[Federal Register Volume 89, Number 76 (Thursday, April 18, 2024)]
[Rules and Regulations]
[Pages 28488-28567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07437]



[[Page 28487]]

Vol. 89

Thursday,

No. 76

April 18, 2024

Part IV





Department of Agriculture





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Food and Nutrition Service





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7 CFR Part 246





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

  Federal Register / Vol. 89 , No. 76 / Thursday, April 18, 2024 / 
Rules and Regulations  

[[Page 28488]]


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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.

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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 [email protected].

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.\1\ 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.'' \2\ 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:
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    \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.
    \2\ 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.
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     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

[[Page 28489]]

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 \3\ 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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    \3\ 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.
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    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.

[[Page 28490]]

     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 \4\ (between 5 and 400 percent of the 
Dietary Reference Intake (DRI)) and recommended food group \5\ 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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    \4\ 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.
    \5\ 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.
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    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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    \6\ 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.
    \7\ 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.
    \8\ 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.
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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

[[Page 28491]]

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.

------------------------------------------------------------------------
                                                      Summary of final
           Section             Summary of proposed   revisions based on
                                    revisions          public comment
------------------------------------------------------------------------
A. Fruits and Vegetables....  1. Increase the CVV   Finalize as
                               maximum monthly       proposed.
                               allowances for
                               child, pregnant,
                               breastfeeding, and
                               postpartum
                               participants.
                              2. Require WIC State  Finalize as
                               agencies to           proposed.
                               authorize at least
                               one other form of
                               fruits and
                               vegetables in
                               addition to fresh.
                              3. Require vendors    Finalize as
                               to stock at least     proposed.
                               three varieties of
                               vegetables.
                              4. Expand what can    Finalize as
                               be purchased with     proposed.
                               the CVV.
B. Juice....................  1. Reduce or remove   Reduce juice amounts
                               the maximum monthly   to 64 fluid ounces
                               allowance for juice.  for child and all
                              2. Allow CVV as a      adult participants.
                               substitute for       Finalize as
                               juice.                proposed.
C. Milk and Milk              1. Reduce maximum     Finalize as
 Substitutions.                monthly allowances    proposed.
                               of milk.
                              2. Require            Finalize as
                               authorization of      proposed.
                               lactose-free milk.
                              3. (a) Permit only    3a. Finalize as
                               unflavored milk,      proposed.
                               including lactose-   3b. Establish an
                               free milk, and (b)    added sugars limit
                               reduce total sugars   for yogurt and
                               allowed in yogurt     plant-based milk
                               and plant-based       alternatives.
                               milk substitutions.
                              4. Add a (a) calcium  4a. Add a minimum
                               specification for     calcium
                               tofu [200             specification of
                               milligrams per 100    100 milligrams per
                               grams of tofu] and    100 grams of tofu.
                               (b) vitamin D        4b. Add a minimum
                               specification for     vitamin D
                               yogurt [100           specification of
                               international units   106 IU (2.67
                               (IU) (2.5             micrograms) per 8
                               micrograms) per 8     oz (1 cup) of
                               ounces of yogurt].    yogurt and extend
                                                     the implementation
                                                     timeline.
                              5. Increase yogurt    Finalize as
                               substitution          proposed.
                               amounts for milk.
                              6. Add soy-based      Allow plant-based
                               yogurts and soy-      yogurts and plant-
                               based cheeses as      based cheeses.
                               substitution
                               options for milk.
                              7. Update the FDA     Finalize as
                               standard of           proposed.
                               identity citations
                               for yogurt.
                              8. Allow reduced-fat  Finalize as
                               yogurts for 1-year-   proposed.
                               old children
                               without
                               restrictions.
                              9. Remove cheese as   Finalize as
                               a food category       proposed.
                               from the fully
                               breastfeeding food
                               package.
D. Infant Foods.............  1. Reduce infant      Finalize as
                               cereal, infant        proposed.
                               fruits and
                               vegetables, and
                               infant meat.
                              2. Increase CVV       Finalize as
                               substitution          proposed.
                               amounts for infant
                               fruits and
                               vegetables, allow
                               forms other than
                               fresh, and lower
                               the minimum age for
                               infants to receive
                               a CVV.
                              3. Prohibit added     No change to current
                               fats in infant        provision.
                               foods.
E. Add Infant Formula         1. Increase formula   Finalize as proposed
 Flexibilities and Create a    amounts in the
 Separate Food Package for     first month for
 Partially (Mostly)            partially (mostly)
 Breastfeeding Participants.   breastfed infants.
                              2. Allow all          Finalize as
                               prescribed infant     proposed.
                               formula quantities
                               to be considered
                               ``up to'' amounts.
                              3. Create a separate  Finalize as
                               and enhanced food     proposed.
                               package for
                               partially (mostly)
                               breastfeeding
                               participants.
F. Breakfast Cereals........  1. Change whole       Finalize as
                               grain criteria for    proposed.
                               breakfast cereals.
                              2. Require all        Require 75 percent
                               breakfast cereals     of breakfast
                               meet whole grain      cereals meet whole
                               criteria.             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)

[[Page 28492]]

 
G. Whole Wheat Bread, Whole   1. Revise (reduce     Finalize as
 Grain Bread, and Whole        for children and      proposed.
 Grain Options.                increase for
                               pregnant,
                               postpartum, and
                               breastfeeding
                               participants) MMA
                               for whole wheat and
                               whole grain bread
                               and other whole
                               grain options.
                              2. Change criteria    Finalize as
                               for whole grain       proposed.
                               breads.
                              3. Expand whole       Add proposed whole
                               grain options.        grain options and
                                                     allow for
                                                     additional whole
                                                     grain options that
                                                     meet
                                                     specifications.
H. Canned Fish..............  1. Add canned fish    Add canned fish to
                               to food packages      food packages for
                               for children (2       children (1 through
                               through 4 years)      4 years) and allow
                               and specify           canned light tuna
                               varieties.            and chub mackerel
                                                     for children
                              2. Add canned fish    Finalize as
                               to food packages      proposed.
                               for pregnant,
                               partially (mostly)
                               breastfeeding, and
                               postpartum
                               participants not
                               currently receiving
                               canned fish, revise
                               amounts for fully
                               breastfeeding
                               participants, and
                               revise WIC-eligible
                               varieties.
I. Legumes and Eggs.........  1. Require WIC State  Finalize as
                               agencies to           proposed.
                               authorize both
                               dried and canned
                               legumes.
                              2. Require            Finalize as
                               authorization of      proposed.
                               legumes and peanut
                               butter as
                               substitutes for
                               eggs and allow WIC
                               State agencies to
                               choose to authorize
                               tofu to substitute
                               for eggs.
                              3. Requested comment  Implement a
                               on nut and seed       provision to allow
                               butters.              WIC State agencies
                                                     the option to
                                                     authorize nut and
                                                     seed butters as a
                                                     substitute for
                                                     peanut butter.
J. Maximum Monthly            1. Allow WIC State    Finalize as
 Allowances.                   agencies to           proposed.
                               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).
------------------------------------------------------------------------

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 (Sec.  246.10(e)(10) and 
(11), Tables 2 and 3) \9\
---------------------------------------------------------------------------

    \9\ 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) \10\ for 
the purchase of fruits

[[Page 28493]]

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 
(Sec.  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 (Sec.  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 \11\ 
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.
---------------------------------------------------------------------------

    \11\ 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 
(Sec.  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 (Sec.  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 (Sec.  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

[[Page 28494]]

assistance, such as guidance or training depending on need.
b. Codify That White Potatoes Are WIC Eligible (Sec.  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 (Sec.  
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 (Sec.  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.\12\ 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.
---------------------------------------------------------------------------

    \12\ 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.

[[Page 28495]]

2. Allow CVV as a Substitute for Juice (Sec.  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 Sec.  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 \13\ substitution options for milk.
---------------------------------------------------------------------------

    \13\ 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 (Sec.  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

[[Page 28496]]

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.\14\ 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 (Sec.  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 (Sec.  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 (Sec.  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

[[Page 28497]]

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 \15\ 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.
---------------------------------------------------------------------------

    \15\ 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

[[Page 28498]]

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 (Sec.  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

[[Page 28499]]

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 (Sec.  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 (Sec.  
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

[[Page 28500]]

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 
(Sec.  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

[[Page 28501]]

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 \18\ 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.
---------------------------------------------------------------------------

    \18\ 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

[[Page 28502]]

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 (Sec.  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 
(Sec.  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 (Sec.  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

[[Page 28503]]

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 (Sec.  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 Sec.  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 (Sec.  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,

[[Page 28504]]

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.'' \20\ 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 (Sec.  
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 (Sec.  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.

[[Page 28505]]

    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 (Sec.  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.\21\
---------------------------------------------------------------------------

    \21\ 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 (Sec.  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

[[Page 28506]]

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 (Sec.  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 (Sec.  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,\22\ and provided the MMA 
requirements are met (see section J. Maximum Monthly Allowances (MMA)).
---------------------------------------------------------------------------

    \22\ Whole grain options must be without added sugars, fats, 
oils, or salt (i.e., sodium) as specified in Sec.  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 Sec.  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 Sec.  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) 
(Sec.  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

[[Page 28507]]

the EPA-FDA \23\ advice for eating fish and DGA recommendations.
---------------------------------------------------------------------------

    \23\ Advice about Eating Fish [verbar] 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 (Sec.  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 (Sec.  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 Sec.  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 Sec.  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 (Sec.  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

[[Page 28508]]

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 (Sec.  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 (Sec.  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) (Sec. Sec.  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.

[[Page 28509]]

    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 Sec.  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 (Sec.  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 (Sec.  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 (Sec.  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 (Sec.  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 Sec.  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 (Sec.  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

[[Page 28510]]

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 that Federal regulations at Sec.  
246.10(d)(1) do not require medical documentation to issue food 
substitutions outside of Food Package III (except for infant formula). 
The WIC competent professional authority provides nutrition education 
that addresses nutrition risks identified with diets that restrict 
certain foods and/or food groups, and WIC State agencies are encouraged 
to continue ongoing communication between WIC and healthcare providers 
as necessary. Regarding the request to determine product substitutions 
in advance and not in retail settings, WIC State agencies are 
responsible for determining the brands, types, and forms of foods 
authorized, including the substitution options they elect to authorize. 
In some situations, such as tailoring a food package for a participant 
with a peanut allergy, the determination to issue legumes instead of 
peanut butter is made at the time the food package is issued. In other 
instances, the WIC State agency may allow the participant to select 
from a range of allowable options at the time of purchase at the store 
for other foods, such as canned salmon or canned tuna, and selecting 
brown rice, corn or wheat tortillas, or whole-grain barley based on 
their preference and product availability.

E. Annual Inflation Adjustment for the Cash-Value Voucher (CVV) (Sec.  
246.16(j))

    This final rule codifies updating the base year (from 2008 to 2022) 
for the annual inflation adjustment to the CVV amounts as summarized in 
the 2022 proposed rule.
    Most commenters expressed support for this provision, stating that 
it helps to offset increased food costs, ensures that participants 
obtain the recommended intake of fruits and vegetables, and allows for 
the continuity of the benefit. A few commenters stated that the 
rounding procedure as described in Sec.  246.16(j)(5) should be revised 
so that the inflation adjustment is rounded up to the nearest multiple 
of $1 (not rounded down to the next multiple of $1 as is currently in 
regulation). The approach selected by FNS aligns with the one used in 
the Supplemental Nutrition Assistance Program (SNAP), which also rounds 
inflation adjustments down to the next multiple of $1 (7 CFR 
273.10(e)(4)(ii)), as well as the National School Lunch Program's 
national average payment rates, which are rounded down to the nearest 
cent (7 CFR 210.4(b)). The 2022 proposed rule did not request public 
comment or make any changes to the current rounding procedures. 
Therefore, the Department is not making this change in this final rule.
    One commenter opposed, stating that the CVV amounts should not be 
increased for inflation for at least five years since the 2023 amounts 
should be sufficient for now. The Department disagrees with this 
suggestion since unadjusted CVV amounts would over time decrease the 
amounts of fruits and vegetables participants could purchase, thereby 
conflicting with NASEM's recommendation to provide approximately half 
of the recommended daily amounts of fruits and vegetables for adults 
and children.

F. Conforming Revisions and Editorial Corrections (Sec.  246.10)

    This final rule codifies conforming revisions and corrections to 
typographical and grammatical errors as well as improvements for 
conciseness and clarity of final provisions. The changes will have no 
substantive effect on the public.

V. Implementation

    The Department initially proposed WIC State agencies would have 18 
months from publication of the final rule to implement the revisions to 
the food packages and all other provisions in the rule. Additionally, 
the Department proposed that once the WIC State agency began issuing 
each new food package, it be done on a State agency-wide basis. The 
Department requested comments on the administrative burden associated 
with both proposed implementation components.
    Commenters generally highlighted time, limited resources, and 
extensive system changes needed to successfully implement the 
provisions in this final rule. These changes included MIS changes, 
administrative time associated with the identification and review of 
new products, changes to shopping applications, participant education, 
work with retailers, and food product development. While WIC State 
agencies need to ensure their MIS is flexible to adapt to this and 
other changes effected through this rulemaking, the Department 
acknowledges that at any given time WIC State agencies are at different 
stages of updating their systems. To allow for the MIS changes this 
final rule requires, the Department extended the implementation 
timeframe for this final rule.
    After evaluating comments, the Department is providing a 24-month 
implementation timeline for all provisions, with two exceptions: a 60-
day implementation timeline for the revised CVV amounts for all 
children and women participants, and a 36-month timeline for 
implementing the Vitamin D specification in yogurt. WIC State agencies 
are allowed and encouraged to implement the provisions earlier than the 
24-month timeline; however, they must issue food benefits based on 
either the new food package in its entirety or maintain the current 
food package. For example, a WIC State agency may not add fish to the 
current foods and quantities available under the children's food 
package and make no other changes. A WIC State agency may, however, 
phase-in the new WIC food packages on a participant category basis. WIC 
State agencies may also implement any provisions expanding substitution 
options (e.g., additional whole grain options) at any time, including 
before completing the phasing in of the new food packages. To minimize 
participant and vendor confusion, once the WIC State agency begins 
issuing the new WIC food packages, it must be done on a State agency-
wide basis.
    With near unanimous support of a CVV increase in public comments in 
response to the proposed rule, implementation of the final CVV amounts 
60 days after publication of the final rule promotes timely access to 
the scientifically recommended amounts of fruits and vegetables. In 
addition, WIC State agencies need less time to update their MIS to 
issue the new amounts.
    Among the commenters who opposed or expressed concern for the 
proposed vitamin D specification for yogurt, the primary concern was 
marketplace availability followed by a concern about manufacturers' 
willingness to modify products. Several commenters expressed their 
support for implementing a vitamin D specification for WIC-eligible 
yogurts but requested USDA provide a longer timeframe for this 
provision to allow for product reformulation. Based on information 
regarding the lifecycle for reformulated and new products, USDA agrees 
that

[[Page 28511]]

extending implementation of this provision to 36 months would allow 
sufficient time to reformulate products as well as time for WIC State 
agencies to review and select products and work with vendors.
    The implementation dates are as follows:
     WIC State agencies must implement the provision in tables 
2 and 3 to 7 CFR 246.10(e)(10) and (11) increasing the cash value 
voucher, adjusted for inflation, for children to $26, pregnant and 
postpartum women to $47, and partial and fully breastfeeding women to 
$52 on June 17, 2024.
     WIC State agencies must implement the provision in table 4 
to 7 CFR 246.10(e)(12) that establishes a minimum vitamin D requirement 
for yogurt no later than April 19, 2027.
     WIC State agencies must implement all other required 
provisions of this rule no later than April 20, 2026.

Procedural Matters

Executive Order 12866, 13563, and 14094

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. Executive Order 14094 of April 6, 2023, focuses on 
modernizing regulatory review and updates the definition of a 
significant regulation.
    This final rule has been determined to be significant under section 
3(f)(1) of Executive Order (E.O.) 12866, as amended by E.O. 14094, and 
was reviewed by the Office of Management and Budget (OMB) in 
conformance with Executive Order 12866.

Regulatory Impact Analysis

    As required for all rules that have been designated as Significant 
by the Office of Management and Budget, a Regulatory Impact Analysis 
(RIA) was developed for this final rule. It follows this rule as 
appendix A. The following summarizes the conclusions of the regulatory 
impact analysis:
Need for Action
    Section 17 of the Child Nutrition Act mandates that the United 
States Department of Agriculture (USDA) conduct a comprehensive 
scientific review of the WIC food packages at least every ten years and 
revise the foods available, as needed, to reflect nutritional science, 
public health concerns, and cultural eating patterns (42 U.S.C. 
1786(f)(11)(C)). This rule makes changes that 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 food packages that accommodate participants' 
personal and cultural food preferences and special dietary needs; 
provide more equitable access to supplemental foods; and better promote 
and support individual breastfeeding goals of participants to help 
establish successful long-term breastfeeding.
Benefits
    The changes to the WIC food packages enacted under this rule 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 in prescribing food packages to accommodate 
participant personal and cultural food preferences and special dietary 
needs, and better promote and support the establishment of successful 
long-term breastfeeding.
    The increases in the value of the cash-value voucher (CVV) for 
fruits and vegetables, increases in canned fish, and changes to whole 
grain requirements will better align the WIC food packages with the 
2020-2025 DGA. The DGA identified average daily food group intakes of 
fruits, vegetables, seafood, and whole grains as falling below the 
recommended intake ranges for adults and children.\24\ Increased 
consumption of these foods is expected to increase intakes of key 
nutrients, including dietary fiber, potassium, vitamin D, vitamin A, 
vitamin C, folate, and polyunsaturated fatty acids. Dietary fiber, 
potassium, and vitamin D, considered nutrients of public health concern 
in the general U.S. population, are currently also under-consumed by 
WIC participants.25 26
---------------------------------------------------------------------------

    \24\ Gleason, S., Hansen, D., & Wakar, B. (2021). Indicators of 
diet quality, nutrition, and health for Americans by program 
participation status, 2011-2016: WIC report. Prepared by Insight 
Policy Research, Contract No. GS-10F-0136X. Alexandria, VA: U.S. 
Department of Agriculture, Food and Nutrition Service, Office of 
Policy Support, Project Officer: Michael Burke. www.fns.usda.gov/research-and-analysis.
    \25\ Ibid.
    \26\ Borger, C., Zimmerman, T., Vericker, T., et al. (2020). WIC 
Infant and Toddler Feeding Practices Study 2: Fourth Year Report. 
Prepared by Westat, Contract No. AG-3198-K-15-0033 and AG-3198-K-15-
0050. Alexandria, VA: U.S. Department of Agriculture, Food and 
Nutrition Service, Office of Policy Support, Project Officer: 
Courtney Paolicelli. Available online at: www.fns.usda.gov/research-and-analysis.
---------------------------------------------------------------------------

    NASEM's analysis estimates that in order to meet half of the 
recommended intakes of fruits and vegetables, WIC participants would 
need to spend $24, $43, or $47 (adjusted for inflation to FY 2022), 
depending on participant category, to meet 50 percent of the 
recommended intakes for fruits and vegetables. This suggests that the 
current regulatory CVV levels (which would have been $9 for children 
and $11 for pregnant, postpartum, and breastfeeding individuals in FY 
2022 had Congress not temporarily enacted higher levels through annual 
appropriations that aligned with the NASEM recommendations) only 
provide enough for around 19 percent and 12 percent of recommended 
fruit and vegetable intakes for these groups, respectively. By 
increasing the value of the CVV to the levels proposed by NASEM to meet 
50 percent of the recommended fruit and vegetable intakes, the rule is 
expected to significantly increase fruit and vegetable purchases and 
consumption among WIC participants.
    While it is difficult to quantify the full extent of projected 
benefits associated with the revisions to the WIC food packages, USDA's 
and NASEM's analyses find that the revisions better align the WIC food 
packages with the latest nutrition recommendations in the DGA and 
accordingly will support participants in achieving healthy dietary 
patterns. The 2020-2025 DGA highlights the importance of a healthy 
dietary pattern to help achieve a healthy body weight and reduce the 
risk of chronic disease. The DGA also emphasizes the importance of 
exposing young children to nutrient-dense foods at an early age to 
support the establishment of healthy dietary patterns. By supporting 
healthy dietary patterns among pregnant women, the changes to the WIC 
food packages will advance the Program's capacity to address nutrition-
related causes of maternal and infant morbidity and mortality. The 
Department finds that this rule presents an effective approach to 
supporting pregnant participants and families with infants and young 
children in achieving balanced, healthy diets and broadly promoting 
public health.
Costs
    The Department estimates that the rule to revise regulations 
governing the WIC food packages would result in a net

[[Page 28512]]

increase in Federal WIC spending of $4.9 billion, in the form of 
Federal transfer payments for increased WIC food expenditures, over 
five years from FY 2025 through FY 2029. This increase in Federal WIC 
food expenditures is driven by the increase in the CVV, which is 
estimated to increase WIC food expenditures by $5.6 billion over five 
years when compared to current CVV levels as outlined in 7 CFR 246.10. 
However, the CVV levels in this rule were enacted on a temporary basis 
for FY 2022, FY 2023, and FY 2024. As a result, when compared to the FY 
2022, FY 2023, and FY 2024 WIC food packages, the CVV increase made 
permanent in this rule would not impact Federal WIC expenditures. With 
the CVV impact zeroed out of the overall cost estimate for the rule, 
the remaining provisions are expected to result in a net decrease in 
Federal WIC food spending of $617 million over five years, or about a 
2.3 percent reduction in total food expenditures when compared to the 
food packages as currently enacted in FY 2023. These estimates are 
summarized at the food category level in the RIA in appendix A at the 
end of this document, where all changes under a given food category 
(e.g., changes to quantity issued, expanded substitution options, and 
flexibility in package sizes) are considered for their collective 
impacts on projected quantities redeemed and unit costs. Based on the 
implementation timeline described above, these cost estimates assume 
that the CVV increase will be fully in effect in FY 2025 and that the 
other provisions will be fully in effect beginning in FY 2026.
    As described above, the increase in value of the CVV accounts for 
most of the increased Federal spending, adding around $5.6 billion in 
costs over five years. This estimate assumes that the redemption rate 
of the increased CVV will continue at 2020 redemption levels (71.6 
percent) and accounts for annual inflation adjustments. The addition of 
canned fish to most food packages is estimated to add around $213 
million in additional spending over five years. The increase to the 
amounts of jarred infant fruits and vegetables that can be substituted 
for CVV and the expansion of the allowable age range to substitute CVV 
for jarred fruits and vegetables are estimated to increase redemptions 
for these items, adding $119 million in additional spending over five 
years, despite the reduction in the quantity of jarred fruits and 
vegetables issued to fully breastfed infants. Requiring all State 
agencies to authorize both dry and canned legumes is estimated to 
increase costs by $16 million over five years as some participants 
shift from purchasing dry legumes to more costly canned legumes.
    The remaining provisions will either result in net savings at the 
food category level or are not estimated to have a significant impact 
on costs. Although the expanded substitution options for milk and juice 
are expected to increase redemption rates for these food categories, 
the reductions to the maximum monthly allowances issued are still 
expected to result in a net savings of $118 million for milk and $640 
million for juice over five years. The estimated savings associated 
with the reduction in the allowances for juice offset part of the costs 
of the increase to the CVV--encouraging greater consumption of whole 
fruits and vegetables as emphasized in the DGA. While the rule will 
increase the amount of infant formula allowed in the first month for 
partially breastfed infants, this change is intended to support 
continued breastfeeding and is estimated to result in a shift of 5 
percent of infant mother dyads from fully formula feeding food packages 
to partially breastfeeding food packages, which would ultimately lead 
to a net savings of $34 million on infant formula over five years. The 
changes to infant meats, infant cereals, whole wheat/whole grains, 
breakfast cereal, and cheese are also expected to result in cost 
savings as summarized in Table 2d of the RIA in appendix A at the end 
of this document.
    In addition to the above impact on Federal transfer payments, the 
Department also estimates that WIC State agencies and local agencies 
will incur an increase in administrative burden associated with 
administering and explaining the changes to participants. This 
additional administrative burden is expected to account for about $179 
million in State agency and local agency labor costs over five years 
between FY 2025 and FY 2029. These administrative costs are considered 
allowable expenses for State agencies under their annually awarded 
Nutrition Services and Administration (NSA) grants. In general, the 
Department expects that State agencies will be able to absorb the costs 
associated with implementing the provisions under this rule with 
current NSA funds.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies 
to analyze the impact of rulemaking on small entities and consider 
alternatives that would minimize any significant impacts on a 
substantial number of small entities. Pursuant to that review, it has 
been certified that this rule will not have a significant impact on a 
substantial number of small entities. This final rule will not have a 
significant adverse impact on small entities in the Special 
Supplemental Nutrition Program for Women, Infants, and Children; the 
impact is not significant as it allows for greater options and 
flexibilities within approved food lists for State and local agencies 
to offer participants. State agencies are already required on an annual 
basis to review their approved foods lists.
    Factual Basis: The provisions of this final rule will apply to 
small local agencies operating the Special Supplemental Nutrition 
Program for Women, Infants and Children and to State agency staff who 
must monitor local agencies in remote locations. These entities meet 
the definition of ``small governmental jurisdiction'' and ``small 
entity'' in the Regulatory Flexibility Act. These entities will not be 
negatively impacted by the changes and options in this rule.
    As discussed in the Regulatory Impact Analysis (RIA), this rule is 
not expected to change the administrative burden on most vendors. There 
may be a small one-time burden on small vendors to stock three 
varieties of vegetables instead of two, but the overall burden on 
vendors will remain substantially unchanged. Requiring vendors to stock 
at least three vegetables serves to improve access and equity to 
nutritious foods for WIC participants by providing a greater variety of 
vegetables, particularly important for those living in locations where 
it is difficult to access vegetables.
    The Department does not routinely track data necessary to determine 
how WIC benefit redemptions vary by most vendor characteristics, 
including indicators for whether the store is a small business or 
independent grocer. The Department estimates that due to the one-time 
stocking burden, approximately 150 vendors may decide to discontinue 
participation in the Program out of approximately 40,000 total vendors, 
or approximately one to two vendors per State agency, on average. This 
estimate assumes that, among vendors with WIC redemptions in the bottom 
10 percent nationwide, those such as small convenience stores that 
offer limited grocery items may have the greatest difficulty stocking 
one additional vegetable. Comments from the public on this assumption 
were requested in the proposed RIA and none were received.

[[Page 28513]]

    Due to the unavailability of data on vendor size, the Department 
does not have estimated costs for small vendors to offer a third 
variety of vegetables. However, based on the estimated number of small 
vendors that could be impacted, this rule will not have a significant 
economic impact on a substantial number of small entities. The updated 
stocking requirement will require vendors to carry one additional form 
of vegetable and will allow vendors to meet this requirement by 
stocking fresh, canned, or frozen vegetables, depending on their 
policies. Given the flexibility in this requirement, the Department 
anticipates minimum negative impact on vendors and, in the long-term, 
and expects that the administrative burden on vendors will remain 
substantially unchanged.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as a ``major rule'', as defined by 5 U.S.C. 804(2).

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local and Tribal 
governments, and the private sector. Under section 202 of the UMRA, the 
Department generally must prepare a written statement, including a cost 
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures by State, local or Tribal 
governments, in the aggregate, or the private sector, of $146 million 
or more (when adjusted for inflation; gross domestic product (GDP) 
deflator source: Table 1.1.9 at https://www.bea.gov/iTable) in any one 
year. When such a statement is needed for a rule, section 205 of the 
UMRA generally requires the Department to identify and consider a 
reasonable number of regulatory alternatives and adopt the most cost 
effective or least burdensome alternative that achieves the objectives 
of the rule.
    This final rule does not contain Federal mandates (under the 
regulatory provisions of Title II of the UMRA) for State, local, and 
Tribal governments, or the private sector of $146 million or more in 
any one year. Thus, the rule is not subject to the requirements of 
sections 202 and 205 of the UMRA.

Executive Order 12372

    The Special Supplemental Nutrition Program for Women, Infants and 
Children (WIC) is listed in the Catalog of Federal Domestic Assistance 
under Number 10.557 and is subject to Executive Order 12372, which 
requires intergovernmental consultation with State and local officials 
(see 2 CFR chapter IV). Since WIC is State-administered, USDA's FNS 
Regional Offices have formal and informal discussions with State and 
local officials, including representatives of Indian Tribal 
Organizations, on an ongoing basis regarding program requirements and 
operations. This provides USDA with the opportunity to receive regular 
input from program administrators and contributes to the development of 
feasible program requirements.

Federalism Summary Impact Statement

    Executive Order 13132 requires Federal agencies to consider the 
impact of their regulatory actions on State and local governments. 
Where such actions have federalism implications, agencies are directed 
to provide a statement for inclusion in the preamble to the regulations 
describing the agency's considerations in terms of the three categories 
called for under section (6)(b)(2)(B) of Executive Order 13132. The 
Department has considered the impact of this rule on State and local 
governments and has determined that this rule does not have federalism 
implications. Therefore, under section 6(b) of the Executive order, a 
federalism summary is not required.

Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule is intended to have preemptive effect 
with respect to any State or local laws, regulations, or policies which 
conflict with its provisions or which would otherwise impede its full 
and timely implementation. This rule is not intended to have 
retroactive effect. Prior to any judicial challenge to the provisions 
of this final rule, all applicable administrative procedures must be 
exhausted.

Civil Rights Impact Analysis

    FNS has reviewed this final rule in accordance with USDA Regulation 
4300-004, Civil Rights Impact Analysis, to identify and address any 
major civil rights impacts the final rule might have on minorities, 
women, and persons with disabilities. A comprehensive Civil Rights 
Impact Analysis (CRIA) was conducted on the final rule, including an 
analysis of participant data and provisions contained in the final 
rule. The CRIA outlines outreach, mitigation, and monitoring strategies 
to lessen any possible civil rights impacts. The CRIA concludes by 
stating FNS believes that the promulgation of this final rule will 
impact WIC State agencies including Indian Tribal Organizations (ITOs), 
WIC vendors, WIC local agencies and clinic sites, food producers and 
manufacturers, and WIC participants. Specifically, WIC participants 
will be impacted by the changes to the WIC food packages to align with 
the latest nutrition science, accommodate special dietary needs and 
personal and cultural food preferences, and promote breastfeeding. WIC 
vendors will be required to consistently stock three vegetable 
varieties. State agencies, including ITOs, will have to identify new 
foods and package sizes and update their WIC Approved Product Lists 
consistent with the changes outlined in the final rule. WIC local 
agency and clinic staff will have to review and update procedures to 
ensure they prescribe the revised food package correctly and accurately 
communicate the changes to participants. Additionally, although the 
final rule's changes to the food packages were selected to align with 
available products, there may be a minimal need for food manufacturers 
to reformulate products or create new products or package sizes. 
However, FNS finds that the implementation of the outreach, mitigation, 
and monitoring strategies by the FNS Civil Rights Division and FNS WIC 
may lessen these impacts. If deemed necessary, FNS Civil Rights 
Division will propose further mitigation and outreach strategies to 
alleviate impacts that may result from the implementation of the final 
rule.

