[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Proposed Rules]
[Pages 71090-71162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24705]



[[Page 71089]]

Vol. 87

Monday,

No. 223

November 21, 2022

Part III





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; Proposed Rule

  Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / 
Proposed Rules  

[[Page 71090]]


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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: Proposed rule.

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SUMMARY: This rulemaking proposes to revise regulations governing the 
WIC food packages to align them with the current Dietary Guidelines for 
Americans and reflect recommendations made by the National Academies of 
Sciences, Engineering and Medicine (NASEM) in its 2017 report, ``Review 
of WIC Food Packages: Improving Balance and Choice,'' while promoting 
nutrition security and equity and taking into account program 
administration considerations. The proposed 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; provide more equitable access to supplemental foods; and 
better promote and support individual breastfeeding goals of 
participants to help establish successful long-term breastfeeding.

DATES: Written comments must be received on or before February 21, 2023 
to be assured of consideration. Online comments submitted through the 
Federal eRulemaking Portal on this proposed rule must be received on or 
before February 21, 2023.

ADDRESSES: The Food and Nutrition Service, USDA, invites interested 
persons to submit written comments on this proposed rule. USDA seeks 
comment on all aspects of this proposal. Comments may be submitted in 
writing by one of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Regular U.S. Mail: WIC Administration, Benefits, and 
Certification Branch, Policy Division, Food and Nutrition Service, P.O. 
Box 2885, Fairfax, Virginia 22031-0885.
     Overnight, Courier, or Hand Delivery: Allison Post, WIC 
Administration, Benefits, and Certification Branch, Policy Division, 
Food and Nutrition Service, 1320 Braddock Place, 3rd Floor, Alexandria, 
Virginia 22314.
    All written comments submitted in response to this proposed rule 
will be included in the record and will be made available to the 
public. Please be advised that the substance of the comments and the 
identity of the individuals or entities submitting the comments will be 
subject to public disclosure. FNS will make the written comments 
publicly available online at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Allison Post, Chief, Administration, 
Benefits, and Certification Branch, Policy Division, Food and Nutrition 
Service, USDA, 1320 Braddock Place, 3rd Floor, Alexandria, Virginia 
22314, (703) 305-2746 OR usda.gov">Allison.Post@usda.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    This rulemaking proposes to revise regulations governing the WIC 
\1\ food packages to align them with the Dietary Guidelines for 
Americans (DGA), 2020-2025 \2\ and reflect the National Academies of 
Sciences, Engineering and Medicine's (NASEM) recommendations,\3\ while 
promoting nutrition security and equity, and program administration 
considerations in implementing the proposed changes. The proposed 
changes are discussed in detail in part III. This part provides a brief 
background on the WIC food packages and the prior review of and changes 
to the WIC food packages.
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    \1\ The authorizing legislation for WIC uses the word ``women'' 
in the Program title and thus it is used in the title for this 
proposed rule. However, gender neutral language is used when 
possible throughout this proposed rule.
    \2\ U.S. Department of Agriculture and U.S. Department of Health 
and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th 
Edition. December 2020. Available at: Home [verbar] Dietary 
Guidelines for Americans. Referred to in this proposed rule as 
``2020-2025 DGA'' or ``DGA.''
    \3\ National Academies of Sciences, Engineering, and Medicine. 
``Review of WIC Food Packages: Improving Balance and Choice: Final 
Report,'' 2017. Available at internet site: https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice.
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A. WIC Food Packages

    WIC provides supplemental foods to address the nutritional needs of 
low-income pregnant, breastfeeding, and non-breastfeeding postpartum 
individuals, infants, and children up to 5 years of age at nutritional 
risk. Supplemental foods and nutrition education are the primary means 
by which WIC affects the dietary quality and behavior of participants. 
WIC also is intended to serve as an adjunct to health care during 
critical times of growth and development to prevent health problems and 
to improve the health status of Program participants.
    The specific amounts and categories of foods provided by the WIC 
food packages are intended to be supplemental to an individual's diet 
and provide specific nutrients determined by nutritional research to be 
lacking in the diets of WIC's target population. Every WIC participant 
receives supplemental foods on a monthly basis from one of seven 
science-based food packages, according to their participant category 
and nutritional needs.
    By design, the quantities and types of foods included in the WIC 
food packages are intended to (1) contribute to an overall dietary 
pattern consistent with the DGA, and (2) deliver priority nutrients to 
participants to meet their supplemental nutrition needs.
    The seven food packages currently 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 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

    Depending on the food package, the authorized food categories 
include: infant formula, cereal, and foods; exempt infant formulas; 
WIC-eligible nutritionals; \4\ milk; cheese; breakfast cereal; juice; 
fruits and vegetables; whole wheat/whole grain bread; eggs; legumes and 
peanut butter; and canned

[[Page 71091]]

fish. Food categories and quantities,\5\ as well as minimum nutritional 
requirements, are established at the Federal level and outlined in WIC 
Program regulations at 7 CFR 246.10.
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    \4\ 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.
    \5\ At the individual level, food packages are tailored to meet 
a participant's needs, such as eliminating or substituting foods 
(e.g., dry beans for peanut butter) due to a special dietary need 
(e.g., allergy, medical condition), cultural or personal 
preferences, or in situations where a participant cannot use or 
refuses the item.
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    As part of the WIC certification process, a comprehensive nutrition 
assessment \6\ is conducted for each individual WIC participant. 
Through this process, medical conditions and/or special dietary needs 
as well as cultural and personal preferences are identified. Food 
packages can be tailored to accommodate the nutritional needs, personal 
and cultural preferences, and housing/living conditions of individual 
participants (e.g., a medical condition such as a food allergy, or if a 
participant cannot use or refuses a food item). This individual 
nutrition tailoring involves modifying the food types or forms issued 
to the participant to best meet their individual supplemental needs and 
dictates what foods a participant can purchase with their benefits, 
consistent with State agency policies. For example, nutrition tailoring 
could entail issuing a participant lactose-free milk as an alternative 
to regular cow's milk (e.g., due to an intolerance or preference). In 
addition to tailoring the food package to meet the individual's 
nutritional needs, personal and cultural preferences and housing/living 
conditions, WIC staff instructs participants on how to redeem their WIC 
food benefits at retail vendors to include information about 
substitution options that are available within each food package. It is 
through nutrition tailoring and the issuance of Food Package III that 
WIC conforms with Section 504 of the Rehabilitation Act by providing 
participants with special dietary needs with the supplemental foods 
that meet their medical needs.
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    \6\ A comprehensive nutrition assessment includes a review of 
anthropometric measurements; blood iron levels; medical conditions; 
dietary practices and needs; and predisposing conditions (e.g., 
homelessness and migrancy).
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    The WIC Program is administered by 89 WIC State agencies, including 
the 50 States, 33 Indian Tribal Organizations, 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). WIC State agencies identify the brands and package sizes that 
will be made available to their participants in accordance with Federal 
WIC regulations and consider factors such as product availability, 
participant acceptance, variety of choices, 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 implement administrative adjustments to 
manage food costs. State agencies include a list of acceptable foods in 
their State Plans submitted annually for FNS approval.
    Participants may redeem their benefits for the foods included in 
their food packages at retail vendors authorized by the State agency, 
and, in some instances, through home delivery or direct distribution 
systems operated by the State agency; there are roughly 40,000 WIC-
authorized vendors nationwide.

B. Prior Review and Update of the WIC Food Packages

    In 2003, FNS contracted with the Institute of Medicine (IOM, now 
known as the National Academies of Sciences, Engineering and Medicine 
or NASEM) to independently review the WIC food packages. This 22-month 
study was the first comprehensive review of the food packages since 
1980. FNS tasked IOM with reviewing the nutritional needs of the WIC 
population and recommending changes to the WIC food packages. In 2006, 
IOM released its report, ``WIC Food Packages: Time for a Change,'' 
which cited fundamental changes that have occurred in the major health 
and nutrition risks faced by WIC's target population, including 
overweight and obesity; diets lacking in whole grains, fruits, and 
vegetables; and short duration of breastfeeding.\7\ The report provided 
the scientific basis for the proposed rule that FNS published in August 
2006.\8\ This proposed rule garnered broad support from public 
commenters, the majority of whom were Program participants.
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    \7\ WIC Food Packages: Time for a Change [verbar] USDA-FNS.
    \8\ Federal Register: Special Supplemental Nutrition Program for 
Women, Infants and Children (WIC): Revisions in the WIC Food 
Packages (71 FR 44784).
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    Using the comments received, FNS published an interim rule in 
December 2007 that implemented revised food packages.\9\ Due to the 
extent and comprehensive nature of the revisions, FNS provided an 
extended public comment period on the interim rule to obtain comments 
on the impacts of implementing the new food packages. A final rule was 
published in March 2014.\10\ The revisions in that rule aligned the 
food packages more closely with updated nutrition science, 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 
food packages to accommodate participants' cultural food preferences. 
Key changes implemented as a result of the interim and final rules 
include:
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    \9\ Interim Rule: Revisions in the WIC Food Packages [verbar] 
USDA-FNS (72 FR 68966).
    \10\ Final Rule: Revisions in the WIC Food Packages [verbar] 
USDA-FNS (79 FR 12274).
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     Introduction of the cash-value voucher (CVV) \11\ for the 
purchase of fruits and vegetables.
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    \11\ (Sec.  246.2) Cash-value voucher means a fixed dollar 
amount check, voucher, electronic benefit transfer (EBT) card or 
other document which is used by a participant to obtain authorized 
fruits and vegetables. Cash-value voucher is also known as cash-
value benefit (CVB) in an EBT environment.
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     Addition of whole grains (e.g., bread, tortillas, brown 
rice, etc.).
     Addition of soy-based beverage and tofu as milk 
alternatives.
     Reductions in some foods (e.g., milk, egg, and juice) to 
better align with the supplemental nature of the Program.
     Allowance for participants in Food Package III to receive 
all authorized WIC foods.

II. Framework for Developing the Proposed Changes to the WIC Food 
Packages

    This part summarizes the framework used to develop the proposed 
changes to the WIC food packages, including the 2017 NASEM report, the 
2020-2025 DGA, promotion of nutrition security and equity, and program 
administration considerations, and outlines the goals of the proposed 
changes.

