. This date is a deadline, thus if products that meet the vitamin D specification are available sooner, WIC State agencies may and are encouraged to authorize these products in advance of this date.

Most commenters, including WIC State agencies, supported adding a vitamin D specification to yogurt to improve participant health, citing the underconsumption of this nutrient. The primary concern among commenters, including a couple of WIC State agencies, who supported and opposed this provision was marketplace availability and the potential for reducing or eliminating all currently authorized yogurts followed by a concern about manufacturers' willingness to modify products. However, through the public comment process, an industry advocacy group and several yogurt manufacturers expressed their support for a vitamin D specification for WIC-eligible yogurts. No manufacturers or industry representatives submitted comments in opposition to adding a vitamin D specification, and two of the manufacturers and an industry advocacy group recommended that USDA implement a specification to match the minimum optional vitamin D fortification amount outlined in the FDA's updated SOI for yogurt (21 CFR 131.200), which states that: “If added, vitamin D must be present in such quantity that the food contains not less than 10 percent Daily Value per Reference Amount Commonly Consumed (RACC) thereof, within limits of current good manufacturing practices.” With a RACC of 6 ounces and a Daily Value of 800 IU (20 micrograms), the minimum amount of

vitamin D the FDA SOI requires if yogurt is optionally fortified with vitamin D is 80 IU (2.0 micrograms) per 6-ounce serving. This amount meets the FDA definition of a “good source” of a nutrient and translates to approximately 106 IU (2.67 micrograms) per 8 ounces, slightly higher than the 2022 proposed rule's 100 IU (2.5 micrograms) per 8 ounces. The Department finds merit in industry's request to align vitamin D specifications for WIC-eligible yogurts with the FDA's SOI for yogurt (21 CFR 131.200) when yogurt is voluntarily fortified with vitamin D and is modifying the proposed specification accordingly.

Industry commenters also requested USDA extend implementing this provision to 30 months to allow time for manufacturers to reformulate products. The Department finds this timeline to be reasonable based on the current marketplace requirements for vitamin D in yogurt and the Department's experience with review of reformulated and new products. To allow additional time for WIC State agencies' product review and APL and MIS updates, the Department is further extending the implementation date for the vitamin D requirement for yogurt by an additional 6 months, for a total of 36 months after publication of this final rule.

USDA received one comment stating that vitamin D is already present in several other fortified WIC-eligible foods and this nutrient should be obtained through active time outdoors. As noted in the proposed rule, the DGA identifies vitamin D as a nutrient of public health concern for people in all life stages and notes that vitamin D recommendations are hard to achieve through natural sources from diet alone and would require consuming foods and beverages fortified with this vitamin. The DGA also notes that some individuals may have difficulty producing sufficient vitamin D from sunlight exposure. Additionally, the Centers for Disease Control and Prevention (CDC)

16

and National Institute of Health (NIH)

17

encourage vitamin D consumption through food or dietary supplements to reduce UV exposure and ensure an adequate amount is obtained when neighborhood conditions like weather, crime, traffic, and lack of outdoor space for safe play limit the ability to spend time outdoors.

16

The Center for Disease Control and Prevention notes “there is no know level of UV exposure that would increase vitamin D levels without also increasing skin cancer risk.

https://www.cdc.gov/cancer/skin/basic_info/outdoors.htm.

17

National Institutes of Health guidance for vitamin D states that clothing and sunscreen can block skin production of vitamin D and that neighborhood social conditions may reduce sun exposure (

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6843675/

) and NIH fact sheet

“

Vitamin D—Health Professional Fact Sheet,” (

https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/

).

6. Allow Reduced-Fat Yogurts for 1-Year-Old Children Without Restrictions (§ 246.10(e)(10) and (11), Tables 2 and 3)

This final rule codifies allowing reduced-fat yogurts for 1-year-old children without restriction as summarized in the 2022 proposed rule (

i.e.,

both whole fat and reduced-fat yogurts may be issued to children 12-13 months of age without consultation with the participant's healthcare provider).

Commenters, including several WIC State agencies, largely supported this provision, citing that the DGA dietary pattern for children 12 through 23 months of age includes low-fat plain yogurts in the dairy food group for this age category to support consumption of a combination of foods to meet nutrient needs within limited calories. Commenters also stated that the change would expand yogurt variety and participant choice for children in this age group, improve participants' shopping experience because of the expanded options it affords, increase access to and consumption of dairy/yogurt, and reduce administrative, participant, and healthcare provider burden. The few commenters who opposed this provision, including WIC State agencies, stated that this change would create an administrative burden, requiring WIC State agencies to re-work the current category/subcategory structure on the MIS for the different fat levels of yogurt, and requesting to retain whole fat yogurt as the default standard issuance and allow the participant to determine which yogurt best suits their needs at the store.

The Department appreciates support for this provision and highlights the change to allow whole and low-fat yogurts as standard issuance to children 12 to 23 months of age aligns with the 2020-2025 DGA and expands yogurt variety and participant choice. While there are administrative efforts associated with the change, this one-time effort to update the MIS reduces the ongoing administrative burden of prescribing fat content at the time of food package prescription, as well as participant and healthcare provider burden associated with the current WIC State agency option to require (if necessary) a consultation with the child's health care provider to issue low-fat (0.5-2 percent) or nonfat yogurt.

The Department received one comment expressing concern the change may increase the amount of sugar young children consume, given the relatively higher added sugar content of low-fat yogurt. Through this rulemaking, USDA is reducing added sugars provided through the WIC food packages by no longer allowing flavored milk and placing limits on added sugars for WIC-eligible plant-based beverages and dairy and plant-based yogurts. The Department believes this change allows modest flexibility to participants within the DGA-recommended limits on sugars that supports a healthy dietary pattern over time and that through nutrition education WIC staff can work with parents and caretakers to identify the yogurt that works for them and encourage foods and beverages with little to no added sugars.

7. Remove Cheese From the Fully Breastfeeding Food Package (§ 246.10(e)(7)(ii) and (e)(10) and (11), Tables 2 and 3)

This final rule removes cheese as a separate food category for fully breastfeeding participants (Food Package VII) as NASEM recommended to provide a better balance of nutrients and align with the DGA recommendation for reducing saturated fat consumption. Participants receiving the fully breastfeeding food package will continue to be able to substitute cheese for milk like all other participants receiving milk in their food package.

The Department received several comments in support of this provision, including from several WIC State agencies, stating that reducing the cheese allotment would be consistent with NASEM and DGA recommendations regarding reducing saturated fat intake and provide a better balance of nutrients. Commenters also noted that retaining the ability to substitute cheese for milk allows participants continued access to this food. Some commenters opposed this provision, including several WIC State agencies, asserting that it is detrimental to nursing mothers who have increased caloric needs and particularly so for individuals who are lactose intolerant but may tolerate cheese. These comments also discussed the overall importance of dairy products to health and nutrition and that removing cheese could limit calcium and protein for breastfeeding participants and disincentivize fully breastfeeding.

The Department reiterates that cheese remains available to all participants (except for infants) as a partial milk substitution. While participants receiving the fully breastfeeding food package will no longer have cheese as a separate food item, they are still able

to substitute cheese for milk like all other participants issued milk in their food package. Thus, the revised fully breastfeeding food package continues to provide access to dairy in an amount consistent with the supplemental nature of WIC by providing 71 percent of the DGA dietary pattern recommendations (compared to the current fully breastfeeding food package that provides 119 percent). This change aligns with DGA recommendations for reducing saturated fat consumption and DGA guidance to consume a balanced diet that meets, but does not exceed, recommended food group and subgroup amounts and nutrients appropriate for an individual's life stage. With a greater CVV, more canned fish and eggs, and both legumes and peanut butter, the fully breastfeeding food package provides a food benefit consistent with higher caloric needs during this life stage and a better balance of nutrients. Further, as this rule expands options for participants who are lactose-intolerant, such as adding plant-based yogurt and plant-based cheese options and requiring WIC State agencies to authorize lactose-free milk, this rulemaking is expected to improve equitable access to key nutrients WIC supplemental foods provide.