Executive Order 13175

    Executive Order 13175 requires Federal agencies to consult and 
coordinate with Tribes on a government-to-government basis on policies 
that have Tribal implications, including regulations, legislative 
comments or proposed legislation, and other policy statements or 
actions that have substantial direct effects on one or more Indian 
Tribes, on the relationship between the Federal Government and Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes. On November 30, 2021, FNS 
provided opportunity for consultation on the rule and received 
substantive feedback from several Tribal leaders which was taken into 
consideration during the development of this final rule, including 
support for more traditional foods, consideration of impacts on small 
or Tribal stores, and swift publication of the rulemaking. FNS will 
explore

[[Page 28514]]

additional opportunities for engagement as needed. Once the proposed 
rule was published in the Federal Register, FNS encouraged stakeholders 
representing ITOs to provide input on whether the proposed rule poses 
any adverse tribal implications. Several ITOs provided public comment 
on multiple aspects of the proposed rule. The Department considered all 
comments, including those received by ITOs. No Tribes requested 
additional consultation after the proposed rule was published. We are 
unaware of any current Tribal laws that could be in conflict with this 
final rule. If a Tribe requests consultation in the future, FNS will 
work with the Office of Tribal Relations to ensure meaningful 
consultation is provided.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; 5 CFR part 
1320) requires that the Office of Management and Budget (OMB) approve 
all collections of information by a Federal agency before they can be 
implemented. Respondents are not required to respond to any collection 
of information unless it displays a current valid OMB control number.
    In accordance with the Paperwork Reduction Act of 1995, this final 
rule revises existing information collection requirements currently 
approved under OMB Control Number 0584-0043, ``Special Supplemental 
Nutrition Program for Women, Infants, and Children (WIC) Program 
Regulations--Reporting and Recordkeeping Burden'' (expiration date 
January 31, 2027), and contains new requirements for the same 
information collection. These information collection requirements are 
subject to review and approval by OMB.
    The Department published the proposed rule, ``Special Supplemental 
Nutrition Program for Women, Infants, and Children (WIC): Revisions in 
the WIC Food Packages,'' in the Federal Register on November 21, 2022 
(FR 71090). In connection with the proposed rule, the Department 
submitted an Information Collection Request (ICR) discussing the 
information requirements impacted by the rule to OMB for review.\27\ 
The proposed rule requested public comment on proposed changes in the 
information collection burden that would result from this rule. No 
comments were received on the proposed information collection 
requirements and associated burdens. Comments received on other 
sections of the proposed rule highlighted the administrative burden 
required of State agencies to successfully implement the provisions in 
the final rule. The Department evaluated the administrative burden 
comments received on individual provisions throughout the rule and 
cross referenced them with the proposed changes in the ICR. The 
Department did not receive any comments disputing the estimated 
administrative burden as a result of this rulemaking. Therefore, the 
Department believes this administrative burden has been appropriately 
captured in the burden estimates that were presented with the proposed 
rule.
---------------------------------------------------------------------------

    \27\ See ICR Reference No: 202211-0584-006, available at: 
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202211-0584-001.
---------------------------------------------------------------------------

    This final rule does not change the information collection 
requirements that were proposed in the proposed rule. However, the 
baseline number of hours currently approved under OMB Control Number 
0584-0043 have been updated since the proposed rule was published, due 
to the regular revision of the WIC Program ICR. The revisions to the 
existing information collection requirements and the introduction of 
new information collection requirements that will take effect with the 
final rule will result in an overall increase in burden hours for State 
and local agencies, applicants for Program benefits, and businesses 
responding to these requirements. These changes are contingent upon OMB 
approval under the Paperwork Reduction Act of 1995. When the 
information collection requirements have been approved, the Department 
will publish a separate action in the Federal Register announcing OMB 
approval.
    Title: Special Supplemental Nutrition Program for Women, Infants, 
and Children (WIC) Program Regulations--Reporting and Recordkeeping 
Burden.
    OMB Number: 0584-0043.
    Expiration Date: January 31, 2027.
    Type of Request: Revision of a currently approved collection.
    Abstract: This is a revision of existing information collection 
requirements in the information collection under OMB Control Number 
0584-0043 that are affected by this rulemaking. This final rule revises 
regulations governing the WIC food packages to align them with the 
current Dietary Guidelines for Americans and to reflect recommendations 
from the National Academies of Sciences, Engineering, and Medicine 
while promoting nutrition security and equity and considering program 
administration. This final rule impacts the burden associated with 
reporting and recordkeeping requirements for State and local agencies, 
reporting requirements for Program applicants and participants, and 
reporting requirements for businesses. The average burden per 
respondent and the annual burden hours are summarized and explained 
below.
(i) Burden Revisions Related to Certification
    During the certification process, a program applicant or 
participant provides pertinent data, receives notification of their 
rights and responsibilities, receives information on other health-
related and public assistance programs, is assigned a food package 
based on their nutrition risk assessment and categorical eligibility, 
and receives their initial nutrition education including breastfeeding 
promotion and support. Currently, the Department estimates that it 
takes 25 minutes per applicant or participant to complete this 
certification process. Due to the program (food package) changes in 
this rule, the Department estimates that the certification process will 
take an additional three minutes to complete per participant. These 
three minutes account for the time required for clinic staff to review 
updated procedures, correctly prescribe the food package with the 
changes, and communicate the changes to each participant. Therefore, 
the Department estimates that going forward, certification will require 
28 minutes (0.4676 hours) per applicant or participant. This change 
will increase the reporting burden for State and local agencies and 
program applicants and participants as follows:
     For the 1,379,126 adult participants, the Department 
estimates an additional 69,094.21 hours (3 minutes or 0.0501 hours x 
1,379,126 participants) of reporting burden for certification. This 
will add 48,365.95 hours to the annual reporting burden for the 1,267 
government local agencies that perform certifications for 70 percent of 
adult participants (0.7 x 1,379,126 = 965,388.20 adult participants), 
and 20,728.26 hours to the annual reporting burden for the 543 non-
profit local agencies that perform certifications for the remaining 30 
percent of adult participants (0.3 x 1,379,126 = 413,737.80 adult 
participants).
     For the 3,400,090 child participants, the Department 
estimates an additional 170,344.51 hours (0.0501 hours x 3,400,090 
participants) of reporting burden for certification. This will add 
119,241.16 hours to the annual reporting burden for the 1,267 
government local agencies that perform certifications for 70 percent of 
child participants (0.7 x 3,400,090 = 2,380,063 child participants), 
and 51,103.35 hours to the annual reporting burden for the 543 non-
profit local agencies that

[[Page 28515]]

perform certifications for the remaining 30 percent of child 
participants (0.3 x 3,400,090 = 1,020,027 child participants).
     For the 1,464,744 infant participants, the Department 
estimates an additional 73,383.67 hours (0.0501 hours x 1,464,744 
participants) of reporting burden for certification. This will add 
51,368.57 hours to the annual reporting burden for the 1,267 government 
local agencies that perform certifications for 70 percent of infant 
participants (0.7 x 1,464,744 = 1,025,320.80 infant participants), and 
22,015.10 hours to the annual reporting burden for the remaining 543 
non-profit local agencies that perform certifications for the remaining 
30 percent of infant participants (0.3 x 1,464,744 = 439,423.20 infant 
participants).
    Additionally, the Department estimates that communicating the food 
package changes in this rule to current participants will require a 
one-time, five-minute (0.0835 hours) explanation per participant. An 
estimated 521,370.66 burden hours will be required for all current WIC 
participants to receive this explanation (6,243,960 participants x 5 
minutes or 0.0835 hours = 521,370.66 hours). Staff at the 1,267 
government local agencies will require 364,959.46 hours to provide this 
explanation to the 70 percent of WIC participants they serve (0.7 x 
6,243,960 = 4,370,772 participants x 0.0835 hours = 364,959.46 hours), 
and staff at the 543 non-profit local agencies will require 156,411.20 
hours to provide this explanation to the remaining 30 percent of WIC 
participants they serve (0.3 x 6,243,960 = 1,873,188 participants x 
0.0835 hours = 156,411.20 hours).
(ii) Burden Revisions Related to Updating Food Lists
    Each State agency is required to identify foods that are acceptable 
for use in the Program in their jurisdiction, in accordance with 
program regulations. This includes establishing criteria for and 
identifying foods, substitutions, brands and packaging the State agency 
will authorize for use in the Program. The rule includes additional 
requirements and options for WIC-authorized foods that will impact 
State agencies' identification of foods, substitutions, brands, and 
packaging acceptable for use in the Program to include:
     Requiring one other form of fruits and vegetables in 
addition to fresh.
     Allowing greater flexibility to authorize additional 
package sizes (e.g., fresh fruits and vegetables, yogurt, bread).
     Allowing plant-based yogurts and plant-based cheeses as 
substitution options for milk.
     Requiring the authorization of lactose-free milk.\28\
---------------------------------------------------------------------------

    \28\ Although, currently an option (not a requirement) all 
states and most ITOs already authorize some kind of lactose-free 
milk.
---------------------------------------------------------------------------

     Allowing additional whole grain options as substitutes for 
bread.
     Requiring the authorization of canned legumes in addition 
to dry legumes.
     Allowing the authorization of nut and seed butters as an 
alternative to peanut butter.
    Currently, the Department estimates that identifying foods for use 
in the Program takes an average of 40 hours per State agency each year. 
With the changes to acceptable foods in the rule, the Department 
estimates that, on average, it will take each State agency an 
additional three hours (based on an estimated range of 2 to 4 hours per 
State agency) to comply with this regulatory provision. This represents 
an average of a 5 to 10 percent increase in burden time. Therefore, the 
Department estimates 3,827 total annual burden hours for this provision 
(89 State agencies x 43 hours per State agency), which is an increase 
of 267 hours due to the rule.
(iii) Burden Revisions Related to Training State and Local Agencies
    Each State agency is required to provide local agencies with a list 
of foods that are acceptable for use in the Program in their 
jurisdiction. Due to the changes in the WIC food packages the food 
lists will be revised. State agencies will need to develop and deliver 
training for local agencies on the revised food lists. In addition, 
State agencies will attend an FNS-provided training about the food 
package changes. These training activities result in a one-time 
estimated burden of five hours for each State agency (one hour to 
attend the FNS training, three hours to develop State agency-specific 
trainings for local agencies, and one hour to provide training to local 
agencies). The Department estimates an additional one-time State agency 
reporting burden of 445 hours for these training activities (89 State 
agencies x 5 hours = 445 hours).
    Local agencies will be required to attend the hour-long training on 
updated food lists provided by their State agency. Therefore, the 
Department estimates an additional one-time burden of 1,267 hours for 
the 1,267 government local agencies and 543 hours for the 543 non-
profit local agencies to attend their State agency training.
(iv) Burden Revisions Related to Vendor Authorization
    The Department estimates that the new requirement for WIC-
authorized retail vendors to stock three varieties of vegetables 
(currently vendors are required to stock two varieties) will result in 
150 fewer vendors submitting applications and/or fewer vendors signing 
agreements. This estimate assumes that among vendors with WIC 
redemptions in the bottom 10 percent nationwide, those such as small 
convenience stores that offer limited grocery items may have the 
greatest difficulty stocking an additional vegetable, and therefore 
will be most impacted by the small increase in the minimum stock 
requirement in the final rule (37,417 retail vendors - 150 = 37,267 
retail vendors).
    State agencies are required to enter into a written agreement with 
retail vendors. State agencies must review completed application forms 
and sign a vendor agreement where the agreement period must not exceed 
three years. The Department estimates that one-third of all retail 
vendors will submit applications each year and that it requires the 
State agency 40 minutes (0.668 hours) to review each application and 
agreement. With the expected decrease in the number of retail vendors 
due to the rule, the Department estimates a decrease in the associated 
State agency reporting burden of 33.07 hours (0.33 x 150 retail vendors 
= 49.50 fewer applications and agreements to review x 0.668 hours = 
30.07 fewer hours).
    Additionally, retail vendors spend an estimated one hour every 
three years completing these applications or agreements. With the 
expected decrease in the number of retail vendors due to the rule, the 
Department estimates a decrease in the associated retail vendor 
reporting burden of 49.50 hours (0.33 x 150 retail vendors = 49.50 
fewer vendors completing applications and agreements x 1 hour = 49.50 
fewer hours).
    The Department further estimates that each retail vendor 
application and agreement requires onehour to collect and record in the 
State agency's recordkeeping system; most State agencies use an 
electronic MIS for this purpose. With the expected decrease in the 
number of retail vendors due to the rule, the Department estimates a 
decrease in the State agency recordkeeping burden associated with 
collecting and recording vendor applications and agreements of 49.50 
hours (0.33 x 150 retail vendors = 49.50 fewer vendors completing 
applications

[[Page 28516]]

and agreements x 1 hour = 49.50 fewer hours).
(v) Additional Burden Considerations
    This rule includes breast pumps as a Program benefit and adds 
reference to the sale or offer to sell breast pumps to the definition 
of participant violation (Sec.  246.2). In addition, the change 
(increase) to the dollar threshold for participant violations (Sec.  
246.16(u)(2)(i)) will result in a decrease in the number of participant 
claims. Taken together these two provisions will offset each other and 
will not have an impact on the investigation and complaints filed and 
therefore will not impact the currently approved burden estimate for 
Sec.  246.23(c)(1) (disposition of participant claims).
    Respondents: Businesses or other for-profit Organizations, non-
profit WIC local agencies, State, local, or Tribal government, and 
individuals and households. Respondent groups identified include State 
Agencies (including Indian Tribal Organizations and U.S. Territories), 
applicants for Program benefits, and retail vendors.
    Estimated Number of Respondents: 6,283,126.
    Estimated Number of Responses per Respondent: 3.98.
    Estimated Total Annual Burden on Respondents: 6,920,986.07 hours.

[[Page 28517]]



                                                  Estimated Annual Reporting & Recordkeeping Burden for 0584-0043 as a Result of the Rulemaking
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                     Estimated       Estimated
                                                             Estimated       Annual                     Average      Estimated         Hours         change in       change in         Total
        Regulation citation            Description of        number of     responses    Total annual     burden    total annual      currently     burden hours    burden hours      estimated
                                         activities         respondents       per         responses    hours per   burden hours   approved under      due to          due to         change in
                                                                           respondent                   response                  OMB #0584-0043    rulemaking      adjustments    burden hours
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Reporting
                                                      State and Local Agencies (including Indian Tribal Organizations and U.S. Territories)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.7(b), (i), (n) Women..........  Certification.......        1,267.00       761.95      965,388.20     0.4676      451,415.52      403,049.57      +48,365.95            0.00      +48,365.95
246.7(i) Children.................  Certification.......        1,267.00     1,878.50    2,380,063.00     0.4676    1,112,917.46      993,676.30     +119,241.16            0.00     +119,241.16
246.7(i) Infants..................  Certification.......        1,267.00       809.25    1,025,320.80     0.4676      479,440.01      428,071.43      +51,368.57            0.00      +51,368.57
246.7(i)..........................  Explaining food             1,267.00     3,449.70    4,370,772.00     0.0835      364,959.46            0.00     +364,959.46            0.00     +364,959.46
                                     package updates.
246.10(b)(1)......................  Identification of              89.00         1.00           89.00      43.00        3,827.00        3,560.00         +267.00            0.00         +267.00
                                     acceptable foods.
246.10(b)(2)(i)...................  Attend, develop, and           89.00         1.00           89.00       5.00          445.00            0.00         +445.00            0.00         +445.00
                                     provide training to
                                     local agencies on
                                     revised food lists.
246.10(b)(2)(i)...................  Local agency                1,267.00         1.00        1,267.00       1.00        1,267.00            0.00       +1,267.00            0.00       +1,267.00
                                     training on revised
                                     food lists.
246.12(h).........................  Vendor applications               89       138.18       12,298.11      0.668        8,215.14        8,248.20          -33.07            0.00          -33.07
                                     & agreements.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Reporting
                                                                                 Applicants for Program Benefits
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.7(i) Women....................  Certification.......    1,379,126.00         1.00    1,379,126.00     0.4676      644,879.32      575,785.11      +69,094.21            0.00      +69,094.21
246.7(i) Children.................  Certification.......    3,400,090.00         1.00    3,400,090.00     0.4676    1,589,882.08    1,419,537.58     +170,344.51            0.00     +170,344.51
246.7(i) infants..................  Certification.......    1,464,744.00         1.00    1,464,744.00     0.4676      684,914.29      611,530.62      +73,383.67            0.00      +73,383.67
246.7(i)..........................  Explaining food         6,243,960.00         1.00    6,243,960.00     0.0835      521,370.66            0.00     +521,370.66            0.00     +521,370.66
                                     package updates.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Reporting
                                                   Retail Vendors (WIC-Authorized Food Stores) and Businesses (Non-Profit WIC Local Agencies)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.7(i) Women....................  Certification.......          543.00       761.95      413,737.80     0.4676      193,463.80      172,735.53      +20,728.26            0.00      +20,728.26
246.7(i) Children.................  Certification.......          543.00     1,878.50    1,020,027.00     0.4676      476,964.63      425,861.27      +51,103.35            0.00      +51,103.35
246.7(i) infants..................  Certification.......          543.00       809.25      439,423.20     0.4676      205,474.29      183,459.19      +22,015.10            0.00      +22,015.10
246.7(i)..........................  Explaining food               543.00     3,449.70    1,873,188.00     0.0835      156,411.20            0.00     +156,411.20            0.00     +156,411.20
                                     package updates.
246.10(b)(2)(i)...................  Local agency                  543.00         1.00          543.00       1.00          543.00            0.00         +543.00            0.00         +543.00
                                     training on revised
                                     food lists.
246.12(h)(1)(i)...................  Vendor applications        12,298.11         1.00       12,298.11       1.00       12,298.11       12,347.61          -49.50            0.00          -49.50
                                     & agreements.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Recordkeeping
                                                           State Agencies (including Indian Tribal Organizations and U.S. Territories)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.12(h)(1)(i)...................  Vendor applications            89.00       138.18       12,298.11       1.00       12,298.11       12,347.61          -49.50            0.00          -49.50
                                     & agreements.
    Total.........................  ....................       6,283,126         3.98   25,014,722.33       0.28    6,920,986.07    5,250,210.02   +1,670,776.05            0.00   +1,670,776.05
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 28518]]

    Summary of Requested Burden Revisions:

                              Summary of Requested Burden Revisions to # 0584-0043
----------------------------------------------------------------------------------------------------------------
                                                                     Responses      Respondents     Time burden
----------------------------------------------------------------------------------------------------------------
Current Inventory: Total Burden.................................      55,379,381       6,283,276      15,686,416
    Current Inventory: Reporting................................      42,789,469       6,283,276      15,400,737
    Current Inventory: Recordkeeping............................      12,589,883          39,316         285,664
    Current Inventory: Public Disclosure........................              29              29              15
----------------------------------------------------------------------------------------------------------------
Total Burden Revision Requested.................................      67,869,052       6,283,126      17,357,192
    Burden Revision Requested: Reporting........................      55,279,189       6,283,126      17,071,563
    Burden Revision Requested: Recordkeeping....................      12,589,833          39,316         285,615
    Burden Revision Requested: Public Disclosure................              29              29              15
----------------------------------------------------------------------------------------------------------------
Difference in Total Burden from Rulemaking......................      12,489,671            -150       1,670,776
----------------------------------------------------------------------------------------------------------------

E-Government Act Compliance

    FNS is committed to complying with the E-Government Act of 2002 to 
promote the use of the internet and other information technologies to 
provide increased opportunities to provide for citizen access to 
government information and services, and for other purposes.

List of Subjects in 7 CFR Part 246

    Administrative practice and procedure, Civil rights, Food 
assistance programs, Foods, Grants administration, Grant programs--
health, Grant programs--social programs, Indians, Infants and children, 
Maternal and child health, Nutrition, Penalties, Public health, 
Reporting and recordkeeping requirements, Women.

    Accordingly, Food and Nutrition Service amends 7 CFR part 246 as 
follows:

PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS 
AND CHILDREN

0
1. The authority citation for part 246 continues to read as follows:

    Authority: 42 U.S.C. 1786.


0
2. Amend Sec.  246.2 by:
0
a. Adding the definition for ``Disability'' in alphabetical order:
0
b. Removing the definition for ``Individual with disabilities;''
0
c. Revising the definition for ``Participant violation;'' and
0
d. Removing the definition ``WIC-eligible nutritionals for participants 
with qualifying conditions (hereafter referred to as ``WIC-eligible 
nutritionals)'' and adding the definition ``WIC-eligible nutritionals 
for participants with qualifying conditions (hereafter referred to as 
``WIC-eligible nutritionals'')'' in its place.
    The additions and revision read as follows:


Sec.  246.2  Definitions.

* * * * *
    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. See 28 CFR 35.108.
* * * * *
    Participant violation means any deliberate action of a participant, 
parent, or caretaker of an infant or child participant, or proxy that 
violates Federal or State statutes, regulations, policies, or 
procedures governing the Program. Participant violations include, but 
are not limited to, deliberately making false or misleading statements 
or deliberately misrepresenting, concealing, or withholding facts, to 
obtain benefits; selling or offering to sell WIC benefits, cash-value 
vouchers, paper food instruments, EBT cards, supplemental foods, or 
breast pumps in person, in print, or online; exchanging or attempting 
to exchange WIC benefits, cash-value vouchers, paper food instruments, 
EBT cards, supplemental foods, or breast pumps for cash, credit, 
services, non-food items, or unauthorized food items, including 
supplemental foods in excess of those listed on the participant's food 
instrument; threatening to harm or physically harming clinic, farmer, 
farmers' market, or vendor staff; and dual participation.
* * * * *
    WIC-eligible nutritionals for participants with qualifying 
conditions (hereafter referred to as ``WIC-eligible nutritionals'') 
means certain enteral products that are specifically formulated and 
commercially manufactured (as opposed to a naturally occurring 
foodstuff used in its natural state) to provide nutritional support for 
individuals with a qualifying condition, when the use of conventional 
foods is precluded, restricted, or inadequate. Such WIC-eligible 
nutritionals must serve the purpose of a food, meal, or diet (may be 
nutritionally complete or incomplete) and provide a source of calories 
and one or more nutrients; be designed for enteral digestion via an 
oral or tube feeding; and may not be a conventional food, drug, 
flavoring, or enzyme. WIC-eligible nutritionals include many, but not 
all, products that meet the definition of medical food in section 
5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)).

0
3. Amend Sec.  246.7 by revising paragraph (j)(10) to read as follows:


Sec.  246.7  Certification of participants.

* * * * *
    (j) * * *
    (10) During WIC certification, every Program applicant, parent, or 
caretaker shall be informed that selling or offering to sell WIC 
benefits, cash-value vouchers, paper food instruments, EBT cards, 
supplemental foods, or breast pumps in person, in print, or on-line is 
a participant violation.
* * * * *

0
4. Revise Sec.  246.10 to read as follows:


Sec.  246.10   Supplemental foods.

    (a) General. This section prescribes the requirements for providing 
supplemental foods to participants. The State agency must ensure that 
local agencies comply with this section.
    (b) State agency responsibilities. (1) State agencies may:
    (i) Establish criteria in addition to the minimum Federal 
requirements in table 4 to paragraph (e)(12) of this section for the 
supplemental foods in their States, except that the State agency may 
not selectively choose which eligible fruits and vegetables are 
available to participants. These State agency criteria could address, 
but not be limited to, other nutritional standards, competitive

[[Page 28519]]

cost, State-wide availability, and participant appeal. For eligible 
fruits and vegetables, State agencies may restrict packaging, e.g., 
plastic containers, and package sizes such as single serving of 
processed fruits and vegetables available for purchase with the cash-
value voucher. In addition, State agencies may identify certain 
processed WIC-eligible fruits and vegetables on food lists where the 
potential exists for vendor or participant confusion in determining 
authorized WIC-eligible items.
    (ii) Make food package adjustments to better accommodate 
participants who are homeless. At the State agency's option, these 
adjustments would include, but not be limited to, issuing authorized 
supplemental foods in individual serving-size containers to accommodate 
lack of food storage or preparation facilities.
    (iii) Authorize package sizes, in addition to those authorized to 
fulfill paragraph (b)(2)(i) of this section, that increase participant 
variety and choice, except WIC formula, which must be authorized in 
sizes that correspond with the maximum monthly allowances per 
paragraphs (e)(9) and (11) of this section.
    (2) State agencies must:
    (i) Identify the brands of foods and package sizes that are 
acceptable for use in the Program in their States in accordance with 
the requirements of this section; all State agencies must authorize at 
least one package size (or combination of package sizes) that equal or 
add up to the maximum monthly allowances of all authorized supplemental 
foods in each of the food packages. State agencies must also provide to 
local agencies, and include in the State Plan, a list of acceptable 
foods and their maximum monthly allowances as specified in tables 1 
through 4 to paragraphs (e)(9) through (12) of this section; and
    (ii) Ensure that local agencies:
    (A) Make available to participants the maximum monthly allowances 
of authorized supplemental foods, except as noted in paragraph (c) of 
this section, inform participants about the maximum monthly allowances 
of authorized supplemental foods to which they are entitled as a 
Program participant and any food substitution options as specified in 
tables 1 through 3 to paragraphs (e)(9) through (11) of this section 
that the State agency authorizes, and abide by the authorized 
substitution rates for WIC food substitutions as specified in tables 1 
through 3 to paragraphs (e)(9) through (11);
    (B) Make available to participants more than one food from each WIC 
food category except for the categories of peanut butter and eggs, and 
any of the WIC-eligible fruits and vegetables (fresh or processed) in 
each authorized food package as listed in paragraph (e) of this 
section;
    (C) Authorize only a competent professional authority to prescribe 
the categories of authorized supplemental foods in quantities that do 
not exceed the regulatory maximum and are appropriate for the 
participant, taking into consideration the participant's nutritional 
and breastfeeding needs; and
    (D) Advise participants or their caretaker, when appropriate, that 
the supplemental foods issued are only for their personal use. However, 
the supplemental foods are not authorized for participant use while 
hospitalized on an in-patient basis. In addition, consistent with Sec.  
246.7(m)(1)(i)(B), supplemental foods are not authorized for use in the 
preparation of meals served in a communal food service. This 
restriction does not preclude the provision or use of supplemental 
foods for individual participants in a nonresidential setting (e.g., 
child care facility, family day care home, school, or other educational 
program); a homeless facility that meets the requirements of Sec.  
246.7(m)(1); or, at the State agency's discretion, a residential 
institution (e.g., home for pregnant teens, prison, or residential drug 
treatment center) that meets the requirements currently set forth in 
Sec.  246.7(m)(1) and (2).
    (c) Nutrition tailoring. Nutrition tailoring is the process of 
modifying an individual food package to better meet the supplemental 
nutritional needs of each participant. It entails making substitutions, 
reductions, and/or eliminations to food types and physical food forms 
in accordance with paragraphs (e)(9) through (11) of this section to 
accommodate special dietary needs, cultural practices, and/or personal 
preference. The full maximum monthly allowances of all supplemental 
foods in all food packages must be made available to participants 
unless medically or nutritionally warranted. Reductions in these 
amounts cannot be made for cost-savings, administrative convenience, 
caseload management, or to control vendor abuse. Reductions in these 
amounts or eliminations of foods cannot be made for categories, groups, 
or subgroups of WIC participants and may be done only after a nutrition 
assessment and offering substitution options available in the State in 
accordance with paragraphs (e)(9) through (11) and State agency policy. 
The provision of less than the maximum monthly allowances of 
supplemental foods to an individual WIC participant in all food 
packages is appropriate only when:
    (1) Medically or nutritionally warranted (e.g., to eliminate a food 
due to a food allergy);
    (2) A participant refuses or cannot use the maximum monthly 
allowances, or chooses to take less than the maximum monthly allowance; 
or
    (3) The quantities necessary to supplement another program's 
contribution to fill a medical prescription would be less than the 
maximum monthly allowances.
    (d) Medical documentation--(1) Supplemental foods requiring medical 
documentation. Medical documentation is required for the issuance of 
the following supplemental foods:
    (i) Any non-contract brand infant formula;
    (ii) Any infant formula prescribed to an infant, child, or adult 
who receives Food Package III (see paragraph (e)(3) of this section);
    (iii) Any exempt infant formula;
    (iv) Any WIC-eligible nutritional;
    (v) Any authorized supplemental food issued to participants who 
receive Food Package III; and
    (vi) Any contract brand infant formula that does not meet the 
requirements in table 4 to paragraph (e)(12) of this section.
    (2) Medical documentation for other supplemental foods. (i) State 
agencies may authorize local agencies to issue a non-contract brand 
infant formula that meets the requirements in table 4 to paragraph 
(e)(12) of this section without medical documentation in order to meet 
religious eating patterns; and
    (ii) The State agency has the discretion to require medical 
documentation for any contract brand infant formula other than the 
primary contract infant formula and may decide that some contract brand 
infant formula may not be issued under any circumstances.
    (3) Medical determination. For purposes of this paragraph (d), 
medical documentation means that a health care professional licensed to 
write medical prescriptions under State law has:
    (i) Made a medical determination that the participant has a 
qualifying condition as described in paragraphs (e)(1) through (7) of 
this section that dictates the use of the supplemental foods, as 
described in paragraph (d)(1) of this section; and
    (ii) Provided the written documentation that meets the technical 
requirements described in paragraphs (d)(4)(ii) and (iii) of this 
section.
    (4) Technical requirements--(i) Location. All medical documentation

[[Page 28520]]

must be kept on file (electronic or hard copy) at the local clinic. The 
medical documentation kept on file must include the initial telephone 
documentation, when received as described in paragraph (d)(4)(iii)(B) 
of this section.
    (ii) Content. All medical documentation must include the following:
    (A) The name of the authorized WIC formula (infant formula, exempt 
infant formula, WIC-eligible nutritional) prescribed, including amount 
needed per day;
    (B) The authorized supplemental food(s) appropriate for the 
qualifying condition(s) and their prescribed amounts;
    (C) Length of time the prescribed WIC formula and/or supplemental 
food is required by the participant;
    (D) The qualifying condition(s) for issuance of the authorized 
supplemental food(s) requiring medical documentation, as described in 
paragraphs (e)(1) through (7) of this section; and
    (E) Signature, date, and contact information (or name, date, and 
contact information), if the initial medical documentation was received 
by telephone and the signed document is forthcoming, of the health care 
professional licensed by the State to write prescriptions in accordance 
with State laws.
    (iii) Written confirmation--(A) General. Medical documentation must 
be written and may be provided as an original written document, an 
electronic document, or by facsimile or telephone to a competent 
professional authority until written confirmation is received.
    (B) Medical documentation provided by telephone. Medical 
documentation may be provided by telephone to a competent professional 
authority who must promptly document the information. The collection of 
the required information by telephone for medical documentation 
purposes may only be used until written confirmation is received from a 
health care professional licensed to write medical prescriptions and 
used only when absolutely necessary on an individual participant basis. 
The local clinic must obtain written confirmation of the medical 
documentation within a reasonable amount of time (i.e., one- or two-
weeks' time) after accepting the initial medical documentation by 
telephone.
    (5) Medical supervision requirements. Due to the nature of the 
health conditions of participants who are issued supplemental foods 
that require medical documentation, close medical supervision is 
essential for each participant's dietary management. The responsibility 
remains with the participant's health care provider for this medical 
oversight and instruction. This responsibility cannot be assumed by 
personnel at the WIC State or local agency. However, it would be the 
responsibility of the WIC competent professional authority to ensure 
that only the amounts of supplemental foods prescribed by the 
participant's health care provider are issued in the participant's food 
package.
    (e) Food packages. There are seven food packages available under 
the Program that may be provided to participants. The authorized 
supplemental foods must be prescribed from food packages according to 
the category and nutritional needs of the participants. Breastfeeding 
assessment and the mother's plans for breastfeeding serve as the basis 
for determining food package issuance for all breastfeeding women. The 
intent of the WIC Program is that all breastfeeding women be supported 
to exclusively breastfeed their infants and to choose the fully 
breastfeeding food package without infant formula. Breastfeeding 
mothers whose infants receive formula from WIC are to be supported to 
breastfeed to the maximum extent possible with minimal supplementation 
with infant formula. Formula amounts issued to a breastfed infant are 
to be tailored to meet but not exceed the infant's nutritional needs. 
The seven food packages are as follows:
    (1) Food Package I--Infants birth through 5 months--(i) Participant 
category served. This food package is designed for issuance to infants 
from birth through age 5 months who do not have a condition qualifying 
them to receive Food Package III (see paragraph (e)(3) of this 
section). The following infant feeding variations are defined for the 
purposes of assigning food quantities and types in Food Packages I: 
Fully breastfeeding (the infant doesn't receive formula from the WIC 
Program); partially (mostly) breastfeeding (the infant is breastfed but 
also receives infant formula from WIC up to the maximum allowance 
described for partially (mostly) breastfed infants in table 1 to 
paragraph (e)(9) of this section; and fully formula fed (the infant is 
not breastfed or is breastfed minimally (the infant receives infant 
formula from WIC in quantities that exceed those allowed for partially 
(mostly) breastfed infants).
    (ii) Infant feeding age categories--Birth through 5 months. Three 
infant food packages are available from birth through 5 months--fully 
breastfeeding, partially (mostly) breastfeeding, or fully formula-fed.
    (iii) Infant formula requirements. This food package provides iron-
fortified infant formula that is not an exempt infant formula and that 
meets the requirements in table 4 to paragraph (e)(12) of this section. 
The issuance of any contract brand or noncontract brand infant formula 
that contains less than 10 milligrams of iron per liter (at least 1.5 
milligrams iron per 100 kilocalories) at standard dilution is 
prohibited. Except as specified in paragraph (d) of this section, local 
agencies must issue as the first choice of issuance the primary 
contract infant formula, as defined in Sec.  246.2, with all other 
infant formulas issued as an alternative to the primary contract infant 
formula. Noncontract brand infant formula and any contract brand infant 
formula that does not meet the requirements in table 4 to paragraph 
(e)(12) of this section may be issued in this food package only with 
medical documentation of the qualifying condition. A health care 
professional licensed by the State to write prescriptions must make a 
medical determination and provide medical documentation that indicates 
the need for the infant formula. For situations that do not require the 
use of an exempt infant formula, such determinations include, but are 
not limited to, documented formula intolerance, food allergy or 
inappropriate growth pattern. Medical documentation must meet the 
requirements described in paragraph (d) of this section.
    (iv) Physical forms. Local agencies must issue all WIC formulas 
(infant formula, exempt infant formula and WIC-eligible nutritionals) 
in concentrated liquid or powder physical forms. Ready-to-feed WIC 
formulas may be authorized when the competent professional authority 
determines and documents that:
    (A) The participant's household has an unsanitary or restricted 
water supply or poor refrigeration;
    (B) The person caring for the participant may have difficulty in 
correctly diluting concentrated or powder forms; or
    (C) The WIC infant formula is only available in ready-to-feed.
    (v) Authorized category of supplemental foods. Infant formula is 
the only category of supplemental foods authorized in this food 
package. Exempt infant formulas and WIC-eligible nutritionals are 
authorized only in Food Package III (see paragraph (e)(3) of this 
section). The maximum monthly allowances, allowed options, and 
substitution rates of supplemental foods for infants in Food Packages I 
are stated