A. The 2017 NASEM Report

    In 2014, FNS 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 required USDA to conduct a 
scientific review of the WIC food packages at least every ten years. 
FNS tasked NASEM with issuing both a set of cost-neutral 
recommendations and offering additional recommendations not constrained 
by cost-neutrality to identify and prioritize additional changes should 
a higher level of funding be appropriated. 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 benefit redemption

[[Page 71092]]

data, the 2015-2020 DGA, and, for children under age 2 years, 
recommendations of the American Academy of Pediatrics (AAP), the 
Academy of Nutrition and Dietetics, and the World Health Organization, 
among other authoritative organizations. In 2017, NASEM published its 
recommendations in the report, ``Review of WIC Food Packages: Improving 
Balance and Choice: Final Report,'' \12\ which informed many of the 
revisions in this proposed rule.
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    \12\ National Academies of Sciences, Engineering, and Medicine 
2017. Review of WIC Food Packages: Improving Balance and Choice: 
Final Report. Washington, DC: The National Academies Press. 
Available at internet site: https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice.
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    Using a systematic process, NASEM developed recommendations to 
satisfy the following seven criteria:
    (1) The packages provide a balanced supplement to the diets of 
women and children.
    (2) The packages contribute to reduced prevalence of inadequate and 
excessive nutrient intake.
    (3) The packages contribute to a dietary pattern that is consistent 
with the 2015-2020 DGA for individuals 2 years of age and older.
    (4) The packages 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.
    (5) The foods in the packages are available in forms and amounts 
suitable for low-income persons who may have limited transportation 
options, storage, and cooking facilities.
    (6) The foods in the packages are readily acceptable, commonly 
consumed, widely available, take into account cultural eating patterns 
and food preferences, and provide incentives for families to 
participate in the WIC Program.
    (7) The foods in the packages do not create an undue burden on 
State agencies or vendors.
    NASEM's review emphasized the ``supplemental'' nature of the food 
packages--that they are meant to provide a balanced supplement to 
participants' diets. Accordingly, NASEM designed food packages that 
provide moderate proportions of individuals' nutrients requirements and 
recommended food group amounts 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 required nutrients (between 5 and 400 percent of 
the Dietary Reference Intake (DRI)) and recommended food groups 
(between 0 and 177 percent of recommended intake amounts),\13\ NASEM 
recommended reducing foods that provide more-than-supplemental amounts 
and increasing foods needed to improve intake of priority nutrients and 
food groups.
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    \13\ Zero refers to the lack of seafood in the majority of 
current WIC food packages.
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B. The Dietary Guidelines for Americans (DGA) 2020-2025

    On December 29, 2020, the USDA and the U.S. Department of Health 
and Human Services published the 2020-2025 DGA, which provide 
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. Because NASEM's review and 
recommendations were based on the 2015-2020 DGA, to ensure continued 
alignment with the current DGA, FNS conducted a thorough review of the 
new guidelines and incorporated relevant updates into the proposed 
changes to the WIC food packages.

C. Nutrition Security and Equity, and Program Administration 
Considerations

    The Department developed proposed changes to the WIC food packages 
to align with NASEM and DGA recommendations, while promoting nutrition 
security and equity, and taking into account program administration 
considerations. The proposed changes would expand substitution options 
for participants with dietary restrictions to align with Section 504 of 
the Rehabilitation Act. The Department has prioritized improving 
nutrition security and equity, where individuals have consistent access 
to and availability of foods and beverages that promote well-being and 
prevent disease, particularly among our nation's most socially 
disadvantaged populations.\14\
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    \14\ Mozaffarian D, Fleischhacker S, Andr[eacute]s J. 
Prioritizing Nutrition Security in the US. JAMA. 2021;325(16):1605-
1606. doi: https://doi.org/10.1001/jama.2021.1915).
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    USDA's nutrition programs are the most far-reaching tools available 
to support nutrition security. The proposed changes to the food 
packages were considered within the framework of enhancing WIC 
participants' equitable access to nutritious foods and better meeting 
their special dietary needs due to medical conditions (e.g., allergies, 
intolerances) or limited cooking or storage facilities, cultural 
traditions, and personal preferences (e.g., vegetarian diets).
    Guided by the nutritional science presented in NASEM's report, the 
2020-2025 DGA, and in recognition of the importance of nutrition 
security, FNS is proposing revisions to the food packages that 
prioritize WIC participants' supplemental nutrition needs over 
maintaining cost neutrality. The proposed changes (described below in 
part III, ``Proposed Revisions to the WIC Food Packages'') are intended 
to achieve a better balance of nutrients and align with the 
supplemental nature of the Program.
    In addition, in developing the proposed changes, the Department 
considered the potential impact on program administration. Accordingly, 
the proposed changes reflect efforts to promote ease of implementation 
for State agencies, local agencies, vendors, and participants. These 
program administration considerations are discussed in Part III below.

D. Goals of the Proposed Changes to WIC Food Packages

    The proposed changes are designed to achieve the following:
     Provide additional flexibility, variety, and choice to 
build on current reasonable modifications for individuals with special 
dietary needs due to medical conditions, as well as accommodations for 
people with limited cooking and/or storage facilities or 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 (i.e., partially or fully).
     Provide foods in amounts that are more consistent with the 
supplemental nature of the Program.
     Provide a better balance of required nutrients and align 
with the 2020-2025 DGA, which emphasize nutrient-dense foods and 
beverages.
     Align with 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.
     Build on the 2014 changes to the WIC food packages and the 
positive impact those changes had on participant

[[Page 71093]]

diet quality and reduced prevalence of obesity among 
children.15 16 17
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    \15\ 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.
    \16\ 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.
    \17\ 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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    These goals provided the basis for the proposed changes to the food 
packages presented in part III below.

III. Proposed Revisions to the WIC Food Packages

    The proposed revisions to the WIC food packages align with the 2017 
NASEM report and the 2020-2025 DGA, promote nutrition security and 
equity, and account for program administration considerations. This 
part first summarizes the proposed changes to the food packages in the 
table below and then describes the proposed changes in detail, 
including the underlying rationale, in the sections that follow.

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           Section                     Summary of proposed change
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A. Fruits and Vegetables.....  1. Increase CVV maximum monthly
                                allowances for child, pregnant,
                                breastfeeding, and postpartum
                                participants.
                               2. Require State agencies to authorize at
                                least one other form of fruits and
                                vegetables in addition to fresh.
                               3. Require vendors to stock at least
                                three varieties of vegetables.
                               4. Expand what can be purchased with the
                                CVV.
B. Juice.....................  1. Reduce or remove maximum monthly
                                allowance for juice.
                               2. Allow CVV as a substitute for juice.
C. Milk and Milk               1. Reduce maximum monthly allowances of
 Substitutions.                 milk.
                               2. Require authorization of lactose-free
                                milk.
                               3. Permit only unflavored milk and reduce
                                total sugars allowed in yogurt and soy-
                                based beverages.
                               4. Add a calcium specification for tofu
                                and a vitamin D specification for
                                yogurt.
                               5. Increase yogurt substitution amounts
                                for milk.
                               6. Add soy-based yogurts and soy-based
                                cheeses as substitution options for
                                milk.
                               7. Update Food and Drug Administration
                                (FDA) standard of identity citations for
                                yogurt.
                               8. Allow reduced-fat yogurts for 1-year-
                                old children without restrictions.
                               9. Remove cheese as a food category from
                                the fully breastfeeding food package.
D. Infant Foods..............  1. Reduce infant cereal, infant fruits
                                and vegetables, and infant meat.
                               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.
                               3. Prohibit added fats in infant foods.
E. Add Infant Formula          1. Increase formula amounts in the first
 Flexibilities and Create a     month for partially (mostly) breastfed
 Separate Food Package for      infants.
 Partially (Mostly)            2. Allow all prescribed infant formula
 Breastfeeding Participants.    quantities to be considered ``up to''
                                amounts.
                               3. Create a separate and enhanced food
                                package for partially (mostly)
                                breastfeeding participants.
F. Breakfast Cereals.........  1. Change whole grain criteria for
                                breakfast cereals.
                               2. Require all breakfast cereals meet
                                whole grain criteria.
G. Whole Wheat Bread, Whole    1. Revise (reduce for children and
 Grain Bread, and other Whole   increase for pregnant, postpartum, and
 Grain Options.                 breastfeeding participants) maximum
                                monthly allowances for whole wheat and
                                whole grain bread and other whole grain
                                options.
                               2. Change criteria for whole grain
                                breads.
                               3. Expand whole grain options.
H. Canned Fish...............  1. Add canned fish to food packages for
                                children (2 through 4 years) and specify
                                WIC-eligible varieties for children.
                               2. 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.
I. Legumes and Eggs..........  1. Require State agencies to authorize
                                both dried and canned legumes.
                               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.
J. Maximum Monthly Allowances  1. Allow State agencies to authorize a
                                greater variety of package sizes to
                                increase variety and choice, while still
                                providing participants with package
                                sizes that ensure they can receive the
                                full benefit amount (i.e., at least one
                                package size, or a combination of sizes,
                                must add up to the full maximum monthly
                                allowance).
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A. Fruits and Vegetables

    As recommended by NASEM, the proposed rule would increase the CVV 
amount for child, pregnant, postpartum, and breastfeeding participants; 
require the authorization of an additional form of fruits and 
vegetables beyond fresh, dependent on participant category; require 
vendors to stock at least three varieties of vegetables; and expand 
what 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)
    This rulemaking proposes to increase the monthly CVV amounts to 
provide $24 for child participants, $43 for

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pregnant and postpartum participants, and $47 for partially (mostly) 
and fully breastfeeding participants (with annual adjustments for 
inflation), depending on category (current regulatory amounts are $9 
for children and $11 per month for pregnant, postpartum, and 
breastfeeding participants).\18\ The proposed increases reflect the 
amounts recommended by NASEM (determined to provide approximately half 
of the recommended daily amounts of fruits and vegetables for adults 
and children), outside of cost neutrality, and adjusted upward for 
inflation, and the amounts in the Department's Fiscal Year 2022 budget. 
The proposed 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). 
In alignment with NASEM's emphasis on providing supplemental amounts of 
foods and nutrients and with the DGA recommendation for greater fruit 
and vegetable consumption to achieve a healthy dietary pattern, the 
proposed revised amounts would afford participants greater choice and 
variety to select fruits and vegetables that accommodate their cultural 
and other food preferences. The following are the proposed CVV maximum 
monthly allowances for the purchase of fruits and vegetables by 
participant category (monthly CVV amounts would be adjusted annually 
for inflation):
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    \18\ This change would sustain a temporary, legislation-based 
increase in the CVV that has been in place since October 1, 2021 and 
will remain through the end of fiscal year (FY) 2022 as a result of 
two continuing resolutions (Pub. L. 117-43 and Pub. L. 117-70) and 
the Agriculture, Rural Development, Food and Drug Administration, 
and Related Agencies Appropriations Act, 2022 (Pub. L. 117-103).