The following provisions did not receive significant or substantial public comment; this final rule codifies the following provisions as summarized in the 2022 proposed rule:

• Require all State agencies to authorize unflavored lactose-free milk.

• Increase yogurt substitution amounts from 1 quart of yogurt for 1 quart of milk to allow up to 2 quarts of yogurt for 2 quarts of milk.

• Expand substitution options by removing the limitation that no more than a total of 4 quarts of milk (for participants in Food Packages IV-VI) or 6 quarts of milk (for participants in Food Package VII) may be substituted for a combination of cheese, yogurt, or tofu.

• Create separate food packages for children 12 through 23 months (Food Package IV-A) providing 12 quarts of milk and children 2 through 4 years (Food Package IV-B) providing 14 quarts of milk.

• Update the FDA Standard of Identity (SOI) citations for yogurt.

D. Infant Foods

As NASEM recommended, this final rule reduces the amount of infant cereal for all infants and reduces the amount of infant fruits and vegetables and infant meat for fully breastfed infants. This final rule also increases substitution amounts for infant fruits and vegetables; allows forms other than fresh; and lowers the minimum age for all infants to receive a CVV. These changes provide supplemental quantities and align with AAP's complementary feeding recommendations. This final rule does not exclude “added fats” from the ingredients authorized for infant foods as originally proposed.

Early Introduction of Peanut Butter to Infants

This final rule does not address the early introduction of peanut butter to infants. While the Department appreciates comments on this topic in conjunction with comments on the proposed changes to infant foods, the topic is outside the scope of this final rule. Infants ages 6 through 11 months receive complementary foods in the categories of infant cereals, infant food fruits and vegetables, and infant food meat. Currently, a legumes and peanut butter category is not part of the infant food packages. In their 2017 report, NASEM did not recommend changes to include new infant foods, such as legumes and peanut butter, to the infant food packages or review the appropriate amount of peanut butter to include in the infant food package if such changes were made. The Department recognizes there is an evolving body of scientific data that supports the early introduction of peanut-containing foods to help prevent a food allergy to peanuts; however, the applicability to the WIC food packages still requires further exploration and this topic may be included as part of the next comprehensive scientific review of the WIC food packages.

1. Reduce Infant Cereal, Infant Fruits and Vegetables, and Infant Meat (§ 246.10(e)(9), Table 1)

This final rule codifies the reductions to infant foods as summarized in the 2022 proposed rule. The revisions do not change the types of infant foods offered, maintaining alignment with DGA recommendations to introduce foods from all food groups starting at about 6 months of age and to include foods rich in iron and zinc, particularly for infants fed human milk. The reduction to infant foods provides appropriate supplemental quantities, as NASEM recommended, and align with the AAP's complementary feeding recommendations. In the interest of clarity, reduction to infant cereal, infant fruits and vegetables, and infant meat are discussed separately in this section.

a. Infant Cereal

Based on NASEM recommendations, this final rule codifies the reduction in the amount of infant cereal from 24 ounces to 16 ounces for fully breastfed infants and from 24 ounces to 8 ounces for partially (mostly) breastfed and fully formula fed infants. NASEM's review identified the current infant food packages as providing 150 percent of the maximum amounts of infant cereal recommended by the AAP.

Many commenters, including multiple WIC State agencies, expressed support for the reduction in infant cereal noting alignment with NASEM and AAP recommendations. Multiple WIC State agencies reported low redemption rates of infant cereal, and another commenter stated that cereal is often used as a starter food for infants up to 9 months of age and not used much thereafter. Some commenters expressed concern about reducing cereal for breastfed infants as it is a reliable source of iron for infants past 6 months of age, especially for infants who do not receive iron-fortified formula and for the WIC population, which has higher nutritional risk.

One commenter stated that the 2017 NASEM report reflects an incorrectly calculated AAP recommendation for infant cereal. The Department does not agree with this comment. NASEM's recommendations are based on the AAP's 2014 Pediatric Nutrition, 7th Edition recommendations, which were unchanged in their 2020 update and remain current.

The Department agrees that providing iron and zinc rich foods to infants 6 months of age and older is important, especially for fully breastfed infants. This final rule provides infant cereal in amounts that align with the NASEM and current AAP recommendations and recognize that breastfed infants may require more iron and zinc fortified cereal than formula fed infants because human milk contains low levels of these nutrients. USDA may further assess adequate iron intake through infant cereal during the next comprehensive review of the WIC food packages.

Arsenic in Infant Cereal

In addition to comments on the amount of infant cereal in WIC food packages, the Department received a few comments encouraging the removal of infant rice cereal as a WIC-eligible food, citing high arsenic levels. Through comments, the Department is aware that several WIC State agencies have already removed refined infant rice cereals from APLs due to concerns of arsenic levels. One commenter suggested requiring infant cereals to be whole grain with the exclusion of brown rice as a method of reducing exposure to arsenic, while others acknowledged arsenic concerns

but encouraged USDA to keep infant rice cereal as a WIC-eligible due to the importance of having gluten-free options.

The Department is following the recommendations of the FDA's Closer to Zero

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plan to reduce dietary exposure to contaminants (including arsenic) to as low as possible while maintaining access to nutritious foods. FDA states arsenic is found in both inorganic and organic forms and that inorganic arsenic is generally considered more toxic than organic arsenic. The amount of inorganic arsenic found in rice products, such as infant rice cereals, varies among manufacturers. To ensure infant safety, FDA has established an action level for inorganic arsenic in infant rice cereals that is intended to reduce the possible risks of neurodevelopmental delays and other health problems that may occur from consuming inorganic arsenic. Production of infant rice cereals by companies following FDA's current good manufacturing practices helps to ensure the safety of this food category. The Department agrees infant rice cereal is an important gluten-free alternative and is maintaining this as an option in the WIC food packages consistent with FDA guidance. WIC State agencies are encouraged to authorize a variety of infant cereal grain types and maintain their authority to establish criteria in addition to the minimum Federal requirements, to include limiting infant rice cereal if deemed necessary. USDA will continue to work with FDA to communicate key messaging regarding the safety of the food supply when appropriate.

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Food and Drug Administration's Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods (

https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods

).

b. Infant Fruits and Vegetables

As NASEM recommended, this final rule codifies the reduction in jarred infant fruits and vegetables for fully breastfed infants from 256 ounces per month to 128 ounces per month. According to NASEM, the current fruit and vegetable amount in the fully breastfed food package provides more than a one cup-equivalent of fruits and vegetables per day, an amount difficult for 6 through 11-month-old infants to consume. The revised amount aligns with the amount currently provided to partially (mostly) breastfed and fully formula fed infants.

Many commenters, including WIC State agencies, expressed support for the proposed reductions in infant fruits and vegetables due to low redemption rates and the importance of introducing a variety of foods—in multiple forms—to infants beginning at about 6 months. The Department agrees. As noted in the 2022 proposed rule, the current food package provides fully breastfed infants with more than a one cup-equivalent of fruits and vegetables per day, an amount difficult for an infant 6 to 11 months of age to consume.

The few comments in opposition cited general concern for a reduction in the amount of food provided, noting this may disincentivize the fully breastfeeding food package. The Department appreciates this concern and believes that the numerous changes to this food package, designed to increase variety, choice, and flexibility will provide continued appeal for fully breastfeeding participants. In addition, the Department notes that the reduction aligns with the overarching rationale for this rulemaking to provide supplemental amounts of food and improve the balance of foods and nutrients in the food packages.

The Department also received one suggestion to codify the reduced amount but introduce this provision beginning at 4 months of age. While the Department recognizes some infants may show developmental signs of readiness for nutrient-dense complementary solid foods before 6 months of age, the AAP recommends complementary foods should be introduced to infants at about 6 months of age.

c. Infant Meats

This final rule codifies the reduction in infant meats for fully breastfed infants from 77.5 to 40 ounces, as summarized in the 2022 proposed rule. This revised amount provides approximately 65 percent of the AAP-recommended maximum (previously 130 percent).