[[Page 28521]]

in table 1 to paragraph (e)(9) of this section.
    (2) Food Package II--Infants 6 through 11 months--(i) Participant 
category served. This food package is designed for issuance to infants 
from 6 through 11 months of age who do not have a condition qualifying 
them to receive Food Package III (see paragraph (e)(3) of this 
section).
    (ii) Infant food packages. Three food packages for infants 6 
through 11 months are available--fully breastfeeding, partially 
(mostly) breastfeeding, or fully formula fed.
    (iii) Infant formula requirements. The requirements for issuance of 
infant formula in Food Package I, specified in paragraphs (e)(1)(iii) 
and (iv) of this section, also apply to the issuance of infant formula 
in Food Package II.
    (iv) Authorized categories of supplemental foods. Infant formula, 
infant cereal, and infant foods are the categories of supplemental 
foods authorized in this food package. The maximum monthly allowances, 
allowed options, and substitution rates of supplemental foods for 
infants in Food Packages II are stated in table 1 to paragraph (e)(9) 
of this section.
    (3) Food Package III--Participants with qualifying conditions--(i) 
Participant category served and qualifying conditions. This food 
package is reserved for issuance to women, infants, and children who 
have a documented qualifying condition that requires the use of a WIC 
formula (infant formula, exempt infant formula, or WIC-eligible 
nutritional) because the use of conventional foods is precluded, 
restricted, or inadequate to address their special nutritional needs. 
Medical documentation must meet the requirements described in paragraph 
(d) of this section. Participants who are eligible to receive this food 
package must have one or more qualifying conditions, as determined by a 
health care professional licensed to write medical prescriptions under 
State law. The qualifying conditions include but are not limited to 
premature birth, low birth weight, failure to thrive, inborn errors of 
metabolism and metabolic disorders, gastrointestinal disorders, 
malabsorption syndromes, immune system disorders, severe food allergies 
that require an elemental formula, and life threatening disorders, 
diseases and medical conditions that impair ingestion, digestion, 
absorption, or the utilization of nutrients that could adversely affect 
the participant's nutrition status. This food package may not be issued 
solely for the purpose of enhancing nutrient intake or managing body 
weight.
    (ii) Non-authorized issuance of Food Package III. This food package 
is not authorized for:
    (A) Infants whose only condition is:
    (1) A diagnosed formula intolerance or food allergy to lactose, 
sucrose, milk protein, or soy protein that does not require the use of 
an exempt infant formula; or
    (2) A non-specific formula or food intolerance;
    (B) Women and children who have a food intolerance to lactose or 
milk protein that can be successfully managed with the use of one of 
the other WIC food packages (i.e., Food Packages IV through VII (see 
paragraph (e)(4) through (7) of this section); or
    (C) Any participant solely for the purpose of enhancing nutrient 
intake or managing body weight without an underlying qualifying 
condition.
    (iii) Restrictions on the issuance of WIC formulas in ready-to-feed 
(RTF) forms. WIC State agencies must issue WIC formulas (infant 
formula, exempt infant formula, and WIC-eligible nutritionals) in 
concentrated liquid or powder physical forms unless the requirements 
for issuing RTF are met as described in paragraph (e)(1)(iv) of this 
section. In addition to those requirements, there are two additional 
conditions which may be used to issue RTF in Food Package III:
    (A) If a ready-to-feed form better accommodates the participant's 
condition; or
    (B) If it improves the participant's compliance in consuming the 
prescribed WIC formula.
    (iv) Unauthorized WIC costs. All apparatuses or devices (e.g., 
enteral feeding tubes, bags, and pumps) designed to administer WIC 
formulas are not allowable WIC costs.
    (v) Authorized categories of supplemental foods. The supplemental 
foods authorized in this food package require medical documentation for 
issuance and include WIC formula (infant formula, exempt infant 
formula, and WIC-eligible nutritionals), infant cereal, infant foods, 
milk, eggs, canned fish, fresh and other State-authorized forms of 
fruits and vegetables, breakfast cereal, whole wheat/whole grain bread, 
juice, and legumes and/or peanut butter. The maximum monthly 
allowances, allowed options, and substitution rates of supplemental 
foods for infants in Food Package III are stated in table 1 to 
paragraph (e)(9) of this section. The maximum monthly allowances, 
allowed options, and substitution rates of supplemental foods for 
children and women in Food Package III are stated in table 3 to 
paragraph (e)(11) of this section.
    (vi) Coordination with medical payors and other programs that 
provide or reimburse for formulas. WIC State agencies must coordinate 
with other Federal, State, or local government agencies or with private 
agencies that operate programs that also provide or could reimburse for 
exempt infant formulas and WIC-eligible nutritionals benefits to mutual 
participants. At a minimum, a WIC State agency must coordinate with the 
State Medicaid Program for the provision of exempt infant formulas and 
WIC-eligible nutritionals that are authorized or could be authorized 
under the State Medicaid Program for reimbursement and that are 
prescribed for WIC participants who are also Medicaid recipients. The 
WIC State agency is responsible for providing up to the maximum amount 
of exempt infant formulas and WIC-eligible nutritionals under Food 
Package III in situations where reimbursement is not provided by 
another entity.
    (4) Food Package IV-A and B--Children 1 through 4 years--(i) 
Participant category served. This food package is designed for issuance 
to children 1 through 4 years of age who do not have a condition 
qualifying them to receive Food Package III (see paragraph (e)(3) of 
this section) and is divided into: Food Package IV-A for children 1 to 
less than 2 years of age (i.e., 12 through 23 months) and Food Package 
IV-B for children 2 years through 4 years of age.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fresh and other State-authorized forms of fruits and 
vegetables, whole wheat/whole grain bread, eggs, legumes or peanut 
butter, and canned fish are the categories of supplemental foods 
authorized for both Food Package IV-A and IV-B. The maximum monthly 
allowances, allowed options, and substitution rates of supplemental 
foods for children in Food Packages IV-A and IV-B are stated in table 2 
to paragraph (e)(10) of this section.
    (5) Food Package V-A and B--Pregnant and partially (mostly) 
breastfeeding women--(i) Participant categories served. This food 
package is designed for issuance to three categories of women who do 
not have a condition qualifying them to receive Food Package III (see 
paragraph (e)(3) of this section) and is divided into: Food Package V-A 
for issuance to women with singleton pregnancies and Food Package V-B 
for issuance to women pregnant with two or more fetuses and, for up to 
1 year postpartum, partially (mostly) breastfeeding women whose 
partially (mostly) breastfed infants receive

[[Page 28522]]

formula from the WIC Program in amounts that do not exceed the maximum 
allowances described in table 1 to paragraph (e)(9) of this section. 
Women partially (mostly) breastfeeding more than one infant from the 
same pregnancy and pregnant women fully or partially breastfeeding 
singleton infants are eligible to receive Food Package VII as described 
in paragraph (e)(7) of this section.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fresh and other State-authorized forms of fruits and 
vegetables, whole wheat/whole grain bread, eggs, legumes and peanut 
butter, and canned fish are the categories of supplemental foods 
authorized in this food package. The maximum monthly allowances, 
allowed options, and substitution rates of supplemental foods for women 
in Food Packages V-A and V-B are stated in table 2 to paragraph (e)(10) 
of this section.
    (6) Food Package VI--Postpartum women--(i) Participant categories 
served. This food package is designed for issuance to women up to 6 
months postpartum who are not breastfeeding their infants, and to 
breastfeeding women up to 6 months postpartum whose participating 
infant receives more than the maximum amount of formula allowed for 
partially (mostly) breastfed infants as described in table 1 to 
paragraph (e)(9) of this section and who do not have a condition 
qualifying them to receive Food Package III (see paragraph (e)(3) of 
this section).
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fresh and other State-authorized forms of fruits and 
vegetables, whole wheat/whole grain bread, eggs, legumes or peanut 
butter, and canned fish are the categories of supplemental foods 
authorized in this food package. The maximum monthly allowances, 
allowed options, and substitution rates of supplemental foods for women 
in Food Package VI are stated in table 2 to paragraph (e)(10) of this 
section.
    (7) Food Package VII--Fully breastfeeding--(i) Participant 
categories served. This food package is designed for issuance to 
breastfeeding women up to 1 year postpartum whose infants do not 
receive infant formula from WIC (these breastfeeding women are assumed 
to be exclusively breastfeeding their infants) and who do not have a 
condition qualifying them to receive Food Package III (see paragraph 
(e)(3) of this section). This food package is also designed for 
issuance to women partially (mostly) breastfeeding multiple infants 
from the same pregnancy, and pregnant women who are also partially 
(mostly) breastfeeding singleton infants and who do not have a 
condition qualifying them to receive Food Package III. Women fully 
breastfeeding multiple infants from the same pregnancy receive 1.5 
times the supplemental foods provided in Food Package VII.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fresh and other State-authorized forms of fruits and 
vegetables, whole wheat/whole grain bread, eggs, legumes and peanut 
butter, and canned fish are the categories of supplemental foods 
authorized in this food package. The maximum monthly allowances, 
allowed options, and substitution rates of supplemental foods for women 
in Food Package VII are stated in table 2 to paragraph (e)(10) of this 
section.
    (8) Supplemental foods--Maximum monthly allowances, options and 
substitution rates, and minimum requirements. Tables 1 through 3 to 
paragraphs (e)(9) through (11) of this section specify the maximum 
monthly allowances of foods in WIC food packages and identify WIC food 
options and substitution rates. Table 4 to paragraph (e)(12) of this 
section describes the minimum requirements and specifications of 
supplemental foods in the WIC food packages.
    (9) Full nutrition benefit and maximum monthly allowances 
supplemental foods for infants in Food Packages I, II, and III. Full 
nutrition benefit and maximum monthly allowances, options, and 
substitution rates of supplemental foods for infants in Food Packages 
I, II, and III (see paragraph (e)(1), (2), and (3) of this section) are 
stated in table 1 to this paragraph (e)(9) as follows:

 Table 1 to Paragraph (e)(9)--Food Packages I, II, and III: Full Nutrition Benefit (FNB) and Maximum Monthly Allowances (MMA) of Supplemental Foods for
                                                  Infants by Feeding Option and Food Package Timeframe
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Fully Formula Fed (FF)           Partially (mostly) Breastfed (BF/FF)            Fully Breastfed (BF)
                                 -----------------------------------------------------------------------------------------------------------------------
                                  Food Packages I-FF                      Food Packages IBF/
            Foods \1\                & III-FF A: 0     Food Packages II-   FF & III BF/FF A:   Food Packages II                       Food Package II-BF
                                   through 3 months      FF & III-FF 6    0 through 3 months   BF/FF & III BF/FF   Food Package I-BF     6 through 11
                                    B: 4 through 5     through 11 months    B: 4 through 5       6 through 11     0 through 5 months        months
                                        months                                  months              months
--------------------------------------------------------------------------------------------------------------------------------------------------------
WIC
Formula 2 3 4 5 6 7 8...........  A: FNB = Up to 806  FNB = Up to 624 fl  A: FNB = Up to 364  FNB = Up to 312 fl  N/A...............  N/A.
                                   fl oz. MMA= 823     oz. MMA = 630 fl    fl oz. MMA = 388    oz. MMA = 315 fl
                                   fl reconstituted    oz reconstituted    fl oz               oz reconstituted
                                   liquid              liquid              reconstituted       liquid
                                   concentrate or      concentrate or      liquid              concentrate or
                                   832 fl oz RTF or    643 fl oz RTF or    concentrate or      338 fl oz RTF or
                                   870 fl oz           696 fl oz           384 fl oz RTF or    384 fl oz
                                   reconstituted       reconstituted       435 fl oz           reconstituted
                                   powder.             powder.             reconstituted       powder.
                                                                           powder.
                                  B: FNB = Up to 884  ..................  B: FNB = Up to 442
                                   fl oz. MMA = 896                        fl oz. MMA = 460
                                   fl oz                                   fl oz
                                   reconstituted                           reconstituted
                                   liquid                                  liquid
                                   concentrate or                          concentrate or
                                   913 fl oz RTF or                        474 fl oz RTF or
                                   960 fl oz                               522 fl oz
                                   reconstituted                           reconstituted
                                   powder.                                 powder.
Infant Cereal 9 10 11...........  N/A...............  8 oz..............  N/A...............  8 oz..............  N/A...............  16 oz.
Infant food fruits and            N/A...............  128 oz............  N/A...............  128 oz............  N/A...............  128 oz.
 vegetables 9 10 11 12 13.
Infant food meat 9 10...........  N/A...............  N/A...............  N/A...............  N/A...............  N/A...............  40 oz.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: Abbreviations in order of appearance in table: FF = fully formula fed; BF/FF = partially (mostly) breastfed; BF = fully breastfed; RTF = ready-to-
  feed; N/A = Not applicable (the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 to paragraph (e)(12) of this section describes the minimum requirements and specifications for supplemental foods. The competent
  professional authority (CPA) is authorized to determine nutritional risk and prescribe supplemental foods in Food Packages I, II, and III (see
  paragraphs (e)(1), (2), and (3) of this section) (per medical documentation), as established by State agency policy. Food Package III is issued to
  participants with qualifying medical conditions. A WIC formula is issued to participants receiving Food Package III under the direction of a health
  care provider.

[[Page 28523]]

 
\2\ Amounts represent the FNB defined as the minimum amount of reconstituted fluid ounces of liquid concentrate infant formula as specified for each
  infant food package category and feeding variation. The FNB is based on a 13-ounce can that formed the basis of substitution rates for other physical
  forms of infant formula (i.e., powder and RTF infant formula).
\3\ Following a WIC nutrition and breastfeeding assessment of the needs of the dyad, breastfed infants, even those in the fully formula fed category,
  should be issued the quantity of formula needed to support any level of breastfeeding up to the FNB. This amount may be less than the FNB.
\4\ WIC formula means infant formula, exempt infant formula, or WIC-eligible nutritionals. Infant formula may be issued for infants in Food Packages I,
  II and III. Medical documentation is required for issuance of WIC formula and other supplemental foods in Food Package III. Only infant formula may be
  issued for infants in Food Packages I and II.
\5\ State agencies must issue whole containers that are all the same size of the same physical form.
\6\ The MMA is specified in reconstituted fluid ounces for liquid concentrate, RTF liquid, and powder forms of infant formula and exempt infant formula.
  Reconstituted fluid ounce is the form prepared for consumption as directed on the container. Formula provided to infants in any form may not exceed
  the MMA.
\7\ The FNB is intended to provide close to 100 percent of the nutritional needs of a non-breastfed infant from birth to 6 months. State agencies must
  provide at least the FNB authorized to non-breastfed infants up to the MMA for the physical form of the product specified for each food package
  category unless the food package is tailored to allow ``up to'' amounts to support breastfeeding.
\8\ State agencies may round up to issue whole containers of infant formula over the food package timeframe. State agencies must use the methodology
  described in accordance with paragraph (h)(1) of this section.
\9\ Per paragraph (b)(2)(ii)(A) of this section, State agencies must make the full MMA of all foods available to participants by providing at least one
  package size (or combination of sizes) that add up to the full MMA. However, per paragraph (b)(1)(iii) of this section, State agencies may authorize
  other package sizes (excluding WIC formula) to increase participant variety and choice.
\10\ State agencies may round up to issue whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the food package
  timeframe. State agencies must use the methodology described in accordance with paragraph (h)(2) of this section.
\11\ In lieu of infant foods (cereal, fruit, and vegetables), infants older than 6 months of age in Food Package III may receive WIC formula (infant
  formula, exempt infant formula, or WIC-eligible nutritionals) at the same MMA as infants ages 4 through 5 months of age of the same feeding option.
\12\ At State agency option, infants 6 through 11 months in Food Packages II and III may receive a cash-value voucher (CVV) to purchase fruits and
  vegetables in lieu of the infant food fruits and vegetables. Fully breastfed infants, partially (mostly) breastfed infants, and fully formula fed
  infants may substitute half (64 oz.) or all (128 oz.) of jarred infant fruits and vegetables with a $10 or $20 CVV, respectively. The monthly value of
  the CVV substitution amounts for infant fruits and vegetables will be adjusted annually for inflation consistent with the annual inflation adjustments
  made to CVV values for women and children. State agencies must authorize fresh and one other form (frozen or canned). Dried fruits and vegetables are
  not authorized for infants. The CVV may be redeemed for any eligible fruit and vegetable (refer to table 4 of paragraph (e)(12) of this section and
  its footnotes).
\13\ State agencies may not categorically issue a CVV for infants 6 through 11 months. The CVV is to be provided to the participant only after an
  individual nutrition assessment, as established by State agency policy. State agencies must ensure that appropriate nutrition education is provided to
  the caregiver addressing developmental readiness, safe food preparation, storage techniques, and feeding practices to make certain participants are
  meeting their nutritional needs in a safe and effective manner.

    (10) Maximum monthly allowances of supplemental foods in Food 
Packages IV through VII. The maximum monthly allowances, options, and 
substitution rates of supplemental foods for children and women in Food 
Packages IV through VII (see paragraphs (e)(4) through (7) of this 
section) are stated in table 2 to this paragraph (e)(10) as follows:

Table 2 to Paragraph (e)(10)--Food Packages IV, V, VI, and VII: Maximum Monthly Allowances (MMA) of Supplemental
                                          Foods for Children and Women
----------------------------------------------------------------------------------------------------------------
                                       Children                                  Women
                                 -------------------------------------------------------------------------------
                                                       Food Package V A:
                                  Food Package IV A:      Pregnant B:       Food Package VI    Food Package VII
            Foods \1\                12 through 23    Partially (Mostly)   Postpartum (up to         Fully
                                      months B: 2      Breastfeeding (up       6 months        Breastfeeding (up
                                    through 4 years        to 1 year        postpartum) \3\     to 1 year post-
                                                        postpartum) \2\                           partum) 4 5
----------------------------------------------------------------------------------------------------------------
Juice, single strength 6 7......  64 fl oz..........  64 fl oz..........  64 fl oz..........  64 fl oz.
Milk, fluid 8 9 10 11 12 13 14    A: 12 qt. 8 9 11    16 qt.8 10 11 12    16 qt.8 10 11 12    16 qt.8 10 11 12
 15.                               12 14               13 15.              13 15.              13 15
                                  B: 14 qt.8 10 11
                                   12 13 14.
Breakfast cereal \16\...........  36 oz.............  36 oz.............  36 oz.............  36 oz.
Eggs \17\.......................  1 dozen...........  1 dozen...........  1 dozen...........  2 dozen.
Fruits and vegetables 18 19.....  $24.00 CVV........  A: $43.00 CVV.      $43.00 CVV........  $47.00 CVV.
                                                      B: $47.00 CVV.....
Whole wheat or whole grain bread  24 oz.............  48 oz.............  48 oz.............  48 oz.
 \20\.
Fish (canned) 21 22.............  6 oz..............  A: 10 oz.           10 oz.............  20 oz.
                                                      B: 15 oz..........
Mature Legumes and/or Peanut      1 lb dry or 64 oz   1 lb dry or 64 oz   1 lb dry or 64 oz   1 lb dry or 64 oz
 butter \23\.                      canned Or 18 oz.    canned And 18 oz.   canned Or 18 oz.    canned And 18 oz.
----------------------------------------------------------------------------------------------------------------
Note: Abbreviations in order of appearance in table: N/A = Not applicable (the supplemental food is not
  authorized in the corresponding food package); CVV = cash-value voucher.
\1\ Table 4 to paragraph (e)(12) of this section describes the minimum requirements and specifications for
  supplemental foods. Per paragraph (b)(2)(ii)(A) of this section, State agencies must make the full MMA of all
  foods available to participants by providing at least one package size (or combination of sizes) that add up
  to the full MMA. However, per paragraph (b)(1)(iii) of this section, State agencies may authorize other
  package sizes to increase participant variety and choice. The competent professional authority (CPA) is
  authorized to determine nutritional risk and prescribe supplemental foods as established by State agency
  policy.
\2\ Food Package V-A (see paragraph (e)(5) of this section) is issued to women participants with singleton
  pregnancies. Food Package V-B (see paragraph (e)(5)) is issued to two categories of WIC participants:
  breastfeeding women whose partially (mostly) breastfed infants receive formula from WIC in amounts that do not
  exceed the maximum formula allowances, as appropriate for the age of the infant as described in table 1 to
  paragraph (e)(9) of this section, and women pregnant with two or more fetuses.
\3\ Food Package VI is issued to two categories of WIC participants: non-breastfeeding postpartum women and
  breastfeeding postpartum women whose infants receive more than the maximum infant formula allowances from WIC
  for partially (mostly) breastfed infants, as appropriate for the age of the infant as described in table 1 to
  paragraph (e)(9) of this section.
\4\ Food Package VII is issued to three categories of WIC participants: fully breastfeeding women whose infants
  do not receive formula from WIC; women partially (mostly) breastfeeding multiple infants from the same
  pregnancy; and pregnant women who are also fully or partially (mostly) breastfeeding singleton infants.
\5\ Women fully breastfeeding multiple infants from the same pregnancy are prescribed 1.5 times the MMA.
\6\ Combinations of single-strength and concentrated juices may be issued provided that the total volume does
  not exceed the MMA for single-strength juice.
\7\ Children and women may choose to substitute a $3 CVV for the full juice amount (64 fluid ounces). The
  monthly value of the CVV substitution amount for juice will be adjusted annually for inflation consistent with
  the annual inflation adjustments made to CVV values for women and children. A partial CVV substitution for
  juice is not authorized. The CVV may be redeemed for any eligible fruit and vegetable (refer to table 4 of
  paragraph (e)(12) to this section and its footnotes).
\8\ Regular and lactose-free milk must be authorized. ``Regular milk'' refers to milk that conforms to FDA
  standard of identity 21 CFR 131.110 and contains lactose exclusive of fat content (e.g., low-fat milk). State
  agencies have the option to authorize plant-based milk alternatives, yogurts, and cheeses, described in table
  4 to paragraph (e)(12) of this section and its footnotes, as milk substitution options when individually
  tailoring food packages.
\9\ Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). Whole fat or low-
  fat yogurts may be substituted for fluid milk for 1-year-old children, and both are standard issuance when
  substituting yogurt. Fat-reduced milks or nonfat yogurt may be issued to 1-year-old children for whom
  overweight or obesity is a concern. The need for fat-reduced milks or nonfat yogurt for 1-year-old children
  must be based on an individual nutritional assessment.

[[Page 28524]]

 
\10\ Low-fat (1%) or nonfat milks are the standard milk for issuance to children >=24 months of age and women.
  Reduced-fat (2%) milk is authorized only for participants with certain conditions, including but not limited
  to, underweight and maternal weight loss during pregnancy. The need for reduced-fat (2%) milk for children
  receiving Food Package IV-B and women must be based on an individual nutritional assessment.
\11\ Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of
  fluid milk (i.e., 1:2 fluid ounce substitution ratio). Dry milk may be substituted at an equal reconstituted
  rate to fluid milk.
\12\ For children and women, 1 pound of cheese (dairy and/or plant-based) may be substituted for 3 quarts of
  milk; 1 quart of yogurt (dairy and/or plant-based) may be substituted for 1 quart of milk with a maximum of 2
  quarts of yogurt that may be substituted for 2 quarts of milk. Women receiving Food Package VII may substitute
  up to of 2 pounds of cheese for 6 quarts of milk. For children and women in Food Packages IV through VI, no
  more than 1 pound of cheese may be substituted. State agencies do not have the option to issue additional
  amounts of cheese or yogurt beyond these maximums even with medical documentation.
\13\ For children >=24 months of age (Food Package IV-B) and women, low-fat or nonfat yogurts are the only types
  of yogurts authorized.
\14\ When individually tailoring food packages for children, plant-based milk alternatives may be substituted
  for milk on a quart for quart basis up to the total MMA of milk; tofu may be substituted for milk for children
  at the rate of 1 pound of tofu per 1 quart of milk up to the MMA for milk.
\15\ When individually tailoring food packages for women, plant-based milk alternatives may be substituted for
  milk on a quart for quart basis up to the total MMA of milk; tofu may be substituted for milk at the rate of 1
  pound of tofu per 1 quart of milk up to the total MMA of milk.
\16\ At least 75 percent of cereal on a State agency's authorized food list must meet whole grain criteria for
  breakfast cereal (refer to table 4 to paragraph (e)(12) of this section and its footnotes).
\17\ State agencies must authorize substitution of dry legumes (1 pound), canned legumes (64 ounces), and peanut
  butter (18 ounces) for each 1 dozen eggs when individually tailoring food packages. At State agency option,
  State agencies may authorize tofu (1 pound) or nut and seed butters (18 ounces) to substitute for each 1 dozen
  eggs when individually tailoring food packages.
\18\ State agencies must authorize fresh and one other form of processed (i.e., canned (shelf-stable), frozen,
  and/or dried) fruits and vegetables. State agencies may choose to authorize additional or all processed forms
  of fruits and vegetables. The CVV may be redeemed for any eligible fruit and vegetable (refer to table 4 to
  paragraph (e)(12) of this section and its footnotes). Except as authorized in paragraph (b)(1)(i) of this
  section, State agencies may not selectively choose which fruits and vegetables are available to participants.
  For example, if a State agency chooses to offer dried fruits, it must authorize all WIC-eligible dried fruits.
\19\ The monthly value of the fruit/vegetable CVV will be adjusted annually for inflation using fiscal year 2022
  as the base year as described in Sec.   246.16(j).
\20\ Whole wheat or whole grain bread must be authorized. State agencies have the option to also authorize other
  whole grain options as described in table 4 to paragraph (e)(12) of this section and its footnotes.
\21\ Issuance of smaller container sizes is encouraged to reduce the likelihood of exceeding a safe weekly
  consumption level of methylmercury. The U.S. Food and Drug Administration (FDA) and the U.S. Environmental
  Protection Agency (EPA) provide joint advice regarding fish consumption to limit methylmercury exposure for
  children. As noted in their 2021 joint advice, depending on body weight, some women and some children should
  choose fish lowest in methylmercury or eat less fish than the amounts in the 2020-2025 Dietary Guidelines for
  Americans (DGA) Healthy US-Style Dietary Pattern. More information is available on the FDA and EPA websites at
  FDA.gov/fishadviceandEPA.gov/fishadvice.
\22\ As noted in the 2021 FDA-EPA joint advice about eating fish, for some children, depending on age and
  caloric needs, the amounts of fish in the 2020-2025 DGA are higher than in the FDA-EPA advice. The DGA states
  that to consume these higher amounts, these children should consume only fish from the ``Best Choices'' list
  that are even lower in mercury--among the WIC-eligible varieties, this includes Atlantic mackerel, salmon, and
  sardines.
\23\ State agencies are required to offer both mature dry (1 pound) and canned (64 ounces) legumes. Food
  Packages V and VII must provide both legumes and peanut butter. However, when individually tailoring these
  food packages, State agencies may issue the following combinations: 1 pound dry and 64 oz. canned legumes (and
  no peanut butter); 2 pounds dry or 128 oz. canned legumes (and no peanut butter); or 36 oz. peanut butter (and
  no legumes). State agencies also have the option to authorize other nut and seed butters as a substitute for
  peanut butter (on a 1:1 ounce substitution ratio), as described in table 4 to paragraph (e)(12) of this
  section and its footnotes, when individually tailoring food packages.

    (11) Maximum monthly allowances of supplemental foods for children 
and women with qualifying conditions in Food Package III. The maximum 
monthly allowances, options, and substitution rates of supplemental 
foods for participants with qualifying conditions in Food Package III 
are stated in table 3 to this paragraph (e)(11) as follows:

   Table 3 to Paragraph (e)(11)--Food Package III: Maximum Monthly Allowances (MMA) of Supplemental Foods for
                                  Children and Women With Qualifying Conditions
----------------------------------------------------------------------------------------------------------------
                                       Children                                  Women
                                 -------------------------------------------------------------------------------
                                                        A: Pregnant B:                               Fully
            Foods \1\              A: 12 through 23   Partially (Mostly)   Postpartum (up to   Breastfeeding (up
                                      months B: 2      Breastfeeding (up       6 months            to 1 year
                                    through 4 years        to 1 year        postpartum) \3\     postpartum) 4 5
                                                        postpartum) \2\
----------------------------------------------------------------------------------------------------------------
Juice, single strength 6 7......  64 fl oz..........  64 fl oz..........  64 fl oz..........  64 fl oz.
WIC formula 8 9.................  Up to 455 fl oz     Up to 455 fl oz     Up to 455 fl oz     Up to 455 fl oz
                                   liquid              liquid              liquid              liquid
                                   concentrate.        concentrate.        concentrate.        concentrate.
Milk, fluid 10 11 12 13 14 15 16  A: 12 qt. 10 11 13  16 qt. 10 12 13 14  16 qt. 10 12 13 14  16 qt. 10 12 13 14
 17.                               14 16..             15 17.              15 17.              15 17
                                  B: 14 qt.10 12 13
                                   14 15 16.
Breakfast cereal 18 19..........  36 oz.............  36 oz.............  36 oz.............  36 oz.
Eggs 20.........................  1 dozen...........  1 dozen...........  1 dozen...........  2 dozen.
Fruits and vegetables 21 22 23..  $24.00 CVV........  A: $43.00 CVV.....  $43.00 CVV........  47.00 CVV.
                                                      B: $47.00 CVV.....
Whole wheat or whole grain bread  24 oz.............  48 oz.............  48 oz.............  48 oz.
 24.
Fish (canned) 25 26.............  6 oz..............  A: 10 oz..........  10 oz.............  20 oz.
                                                      B: 15 oz..........
Mature Legumes..................  1 lb dry or 64 oz   1 lb dry or 64 oz   1 lb dry or 64 oz   1 lb dry or 64 oz
and/or..........................   canned.             canned.             canned.             canned
Peanut butter 27................  Or................  And...............  Or................  And
                                  18 oz.............  18 oz.............  18 oz.............  18 oz.
----------------------------------------------------------------------------------------------------------------
Note: Abbreviations in order of appearance in table: N/A = Not applicable (the supplemental food is not
  authorized in the corresponding food package); CVV = cash-value voucher.
\1\ Table 4 to paragraph (e)(12) of this section describes the minimum requirements and specifications for
  supplemental foods. Food Package III is issued to participants with qualifying medical conditions that require
  use of a WIC formula and supplementary foods under the direction of a health care provider. Per paragraph
  (b)(2)(ii)(A) of this section, State agencies must make the full MMA of all foods available to participants by
  providing at least one package size (or combination of sizes) that add up to the full MMA. However, per
  paragraph (b)(1)(iii) of this section, State agencies may authorize other package sizes (excluding WIC
  formula) to increase participant variety and choice. The competent professional authority (CPA) is authorized
  to determine nutritional risk and prescribe supplemental foods per medical documentation, as established by
  State agency policy.
\2\ Food Package III-A for women is issued to participants with singleton pregnancies. Food Package III-B for
  women is issued to two categories of participants: women pregnant with two or more fetuses and breastfeeding
  women whose partially (mostly) breastfed infants receive formula from WIC in amounts that do not exceed the
  maximum formula allowances, as appropriate for the age of the infant as described in table 1 to paragraph
  (e)(9) of this section.
\3\ This food package is issued to two categories of WIC participants: non-breastfeeding postpartum women and
  breastfeeding postpartum women whose infants receive more than the maximum infant formula allowances from WIC
  for partially (mostly) breastfed infants, as appropriate for the age of the infant as described in table 1 to
  paragraph (e)(9) of this section.
\4\ This food package is issued to three categories of WIC participants: fully breastfeeding women whose infants
  do not receive formula from WIC; women partially (mostly) breastfeeding multiple infants from the same
  pregnancy; and pregnant women who are also fully or partially (mostly) breastfeeding singleton infants.
\5\ Women fully breastfeeding multiple infants from the same pregnancy are prescribed 1.5 times the MMA.
\6\ Combinations of single-strength and concentrated juices may be issued provided that the total volume does
  not exceed the MMA for single-strength juice.

[[Page 28525]]

 
\7\ As determined appropriate by the health care provider per medical documentation, children and women may
  choose to substitute a $3 CVV for the full juice amount (64 fluid ounces)--a partial CVV substitution for
  juice is not authorized--or use their $3 CVV for jarred infant food fruits and vegetables. State agencies must
  use the conversion of $1 CVV = 6.25 ounces of jarred infant food fruits and vegetables. The monthly value of
  the CVV substitution amount for juice will be adjusted annually for inflation consistent with the inflation
  adjustments made to women and children's CVV values.
\8\ WIC formula means infant formula, exempt infant formula, or WIC-eligible nutritionals. Participants may
  receive up to 455 fluid ounces of a WIC formula (liquid concentrate) as determined appropriate by the health
  care provider per medical documentation. The number of fluid ounces refers to the amount as prepared according
  to directions on the container.
\9\ Powder and ready-to-feed may be substituted at rates that provide comparable nutritive value.
\10\ Regular and lactose-free milk must be authorized. ``Regular milk'' refers to milk that conforms to FDA
  standard of identity 21 CFR 131.110 and contains lactose exclusive of fat content (e.g., low-fat milk). State
  agencies have the option to authorize plant-based milk alternatives, yogurts, and cheeses, described in table
  4 of paragraph (e)(12) of this section and its footnotes, as determined appropriate by the health care
  provider per medical documentation.
\11\ Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). Whole fat or
  low-fat yogurts may be substituted for fluid milk for 1-year-old children, and both are standard issuance when
  substituting yogurt. Fat-reduced milks or nonfat yogurt may be issued to 1-year-old children as determined
  appropriate by the health care provider per medical documentation.
\12\ Low-fat (1%) or nonfat milks are the standard milk for issuance to children >=24 months of age and women.
  Whole milk or reduced-fat (2%) milk may be substituted for low-fat (1%) or nonfat milk for children >=24
  months of age and women as determined appropriate by the health care provider per medical documentation.
\13\ Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of
  fluid milk (a 1:2 fluid ounce substitution ratio). Dry milk may be substituted at an equal reconstituted rate
  to fluid milk.
\14\ For children and women, 1 pound of cheese (dairy- and/or plant-based) may be substituted for 3 quarts of
  milk and 1 quart of yogurt (dairy- and/or plant-based) may be substituted for 1 quart of milk as determined
  appropriate by the health care provider per medical documentation. A maximum of 2 quarts of yogurt that may be
  substituted for 2 quarts of milk for both children and women. Fully breastfeeding women may substitute up to 2
  pounds of cheese for 6 quarts of milk. Children and pregnant, partially breastfeeding, and postpartum women
  may substitute no more than 1 pound of cheese. State agencies do not have the option to issue additional
  amounts of cheese or yogurt beyond these maximums even with medical documentation.
\15\ For children >=24 months of age and women, low-fat or nonfat yogurts are the only types of yogurts
  authorized. Whole or reduced-fat yogurt may be substituted for low-fat or nonfat yogurt for children >=24
  months of age and women as determined appropriate by the health care provider per medical documentation.
\16\ For children, issuance of tofu and plant-based milk alternatives may be substituted for milk as determined
  appropriate by the health care provider per medical documentation. Plant-based milk alternatives may be
  substituted for milk for children on a quart for quart basis up to the total MMA of milk. Tofu may be
  substituted for milk for children at the rate of 1 pound of tofu per 1 quart of milk up to the MMA of milk, as
  determined appropriate by the health care provider per medical documentation.
\17\ For women, plant-based milk alternatives may be substituted for milk on a quart for quart basis up to the
  total MMA of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart of milk up to
  the MMA of milk, as determined appropriate by the health care provider per medical documentation.
\18\ 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal as determined
  appropriate by the health care provider per medical documentation.
\19\ At least 75 percent of cereals authorized on a State agency's authorized food list must meet whole grain
  criteria for breakfast cereal (refer to table 4 to paragraph (e)(12) of this section and its footnotes).
\20\ State agencies must authorize substitution of dry legume (1 pound), canned legumes (64 ounces), and peanut
  butter (18 ounces) for each 1 dozen eggs and, at State agency option, State agencies may authorize tofu (1
  pound) or nut and seed butters (18 ounces) to substitute for each 1 dozen eggs as determined appropriate by
  the health care provider per medical documentation.
\21\ State agencies must authorize fresh and one other form (i.e., canned (shelf-stable), frozen, and/or dried)
  of fruits and vegetables. State agencies may choose to authorize additional or all processed forms of fruits
  and vegetables. The CVV may be redeemed for any eligible fruit and vegetable (refer to table 4 to paragraph
  (e)(12) of this section and its footnotes). Except as authorized in paragraph (b)(1)(i) of this section, State
  agencies may not selectively choose which fruits and vegetables are available to participants. For example, if
  a State agency chooses to offer dried fruits, it must authorize all WIC-eligible dried fruits.
\22\ Children and women whose special dietary needs require the use of pureed foods may receive commercial
  jarred infant food fruits and vegetables in lieu of the CVV. For children and women who require jarred infant
  food fruits and vegetables in place of the CVV, State agencies must use the conversion of $1 CVV = 6.25 ounces
  of jarred infant food fruits and vegetables. Infant food fruits and vegetables may be substituted for the CVV
  as determined appropriate by the health care provider per medical documentation.
\23\ The monthly value of the fruit/vegetable CVV will be adjusted annually for inflation as described in Sec.
  246.16(j).
\24\ Whole wheat or whole grain bread must be authorized. State agencies have the option to also authorize other
  whole grain options as described in table 4 to paragraph (e)(12) of this section and its footnotes.
\25\ Issuance of smaller container sizes is encouraged to reduce the likelihood of exceeding a safe weekly
  consumption level of methylmercury. The U.S. Food and Drug Administration (FDA) and the U.S. Environmental
  Protection Agency (EPA) provide joint advice regarding fish consumption to limit methylmercury exposure for
  children. As noted in their 2021 joint advice, depending on body weight, some women and some children should
  choose fish lowest in methylmercury or eat less fish than the amounts in the 2020-2025 DGA Healthy US-Style
  Dietary Pattern. More information is available on the FDA and EPA websites at FDA.gov/fishadviceandEPA.gov/fishadvice fishadvice.
\26\ As noted in the 2021 FDA-EPA joint advice about eating fish, for some children, depending on age and
  caloric needs, the amounts of fish in the 2020-2025 DGA are higher than in the FDA-EPA advice. The DGA states
  that to consume these higher amounts, these children should consume only fish from the ``Best Choices'' list
  that are even lower in mercury--among the WIC-eligible varieties, these include Atlantic mackerel, salmon, and
  sardines.
\27\ State agencies are required to offer both mature dry (1 pound) and canned (64 ounces) legumes. For food
  packages that provide both legumes and peanut butter, State agencies may issue the following combinations: 1
  pound dry and 64 oz. canned legumes (and no peanut butter); 2 pounds dry or 128 oz. canned legumes (and no
  peanut butter); or 36 oz. peanut butter (and no legumes). State agencies have the option to authorize other
  nut and seed butters as a substitute for peanut butter (on a 1:1 ounce substitution ratio), as described in
  table 4 of paragraph (e)(12) of this section and its footnotes, as determined appropriate by the health care
  provider per medical documentation.