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), (ii), (ii), and (ii), and (9) 
Through (11))
    As recommended by NASEM, the proposed rule would require State 
agencies to 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 require fresh 
and at least one other form (frozen or canned) for the CVV substitution 
for infants (ages 6 through 11 months) food packages. Dried fruits and 
vegetables are not authorized for infants since they pose a choking 
hazard.\19\
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    \19\ United States Department of Agriculture. Infant Nutrition 
and Feeding: A Guide for Use in the Special Supplemental Nutrition 
Program for Women, Infants and Children (WIC). 2019. Available at 
internet site: Infant Nutrition and Feeding Guide [verbar] WIC Works 
Resource System (usda.gov).
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    Certain processed fruits and vegetables offer similar nutrition 
benefits to fresh forms, are less perishable, and can be suitable for 
those who have allergic reactions to certain raw fruits and vegetables. 
Additionally, limiting fruits and vegetables to fresh only may 
compromise seasonally and geographically available options for 
participants. Thus, this change would further provide participants with 
greater flexibility to accommodate various storage or cooking 
conditions as well as special dietary needs (e.g., allergy/intolerance 
to fruits and vegetables) and cultural and personal food preferences. 
Requiring an additional form of fruits and vegetables also promotes 
equity by ensuring participants have access to a variety of options, 
including those that are available seasonally and in certain geographic 
regions.
    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, 
81 State agencies authorized a form other than fresh. Therefore, the 
Department anticipates that the proposed change would have minimal 
impact on most State agencies, while ensuring greater participant 
choice in those States currently not authorizing other forms of fruits 
and vegetables. Additionally, with the proposed 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 benefit, 
as well as less food waste.\20\
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    \20\ https://www.usda.gov/foodwaste/.
---------------------------------------------------------------------------

    Current regulations allow State agencies the option to provide a 
CVV for only fresh fruits and vegetables as a substitute for jarred 
infant fruits and vegetables. Consistent with the proposed change to 
the child, pregnant, postpartum, and breastfeeding food packages, this 
proposed rule would allow State agencies the option to provide a CVV 
for fresh and at least one other form of fruits and vegetables (frozen 
and/or canned; dried would not be authorized for infants) as a 
substitute for jarred infant fruits and vegetables (see section D 
below, ``Infant Foods''). However, given potential concerns about 
sodium amounts in frozen and/or canned forms of vegetables exceeding 
infants' needs, the Department requests public comment to better 
understand the impact of, and potential barriers to, the proposed 
change to allow fresh and other forms (frozen and/or canned) of fruits 
and vegetables as an option in the infant food package.
    The Department also requests public comment on the impact and 
feasibility of requiring State agencies to authorize all forms of 
fruits and vegetables (fresh, frozen, canned, and dried) for CVV 
redemption for pregnant, postpartum, breastfeeding, and child 
participants, specifically the potential burden on State agencies and 
vendors. The Department also seeks comment on the potential for 
confusion among households with infant participants whose benefits are 
aggregated with children and women participants who may receive dried 
forms.
3. Require Vendors To Stock at Least Three Varieties of Vegetables 
(Sec.  246.12(g)(3)(i))
    As recommended by NASEM, the proposed rule would require 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 of WIC redemption data showed that on average 
a much higher proportion of the CVV is redeemed for fruits (67 percent) 
compared to vegetables (33 percent). NASEM also cited the low intake of 
vegetables (particularly in contrast to fruits) in all WIC participant 
categories and recommended increased stocking requirements for 
vegetables. In a systematic review of fruit and vegetable purchases and 
consumption among WIC participants (after the 2009 WIC food packages 
changes) the evidence generally points toward increased variety in 
stores as a result of increased minimum stocking requirements and 
increased consumption of fruits and vegetables.\21\ Thus, the proposed 
change is intended to increase the purchase and consumption of 
vegetables among WIC participants, particularly given the proposed 
increase to the value of the CVV, by requiring vendors to offer more 
variety for participants to select from. In addition, the proposed 
change is intended to promote equity by ensuring all participants, 
regardless of where they

[[Page 71095]]

redeem benefits, have access to a variety of vegetables.
---------------------------------------------------------------------------

    \21\ Fruit and Vegetable Purchases and Consumption among WIC 
Participants after the 2009 WIC Food Package Revision: A Systematic 
Review--PMC (nih.gov).
---------------------------------------------------------------------------

    The proposed change to the Federal minimum stocking requirement for 
vegetables may present a challenge for some vendors. Therefore, the 
Department requests public comment regarding the proposed increased 
vegetable stocking requirement on vendors, particularly remote and/or 
small vendors, to better understand the potential effects of this 
change.
4. Expand What Can Be Purchased With the CVV (Sec.  246.10(e)(12), 
Table 4)
    The Department proposes to allow fresh herbs, codify that State 
agencies cannot exclude white potatoes from purchase with the CVV, and 
allow larger sizes of packaged fresh fruits and vegetables.
a. Allow Fresh Herbs (Sec.  246.10(e)(12), Table 4)
    The Department proposes to allow the purchase of fresh, cut herbs 
with the CVV to increase participant choice in conjunction with the 
proposed increase to the CVV value, accommodate cultural eating 
patterns, and align with the DGA, which categorize herbs (e.g., 
cilantro and basil) as ``Dark-Green Vegetables.'' Additionally, herbs 
can help enhance the flavor of foods as a strategy to reduce added 
sugars, saturated fat, and/or sodium, as well as to potentially 
increase consumption of other vegetables. Spices and dried herbs would 
remain ineligible for purchase with the CVV.
b. Codify That White Potatoes Are WIC-Eligible (Sec.  246.10(e)(12), 
Table 4)
    The WIC food packages final rule, published in March 2014, excluded 
the purchase of white potatoes with the CVV. This was an IOM 
recommendation based on data indicating that starchy vegetable 
consumption met or exceeded the recommended amounts. Subsequently, the 
Consolidated and Further Continuing Appropriations Act, 2015 (the Act, 
Pub. L. 113-235), enacted on December 16, 2014, precluded the exclusion 
or restriction of the eligibility of any variety of fresh, whole, or 
cut vegetables (except vegetables with added sugars, fats, or oils) in 
the WIC Program. In response to the Act, FNS issued WIC Policy 
Memorandum #2015-3: Eligibility of White Potatoes for Purchase with the 
Cash-Value Voucher,\22\ allowing the purchase of white potatoes with 
the CVV. Thus, the Department proposes to codify in regulations the 
requirements of the Act by removing white potatoes as an excluded 
vegetable. This would not be a change to current Program requirements.
---------------------------------------------------------------------------

    \22\ Eligibility of White Potatoes for Purchase with the Cash-
Value Voucher [verbar] USDA-FNS.
---------------------------------------------------------------------------

c. Allow Larger Sizes of Packaged Fresh Fruits and Vegetables (Sec.  
246.10(e)(12), Table 4)
    The Department is proposing to permit larger sizes of packaged 
fresh fruit and vegetables that are currently disallowed under the term 
``party trays'' to provide additional variety and choice for 
participants. Such food items may also increase consumption of fruits 
and vegetables as they are already prepared and ready to eat. Eligible 
products must meet current requirements in that they may not contain 
added sugars, fats, or oils (which may appear in the form of dips, 
sauces, or glazes). Nutrition education provided to participants may 
address consideration of package size selections for individual 
consumption to minimize food spoilage.
    Regulations (Sec.  246.10(b)(1)(i)) only allow State agencies to 
restrict container size of processed fruits and vegetables. Therefore, 
the proposed change in this section would result in all packages of 
fresh fruits and vegetables being WIC-eligible, regardless of package 
size. As such, the Department is requesting public comments 
specifically on any potential challenges to implementing the allowance 
of larger sizes of packaged fresh fruits and vegetables for State 
agencies, particularly related to managing approved product lists.

B. Juice

    As recommended by NASEM and to align with the DGA, the Department 
proposes to reduce juice in the child, pregnant and breastfeeding food 
packages, eliminate juice for postpartum participants, and allow the 
substitution of a $3 CVV for the full juice amount.
1. Reduce or Remove Maximum Monthly Allowance for Juice (Sec.  
246.10(e)(10) and (11), Tables 2 and 3)
    The proposed reduction of juice in the child, pregnant and 
breastfeeding food packages would better provide supplemental 
quantities of juice and align with the latest dietary guidance. The DGA 
emphasize the consumption of whole forms of fruits and vegetables over 
juice. While the DGA includes 100% 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 fruit juice amounts 
that should contribute toward an overall dietary pattern. Juice is not 
a separate food subgroup (like dark-green vegetables) in the dietary 
patterns that Americans should consume each day. Additionally, the DGA 
recognizes juice as lower in dietary fiber than whole fruits or 
vegetables. The DGA identify 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.
    With this proposed change, the child, pregnant and breastfeeding 
food packages would contain 64 fluid ounces of juice per month and 
juice would be eliminated for postpartum participants, who have lower 
caloric needs relative to those who are pregnant and lactating. 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 fruit juice. The reduced quantities would 
provide approximately 27 to 53 percent of DGA-recommended limits for 
children and most participants.\23\
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    \23\ For children ages 12 to 23 months, the reduced juice 
quantity provides 53% of the upper DGA limit based on 4 oz/day for 
700-1000 kcal. For children 2 to 4 years, the reduced juice quantity 
provides 36%-53% of the upper DGA limit based on 4-6 oz/day for 
1000-1600 kcals. For all pregnant and breastfeeding food packages, 
the reduced juice quantity provides 27% of the upper DGA limit based 
on 8 oz/day for 2000-2400 kcals.
---------------------------------------------------------------------------

    The following are the proposed maximum monthly allowances for 
juice:
     Child, pregnant and breastfeeding participants: 64 fluid 
ounces.
     Postpartum participants: 0 fluid ounces.
2. Allow CVV as a Substitute for Juice (Sec.  246.10(e)(10) and (11), 
Tables 2 and 3)
    As recommended by NASEM, this proposed rule would allow 
participants to substitute a $3 CVV for the full juice amount (64 fluid 
ounces). This change would provide additional flexibility to 
accommodate special dietary needs, cultural and personal preferences 
and align with a healthy dietary pattern as recommended by the DGA that 
includes mostly whole fruits and vegetables in nutrient dense forms. In 
conjunction with the proposal to significantly increase the CVV for 
pregnant, postpartum, breastfeeding, and child participants, these 
changes would encourage the consumption of whole fruits and vegetables 
versus juice. The monthly value of the CVV substitution amount for 
juice will be adjusted annually for inflation consistent with the 
inflation adjustments made to pregnant, postpartum, breastfeeding, and 
child participant CVV values.