Many commenters, including WIC State and local agencies, expressed support for the reduction of infant meats in the fully breastfeeding package to align with the supplemental nature of the program and cited low redemption rates of infant meats. Several commenters stated that many of their WIC clients do not like the single ingredient jarred infant meats. Another commenter stated that pureed meats are one of the lowest redeemed foods and are not as culturally acceptable within their Tribe as other protein sources. There were few comments in opposition to this provision. Some commenters stated that meats are a good source of complete protein, heme iron, zinc, and other vitamins and minerals that support neurologic development and immune function, especially among breastfed infants that do not receive iron supplementation in formula. Another commenter stated that meat-based protein is considered optimal for infants as it is a high-quality protein and digested and absorbed more efficiently.

The Department agrees that infant meats provide a good source of iron and zinc that is important for fully breastfed infants. However, reducing infant meats to a supplemental quantity is consistent with the goals of this rulemaking and dietary guidance to consume a balanced diet that meets but does not exceed recommended amounts of foods and nutrients.

Infant Meat Redemption

Due to the low redemption of infant meat and the importance of this food as an iron source for fully breastfed infants, the Department requested public comment on ways to support increased redemption of infant meats, and iron-rich foods in general, for fully breastfed infants. Several commenters requested USDA allow alternatives to infant jarred meats, such as infant combination foods containing meats and vegetables, or allowing meat alternatives such as eggs, legumes, and tofu. Other commenters recommended adding fresh meat and fish to infant food packages. The Department appreciates these suggestions but believes that before such changes can be incorporated, additional research is needed to identify and develop strategies to increase iron consumption among WIC infants, as well as identify good sources of heme iron that meet eligibility criteria for WIC. Although no changes were made in this final rule in response to these comments, the Department will consider these comments in the future development of nutrition education and resources.

The Department appreciates the suggestions to increase redemption and consumption of infant meat and alternate options for iron-rich foods. NASEM considered inclusion of infant meat dinners (which contain meat and vegetables) but determined the amount of iron per ounce is significantly lower compared to single ingredient products. NASEM also determined that the non-heme iron found in eggs, tofu, and legumes would not be nutritionally equivalent to the heme iron available in infant meats. Regarding seafood for infants, while the current EPA-FDA advice for eating fish

19

provides updated information about

methylmercury exposure for younger children, neither agency has issued advice on which varieties of fish are safe or how much to recommend for infants to limit methylmercury exposure. Further, the DGA does not provide an infant dietary pattern with recommended amounts and types of fish. The Department may include an assessment of the amounts and types of fish that could be available in infant food packages during the next comprehensive review of the WIC food packages.

19

Advice about Eating Fish (

https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-updated-advice-about-eating-fish

).

Commenters also highlighted the importance of nutrition education as a way to improve iron consumption. The Department agrees that nutrition education can be used to encourage consuming iron rich foods, including those containing meat, and this messaging should continue to be part of the nutrition education provided to WIC participants.

2. Increase CVV Substitution Amounts for Infant Fruits and Vegetables, Allow Forms Other Than Fresh, and Lower the Minimum Age for Infants To Receive a CVV (§ 246.10(e)(9), Table 1)

This final rule codifies the increase to the CVV substitution amount for infants; allows the CVV for infants to be used to purchase at least one other form of fruits and vegetables in addition to fresh (see section A. Fruits and Vegetables. Require One Other Form of Fruits and Vegetables in Addition to Fresh); and lowers the age (from 9 to 6 months) at which the CVV can be substituted for infant fruits and vegetables, as summarized in the 2022 proposed rule.

Many commenters expressed support for all three actions in this provision, stating they better meet the needs of and empower families to prepare more foods at home, accommodate varied food preferences, and are more consistent with the developmental progression of feeding complementary foods. One commenter suggested allowing the CVV substitution to begin at 4 months of age, which the Department will not implement as NASEM and the DGA recommend introducing complementary foods around 6 months of age (see b. Infant Fruits and Vegetables above).

One commenter opposed this provision, stating that allowing the CVV substitution would be inconsistent with NASEM recommendations and reduce the net fruit and vegetable servings obtained through WIC and expressed concern that substituting a CVV for infant fruit and vegetable purees may result in older family members consuming the food, instead of the infant as intended. The Department clarifies this provision mirrors NASEM's recommendation to provide either: 128 ounces of infant fruits and vegetables; 64 ounces of infant fruits and vegetables and a $10 CVV; or no infant fruits and vegetables and a $20 CVV, and that all three options support a supplemental amount of fruits and vegetables for infants. Substituting jarred infant fruits and vegetables with the CVV may allow participants to buy more servings of these foods and allow caregivers to prepare foods with developmentally appropriate textures for older infants. Regarding the potential of another family member using the infant CVV, the Department appreciates this concern and believes it is addressed through education at the time of food package issuance, which includes instructions that all foods issued—not just the CVV substitution—are intended for participant use only.

3. Withdraw Proposed Provision To Prohibit Added Fats in Infant Foods (§ 246.10(e)(12), Table 4)

This final rule will not codify excluding “added fats” from the ingredients allowed in infant foods as summarized in the 2022 proposed rule. The Department proposed this change to align infant food packages with the healthy eating patterns of children as they grow. However, several commenters expressed general concern about this proposed provision, finding the recommendation vague and affirming that variables (such as those described below) would need to be considered to carry out the provision effectively. Other commenters discussed the benefits of fats, including omega-3 fatty acids needed for brain development. One commenter questioned the availability of infant meats without broth/gravy containing added fats, suggesting USDA consider excluding added fats from infant cereal, fruits, and vegetables only. The Department finds merit in the concerns commenters expressed pertaining to restricting all added fats from infant foods which would include polyunsaturated fats which play a role in brain development of infants as well as the operational feasibility of implementing this provision. USDA may consider additional research during the next comprehensive review of the food package to determine if restricting added fats is feasible in a way that supports infants' comprehensive nutrition needs and program administration.

E. Add Infant Formula Flexibilities and Create a Separate Food Package for Partially (Mostly) Breastfeeding Participants

This final rule increases formula amounts in the first month for partially (mostly) breastfed infants; allows all prescribed infant formula quantities to be considered “up to” amounts; and creates a separate and enhanced food package for partially (mostly) breastfeeding participants. These changes will be codified as proposed, with no modification, and will collectively add flexibilities to infant formula amounts and create a separate food package to strengthen support individual breastfeeding goals to help participants establish successful long-term breastfeeding.

1. Increase Formula Amounts in the First Month for Partially (Mostly) Breastfed Infants (§ 246.10(e)(1)(ii) and (e)(9), Table 1)

This final rule codifies the increased maximum monthly infant formula amounts for partially (mostly) breastfed infants in the first month from 104 fluid ounces to up to 364 fluid ounces, as summarized in the proposed rule. Consistent with current requirements, the amount of formula issued will continue to be tailored based on an individual nutrition and breastfeeding assessment. [Note: The revised amount of 364 fluid ounces reflects the FNB and corresponds to the MMA of 388 fluid ounces of reconstituted liquid concentrate, 384 fluid ounces of ready-to-feed, or 435 fluid ounces of reconstituted powder formula for partially breastfed infants aged one through three months. Therefore, this provision eliminates the need for the birth to one month feeding category.]

This proposed change received support from many commenters, who cited that the change would assist participants in achieving their breastfeeding goals, ensure infants receive adequate nutrition, increase breastfeeding duration, and decrease premature categorization of fully formula-fed infants. A few commenters requested USDA focus on providing education and counseling resources to help WIC staff support participants in the early postpartum period. They also requested additional breastfeeding supports to address breastfeeding challenges as well as additional funding for training staff and incentivizing the breastfeeding packages. One commenter requested the Department consider making the “up to” 364 ounces in the first month a WIC State agency option. A few commenters mentioned that more

research is needed to determine if the presence of formula on the WIC EBT card impacts a participant's breastfeeding journey.