    (12) Minimum requirements and specifications for supplemental 
foods. Table 4 to this paragraph (e)(12) describes the minimum 
requirements and specifications for supplemental foods in all food 
packages:

  Table 4 to Paragraph (e)(12)--Minimum Requirements and Specifications
                         for Supplemental Foods
------------------------------------------------------------------------
                                            Minimum requirements and
           Categories/foods                      specifications
------------------------------------------------------------------------
WIC Formula:
    Infant Formula...................  All authorized infant formulas
                                        must:
                                       (1) Meet the definition for an
                                        infant formula in section 201(z)
                                        of the Federal Food, Drug, and
                                        Cosmetic Act (21 U.S.C. 321(z))
                                        and meet the requirements for an
                                        infant formula under section 412
                                        of the Federal Food, Drug and
                                        Cosmetic Act, as amended (21
                                        U.S.C. 350a), and the
                                        regulations at 21 CFR parts 106
                                        and 107;
                                       (2) Be designed for enteral
                                        digestion via an oral or tube
                                        feeding;
                                       (3) Provide at least 10 mg iron
                                        per liter (at least 1.5 mg iron/
                                        100 kilocalories) at standard
                                        dilution;
                                       (4) Provide at least 67
                                        kilocalories per 100 milliliters
                                        (approximately 20 kilocalories
                                        per fluid ounce) at standard
                                        dilution; and
                                       (5) Not require the addition of
                                        any ingredients other than water
                                        prior to being served in a
                                        liquid state.
    Exempt Infant Formula............  All authorized exempt infant
                                        formula must:
                                       (1) Meet the definition and
                                        requirements for an exempt
                                        infant formula under section
                                        412(h) of the Federal Food,
                                        Drug, and Cosmetic Act, as
                                        amended (21 U.S.C. 350a(h)), and
                                        the regulations at 21 CFR parts
                                        106 and 107; and
                                       (2) Be designed for enteral
                                        digestion via an oral or tube
                                        feeding.
    WIC-eligible Nutritionals \1\....  Certain enteral products that are
                                        specifically formulated and
                                        commercially manufactured (as
                                        opposed to a naturally occurring
                                        foodstuff used in its natural
                                        state) to provide nutritional
                                        support for individuals with a
                                        qualifying condition, when the
                                        use of conventional foods is
                                        precluded, restricted, or
                                        inadequate. Such WIC-eligible
                                        nutritionals must serve the
                                        purpose of a food, meal, or diet
                                        (may be nutritionally complete
                                        or incomplete) and provide a
                                        source of calories and one or
                                        more nutrients; be designed for
                                        enteral digestion via an oral or
                                        tube feeding; and may not be a
                                        conventional food, drug,
                                        flavoring, or enzyme.
Milk, Milk Alternatives, and Milk
 Substitutions:

[[Page 28526]]

 
    Cow's Milk \2\...................  Must conform to FDA Standard of
                                        Identity for whole, reduced-fat,
                                        low-fat, or nonfat milks (21 CFR
                                        131.110). Must be pasteurized.
                                        Only unflavored milk is
                                        permitted. May be fluid, shelf-
                                        stable, evaporated (21 CFR
                                        131.130), or dry.
                                       Dry whole milk must conform to
                                        FDA Standard of Identity (21 CFR
                                        131.147). Nonfat dry milk must
                                        conform to FDA Standard of
                                        Identity (21 CFR 131.127).
                                       Cultured milks must conform to
                                        FDA Standard of Identity for
                                        cultured milk, e.g., cultured
                                        buttermilk, kefir cultured milk,
                                        acidophilus cultured milk (21
                                        CFR 131.112).
                                       Acidified milk must conform to
                                        FDA Standard of Identity for
                                        acidified milk, e.g., acidified
                                        kefir milk, acidified
                                        acidophilus milk or acidified
                                        buttermilk (21 CFR 131.111).
                                       Whole, reduced-fat, low-fat, and
                                        nonfat cow's milk types and
                                        varieties must contain at least
                                        400 IU of vitamin D per quart
                                        (100 IU per cup) and 2,000 IU of
                                        vitamin A per quart (500 IU per
                                        cup).
    Goat's Milk......................  Must be pasteurized. Only
                                        unflavored milk is permitted.
                                        May be fluid, shelf-stable,
                                        evaporated, or dry (i.e.,
                                        powdered).
                                       Whole, reduced-fat, low-fat, and
                                        nonfat goat's milk must contain
                                        at least 400 IU of vitamin D per
                                        quart (100 IU per cup) and 2,000
                                        IU of vitamin A per quart (500
                                        IU per cup).
    Plant-based Milk Alternatives....  Must contain <=10 g of added
                                        sugars per cup and be fortified
                                        to meet the following nutrient
                                        levels (amounts are provided per
                                        cup): 276 mg calcium, 8 g
                                        protein, 500 international units
                                        vitamin A, 100 IU (2.5
                                        micrograms) vitamin D, 24 mg
                                        magnesium, 222 mg phosphorus,
                                        349 mg potassium, 0.44 mg
                                        riboflavin, and 1.1 mcg vitamin
                                        B12, in accordance with FDA-
                                        issued fortification guidelines.
                                        May be flavored or unflavored.
    Cheese...........................  Domestic cheese made from 100
                                        percent pasteurized milk. Must
                                        conform to FDA Standard of
                                        Identity (21 CFR part 133);
                                        Monterey Jack, Colby, natural
                                        Cheddar, Swiss, Brick, Muenster,
                                        Provolone, part-skim or whole
                                        Mozzarella, pasteurized process
                                        American, or blends of any of
                                        these cheeses are authorized.
                                       Cheeses that are labeled low,
                                        free, reduced, less or light in
                                        sodium, fat or cholesterol are
                                        WIC-eligible.
    Plant-based Cheese Alternatives..  Must contain a minimum of 250 mg
                                        of calcium and 6.5 g of protein
                                        per 1.5 ounces. Plant-based curd
                                        cheeses are not authorized.
    Yogurt (cow's milk)..............  Must be pasteurized, conform to
                                        FDA Standard of Identity (21 CFR
                                        131.200) and contain <=16 grams
                                        of added sugar and a minimum of
                                        106 IU (2.67 micrograms) of
                                        vitamin D per 8 ounces. May be
                                        plain or flavored. Yogurts that
                                        are fortified with vitamin A and
                                        other nutrients may be allowed
                                        at the State agency's option.
                                        Yogurts sold with accompanying
                                        mix-in ingredients such as
                                        granola, candy pieces, honey,
                                        nuts, and similar ingredients
                                        are not authorized. Drinkable
                                        yogurts are not authorized.
    Plant-based Yogurt Alternatives..  Must contain <=16 g of added
                                        sugars and a minimum of 250 mg
                                        of calcium, 6.5 g of protein,
                                        and 106 IU (2.67 micrograms) of
                                        vitamin D per 8 ounces. May be
                                        plain or flavored.
                                       Plant-based yogurts sold with
                                        accompanying mix-in ingredients
                                        such as granola, candy pieces,
                                        honey, nuts, and similar
                                        ingredients are not authorized.
                                        Drinkable yogurts are not
                                        authorized.
    Tofu.............................  Must contain a minimum of 100 mg
                                        of calcium per 100 g of tofu.
                                        May not contain added fats,
                                        sugars, oils, or sodium.
Juice................................  Must be pasteurized 100 percent
                                        unsweetened fruit juice. Must
                                        contain at least 30 mg of
                                        vitamin C per 100 mL of juice.
                                        Must conform to FDA Standard of
                                        Identity as appropriate (21 CFR
                                        part 146) or vegetable juice
                                        must conform to FDA Standard of
                                        Identity as appropriate (21 CFR
                                        part 156). Except for 100
                                        percent citrus juices, State
                                        agencies must verify the vitamin
                                        C content of all State-approved
                                        juices. Juices that are
                                        fortified with other nutrients
                                        may be allowed at the State
                                        agency's option. Juice may be
                                        fresh, from concentrate, frozen,
                                        canned, or shelf stable. Blends
                                        of authorized juices are
                                        allowed.
                                       Vegetable juice may be regular or
                                        lower in sodium.
Eggs.................................  Fresh shell domestic hens' eggs
                                        or dried eggs mix (must conform
                                        to FDA Standard of Identity in
                                        21 CFR 160.105) or pasteurized
                                        liquid whole eggs (must conform
                                        to FDA Standard of Identity in
                                        21 CFR 160.115).
                                       Hard boiled eggs, where readily
                                        available for purchase in small
                                        quantities, may be provided for
                                        homeless participants.
Breakfast Cereal (Ready-to-eat and     Must contain a minimum of 28 mg
 instant and regular hot cereals).      iron per 100 g dry cereal.
                                       Must contain <=21.2 g of added
                                        sugar per 100 g dry cereal (<=6
                                        g per dry oz.)
                                       Seventy five percent of cereals
                                        on the State agency authorized
                                        food list must contain whole
                                        grain as the first ingredient.
Fruits and vegetables (fresh and       Any variety of fresh (as defined
 processed) 3 4 5 6 7.                  by 21 CFR 101.95) whole or cut
                                        fruit without added sugars.
                                       Any variety of fresh (as defined
                                        by 21 CFR 101.95) whole or cut
                                        vegetable without added sugars,
                                        fats, or oils.
                                       Any variety of canned fruits
                                        (must conform to FDA standard of
                                        identity as appropriate (21 CFR
                                        part 145)); including
                                        applesauce, juice pack or water
                                        pack without added sugars, fats,
                                        oils, or salt (i.e., sodium).
                                        The fruit must be listed as the
                                        first ingredient.
                                       Any variety of frozen fruits
                                        without added sugars, fats,
                                        oils, or salt (i.e., sodium).
                                       Any variety of canned or frozen
                                        vegetables without added sugars,
                                        fats, or oils. Vegetable must be
                                        listed as the first ingredient.
                                        May be regular or lower in
                                        sodium. Must conform to FDA
                                        standard of identity as
                                        appropriate (21 CFR part 155).
                                       Any type of dried fruits or dried
                                        vegetables without added sugars,
                                        fats, oils, or salt (i.e.,
                                        sodium).
                                       Any type of immature beans, peas,
                                        or lentils, fresh or in canned
                                        \4\ forms.
                                       Any type of frozen beans
                                        (immature or mature). Beans
                                        purchased with the CVV may
                                        contain added vegetables and
                                        fruits, but may not contain
                                        added sugars, fats, oils, or
                                        meat as purchased. Canned beans,
                                        peas, or lentils may be regular
                                        or lower in sodium content.
                                       State agencies must allow organic
                                        forms of WIC-eligible fruits and
                                        vegetables.
Whole Wheat Bread, Whole Grain Bread,
 and Whole Grain Options:
    Bread............................  Whole wheat bread must conform to
                                        FDA Standard of Identity (21 CFR
                                        136.180). (Includes whole wheat
                                        buns and rolls.) ``Whole wheat
                                        flour'' and/or ``bromated whole
                                        wheat flour'' must be the only
                                        flours listed in the ingredient
                                        list.
                                       OR
                                       Whole grain bread must conform to
                                        FDA Standard of Identity (21 CFR
                                        136.110) (includes whole grain
                                        buns and rolls)
                                       AND
                                       Must contain at least 50 percent
                                        whole grains with the remaining
                                        grains being either enriched or
                                        whole grains.\8\
    Whole Grain Options..............  Brown rice, wild rice, quinoa,
                                        bulgur (cracked wheat), oats,
                                        whole-grain barley, millet,
                                        triticale, amaranth, cornmeal
                                        (including blue), corn masa
                                        flour, whole wheat macaroni
                                        (pasta) products, whole wheat
                                        bread products (i.e., pita,
                                        English muffin, bagels, naan),
                                        soft corn or whole wheat
                                        tortillas, buckwheat, teff,
                                        kamut, sorghum, wheat berries
                                        without added sugars, fats,
                                        oils, or salt (i.e., sodium).
                                        May be instant-, quick-, or
                                        regular-cooking.
                                       State agencies have the option to
                                        authorize other intact whole
                                        grain options without added
                                        sugars, fats, oils, or salt
                                        (i.e., sodium).
                                       Corn meal (including blue) must
                                        conform to FDA Standard of
                                        Identity 21 CFR 137.260 &
                                        aligning with USDA School Meal
                                        Guidance.
                                       Soft corn or whole wheat
                                        tortillas. Soft corn tortillas
                                        made from ground masa flour
                                        (corn flour) using traditional
                                        processing methods are WIC-
                                        eligible, e.g., whole corn, corn
                                        (masa), whole ground corn, corn
                                        masa flour, masa harina, and
                                        white corn flour. For whole
                                        wheat tortillas, ``whole wheat
                                        flour'' must be the only flour
                                        listed in the ingredient list.
                                        States may offer tortillas made
                                        with folic acid-fortified corn
                                        masa flour.

[[Page 28527]]

 
                                       Whole wheat macaroni (pasta)
                                        products. Must conform to FDA
                                        Standard of Identity (21 CFR
                                        139.138) and have no added
                                        sugars, fats, oils, or salt
                                        (i.e., sodium). ``Whole wheat
                                        flour'' and/or ``whole durum
                                        wheat flour'' must be the only
                                        flours listed in the ingredient
                                        list. Other shapes and sizes
                                        that otherwise meet the FDA
                                        Standard of Identity for whole
                                        wheat macaroni (pasta) products
                                        (21 CFR 139.138), and have no
                                        added sugars, fats, oils, or
                                        salt (i.e., sodium), are also
                                        allowed (e.g., whole wheat
                                        rotini, and whole wheat penne).
Fish (canned) \4\....................  Light tuna (must conform to FDA
                                        Standard of Identity (21 CFR
                                        161.190));
                                       Salmon (Pacific salmon must
                                        conform to FDA standard of
                                        identity (21 CFR 161.170));
                                       Sardines; and
                                       Mackerel (N. Atlantic Scomber
                                        scombrus, Chub Pacific Scomber
                                        japonicas) \9\
                                       May be packed in water or oil.
                                        Pack may include bones or skin.
                                        Only boneless varieties of fish
                                        may be provided to children at
                                        State agency option. Added
                                        sauces and flavorings, e.g.,
                                        tomato sauce, mustard, lemon,
                                        are authorized at the State
                                        agency's option. May be regular
                                        or lower in sodium content.
Mature Legumes, Peanut Butter, and
 Peanut Butter Substitutions:
    Mature Legumes (dry beans and      Any type of mature dry beans,
     peas) \10\.                        peas, or lentils in dry-packaged
                                        and canned \4\ forms. Examples
                                        include but are not limited to
                                        black beans, black-eyed peas,
                                        garbanzo beans (chickpeas),
                                        great northern beans, white
                                        beans (navy and pea beans),
                                        kidney beans, mature lima
                                        (``butter beans''), fava beans,
                                        mung beans, pinto beans,
                                        soybeans/edamame, split peas,
                                        lentils, and refried beans. Does
                                        not include green beans or green
                                        peas. All categories exclude
                                        soups. May not contain added
                                        sugars, fats, oils, vegetables,
                                        fruits, or meat as purchased.
                                        Canned legumes may be regular or
                                        lower in sodium content.\11\
                                       Baked beans may only be provided
                                        for participants with limited
                                        cooking facilities.\11\
    Peanut Butter....................  Peanut butter and reduced-fat
                                        peanut butter must conform to
                                        FDA Standard of Identity (21 CFR
                                        164.150); creamy or chunky,
                                        regular, or reduced-fat, salted
                                        or unsalted forms are allowed.
                                        Peanut butters with added
                                        marshmallows, honey, jelly,
                                        chocolate, or similar
                                        ingredients are not authorized.
Nut and Seed Butters.................  Must provide comparable nutritive
                                        value to peanut butter (i.e.,
                                        protein and iron).
                                       May be creamy or chunky, regular,
                                        or reduced-fat, salted or
                                        unsalted forms are allowed. Nut
                                        and seed butter with added
                                        marshmallows, honey, jelly,
                                        chocolate, or similar
                                        ingredients are not authorized.
Infant Foods:
    Infant Cereal....................  Infant cereal must contain a
                                        minimum of 45 mg of iron per 100
                                        g of dry cereal.\12\
    Infant Fruits....................  Any variety of single ingredient
                                        commercial infant food fruit
                                        without added sugars, starches,
                                        or salt (i.e., sodium). Texture
                                        may range from strained through
                                        diced. The fruit must be listed
                                        as the first ingredient.\13\
    Infant Vegetables................  Any variety of single ingredient
                                        commercial infant food
                                        vegetables without added sugars,
                                        starches, or salt (i.e.,
                                        sodium). Texture may range from
                                        strained through diced. The
                                        vegetable must be listed as the
                                        first ingredient.\14\
    Infant Meat......................  Any variety of commercial infant
                                        food meat or poultry as a single
                                        major ingredient, with added
                                        broth or gravy. Added sugars or
                                        salt (i.e., sodium) are not
                                        allowed. Texture may range from
                                        pureed through diced.\15\
------------------------------------------------------------------------
Note: FDA = Food and Drug Administration of the U.S. Department of
  Health and Human Services. Foods must comply with labeling
  requirements consistent with 21 CFR parts 130 and 101.
\1\ The following are not considered a WIC-eligible nutritional:
  Formulas used solely for the purpose of enhancing nutrient intake,
  managing body weight, or addressing picky eaters or used for a
  condition other than a qualifying condition (e.g., vitamin pills,
  weight control products, etc.); medicines or drugs as defined by the
  Federal Food, Drug, and Cosmetic Act as amended; enzymes, herbs, or
  botanicals; oral rehydration fluids or electrolyte solutions;
  flavoring or thickening agents; and feeding utensils or devices (e.g.,
  feeding tubes, bags, pumps) designed to administer a WIC-eligible
  formula.
\2\ All authorized milks must conform to FDA Standards of Identity for
  milks as defined by 21 CFR part 131 and meet WIC's requirements for
  vitamin fortification as specified in table 4 to paragraph (e)(12) of
  this section. Additional authorized milks include, but are not limited
  to calcium-fortified, lactose-reduced, organic, and UHT pasteurized
  milks. Other milks are permitted at the State agency's discretion
  provided that the State agency determines that the milk meets the
  minimum requirements for authorized milk.
\3\ Processed refers to frozen, canned (see footnote 4 to this table 4),
  or dried.
\4\ Canned refers to processed food items in cans or other shelf-stable
  containers, e.g., jars, pouches.
\5\ Fresh herbs, cut at the root or with the root intact, are
  authorized. The following are not authorized: spices and dried herbs;
  seeds; potted plants with vegetables, fruits or herbs; creamed
  vegetables or vegetables with added sauces; fresh fruits and/or
  vegetables packaged with dips, sauces, or glazes; mixed vegetables
  containing noodles, nuts, or sauce packets; vegetable-grain (e.g.,
  pasta, rice) mixtures; fruit-nut mixtures; breaded vegetables; fruits
  and vegetables for purchase on salad bars; peanuts or other nuts;
  ornamental and decorative fruits and vegetables such as chili peppers
  or garlic on a string, gourds, painted pumpkins, fruit baskets, and
  decorative blossoms and flowers; and foods containing fruits such as
  blueberry muffins and other baked goods. Home-canned and home-
  preserved fruits and vegetables are not authorized.
\6\ Excludes catsup or other condiments; pickled vegetables; olives;
  soups; juices; and fruit leathers and fruit roll-ups. Canned tomato
  sauce, tomato paste, salsa, and spaghetti sauce without added sugar,
  fats, or oils are authorized.
\7\ State agencies have the option to allow only lower sodium canned
  vegetables for purchase with the cash-value voucher.
\8\ One of the following criteria must be met to confirm the product
  provides 50% or more whole grains: (1) product labeling contains the
  FDA health claim ``Diet rich in whole grain foods and other plant
  foods and low in total fat, saturated fat, and cholesterol may reduce
  the risk of heart disease and some cancers'' OR ``Diets rich in whole
  grain foods and other plant foods, and low in saturated fat and
  cholesterol, may help reduce the risk of heart disease''; (2) meets
  the ``rule of three'' criteria (i.e., the first ingredient (or second
  after water) must be whole grain, and the next two grain ingredients
  (if any) must be whole grains, enriched grains, bran or germ; (3) the
  manufacturer provides written documentation that the product contains
  50% or more whole grains by weight.
\9\ King mackerel is not authorized.
\10\ Mature dry beans, peas, or lentils in dry-packaged and canned forms
  are authorized under the mature legume category. Immature varieties of
  fresh or canned beans and frozen beans of any type (immature or
  mature) are authorized for purchase with the cash-value voucher only.
  Juices are provided as a separate WIC food category and are not
  authorized under the fruit and vegetable category.
\11\ The following are not authorized in the mature legume category:
  soups; immature varieties of legumes, such as those used in canned
  green peas, green beans, snap beans, yellow beans, and wax beans;
  baked beans with meat, e.g., beans and franks; beans containing added
  sugars (except for baked beans), fats, oils, meats, fruits, or
  vegetables.
\12\ Infant cereals containing infant formula, milk, fruit, or other non-
  cereal ingredients are not allowed.
\13\ Mixtures with cereal or infant food desserts (e.g., peach cobbler)
  are not authorized; however, combinations of single ingredients (e.g.,
  apple-banana) and combinations of single ingredients of fruits and/or
  vegetables (e.g., apples and squash) are allowed.
\14\ Combinations of single ingredients (e.g., peas and carrots) and
  combinations of single ingredients of fruits and/or vegetables (e.g.,
  apples and squash) are allowed. Mixed vegetables with white potato as
  an ingredient (e.g., mixed vegetables) are authorized.
\15\ Infant food combinations (e.g., meat and vegetables) and dinners
  (e.g., spaghetti and meatballs) are not allowed.

    (f) USDA purchase of commodity foods. (1) At the request of a State 
agency, FNS may purchase commodity foods for the State agency using 
funds allocated to the State agency. The commodity foods purchased and 
made available to the State agency must be equivalent to the foods 
specified in table 4 to paragraph (e)(12) of this section.
    (2) The State agency must:
    (i) Distribute the commodity foods to its local agencies or 
participants; and
    (ii) Ensure satisfactory storage facilities and conditions for the 
commodity foods, including documentation of proper insurance.
    (g) Infant formula manufacturer registration. Infant formula

[[Page 28528]]

manufacturers supplying formula to the WIC Program must be registered 
with the Secretary of Health and Human Services under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Such manufacturers 
wishing to bid for a State contract to supply infant formula to the 
Program must certify with the State health department that their 
formulas comply with the Federal Food, Drug, and Cosmetic Act and 
regulations in this chapter issued pursuant to the Act.
    (h) Rounding up. State agencies may round up to the next whole 
container for either infant formula or infant foods (infant cereal, 
fruits, vegetables, and meat). State agencies that use the rounding up 
option must calculate the amount of infant formula or infant foods 
provided according to the requirements and methodology as described in 
this section.
    (1) Infant formula. State agencies must use the maximum monthly 
allowance of reconstituted fluid ounces of liquid concentrate infant 
formula as specified in table 1 to paragraph (e)(9) of this section as 
the full nutritional benefit (FNB) provided by infant formula for each 
food package category and infant feeding option (e.g., Food Package IA 
fully formula fed, IA-FF (see paragraph (e)(1) of this section)).
    (i) For State agencies that use rounding up of infant formula, the 
FNB is determined over the timeframe (the number of months) that the 
participant receives the food package. In any given month of the 
timeframe, the monthly issuance of reconstituted fluid ounces of infant 
formula may exceed the maximum monthly allowance or fall below the FNB; 
however, the cumulative average over the timeframe may not fall below 
the FNB without individual tailoring to allow ``up to'' amounts to 
support breastfeeding. In addition, the State agency must:
    (A) Use the methodology described in paragraph (h)(1)(ii) of this 
section for calculating and dispersing the rounding up option;
    (B) Issue infant formula in whole containers that are all the same 
size; and
    (C) Disperse the number of whole containers as evenly as possible 
over the timeframe with the largest monthly issuances given in the 
beginning of the timeframe.
    (ii) The methodology to calculate rounding up and dispersing infant 
formula to the next whole container over the food package timeframe is 
as follows:
    (A) Multiply the FNB amount for the appropriate food package and 
feeding option (e.g., Food Package IA fully formula fed, IA-FF (see 
paragraph (e)(1) of this section)) by the timeframe the participant 
will receive the food package to determine the total amount of infant 
formula to be provided.
    (B) Divide the total amount of infant formula to be provided by the 
yield of the container (in reconstituted fluid ounces) issued by the 
State agency to determine the total number of containers to be issued 
during the timeframe that the food package is prescribed.
    (C) If the number of containers to be issued does not result in a 
whole number of containers, the State agency must round up to the next 
whole container in order to issue whole containers.
    (2) Infant foods. (i) State agencies may use the rounding up option 
to the next whole container of infant food (infant cereal, fruits, 
vegetables, and meat) when the maximum monthly allowance cannot be 
issued due to varying container sizes of authorized infant foods.
    (ii) State agencies that use the rounding up option for infant 
foods must:
    (A) Use the methodology described in paragraph (h)(2)(iii) of this 
section for calculating and dispersing the rounding up option;
    (B) Issue infant foods in whole containers; and
    (C) Disperse the number of whole containers as evenly as possible 
over the timeframe (the number of months the participant will receive 
the food package).
    (iii) The methodology to round up and disperse infant food is as 
follows:
    (A) Multiply the maximum monthly allowance for the infant food by 
the timeframe the participant will receive the food package to 
determine the total amount of food to be provided.
    (B) Divide the total amount of food provided by the container size 
issued by the State agency (e.g., ounces) to determine the total number 
of food containers to be issued during the timeframe that the food 
package is prescribed.
    (C) If the number of containers to be issued does not result in a 
whole number of containers, the State agency must round up to the next 
whole container in order to issue whole containers.
    (i) Plans for cultural substitutions. (1) The State agency may 
submit to FNS a plan for substitution of food(s) acceptable for use in 
the Program in addition to the supplemental foods outlined in (see 
paragraph (e)(12) of this section) to allow for different cultural 
eating patterns. The plan shall provide the State agency's 
justification, including a specific explanation of the cultural eating 
pattern and other information necessary for FNS to evaluate the plan as 
specified in paragraph (i)(2) of this section.
    (2) FNS will evaluate a State agency's plan for substitution of 
foods for different cultural eating patterns based on the following 
criteria:
    (i) Any proposed substitute food must be nutritionally equivalent 
or superior to the food it is intended to replace.
    (ii) The proposed substitute food must be widely available to 
participants in the areas where the substitute is intended to be used.
    (iii) The cost of the substitute food must be assessed and 
comparable to the cost of the food it is intended to replace.
    (3) FNS will make a determination on the proposed plan based on the 
evaluation criteria specified in paragraph (i)(2) of this section, as 
appropriate. The State agency shall substitute foods only after 
receiving the written approval of FNS.

0
5. Amend Sec.  246.11 by revising paragraph (a)(1) to read as follows:


Sec.  246.11   Nutrition education.

    (a) * * *
    (1) Nutrition education including breastfeeding promotion and 
support shall be considered a benefit of the Program and shall be made 
available at no cost to the participant. Nutrition education including 
breastfeeding promotion and support, shall be designed to be easily 
understood by participants, and it shall bear a practical relationship 
to participant nutritional needs, household situations, and cultural 
preferences including information on how to select food for themselves 
and their families as well as the maximum monthly allowances of 
authorized supplemental foods to which they are entitled as a Program 
participant.
* * * * *

0
6. Amend Sec.  246.12 by revising paragraphs (g)(3)(i) and (u)(2)(i) to 
read as follows:


Sec.  246.12   Food delivery methods.

* * * * *
    (g) * * *
    (3) * * *
    (i) Minimum variety and quantity of supplemental foods. The State 
agency must establish minimum requirements for the variety and quantity 
of supplemental foods that a vendor applicant must stock to be 
authorized. These requirements include that the vendor stock at least 
two different fruits, three different vegetables, and at least one 
whole grain cereal authorized by

[[Page 28529]]

the State agency. The State agency may not authorize a vendor applicant 
unless it determines that the vendor applicant meets these minimums. 
The State agency may establish different minimums for different vendor 
peer groups. The State agency may not authorize a vendor applicant 
unless it determines that the vendor applicant obtains infant formula 
only from sources included on the State agency's list described in 
paragraph (g)(11) of this section.
* * * * *
    (u) * * *
    (2) * * *
    (i) General. Except as provided in paragraphs (u)(2)(ii) and (iii) 
of this section, whenever the State agency assesses a claim of $1,000 
or more, assesses a claim for dual participation, or assess a second or 
subsequent claim of any amount, the State agency must disqualify the 
participant for one year.
* * * * *

0
7. Amend Sec.  246.16 by revising paragraphs (j) introductory text and 
(j)(1) through (4)


Sec.  246.16  Distribution of funds.

* * * * *
    (j) Inflation adjustment of the fruit and vegetable voucher. The 
monthly cash value of the fruit and vegetable voucher shall be adjusted 
annually for inflation. Adjustments are effective the first day of each 
fiscal year beginning on or after October 1 each year. The inflation-
adjusted value of the voucher shall be equal to a base value increased 
by a factor based on the Consumer Price Index for All Urban Consumers 
(CPI-U) for fresh fruits and vegetables, as provided in this section.
    (1) Adjustment year. The adjustment year is the fiscal year that 
begins October 1 of the current calendar year.
    (2) Base value of the fruit and vegetable voucher. The base year 
for calculation of the value of the fruit and vegetable voucher is 
fiscal year 2022. The base value to be used equals:
    (i) $24 for children;
    (ii) $43 for pregnant and postpartum women; and
    (iii) $47 for breastfeeding (fully and partially (mostly)) women.
    (3) Adjusted value of the fruit and vegetable voucher. The adjusted 
value of the fruit and vegetable voucher is the cash value of the 
voucher for adjustment years beginning on or after October 1, 2022. The 
adjusted value is the base value increased by an amount equal to the 
base value of the fruit and vegetable voucher:
    (i) Multiplied by the inflation adjustment described in paragraph 
(j)(4) of this section; and
    (ii) Subject to rounding as described in paragraph (j)(5) of this 
section.
    (4) Inflation adjustment. The inflation adjustment of the fruit and 
vegetable voucher shall equal the percentage (if any) by which the 
annual average value of the Consumer Price Index for fresh fruits and 
vegetables, computed from monthly values published by the Bureau of 
Labor Statistics, for the twelve months ending on March 31 of the 
fiscal year immediately prior to the adjustment year, exceeds the 
average of the monthly values of that index for the twelve months 
ending on March 31, 2021.
* * * * *

Cynthia Long,
Administrator, Food and Nutrition Service.

    Note:  The following appendix will not appear in the Code of 
Federal Regulations.

Appendix A--Regulatory Impact Analysis

I. Statement of Need

    Section 17 of the Child Nutrition Act of 1966 (Pub. L. 89-642) 
mandates that the USDA conduct a comprehensive scientific review of 
the WIC food packages at least every ten years and revise the foods 
available, as needed, to reflect nutritional science, public health 
concerns, and cultural eating patterns (42 U.S.C. 1786(f)(11). This 
rule makes changes that 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 food packages that accommodate participants' personal and 
cultural food preferences and special dietary needs; 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 of participants to help establish successful long-term 
breastfeeding.