C. Milk and Milk Substitutions

    As recommended by NASEM to improve the nutritional quality of the

[[Page 71096]]

WIC food packages, align with the DGA, and provide a better balance of 
foods, the Department proposes a variety of changes to milk and milk 
substitutions in the WIC food packages:
     Reduce the amount of milk provided in all child, pregnant, 
postpartum, and breastfeeding participant food packages.
     Require authorization of lactose-free milk.
     Permit only unflavored milk and reduce the total sugars 
allowed in yogurt and soy-based beverages.
     Add calcium specifications for tofu and vitamin D 
specifications for yogurt.
     Increase yogurt substitution amounts.
     Add substitution options for milk.
     Update the FDA standards of identity citations for yogurt.
     Allow reduced-fat yogurts for 1-year-old children without 
restrictions.
     Remove cheese from the fully breastfeeding food package.
1. Reduce Maximum Monthly Allowances of Milk (Sec.  246.10(e)(10) and 
(11), Tables 2 and 3)
    In the current food packages, milk provides 85 to 128 percent of 
the amount of dairy recommended in the DGA Healthy U.S.-Style Dietary 
Pattern. The supplemental quantities of milk under this proposed rule 
would provide approximately 71 to 96 percent of the amount recommended 
by the DGA Healthy U.S.-Style Dietary Pattern for the dairy food 
group.\24\ The proposed 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. Compared to current maximum 
monthly allowances for milk, children (depending on age) would receive 
2 to 4 quarts less per month. Pregnant and partially (mostly) 
breastfeeding participants would receive 6 quarts less per month, fully 
breastfeeding participants would receive 8 quarts less per month, and 
the amount for postpartum participants would remain unchanged.
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    \24\ For children ages 12 to 23 months, the reduced milk 
quantity provides 80-96% of the DGA based on 1 and \2/3\ cup-2 cup 
eq/day for 700-1000 kcal. For children 2 to 4 years, the reduced 
milk quantity provides 75-93% of the DGA based on 2-2.5 cup eq/day 
for 1000-1600 kcals. For all women food packages, the reduced milk 
quantity provides 71% of the DGA based on 3 cup eq/day for 2000-2400 
kcals.
---------------------------------------------------------------------------

    The following are the proposed maximum monthly allowances (MMA) for 
milk:

------------------------------------------------------------------------
                                                                Proposed
                                                                MMA for
                     Participant category                         milk
                                                                (quarts)
------------------------------------------------------------------------
Children 1 year (12 through 23 months).......................         12
Children 2 through 4 years...................................         14
Pregnant.....................................................         16
Partially (Mostly) & Fully Breastfeeding.....................         16
Postpartum...................................................         16
------------------------------------------------------------------------

    Due to the different quantities of milk prescribed for children 12 
through 23 months of age compared to children 2 through 4 years of age, 
the Department is proposing to create Food Package IV-A (children 12 
through 23 months) and Food Package IV-B (children 2 through 4 years). 
This differentiation would also align with the differences in fat 
content in the standard milk issued for these two age groups and the 
proposed change to add canned fish to the food package for children 2 
through 4 years of age (see Section H ``Canned Fish'', below).
2. Require Authorization of Lactose-Free Milk (Sec.  246.10(e)(3)(10) 
Through (12), Tables 2 Through 4)
    Currently it is a State agency option to authorize lactose-free 
milk. Data from a WIC study and FNS Regional Office \25\ input indicate 
that almost all WIC State agencies authorize lactose-free milk, 
suggesting that a regulatory change requiring State agencies to 
authorize lactose-free milk would not result in additional 
administrative efforts. Additionally, this proposed change improves 
consistency regarding lactose-free milk across FNS nutrition assistance 
programs. Therefore, to further promote nutrition security and equity 
the Department proposes to require State agencies to authorize both 
fluid and lactose-free milk, with the intent of ensuring additional 
options for participants with special dietary needs and preferences 
across all State agencies.
---------------------------------------------------------------------------

    \25\ U.S. Department of Agriculture, Food and Nutrition Service, 
Office of Policy Support. WIC Food Packages Policy Options Study II, 
by B. Thorn, N. Huret, D. Bellows, E. Ayo, R. Myers, and E.Wilcox-
Cook. Project Officer: Grant Lovellette. Alexandria, VA: October 
2015. Available at: https://www.fns.usda.gov/wic/wic-food-package-policy-options-ii.
---------------------------------------------------------------------------

3. Permit Only Unflavored Milk and Reduce Total Sugars Allowed in 
Yogurt and Soy-Based Beverages (Sec.  246.10(e)(12), Table 4)
    As recommended by NASEM, this rule proposes to revise the total 
sugars requirements for milk, yogurt and soy-based beverages offered in 
WIC to align with the DGA, which emphasize nutrient dense foods and 
beverages--among other aspects, nutrient-dense foods and beverages 
include little or no added sugars. As noted in the DGA, nutrient dense 
foods and beverages are particularly important for toddlers since their 
relatively high nutrient needs leave virtually no room for added sugars 
in their 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 proposed 
changes are also consistent with the reduction in total sugars in the 
Child and Adult Care Food Program (CACFP). As a result, the Department 
proposes the following revisions that would limit total sugars:
     Unflavored milk only.
     Plain or flavored yogurt with <=30 grams of total sugars 
per 8 ounces.
     Soy-based beverage with <=12 grams of total sugars per 8 
ounces.
    For yogurt, the total sugars limit would be reduced from <=40 grams 
per 8 ounces to <=30 grams per 8 ounces. Since there are no total 
sugars limits for soy-based beverages, this proposed rule would require 
that a soy-based beverage not exceed 12 grams of total sugars per 8 
fluid ounces. The Department requests public comment on the proposed 
limit on total sugars for yogurt and soy-based beverage, with specific 
interest in the use of an added sugars limit instead of a total sugars 
limit such as the suggested added sugars limits for yogurt provided in 
Table 6.5 (page 303) of the NASEM report \26\ or an alternative. While 
NASEM provided an added sugars limit for yogurt in its 2017 report, the 
final recommendation was for a total sugars limit given that FDA's 
regulation to include added sugars on food labels was not yet 
implemented. Thus, NASEM could not review and compare the suggested 
added sugars limits against marketplace availability, a core tenet of 
their charge in this report. USDA recognizes there is value in aligning 
with the DGA recommendation to reduce added sugars while maintaining 
consistency with other Federal Child Nutrition Programs. With FDA's 
labeling requirement for added sugars now in place, USDA seeks 
additional information on the marketplace availability, administrative 
burden, and nutritional impacts of implementing an added sugar 
requirement.
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    \26\ https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice.
---------------------------------------------------------------------------

    To further accommodate special dietary needs and cultural and 
personal

[[Page 71097]]

preferences, the Department requests public comment on the availability 
of other plant-based beverages (e.g., oat, almond) that would meet the 
nutrient specifications for WIC-eligible soy beverages, as described in 
current WIC regulations (Sec.  246.10(e)(12), Table 4) (i.e., be 
nutritionally equivalent to milk). The 2020-2025 DGA currently includes 
fortified soy beverages, which are fortified with calcium, vitamin A 
and vitamin D, as part of the dairy group because they are similar to 
milk based on nutrient content and use in meals. Other products sold as 
``milks'' but made from plants (e.g., almond, rice, coconut, oat, and 
hemp ``milks'') may contain calcium and be consumed as a source of 
calcium, but they are not included as part of the dairy group because 
their overall nutritional content is not similar to dairy milk and 
fortified soy beverages. Due to the rapid growth of the plant-based 
beverage industry and the potential over time for plant-based milk 
alternatives to meet the nutrient specifications of the Program, the 
Department requests public comment on the feasibility (e.g., cost, 
State-wide product availability) of allowing other plant-based milk 
alternatives that meet Federal WIC nutrient specifications for soy 
beverage.
4. Add a Calcium Specification for Tofu and a Vitamin D Specification 
for Yogurt (Sec.  246.10(e)(12), Table 4)
    In accordance with NASEM recommendations, the proposed rule would 
add nutrient specifications for calcium for tofu and vitamin D for 
yogurt. Currently, tofu, a milk substitution option, is required to be 
calcium-set prepared with calcium salts with no minimum amount of 
calcium. Similarly, yogurt currently has no specifications for vitamin 
D. These nutrients are critical for healthy development, and the DGA 
identify vitamin D and calcium as nutrients of public health concern as 
well as highlight the importance of vitamin D for calcium absorption. 
The DGA also note that vitamin D recommendations are harder to achieve 
through natural sources from diet alone and would require consuming 
foods and beverages fortified with this nutrient. Therefore, the 
Department proposes changes to ensure that WIC milk substitutes provide 
an amount of calcium and vitamin D that is closer to milk. The proposed 
rule would add nutrient specifications for calcium for tofu and vitamin 
D for yogurt as follows:
     Tofu with a minimum of 200 milligrams of calcium per 100 
grams.
     Plain or flavored yogurt with 100 IU (2.5 micrograms) of 
vitamin D per 8 ounces.
    The calcium specification for tofu would ensure that those who do 
not consume milk or yogurt due to special dietary needs (e.g., allergy, 
medical condition) or cultural or personal preferences could still 
obtain calcium through the tofu option. The Department requests public 
comment on the proposed vitamin D amount for yogurt and on the 
availability of yogurts and tofu meeting the proposed specifications.
5. Increase Yogurt Substitution Amounts for Milk (Sec.  246.10(e)(10) 
and (11), Tables 2 and 3)
    As recommended by NASEM, the proposed rule would increase the 
amount of yogurt that can be substituted for milk. This change would 
maintain the ratio of 1 quart of yogurt for 1 quart of milk that is 
currently allowed but would increase the maximum substitution of yogurt 
for milk from 1 to 2 quarts. By providing additional flexibility and 
variety this change would better accommodate participant special 
dietary needs and cultural and personal preferences. The following 
proposed monthly maximum substitution amounts for child, pregnant, 
postpartum, and breastfeeding participants would allow:
     2 quarts of yogurt for 2 quarts of milk.
    To further increase participant variety and choice, as well as in 
consideration of the proposed additional nutrient specifications for 
yogurt and tofu, the Department proposes to 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. 
Lifting this restriction would allow participants to substitute all 
three (cheese, yogurt, and tofu) in combination at their current 
substitution rates and current (1 pound of cheese; 1 pound of tofu) and 
proposed (2 quarts of yogurt) maximum substitution amounts.
    Although NASEM recommended a maximum range (30 to 32 ounces) for 
yogurt, the Department is not proposing this change. This 
recommendation was intended to allow more flexibility in products' 
package sizes that equal or add up to the proposed range. The 
Department recognizes the value of increasing package size flexibility 
for participants; therefore, the Department is proposing to allow State 
agencies the option to authorize additional package sizes that may not 
equal or add up to the full maximum monthly amount (see section J 
``Maximum Monthly Allowances'') for all WIC allowable foods (excluding 
formula), thus allowing for greater overall flexibility and choice for 
participants that would apply to yogurt and other products. State 
agencies would continue to be required to authorize package sizes that 
add up to or provide the full amount. For example, State agencies would 
still be required to authorize packages sizes of yogurt that equal or 
add up to the maximum monthly allowance of 32 ounces (one quart) but 
may also authorize package sizes of yogurt that do not equal or add up 
to 32 ounces (e.g., 5.3-ounce containers). Therefore, the proposed 
flexibility related to maximum monthly allowances negates the need to 
implement a maximum range specific to yogurt.
    NASEM also recommended that the partial substitution option of 
cheese for milk be revised to only allow 1 pound of cheese plus 1 quart 
of yogurt for 4 quarts of milk. This was intended to help alleviate the 
``dangling quart'' that arises when cheese is substituted for milk 
given the current option of one pound of cheese for 3 quarts of milk. 
However, State agencies currently have the option to make available 
other authorized milk alternatives to fulfill the milk maximum 
allowance, such as a quart of yogurt or a 12-ounce can of evaporated 
milk. State agencies also currently have the option to prescribe half 
gallon containers of milk every other month for participants in lieu of 
the ``dangling quart.'' Only allowing cheese plus yogurt as a partial 
substitution for milk would limit this option to those State agencies 
that authorize yogurt and require issuing a food that participants may 
not want. Such a change would also require State agencies that 
currently do not authorize yogurt to do so for participants to be able 
to substitute cheese. Thus, the Department is not proposing to change 
the current cheese substitution option.
6. Add Soy-Based Yogurts and Soy-Based Cheeses as Substitution Options 
for Milk (Sec.  246.10(e)(10) Through (12), Tables 2 Through 4)
    As recommended by NASEM, this proposed rule would add soy-based 
yogurts and cheeses, with nutrient specifications for calcium and 
protein, as milk substitution options. This would provide additional 
flexibility, variety, and choice to the food packages to accommodate 
special dietary needs and cultural and personal participant 
preferences. Currently, only cow's milk-