Increasing the amount of infant formula in the first month for partially (mostly) breastfed infants, as NASEM recommended, encourages participants in the early postpartum period to try to breastfeed or extend breastfeeding duration by providing flexibility to tailor formula amounts based on an individual nutrition and breastfeeding assessment. As NASEM noted, this change is intended to prevent the premature categorization of an infant as “fully formula fed” and a mother as “postpartum” and allow the mother to receive the partially (mostly) breastfeeding food package to support nutritional needs and breastfeeding goals. USDA agrees with commenters who stated that early postpartum anticipatory guidance and frequent contact with skilled breastfeeding staff are key ways to encourage and support WIC participants in reaching their individual breastfeeding goals. The Department finds merit with the comments requesting further examination of the impact of this provision on breastfeeding duration and will consider this for future research opportunities.

2. Allow Prescribed Infant Formula Quantities To Be Considered “up to” Amounts (§ 246.10(e)(9), Table 1)

This final rule codifies that all prescribed infant formula quantities will be considered “up to” amounts as summarized in the 2022 proposed rule. This change is intended to reduce interference with the successful establishment of breastfeeding.

Many commenters expressed support for allowing all prescribed infant formula quantities to be considered “up to” amounts. Specifically, several commenters expressed support for tailoring formula benefits to meet individual needs. An individual commenter thanked the Department for removing the minimum nutrition requirement. One commenter stated the change aligns with recommendations among the healthcare/nutrition community on customized nutrition and another said the change would help establish long-term breastfeeding.

One commenter supported removing the FNB requirement stating that it, and MMAs, create a narrow window of formula amounts that WIC agencies must provide depending on the age of the client. While the Department appreciates this comment, the FNB is intended to provide close to 100 percent of the nutritional needs of a non-breastfed infant from birth to 6 months and is used as the basis for determining comparable MMAs of infant formula across the three physical forms of formula. The MMA is intended to provide infants the FNB with consideration of the reconstituted fluid ounce yields of the physical forms of formula products. However, formula amounts, even those in the fully formula-fed category, can still be individually tailored to meet, but not exceed, the formula needs of breastfeeding infants.

A few commenters had questions about the meaning of this provision as well as operational concerns. One commenter stated they would rather address overissuing/over feeding of formula via education at the time formula is issued. Another commenter requested clarity on what is meant by the phrase “up to” amounts for fully formula fed infants. The Department clarifies that across all infant food packages, formula amounts should be considered “up to” amounts to emphasize the importance of assessing the actual need for formula and reduce the possibility of interfering with the successful establishment of the participant's desired breastfeeding behavior. One commenter stated this change will be a burden for MIS changes because the FNB serves as a cutoff to determine whether participants are fully formula feeding or partially (mostly) breastfeeding and that WIC State agencies using the roundup method still need an FNB. The Department appreciates this concern and provides further clarification on implementation related comments in section V. Implementation.

Iron Standard Comments

Although the Department did not propose a revision to the iron standard for infant formula, it did seek comment on the current infant formula iron requirement of at least 10 milligrams of iron per liter (at least 1.5 milligrams per 100 kcal) of formula. Several commenters stated that the current requirement for iron-fortified formula should remain, noting iron-deficiency anemia continues to be a health concern for infants in the United States. A few commenters said they would support a change if backed by evidence. One commenter stated they support reducing the standard if this allows for a greater variety of formula to be available for WIC participants without compromising infant health. Another commenter noted that because infants normally have dietary iron sources other than formula (especially fortified infant cereal and meats), that 12 milligrams of iron per liter in formula appears to supply more iron than is necessary. In its comments, the AAP concluded that infant formula containing 12 milligrams of elemental iron per liter is safe for its intended use. One commenter requested that USDA consider revising the minimum iron requirements for infant formula to be consistent with the 1 milligram per 100 kcal requirement under § 246.10(e)(1)(iii) for iron-fortified infant formulas.

The Department appreciates the comments provided and agrees with most commenters that a regulatory change to the current iron specifications for infant formula is not warranted at this time due to inadequate evidence available to support a modification. The Department agrees with NASEM that updated data is needed to understand the optimal level of iron in infant formula, particularly in cases where the baseline iron status of infants is not optimal. The FDA announced on May 19, 2023, that NASEM will conduct a study to look at supply, market competition, and regulation of infant formula in the U.S. The study will explore the current state of the U.S. infant formula market. The study will also examine the differences in nutrition content, labeling, and regulatory requirements between infant formula sold in the U.S. and forms sold in foreign markets. Results of the study will be submitted to Congress and the FDA. New evidence from this study and other available sources regarding iron formula supplementation, including the FDA/NASEM study may be used to inform the next review of the WIC food packages.

3. Create a Separate and Enhanced Food Package for Partially (Mostly) Breastfeeding Participants (§ 246.10(e)(5), (7), (10), and (11), Tables 2 and 3)

This final rule codifies the creation of separate food packages for partially (mostly) breastfeeding participants, as summarized in the proposed rule. Pregnant participants will now receive Food Package V-A and partially (mostly) breastfeeding participants and pregnant participants with two or more fetuses will now receive Food Package V-B.

Many commenters expressed support for creating a separate and enhanced food package for partially (mostly) breastfeeding participants. Several commenters stated it better met the nutrient needs of participants in these categories, better aligned with NASEM recommendations on customized nutrition, supported breastfeeding, more accurately reflected breastfeeding rates,

better categorized participants, and strengthened WIC's ability to address food access and health disparities among participants. Some comments were in support of the new food package for partially (mostly) breastfeeding participants, but encouraged incentivizing breastfeeding in other ways, including through the use of breastfeeding peer counselors and nutrition education.

A few commenters asked that breastfeeding benefits be expanded to two years instead of one year to incentivize breastfeeding. WIC legislation specifies that “breastfeeding women means women up to one year postpartum who are breastfeeding their infants.”

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Therefore, the Department is unable to extend the fully breastfeeding category to participants who are past one year postpartum.

20

42 U.S.C. 1786(b)(1).

Some commenters specifically addressed the food package for participants who are pregnant with or breastfeeding multiples. One commenter stated that participants who are breastfeeding multiples should remain in the same category as pregnant with multiples participants so they can benefit from the extra calories this food package provides. Another commenter asked for a separate food package for breastfeeding multiples, since applying the 1.5 multiplier to the allowed food quantities for Food Package VII can be difficult to translate to actual WIC purchases. The commenter also requested the food package be updated to list specific MMAs in amounts that translate to whole containers. Per the DGA and NASEM's recommendations, participants who are fully breastfeeding multiple infants, pregnant with multiple fetuses, or both pregnant and breastfeeding have higher nutrient and caloric needs than participants with singletons. In the absence of any evidence on the additional energy needs for the participants fully breastfeeding multiple infants, NASEM estimated the additional energy need would be approximately 400 kcal per day for additional milk produced and assumed no further maternal fat mobilization. This represents approximately 50 percent more energy than the fully breastfeeding package supplies, indicating the current regulation to provide 1.5 times Food Package VII to these participants is appropriate. To eliminate concern about providing “half” of a food package, WIC State agencies have the option to issue foods in Food Package VII in amounts averaged over a 2-month timeframe where they issue double the “regular” fully breastfeeding package one month and the “regular” fully breastfeeding package the next month. NASEM did not study, nor did USDA propose a separate WIC food package for participants fully breastfeeding multiple infants.

Several commenters raised concerns that this change could have negative impacts on breastfeeding efforts. A few commenters stated the proposed revision would make the food packages for exclusively breastfeeding participants and partially (mostly) breastfeeding participants similar, minimizing the actual and perceived value of the exclusively breastfeeding package compared to the partially breastfeeding package. Some commenters reasoned the new food package, along with the reduction in benefits for fully breastfeeding participants, would disincentivize participants to fully breastfeed.

The Department appreciates comments highlighting the importance of nutrition education and other resources to support and encourage exclusive breastfeeding and will continue to evaluate and add to breastfeeding support services as needed. The Department clarifies that participants in the fully breastfeeding category will still receive more benefits than partially (mostly) breastfeeding participants due to their higher caloric needs.