II. Background

    Established in 1974, the mission of the Special Supplemental 
Nutrition Program for Women, Infants, and Children (WIC) is to 
safeguard the health of low-income pregnant, postpartum, and 
breastfeeding individuals, infants, and children ages 1 through 4 
years who are at nutritional risk by providing nutritious foods to 
supplement diets, nutrition education (to include breastfeeding 
promotion and support), and referrals to health and other social 
services. Participation in WIC is associated with improved pregnancy 
outcomes and lower infant mortality, and also associated with 
improved diet quality.\29\ In Federal fiscal year (FY) 2023, WIC 
served an average of 6.58 million infants, children, and pregnant, 
breastfeeding, and postpartum individuals per month.\30\
---------------------------------------------------------------------------

    \29\ Caulfield, L., Bennett, W., Gross, S., Hurley, K., 
Ogunwole, S., Venkataramani, M., Lerman, J., Zhang, A., Sharma, R., 
Bass, E. (2022). 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. DOI: 
https://doi.org/10.23970/AHRQEPCCER253.
    \30\ U.S. Department of Agriculture Food and Nutrition Service. 
WIC Data Tables, 2023. Available online at: https://www.fns.usda.gov/pd/wic-program.
---------------------------------------------------------------------------

    The monthly WIC food packages are prescribed to (1) address the 
prevalence of inadequate and excessive nutrient intakes for each WIC 
participant category, (2) contribute to an overall dietary pattern 
consistent with the Dietary Guidelines for Americans (DGA), and (3) 
deliver priority nutrients to participants to meet their 
supplemental nutrition needs. There are seven WIC food packages 
available for the following participant categories:

 Food Package I: Infants birth through 5 months (Fully 
Breastfed, Partially Breastfed, and Fully Formula Fed)
 Food Package II: Infants ages 6 through 11 months (Fully 
Breastfed, Partially Breastfed, and Fully Formula Fed)
 Food Package III: Medically Fragile Women, Infants, and 
Children
 Food Package IV: Children ages 1 through 4 years
 Food Package V: Pregnant & Partially Breastfeeding Women up 
to 1 year postpartum
 Food Package VI: Postpartum Women (minimally or non-
breastfeeding) up to 6 months postpartum
 Food Package VII: Fully Breastfeeding Women up to 1 year 
postpartum

    On December 13, 2010, Congress passed the Healthy, Hunger-Free 
Kids Act of 2010 (Pub. L. 111-296), amending section 17(f)(11) of 
the Child Nutrition Act by mandating that the USDA conduct a 
scientific review of the WIC food packages at least every ten years. 
In response to the mandate, in 2014, FNS contracted with the 
National Academies of Sciences, Engineering, and Medicine (NASEM) to 
conduct a comprehensive review of the current WIC food packages in 
relation to the current nutritional science, dietary guidance, and 
program administration considerations. In 2017, NASEM published its 
recommendations for WIC food package revisions in the report: 
``Review of WIC Food Packages: Improving Balance and Choice'' (the 
``NASEM report'').\31\ Section 17(f)(11) of the Child Nutrition Act 
also requires that WIC supplemental foods are amended as necessary 
to reflect nutrition science, public health concerns, and cultural 
eating patterns. As such, the revisions in this rule largely reflect 
the recommendations from the 2017 NASEM Report.
---------------------------------------------------------------------------

    \31\ National Academies of Sciences, Engineering, and Medicine. 
``Review of WIC Food Packages: Improving Balance and Choice: Final 
Report,'' 2017. Available online at: https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice.
---------------------------------------------------------------------------

    In its report, NASEM recommended modifications to the current 
WIC food

[[Page 28530]]

packages to reduce foods provided in more than supplemental amounts 
and increase foods needed to improve intakes of priority nutrients 
and food groups. NASEM scaled back their recommendations for certain 
food package items, such as the amount of the CVV, in order to 
achieve cost neutrality. However, NASEM provided clear alternative 
nutrition-based recommendations for the Department to consider if 
cost neutrality were not the prevailing principle in rulemaking. 
Since the goal of USDA is to follow science-based recommendations 
that improve health equity and advance nutrition security (meaning 
consistent and equitable access to healthy, safe, and affordable 
food essential to optimal health and well-being), the Department has 
accepted the alternative recommendations for certain food items, 
such as the higher CVV.
    After NASEM released its 2017 report, on December 29, 2020, the 
USDA and the Department of Health and Human Services released the 
Dietary Guidelines for Americans (DGA), 2020-2025,\32\ which provide 
science-based recommendations for healthy dietary patterns by life 
stage and, for the first time since the 1985 edition, specific 
recommendations for infants and children up to 2 years of age, as 
well as for those who are pregnant and breastfeeding.\33\ The 
revisions in this rule align the WIC food packages with the 2020-
2025 DGA and largely reflect the recommendations in the 2017 NASEM 
Report while promoting nutrition security and equity and considering 
program administration.
---------------------------------------------------------------------------

    \32\ Referred to hereafter as ``2020-2025 DGA'' or ``DGA.''
    \33\ U.S. Department of Health and Human Services/U.S. 
Department of Agriculture, ``Dietary Guidelines for Americans, 2020-
2025.'' Available online at: https://www.dietaryguidelines.gov.
---------------------------------------------------------------------------

    In FY 2022, the Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies Appropriations Act 2022 (Pub. 
L. 117-103) directed USDA to temporarily increase the WIC cash-value 
voucher (CVV), which participants use to purchase fruits and 
vegetables, to amounts consistent with NASEM recommendations, 
adjusted for inflation, through September 30, 2022. As a result, the 
CVV was increased to the same amounts that are set in this rule, 
equal to $24 for child participants, $43 for pregnant and postpartum 
participants, and $47 for fully and partially breastfeeding 
participants in FY 2022. The Consolidated Appropriations Act of 2023 
(Pub. L. 117-328) included the same CVV increase, setting CVV values 
at $25 for child participants, $44 for pregnant and postpartum 
participants, and $49 for fully and partially breastfeeding 
participants through September 30, 2023, after adjusting for 
inflation. To date, these legislative provisions have only increased 
the CVV on a time-limited basis. This final rule would make 
permanent the CVV increase initially enacted in FY 2022, by revising 
the regulations governing the WIC food packages. Due to the 
temporary nature of the CVV increases in FY 2022, FY 2023, and FY 
2024, the following analysis presents both the total cost, in terms 
of increased Federal transfers, for the rule as a whole (i.e., 
compared to current regulations and with the cost of CVV included) 
and also for the rule absent the CVV cost impact (i.e., the cost of 
the rule compared to the current WIC food packages as enacted in FY 
2022 through FY 2024).
    On November 21, 2022, USDA published the proposed rule, 
``Special Supplemental Nutrition Program for Women, Infants, and 
Children (WIC): Revisions in the WIC Food Packages.'' \34\ Based on 
comments received on the proposed rule, USDA revised this final rule 
to improve Program access, participant choice, equity, and 
operational and administrative efficiency.
---------------------------------------------------------------------------

    \34\ USDA, ``Special Supplemental Nutrition Program for Women, 
Infants, and Children (WIC): Revisions in the WIC Food Packages,'' 
RIN 0584-AE82, 87 FR 71090, available online at https://www.federalregister.gov/documents/2022/11/21/2022-24705/special-supplemental-nutrition-program-for-women-infants-and-children-wic-revisions-in-the-wic-food.
---------------------------------------------------------------------------

    The revisions finalized in this rule align the WIC food packages 
with the 2020-2025 DGA and largely reflect the recommendations in 
the 2017 NASEM Report with modifications the Department deemed 
necessary for program administration considerations. This final rule 
maintains the supplemental nature of the WIC food package while 
prioritizing changes that support nutrition security.
    In its 2017 report, NASEM included an impact analysis of its 
recommended revisions. The regulatory impact analysis published with 
the proposed rule built on NASEM's analysis to update cost estimates 
for the provisions outlined in the rule and calculated new or 
revised estimates for provisions that expand or modify those 
recommended by NASEM to align with the 2020-2025 DGA and/or 
accommodate program administration considerations.
    This analysis of the final rule follows the methodology of the 
proposed rule analysis, using the most recent possible participation 
data, inflation data, and price data, as well as accounting for 
minor changes made between the proposed and final rules that 
affected the estimated cost (or savings) of the rule. Updating these 
input data resulted in changes in both the baseline cost estimate 
and the cost of the final rule relative to the estimates published 
with the proposed rule; the revised estimates are presented below in 
their entirety.

III. Public Comments on the Regulatory Impact Analysis of the Proposed 
Rule

    On November 21, 2022, the Department published a proposed rule 
to revise the WIC food packages (87 FR 71090). There were no 
comments addressing the regulatory impact analysis (RIA) or the 
validity of USDA's cost estimates of the proposed rule. The 
Department received 15,028 comments addressing the proposed 
increases to the CVV and 20 comments addressing the CVV annual 
inflation adjustment. Comments suggesting alternative 
implementations of the CVV are analyzed in the Alternatives section 
below. Other comments relating to the provisions of the rule are 
described in the preamble text accompanying the rule, and the 
impacts of those are described in the analysis that follows.

IV. Summary of Provisions

    Table 1 summarizes the revisions to regulations governing the 
WIC food packages, alongside current requirements as described in 
Federal Regulations, absent the temporary CVV increase enacted in FY 
2022 (Pub. L. 117-103) and FY 2023 (Pub. L. 117-328).

[[Page 28531]]

[GRAPHIC] [TIFF OMITTED] TR18AP24.112


[[Page 28532]]


[GRAPHIC] [TIFF OMITTED] TR18AP24.113


[[Page 28533]]


[GRAPHIC] [TIFF OMITTED] TR18AP24.114


[[Page 28534]]


[GRAPHIC] [TIFF OMITTED] TR18AP24.115


[[Page 28535]]


[GRAPHIC] [TIFF OMITTED] TR18AP24.116


[[Page 28536]]


[GRAPHIC] [TIFF OMITTED] TR18AP24.117


[[Page 28537]]



V. Impacts

A. Summary of Impacts

    The following analysis describes the estimated impacts of the 
rule on the Federal WIC spending, accounted for in terms of Federal 
transfer payments projected between FY 2025 and FY 2029, as well as 
the key health and nutrition benefits for WIC participants expected 
as a result of the changes. An overview of the cost impacts on 
Federal transfers and on State and local administrative costs is 
followed by a detailed description of impacts on Federal transfers 
by food item and the concomitant participant health benefits by food 
item. The analysis concludes with an in-depth discussion of impacts 
on State agency administrative burden and costs, participation, and 
specific food markets.
    The Department estimates that the rule to revise regulations 
governing the WIC food packages will result in a net increase in 
Federal WIC spending of $4.9 billion over five years from FY 2025 
through FY 2029, which includes the CVV increase as enacted in FY 
2022, FY 2023, and FY 2024. Excluding the CVV increases as currently 
implemented, the provisions of this rule result in a net decrease in 
Federal spending of $617 million over five years between FY 2025 and 
FY 2029. These cost changes only reflect changes in overall Federal 
transfers for WIC food expenditures. In addition to the change in 
food expenditures accounted for in terms of Federal transfers, the 
Department also estimates that WIC State agencies and local agencies 
will incur an increase in administrative burden of about $179 
million in additional labor costs associated with the required State 
and local agency staff time over five years between FY 2025 and FY 
2029.

                        Table 2a--Summary of Transfer and Cost Impacts of the Final Rule
----------------------------------------------------------------------------------------------------------------
                                                              Fiscal year ($ millions)
                                   -----------------------------------------------------------------------------
                                        2025         2026         2027         2028         2029        Total
----------------------------------------------------------------------------------------------------------------
Nominal Federal Transfer Payment       $1,045.8       $937.7       $961.1       $996.1     $1,006.5     $4,947.2
 Stream...........................
Nominal State Agency Cost Stream..         59.7         28.7         29.4         30.1         30.7        178.6
----------------------------------------------------------------------------------------------------------------

    Applying 3 percent and 7 percent discount rates to these nominal 
streams gives present values (in 2024 dollars): \35\
---------------------------------------------------------------------------

    \35\ Note that the discounted streams include both a real 3 and 
7 percent discount component, as well as an additional 2.3-3 percent 
(depending on the year) discount component to undo the inflation 
built into the nominal estimate streams, in order to calculate the 
costs in Table 2b in constant 2024 dollars.

                                 Table 2b--Discounted Transfer and Cost Streams
----------------------------------------------------------------------------------------------------------------
                                                       Fiscal year ($ millions, 2024 dollars)
                                   -----------------------------------------------------------------------------
                                        2025         2026         2027         2028         2029        Total
----------------------------------------------------------------------------------------------------------------
Discounted Federal Transfer
 Payment Stream:
    3 percent.....................       $992.4       $845.8       $823.2       $810.3       $777.5     $4,249.2
    7 percent.....................        956.1        785.1        736.0        698.1        645.2      3,820.5
Discounted State Agency Cost
 Stream:
    3 percent.....................         56.6         25.9         25.2         24.4         23.7        155.9
    7 percent.....................         54.6         24.0         22.5         21.1         19.7        141.9
----------------------------------------------------------------------------------------------------------------

    As required by OMB Circular A-4, the Department has prepared an 
accounting statement showing the annualized estimates of benefits 
and transfers associated with the provisions of this rule, in Table 
2c below. Table 2c takes the discounted streams from Table 2b and 
computes annualized values in FY 2024 dollars.

                                         Table 2c--Accounting Statement
----------------------------------------------------------------------------------------------------------------
                                                                                       Discount
                  Benefits                       Range       Estimate   Year dollar    rate (%)   Period covered
----------------------------------------------------------------------------------------------------------------
Qualitative: Better alignment of the WIC food packages with the latest available science as described by NASEM,
 the DGA, and AAP, and increased choice and flexibility for WIC participants.
----------------------------------------------------------------------------------------------------------------
Program participants, farmers, food processors, food distributors, food retailers
----------------------------------------------------------------------------------------------------------------
    Annualized Monetized ($millions/year)...         n.a.         n.a.         n.a.         n.a.     FY2025-2029
----------------------------------------------------------------------------------------------------------------
                  Transfers                      Range       Estimate   Year dollar    Discount   Period covered
                                                                                         rate
                                                                                             (%)
----------------------------------------------------------------------------------------------------------------
Quantitative: Net cost of proposed changes to the food packages.
----------------------------------------------------------------------------------------------------------------
Federal Government
----------------------------------------------------------------------------------------------------------------

[[Page 28538]]

 
    Annualized Monetized ($millions/year)...         n.a.       $764.1         2024            7     FY2025-2029
                                                                 849.8         2024            3
----------------------------------------------------------------------------------------------------------------
                    Costs                        Range       Estimate   Year dollar    Discount   Period covered
                                                                                         rate
                                                                                             (%)
----------------------------------------------------------------------------------------------------------------
Quantitative: Net increase in State and local WIC agency administrative costs associated with increased State
 agency and local agency administrative burden required to implement the changes to the food packages.
----------------------------------------------------------------------------------------------------------------
State and Local WIC Agencies
----------------------------------------------------------------------------------------------------------------
    Annualized Monetized ($millions/year)...         n.a.         28.4         2024            7     FY2025-2029
                                                                  31.2         2024            3
----------------------------------------------------------------------------------------------------------------

    WIC food expenditures are a function of the number of 
participants receiving each food package, the cost of WIC-eligible 
food items, the quantity of WIC foods issued to each participant, 
and the percentage of WIC foods redeemed by participants (known as 
the ``redemption rate''). These estimates are summarized at the food 
category level in Table 2d, where all changes under a given food 
category (e.g., changes to quantity issued, expanded substitution 
options, and flexibility in package sizes) are collectively 
considered for their impacts on quantities redeemed and unit costs.
    The Department is allowing for an extended implementation window 
for most of the provisions in this final rule; for the purposes of 
these estimates, the Department assumes that the CVV provision will 
be fully in effect in FY 2025 and that the other provisions will be 
fully in effect beginning in FY 2026. The exact implementation 
schedule of the various provisions (except the CVV increase) is 
somewhat left to the discretion of the State agencies; it is 
possible that some State agencies will implement some provisions 
prior to FY 2026 while other State agencies will not implement at 
least some provisions until later in FY 2026 or FY 2027, but the 
Department expects these assumptions to provide an accurate estimate 
of costs across the five-year estimation period. All dollar amounts 
in all tables and text are adjusted for annual inflation, except for 
the values in Tables 2b and 2c above.
    This increase in Federal WIC food expenditures is driven by the 
increase in the CVV, which is estimated to increase WIC food 
expenditures by $5.6 billion over five years when compared to 
current CVV levels as outlined in 7 CFR 246.10. As explained above, 
however, the CVV levels proposed in this rule were recently enacted 
on a temporary basis for FY 2022, FY 2023, and FY 2024. As a result, 
when compared to the FY 2022--FY 2024 enacted food packages, the CVV 
increase made permanent in this rule would not impact Federal WIC 
expenditures. With the CVV impact zeroed out of the overall cost 
estimate for the rule, the remaining provisions are expected to 
result in a net decrease in Federal WIC food spending of $617 
million over five years when compared to the food packages as 
enacted in FY 2023.

     Table 2d--Summary of Estimated Food Costs and Savings of Rule by Food Category, FY 2025 Through FY 2029
----------------------------------------------------------------------------------------------------------------
                                                               Fiscal year (millions)
                                   -----------------------------------------------------------------------------
                                                                                                        5 Year
                                        2025         2026         2027         2028         2029        total
----------------------------------------------------------------------------------------------------------------
Cash Value Voucher (CVV)..........     $1,045.8     $1,076.4     $1,116.9     $1,155.3     $1,169.4     $5,563.8
Fish..............................          0.0         52.1         54.1         55.4         56.6        218.2
Infant Fruits and Vegetables......          0.0         28.3         29.4         30.1         30.8        118.5
Legumes...........................          0.0          3.8          4.0          4.1          4.2         16.1
Breakfast Cereal..................          0.0         -2.1         -2.2         -2.3         -2.3         -9.0
Infant Meats......................          0.0         -3.8         -4.0         -4.1         -4.1        -16.0
Whole Grains......................          0.0         -5.2         -5.4         -5.6         -5.7        -21.9
Infant Formula \a\................          0.0          1.5        -11.4        -11.7        -11.9        -33.5
Cheese............................          0.0         -8.7         -9.1         -9.3         -9.5        -36.6
Infant Cereal.....................          0.0        -23.7        -24.6        -25.2        -25.8        -99.3
Milk..............................          0.0        -28.1        -29.2        -29.9        -30.6       -117.7
Juice.............................          0.0       -152.7       -158.8       -162.4       -166.2       -640.1
Interaction of Infant Formula               0.0          0.0          1.5          1.7          1.7          4.8
 Change Across Food Packages \a\..
Eggs..............................         (**)         (**)         (**)         (**)         (**)         (**)
Fruit and Vegetables Forms and             (**)         (**)         (**)         (**)         (**)         (**)
 Varieties........................
                                   -----------------------------------------------------------------------------
    Total projected cost: compared      1,045.8        937.7        961.1        996.1      1,006.5      4,947.2
     to food packages in current
     Federal Regulations (includes
     cost of CVV) \b\.............
                                   -----------------------------------------------------------------------------

[[Page 28539]]

 
    Total projected cost: compared          0.0       -138.7       -155.8       -159.2       -162.9       -616.5
     to food packages with CVV
     increase as enacted in FY
     2022, FY 2023 and FY 2024 (no
     cost impact of CVV) \b\......
----------------------------------------------------------------------------------------------------------------
Notes:
\a\ The revisions to the amount of infant formula allowed in the partially (mostly) breastfed infant food
  package is estimated, by NASEM, to shift 5 percent of infant-mother dyads from fully formula fed to partially
  (mostly) breastfed food packages one year after implementation. The cost impact directly on infant formula
  spending is provided in the ``Infant Formula'' row. The overall cost impact of shifting infant-mother dyads
  into the partially breastfeeding food package is displayed separately as the ``Interaction of Infant Formula
  Change Across Food Packages.'' This interaction estimate reflects the increase in costs related to shifting
  postpartum participants into the more expensive partially breastfeeding food package. More details are
  provided in the cost impacts section of this analysis.
\b\ FY 2022, FY 2023, and FY 2024 appropriations bills authorized USDA to increase the CVV to a level consistent
  with NASEM recommendations, adjusted for inflation. The CVV values temporarily authorized and enacted for FY
  2022, FY 2023, and FY 2024, are the same CVV values codified in this final rule. This table provides overall
  cost estimates for the rule when comparing to the value of the permanent WIC food packages in the current
  Federal Regulations (i.e., cost of CVV included) as well as the cost estimates when comparing to the food
  packages as enacted in FY 2022, FY 2023, and FY 2024 (i.e., cost of CVV excluded).
** Provisions not estimated to have a meaningful impact on overall WIC food spending.

    The overall change in total Federal spending on WIC is 
summarized in Table 3. The Department estimates the total five-year 
Federal spending on WIC under the current food packages to be $34.9 
billion from FY 2025 through FY 2029; this estimate does not include 
the cost of the temporary increase in the CVV authorized in FY 2022, 
FY 2023, and FY 2024 (see Table 4 for comparisons to FY 2022 through 
FY 2024 enacted expenditures). The additional food costs of $4.9 
billion estimated under this rule will bring total Federal WIC 
spending, in terms of Federal transfers, up to $39.9 billion in 
total from FY 2025 through FY 2029.

                         Table 3--Total Projected Federal WIC Expenditures, FY 2025-2029
----------------------------------------------------------------------------------------------------------------
                                                               Fiscal year (millions)
                                   -----------------------------------------------------------------------------
                                        2025         2026         2027         2028         2029        Total
----------------------------------------------------------------------------------------------------------------
Total Food Expenditures...........     $4,985.8     $5,029.0     $5,233.2     $5,363.7     $5,460.4    $26,072.1
    Cost of Current Food Packages       3,940.1      4,091.2      4,272.1      4,367.5      4,453.9     21,124.8
     \a\..........................
    Cost of CVV Increase as             1,045.8      1,076.4      1,116.9      1,155.3      1,169.4      5,563.8
     enacted in FY 2022, FY 2023,
     and FY 2024 \b\..............
    Incremental Cost of Rule Other          0.0       -138.7       -155.8       -159.2       -162.9       -616.5
     than CVV Increase\ c\........
Total Nutrition Services &              2,542.7      2,666.7      2,796.7      2,886.5      2,927.2     13,819.7
 Administration Costs.............
                                   -----------------------------------------------------------------------------
    Total Federal Expenditures....      7,528.5      7,695.6      8,029.9      8,250.2      8,387.6     39,891.7
----------------------------------------------------------------------------------------------------------------
\a\ Cost of current food packages reflects total annual cost attributable to spending on foods as currently
  described in 7 CFR 246.10--which, absent any legislative adjustments to the CVV, would set CVV levels at $10
  for children and $12 for women in FY 2025.
\b\ Cost of CVV increase reflects the added cost of the CVV increase in this rule, which is equal to the CVV
  increase temporarily enacted in FY 2022, FY 2023, and FY 2024.
\c\ Incremental cost of the rule other than CVV increase reflects the net impact on Federal WIC expenditures of
  all other provisions in this rule absent the CVV increase to demonstrate how the costs would differ from the
  food packages as enacted in FY 2022, FY 2023, and FY 2024.

    In addition to the above increase in food expenditures accounted 
for in terms of Federal transfers, USDA also estimates that WIC 
State agencies and local agencies will incur an increase in 
administrative burden associated with administering and explaining 
the changes to participants (including estimated burden for State 
and local agency staff training). This additional administrative 
burden is expected to account for about $179 million in additional 
labor costs associated with the required State and local agency 
staff time over five years between FY 2025 and FY 2029. These 
administrative costs are considered allowable expenses for State 
agencies under their annually awarded Nutrition Services and 
Administration (NSA) grants. In general, USDA expects that State 
agencies will be able to absorb the costs associated with 
implementing the provisions under this rule with current NSA funds.
    The changes to the WIC food packages are expected to improve 
dietary quality by increasing intake of foods currently under-
consumed by WIC participants, specifically fruits and vegetables, 
whole grains, and seafood.\36\ Increased consumption of these foods 
is expected to increase intakes of key nutrients, including dietary 
fiber, potassium, vitamin D, vitamin A, vitamin C, folate, and 
polyunsaturated fatty acids. Dietary fiber, potassium, and vitamin 
D, considered nutrients of public health concern in the general U.S. 
population, are currently also under-consumed by WIC participants 
37 38 The changes are also expected to improve dietary 
balance by reducing amounts of foods that are currently provided in 
quantities that exceed a moderate proportion of an

[[Page 28540]]

individual's requirement for a nutrient or recommended amount of a 
food group. Although not quantified in this RIA, improved nutrition 
has the potential to improve infant, child, and maternal health 
outcomes, thereby possibly decreasing federal and societal health 
care spending and improving long-term life outcomes for 
participants.\39\
---------------------------------------------------------------------------

    \36\ Gleason, S., Hansen, D., & Wakar, B. (2021). Indicators of 
diet quality, nutrition, and health for Americans by program 
participation status, 2011-2016: WIC report. Prepared by Insight 
Policy Research, Contract No. GS-10F-0136X. Alexandria, VA: U.S. 
Department of Agriculture, Food and Nutrition Service, Office of 
Policy Support, Project Officer: Michael Burke. https://www.fns.usda.gov/wic/indicators-diet-quality-nutrition-and-health-americans-program-participation-status-2011.
    \37\ Ibid.
    \38\ Borger, C., Zimmerman, T., Vericker, T., et al. (2020). WIC 
Infant and Toddler Feeding Practices Study 2: Fourth Year Report. 
Prepared by Westat, Contract No. AG-3198-K-15-0033 and AG-3198-K-15-
0050. Alexandria, VA: U.S. Department of Agriculture, Food and 
Nutrition Service, Office of Policy Support, Project Officer: 
Courtney Paolicelli. Available online at: www.fns.usda.gov/research-and-analysis.
    \39\ See, for example, The U.S. Playbook to Address Social 
Determinates of Health by the Domestic Policy Council, Office of 
Science and Technology Policy (November 2023, available online at 
https://www.whitehouse.gov/wp-content/uploads/2023/11/SDOH-Playbook-3.pdf), and ``Review of Evidence for Health-Related Social Needs 
Interventions'' by M. Tsega et al. (July 2019, available online at 
https://www.commonwealthfund.org/sites/default/files/2019-07/COMBINED_ROI_EVIDENCE_REVIEW_7.15.19.pdf).
---------------------------------------------------------------------------

B. Baseline for Estimate of Program Expenditures

    The total projected baseline Federal cost of WIC under the 
current food package for FY 2025 through 2029 is shown in Table 4 
below. At the Federal level, WIC expenditures are broadly split 
between grants to State agencies to fund food benefits (``food 
costs'') and Nutrition Service and Administration (NSA) grants to 
fund all approved non-food expenses (``NSA costs''). As described 
later in this analysis, the Department estimates that the changes 
under this rule will result in a net increase to WIC food costs but 
will not affect the NSA costs of the Program. Table 4 provides the 
total cost of the current WIC food packages both with and without 
the CVV increase enacted in FY 2022, FY 2023, and FY 2024.
    WIC food costs are a function of the number of participants 
receiving each food package, the retail prices of WIC-eligible food 
items, the quantity of WIC foods issued to each participant, and the 
percentage of WIC foods issued that are redeemed by participants 
(known as the ``redemption rate''). The following describes how each 
of these factors are estimated for FYs 2025 through 2029 in this 
analysis.

                Table 4--Total Projected Baseline Federal WIC Expenditures, Current Food Packages
----------------------------------------------------------------------------------------------------------------
                                                               Fiscal year (millions)
                                   -----------------------------------------------------------------------------
                                        2025         2026         2027         2028         2029        Total
----------------------------------------------------------------------------------------------------------------
Total Food Expenditures...........     $4,985.8     $5,167.7     $5,389.0     $5,522.9     $5,623.3    $26,688.6
    Cost of Current Food Packages       3,940.1      4,091.2      4,272.1      4,367.5      4,453.9     21,124.8
     \a\..........................
    Cost of CVV Increase as             1,045.8      1,076.4      1,116.9      1,155.3      1,169.4      5,563.8
     enacted in FY 2022, FY 2023,
     and FY 2024 \ b\.............
                                   -----------------------------------------------------------------------------
Total Nutrition Services &              2,542.7      2,666.7      2,796.7      2,886.5      2,927.2     13,819.7
 Administration Costs.............
    Total Federal Expenditures....      7,528.5      7,834.4      8,185.7      8,409.3      8,550.4     40,508.3
----------------------------------------------------------------------------------------------------------------
Note: Figures may not sum due to rounding.
\a\ Cost of current food packages reflects total annual cost attributable to spending on foods as currently
  described in 7 CFR 246.10--which, absent any legislative adjustments to the CVV, would have set CVV levels at
  $10 for children and $12 for women in FY 2025.
\b\ Cost of CVV increase reflects the added cost of the CVV increase proposed in this rule, which is equal to
  the CVV increase enacted in FY 2022, FY 2023, and FY 2024.

Participation

    This analysis bases WIC participation projections on the latest 
trends observed through data available in November 2023. After over 
a decade of gradual declines, WIC participation increased slightly 
in FY 2022. Increases in participation have accelerated through FY 
2023; average monthly WIC participation grew to 6.57 million by the 
end of FY 2023--a 5 percent increase over the prior year. While it 
is difficult to attribute this growth to any single factor, 
increased birth rates, alongside recent investments in outreach, 
modernization, and an improved, higher valued food package, may all 
be contributing to the rise in participation.40 41 
Participation growth is expected to continue over the next few years 
before generally leveling off beginning in FY 2027 (see Table 5). 
Within each participant category, this analysis uses data from the 
WIC Participant and Program Characteristics 2018 Food Packages and 
Costs Report (WIC PC 2018 Food Costs Report) to estimate the 
distribution across specific WIC food packages, shown in Table 
5.\42\
---------------------------------------------------------------------------

    \40\ As described earlier in this analysis, Congress authorized 
an increase in the Cash Value Benefit through appropriations bills 
in FY 2022, FY 2023, and FY 2024, which significantly increased the 
value of the food package for many participants. Prior to this, 
under the American Rescue Plan Act (ARPA) in FY 2021 (Pub. L. 117-
2), the Department received additional funding and direction to 
modernize WIC and improve outreach.
    \41\ A recent qualitative study published by the American 
Academy of Pediatrics found that former WIC participants who left 
the program early cited insufficient fruit/vegetable benefits and 
inflexibility of the food benefits (regarding allergens, cultural 
appropriateness, and individual preference) as reasons for their 
exit, suggesting that this rule could help sustain the higher levels 
of participation in WIC that has been recently observed. See 
Cristina M. Gago, Jhordan O. Wynne, Maggie J. Moore, Alejandra 
Cantu-Aldana, Kelsey Vercammen, Laura Y. Zatz, Kelley May, Tina 
Andrade, Terri Mendoza, Sarah L. Stone, Josiemer Mattei, Kirsten K. 
Davison, Eric B. Rimm, Rachel Colchamiro, Erica L. Kenney; Caregiver 
Perspectives on Underutilization of WIC: A Qualitative Study. 
Pediatrics February 2022; 149 (2): e2021053889. 10.1542/peds.2021-
053889.
    \42\ U.S. Department of Agriculture, Food and Nutrition Service, 
Office of Policy Support. Special Supplemental Nutrition Program for 
Women, Infants, and Children (WIC) Participant and Program 
Characteristics 2018 Food Packages and Costs Report, by Nicole 
Kline, Kevin Meyers Mathieu, and Jeff Marr. Project Officer: Grant 
Lovellette. Alexandria, VA., November 2020. Available online at: 
https://www.fns.usda.gov/wic/participant-program-characteristics-2018-food-packages-costs-report.

                                            Table 5--WIC Participation Estimates by Category and Food Package
                                                                     [FY 2025--2029]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Fiscal year participants
                                                              Food package              ----------------------------------------------------------------
                                                                                             2025         2026         2027         2028         2029
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants........................................  ......................................    1,555,711    1,580,980    1,606,659    1,606,819    1,606,980
    FF 0-4 months..............................  I-FF-A................................      236,529      240,371      244,275      244,299      244,324
    FF 4-6 months..............................  I-FF-B................................      167,751      170,476      173,245      173,262      173,279
    BF/FF 0-1 months...........................  I-BF/FF-A.............................        8,388        8,524        8,662        8,663        8,664
    BF/FF 1-4 months...........................  I-BF/FF-B.............................       72,133       73,305       74,495       74,503       74,510
    BF/FF 4-6 months...........................  I-BF/FF-C.............................       45,293       46,028       46,776       46,781       46,785
    BF 0-4 months..............................  I-BF-A................................       63,745       64,781       65,833       65,840       65,846

[[Page 28541]]

 
    BF 4-6 months..............................  I-BF-B................................       33,550       34,095       34,649       34,652       34,656
    FF 6-11 months.............................  II-FF.................................      580,419      589,846      599,427      599,487      599,546
    BF/FF 6-11 months..........................  II-BF/FF..............................      107,361      109,104      110,877      110,888      110,899
    BF 6-11 months.............................  II-BF.................................       98,973      100,581      102,214      102,225      102,235
    FP III.....................................  III-I.................................      141,570      143,869      146,206      146,221      146,235
Children.......................................  ......................................    3,829,645    3,891,847    3,955,060    3,955,456    3,955,852
    12-23 months...............................  IV-A..................................    1,099,108    1,116,960    1,135,102    1,135,216    1,135,329
    2-4 years..................................  IV-B..................................    2,665,433    2,708,726    2,752,722    2,752,997    2,753,273
    FP III.....................................  III-IV................................       65,104       66,161       67,236       67,243       67,249
Women..........................................  ......................................    1,573,019    1,598,569    1,624,534    1,624,696    1,624,859
    Pregnant...................................  V-A *.................................      563,298      572,448      581,746      581,804      581,862
    BF/FF......................................  V-B *.................................      346,379      352,005      357,722      357,758      357,794
    Postpartum.................................  VI....................................      455,232      462,626      470,140      470,187      470,234
    BF.........................................  VII...................................      205,279      208,613      212,002      212,023      212,044
    FP III.....................................  III-V/VI/VII..........................        2,831        2,877        2,924        2,924        2,925
                                                                                        ----------------------------------------------------------------
        Total Participants.....................  ......................................    6,958,375    7,071,396    7,186,253    7,186,971    7,187,690
--------------------------------------------------------------------------------------------------------------------------------------------------------
FF = formula fed; BF/FF = partially (mostly) breastfeeding; BF = fully breastfeeding; FP = food package.
Source: Internal USDA Estimates.