[[Page 71098]]

based varieties of yogurts and cheeses are allowed.
    For participants who do not consume the current dairy-based WIC-
eligible milk substitution options (yogurt and cheese) due to 
allergies, lactose intolerance, or a vegan diet, non-milk-based 
substitution options must still deliver important nutrients. As stated 
above (see section 3. ``Add Nutrient Specifications for Tofu and 
Yogurt''), the DGA identify vitamin D and calcium as nutrients of 
public health concern. Therefore, in addition to the NASEM-recommended 
nutrient specifications for calcium and protein, the Department 
proposes to add a nutrient specification for vitamin D for soy-based 
yogurt, consistent with the proposed requirement in this rulemaking to 
add a vitamin D requirement for cow's milk-based yogurt. The proposed 
soy-based yogurt and cheese milk substitution options for child, 
pregnant, postpartum, and breastfeeding participant food packages would 
therefore include the following minimum nutrient specifications:
     Soy-based yogurts that contain <=30 grams of total sugars 
and at least 250 milligrams of calcium, 6.5 grams of protein, and 100 
International Units (2.5 micrograms) of vitamin D per 8-ounce serving.
     Soy-based cheeses that contain at least 250 milligram of 
calcium and 6.5 gram of protein per 1.5-ounce serving.
    The Department requests public comment on this provision, 
particularly related to the marketplace availability of soy-based 
yogurts and cheeses meeting these proposed nutrient specifications. The 
Department is also requesting public comment on the possibility of a 
State agency option to allow, and the marketplace availability of, 
other plant-based yogurts that meet the proposed specifications for 
cow's milk-based yogurt.
    As described above, the Department also requests public comment on 
the limit of total sugars in soy-based yogurts proposed provision with 
specific interest in the use of an added sugars limit instead of a 
total sugars limit such as the suggested added sugars limits for yogurt 
provided in Table 6.5 (page 303) of the NASEM report \27\ or an 
alternative.
---------------------------------------------------------------------------

    \27\ https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice.
---------------------------------------------------------------------------

7. Update FDA Standard of Identity Citations for Yogurt (Sec.  
246.10(e)(12), Table 4)
    The Department proposes to update the standard of identity 
citations for low-fat and nonfat yogurt to conform with newly published 
regulations from FDA. The FDA issued a final rule \28\ to amend and 
modernize the standard of identity for yogurt that revokes the previous 
standards of identity for low-fat yogurt (21 CFR 131.203) and nonfat 
yogurt (21 CFR 131.206) and amends the standard of identity for yogurt 
(21 CFR 131.200).\29\ The FDA rule was effective July 12, 2021, with a 
compliance date of January 1, 2024.
---------------------------------------------------------------------------

    \28\ Federal Register: Milk and Cream Products and Yogurt 
Products; Final Rule To Revoke the Standards for Low-fat Yogurt and 
Nonfat Yogurt and To Amend the Standard for Yogurt (86 FR 31117, 
June 11, 2021).
    \29\ https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-131/subpart-B/section%20-131.200.
---------------------------------------------------------------------------

8. Allow Reduced-Fat Yogurts for 1-Year-Old Children Without 
Restrictions (Sec.  246.10(e)(10) and (11), Tables 2 and 3)
    To better align with the DGA, the Department proposes to allow 
yogurts other than whole fat yogurt to be issued to children 12 through 
23 months of age based on an individual nutrition assessment. This 
proposed change would eliminate the current State Agency option to 
require (if necessary) a consultation with the child's health care 
provider to issue low-fat (0.5%-2%) or nonfat yogurt to children 12 
through 23 months of age. Whole fat and low-fat yogurt, which is 
referred to as `reduced-fat yogurt' in the DGA, would be the standard 
yogurt for issuance to children 12-23 months of age. 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. This change would expand yogurt variety and 
participant choice for children in this age group as well as reduce 
administrative burden.
9. Remove Cheese From the Fully Breastfeeding Food Package (Sec.  
246.10(e)(7)(ii) and (e)(10) and (11), Tables 2 and 3)
    As recommended by NASEM, this proposed rule would remove 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 and would provide better balance of 
nutrients--the current fully breastfeeding food package provides 159 
percent of the daily recommended amount of calcium from the milk and 
cheese categories. Currently, cheese is only a separate food category 
in Food Package VII. However, cheese is a milk substitution option in 
other food packages (except for infant food packages), meaning that 
cheese can be substituted for a portion of the maximum monthly 
allowance of milk. The Department is not proposing to remove cheese as 
a milk substitute option or adjust the substitution ratio. Therefore, 
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.

D. Infant Foods

    As recommended by NASEM and consistent with the DGA, the proposed 
changes would reduce the amounts of (1) infant cereal for all infants 
and (2) infant fruits and vegetables and infant meat for fully 
breastfed infants; lower the minimum age for the option to substitute 
the CVV for infant fruits and vegetables and increase substitution 
amounts; and exclude added fats as an allowable ingredient in infant 
foods.
    These proposed revisions would not change the types of infant foods 
offered and would maintain 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 proposed reductions in infant foods would provide 
appropriate supplemental quantities and align with the AAP's 
complementary feeding recommendations.
1. Reduce Infant Cereal, Infant Fruits and Vegetables, and Infant Meat 
(Sec.  246.10(e)(9), Table 1)
    For all infants ages 6 through 11 months, this proposed rule would 
reduce the amounts of infant cereal. For fully breastfed infants, this 
proposed rule would reduce the amounts of infant fruits and vegetables 
and infant meat. In response to NASEM's review, which found that the 
current food package provides 150 percent of the maximum amounts of 
infant cereal recommended by the AAP, the proposed rule would reduce 
quantities of infant cereal. The reduced infant cereal quantity for 
partially (mostly) breastfed and fully formula fed infants would 
provide approximately 50 percent of the AAP-recommended amount. The 
reduced infant cereal quantity for fully breastfed infants would 
provide 100 percent of the AAP-recommended amount because iron and zinc 
are critical nutrients for fully breastfed infants.
    According to NASEM, the current food package provides fully 
breastfed infants with more than a one cup-equivalent amount of fruits 
and

[[Page 71099]]

vegetables per day, an amount difficult for 6 through 11-month-old 
infants to consume and with no apparent nutritional rationale (the DGA 
and AAP do not have specific recommendations for infant fruit and 
vegetable consumption for this age group). Further, fully breastfed 
infants do not have a greater need for fruits and vegetables compared 
to other infants. Therefore, the amount of infant fruits and vegetables 
for fully breastfed infants would be reduced (from 256 ounces per 
month) to the amount currently provided to partially (mostly) breastfed 
and fully formula fed infants (128 ounces per month, or a one-half-cup 
equivalent per day). There is no proposed change to the amount of 
infant fruits and vegetables for partially (mostly) breastfed or fully 
formula fed infants.
    Infant meat, still limited to the fully breastfed infant food 
package, would be reduced from 77.5 to 40 ounces per month and provide 
approximately 65 percent of the AAP-recommended maximum amount. This 
reduction addresses NASEM's recommendation based on the finding that 
the current food package provides 130 percent of the amount of infant 
meat recommended by the AAP.
    In summary, this proposed rule would provide the following maximum 
monthly amounts of infant cereal, infant fruits and vegetables, and 
infant meat:
     Fully breastfed infants:

[cir] 16 ounces infant cereal
[cir] 128 ounces infant fruits and vegetables
[cir] 40 ounces infant meat

     Partially (mostly) breastfed and fully formula fed 
infants:

[cir] 8 ounces infant cereal
[cir] 128 ounces infant fruits and vegetables (no change)
[cir] No infant meat (no change)

    Due to the low redemption of infant meat and importance of this 
food as an iron source for fully breastfed infants, the Department 
requests public comment on ways to support increased redemption and 
consumption of this food category, and of iron-rich foods in general, 
for fully breastfed infants.
    NASEM recommended allowing the option to substitute 10 ounces of 
canned fish for the same amount of infant meat, given widespread 
commercial availability and high iron content of fish. However, the 
Department is not proposing this change for a variety of reasons. Most 
importantly, since NASEM released its 2017 report, updated guidance 
(i.e., the 2020-2025 DGA and the FDA and Environmental Protection 
Agency's (EPA) 2021 joint advice about eating fish \30\) provided 
updated information about methylmercury exposure for younger children. 
Although fish can be among the complementary foods offered to an older 
infant, the DGA do not provide an infant dietary pattern with 
recommended amounts and types of fish, nor does the FDA or EPA provide 
guidance about fish consumption for infants as they do for other age 
groups. Currently, there is no scientific guidance for the Department 
to determine which varieties of fish are safe or how much to recommend 
for infants to limit methylmercury exposure.
---------------------------------------------------------------------------

    \30\ Advice about Eating Fish [verbar] FDA.
---------------------------------------------------------------------------

    Another factor the Department considered is the sodium content of 
canned fish. Per ounce, canned fish is typically higher in sodium than 
infant meat. To stay within the DGA recommendations for sodium for 
infants, WIC-eligible canned fish for infants would need to have a 
sodium amount that is close to that for infant meat (approximately 30 
to 40 milligrams of sodium per 2.5 ounces). Such products do not appear 
to be widely available in the marketplace. In addition, package sizes 
currently available for canned fish pose a challenge for ensuring food 
safety and minimizing waste given that low acid canned foods, such as 
fish, should be consumed within 3 to 4 days after opening.\31\ A WIC-
eligible container size would need to be small enough to provide a 
supplemental amount for weekly consumption. To date, the Department is 
not aware of widespread availability of package sizes of canned fish 
that would provide an appropriate portion for infants over the period 
of a week, without significant waste. Therefore, after a careful review 
of updated guidance and considerations of marketplace availability, the 
Department does not propose to add canned fish as a substitute for 
infant meat.
---------------------------------------------------------------------------

    \31\ FoodKeeper App [verbar] FoodSafety.gov.
---------------------------------------------------------------------------