F. Breakfast Cereals

This final rule requires that WIC-eligible whole grain breakfast cereals contain a whole grain as the first ingredient. This rule modifies the initial proposal and requires 75 percent of a WIC State agency's authorized breakfast cereals to meet the whole grain criteria of having whole grain as the first ingredient; and breakfast cereals contain no more than 6 grams of added sugars per dry ounce.

1. Revise Whole Grain Criteria for Breakfast Cereals (§ 246.10(e)(12), Table 4)

This final rule codifies the whole grain criteria for breakfast cereals as summarized in the 2022 proposed rule, requiring WIC-eligible whole grain cereals to contain a whole grain as the first ingredient.

Commenters expressed general support for this provision, with many WIC State agencies appreciating the reduced burden to operationalize the criteria for whole grain breakfast cereal, explaining the current criteria (having whole grain as the primary ingredient by weight and meeting the FDA labeling requirements for making a health claim as a

whole grain food with moderate fat content

) requires careful assessment of the ingredient list and Nutrition Facts label. Several commenters appreciated the Department's intent to align the criteria with other Federal nutrition programs and suggested that for full alignment, USDA modify the provision to allow breakfast cereals with either a whole grain as the first ingredient or at least 50 percent whole grains. While the Department appreciates this suggestion, requiring that whole grain breakfast cereals contain a whole grain as the first ingredient aligns with the goal of easing program administration for WIC State and local agencies, vendors, and participants. The revised criteria will not necessarily preclude a product with at least 50 percent whole grains from qualifying as a WIC-eligible whole grain breakfast cereal.

The few comments opposing this provision cited concern that breakfast cereals with a refined grain as the first ingredient but with more than 50 percent total whole grains would no longer be eligible. The Department understands and addresses this concern by requiring that at least 75 percent of breakfast cereals meet the criteria for whole grain cereal, as discussed below.

2. Require 75 Percent of WIC State Agency Authorized Breakfast Cereals Meet Whole Grain Criteria (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

This final rule codifies the requirement that WIC-eligible breakfast cereals meet the whole grain criteria as summarized in the 2022 proposed rule with modification to require 75 percent of cereals rather than 100 percent of cereals meet the whole grain requirement as initially proposed.

USDA received numerous comments in support of the provision as proposed. In expressions of support, commenters stated that requiring all WIC-eligible breakfast cereals to be whole grain aligns with the DGA recommendation to consume at least half of total grains as whole grains and supports consumption of an under consumed food subgroup and the nutrients whole grains provide. Several commenters suggested the provision would have an added benefit of expanding marketplace availability of whole grain cereals. The Department agrees with the importance of consuming whole grains and clarifies that while the marketplace could expand further, there are numerous breakfast cereals currently available that meet the whole grain criteria, including gluten-free varieties suitable for individuals with allergies to wheat.

While commenters supported the goal of increasing whole grain consumption, the Department received many comments in opposition to requiring that all breakfast cereals meet the whole grain criteria. WIC State agencies cited the increased burden on small vendors and the reduction in participant choice as primary concerns. Some commentors noted that cereal consumption can help drive milk and fruit consumption as well as highlighted the overall nutrients cereals provide (

e.g.,

iron and folate) and hypothesized that the changes would negatively impact consumers who prefer refined grain, rice- and corn-based breakfast cereals. Other commenters expressed the view that this change will better serve participants with high rates of diet-related diseases, including obesity and diabetes, and low levels of whole grain consumption.

The Department appreciates the comments received on this provision and specific suggestions to modify the requirement so that 75 percent of WIC-eligible breakfast cereals meet the whole grain criteria. Breakfast cereal is included in the WIC food packages to deliver key nutrients—primarily iron—to WIC participants. Some highly redeemed WIC cereals deliver key nutrients (

e.g.,

iron, folate) but do not contain whole grains or contain some whole grains but do not have a whole grain as the first ingredient. The Department acknowledges that consuming non-whole grain cereal contributes to the delivery of important nutrients for healthy development, including iron and folate, as well as the nutrients from milk and fruit consumed with it. Additionally, the Department values consistency across Federal nutrition programs and recognizes that in the School Meal Programs, the majority of, but not all, grain items must be whole grain. For these reasons and recognizing a healthy dietary pattern can include whole and refined grains in nutrient-dense forms, the Department is requiring that at least 75—rather than 100—percent of breakfast cereals a WIC State agency authorizes contain whole grain as the first ingredient. The Department remains committed to promoting increased whole grain consumption through nutrition education and highlights that WIC State agencies maintain the option to require that all cereals contain whole grain as the first ingredient. The Department encourages WIC State agencies to utilize redemption data to evaluate participant selections and support shifts in behavior toward the consumption of whole grain breakfast cereals by authorizing an appropriate number and selection of whole grain options.

3. Breakfast Cereals Must Contain No More Than 6 Grams of Added Sugar per Dry Ounce (§ 246.10(e)(12), Table 4)

This final rule codifies a limit of 6 grams of added sugars per dry ounce of breakfast cereal based on public comment as requested in the 2022 proposed rule.

In response to the request for comment on the use of an added sugars limit instead of a total sugars limit for breakfast cereal, the Department received broad general support. Commenters noted an added sugars limit aligns with current dietary guidance and Federal standards for Child Nutrition Programs. Commenters further highlighted that an added sugars limit allows for distinction between naturally occurring sugars and those added during product manufacturing, which is not possible with a total sugars limit. The Department agrees there is value in alignment across Federal nutrition programs and that an added sugars limit is consistent with the 2020-2025 DGA as well as feasible to operationalize following the addition of added sugars to the Nutrition Facts label.

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NASEM provided final recommendations for total sugars in its 2017 report, also providing added sugars limits for specific products should the FDA's regulation to include added sugars on food labels be implemented. With FDA's labeling requirement for added sugars now in place and recognizing value in consistency across Federal Child Nutrition Programs, USDA is replacing total sugar limits with added sugars limits for specific food categories as discussed in this final rule.

Comments in opposition cited concern that an added sugars limit may reduce the number of WIC-eligible breakfast cereals. A small number of WIC State agencies noted the additional burden associated with identifying breakfast cereals meeting the added sugars limit. One commenter suggested an added sugars limit may increase the use of low- and no-calorie sweeteners to retain product palatability. The Department clarifies the added sugars limit maintains the same numeric limit (6 grams) as the current total sugars limit; however, the limit no longer applies to naturally occurring sugars, in effect creating a more permissive standard for products containing naturally occurring sugars. In practice this means that no currently eligible WIC breakfast cereals will be excluded under the added sugars limit. The Department appreciates the burden associated with identifying products that meet WIC specifications and the potential substitution of low- and no-calorie sweeteners for caloric alternatives; however, the Department recognizes these considerations exist regardless of whether the limit applies to total or added sugars.

G. Whole Wheat Bread, Whole Grain Bread, and Other Whole Grain Options

This final rule reduces the amount of whole wheat bread, whole grain bread, and whole grain options in the child food packages and increases the amount in the pregnant, postpartum, and breastfeeding food packages as proposed. This rule also expands whole grain options as proposed with the modification to allow for additional whole grain options that meet regulation requirements.

1. Revise Maximum Monthly Allowances for Whole Wheat, Whole Grain Bread, and Other Whole Grain Options (§ 246.10(e)(10) and (11), Tables 2 and 3)

This final rule codifies the reduction in bread and whole grain options in the child food packages (from 32 to 24 ounces), and the increase in bread and whole grain options in the pregnant, postpartum, and breastfeeding food packages (from 16 to 48 ounces) as summarized in the 2022 proposed rule.

Commenters, including several WIC State agencies, expressed mixed support for this provision, with many generally supporting the increase for pregnant, postpartum, and breastfeeding participants but with some concern cited over the reduced quantities for children. Commenters asserted the importance of consuming and ensuring equitable access to whole grains, highlighting the reduced quantity for children could lead to a reduction in whole grain intake. Consistent with comments received on other provisions reducing quantities of supplemental foods provided, including juice and milk, several WIC State agencies noted the reduced quantity of bread and whole grain options may disincentivize participation and impede participant retention goals. Commenters generally appreciated the Department aligning quantities with the common 24-ounce package size.