Prices of WIC Foods

    Baseline unit costs for WIC food categories are estimated using 
average national retail unit cost data calculated from the 
Information Resources, Inc. (IRI) Infoscan retail dataset.\43\ 
Average per-unit costs were calculated using FY 2018 IRI Infoscan 
retail data on food categories that include WIC-eligible foods. The 
FY 2018 unit cost data are adjusted to account for inflation using 
the U.S. Bureau of Labor Statistics Consumer Price Index for Urban 
Consumers (CPI-U) with food-specific forecasts estimated by the USDA 
Economic Research Service (ERS) for FY 2019 through FY 2024.\44\ 
Inflation for all food categories is estimated for FY 2025 through 
FY 2029 using the forecast for the Thrifty Food Plan index for food 
inflation in the most recent President's Budget request.\45\
---------------------------------------------------------------------------

    \43\ More information about this dataset is available here: 
https://www.ers.usda.gov/topics/food-markets-prices/food-prices-expenditures-and-establishments/using-scanner-data/.
    \44\ ERS food-specific inflation estimates are current as of 
June 26, 2022.
    \45\ As of July 2023, OMB projects annual Thrifty Food Plan 
inflation to be around 2.30 percent annually for FY 2025-FY 2029. 
For more information, see https://www.whitehouse.gov/omb/briefing-room/2023/07/28/the-2024-mid-session-review/.
---------------------------------------------------------------------------

Quantities of WIC Foods Purchased by Program Participants

    The quantity of WIC foods purchased, or redeemed, by 
participants is estimated as the product of the Maximum Monthly 
Allowance (MMA) of each food item multiplied by the estimated 
redemption rate for that item. Baseline estimates use the MMAs under 
the current food packages while the projections for redemption under 
the food package revisions use the MMAs defined under the rule. Key 
changes to MMAs by food item under this rule are summarized above in 
Table 1. Baseline redemption rates are estimated by food category 
using 2020 redemption data that FNS collected from 48 State agencies 
(see the appendix to the RIA, Tables A-1 through A-12 for redemption 
rate estimates by food category).\46\
---------------------------------------------------------------------------

    \46\ According to internal USDA data collected in March 2021 
covering monthly WIC redemptions for all months in calendar year 
2020. Data were requested from all State agencies, but only full 
year data for 2020 were provided by 48 State agencies. While 
redemption data may not be nationally representative, the 48 State 
agencies that reported data serve about 3.48 million WIC 
participants (or around 56 percent of all WIC participants in 2020).
---------------------------------------------------------------------------

C. Food Costs and Benefits of Rule by Food Category

    The following section describes the benefits to WIC participants 
and the estimated impact on the cost of the food packages of the 
changes for each WIC food category. As described previously, all 
cost estimates are adjusted for annual inflation. Apart from the 
CVV, USDA applies NASEM's estimates of the relative impacts of the 
revisions under each food category on redemption rates and unit 
costs, where applicable. NASEM's estimates of the impacts on 
redemption rates are based on several factors, including changes to 
the amount of a food category prescribed, changes to the 
substitution options available, and changes to nutrient requirements 
that may affect participant preferences.
    In general, the most consistent impact on redemption rates was 
driven by changes in the amount of a food item prescribed in the 
revised food packages. To consider this impact, NASEM first used EBT 
data from three State agencies (Kentucky, Michigan, and Nevada) from 
a 2014 report to understand three different types of WIC redemption 
patterns: (1) full redemption, (2) partial redemption, and (3) non-
redemption.\47\ The effect of a decrease in the MMA for an item is 
not computed equally for all three groups, because one would expect 
less of a change, if any, in the redemption rate among the share of 
full redeemers and those not redeeming the food item at all. 
Therefore, NASEM used the EBT data collected in the 2014 report to 
compute what they call an ``implied redemption rate'' based on the 
relative share of partial redeemers unique to each food item and the 
amount of the MMA being reduced.\48\ Beyond the implied redemption 
rates calculated based on changes to the MMA amounts, in order to 
account for other behavioral changes, NASEM made upward or downward 
adjustments to the implied redemption rates based on changes in 
substitution options (such as allowing more yogurt to be substituted 
for milk) and product specifications (including package size 
flexibilities or whole-grain requirements). Explicit details on any 
calculations behind these adjustments are limited in NASEM's report, 
but they are generally based on assumptions of expected consumer 
behavior based on the changes--e.g., increasing substitution options 
would expand options in a particular food category and, therefore, 
is expected to make that food category more popular and increase 
redemption rates. NASEM applied these changes to redemption data 
provided by FNS for 5 unidentified State agencies, as well as to 
redemption data NASEM collected directly from 6 State agencies, in 
order to expand the representativeness of the estimates.\49\
---------------------------------------------------------------------------

    \47\ Phillips, D., Bell, L., Morgan, R., & Pooler, J. (2014). 
Transition to EBT in WIC: Review of impact and examination of 
participant redemption patterns: Final report. Retrieved from 
https://altarum.org/publications/transition-ebt-wic-review-impact-and-examination-participant-redemption-patterns.
    \48\ That is, redemption rate changes for foods were estimated 
differently depending on whether a food had a larger percentage of 
participants redeeming that food fully or partially.
    \49\ For a description of these data, see p. 933-939 of the 
NASEM report.
---------------------------------------------------------------------------

    NASEM's approach poses a few limitations. Without much of a 
precedent for

[[Page 28542]]

such changes and without the opportunity to conduct a viable pilot, 
NASEM had limited data upon which to base their redemption rate 
adjustments. Another limitation is that these estimates do not 
account for variations based on demographic groups because of a lack 
of availability of EBT redemption data matched with participant 
characteristics. While USDA acknowledges these limitations, the 
Department finds NASEM's approach to be reasonable and sufficient 
for these estimates given the lack of available data. While this 
analysis relies on NASEM's methodology to estimate the relative 
impact of the rule on redemption rates for each food item, the 
Department applies these relative impacts to a larger set of 
redemption data collected from 48 State agencies in 2020, as well as 
using the best available WIC participation, food inflation, and food 
price data as of August 2023.
    Although the food costs presented here are updated with the best 
available information and to reflect the food package revisions as 
defined in this rule, including where the Department's provisions 
differ from NASEM's recommendations, NASEM's impact analysis 
provides additional background information, analyses, and discussion 
of rationales (see Appendix U of the 2017 NASEM report, p. 869-988).

Cash Value Voucher (CVV) \50\
---------------------------------------------------------------------------

    \50\ 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.
---------------------------------------------------------------------------

Summary of Changes

     Increase CVV maximum monthly allowances for child, 
pregnant, postpartum, and breastfeeding participants.
    Consistent with the proposed rule and as supported by most 
public comments,\51\ this final rule increases to the CVV maximum 
monthly amounts reflect the amounts recommended by NASEM to provide 
approximately half of the recommended daily amounts of fruits and 
vegetables for adults and children. This change is also 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). The 
increases also reflect 2020-2025 DGA recommendations for the 
applicable life stages of WIC adult participants (postpartum, 
pregnant, and lactating) based on the average caloric needs of these 
various groups (2,000 kcal, 2,200 kcal, and 2,400 kcal, 
respectively).
---------------------------------------------------------------------------

    \51\ The only public comments that did not fully support the 
increase advocated for even higher CVV amounts than proposed by the 
Department; there were no comments opposed to the increase.
---------------------------------------------------------------------------

Context, Behavior Change, and Benefits

    Fruits and vegetables are nutrient dense and associated with a 
reduced risk of chronic diseases,\52\ including high blood 
pressure,\53\ stroke,\54\ heart disease,\55\ diabetes,\56\ and 
specific types of cancer.\57\ A recent study found that adult 
consumption of 5 servings of fruits and vegetables per day (and 
specifically 3 servings of vegetables and 2 servings of fruit) is 
associated with a decrease in the risk of premature death and death 
due to cardiovascular disease, cancer, and respiratory disease.\58\ 
In addition, studies suggest that increasing fruit and vegetable 
intakes or replacing foods of high energy density with foods of 
lower energy density, such as fruits and vegetables, can help with 
management of body weight.59 60 61 Despite the importance 
of fruits and vegetables to a healthy dietary pattern, nearly 90 
percent of the U.S. population does not meet the daily recommended 
intake of vegetables, and around 80 percent do not meet 
recommendations for fruit.\62\ A recent FNS study using 2011-2016 
National Health and Nutrition Examination Survey (NHANES) data found 
that children participating in WIC under the current regulatory food 
package reported overall inadequate intake levels for 
vegetables.\63\ The same study also found that children 
participating in WIC were less likely to consume any amount of whole 
fruits on a given day than higher income children (73 compared to 93 
percent). The DGA emphasize the importance of building a healthy 
dietary pattern in early childhood when taste preferences are 
acquired and maintaining a health dietary pattern across the 
lifespan. WIC can play an important role in supporting families to 
establish and maintain healthy dietary patterns that are rich in 
nutrient-dense fruits and vegetables.
---------------------------------------------------------------------------

    \52\ While the publications cited in this section employ a 
variety of study designs, many lean on the data available in a few 
large prospective cohort studies. These prospective cohort studies, 
such as the well-known Nurses' Health Study, are often limited to a 
predominately White and socioeconomically homogenous sample--while 
this limitation has the benefit of controlling confounding factors 
for this reason, it may also limit the generalizability of findings. 
Moreover, it is relatively rare for the cited studies to control for 
income (which presumably matters because fruits and vegetables can 
be more expensive than many other foods); as such, concern about 
omitted variable bias may be warranted. We request comment on these 
methodological issues, as well as the extent to which the relevant 
literature appropriately sets null hypotheses prior to performing 
statistical tests.
    \53\ Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, 
Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH. A 
clinical trial of the effects of dietary patterns on blood pressure. 
New England Journal of Medicine. 1997 Apr 17;336(16):1117-24.
    \54\ He FJ, Nowson CA, MacGregor GA. Fruit and vegetable 
consumption and stroke: meta-analysis of cohort studies. The Lancet. 
2006 Jan 28;367(9507):320-6.
    \55\ Hung HC, Joshipura KJ, Jiang R, Hu FB, Hunter D, Smith-
Warner SA, Colditz GA, Rosner B, Spiegelman D, Willett WC. Fruit and 
vegetable intake and risk of major chronic disease. Journal of the 
National Cancer Institute. 2004 Nov 3;96(21):1577-84.
    \56\ Muraki I, Imamura F, Manson JE, Hu FB, Willett WC, van Dam 
RM, Sun Q. Fruit consumption and risk of type 2 diabetes: results 
from three prospective longitudinal cohort studies. BMJ. 2013 Aug 
29;347:f5001.
    \57\ Wiseman M. The Second World Cancer Research Fund/American 
Institute for Cancer Research Expert Report. Food, Nutrition, 
Physical Activity, and the Prevention of Cancer: A Global 
Perspective: Nutrition Society and BAPEN Medical Symposium on 
`Nutrition support in cancer therapy'. Proceedings of the Nutrition 
Society. 2008 Aug;67(3):253-6.
    \58\ Dong D. Wang, Yanping Li, Shilpa N. Bhupathiraju, Bernard 
A. Rosner, Qi Sun, Edward L. Giovannucci, Eric B. Rimm, JoAnn E. 
Manson, Walter C. Willett, Meir J. Stampfer, Frank B. Hu. Fruit and 
Vegetable Intake and Mortality: Results From 2 Prospective Cohort 
Studies of U.S. Men and Women and a Meta-Analysis of 26 Cohort 
Studies. Circulation, 2021; DOI: 10.1161/CIRCULATIONAHA.120.048996.
    \59\ Tohill BC, Seymour J, Serdula M, Kettel-Khan L, Rolls BJ. 
What epidemiologic studies tell us about the relationship between 
fruit and vegetable consumption and body weight. Nutr Rev. 
2004;62:365-374.
    \60\ Rolls BJ, Ello-Martin JA, Tohill BC. What can intervention 
studies tell us about the relationship between fruit and vegetable 
consumption and weight management? Nutr Rev. 2004;62(1):1-17.
    \61\ Bertoia ML, Mukamal KJ, Cahill LE, Hou T, Ludwig DS, 
Mozaffarian D, Willett WC, Hu FB, Rimm EB. Changes in intake of 
fruits and vegetables and weight change in United States men and 
women followed for up to 24 years: analysis from three prospective 
cohort studies. PLoS medicine. 2015 Sep 22;12(9):e1001878.
    \62\ See 2020-2025 DGA, p. 30-32.
    \63\ Gleason, S., Hansen, D., & Wakar, B. (2021). Indicators of 
diet quality, nutrition, and health for Americans by program 
participation status, 2011-2016: WIC report. Prepared by Insight 
Policy Research, Contract No. GS-10F-0136X. Alexandria, VA: U.S. 
Department of Agriculture, Food and Nutrition Service, Office of 
Policy Support, Project Officer: Michael Burke. https://www.fns.usda.gov/wic/indicators-diet-quality-nutrition-and-health-americans-program-participation-status-2011.
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    The changes to regulations governing the CVV are expected to 
increase fruit and vegetable consumption among WIC participants by 
supporting the purchase of a greater amount and variety of fruits 
and vegetables that align with individual and cultural 
preferences.\64\ Increasing fruit and vegetable consumption would 
also increase intake of potassium and fiber, both of which USDA 
identifies in the 2020-2025 DGA as dietary components of public 
health concern for underconsumption. An increase in fruit

[[Page 28543]]

and vegetable consumption would also increase intakes of vitamin A, 
vitamin C, and folate, all of which NASEM reported at inadequate 
levels among pregnant, postpartum, and breastfeeding participants.
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    \64\ A number of state-level and/or qualitative studies point to 
increased food security and/or increased participant satisfaction 
since the increase in CVV benefits beginning under ARPA, which 
suggest a positive impact of larger CVV allowances. See, for 
example, the following studies: ``Multi-State WIC Participant 
Satisfaction Survey: Cash Value Benefit Increase During COVID'' 
(https://thewichub.org/multi-state-wic-participant-satisfaction-survey-cash-value-benefit-increasing-during-covid/); ``Increased WIC 
Benefits for Fruits and Vegetables Increases Food Security and 
Satisfaction Among California Households with Young Children'' 
(https://doi.org/10.1016/j.jand.2023.05.018); and ``California WIC 
Participants Report Favorable Impacts of the COVID-Related Increase 
to the WIC Cash Value Benefit'' (https://doi.org/10.3390/ijerph191710604).
---------------------------------------------------------------------------

    NASEM estimated that WIC participants would need to spend $24, 
$43, or $47 (adjusted for inflation to FY 2022), depending on 
participant category, to meet 50 percent of the DGA-recommended 
intakes for vegetables and fruits.\65\ This suggests that the 
current regulatory CVV levels (which would have been $9 for children 
and $11 for pregnant, postpartum, and breastfeeding individuals in 
FY 2022) only provide enough for around 19 percent and 12 percent of 
recommended fruit and vegetable intakes for these groups, 
respectively. Increasing the value of the CVV to the levels 
recommended by NASEM to meet 50 percent of the recommended fruit and 
vegetable intake is likely to increase fruit and vegetable purchases 
and consumption among WIC participants.
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    \65\ USDA notes that, although the CVV should be enough to 
provide approximately 50 percent of the DGA recommended intakes for 
fruits and vegetables on average, the exact percentage of the DGA 
that will be met for an individual participant will vary, due to 
differences in the purchasing power of the CVV in lower and higher 
food price areas.
---------------------------------------------------------------------------

    Congress temporarily authorized a four month increase in CVV 
benefits under the American Rescue Plan Act (ARPA) of 2021 (Pub. L. 
117-2).\66\ Under ARPA authority, State agencies increased the CVV 
for all food packages for child, pregnant, postpartum, and 
breastfeeding participants to $35. Following this increase, Congress 
then authorized temporary increases to the NASEM recommended CVV 
amounts in FY 2022, in FY 2023, and in FY 2024, as described above. 
Public comments received in response to the proposed rule cited 
evidence of the initial, positive impacts of these temporary 
changes, providing a preview of the likely impacts of the CVV 
increases that would be made final in this rule. A large survey of 
WIC participants across five State agencies (including one Indian 
Tribal Organization [ITO]) found that fruit and vegetable 
consumption among children participating in WIC increased by about 
0.27 cup equivalents per day (after excluding juice, legumes, and 
fried potatoes).\67\ The same survey found that 84 percent of 
respondents reported the CVV benefit level was inadequate before the 
temporary increase under ARPA, compared to only 25 percent after the 
increase. Several other commenters provided similar evidence from 
California, Colorado, Delaware, and North Carolina finding that the 
increase to the CVV was very well received by participants and was 
associated with an increase in the amount and/or variety of fruits 
and vegetables consumed.
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    \66\ WIC Policy Memorandum #2021-3: Implementation of the 
American Rescue Plan Act of 2021 (Pub. L. 117-2), ``State Agency 
Option to Temporarily Increase the Cash-Value Voucher/Benefit for 
Fruit and Vegetable Purchases.'' March 24, 2021. Available at: 
https://www.fns.usda.gov/wic/policy-memorandum-2021-3.
    \67\ Ritchie L, Lee D, Felix C, Sallack L, Chauvenet C, Machel 
G, Whaley SE. Multi-State WIC Participant Survey: Cash Value Benefit 
Increase During COVID. The National WIC Association and Nutrition 
Policy Institute, University of California Division of Agriculture 
and Natural Resources. March 2022.
---------------------------------------------------------------------------

Federal Budgetary Costs

    The increase in value of the CVV accounts for most of the 
increased Federal spending under the rule, adding around $5.6 
billion in costs over five years compared to the CVV levels as 
currently established in WIC regulations at 7 CFR 246.10. This 
estimate assumes that the redemption rate of the increased CVV will 
continue at the 2020 level (71.6 percent) and accounts for annual 
inflation adjustments.\68\ Table 6 compares the projected CVV values 
for the current and revised food packages for child, pregnant, 
postpartum, and breastfeeding participants between FY 2025 through 
2029, accounting for annual inflation and rounding down to the 
nearest whole dollar.\69\ As described earlier in this analysis, the 
CVV levels finalized in this rule were temporarily enacted in FY 
2022, FY 2023, and FY 2024. Therefore, compared to WIC food packages 
as enacted in FY 2022 through FY 2024, the changes described in this 
section would have no impact on Federal spending, but would instead 
simply codify these as the new permanent CVV levels in WIC 
regulations.
---------------------------------------------------------------------------

    \68\ See the Uncertainties section for an analysis of the cost 
impact of higher or lower redemption rates on the cost of the CVV 
increase.
    \69\ This is consistent with the requirements for inflating the 
WIC CVV as described in 7 CFR 246.16(j).
---------------------------------------------------------------------------

    The CVV cost estimates only include costs associated with the 
changes to the CVV for child, pregnant, postpartum, and 
breastfeeding participants described above. Any costs associated 
with the CVV substitution option for infants is accounted for under 
the infant fruit and vegetable estimates. Similarly, costs 
associated with the $3 CVV substitution option for juice are 
accounted for in the juice cost estimates.

                                            Table 6--Estimated Changes to CVV Amount by Participant Category
                                                                [FY 2025 through FY 2029]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             2025                2026                2027                2028                2029
         Participant category (food package)         ---------------------------------------------------------------------------------------------------
                                                        Cur.      Rev.      Cur.      Rev.      Cur.      Rev.      Cur.      Rev.      Cur.      Rev.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (IV).......................................       $10       $27       $10       $27       $11       $28       $11       $29       $11       $29
Pregnant (V-A)......................................        13        48        13        49        13        51        14        52        14        53
Partially BF (V-B)..................................        13        53        13        54        13        55        14        57        14        58
Postpartum (VI).....................................        13        48        13        49        13        51        14        52        14        53
Fully BF (VII)......................................        13        53        13        54        13        55        14        57        14        58
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
CVV = Cash-value voucher; Cur. = Current food packages; Rev. = Revised food packages.
CVV values are set using a specific rounding methodology described in 7 CFR 246.16(j) where, after adjusting for inflation annually, the benefit level
  is always rounded down to the nearest whole dollar (e.g., $24.99 would be rounded down to $24). In this analysis, the benefit levels before rounding
  down for the current food package begin in at $9.74 for children and $12.18 for pregnant, postpartum and breastfeeding individuals in FY 2024 to be
  consistent with current budget projections. The benefit levels for the revised food package begin in FY 2022 at $24, $43, and $47 and begin adjusting
  for inflation in FY 2023. Current food packages reflect the permanent CVV levels as currently set in 7 CFR 246.10. Revised food packages reflect the
  CVV levels codified in this rule, which are equal to and make permanent the temporary levels enacted starting in FY 2022, adjusted for inflation.

    To better understand how the increase to the CVV may impact CVV 
redemption rates, USDA collected CVV redemption data from nine large 
State agencies covering the period from April to August 2021, during 
the implementation of a temporary increase to CVV levels authorized 
under the American Rescue Plan Act (ARPA) of 2021 (Pub. L. 117-
2).\70\ Under ARPA authority, these State agencies increased the CVV 
for all food packages for child, pregnant, postpartum, and 
breastfeeding participants to $35. Redemption data during the months 
the increase was implemented indicate only about a 2-percentage 
point decrease in the CVV redemption rate following the 
increase.\71\ The Department assumes that this

[[Page 28544]]

2-percentage point gap would further narrow as participants become 
more accustomed to the increased CVV and as WIC staff continue to 
promote use of the increased CVV through nutrition education. Based 
on these assumptions, the Department assumes there will be no change 
in CVV redemption rates under the CVV levels in this rule. The 
Uncertainties section below includes an analysis of the cost impacts 
of either higher or lower CVV redemption rates.
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    \70\ WIC Policy Memorandum #2021-3: Implementation of the 
American Rescue Plan Act of 2021 (Pub. L. 117-2), State Agency 
Option to Temporarily Increase the Cash-Value Voucher/Benefit for 
Fruit and Vegetable Purchases. March 24, 2021. Available at: https://www.fns.usda.gov/wic/policy-memorandum-2021-3.
    \71\ Data collected from 9 State agencies indicated a 68.4 
percent CVV redemption rate during July and August 2021 under the 
temporary increase to $35 authorized by ARPA. The redemption rate 
for these months was expected to be around 70.5 percent if the CVV 
increase had not occurred, based on CVV redemption data trends in 
2020 and earlier in 2021 for these State agencies. Therefore, we 
attributed approximately a 2-percentage point decrease in CVV 
redemption rates under the $35 CVV.
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Canned Fish

Summary of Changes

     Add canned fish to food packages for children (ages 1 
through 4 years).
     Add canned fish in 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.

Context, Behavior Change, and Benefits

    The revisions add select varieties of canned fish (salmon, 
sardines, Atlantic mackerel, Chub mackerel, and light tuna) to food 
packages for children ages 1 through 4 years and for pregnant, 
postpartum and breastfeeding participants to better align the WIC 
food packages with the DGA and NASEM recommendations. The amount of 
fish offered in the revised food packages provides a supplemental 
quantity of between 17 to 69 percent of the DGA-recommended amounts, 
depending on participant category. This change represents an 
improvement over the current packages, which do not offer fish to 
child, pregnant, postpartum, or partially breastfeeding 
participants, and are consistent with the EPA-FDA advice about 
eating fish. Fish is an important dietary source of polyunsaturated 
fatty acids and other key nutrients; nutrition education will be 
important in encouraging WIC participants to redeem this under-
consumed food, choose lower sodium varieties and amounts that limit 
methylmercury exposure, preserve unused portions of canned fish 
safely, and, for child participants, select boneless canned fish or 
remove bones prior to consumption to prevent choking.

Federal Budgetary Costs

    The changes to the quantities of canned fish are expected to 
increase WIC food spending by an estimated $218 million over five 
years compared to the cost of canned fish in the current food 
packages. This estimate is based on NASEM's assumption that the 
current redemption rate for fish in the food package for fully 
breastfeeding participants, just under 44 percent in 2020, will be 
slightly lower for all food packages receiving fish under the 
revised food package. The Department estimates the redemption rate 
for fish will be around 43 percent across all food packages under 
the revisions.

Infant Fruits and Vegetables

Summary of Changes

     Reduce infant jarred fruit and vegetable amounts for 
fully breastfed infants.
     Expand allowable age range to substitute CVV for infant 
fruits and vegetables and increase substitution amounts.
    The amounts of jarred fruits and vegetables currently provided 
for fully breastfed infants far exceed what is nutritionally 
appropriate for infants. Further, fully breastfed infants do not 
have a greater need for fruits and vegetables compared to other 
infants. Thus, the reduced amounts of jarred fruits and vegetables 
for fully breastfed infants will be the same amounts currently 
provided to partially (mostly) breastfed or fully formula fed 
infants.

Context, Behavior Change, and Benefits

    NASEM found that the current food package for fully breastfed 
infants provides an excessive amount of jarred fruits and vegetables 
per day--more than one cup-equivalent, which is an amount difficult 
for infants 6 through 11 months old to consume daily. Furthermore, 
the more generous amount for fully breastfed infants was not based 
on a nutritional rationale (the DGA and the American Academy of 
Pediatrics (AAP) do not have specific recommendations for the 
quantity of fruit and vegetable consumption for this age group) but 
was recommended by the 2006 Institute of Medicine (IOM, now known as 
the National Academies of Science, Engineering, and Medicine 
(NASEM)) committee to promote full breastfeeding.\72\
---------------------------------------------------------------------------

    \72\ Institute of Medicine. 2006. WIC Food Packages: Time for a 
Change. Washington, DC: The National Academies Press. https://doi.org/10.17226/11280. P. 103.
---------------------------------------------------------------------------

    Reducing the amount of jarred infant fruits and vegetables 
provided to fully breastfeeding infants better aligns this food 
package with the concept of supplemental, particularly since fully 
breastfed infants do not have a greater need for fruits and 
vegetables than infants fed infant formula or a combination of 
infant formula and human milk.
    Expanding the age range at which infants are eligible to 
substitute CVV for infant fruits and vegetables (specifically, by 
lowering the eligible age from 9 months old to 6 months old) and 
increasing substitution amounts will provide additional choice to 
WIC participants to accommodate special dietary needs, cultural 
preferences, and personal preferences without compromising the 
nutritional integrity of the infant food packages. In addition, by 
permitting the purchase of more fruits and vegetables through the 
CVV, a parent or caretaker has the opportunity to introduce a wider 
variety and texture of fruits and vegetables (compared to the jarred 
variety) to the infant according to the infant's developmental 
readiness for textures.\73\ NASEM expects that allowing additional 
CVV substitutions for this age group will increase redemption and 
consumption of fruits and vegetables among this group of WIC 
participants.
---------------------------------------------------------------------------

    \73\ See the DGA recommendations for infants regarding 
developmental readiness for solid foods on p. 57 of the DGA 2020-
2025.
---------------------------------------------------------------------------

Federal Budgetary Costs

    Although this rule decreases the maximum monthly allowance of 
jarred infant fruits and vegetables issued to fully breastfed 
infants, the Department estimates that the changes to infant fruits 
and vegetables under this rule will result in a net increase of $119 
million in Federal WIC spending over five years. These costs are the 
cumulative costs associated with both infant jarred fruit and 
vegetable redemptions and the infant CVV substitution option (i.e., 
the infant CVV costs are reflected here and are separate from the 
costs associated with the CVV increase for child, pregnant, 
postpartum, and breastfeeding participants described above). This 
estimated increase in costs is driven by the expansion of the age 
range and amounts allowed for the CVV substitution option for jarred 
fruits and vegetables. In its report, NASEM estimates that this 
expansion of the infant CVV substitution option, coupled with the 
decrease in jarred fruits and vegetables issued to fully breastfed 
infants, will increase the redemption rate by slightly more than 27 
percent (approximately 15 percentage points, given the 53 percentage 
point baseline rate).\74\ By applying NASEM's analysis to current 
redemption rates, the Department estimates that the redemption rate 
for jarred infant fruits and vegetables will increase from just over 
53 percent in 2020 to around 68 percent under the rule.
---------------------------------------------------------------------------

    \74\ This estimate is based on a combined redemption rate for 
both redemption of infant jarred fruit and vegetables and redemption 
of the infant CVV substitution.
---------------------------------------------------------------------------

Breakfast Cereal

Summary of Changes

     Change whole grain criteria for breakfast cereals.
     Require that 75 percent of approved breakfast cereals 
in each State agency meet whole grain criteria.
     Modify existing breakfast cereal specifications to 
establish an added sugar limit rather than a total sugar limit.
    This final rule will change the criteria for whole grain 
breakfast cereals and require that 75 percent of breakfast cereals 
on a State agency's authorized food list meet the criteria for whole 
grain. This is a change from the proposed rule recommendation that 
100 percent of breakfast cereals meet the whole grain criteria. The 
provisions in this final rule are designed to promote whole grain 
consumption and to improve consistency with the Child Nutrition 
Programs (the Child and Adult Care Food Program (CACFP), the 
National School Lunch Program, and the National School Breakfast 
Program) while maintaining more flexibility than the proposed rule 
in response to concerns raised in public comments. Comments from WIC 
State agencies cited the increased burden on small vendors and the 
reduction in participant choice as primary concerns. This rule also 
finalizes a new provision based on comments regarding sugar 
specifications for breakfast cereals.
    To address inadequate consumption of whole grains and excess 
consumption of refined grains among WIC participants, NASEM 
recommended that all WIC-eligible breakfast cereals meet the 
criteria for whole grain cereal. This is also consistent with the 
DGA recommendation to shift intake from refined to whole-grain 
versions of foods to

[[Page 28545]]

increase whole grain intake. Consequently, the proposed rule 
required all WIC-authorized breakfast cereals be whole grain. The 
Department then specifically requested public comment to better 
understand the impact of the provision requiring all breakfast 
cereals to meet the whole grain criteria.
    Many stakeholders (including many State agencies) supported the 
goal of increasing whole grain consumption but cited concerns with 
the requirement that all cereals be whole grain. Some commenters 
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. Commenters also noted that this change could reduce 
participant choice for individuals with wheat or other grain 
allergies. Additionally, the Department values consistency across 
Federal nutrition programs and recognizes that in the Child 
Nutrition Programs, the majority of, but not all, grains offered in 
a school week must be whole grain rich.\75\ Therefore, recognizing 
that a healthy dietary pattern can include whole and refined grains 
in nutrient-dense forms and to support consistency across Federal 
nutrition programs, this rule codifies that 75 percent of cereals on 
a WIC State agency's authorized food list meet the whole grain 
requirement--a level recommended by public comment.
---------------------------------------------------------------------------

    \75\ See the proposed rule, ``Child Nutrition Programs: 
Revisions to Meal Patterns Consistent With the 2020 Dietary 
Guidelines for Americans,'' available online at https://www.federalregister.gov/documents/2023/02/07/2023-02102/child-nutrition-programs-revisions-to-meal-patterns-consistent-with-the-2020-dietary-guidelines-for.
---------------------------------------------------------------------------

    The Department is also switching the nutrient specifications for 
breakfast cereals in WIC food packages to be based on an added sugar 
limit, rather than a total sugar limit. This change is also 
consistent with the added sugar limits proposed for breakfast 
cereals in the Child Nutrition Programs.

Context, Behavior Change, and Benefits

    These provisions are expected to help address inadequate 
consumption of whole grains (and excess consumption of refined 
grains) among WIC participants. NASEM's analysis of NHANES data 
concluded that the consumption of whole grains by WIC participants 
was poor and that consumption of refined grains by WIC participants 
was excessive. An updated analysis of NHANES data for years 2011-
2016 confirms low intakes of whole grains among young children 
participating in WIC. On a given day, 48 percent of WIC participants 
ages 1 through 4 years consumed whole grains, whereas 82 percent 
consumed refined grains. On average, less than half of grains 
consumed were whole grains.\76\
---------------------------------------------------------------------------

    \76\ Gleason, S., Hansen, D., & Wakar, B. (2021). Indicators of 
diet quality, nutrition, and health for Americans by program 
participation status, 2011-2016: WIC report. Prepared by Insight 
Policy Research, Contract No. GS-10F-0136X. Alexandria, VA: U.S. 
Department of Agriculture, Food and Nutrition Service, Office of 
Policy Support, Project Officer: Michael Burke. https://www.fns.usda.gov/wic/indicators-diet-quality-nutrition-and-health-americans-program-participation-status-2011.
---------------------------------------------------------------------------

    The DGA recommend that at least half of grain intake consist of 
whole grains, as whole grains are nutrient-dense and contribute more 
fiber to a healthy diet than refined grains, but according to the 
DGA, 98 percent of Americans fail to eat enough whole grains, and 74 
percent of Americans consume too many refined grains.
    Although the final rule does not fully implement NASEM's 
recommendation that all breakfast cereals meet the whole grain 
criteria, the final provision is still expected to promote whole 
grain consumption, while continuing to provide access to other key 
nutrients (e.g., iron, folate) in forms that accommodate special 
dietary needs and allow for participant choice.

Federal Budgetary Costs

    While the maximum monthly allowances for breakfast cereal will 
not change under the rule, the Department estimates that the 
revisions to whole grain requirements for cereal will decrease costs 
by approximately $9 million over five years. The decrease in cost is 
driven by the estimated impact of these changes on redemption rates. 
NASEM estimated that the originally proposed changes (i.e., to 
require that 100 percent of breakfast cereals meet the whole grain 
criteria) would decrease redemption rates by 10 percent, based on 
the reduction in allowable cereal options and its analysis showing 
that whole grain cereals are slightly less preferred by participants 
in some States.\77\ By applying NASEM's findings, and reducing 
NASEM's projected impact on redemption rates in half to reflect the 
final provision of requiring 75 percent of cereals meet the whole 
grain requirements rather than 100 percent as NASEM proposed, the 
Department estimates that the redemption rates across all food 
packages for breakfast cereals will decrease by 5 percent--which 
represents about a 2 percentage point decrease from the baseline of 
48 percent to 46 percent under the revised food packages. This 
estimate also accounts for a slight increase in unit costs. NASEM 
estimates that the changes will increase the unit cost of breakfast 
cereals in the WIC food packages by about 9 percent. Again, reducing 
NASEM's projection in half to reflect the final rule, the Department 
estimates that, starting in FY 2025, unit costs for cereal under the 
rule will rise by $0.01 per ounce (from $0.24 to $0.25 per ounce), 
after adjusting for inflation.
---------------------------------------------------------------------------

    \77\ While the NASEM Report acknowledges the increasing market 
availability of allowable cereal options, the actual impact on 
redemption rates of breakfast cereals may vary slightly as the 
market has continued to evolve in the years since NASEM's analysis.
---------------------------------------------------------------------------

Infant Formula

Summary of Changes

     Increase infant formula amounts in the first month for 
partially breastfed infants.
     Allow all prescribed infant formula quantities to be 
considered ``up to'' amounts.
    As recommended by NASEM, the rule increases maximum monthly 
infant formula amounts in the first month for partially (mostly) 
breasted infants from 104 fluid ounces to up to 364 fluid ounces. 
Consistent with current requirements, the amount of formula provided 
would be tailored based on an individual nutrition and breastfeeding 
assessment and would not exceed the maximum 364 fluid ounces per 
month. Tailored issuance of formula in the first month, and 
nutrition and breastfeeding education and support from WIC staff, 
not only maximizes the potential for women to achieve exclusive 
breastfeeding goals, but also to achieve successful partial 
breastfeeding when exclusive breastfeeding is not possible or 
desired.

Context, Behavior Change, and Benefits

    This provision increases the maximum monthly infant formula 
amount in the first month of life for partially (mostly) breastfed 
infants, consistent with NASEM's recommendations. As NASEM notes, 
while current regulations intend to encourage participants who 
initiate breastfeeding to do so exclusively, the current approach 
may cause infants who need more than 104 fluid ounces of formula in 
the first month to be prematurely categorized as fully formula fed 
(and the mother as ``postpartum'') in order to obtain additional 
formula from the Program.
    Breastfeeding is associated with several improved health 
outcomes for both infants and breastfeeding mothers. Individuals who 
breastfeed have a reduced risk of breast and ovarian cancer, 
hypertension, and type 2 diabetes, and their infants have a lower 
risk of asthma, Type-1 diabetes, sudden infant death syndrome 
(SIDS), and gastrointestinal, ear, and lower respiratory 
infections.\78\
---------------------------------------------------------------------------

    \78\ For a review of recent scientific literature on 
breastfeeding and maternal health outcomes, see https://effectivehealthcare.ahrq.gov/sites/default/files/cer-210-breastfeeding-summary.pdf. For evidence on breastfeeding and infant 
outcomes, see Ip S, Chung M, Raman G, et al; Tufts-New England 
Medical Center Evidence-based Practice Center. Breastfeeding and 
maternal and infant health outcomes in developed countries. Evid Rep 
Technol Assess (Full Rep). 2007;153(153):1-186 and American Academy 
of Pediatrics. Breastfeeding and the Use of Human Milk. Pediatrics 
2017;129(3):e827-e841.
---------------------------------------------------------------------------

    The change will increase participant flexibility and provide 
better support for any amount of breastfeeding during the first 
month by providing partially (mostly) breastfeeding infants any 
amount of formula (up to the maximum 364 fluid ounces allowed) to 
support the participant's desired level of breastfeeding. It is 
possible that this provision may extend the duration of 
breastfeeding for some mothers who were previously categorized as 
``postpartum'' prematurely and discontinued breastfeeding. NASEM 
specifically estimates that this increase to the infant formula 
amounts allowed during the first month of an infant's life will 
result in a 5 percent shift in infant-mother dyads moving from the 
fully formula feeding to partially (mostly) breastfeeding food 
packages after the first year of implementation. Public comments 
echoed this assessment, noting that this change would encourage 
breastfeeding and help participants achieve their breastfeeding 
goals.