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)
    As recommended by NASEM, this proposed rule would increase the CVV 
substitution amount for infants; allow the CVV for infants to be used 
to purchase at least one other form (canned or frozen) of fruits and 
vegetables in addition to fresh, which can offer similar nutrition 
benefits to fresh forms (see Section A-2. ``Require One Other Form of 
Fruits and Vegetables in Addition to Fresh'' for more information); and 
lower the age (from 9 to 6 months) at which the CVV can be substituted 
for infant fruits and vegetables. These proposed changes would increase 
participant choice as well as accommodate participant cultural and 
personal preferences. 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. As noted in the DGA, exposure to 
different types of food is important early in life to better develop a 
child's interest and willingness to eat and enjoy a variety of foods.
    The proposed changes to CVV substitution amounts would allow half 
(64 ounces) or all (128 ounces) of jarred infant fruits and vegetables 
to be substituted with a $10 or $20 CVV, respectively, for all food 
packages for infants ages 6 through 11 months. Current regulations 
allow substituting only half of the jarred infant fruits and vegetables 
with a $4 CVV for fully formula-fed and partially (mostly) breastfed 
infants or a $9 CVV for fully breastfed infants. The proposed CVV 
substitution amount for jarred infant fruits and vegetables is based on 
a composite cost of $0.16 per ounce, which gives a conversion rate of 
about $10.00 or 64 ounces of jarred infant fruits and vegetables. This 
composite cost aligns with the conversion rate used by NASEM and was 
further substantiated by the Department using more recent national 
retail data. The monthly value of the CVV substitution amounts for 
infant fruits and vegetables will be adjusted annually for inflation 
consistent with the inflation adjustments made to CVV values in other 
food packages.
    In summary, this proposed rule would provide the following CVV 
substitution amounts and maximum monthly allowances of jarred infant 
fruits and vegetables for infants ages 6 through 11 months:
    [cir] $10 CVV and 64 ounces of jarred infant fruits and vegetables, 
or
    [cir] $20 CVV and no jarred infant fruits and vegetables.
3. Prohibit Added Fats in Infant Foods (Sec.  246.10(e)(12), Table 4)
    The DGA support that infants 6 through 11 months of age should be 
on the path to a healthy dietary pattern that is recommended for those 
aged 12 through 23 months. A healthy dietary

[[Page 71100]]

pattern includes nutrient-dense foods prepared with minimal added 
sugars, refined starches, or sodium as well as foods that are lean or 
in low-fat forms (with the exception of dairy for the 1-year-old). The 
recommendation to limit saturated fat to less than 10 percent of 
calories does not apply to children under age 2 years; however, healthy 
dietary patterns for 12 through 23 months have no remaining calories 
available for consuming additional added sugars, saturated fat, or more 
than the recommended amount of foods. As such, the Department proposes 
to exclude ``added fats'' from the ingredients authorized for infant 
foods. This proposed rule does not intend to imply that total fat 
should be restricted in this age group, rather excluding ``added fats'' 
from the ingredients authorized for infant foods aligns with a healthy 
eating pattern and anticipates the transition that will occur as 
children continue their eating trajectory to a healthy diet.
E. Add Infant Formula Flexibilities and Create a Separate Food Package 
for Partially (Mostly) Breastfeeding Participants
    As recommended by NASEM, this proposed rule would add flexibilities 
to infant formula amounts and create a separate food package to support 
individual breastfeeding goals of participants and may lead to the 
establishment of successful long-term breastfeeding. The proposed 
changes would:
     Increase formula amounts in the first month for partially 
(mostly) breastfed infants.
     Allow all prescribed infant formula quantities to be 
considered ``up to'' amounts.
     Create a separate and enhanced food package for partially 
(mostly) breastfeeding participants.
1. Increase Formula Amounts in the First Month for Partially (Mostly) 
Breastfed Infants (Sec.  246.10(e)(1)(ii) and (e)(9), Table 1)
    As recommended by NASEM, the proposed rule would increase 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. 
[Note: The revised amount of 364 fluid ounces reflects the full 
nutrition benefit that corresponds to the maximum month allowance of 
388 fluid ounce reconstituted liquid concentrate, 384 fluid ounces 
ready-to-feed, or 435 fluid ounces reconstituted powder formula for 
partially breastfed infants aged one through three months. Therefore, 
this proposed provision eliminates the need for the birth to one month 
feeding category.]
    This proposed change is intended to encourage participants in the 
early postpartum period who are not certain they can succeed at 
breastfeeding to try to breastfeed. This change would increase 
flexibility and support for any amount of breastfeeding during the 
first month by providing partially (mostly) breastfeeding participants 
an amount of formula to support their desired level of breastfeeding. 
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 better support her nutritional needs and 
her breastfeeding goals, with the ultimate goal of extending the 
duration of breastfeeding.
2. Allow All Prescribed Infant Formula Quantities To Be Considered ``Up 
To'' Amounts (Sec.  246.10(e)(9), Table 1)
    As recommended by NASEM and consistent with FNS policy and 
guidance, formula quantities in all infant food packages would be ``up 
to'' amounts. Currently in regulations there are maximum monthly 
allowances and minimum, or ``full nutrition benefit,'' \32\ (FNB) 
amounts. The proposed change to ``up to'' amounts would emphasize the 
importance of assessing, by WIC staff, the actual need for formula of 
the breastfeeding mother-infant dyad. Infant formula amounts for 
breastfed infants, even those in the fully formula-fed category, should 
be individually tailored. This change would allow the amount to be less 
than the FNB. The intent of this proposed change is to reduce 
interference with the successful establishment of the mother's desired 
breastfeeding behavior while issuing formula amounts for infants that 
meet their nutritional needs.
---------------------------------------------------------------------------

    \32\ Full nutrition benefit is defined in Sec.  246.2: The 
minimum amount of reconstituted fluid ounces of liquid concentrate 
infant formula as specified in Table 1 of Sec.  246.10(e)(9) for 
each food package category and infant feeding variation (e.g., Food 
Package IA fully formula fed, IA-FF).
---------------------------------------------------------------------------

    Although not proposing revisions to the iron standard for infant 
formula the Department seeks comment about the current iron 
requirement. Iron is important at all stages of a child's development. 
Young children who don't get enough iron are at higher risk for 
developmental problems. Iron fortified infant formula can help reduce 
iron deficiency in formula fed and partially breastfed babies. The 
NASEM review found that the current iron requirement for infant formula 
supports the needs of infants ages 0 to less than 12 months, without 
exceeding the Upper Limit for this age group, and also found that there 
was inadequate evidence available during the time of the study to 
support changing the concentration of iron required in WIC-eligible 
formula.
    Reducing iron deficiency in children remains a public health 
priority and is a Healthy People 2030 objective. In addition, the NASEM 
review observed that inconclusive evidence suggests that iron intake in 
infants is associated with long-term cognitive, motor, and social-
emotional outcomes and that updated data are needed to understand the 
optimal level of infant formula iron, particularly in cases where the 
baseline iron status of infants is poor compared to cases where iron 
status is adequate. The Department requests public comment on the 
current iron standard of 1.5 milligrams of iron per 100 kcal at 
standard dilution, with specific interest in the effect of reducing the 
standard while providing sufficient supplementation to prevent iron 
deficiency in infants.
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)
    Currently, pregnant (singleton pregnancy) and partially (mostly) 
breastfeeding participants receive the same food package (Food Package 
V), with no differentiation in monthly maximum allowances for the foods 
provided. As recommended by NASEM, this proposed rule would create 
separate food packages, with food package V-A for pregnant participants 
and food package V-B for partially (mostly) breastfeeding participants 
and pregnant participants with two or more fetuses (moving the latter 
category from Food Package VII to Food Package V-B). The food package 
changes for partially (mostly) breastfeeding participants would provide 
greater CVV and canned fish amounts compared to the pregnant 
participant food package. For more

[[Page 71101]]

information about the changes to the CVV amounts and canned fish, 
please see sections A: ``Fruits and Vegetables'' and H: ``Canned 
Fish.''
    These enhancements to the partially (mostly) breastfeeding food 
package are intended to promote breastfeeding among participants who 
are not exclusively breastfeeding their infants and align with the 
higher calorie needs of breastfeeding individuals.

F. Breakfast Cereals

    As recommended by NASEM, the proposed revisions would change the 
criteria for whole grain breakfast cereals and require that all 
breakfast cereals meet the criteria for whole grain. These changes are 
designed to increase the amount of whole grains in the food packages 
that provide whole grains and improve consistency with FNS Child 
Nutrition Programs (CACFP, the National School Lunch Program, and the 
National School Breakfast Program).
1. Change Whole Grain Criteria for Breakfast Cereals (Sec.  
246.10(e)(12), Table 4)
    In response to NASEM's recommendation to align the whole grain 
criteria with the FNS Child Nutrition Programs' whole grain criteria, 
the Department proposes to require that WIC-eligible whole grain 
breakfast cereals contain a whole grain as the first ingredient. 
Currently, WIC-eligible whole grain breakfast cereals must have whole 
grain as the primary ingredient by weight and meet the FDA labeling 
requirements for making a health claim as a ``whole grain food with 
moderate fat content'' but does not have to have whole grain as the 
first ingredient. This change in criteria streamlines the process of 
determining whether a breakfast cereal is a whole grain cereal and may 
allow a broader variety of whole grain products for participants to 
choose from, compared to the existing criteria.
2. Require All Breakfast Cereals Meet Whole Grain Criteria (Sec.  
246.10(e)(10) Through (12), Tables 2 Through 4)
    The 2020-2025 DGA notes that 98 percent of Americans fall below 
recommendations for whole grain intake and 74 percent exceed limits for 
refined grains. The DGA also note that 80 percent of refined grains are 
generally eaten as separate food items, such as cereals, breads, 
tortillas, pasta, rice, or pancakes, and that fiber is a nutrient of 
public health concern since low intakes are associated with health 
concerns. Additionally, NASEM's report indicates that 100 percent of 
pregnant, breastfeeding, and postpartum WIC participants and over 93.3 
percent of child participants do not meet recommended whole grain 
intakes.
    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 increase 
whole grain intake and would increase nutrition security and equity by 
increasing participant access to whole grains. Therefore, the 
Department proposes to require that all WIC-authorized breakfast 
cereals be whole grain, in accordance with the criteria described in 
section one (above). Currently, only one-half of the total number of 
breakfast cereals on the State agency's authorized food list must be a 
whole grain cereal.
    The requirement that all breakfast cereals meet the criteria for 
whole grain cereal was first recommended by the IOM in its 2006 report 
and was included in the Department's 2006 proposed rule. However, the 
requirement was not included in the 2007 interim rule due to concerns 
that the proposed whole grain nutritional requirement for breakfast 
cereal would eliminate corn and rice-based cereals, which can be 
alternatives for people with allergies or intolerances. It would have 
also significantly limited the variety and choice of WIC-eligible 
breakfast cereals due to the lack of availability of whole grain 
cereals in the marketplace at the time. As a result, the 2007 interim 
rule revised the nutrient criteria to require at least one-half of all 
breakfast cereals on the State's authorized food list meet the whole 
grain requirement.
    In its most recent review, NASEM reviewed product information 
provided by two large national breakfast cereal manufacturers and found 
that a sufficient number of breakfast cereals (including gluten-free 
varieties for those with celiac disease, allergies or intolerances) 
would meet the proposed whole grain criteria. NASEM also found a 
significant expansion in the availability of whole grain products in 
the marketplace since 2006, thus mitigating previous concerns.
    Sufficient marketplace availability is an important consideration 
before implementing this change since breakfast cereals are a key 
source of important nutrients (e.g., iron). Therefore, the Department 
specifically requests public comment on this change to better 
understand the impact of this provision. While USDA is not proposing a 
change to the specifications for sugar in breakfast cereals, the 
Department recognizes the 2020-2025 DGA recommendation to limit 
consumption of foods higher in added sugars, and requests public 
comment with regard to the use of an added sugars limit instead of a 
total sugars limit for breakfast cereal. The Department specifically 
seeks comment on an added sugars limit for breakfast cereal that would 
maintain palatability of the products, described by NASEM as 
significant contributors to micronutrient intakes in the U.S. 
population and a source of whole grains, while achieving the dietary 
recommendation to limit added sugars consumption and ensuring 
marketplace availability.