The Department agrees that providing whole wheat bread, whole grain bread, and other whole grain options through the WIC food packages is important to support whole grain consumption among WIC participants. The quantities of 24 ounces for children and 48 ounces for pregnant, postpartum, and breastfeeding participants provide up to 53 percent of the whole grain subgroup amount recommended in the DGA dietary patterns, which the Department believes is an appropriate supplemental

amount. Providing quantities that align with common package sizes found in the marketplace supports the Department's goal of providing equitable access to supplemental foods while ensuring operational feasibility. In combination with the codified change to the MMA (see section J: Maximum Monthly Allowances (MMA)) that provides additional flexibility in authorizing package sizes, the change will also ease the burden on vendors to stock the 16-ounce package sizes that may be difficult to acquire.

2. Change Criteria for Whole Grain Breads (§ 246.10(e)(12), Table 4)

This final rule codifies the change in criteria for whole grain bread to require that such breads must contain at least 50 percent whole grains with the remaining grains being either enriched or whole grains as summarized in the 2022 proposed rule. The current requirement that whole grain bread conform to FDA standards of identity, as applicable, is maintained.

Most commenters, including many WIC State agencies, supported the change in criteria for whole grain bread, with several acknowledging the alignment with other Federal nutrition programs. Many commenters stipulated support for this provision as dependent on the Department providing guidance on the evaluation of grain products, noting that product labels often do not easily identify the whole grain composition placing the burden on WIC State agencies to identify allowable products under the revised criteria. Commenters further suggested USDA consider individuals with intolerances or allergies to wheat in finalizing the criteria for whole grain breads.

The Department agrees with the importance of guidance on the evaluation of grain products meeting the criteria for whole grain breads and will support WIC State agencies in the implementation of this provision. The Department understands the importance of providing whole grain foods that do not contain gluten to accommodate special dietary needs and clarifies that in addition to whole wheat bread, which contains gluten, whole grain breads, which may or may not contain gluten depending on the grain(s) included, continue to be WIC-eligible foods. The Department encourages WIC State agencies to authorize whole grain breads without gluten as necessary to meet the needs of their participants. Additionally, the Department is expanding whole grain options in this final rule, as discussed below.

3. Expand Whole Grain Options (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

This final rule codifies the expansion of whole grain options to include the following options as summarized in the 2022 proposed rule: quinoa; wild rice; millet; triticale; amaranth; kamut; sorghum; wheat berries; tortillas made with folic acid-fortified corn masa flour (once available in the marketplace); corn meal (including blue); teff; buckwheat; and whole wheat pita, English muffins, bagels, and naan. Further, based on public comments received, to increase participant choice, and maximize administrative flexibility, this final rule allows WIC State agencies to authorize additional whole grain options that meet nutrient requirements in WIC regulations (

i.e.,

do not include added fats or sugars, salt, or oil,

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and provided the MMA requirements are met (see section J. Maximum Monthly Allowances (MMA)).

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Whole grain options must be without added sugars, fats, oils, or salt (

i.e.,

sodium) as specified in § 246.10 Table 4 of “Final Rule: Revisions in the WIC Food Packages.” 79 FR 12274 (March 4, 2014).

Commenters, including numerous WIC State and local agencies, broadly supported this provision, noting the expanded options will allow participants to enjoy a greater range of nutrient-dense foods while accommodating special dietary needs (

e.g.,

food allergies) and cultural and personal preferences. In expressions of support, several WIC State agencies suggested USDA add additional gluten-free options such as red rice, black rice, freekeh, spelt, and farro, or that USDA include flexibility for WIC State agencies to authorize other nutritionally appropriate whole grain options based on popularity and availability.

The Department agrees with the importance of participant choice and accommodating cultural and personal dietary preferences and appreciates suggestions to further expand whole grain options. The Department recognizes that culturally preferred foods vary and are unique to individual cultural identity and that WIC State agencies are best positioned to determine the whole grain options to authorize to accommodate the needs of their participants. Therefore, through this final rulemaking, USDA provides the option for WIC State agencies to authorize additional whole grain options that do not include added fats or sugars, salt, or oil, including but not limited to the options suggested through public comments (

e.g.,

red rice, black rice, freekeh, spelt, farro). The Department encourages WIC State agencies to add products based on participant appeal in addition to the other factors outlined at § 246.10(b)(1)(i) including nutritional standards, competitive cost, and Statewide availability. If added to the APL, USDA reminds WIC State agencies of the requirement at 7 CFR 246.4(c) to submit an amendment to the State Plan for the current fiscal year to the appropriate USDA FNS Regional Office.

One commenter requested clarification on changes to the minimum stocking requirements for vendors, noting the potential for food waste and economic loss if vendors are required to stock whole grain options that are not popular locally. In response, the Department clarifies that with this provision, there will be no changes to the whole grain stocking requirement of at least one whole grain cereal set in WIC regulations § 246.12(g)(3)(i). The Department recognizes WIC State agencies may choose to establish additional minimum stocking requirements to ensure access to a greater variety of supplemental foods. However, establishing additional minimum stocking requirements cannot have the effect of limiting either the number or distribution of WIC authorized vendors in such a way that participants cannot reasonably redeem their benefits.

H. Canned Fish

This final rule expands the categories of participants receiving canned fish as proposed, with the modification of including 1 year old children, to create more equitable access to this under consumed, nutrient-dense food.

1. Add Canned Fish to Food Packages for Children (1 Through 4 Years) (§ 246.10(e)(4)(ii) and (e)(10) Through (11), Tables 2 Through 3)

This final rule codifies the addition of canned fish to the food packages for children with modification to provide:

• 6 ounces per month for children 2 through 4 years of age, versus 5 ounces as proposed, and

• 6 ounces per month for children 12 through 23 months of age.

In the 2022 proposed rule, out of an abundance of caution for the safety of young children and the concern for methylmercury exposure, USDA limited the addition of canned fish per month to 5 ounces for children 2 through 4 years and excluded canned light tuna as a canned fish option for children. At the time, the Department lacked information on marketplace availability of WIC-eligible canned varieties in sizes that would provide a supplemental amount for 1-year old children and meet

the EPA-FDA

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advice for eating fish and DGA recommendations.

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Advice about Eating Fish | FDA (

https://www.fda.gov/food/consumers/advice-about-eating-fish

)- Recommendations include 2 servings * of fish a week from the “Best Choices” list.

• * Serving size for 1-3 years old is 1 ounce. Serving size for 4-5 years old is 2 ounces.

• Children ages 1-4 years: Canned light tuna and chub mackerel should not be consumed if greater than 2 oz per week is consumed.

Commenters, including WIC State and local agencies, expressed broad support for providing fish in the child food packages, citing the benefits of fish in helping children meet their nutrient needs for optimum growth and development as well as reducing risk of developing chronic diseases. In addition to being supportive of adding fish, the food industry, many WIC State agencies, and professional organizations commented on the importance of providing light tuna as an option for all children 1 to 4 years of age.

To inform this final rule, USDA requested public comment on the availability of 3-ounce or smaller package sizes of canned salmon, Atlantic mackerel, and sardines in boneless varieties, and canned light tuna in package sizes safe for consumption by young children (

i.e.,

2 ounces). In response, many commenters provided information on package size availability and availability of fish without bones including confirmation from the food industry that salmon and light tuna are available in 2.5- to 2.6-ounce sizes and that light tuna is available in 3-ounce sizes. Some WIC State agencies requested an “up to” amount of 6 ounces per month and an increase in allowed fish amount for children to account for the available 2.6-ounce package size. Some WIC State agencies opposed adding fish to the food packages out of concern for availability of canned salmon, Atlantic mackerel, and sardines in rural stores. However, several WIC State agencies stated that 2.5- and 2.6-ounce packages of light tuna with low-sodium options are available in many areas.