[[Page 28546]]

    The change to consider all formula quantities to be issued as 
``up to'' amounts will encourage and enable WIC staff to assess the 
actual formula needs of participants and tailor the quantities of 
infant formula provided accordingly. This change, as recommended by 
NASEM, is intended to reduce interference with the successful 
establishment of the mother's desired breastfeeding behavior while 
appropriately issuing formula amounts that meet infants' nutritional 
needs.

Federal Budgetary Costs

    By increasing the amount of infant formula allowed in the first 
month of life for partially breastfed infants, the Department 
assumes a shift of 5 percent of fully formula fed infants into the 
partially breastfed infant category after one full year of 
implementation, based on NASEM's analysis.\79\ Because the partially 
breastfed infant food packages are less costly than the fully 
breastfed infant food packages, this shift will result in an 
estimated decrease of around $34 million in total Federal spending 
on infant formula in the WIC food packages over five years.
---------------------------------------------------------------------------

    \79\ From the NASEM RIA (p. 973): ``A key assumption of the 
primary analysis is that, under the proposed revisions, 5 percent of 
fully formula-fed mother-infant dyads will shift to corresponding 
fully (mostly) breastfeeding food packages. The committee considered 
the 5 percent shift conservative, given evidence that the 2009 food 
package, which allowed women to either choose between formula-
feeding or fully breastfeeding in the infant's first month of life, 
resulted in an approximately 7 to 11 percent shift of dyads from 
breastfeeding to formula-feeding.''
---------------------------------------------------------------------------

    The revised amounts of infant formula prescribed under this rule 
are also estimated to impact spending in other food categories. As 
described above, NASEM estimates these changes will result in a 5 
percent shift of fully formula fed infants into the partially 
breastfed infant category. This corresponds with a shift of 5 
percent of participants from the postpartum food package (VI) 
category into the partially breastfeeding category (V-B). In this 
analysis, the Department estimates the impact of this shift in 
participant categories separately from the other food-specific cost 
estimates (e.g., the cost estimate provided in Table 2d for the CVV 
does not take this interaction into account), to account for the 
discrete impacts of each. In total, the shift of 5 percent of 
participants from the postpartum food package to the partially 
breastfeeding food package is estimated to increase WIC food costs 
by $5 million over five years. These changes are accounted for by 
calculating the difference in spending between the slightly more 
expensive food package V-B compared to food package VI resulting 
from the 5 percent shift in participants from the postpartum to 
partially breastfeeding category.
    Revising the regulatory language to permit formula quantities 
prescribed as ``up to'' amounts rather than only setting a minimum 
amount for full nutrition benefit is not projected by NASEM to have 
a significant impact on the cost of the food packages. While the 
effect on cost is expected to be minimal, the impact of this 
provision will ultimately depend upon the extent to which it is 
used--both in terms of how frequently formula quantities are 
tailored and the extent to which tailoring formula amounts changes 
the quantities prescribed.

Whole Wheat/Whole Grain Bread and Other Whole Grain Options

Summary of Changes

     Increase whole wheat/whole grain bread and other whole 
grain option amounts for pregnant, postpartum and breastfeeding 
individuals, reduce amounts for children, and revise specifications 
for package sizes.
     Require that whole grain breads contain at least 50 
percent whole grains.
     Expand whole grain options.

Context, Behavior Change, and Benefits

    The revisions largely reflect NASEM's recommendations and will 
provide whole wheat bread, whole grain bread, and whole grain 
options in supplemental amounts that better align with the DGA, 
particularly for women. The DGA recommend that at least half of 
grain intake consist of whole grains, as whole grains are nutrient-
dense and contribute more fiber to a healthy diet than refined 
grains, but according to the DGA, 98 percent of Americans fail to 
eat enough whole grains, and 74 percent of Americans consume too 
many refined grains.
    The reduced amount for children represents the upper end of 
NASEM's recommended range of 16 to 24 ounces and will provide 27 to 
53 percent of DGA recommended amounts, better aligning the 
children's food packages with the supplemental nature of the food 
packages.
    The increased amount for pregnant, postpartum, and breastfeeding 
participants exceeds NASEM's recommended amount (24 ounces). 
Specifically, the Department's amount will provide 40 to 53 percent 
of the DGA recommended whole grain amounts, while the amount 
recommended by NASEM would provide 13 to 27 percent. The increased 
amount will provide and encourage consumption of whole grains, 
consistent with the DGA and in quantities closer to NASEM's 
definition of a supplemental amount. The changes also better align 
the Program with common package sizes found in the marketplace.
    Changing the allowable package sizes will increase the whole 
wheat/whole grain bread choices available for State agencies to 
authorize as WIC-eligible, thereby increasing choice for 
participants. When WIC adopted the 16-ounce bread size, very few 
products on the market adhered to this specification, which required 
manufacturers to produce a relatively limited number of products 
sized specifically for WIC; consequently, WIC participants had 
relatively few choices among different types of WIC-approved breads. 
Although this availability has become less of a problem since the 
implementation of the 2009 WIC food package revisions, far more 
whole wheat/whole grain breads available in the marketplace still 
come in either a 20-ounce or 24-ounce package size as compared to a 
16-ounce package size.\80\ Therefore, allowing State agencies to 
authorize 20- and 24-ounce bread package sizes will decrease burden 
on participants, increase product availability, and likely promote 
intake of whole grains, if participants are able to select whole 
grain products that more closely align with their personal or 
cultural preferences. This change may also decrease burden on small 
vendors who have experienced difficulty stocking the 16-ounce 
package size currently required by WIC.
---------------------------------------------------------------------------

    \80\ According to an ERS analysis, in 2015, 16 oz while grain 
bread packages had a market share of 17 percent, while 20 and 24 oz 
whole grain bread package had market shares of 29 and 28 percent, 
respectively. For more information, see: https://www.ers.usda.gov/amber-waves/2020/april/usda-approved-whole-wheat-bread-package-size-is-now-more-common-and-less-costly-for-the-special-supplemental-nutrition-program-for-women-infants-and-children-wic/.
---------------------------------------------------------------------------

    Finally, the expansion of whole grain options is responsive to 
participant requests for more choices for bread substitutions, while 
still providing priority nutrients, and is intended to increase 
whole grain consumption by offering a greater variety of grains to 
WIC participants.

Federal Budgetary Costs

    The revisions under the whole wheat bread, whole grain bread, 
and other whole grain options contribute to both costs and savings 
under the rule. Overall, these changes result in an estimated 
decrease of about $22 million in food costs over five years.
    NASEM estimates that expanding the number of allowable 
substitution options and providing greater flexibility in package 
sizes would increase the overall redemption rate for whole grains by 
around 13 percent. The rule differs from NASEM's recommendation to 
allow a specific range of package sizes under this category and 
instead allows 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. Despite this variation, the effect on 
redemption rates is expected to be consistent with NASEM's 
projections. By applying NASEM's projections to current rates, the 
Department estimates the rule will increase redemption rates for 
whole wheat bread, whole grain bread, and other whole grain options 
from 44 percent in 2020 to nearly 50 percent after implementation of 
the rule. The increase in the maximum monthly allowance for 
pregnant, postpartum, and breastfeeding participants from 16 ounces 
to 48 ounces is also expected to increase overall food costs 
associated with whole grains in the pregnant, postpartum, and 
breastfeeding food packages.
    The increases in costs described above are more than offset by 
the estimated decrease in unit costs for whole grain products in all 
food packages and the decrease in the maximum monthly allowance of 
whole grains in the food packages for children from 32 ounces to 24 
ounces. In its report, NASEM estimates the cost of 16 ounces of 
whole wheat bread to be $2.35 under the current food package. To 
account for allowing 24-ounce package sizes in the revised food 
package and the addition of alternative whole grain substitutions, 
NASEM computes a composite cost of $2.67 for 24 ounces of whole 
grain products under the revised food

[[Page 28547]]

package.\81\ On a per ounce basis, NASEM's projections amount to a 
24.4 percent decrease in the unit cost of whole grains in the 
revised food package (from $0.147 per ounce in 16-ounce packages to 
$0.111 per ounce in 24-ounce packages). Allowing State agencies the 
option to authorize other intact whole grain options that meet 
specifications defined in regulations, in response to public 
comment, is not expected to significantly impact redemption or costs 
beyond the impacts described above associated with the list of 
products already considered in the proposed rule.
---------------------------------------------------------------------------

    \81\ NASEM's composite cost for whole grain products is weighted 
to 0.76 for whole wheat bread, 0.19 for corn tortillas, and 0.06 for 
oatmeal based on available redemption data from selected States.
---------------------------------------------------------------------------

Cheese

Summary of Changes

     Remove cheese as a food category for fully 
breastfeeding participants to better align with the DGA.
    As recommended by NASEM, this rule removes cheese as a separate 
food category for fully breastfeeding participants (Food Package 
VII). This change aligns with the DGA recommendation for reducing 
saturated fat consumption.

Context, Behavior Change, and Benefits

    Removing cheese as a separate food category for fully 
breastfeeding participants aligns with the DGA recommendation for 
reducing saturated fat consumption. However, cheese remains a milk 
substitution option in the food packages for child, pregnant, 
postpartum, and breastfeeding participants, meaning that cheese can 
be substituted for a portion of the maximum monthly allowance of 
milk. Even with the removal of the standalone cheese category, fully 
breastfeeding participants would still be able to receive two pounds 
of cheese as a partial substitute for milk.

Federal Budgetary Costs

    Removing cheese as a standalone food category is estimated to 
decrease WIC food costs by $37 million over five years.

Infant Meats

Summary of Changes

     Reduce infant meats amounts to better align with AAP 
recommendations.

Context, Behavior Change, and Benefits

    This provision reduces the maximum monthly allowance of infant 
meat for fully breastfed infants from 77.5 to 40.0 ounces. The NASEM 
committee found that the current food package II-BF provides fully 
breastfed infants with approximately 130 percent of the maximum 
amount of infant meat recommended by the AAP. The Committee also 
found that the redemption rate for infant meat, an important source 
of heme iron and zinc for fully breastfed infants, was only about 20 
percent. The rule reduces the amount of infant meat provided to a 
level representing approximately 65 percent of the AAP recommended 
maximum amount. This revision better aligns with the concept of 
providing a supplemental amount of infant meat to fully 
breastfeeding infants.

Federal Budgetary Costs

    Reducing the maximum monthly allowance of infant meats in the 
fully breastfed 6 through 11-month-old infant food package is 
estimated to reduce WIC food costs by $16 million over 5 years. 
NASEM estimates that reducing the quantity of infant meats 
prescribed to fully breastfed infants will increase the overall 
redemption rate--this is largely based on the assumption that when a 
smaller amount is prescribed, a larger proportion of that amount 
will be redeemed by partial redeemers. Applying NASEM's estimates, 
this cost savings assumes a 39 percent increase in the redemption 
rate of infant meats--increasing from around 23 percent in 2020 to 
32 percent under the rule.

Infant Cereal

Summary of Changes

     Reduce infant cereal amounts for all infants to better 
align with AAP recommendations.

Context, Behavior Change, and Benefits

    This provision reduces the maximum monthly allowance of infant 
cereal to fully breastfed infants from 24 to 16 ounces. For 
partially breastfed and fully formula fed infants, the amount is 
reduced from 24 to 8 ounces. The NASEM committee found that the 
current food packages provide approximately 150 percent of the 
maximum amount of infant cereal recommended by the AAP. The 
revisions better align with AAP recommendations for fully breastfed 
infants and with the Program's intent to provide supplemental 
amounts of food for all other infants. The revised infant cereal 
quantities will provide approximately 100 percent of the AAP-
recommended amount for fully breastfeeding infants because fortified 
infant cereal is an important source of the iron and zinc that fully 
breastfed infants need from a commentary food source starting at age 
6 months. The revised quantities will provide 50 percent of the AAP 
recommended amount for partially (mostly) breastfed and fully 
formula fed infants.

Federal Budgetary Costs

    Reducing infant cereals in all infant food packages is estimated 
to reduce WIC food costs by around $99 million over five years. 
NASEM estimates the reduction in the maximum monthly allowance of 
infant cereals will result in a 21 percent increase in the 
redemption rate. Applying NASEM's projections, the Department 
estimates that the redemption rate for infant cereals across all 
infant food packages will increase from 43 percent in 2020 to 53 
percent under the rule.

Milk

Summary of Changes:

     Reduce the amount of milk provided in all child, 
pregnant, postpartum, and breastfeeding participant food packages to 
better align with the DGA.
     Require authorization of unflavored lactose-free milk.
     Permit only unflavored milk and reduce the added sugars 
allowed in yogurt and plant-based milk alternatives and substitutes.
     Add calcium specifications for tofu and vitamin D 
specifications for yogurt.
     Increase yogurt substitution amounts.
     Add plant-based substitution options for milk.
     Update the FDA standards of identity citations for 
yogurt.
     Allow reduced-fat yogurts for 1 year-old children 
without restrictions.
    The revised quantities reflect NASEM recommendations, are more 
consistent with the supplemental nature of the Program and are 
consistent with nutrition education messages to consume 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.

Context, Behavior Change, and Benefits

    The revisions to reduce the amount of milk prescribed to WIC 
participants, as recommended by NASEM, will better align the food 
packages with the supplemental nature of the Program. The current 
food packages provide 85 to 128 percent of the DGA recommendations 
for dairy products. The revision recommended by NASEM and finalized 
in this rule will provide 71 to 96 percent of the amounts 
recommended by DGA. Furthermore, the revised quantities are more 
consistent with nutrition education messages to consume a balanced 
diet that meets, but does not exceed, recommended amounts of food to 
prevent excess weight gain and displacement of other foods that 
provide key nutrients.
    The revisions to the substitution options improve participant 
choice and promote equity in accessing key WIC benefits for 
participants with dietary restrictions and allergies, while ensuring 
that substitution options meet key nutrient specifications. The 
option for substitution of 2 quarts of yogurt in place of 2 quarts 
of milk may improve intakes for participants who prefer dairy in 
this form.
    The final rule will require that all State agencies authorize 
lactose-free milk as a substation available to participants.\82\ In 
addition, the rule allows State agencies the option to authorize 
additional fortified plant-based milk alternative options (other 
than soy, e.g., oat, almond). The rule will also allow State 
agencies the option to permit plant-based yogurt and cheese 
substitution options that meet the established nutrient 
specifications. These options are intended to provide participants 
with flexibility to select substitutions that better accommodate 
special dietary needs as well as cultural and personal preferences 
while still providing critical nutrients.
---------------------------------------------------------------------------

    \82\ Although currently an option (not a requirement), all 
States and most ITOs already authorize some kind of lactose-free 
milk, and, therefore, the Department does not estimate an additional 
cost attributable to this requirement.
---------------------------------------------------------------------------

    The rule allows only unflavored milk and specifies limits on 
added sugar for yogurt and plant-based milk alternatives to better 
align the WIC food package with the DGA, which emphasize nutrient 
dense foods and beverages that provide vitamins, minerals, and other 
health-promoting components with little or no added sugars. As noted 
in the DGA, nutrient dense foods are particularly

[[Page 28548]]

important during the first two years of life when nutrient 
requirements are high relative to body size, leaving virtually no 
room for added sugars in the diet. The DGA also recommend that 
beverages with no added sugars be the primary choice for children to 
assist in the establishment of healthy food choices early in life. 
The revisions align with CACFP provision of milks to children less 
than 5 years of age.

Federal Budgetary Costs

    Reducing the maximum monthly allowance of milk and making the 
other policy changes as described is estimated to reduce WIC food 
costs by $118 million over five years, representing a 2 percent 
decrease of the estimated $4.94 billion that would have been spent 
from FY 2025-2029 on milk products in the absence of this rule (milk 
spending is now estimated to be $4.82 billion from FY 2025-2029 
under this rule).
    The decrease in costs is driven by the decrease in the maximum 
monthly allowance for milk in most food packages under the rule. The 
savings associated with the reduction in milk quantities are 
expected to be partially offset by the changes to milk substitution 
options (including the increase in the amount of yogurt available 
for substitution), which are expected to increase both redemption 
rates and the composite unit cost of milk and milk alternatives. To 
estimate a composite unit cost for milk redemptions that considers 
the combined costs of redeeming milk amounts for fluid milk, cheese, 
and yogurt, this analysis derives a composite unit cost for milk 
redemptions using the same approach that NASEM applies in its report 
and updates NASEM's model with WIC unit cost data for whole and 
reduced-fat milk (accounting for lactose-free and plant-based 
substitutions, see Table 7 notes below), cheese, and yogurt from the 
WIC PC 2018 Food Costs Report. NASEM's composite milk cost model 
represents ``high-cost'' substitution scenarios, within allowable 
substitution limits for cheese and yogurt, across food packages for 
child, pregnant, postpartum, and breastfeeding participants. The 
Department applies current unit cost estimates to this model, 
maintaining NASEM's substitution scenarios, and finds that, 
consistent with NASEM, revisions under the rule are expected to 
increase the composite unit cost for the milk category across all 
food packages, as shown below in Table 7. The increase in this 
composite unit cost reflects an expected shift towards an increase 
in the proportion of milk that is substituted for yogurt. The 
increase in yogurt redemptions, relative to milk, is the combined 
result of three factors: (1) reduction in quantity of milk in most 
food packages, (2) an increase in the amount of yogurt that 
participants are allowed to substitute for milk, and (3) increased 
flexibility in allowable yogurt package sizes.
    Cost estimates for milk also apply NASEM's assumptions about the 
impact of the revisions on redemption rates. NASEM estimates that 
the revisions under their proposal, particularly the additional 
amount of yogurt authorized for substitution, is expected to 
increase redemption rates across all food packages (see the appendix 
to the RIA, Table A-10 for detailed redemption rates).

        Table 7--Composite Unit Price for Milk and Milk Alternatives in Current and Revised Food Packages
----------------------------------------------------------------------------------------------------------------
                                             Current                                    Revised
                          --------------------------------------------------------------------------------------
       Food package          MMA                           Composite     MMA                          Composite
                             (qt)   Substitution scheme   cost ($/qt)    (qt)   Substitution scheme  cost ($/qt)
----------------------------------------------------------------------------------------------------------------
IV-A.....................       16  12 qt milk + 1 lb           1.13        12  8 qt milk + 1 lb            1.21
                                     cheese + 1 qt                               cheese + 1 qt
                                     yogurt.                                     yogurt.
IV-B.....................       16  12 qt milk + 1 lb           1.08        14  11 qt milk + 0.5 lb         1.11
                                     cheese + 1 qt                               cheese + 1.5 qt
                                     yogurt.                                     yogurt.
V-A......................       22  18 qt milk + 1 lb           1.01        16  13 qt milk + 0.5 lb         1.08
                                     cheese + 1 qt                               cheese + 1.5 qt
                                     yogurt.                                     yogurt.
V-B......................       22  18 qt milk + 1 lb           1.01        16  13 qt milk + 0.5 lb         1.08
                                     cheese + 1 qt                               cheese + 1.5 qt
                                     yogurt.                                     yogurt.
VI.......................       16  12 qt milk + 1 lb           1.08        16  13 qt milk + 0.5 lb         1.07
                                     cheese + 1 qt                               cheese + 1.5 qt
                                     yogurt.                                     yogurt.
VII......................       24  19 qt milk + 1 lb           1.00        16  12 qt milk + 1 lb           1.09
                                     cheese + 1 qt                               cheese + 1 qt
                                     yogurt.                                     yogurt.
----------------------------------------------------------------------------------------------------------------
Notes: Unit costs for milk come from the FY 2018 IRI Infoscan retail dataset and already account for the price
  of lactose-free milk. Adjustments to the unit cost for milk are also adjusted to account for substitutions of
  soy beverages based on data published in the 2018 WIC PC Food Costs report, applying weights of 0.979 to whole
  milk and 0.021 to soy beverages for food package IV-A, 0.971 to reduced fat milk and 0.029 to soy beverages in
  food package IV-B, 0.966 for milk and 0.034 for soy in food package V, 0.972 for milk and 0.028 for soy in
  food package VI, and 0.959 for milk and 0.041 for soy in food package VII. Baseline, unweighted unit costs in
  2018 (per ounce) were $0.027 for whole milk, $0.025 for reduced-fat milk, $0.053 for soy beverages, $0.088 for
  yogurt, and $0.292 for cheese (Source: IRI Infoscan dataset analysis). Weighted unit costs for lactose-free
  milk are incorporated into the unit cost estimates for whole milk and reduced-fat milk.
Table adapted from NASEM Report (Appendix U, p. 950-955).

    As of FY 2015 (the most recent data available), flavored milk 
was only authorized by three States and 14 Indian Tribal 
Organizations--collectively covering only around 3 percent of total 
WIC participants. As a result, the provision to no longer allow 
flavored milk is not expected to have a significant impact on 
overall costs or redemptions because this only represents a policy 
change for a small proportion of participants.
    While this final rule adds additional plant-based milk 
substitution options, these options are not expected to have a 
significant impact on costs. It is expected that the vast majority 
of participants opting for the newly added plant-based milk 
alternatives (such as oat and almond milk) would have otherwise 
elected for the existing, similarly priced soy-based beverage or 
lactose-free milk options under the current food packages. While 
these options do importantly provide a new pathway for participants 
with concurrent soy and dairy allergies to access their full WIC 
benefits in this category, the coexistence of soy and dairy 
allergies is relatively rare, and any additional redemption of 
benefits under this accommodation would not be significant from a 
cost perspective.\83\
---------------------------------------------------------------------------

    \83\ Prevalence of soy allergy alone is estimated to be about 
0.27 percent of the general population. See: Katz, Y., Gutierrez-
Castrellon, P., Gonz[aacute]lez, M. G., Rivas, R., Lee, B. W., & 
Alarcon, P. (2014). A comprehensive review of sensitization and 
allergy to soy-based products. Clinical reviews in allergy & 
immunology, 46(3), 272-281. https://doi.org/10.1007/s12016-013-8404-9.
---------------------------------------------------------------------------

Juice

Summary of Changes

     Reduce juice amounts for child, pregnant, postpartum, 
and breastfeeding participants.
     Allow CVV juice substitution.

Context, Behavior Change, and Benefits

    The reduction of juice in food packages for child, pregnant, 
postpartum, and breastfeeding participants better aligns the food 
packages with the latest dietary guidance and with the supplemental 
intent of the Program. The current food packages provide between 96 
and 144 fluid ounces (depending on participant category), or 40 to 
107 percent of DGA-recommended limits for juice. The reduced 
quantities will provide

[[Page 28549]]

approximately 26 to 53 percent of DGA-recommended limits.
    The DGA emphasize the consumption of whole forms of fruits and 
vegetables over juice. While the DGA include 100 percent juice as 
part of the fruit and vegetable food category, it emphasizes whole 
fruit and a variety of vegetables from all subgroups, it places 
limits on juice amounts that should contribute towards an overall 
dietary pattern, and juice is not a recommended food. Also, juice is 
neither a separate food category nor a subgroup (like dark-green 
vegetables) in the dietary patterns that Americans should consume 
each day.
    As noted by the NASEM committee, the AAP recommends that most 
fruit intake should be from whole fruit because whole fruit also 
contributes fiber and other important plant-based compounds that are 
removed during fruit juice processing.
    The option for CVV substitution of juice aligns with both the 
AAP and DGA recommendations and provides additional flexibility to 
WIC participants by allowing them to select from options that may 
better meet their special dietary needs, cultural needs, and 
personal preferences. These changes will likely increase the 
consumption of whole fruits and vegetables among participants that 
prefer this substitution over juice.
    All juice offered through the WIC food packages will be 64 fluid 
ounces, potentially decreasing vendor burden by streamlining options 
across food packages.

Federal Budgetary Costs

    The reduction of juice in all food packages accounts for an 
estimated net decrease of $640 million in WIC food costs over five 
years. This estimate also accounts for an expected increase in the 
redemption rate of the juice benefit as a result of the added $3 CVV 
juice substitution option, which slightly offsets cost savings. 
Specifically, NASEM estimates that the CVV substitution, combined 
with the overall decrease in amounts of juice issued, will increase 
the redemption rate of juice by about 13 percent. Applying NASEM's 
estimate to current rates, the Department estimates that redemption 
rates for juice, including the $3 CVV juice substitution, will 
increase from 63 percent in 2020 to 71 percent under the rule. Like 
the estimates for infant jarred fruit and vegetable redemptions, the 
estimated redemption rate for juice in the revised food packages 
accounts for both redemption of juice and redemption of the $3 CVV 
substitution for juice.

Legumes and Eggs

Summary of Changes

     Require both dry and canned legumes be allowed.
     Add required and optional substitution options for 
eggs.
     Add optional substitution options for peanut butter.

Context, Behavior Change, and Benefits

    As recommended by NASEM, this rule will require State agencies 
to authorize dried and canned legumes. Currently only dried legumes 
are required, and it is a State agency option to allow canned 
legumes. The NASEM committee noted that consumption of legumes, a 
source of fiber, protein, B vitamins, iron, zinc, and other 
nutrients, was below recommended amounts across WIC participant 
subgroups. To help address under-consumption of this nutrient-rich 
food, this provision will require State agencies to authorize both 
dried and canned legumes for WIC participants. State agencies are 
currently only required to authorize dried legumes, and allowing 
canned legumes is a State agency option.\84\ Requiring canned 
legumes will reduce burden for those participants who currently do 
not have access to canned legumes and who do not have the time or 
ability to prepare dried legumes.
---------------------------------------------------------------------------

    \84\ According to the 2015 WIC Food Packages Policy Options 
report, 85 percent of State agencies authorized canned legumes in FY 
2015. For more information, see: Thorn, B., Huret, N., Bellows, D., 
Ayo, E., Myers, R., & Wilcox-Cook, E. (2015). WIC Food Packages 
Policy Options Study II. Project Officer: Grant Lovellette. 
Alexandria, VA: U.S. Department of Agriculture, Food and Nutrition 
Service, Office of Policy Support. Available online at: https://www.fns.usda.gov/wic/wic-food-package-policy-options-ii.
---------------------------------------------------------------------------

    Based on NASEM's recommendations, with modification, the final 
rule requires that State agencies allow the substitution of eggs 
with legumes or peanut butter when individually tailoring food 
packages. The rule also allows State agencies the option to 
authorize tofu as a substitute for eggs. Like eggs, legumes and 
peanut butter (to a lesser extent) are sources of choline, and both 
are sources of iron. Given iron's role in growth and development, 
the prevalence of inadequate intake among the WIC population, and 
the health consequences of inadequate intake, offering foods with 
iron is critical to WIC participants' health.
    In addition, peanut butter and legumes are required foods in the 
food packages; therefore, the Department anticipates no additional 
administrative effort related to identifying and authorizing these 
foods as substitutes for eggs. Requiring peanut butter and legumes 
as substitutes for eggs is nutritionally appropriate, will not 
result in increased administrative burden, and increases equity in 
program delivery.
    The rule also allows State agencies the option to authorize tofu 
as a substitute for eggs. Similar to eggs, tofu is a source of 
choline. Appropriate food package tailoring and nutrition education 
will need to address other food sources of iron, especially for 
participants determined to have low iron levels.
    A new provision in the final rule allows State agencies the 
option to authorize nut and seed butters as an alternative to peanut 
butter when individually tailoring food packages for children and 
women for nutrition reasons (e.g., special dietary needs, 
underweight, and cultural food preferences). While NASEM did not 
recommend alternative nut and seed butter substitutions, comments 
overwhelmingly supported allowing nut and seed butters as 
alternatives to peanut butter. This added choice will allow 
participants with peanut allergies the ability to receive 
nutritionally appropriate alternatives to peanut butter in their 
food package.

Federal Budgetary Costs

    Requiring all State agencies to authorize canned legumes is 
expected to increase food costs by around $16 million over five 
years. This increase in costs is the result of both an estimated 
increase in the composite unit cost of legumes and a slight increase 
in redemption rates. The Department estimates that requiring State 
agencies to authorize canned legumes will slightly increase 
redemption rates from 38 percent in 2020 up to 39 percent under the 
rule. This increase is less than the increase that NASEM projects 
because NASEM's estimate also considers the effect of reducing the 
amounts of legumes issued--which is not changed in this rule. The 
estimated increase in redemption rates for legumes is also small 
because this provision only represents a policy change for an 
estimated 15 percent of WIC participants.\85\ Similarly, the 
expanded availability of canned legumes to this group of 
participants is also estimated to slightly increase the composite 
unit price of legumes from $2.57 in the current food package to 
$2.62 under the rule as canned legumes are generally more expensive 
than dry legumes.\86\
---------------------------------------------------------------------------

    \85\ Thorn, B., Huret, N., Bellows, D., Ayo, E., Myers, R., & 
Wilcox-Cook, E. (2015). WIC Food Packages Policy Options Study II. 
Project Officer: Grant Lovellette. Alexandria, VA: U.S. Department 
of Agriculture, Food and Nutrition Service, Office of Policy 
Support. Available online at: https://www.fns.usda.gov/wic/wic-food-package-policy-options-ii.
    \86\ Composite unit price of legumes represents the weighted 
average price per ``allotment''--either 16 ounces of dry beans, 64 
ounces of canned beans, or 18 ounces of peanut butter. Replicating 
NASEM's analysis, weights of 0.5, 0.31, and 0.19 were applied to 
peanut butter, dry beans, and canned beans, respectively, in the 
composite unit cost for legumes in the current food packages. To 
account for an increase in canned bean purchasing, weights of 0.5, 
0.29, and 0.21 are applied to peanut butter, dry beans, and canned 
beans, respectively, under the revised food packages.
---------------------------------------------------------------------------

    Requiring that State agencies offer legumes or peanut butter as 
a substitution for eggs is not projected to have a significant 
impact on food costs. Currently, participants are prescribed legumes 
or peanut butter in amounts that exceed the DGA recommended amounts 
for the food subgroups these items are within, and redemption rates 
for legumes and peanut butter are some of the lowest redemption 
rates among WIC food categories. Substitutions are limited to 
participants with an egg allergy, vegan participants, or for other 
nutritional reasons determined by the State agency. In 2018, only 1 
percent of WIC participants in a study sample representative of 12 
State agencies reported having an egg allergy.\87\ The same study 
found only around 2 percent of participants reported being 
vegetarian--although USDA does not have data on prevalence of vegan 
diets among WIC participants, data on the general U.S. population 
suggest that vegan diets are even

[[Page 28550]]

less common than vegetarian diets.\88\ Therefore, while these policy 
changes provide important substitution options, their use is 
expected to be rare.
---------------------------------------------------------------------------

    \87\ Gleason, S., Wroblewska, K., Trippe, C., Kline, N., Meyers 
Mathieu, K., Breck, A., Marr, J., & Bellows, D. (2021). WIC Food 
Cost-Containment Practices Study: Final report. U.S. Department of 
Agriculture, Food and Nutrition Service. Available at: https://www.fns.usda.gov/wic/wic-food-cost-containment-practices-study.
    \88\ Gallup. ``Snapshot: Few Americans Vegetarian or Vegan.'' 
August 1, 2018. Available at: https://news.gallup.com/poll/238328/snapshot-few-americans-vegetarian-vegan.aspx.
---------------------------------------------------------------------------

    Allowing State agencies to offer other nut and seed butters as 
substitutions for peanut butter is also not projected to have a 
significant impact on food costs. In 2018, only 1 percent of WIC 
participants in a study sample representative of 12 State agencies 
reported having a peanut allergy.\89\ Furthermore, an internal USDA 
analysis of NHANES 24-Hour Dietary Recall Data from 2017-2020 found 
that, among individuals who report consuming any kind of nut butter, 
94 percent of nut butter consumption is peanut butter, 6 percent is 
almond butter, and all other kinds of nut and seed butters combined 
account for less than 1 percent of nut and seed butter consumption. 
These data points suggest that use of the nut and seed butter 
substitution would be rare, even when extended to participant 
preference and, therefore, likely would not have a meaningful impact 
on WIC food costs.
---------------------------------------------------------------------------

    \89\ Gleason, S., Wroblewska, K., Trippe, C., Kline, N., Meyers 
Mathieu, K., Breck, A., Marr, J., & Bellows, D. (2021). WIC Food 
Cost-Containment Practices Study: Final report. U.S. Department of 
Agriculture, Food and Nutrition Service. Available at: https://www.fns.usda.gov/wic/wic-food-cost-containment-practices-study.
---------------------------------------------------------------------------

Fruit and Vegetables Forms and Varieties

Summary of Changes

     State agencies required to authorize an additional form 
of fruits and vegetables.
     Require vendors to stock at least 3 different 
vegetables.
     Expand what can be purchased with the CVV.

Context, Behavior Change, and Benefits

    As recommended by NASEM, the rule requires State agencies to 
authorize fresh and at least one other form (frozen, canned, and/or 
dried) of both fruits and vegetables for the food packages for 
child, pregnant, postpartum, and breastfeeding participants and 
require fresh and at least one other form (frozen or canned) for the 
CVV substitution for infant (ages 6 through 11 months) food 
packages.
    Currently, WIC State agencies are not required, but may choose, 
to authorize other forms of fruits and vegetables in addition to 
fresh for child, pregnant, postpartum, and breastfeeding 
participants. In 2021, only eight of 89 State agencies did not 
authorize a form other than fresh. Therefore, the Department 
anticipates that the change will have minimal impact on most State 
agencies, while ensuring greater participant choice in those State 
agencies currently not authorizing other forms of fruits and 
vegetables. Additionally, with the increase in the CVV, having the 
option to buy other forms that are not as perishable as fresh may 
encourage fuller redemption and consumption of the fruits and 
vegetables benefit.
    As recommended by NASEM, the rule also requires vendors to stock 
at least three varieties of vegetables. Currently, vendors are 
required to stock two varieties of vegetables. NASEM recommended the 
requirement for stocking a greater variety of vegetables as opposed 
to fruits because its review noted higher redemption of fruits 
compared to vegetables in two State agencies.\90\ NASEM also cited 
the lower intake of vegetables (particularly in contrast to fruits) 
in all WIC participant categories and recommended increased stocking 
requirements for vegetables.
---------------------------------------------------------------------------

    \90\ Other data sources (e.g., WIC Infant and Toddler Feeding 
Practices Study 2, available at https://www.fns.usda.gov/wic/infant-and-toddler-feeding-practices-study-2-fourth-year-report) also find 
that intake of vegetables among WIC participants is lower than the 
intake of fruits.
---------------------------------------------------------------------------

    Thus, the change is intended to increase the purchase and 
consumption of vegetables among WIC participants, particularly given 
the increase to the value of the CVV, by requiring vendors to offer 
more variety for participants to select from. If participants have 
more vegetables from which to select, they may redeem their CVV for 
more vegetables and increase their vegetable consumption. In 
addition, the change is intended to promote equity by ensuring all 
participants, regardless of where they redeem benefits, have access 
to a variety of vegetables, while incurring minimal additional 
burden on small vendors.
    This revision could also have the spillover effect of increasing 
general availability of different types of vegetables in areas 
served by small WIC vendors, as those additional vegetable types 
will be available for retail purchase by the general public.
    This rule also finalizes the provision to allow fresh herbs, to 
codify that State agencies cannot exclude white potatoes from 
purchase with the CVV, and to allow larger sizes of packaged fresh 
fruits and vegetables. The WIC CVV provides participants with 
flexibility to purchase fruits and vegetables that meet their 
dietary, taste, and cultural preferences. Expanding CVV-eligible 
items further to include fresh herbs and larger packages of fruits 
and vegetables is intended to encourage healthier dietary patterns 
and support increased convenience. Increased use of fresh herbs in 
diets can help enhance the flavor of foods in place of added sugar, 
fats, and sodium. Packaged fruits and vegetables provide a more 
convenient option for participants who see preparation time as a 
barrier to consumption.