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

    As recommended by NASEM and supported by the DGA, the proposed 
revisions would reduce the amount of bread provided to children, 
increase the amount of bread provided to pregnant, postpartum, and 
breastfeeding participants, change the criteria for WIC-eligible whole 
grain breads, and expand whole grain options.
1. Revise Maximum Monthly Allowances for Whole Wheat and Whole Grain 
Bread and Other Whole Grain Options (Sec.  246.10(e)(10) and (11), 
Tables 2 and 3)
    As recommended by NASEM, with modification, the proposed changes 
would provide whole wheat bread, whole grain bread, and whole grain 
options in supplemental amounts that better align with the DGA, 
particularly for pregnant, postpartum, and breastfeeding participants. 
The proposed revision would reduce (from 32 to 24 ounces) the quantity 
of bread or whole grain options for children. The reduced amount for 
children represents the upper end of NASEM's recommended range of 16 to 
24 ounces and would provide 27 to 53 percent of the whole grains 
subgroup amount recommended in the DGA Healthy U.S.-Style Dietary 
Pattern.\33\ The proposed revision would increase (from 16 to 48 
ounces) the amount for pregnant, postpartum, and breastfeeding 
participants. This proposed increased

[[Page 71102]]

amount exceeds NASEM's recommended amount (24 ounces). The Department's 
proposed amount would provide 40 to 53 percent of the DGA recommended 
whole grains subgroup amount, while the amount recommended by NASEM 
would provide 13 to 27 percent. The increased amount would provide and 
encourage consumption of whole grains, consistent with the DGA, in 
quantities closer to NASEM's definition of a supplemental amount and 
align with common package sizes found in the marketplace.
---------------------------------------------------------------------------

    \33\ For children ages 12 to 23 months, the reduced whole wheat 
bread/whole grain bread quantity provides 40-53% of the DGA based on 
1.5-2 oz eq/day for 700-1,000 kcal. For children 2 to 4 years, the 
reduced whole wheat bread/whole grain bread quantity provides 27-53% 
of the DGA based on 1.5-3 oz. eq/day for 1,000-1,600 kcals. For 
postpartum, pregnant, and breastfeeding participants, the increased 
whole wheat bread/whole grain bread quantity provides 40%-53% of the 
DGA based on 3-4 oz eq/day for 2,000-2,400 kcals.
---------------------------------------------------------------------------

    The proposed changes would provide the following monthly maximum 
amounts of whole wheat bread, whole grain bread, and whole grain 
options:

 Children 1 through 4 years: 24 ounces
 Pregnant, Postpartum, and Breastfeeding: 48 ounces

    NASEM also recommended a range for whole grains; however, the 
Department is not proposing this change. To achieve NASEM's intent to 
provide greater flexibility, the Department instead proposes changes to 
requirements related to the maximum monthly amounts (see Section J: 
``Maximum Monthly Amounts''). The Department will maintain the 
requirement for State agencies to provide participants with the full 
amount by ensuring one or more State-authorized package sizes equal or 
add up to the full amount, while providing the flexibility to also 
authorize packages sizes that may not add up to full amount, if the 
participant chooses to take less. This proposed change could 
potentially ease the burden on small vendors who have expressed 
difficulty stocking the currently required package sizes.
    The Department is not in support of NASEM's recommendation to limit 
bread options to 100 percent whole wheat as this would remove other 
whole grain breads from being WIC-eligible, thus limiting variety and 
choice for participants. Currently, State agencies can authorize whole 
wheat and/or whole grain bread such as whole grain rye, pumpernickel, 
oat, and honey wheat.
2. Change Criteria for Whole Grain Breads (Sec.  246.10(e)(12), Table 
4)
    Using NASEM's principle of aligning with CACFP guidance on 
breakfast cereal whole grain criteria, the Department is similarly 
proposing to change the whole grain criteria for WIC-eligible whole 
grain bread, consistent with CACFP. Currently, WIC regulations require 
whole grain bread meet all of the following: conform to FDA standards 
of identity as applicable, have a whole grain as the primary ingredient 
by weight, and meet the FDA labeling requirements for making a health 
claim as a ``whole grain food with moderate fat content.'' The proposed 
change would maintain the requirement for the FDA standards of 
identity, as applicable, and replace the primary ingredient and FDA 
labeling criteria with the requirement that whole grain bread contain 
at least 50 percent whole grains with the remaining grains being either 
enriched or whole grains. Because the whole grain content of food 
products is not always easily identifiable on a product label, the 
Department would provide additional guidance on evaluation of grain 
products as needed.
    The Department requests public comment on the impact of adopting 
the revised criteria for whole grain breads.
3. Expand Whole Grain Options (Sec.  246.10(e)(10) Through (12), Tables 
2 Through 4)
    The Department proposes to expand whole grain options beyond those 
specifically recommended by NASEM, which would provide participants 
with additional variety, and choice to accommodate special dietary 
needs (e.g., food allergies) and cultural and personal preferences 
while promoting increased consumption of whole grains overall. The 
proposed expansion of whole grain options is responsive to participant 
requests for more choices for bread substitutions, while still 
providing important priority nutrients, and is intended to increase 
whole grain consumption by offering a greater variety of grains.
    The DGA recommend making at least half of all grains consumed whole 
grains and notes that whole grains are currently under-consumed by the 
U.S. population. Further, as noted above, NASEM's report indicates that 
refined grain intake of WIC participants is excessive. The current 
whole grain options for WIC participants are brown rice, bulgur, oats, 
whole-grain barley, and whole wheat macaroni products without added 
sugars, fats, oils, or salt (i.e., sodium), and soft corn or whole 
wheat tortillas. The proposed additional whole grain options would add: 
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. 
These additional options are nutritionally appropriate items that WIC 
State and local agency staff and participants expressed interest in 
adding to the food packages via NASEM's public comment process. The 
additional proposed whole grain options align with products allowed in 
other FNS Programs.

H. Canned Fish

    In alignment with the DGA and NASEM recommendations, the proposed 
rule would add canned fish, which refers to processed products in cans, 
pouches, or other shelf-stable containers (see Sec.  246.10(e)(12)), to 
several food packages, including the child food packages (for children 
ages 2 through 4 years) and food packages for pregnant, postpartum and 
partially (mostly) breastfeeding participants (currently fish is only 
provided to fully breastfeeding participants) and reduce the amount of 
canned fish currently provided to fully breastfeeding participants. 
These changes would expand the categories of participants receiving 
canned fish, creating more equitable access to this under-consumed 
food.
    NASEM recommended adding canned fish to the additional food 
packages on a three-month rotation, alternating with peanut butter and 
legumes, to achieve a cost-neutral change. In this proposed rule, the 
Department instead proposes to maintain the monthly provision of peanut 
butter and legumes and add canned fish on a monthly basis to pregnant, 
postpartum, and partially (mostly) breastfeeding and child food 
packages (for children 2 through 4 years). In evaluating the three-
month rotation recommendation, the Department determined that this 
could be confusing to participants and 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.
1. Add Canned Fish to Food Packages for Children (2 Through 4 Years) 
and Specify WIC-Eligible Varieties for Children (Sec.  
246.10(e)(4)(ii), and (10) Through (12), Tables 2 Through 4)
    As recommended by NASEM, with modifications, and in alignment with 
the DGA, this proposed rule would add 5 ounces of canned fish per month 
to the food packages for children ages 2 through 4 years. The only 
types of canned fish allowed for children would be salmon, sardines, 
and Atlantic mackerel. It is important to note that with the 
implementation of this proposed change, WIC nutrition

[[Page 71103]]

education would need to encourage parents/caretakers to select boneless 
canned fish or remove bones prior to consumption to prevent choking; 
choose lower sodium varieties; use the fish within 3 to 4 days of 
opening the can to ensure food safety; and serve fish varieties and 
amounts that limit the potential for methylmercury exposure. In 
addition, the Department would encourage WIC State agencies to 
authorize smaller package sizes whenever possible (i.e., 2.5 ounces).
    The proposed monthly maximum amount of canned fish for children (2 
through 4 years of age) would be as follows:

 Children 2 through 4 years: 5 ounces canned fish

    Based on the FDA and Environmental Protection Agency (EPA) 2014 
joint advice on eating fish for breastfeeding and pregnant individuals, 
individuals who might become pregnant, and children, NASEM also 
recommended canned fish for 1-year-old children and allowing fish to be 
substituted for infant meat. However, based on updated Federal 
guidance, the Department is not proposing these changes. Specifically, 
in 2021 34 35 the FDA and EPA updated their joint advice 
about eating fish, which incorporates 2020-2025 DGA recommendations; 
identifies fish types and serving sizes safe for consumption based on 
estimated methylmercury exposure; and newly includes advice for 
children age 1 year (previous advice included recommendations for 
children 2 to 11 years), including a subset list of ``Best Choices'' 
that contain lower methylmercury to support children age 1 year in 
consuming the quantities recommended in the Healthy U.S.-Style Dietary 
Pattern without exceeding limits for estimated methylmercury exposure. 
The advice also indicates that many commonly consumed fish types 
(including light canned tuna, a WIC-eligible variety) should be limited 
to the amounts in the FDA-EPA Fish Advice (footnote) due to their 
methylmercury content. To the Department's knowledge, other WIC-
eligible fish varieties that are part of the ``Best Choices'' subset 
(i.e., salmon, sardines, and Atlantic mackerel) are not widely 
available in the marketplace in sizes appropriate for infants or 1-year 
old children to meet the FDA-EPA guidance and DGA recommendations or to 
provide supplemental amounts. Therefore, it is not feasible to safely 
include fish in WIC food packages for infants or 1-year-old children.
---------------------------------------------------------------------------

    \34\ https://www.epa.gov/fish-tech/epa-fda-advice-about-eating-fish-and-shellfish.
    \35\ Advice about Eating Fish [verbar] FDA.
---------------------------------------------------------------------------

    The Department specifically requests public comment on the 
availability of 3-ounce or smaller package sizes (e.g., 1 oz. pouch) of 
salmon, Atlantic mackerel, and sardines \36\ in boneless varieties for 
the potential of adding fish to the 1-year-old food package. The 
Department also requests public comment on the marketplace availability 
of canned light tuna in package sizes safe for consumption by young 
children (i.e., 2 oz.).
---------------------------------------------------------------------------

    \36\ This list is not representative of all fish included in 
FDA's ``Best Choices'' category; the full list is available at: 
https://www.fda.gov/food/metals-and-your-food/technical-information-development-fdaepa-advice-about-eating-fish-those-who-might-become-or-are.
---------------------------------------------------------------------------

2. Add Canned Fish in Food Packages for Pregnant, Postpartum, and 
Partially (Mostly) Breastfeeding Participants, Revise Amounts for Fully 
Breastfeeding Participants, and Revise WIC-Eligible Varieties (Sec.  
246.10(e)(5)(ii), (e)(6)(ii), and (e)(10) Through (12), Tables 2 
Through 4)
    As recommended by NASEM, with modifications, this proposed rule 
would add canned fish to the pregnant, partially (mostly) 
breastfeeding, and postpartum participant food packages on a monthly 
basis. Currently, canned fish is included only in the fully 
breastfeeding food package and the proposed changes would decrease the 
monthly amount from 30 to 20 ounces. Proposed monthly fish amounts for 
these food packages align with NASEM's supplemental approach and DGA 
dietary patterns. In addition, the proposed monthly amounts of fish are 
consistent with NASEM's overall approach to enhancing the food package 
for partially (mostly) breastfeeding participants to promote 
breastfeeding.
    The proposed monthly maximum amounts of canned fish for pregnant, 
postpartum, partially (mostly) and fully breastfeeding participants 
would be as follows:

 Pregnant and postpartum: 10 ounces canned fish
 Partially (mostly) breastfeeding: 15 ounces canned fish
 Fully breastfeeding: 20 ounces canned fish

    Additionally, 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, the Department 
is proposing to eliminate jack mackerel as an allowable fish type for 
the WIC Program.
    The Department will use any updated FDA-EPA guidance on fish, as 
appropriate, when developing a final rule as it relates to fish types 
and serving sizes safe for consumption based on estimated methylmercury 
exposure.