In alignment with NASEM and DGA recommendations and EPA-FDA joint advice about eating fish, and in consideration of the numerous comments and evidence received on marketplace availability of smaller container sizes of WIC-eligible varieties of canned fish in both boneless and bone-in options, this final rule adds 6 ounces of canned fish to the food packages for children 1 through 4 years of age in the same varieties as canned fish offered to pregnant, postpartum, and breastfeeding participants (

i.e.,

salmon, sardines, Atlantic mackerel, Chub mackerel, and light tuna).

The Department appreciates and agrees with comments highlighting the important role WIC nutrition education will have in encouraging parents and caretakers to select boneless canned fish or remove bones prior to consumption to prevent choking, choose lower sodium varieties and amounts that limit methylmercury exposure, and preserve unused portions of canned fish safely.

2. Add Canned Fish in Food Packages for Pregnant, Postpartum, and Partially (Mostly) Breastfeeding Participants; Revise Amounts for Fully Breastfeeding Participants (§ 246.10(e)(5)(ii), (e)(6)(ii), and (e)(10) and (11), Tables 2 and 3)

This final rule codifies the monthly amounts of canned fish for pregnant, postpartum, and partially (mostly) and fully breastfeeding participants as summarized in the 2022 proposed rule:

• Pregnant and postpartum: 10 ounces canned fish

• Partially (mostly) breastfeeding: 15 ounces canned fish

• Fully breastfeeding: 20 ounces canned fish

Commenters expressed broad support for adding canned fish to the WIC food packages for pregnant, postpartum, and partially (mostly) breastfeeding participants and revising amounts for fully breastfeeding participants. In expressions of support, commenters asserted that omega-3 fish oils are essential for reducing risk for pre-term births and other such complications and that the changes would provide more equitable access to a nutrient-dense food choice, for which current intakes fall below DGA-recommended levels. A WIC State agency commented that the change will improve nutrient content and versatility of the WIC food packages. The Department appreciates comments expressing concern about the reduction of canned fish for the fully breastfeeding food package and requests to increase amounts of canned fish for partially (mostly) and fully breastfeeding participants. The revised monthly canned fish amounts for all pregnant, postpartum, and breastfeeding participants align with the supplemental nature of WIC and recommendations for DGA healthy dietary patterns.

3. Revise WIC-Eligible Varieties (§ 246.10(e)(12), Table 4)

This final rule codifies removing jack mackerel from the WIC-eligible canned fish varieties as summarized in the 2022 proposed rule.

Commenters expressed broad support for revising WIC-eligible fish varieties. One WIC state agency expressed opposition to the exclusion of jack mackerel, adding that the decision would increase its administrative burden. The FDA and EPA currently do not have methylmercury data on the commercial canned fish product “jack mackerel” and do not include this product in their joint advice about eating fish. Furthermore, the FDA guidance on defining jack mackerel species referenced in §  246.10(e)(12) is no longer available. Due to the lack of data on methylmercury levels in jack mackerel, this final rule retains the provision to remove jack mackerel as an allowable fish type for WIC. All other WIC-eligible varieties of canned fish (

i.e.,

salmon, sardines, Atlantic mackerel, Chub mackerel, and light tuna) will be available to child, pregnant, postpartum, and breastfeeding participants.

In response to the request USDA received to remove “canned” from the name of the fish category to account for other package types, the Department clarifies that § 246.10(e)(12), table 4 outlines minimum requirements and specifications for canned fish and defines that “canned” fish refers to processed food items in cans or other shelf-stable containers such as jars or pouches, which serves to denote that fresh and frozen fish are not WIC-eligible items.

I. Legumes and Eggs

This final rule requires authorizing both dried and canned legumes; requires substituting legumes and peanut butter for eggs in certain situations; and provides the option to substitute tofu for eggs as proposed. This rule will also provide the option for State agencies to authorize nut and seed butters as a modification to the proposed rule. The changes allow participants (except infants) to substitute the following for one dozen eggs to accommodate special dietary needs, cultural practices, and personal preferences:

• 1 pound dry or 64 ounces canned legumes

• 18 ounces peanut butter

• 1 pound tofu (as State agency option)

• 18 ounces of nut or seed butter (as State agency option)

1. Require Both Dried and Canned Legumes (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

This final rule codifies the requirement for WIC State agencies to authorize both dried and canned legumes as summarized in the 2022 proposed rule. Prior to this rulemaking, regulations only required dried legumes

and State agencies had the option to allow canned legumes.

Commenters expressed broad support for this change to increase flexibility and choice for participants, specifically citing the time-saving benefits of canned legumes, flexibility for participants lacking knowledge or equipment to prepare dried legumes, and potential increases in redemption rates. The Department agrees that this change will reduce a potential barrier to preparing and consuming legumes for participants who are unable to prepare dried legumes.

Among comments were requests to allow frozen unflavored legumes and small amounts of added sugars in canned legumes, reasoning that some canning processes require sugar to maintain the quality and structure of the food. USDA currently allows small amounts of added sugar to canned legumes for processing. The Department clarifies that WIC State agencies will retain their current authority to elect to authorize only low/lower sodium canned varieties. Regarding adding frozen legumes to the list of authorized legumes, currently, frozen legumes can be purchased with the CVV. The Department will explore the feasibility of adding frozen legumes to the legumes category for consideration in future rulemaking.

USDA did not receive any comments in opposition, though a few commenters noted the potential need for MIS changes. The Department addresses this concern for all categories of food in section V. Implementation.

2. Require Authorization of Legumes and Peanut Butter as Substitutes for Eggs and Allow State Agencies To Choose To Authorize Tofu To Substitute for Eggs (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

This final rule codifies the requirement for WIC State agencies to allow participants to substitute legumes and peanut butter for eggs and the option for WIC State agencies to authorize tofu as a substitute for eggs as summarized in the 2022 proposed rule.

Numerous commenters, including several WIC State agencies, expressed support for this provision citing a greater variety to accommodate special dietary needs, cultural practices, or personal preferences, as outlined in the 2022 proposed rule. In conjunction with this provision, the Department requested comment on the impact of requiring WIC State agencies to authorize tofu as an egg substitution. Some commenters expressed concern with the substitution of tofu for eggs, stating that eggs are high-protein, low-cost, and a better nutrition source than tofu. While the Department agrees that eggs are a high-protein, low-cost food, it believes the proposed substitutions are appropriate for those who cannot or choose not to eat eggs due to allergies or food preferences. As noted in the 2022 proposed rule, allowing tofu as a substitute for eggs provides participants with a source of iron and choline when eggs, legumes, and peanut butter are not acceptable food choices. However, the Department appreciates the comment from a WIC State agency expressing concern that tofu may not be readily accessible and clarifies that while legumes and peanut butter must be offered to participants as egg substitutions, authorizing tofu as a substitute for eggs is a WIC State agency option. A few commenters expressed concerns related to implementation in MIS and point of sale systems. The Department addresses MIS concerns for all categories of section V. Implementation.

3. Allow WIC State Agencies the Option To Authorize Nut and Seed Butters as a Substitute for Peanut Butter (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

This final rule codifies the WIC State agency option to authorize nut and seed butters as a substitute for peanut butter based on public comment as requested in the 2022 proposed rule. While NASEM did not recommend alternative nut and seed butter as substitutions, the Department recognizes nut and seed butters are included in a healthy dietary pattern as recommended by the DGA and requested public comment on allowing these products as a peanut butter or legume substitution option to further accommodate participants with food allergies. The Department specifically requested comments on the commercial availability of nut and seed butters that are nutritionally comparable to peanut butter/legumes in terms of specific nutrients (

e.g.,

protein, iron).

Commenters overwhelmingly supported allowing nut and seed butters as substitute for peanut butter, stating that many nut and seed butters could be nutritionally equivalent to peanut butter for protein, iron, choline, and fiber. They also discussed the prevalence and severity of peanut allergies and the importance of WIC food packages providing foods nutritionally equivalent to peanut butter.