Federal Budgetary Costs

    The requirement for State agencies to authorize at least one 
additional form of fruits and vegetables other than fresh, the 
requirement that vendors stock at least three varieties of 
vegetables, and expanding what can be purchased with the CVV are not 
expected to increase food costs in WIC. Both provisions may incur 
some initial administrative burden on State agencies and vendors (as 
discussed in the Administrative Impacts section below); however, 
these administrative impacts are expected to be minimal and short-
lived. Furthermore, because 81 out of 89 State agencies already 
authorize at least one form of fruits and vegetables other than 
fresh, the impact of this provision will only impact a small number 
of State agencies.

D. Impacts on Amounts of Food Groups Issued

    As described above, the changes to the WIC food packages will 
improve the balance of nutritious foods to align with 
recommendations from NASEM, the 2020-2025 DGA, and the AAP. The 
changes also better reflect the supplemental nature of the WIC food 
package. Table 8 and Table 9 below summarize the estimated 
proportions of DGA daily recommended intakes for child (ages 2 
through 4 years) and for pregnant participants, respectively, to 
provide examples of the impacts of the rule on the food package 
contents.
    The 2020-2025 DGA identified average daily food group intakes of 
vegetables, seafood, and whole grains as falling below the 
recommended intake ranges for women and children across the general 
population. The DGA and the AAP \91\ also emphasize the consumption 
of whole fruits and vegetables over juice. A recent FNS study using 
2011-2016 NHANES data found that children participating in WIC under 
the current food package report overall inadequate intake levels for 
vegetables, seafood, and whole grains.\92\ The same study also found 
that children participating in WIC are less likely to consume any 
amount of whole fruits on a given day than higher income children 
(73 compared to 93 percent), but are also significantly more likely 
to consume 100 percent fruit juice (73 compared to 47 percent). As 
described in the previous section, and illustrated in Table 8 and 
Table 9 below, this rule will help WIC participants narrow these 
gaps in intake by improving the ratio of whole grain relative to 
refined grains and increasing the amounts of fish, whole fruits, and 
vegetables available in the WIC food packages.
---------------------------------------------------------------------------

    \91\ Heyman MB, Abrams SA, AAP SECTION ON GASTROENTEROLOGY, 
HEPATOLOGY, AND NUTRITION, AAP COMMITTEE ON NUTRITION. Fruit Juice 
in Infants, Children, and Adolescents: Current Recommendations. 
Pediatrics. 2017;139(6):e20170967
    \92\ Gleason, S., Hansen, D., & Wakar, B. (2021). Indicators of 
diet quality, nutrition, and health for Americans by program 
participation status, 2011-2016: WIC report. Prepared by Insight 
Policy Research, Contract No. GS-10F-0136X. Alexandria, VA: U.S. 
Department of Agriculture, Food and Nutrition Service, Office of 
Policy Support, Project Officer: Michael Burke. https://www.fns.usda.gov/wic/indicators-diet-quality-nutrition-and-health-americans-program-participation-status-2011.
---------------------------------------------------------------------------

    To estimate the level of fruits relative to vegetables that 
should be accounted for when considering the proportion of DGA 
recommendations provided in the WIC food packages, NASEM based its 
estimates on the assumption that 67 percent of the CVV is typically 
spent on fruits while 33 percent is spent on vegetables--based on 
data collected from Wyoming and Texas at the time of NASEM's 
analysis. This ratio of CVV redemption for fruits relative to 
vegetables is consistent with more recent internal USDA data 
collected from Ohio, Wyoming, and Texas in 2018 as part of a 
forthcoming study on CVV redemption patterns. Therefore, USDA 
maintains NASEM's assumptions on

[[Page 28551]]

relative CVV redemptions to the calculations for fruit and vegetable 
coverage under the current food packages in Table 8 and Table 9. 
However, USDA projects that the share of vegetables to fruits 
purchased with the CVV will even out at the increased CVV levels in 
this rule.\93\ USDA estimates that 50 percent of CVV spending will 
be used to purchase fruits and 50 percent used to purchase 
vegetables at the revised benefit levels.
---------------------------------------------------------------------------

    \93\ USDA expects that fruit and vegetable purchasing will be 
redeemed at closer to 50/50 split at the revised CVV level. This 
projection is based on the DGA coverage level for fruit in the 
current food package and the expectation that participants would not 
exceed DGA recommended fruit intakes under the higher CVV level (as 
would be the case if fruit continued to account for 67 percent of 
CVV redemption). If participants continued to use 67 percent of the 
increased CVV towards fruit and 33 percent towards vegetables, then 
children ages 2 to 4 years would receive 109 percent of the DGA 
recommended intake for fruits.
---------------------------------------------------------------------------

    The rule will decrease the amount of total dairy and refined 
grains in the food packages for child, pregnant, postpartum, and 
breastfeeding participants. The decrease in the proportion of 
refined grains is the result of the revised whole grain breakfast 
cereal requirements described above. This change improves the 
balance between whole and refined grains and aligns with DGA 
guidelines that emphasize that at least half of total grain intake 
should be in the form of whole grains. The decrease in total dairy, 
as described in the previous section, will better align the food 
packages with the supplemental nature of WIC. Although the maximum 
monthly allowance for legumes exceeds the DGA daily recommended 
intakes for children and the allowance for peanut butter exceeds 
daily recommended intakes for children and women, USDA chose not to 
decrease the amounts provided for either food. This decision was 
made partly due to market availability, as it is more difficult to 
find package sizes for beans or peanut butter that fall below the 
current maximum allowances.

  Table 8--Proportion of 2020-2025 DGA-Recommended Daily Amounts of Food Groups in the Current and Revised Food Packages for Children Ages 2 Through 4
                                                    Years Assuming Full Redemption: Food Package IV-B
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Current            Revised
                                                                                             DGA Daily ------------------------------------- Change in %
           WIC food category                 DGA food group               Units/day         Intake \a\  WIC MMA            WIC MMA    % of    of DGA met
                                                                                                          \b\    % of DGA    \b\      DGA        \c\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total fruit...........................  Total Fruit.............  c-eq....................        1.25     0.90       72      0.95       76            4
    Juice, 100%.......................  ........................  c-eq....................        0.63     0.53       85      0.27       43          -43
    Fruit (CVV) \c\...................  ........................  c-eq....................        0.63     0.37       58      0.68      109           51
Total vegetables......................  Total Vegetables........  c-eq....................        1.50     0.31       20      0.81       54           34
    Vegetables (CVV)\d\...............     Vegetables (CVV).....  c-eq....................        1.50     0.18       12      0.68       46           34
    Legumes...........................     Legumes..............  c-eq....................        0.07     0.13      177      0.13      177            0
Total dairy...........................  Total dairy.............  c-eq....................        2.50     2.13       85      1.87       75          -10
Total grains..........................  Total grains............  oz-eq...................        4.50     2.27       50      2.00       44           -6
    Breakfast cereal..................  Refined grains..........  oz-eq...................        2.25     0.97       43      0.78       35           -9
    Breakfast cereal..................  Whole grains............  oz-eq...................        2.25     0.23       58      0.42       54           -3
    Bread.............................  Whole grains............  oz-eq...................  ..........     1.07  ........     0.80
Total protein foods...................  Total protein foods.....  oz-eq...................        3.50     1.00       28      1.20       33            6
                                           Nuts, seeds, and soy.  oz-eq...................
    Peanut butter.....................  ........................  ........................        0.36     0.60      167      0.60      167            0
    Eggs..............................     Meat, poultry, eggs..  oz-eq...................        2.36     0.40       17      0.40       17            0
Fish..................................     Seafood..............  oz-eq...................        0.71     0.00        0      0.20       28           28
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: DGA = Dietary Guidelines for Americans; MMA = Maximum monthly allowance; c-eq = cup-equivalent; oz-eq = ounce equivalent.
\a\ DGA daily intake recommendations based on a 1,300 calorie diet.
\b\ For alignment with DGA daily intake recommendations, WIC MMA represented in terms of daily amounts rather than monthly.
\c\ Change in % of DGA met is displayed as percentage point change.
\d\ CVV MMA in current food package assumes 67 percent redeemed on fruits and 33 percent redeemed on vegetables; CVV MMA in revised food package assume
  50 percent redeemed on fruits and 50 percent redeemed on vegetables. CVV intake estimates are based on assumption of fruit and vegetable unit cost of
  $0.55/cup-equivalent and $9 CVV in FY 2018, around the time of NASEM's estimates, under current food package compared to unit cost of $0.61/cup-
  equivalent, accounting for inflation, and $25 CVV in revised package in FY 2024.


Table 9--Proportion of 2020-2025 DGA-Recommended Amounts of Food Groups in the Current and Revised Food Packages for Pregnant Participants Assuming Full
                                                              Redemption: Food Package V-A
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Current            Revised
                                                                                             DGA Daily ------------------------------------- Change in %
           WIC food category                 DGA food group               Units/day         Intake \a\  WIC MMA            WIC MMA    % of    of DGA met
                                                                                                          \b\    % of DGA    \b\      DGA        \c\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total fruit...........................  Total Fruit.............  c-eq....................        2.00     1.05       52      1.50       75           22
    Juice, 100%.......................  ........................  c-eq....................        1.00     0.60       60      0.27       27          -33
    Fruit (CVV) \c\...................  ........................  c-eq....................        1.00     0.45       45      1.23      123           78
Total vegetables......................  Total Vegetables........  c-eq....................        3.00     0.47       16      1.48       49           34
    Vegetables (CVV) \d\..............     Vegetables (CVV).....  c-eq....................        3.00     0.22        7      1.23       41           34
    Legumes...........................  Legumes.................  c-eq....................        0.29     0.25       88      0.25       88            0
Total dairy...........................  Total dairy.............  c-eq....................        3.00     2.93       98      2.13       75          -23
Total grains..........................  Total grains............  oz-eq...................        7.00     1.73       25      2.80       40           15
    Breakfast cereal..................  Refined grains..........  oz-eq...................        3.50     0.97       28      0.78       22           -5
    Breakfast cereal..................  Whole grains............  oz-eq...................        3.50     0.23       22      0.42       58           36
    Bread.............................  Whole grains............  oz-eq...................  ..........     0.53  ........     1.60
Total protein foods...................  Total protein foods.....  oz-eq...................        6.00     1.60       27      1.93       32            6
                                           Nuts, seeds, and soy.  oz-eq...................
    Peanut butter.....................  ........................  ........................        0.71     1.20      168      1.20      168            0
    Eggs..............................  Meat, poultry, eggs.....  oz-eq...................        4.43     0.40        9      0.40        9            0

[[Page 28552]]

 
    Fish..............................  Seafood.................  oz-eq...................        1.29     0.00        0      0.33       26           26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: DGA = Dietary Guidelines for Americans; MMA = Maximum monthly allowance; c-eq = cup-equivalent; oz-eq = ounce equivalent.
\a\ DGA daily intake recommendations based on a 2,200 calorie diet.
\b\ For alignment with DGA daily intake recommendations, WIC MMA represented in terms of daily amounts rather than monthly.
\c\ Change in % of DGA met is displayed as percentage point change.
\d\ CVV MMA in current food package assumes 67 percent redeemed on fruits and 33 percent redeemed on vegetables; CVV MMA in revised food package assume
  50 percent redeemed on fruits and 50 percent redeemed on vegetables. CVV intake estimates are based on assumption of fruit and vegetable unit cost of
  $0.55/cup-equivalent and $11 CVV in FY 2018, around the time of NASEM's estimates, under current food package compared to unit cost of $0.61/cup-
  equivalent, accounting for inflation, and $45 CVV in revised package in FY 2024.

E. Administrative Impacts

Participant Burden

    The rule is not expected to substantially change the 
administrative burden on participants. The general benefits and 
requirements of the Program are not changing. There will be a one-
time burden on participants, estimated to account for an additional 
5 minutes per participant, to become familiar with the new food 
packages and with new foods (e.g., nutrition education around canned 
fish consumption). In addition, the Department expects the revised 
food packages may take longer to explain than the current food 
packages on an ongoing basis because it may take longer to explain 
the expanded substitution options and package size flexibilities--to 
account for this, the Department estimates participants will spend 
an additional 3 minutes learning about the food package options at 
each certification appointment.

WIC Local Agency Burden

    The rule is not expected to substantially change the long-term 
administrative burden on local WIC agencies. The general benefits 
and requirements of the Program are not changing. The Department 
estimates there will be a one-time 1-hour burden for local agencies 
to attend State Agency provided training on the food package 
changes. The food package changes are also expected to have both a 
short-term and ongoing impact on the length of WIC appointments. 
There will be a one-time burden on local WIC agencies for helping 
WIC participants become familiar with the new food package and with 
new foods, which is estimated to take local agencies about 5 minutes 
per participant in the first year the food package revisions are 
implemented (estimated to be FY 2026). In addition, the Department 
expects the revised food packages may take longer to explain than 
the current food packages on an ongoing basis because of the 
additional food package size flexibilities and additional 
substitution options--to account for this, USDA estimates local 
agencies will spend an additional 3 minutes explaining the food 
packages at each WIC certification appointment. The Department 
sought input from FNS Regional Office staff in making these 
estimates. The Department notes that comments on this assumption 
were requested in the proposed regulatory impact analysis, but no 
comments on the specifics of the burden assumptions or calculations 
were received.

WIC State Agency Burden

    The general benefits and requirements of the Program are not 
changing. However, the rule includes additional requirements and 
options for WIC-authorized foods that will impact State agencies' 
identification of foods, substitutions, brands, and packaging 
acceptable for use in the Program. The Department estimates a slight 
increase (5 to 10% increase, or about 3 hours per State agency) in 
the amount of time it takes annually for State agencies to identify 
foods that are acceptable for use in the Program in their State. In 
addition, the Department estimates 5 hours of training activities 
added to the burden in the first year related to the food package 
changes (this includes attending FNS training, developing guidance 
materials and providing other technical assistance to local 
agencies). Also, there may be a one-time burden on State WIC 
agencies for programming the new food packages into their MIS, but 
the Department expects that these activities can be absorbed into 
existing State WIC agency administrative processes for system 
maintenance and program administration, and the Department expects 
that the long-term administrative burden on State WIC agencies to be 
minimal. The Department notes that comments on this assumption were 
requested in the proposed regulatory impact analysis, and none were 
received.

Vendor Burden

    The rule is not expected to change the administrative burden on 
most vendors. The general benefits and requirements of the Program 
are not changing. There may be a small one-time burden on small 
vendors if they currently only stock two varieties of vegetables, as 
the rule would require them to stock at least three varieties of 
vegetables, but the Department expects that the long-term 
administrative burden on vendors will remain substantially 
unchanged. The Department notes that other provisions of the rule 
may decrease burden, at least on some vendors--for example, allowing 
20 or 24 ounce package sizes for whole grain breads may lessen the 
burden on small vendors that have difficulty stocking the less 
common 16 ounce package size currently required by WIC, or allowing 
canned legumes to be stocked instead of dry legumes. Therefore, the 
total burden change to the average vendor will likely be minimal, 
though the burden changes may vary from vendor to vendor. The 
Department estimates that, as a result of the one-time burden on 
vendors to stock three varieties of vegetables, approximately 150 
vendors will decide to discontinue participation in the Program (out 
of approximately 40,000 total vendors). This estimate assumes that 
among vendors with WIC redemptions in the bottom 10 percent 
nationwide, those such as small convenience stores that offer 
limited grocery items may have the greatest difficulty stocking an 
additional vegetable, and therefore would be most likely to be 
impacted. The Department notes that comments on this assumption were 
requested in the proposed regulatory impact analysis, and none were 
received.

Food Manufacturer Burden

    The changes to the food packages were selected to align with 
products currently available on the market, so the Department 
expects that the new food package implementation to have exceedingly 
minimal effects on food manufacturers' need to reformulate products 
or create new products or package sizes. The Department expects that 
most manufacturers will not have to reformulate any products to meet 
the requirements of this rule; in those rare cases where minor 
reformulation or repackaging may be necessary, USDA does not expect 
this burden to be more pronounced than the burden of regularly 
reviewing and reformulating products within a competitive 
marketplace, so USDA expects the long-term administrative burden on 
food manufacturers to remain substantially unchanged. The Department 
notes that comments on this assumption were requested in the 
proposed regulatory impact analysis, and none were received.

Administrative Costs

    As described above, USDA expects most administrative burden and 
costs associated with this rule to be highly localized, most to be 
one-time and minimal, and/or to be absorbed within current 
programmatic overhead. Specifically, USDA only expects measurable 
administrative cost increases for State agencies and local agencies 
to account for the added time for the identification of

[[Page 28553]]

authorized foods and for the explanation of the food package changes 
to WIC participants. USDA estimates total administrative costs to 
State agencies and local agencies to a one-time amount of about 
$31.6 million in FY 2025.
    A detailed accounting of the State agency and local agency 
burden (OMB 0584-0043) is provided in the annual burden adjustment 
estimates published with this rule. Information provided by FNS 
Regional Office staff (with direct, routine contact with State 
agencies) was used to determine the burden estimates. In total, USDA 
estimates that each of the 89 State agencies will spend an 
additional 3 hours identifying acceptable foods in the first year 
the provisions are implemented, or about 267 total hours across all 
State agencies. This increase in burden is estimated to increase 
State agency administrative costs by around $16,000 in FY 2025. As 
described above, State and local WIC agencies are also expected to 
incur some burden for training activities related to the changes. 
The 5 hours estimated for State agency training activities is 
estimated to increase administrative costs by around $27,000 while 
the 1 hour of training for each of the 1,808 local agencies is 
estimated to increase administrative costs by around $99,000. USDA 
also estimates that in the first year following the food package 
changes, WIC staff at the local agency level will take an additional 
5 minutes per participant to explain the food package changes to all 
participants. Multiplying this time by the over 6 million annual WIC 
participants, accounts for approximately 572,000 add burden hours at 
a cost of $31.4 million in FY 2025. As described above, the 
Department also expects local agency staff will take an additional 3 
minutes to explain the options in the revised food packages at each 
WIC certification appointment on an ongoing basis. While this is a 
small change at the individual level, when applied to all 
approximately 10 million WIC certifications estimated per year, this 
additional staff time is estimated to account for an additional $147 
million in administrative costs over five years. Taken together, the 
administrative burden for State and local agency staff is estimated 
to amount to 1,085,018 hours at a total cost of $179 million over 
five years from FY 2025 through FY 2029.

                           Table 10--Administrative Costs Associated With Staff Burden
----------------------------------------------------------------------------------------------------------------
                                                                      Fiscal year
                                                ------------------------------------------------------
                                   Additional                   Annual cost (millions)                   Total
                                  burden hours  ------------------------------------------------------
                                                   2025       2026       2027       2028       2029
----------------------------------------------------------------------------------------------------------------
State Agency Staff Burden:
    Identifying acceptable                  267    $0.016        n/a        n/a        n/a        n/a     $0.016
     foods.....................
    State agency training                   445     0.027        n/a        n/a        n/a        n/a      0.027
     activities................
Local Agency Staff Burden:
    Local agency training                 1,808     0.099        n/a        n/a        n/a        n/a      0.099
     activities................
    Explaining food package             572,282    31.485        n/a        n/a        n/a        n/a     31.485
     changes (one-time)........
    Explaining revised food             510,216    28.070    $28.716    $29.376    $30.052    $30.743    146.956
     package options (ongoing).
                                --------------------------------------------------------------------------------
        Total..................       1,085,018    59.698     28.716     29.376     30.052     30.743    178.584
----------------------------------------------------------------------------------------------------------------
Notes:
Hourly labor costs are based on Bureau of Labor and Statistics (BLS) estimates for total compensation for FY2022
  and inflated to FY 2025-FY 2029 according to the CPI-W projections in OMB's economic assumptions for the
  FY2024 President's Budget request.
State agency staff labor costs use BLS Hourly Total Cost of Compensation for all State and Local workers, series
  CMU3010000000000D, available at: https://data.bls.gov/timeseries/CMU3010000000000D.
Local agency staff labor costs use BLS Hourly Total Cost of Compensation for state and local workers in
  healthcare and social assistance industries, series CMU3016200000000D, available at: https://beta.bls.gov/dataViewer/view/timeseries/CMU3016200000000D dataViewer/view/timeseries/CMU3016200000000D.

F. Participation Impacts

    As noted in the above analysis, the Department's primary 
estimate includes a shift of 5 percent of fully formula-fed infant-
mother dyads to partially breastfeeding dyads, similar to the 
assumptions made in the NASEM cost analysis. Other than the shift 
towards increased breastfeeding under the revised food packages (as 
described above), NASEM projects the rest of their cost neutral food 
package changes will not have a meaningful impact on participation. 
This final rule goes beyond NASEM's cost neutral recommendations for 
the CVV, so it is reasonable to consider an additional participation 
impact from this provision. The Department expects that much of the 
potential participation impact of the CVV on participation will have 
already been realized in FY 2022 through FY 2024, however, due to 
the implementation of the higher CVV amounts in those years. 
Nevertheless, it is possible that this rule could have a modest, 
conceptual participation impact by sustaining the levels of 
participation seen in FY 2022-FY 2023 and thus far in FY 2024 if 
compared to a hypothetical future in which CVV values return to pre-
2021 CVV levels.
    Beyond FY 2023, the baseline and revised costs presented in this 
analysis also both assume increases in WIC participation as a result 
of ongoing efforts supported by the $390 million in additional WIC 
funding made available in the American Rescue Plan Act of 2021 
(ARPA, Pub. L. 117-2) to carry out outreach, innovation, and program 
modernization. Therefore, as described in the baseline section 
above, it is difficult to attempt to disentangle any single, 
potential participation impact from several concurrent factors that 
may be affecting WIC participation.
    The Department acknowledges that, because the rule goes beyond 
NASEM's cost neutral recommendations (particularly in the increases 
to the CVV), the rule may be more likely to have an impact on 
participation. Given planned efforts to increase participation and 
retention under ARPA, as described above, however, as well as the 
fact that the CVV increases have already been implemented in FY 
2022, FY 2023, and FY 2024, the Department is uncertain at this time 
how much of an increase in participation may be attributable solely 
to the rule. The Department presents additional cost estimates in 
the Uncertainties section below, which demonstrate how the cost of 
the rule would be affected if participation remains flat or 
increases compared to our primary estimate.

G. Market Impacts

    Generally, the changes made by this rule attempt to align with 
products widely available in the current marketplace and to provide 
WIC participants with additional choices to meet their cultural and 
personal preferences, and special dietary needs, while at the same 
time providing food packages that supply appropriate, supplemental 
amounts of key nutrient-dense foods. For example, the package size 
flexibilities, and the addition of canned legumes, milk 
substitutions, forms of fruit and vegetables, etc. are all designed 
to increase product choice in line with products currently available 
in the U.S. food marketplace and should not result in additional 
burden on food manufacturers. The Department anticipates that the 
general impact of this rule on the wider U.S. food market will be 
small and easily absorbed by the competitive marketplace. The 
Department notes that comments on this assumption were requested in 
the proposed regulatory impact analysis, and none were received.
    The dollar impacts of the rule on the different food categories 
are presented in our

[[Page 28554]]

primary estimate in Table 2d. For all food categories, the 
Department expects that the change in food purchases attributable to 
the rule will comprise only a small fraction of the total market for 
each food category in the United States. For example, the Department 
estimates that the total net change to the U.S. baby food market 
will be less than $100 million over 5 years; however, the baby food 
market in the United States was estimated to be approximately $13 
billion in 2018, growing to $17 billion by 2026,\94\ so the changes 
represent less than 0.2 percent of the total U.S. baby food market 
over the estimate period. Similarly, the U.S. canned fish market was 
estimated to be approximately $5 billion in 2021, so the increase in 
fish represents approximately 0.5 percent of the total U.S. canned 
fished market. The changes will cause even smaller impacts to the 
breakfast cereal, grain, cheese, and fluid milk markets--for 
example, an internal USDA market analysis using IRI retail scanner 
data estimates that the decrease in milk spending represents 0.1 
percent of the U.S. fluid milk market; the decrease in cheese 
spending represents 0.04 percent of the U.S. cheese market; and the 
decrease in cereal spending represents 0.02 percent of the U.S. 
cereal market. The Department expects that the competitive 
marketplaces for the various food items will easily absorb the 
changes in purchasing patterns attributable to this rule without 
disruption or significant price changes.
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    \94\ For more information, see https://www.alliedmarketresearch.com/us-baby-food-market.
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    The two biggest cost provisions affect the juice market (the 
decrease in juice) and the fruit and vegetable market (the increase 
in CVV value). Even in these instances, the Department expects the 
competitive marketplaces to absorb these changes with minimal 
disruption. The U.S. juice market was estimated to be $24 billion in 
2021, growing to $27 billion by 2026.\95\ Even though the decrease 
in juice attributable to WIC may seem substantial, it accounts for 
only about 0.5 percent of the total U.S. juice market over the 
estimate period; a separate, internal USDA market analysis using IRI 
scanner data estimated that the decrease in juice spending will 
account for 0.8 percent of the U.S. juice market. Furthermore, many 
fruit juice manufacturers produce alternate products that will be 
purchasable with the CVV in many States (e.g., frozen fruits, canned 
fruits, dried fruits, etc.), so many fruit juice manufacturers will 
have the opportunity to substitute at least some of the decrease in 
spending on their juice products with increased spending on other 
products.
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    \95\ For more information, see https://www.statista.com/outlook/cmo/non-alcoholic-drinks/juices/united-states.
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    Similarly, the Department anticipates that the U.S. fruit and 
vegetable market is large and varied enough to absorb the increased 
purchasing power of the CVV with minimal disruption (in reality, the 
U.S. fruit and vegetable market has already absorbed the increased 
purchasing power of the CVV with minimal disruption, as the increase 
has been in effect since FY 2022). The total size of the U.S. fruit 
and vegetable market is more difficult to estimate with non-
proprietary data sources (the Department did not have access to the 
necessary proprietary data sources on the U.S. fruit and vegetable 
market when preparing this analysis); however, ERS estimates that 
farm cash receipts for ``vegetables and melons,'' ``fruits and 
nuts,'' and ``mushrooms'' combined was approximately $47 billion in 
2020.\96\ The value of the processed fruit and vegetable market in 
North America may have been approximately $90 billion in 2020.\97\ 
Just as examples, the increase in the CVV value would account, 
separately, for less than 2 percent of the value of farm cash 
receipts, and for less than 1 percent of the processed fruit and 
vegetable market.
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    \96\ See https://data.ers.usda.gov/reports.aspx?ID=17845.
    \97\ For more information, see https://www.gminsights.com/industry-analysis/processed-fruits-and-vegetables-market.
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    The increase in economic activity attributable to the rule will 
also increase revenues to farmers, farmers' markets (to the extent 
that WIC participants choose to redeem their additional CVV benefits 
at farmers' markets), food processors, food distributors, and food 
retailers. The Department does not attempt to estimate separate 
direct or indirect effects for each of these economic sectors, such 
an estimate would be too complex and too uncertain to estimate with 
precision.

H. Uncertainties

WIC Participation Trends

    As stated above and outlined in Table 5, the primary analysis 
assumes WIC participation growth is consistent with current 
projections. These estimates assume an increase in participation 
through FY 2027 with slowing participation growth through FY 2028 
and FY 2029. Table 11, below, compares the cost of the rule under 
current participation projections compared to a model that assumes 
flat WIC participation across all categories between FY 2025 to FY 
2029 (remaining flat at projected FY 2024 average participation of 
6.85 million). As shown below, the projected increase in 
participation accounts for $187 million of the food cost of the rule 
over five years. An additional 1 percent participation growth each 
year above our primary estimate would increase food costs by an 
additional $148 million over five years.

                          Table 11--Projected Food Cost of Rule by Participation Change
----------------------------------------------------------------------------------------------------------------
                                                            Fiscal year (millions)
                                        -------------------------------------------------------------    Total
                                             2025        2026       2027        2028         2029
----------------------------------------------------------------------------------------------------------------
Additional Growth: Primary Analysis +      $1,056.04    $956.25    $989.80    $1,036.10    $1,057.33    $5,095.5
 1% additional annual growth per year
 between FY 2025 and FY 2029...........
Primary Analysis.......................     1,045.75     937.70     961.14       996.15     1,006.49     4,947.2
No Growth: Flat WIC participation among     1,029.04     907.97     915.79       949.05       958.81     4,760.7
 all participant categories, FY 2025-
 2029..................................
----------------------------------------------------------------------------------------------------------------

Cash-Value Voucher Redemption Rate

    Compared to the current food packages outlined in 7 CFR 246.10, 
the increase to the CVV accounts for the largest share of the costs 
associated with the rule, and as such, even small variations in the 
model for the CVV cost estimates can result in large changes to the 
cost of the rule. Redemption rates for all WIC-eligible foods, 
including the CVV, vary by State agency and by month or season. 
Redemption rate data is also relatively new, as many States have 
only fully implemented electronic benefits transfer (EBT) in WIC 
over the past few years.\98\ USDA does not yet have a routine 
process in place for collecting EBT data on an ongoing basis. There 
also remains some uncertainty around how such a large increase to 
the CVV amount will impact CVV redemption rates. Preliminary data, 
described earlier in this analysis, suggest that CVV redemption 
rates in selected States have remained close to typical levels even 
under the temporary increase to a $35 CVV for all participants 
authorized under ARPA. Based on the data collected during the ARPA 
temporary CVV increase, the Department estimates in this analysis 
assume CVV redemption rates will maintain at 71.6 percent in both 
the current and revised food packages. Table 12, below, illustrates 
the impact on the food cost of the rule if the actual CVV redemption 
rate is just 3 percentage points higher or 3 percentage points lower 
than the current projections. A 3-percentage point change in the CVV 
redemption rate under this model is estimated to account for a $233 
million change in the cost of the revised CVV benefit amounts under 
this rule.
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    \98\ EBT redemption data allows for analysis of redemptions at 
the food item level. Prior to the onset of EBT, data on redemption 
of paper WIC food vouchers were generally limited to overall 
redemption of WIC benefit values.

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                   Table 12--Projected Food Cost of CVV Increase at Different Redemption Rates
----------------------------------------------------------------------------------------------------------------
                                                            Fiscal year (millions)
                                        -------------------------------------------------------------    Total
                                             2024        2025       2026        2027         2028
----------------------------------------------------------------------------------------------------------------
Higher (+3): 74.6 percent..............     $1,089.6     $982.8   $1,008.0     $1,044.6     $1,055.5    $5,180.5
Current: 71.6 percent..................      1,045.8      937.7      961.1        996.1      1,006.5     4,947.2
Lower (-3): 68.6 percent...............      1,001.9      892.6      914.3        947.7        957.5     4,714.0
----------------------------------------------------------------------------------------------------------------

VI. Alternatives

Additional CVV Increase for Pregnant Participants

    Some public comments requested that USDA further increase the 
CVV for pregnant participants to match the CVV for breastfeeding 
participants. The amounts in this rule reflect NASEM's evidence-
based recommendations to provide approximately half of the 
recommended daily amounts of fruits and vegetables for each 
participant group and are consistent with supplemental amounts 
relative to the 2020-2025 DGA recommendations for the applicable 
life stages of WIC adult participants (postpartum, pregnant, and 
lactating) based on the average caloric needs of these various 
groups (2,000 kcal, 2,200 kcal, and 2,400 kcal, respectively). 
Therefore, the Department does not make the requested change in this 
final rule. If the CVV value for pregnant participants were 
increased to match the levels for breastfeeding participants, then 
the final rule would increase Federal spending by an additional $119 
million over five years between FY 2025 and FY 2029.

Rounding CVV Up

    USDA received public comments calling for a change to the 
rounding procedure used when adjusting the CVV for inflation as 
described in Sec.  246.16(j)(5). The commenters suggested that the 
CVV be rounded up to the nearest multiple of $1 instead of rounded 
down as currently defined in regulations. In their report, NASEM 
made no recommendations regarding the rounding procedures. The 
proposed rule did not include any changes to the current rounding 
procedures or request public comment. The approach selected by FNS 
aligns with the one used in the Supplemental Nutrition Assistance 
Program (SNAP), which also rounds inflation adjustments down to the 
next multiple of $1 (7 CFR 273.10), as well as the National School 
Lunch Program's national average payment rates, which are rounded 
down to the nearest cent (7 CFR 210.4(b)). Therefore, the Department 
is not making this change in this rule. If the CVV were to be 
rounded up instead of rounded down, beginning in FY 2025, this 
change would increase the cost of the CVV changes in this rule by a 
total of $234 million over five years between FY 2025 and FY 2029.

NASEM's Proposed Fish and Legumes Rotation

    NASEM recommended adding canned fish to the child, pregnant, 
postpartum, and partially breastfeeding participant food packages on 
a three-month rotation, alternating with peanut butter and legumes. 
The Department decided to reject this alternative in favor of 
providing canned fish to all pregnant, postpartum and breastfeeding 
participants and most child participants while keeping the existing 
peanut butter and legume benefits.
    In evaluating the three-month rotation recommendation, the 
Department determined that this would be too confusing to 
participants and would be administratively challenging to implement. 
There are currently no WIC foods provided on a three-month rotation. 
In addition, the cost neutrality constraints that NASEM applied in 
making its recommendations are outweighed by the Department's goals 
of promoting nutrition security and equitable access to foods.

Appendix: Detailed Cost Estimates

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