The Department recognizes allergies to peanuts and other tree nuts as being among the most common food allergies in children in the United States. In USDA's School Meal Programs, schools must provide meal modifications for participants with disabilities, which may include providing substitutions for students with peanut or tree nut allergies. This requirement for the School Meal Programs and allowing nut and seed butters as a substitute to peanut butter as a WIC State agency option, both support access for participants with food allergies. Since peanut butter serves as a source of iron—a priority nutrient NASEM identified for WIC participants and a DGA nutrient of public health concern for women who are pregnant—in the WIC food packages, this final rule allows WIC State agencies the option to authorize nut and seed butters that provide a comparable nutritive value to peanut butter (

i.e.,

protein and iron). This substitution will be extended to participants through individual tailoring of the WIC food packages to accommodate special dietary needs, cultural practices, or personal preferences.

As individuals who are allergic to peanuts may also be allergic to tree nuts, the Department encourages WIC State agencies to consider authorizing a suitable option (

i.e.,

at least one seed butter) for these participants. The Department does not expect this change to result in a meaningful cost impact at the National level, as discussed in the accompanying Regulatory Impact Analysis. WIC State agencies should take a measured approach to product selection, which considers cost-containment policies and practices, when establishing their WIC authorized food list.

J. Maximum Monthly Allowances (MMA) (§§ 246.10(b)(1)(iii), (b)(2)(i), and (b)(2)(ii)(A); 246.11(a)(1))

This final rule codifies the option for WIC State agencies to authorize additional product package sizes that provide less than the full MMA as summarized in the 2022 proposed rule. WIC State agencies are still required to make available the full MMA amounts to participants (

i.e.,

at least one package size, or a combination of sizes, must add up to the full MMA for each food in each of the WIC food packages). This final rule also codifies that, in instances where multiple household members are receiving the same food, WIC State agencies may authorize package sizes that exceed the MMA for each individual WIC food package (

i.e.,

aggregate WIC benefits) provided the amount does not exceed the total of the combined MMA for the household. Foods on a WIC State agency's APL must continue to meet the needs of each individual WIC food package prescription.

Many commenters, including WIC State agencies, expressed general support, stating that providing greater package size flexibility reduces barriers to WIC shopping and increases options for participants; and more options save time and transportation costs for participants by reducing the need to shop at multiple stores and/or make return trips, particularly for those in rural and/or Tribal areas; reduce barriers to benefit redemption and WIC participation; and could ease burdens for small vendors who have expressed difficulty stocking the currently required package sizes. One commenter supported the change and noted participant education would be critical to show that redeeming a certain size may prevent the redemption of full benefits.

In requesting comments on this added WIC State agency flexibility, the Department also requested public comment on requiring State agencies to authorize both package sizes that equal or add up to the MMA (to ensure participants have a pathway to receiving the full food benefits to which program participation entitles them) and packages sizes that do not (to ensure greater variety and choice). Some commenters raised concerns with such a requirement, noting that implementation would require burdensome technical efforts or that the flexibility in approving package sizes could increase the APL size and potentially make it unmanageable. However, a few commenters requested that USDA require WIC State agencies to approve varying food package sizes to create distribution and retail efficiencies in addition to participant flexibility and choice.

The Department acknowledges the administrative burden of requiring WIC State agencies to authorize both package sizes that equal or add up to the MMA and packages sizes that do not for each food category, thus retained the latter as a WIC State agency option in this final rule. WIC State agencies wishing to exercise this option may do so at a rate reasonable to retain a manageable APL size and, as an option, are not required to do so by the implementation date for required provisions. To meet participants' needs, the Department encourages WIC State agencies to provide as much variety and choice as possible for as many food categories as possible, to the extent that is administratively and financially feasible given cost containment measures. Additionally, the Department agrees with commenters who noted the importance of education to ensure participants receive the greatest benefit from their WIC food package and reminds WIC State agencies of this requirement as outlined in § 246.10(b)(2)(ii)(A).

IV. Miscellaneous Related Revisions and Editorial Corrections

This final rule updates the definition of

individual with disabilities,

adds breast pumps as a WIC benefit and corresponding participant violation provisions, clarifies the definition of WIC-eligible nutritionals, adds clarifying language to nutrition tailoring, updates the base year for the annual inflation adjustment to the CVV amounts, and makes conforming revisions and editorial corrections.

A. Definition of Individual With Disabilities (§ 246.2)

This final rule codifies an update to the definition of disability as summarized in the 2022 proposed rule: the term disability means, with respect to an individual, a physical or mental impairment that substantially limits one or more of the major life activities of such individual, a record of such an impairment, or being regarded as having such an impairment as described in 28 CFR 35.108.

Commenters were in broad support of this provision and no commenters opposed.

B. Breast Pumps as a Program Benefit (§ 246.2, 246.7(j)(10), and 246.16(u)(2)(i)))

This final rule codifies including breast pumps as a WIC benefit and adds reference to the sale or offer to sell breast pumps to the definition of

participant violation

(§ 246.2) as summarized in the 2022 proposed rule. It also codifies a conforming provision to ensure that every WIC applicant, parent, or caretaker is informed that selling or offering to sell WIC benefits is a participant violation and increases the dollar threshold for disqualification from $100 to $1,000. This update means that whenever a WIC State agency assesses a claim of $1,000 or more, assesses a claim for dual participation, or assesses a second or subsequent claim of any amount, the WIC State agency must disqualify the participant for one year.

All comments on this provision generally supported the change. Several commenters, including WIC State agencies, expressed support for the dollar threshold, while some commenters requested adjustments to the threshold to a lower amount, such as $500, to allow WIC State agencies to act sooner to address violations. A WIC State agency added that the agency rarely encounters participants who are selling or offering breast pumps, but instead deals with many participants who fail to return the WIC-owned pump. The Department supports WIC State and local agencies in implementing policies and procedures to retrieve breast pumps, without the threat of disqualification, before the dollar threshold is reached.

C. WIC-Eligible Nutritionals (§ 246.2)

This final rule codifies clarifying language to the definition of WIC-eligible nutritionals, which are enteral products specifically formulated to provide nutritional support for those with qualifying conditions (see § 246.2 for full definition), as summarized in the 2022 proposed rule, to convey the intent that homemade formulas and manufactured products in the marketplace that appear to be blenderized foods (

i.e.,

conventional foods liquified in a blender) do not meet WIC-eligible nutritionals requirements.

A few commenters, including WIC State agencies, supported the updated definition and added it would clarify which foods qualify and would better enable WIC State agencies to enforce which products can be categorized as WIC-eligible nutritionals. A few commenters, including WIC State agencies, urged USDA to continue to include commercially blenderized tube feedings in the definition, stating that commercially blenderized tube feedings meet the definition of a WIC-eligible nutritional, are nutritionally complete, intended for use under medical supervision, and are not equivalent to manufactured blenderized conventional foods. They also requested guidance regarding manufactured products that appear to be blenderized as they have seen an increase in requests. The Department clarifies that commercially blenderized medical foods that meet the requirements of the definition will continue to be eligible for WIC. No commenters opposed.

D. Nutrition Tailoring (§ 246.10(c))

This final rule codifies adding clarifying language to nutrition tailoring that exists in current policy and language to convey that nutrition tailoring also involves making substitutions to the types and forms of foods to accommodate an individual participant's food allergy or intolerance, cultural preferences, and medical or special dietary needs, as well as situations where the participant refuses or cannot use the item, as summarized in the 2022 proposed rule. This final rule also codifies the clarification that offering a participant substitution in

accordance with WIC State agency policy and Federal regulations is the first step before eliminating or reducing foods and must be based on their nutrition assessment.

Commenters, including WIC State and local agencies, were supportive of this provision, stating that the revisions will help accommodate participants with food allergies, cultural preferences, and dietary needs, and promote safety for participants with food allergies. Some commenters urged USDA to ensure product substitutions are determined in advance and not in retail settings and requested to exclude the required documentation needed when a participant requests a change to a food package based on preference.

The Department clarifies tha

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