I. Legumes and Eggs

    As recommended by NASEM, the proposed changes would require State 
agencies to authorize canned legumes in addition to dried legumes. The 
Department also proposes to require State agencies to authorize peanut 
butter and legumes, and to give State agencies the option to authorize 
tofu, as substitutes for eggs. Such authorization would be to provide 
greater variety and choice for participants who have an egg allergy, 
are vegan, or for other reasons (e.g., cultural preferences) as 
determined by the State agency's policy. Currently there is no 
substitution option for eggs, except for participants experiencing 
homelessness. These proposed revisions expand upon NASEM's 
recommendation to permit the substitution of legumes for eggs if a 
participant has an egg allergy or is vegan.
    While NASEM recommended reducing quantities of peanut butter and 
legumes to supplemental levels via a three-month rotation (previously 
described in section H ``Canned Fish''), the Department anticipates 
that such an approach would pose undue challenges for State agencies 
and participants. Further, the Department is unable to reduce monthly 
amounts of peanut butter and legumes since they are not generally 
available in smaller package sizes than those currently authorized. As 
such, the Department will maintain the current monthly amounts of 
peanut butter and legumes. The following changes related to legumes and 
eggs are proposed:
1. Require Both Dried and Canned Legumes (Sec.  246.10(e)(10) Through 
(12), Tables 2 Through 4)
    As recommended by NASEM, this proposed change would 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. For participants in States that do not exercise this option, 
the change would reduce a potential barrier to preparing and consuming 
legumes for participants who may not have the time or ability to 
prepare dried beans. State agencies will

[[Page 71104]]

retain their current authority to authorize only low/lower sodium 
canned varieties.
    The Department requests public comment on any potential barriers 
and/or unanticipated effects of requiring State agencies to offer both 
dried and canned legumes.
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)
    Based on NASEM's recommendations, with modification, the proposed 
changes would require that State agencies allow the substitution of 
eggs with legumes and peanut butter if a participant has an egg 
allergy, is vegan, or for other reasons (e.g., cultural preferences) as 
determined by State agency policy and allow 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. For 
these reasons, the Department has determined that requiring peanut 
butter and legumes as substitutes for eggs is nutritionally 
appropriate, promotes equity, and will not increase administrative 
burden.
    The Department also proposes to allow State agencies the option to 
authorize tofu as a substitute for eggs. Like eggs, tofu is a source of 
choline and iron. Currently, State agencies have the option to 
authorize tofu as a milk substitute and as of publication of this 
proposed rule, 54 of the 89 State agencies permit this option. Allowing 
the option to authorize it as an egg substitute creates more State 
agency flexibility and would give participants more options, 
particularly for those participants with special dietary needs that 
preclude the ability to receive peanut butter or legumes in lieu of 
eggs.
    Since eggs are a source of heme iron (more readily absorbed by the 
body) and legumes, peanut butter, and tofu are sources of non-heme iron 
(less readily absorbed), appropriate food package tailoring and 
nutrition education would need to address other food sources of iron, 
especially for participants determined to have low iron levels.
    This change would allow children and all other participant 
categories (except infants) to substitute the following for one dozen 
eggs if a participant has an egg allergy or is vegan, or for other 
reasons (e.g., cultural preferences) as determined by the State 
agency's policy:

 1 pound dry or 64 ounces canned legumes
 18 ounces peanut butter
 1 pound tofu (at State agency option)

    The Department recognizes that it is currently a State agency 
option to authorize tofu as a substitute for milk, therefore, not all 
State agencies authorize this food item. The Department requests public 
comment on the impact of requiring State agencies to authorize tofu as 
an egg substitute for participants who have an egg allergy or are 
vegan, or for other reasons (e.g., cultural preferences) as determined 
by the State agency's policy.
    The Department also requests public comment on allowing other nut 
and seed butters as a legume or peanut butter substitution option to 
further accommodate participants with food allergies. To be consistent 
with the scientifically based standards described in this proposed 
rule, the Department is especially interested in public comment on the 
commercial availability of nut and seed butters that are nutritionally 
equivalent (or close) to peanut butter/legumes in terms of the priority 
nutrients (e.g., protein, iron).

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

    To further expand participant variety and choice, this proposed 
rule would allow State agencies more flexibility when authorizing 
product package sizes (with the exception of WIC formula) \37\ for 
their approved product lists. WIC State agencies would continue to be 
required to make available the full maximum monthly allowance (MMA) 
amounts to participants (i.e., at least one package size, or a 
combination of sizes, must add up to the full MMA provided in each of 
the food packages). However, this change would allow State agencies to 
authorize additional product package sizes that provide less than the 
full MMA. Participants could therefore choose to redeem less than the 
full amount their food package provided. This flexibility would allow 
States to offer more product package sizes, thus giving participants 
more variety and choice of foods available with their WIC food 
benefits. The Department encourages State agencies to provide 
participants with 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, to meet their 
participants' needs. The Department recognizes that, as part of their 
administrative option granted under Sec.  246.10(b)(1)(i), modifying 
authorized package sizes is among the strategies State agencies use to 
control costs for the set funds they receive to administer their WIC 
programs; therefore, the Department is requesting public comment on 
requiring State agencies to authorize both package sizes that equal or 
add up to the maximum monthly allowance (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).
---------------------------------------------------------------------------

    \37\ WIC formula includes infant formula, exempt infant formula 
and WIC-eligible nutritionals. WIC formula must be authorized in 
sizes that correspond with the maximum monthly allowances per Sec.  
246.10(e)(9) and (11).
---------------------------------------------------------------------------

    Additionally, to accommodate instances when there are two or more 
participants from the same household (e.g., a breastfeeding participant 
and a two-year old child), currently State agencies may aggregate food 
amounts but may not authorize container sizes that exceed the MMA for 
an individual participant. In current guidance, the Department notes 
that aggregation may be useful when benefits are issued via electronic 
benefits transfer (EBT). With the vast majority of State agencies now 
issuing benefits via EBT and the rest working toward EBT in the near 
term, the Department is proposing to allow State agencies to authorize 
package sizes that exceed the MMA for each individual food package to 
increase variety and choice for households with multiple participants. 
However, the household would still not be able to exceed the total of 
the combined MMA. Additionally, the Department would still require that 
foods on State agency authorized food lists meet the needs of each 
individual food package prescription. Therefore, some foods may not be 
aggregated for issuance to two or more participants from the same 
family but in a different participant category (e.g., canned fish where 
certain types authorized for pregnant, postpartum, and breastfeeding 
participants are not authorized for child participants). Additionally, 
the requirement in Sec.  246.10(b)(2)(ii)(D) that local agencies advise 
participants or their caretakers

[[Page 71105]]

that the supplemental foods are only for the participant's personal use 
remains in effect. This information is an important component of 
nutrition education for agencies that aggregate food benefits.
    This proposed flexibility would not change the requirements in 
Sec.  246.10(b)(2)(i) that State agencies identify the brands and 
packages sizes of foods that are acceptable for use in the Program in 
their State and must provide to local agencies, and include in the 
State Plan, a list of acceptable foods and their maximum monthly 
allowances. The Department requests comments from stakeholders about 
its intention to increase State agency flexibility when authorizing 
package sizes for WIC-eligible foods.

IV. Miscellaneous Related Revisions and Editorial Corrections

    This part describes additional proposed amendments, which include 
updating the definition of Individual with disabilities, adding breast 
pumps as a Program benefit and corresponding participant violation 
provisions, clarifying the definition of WIC-eligible nutritionals, 
adding clarifying language to nutrition tailoring, updating the base 
year for the annual inflation adjustment to the CVV amounts, and making 
conforming revisions and editorial corrections.

A. Definition of Individual With Disabilities (Sec.  246.2)

    The proposed rule would update the definition of disability by 
removing the words ``handicapped person'' and adding that 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.

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

    The proposed rule would include breast pumps as a Program benefit 
and add reference to the sale or offer to sell breast pumps to the 
definition of participant violation (Sec.  246.2). While previous FNS 
guidance excluded breast pumps from participant violations, upon 
further review, FNS has determined that breast pumps are a Program 
benefit when purchased with WIC funds and provided to participants. 
Therefore, consistent with other Program benefits, breast pumps are 
covered by the benefits in the regulatory definition of participant 
violation. A conforming regulatory provision (Sec.  246.7(j)(10)) would 
ensure that every Program applicant, parent or caretaker be informed 
that selling or offering to sell WIC benefits, including cash-value 
vouchers, food instruments, EBT cards, supplemental foods, or breast 
pumps in person, in print, or on-line is a participant violation.
    While previous guidance excluded breast pumps from participant 
violations in part to provide some protection for infants from being 
sanctioned or disqualified from the Program, State agencies are 
provided other regulatory flexibility for this purpose (e.g., an 
exception for infants for mandatory disqualification as described in 
Sec.  246.12(u)(2)(ii)). Additionally, the dollar threshold at Sec.  
246.12(u)(2)(i) for disqualification is proposed to be increased from 
$100 to $1,000, which FNS feels is appropriate to indicate a pattern of 
Federal participant violations. This update means that whenever the 
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 State agency must disqualify the participant for one year.

C. WIC-Eligible Nutritionals (Sec.  246.2)

    The Department is proposing to clarify the definition of WIC-
eligible nutritionals, enteral products specifically formulated to 
provide nutritional support for those with qualifying conditions (see 
Sec.  246.2 for full definition), 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.

D. Nutrition Tailoring (Sec.  246.10(c))

    The proposed rule would add clarifying language to nutrition 
tailoring (Sec.  246.10(c)) that exists in current policy, as indicated 
in Sec.  246.10(e)(9) through (11). The current regulation for 
nutrition tailoring focuses on eliminating or reducing foods and was 
meant to specify the conditions under which the full food benefit 
(i.e., the maximum monthly allowance) is not provided to a participant. 
However, nutrition tailoring also involves making substitutions to the 
types and forms of foods, as specified in Sec.  246.10(e)(9) through 
(11), and is meant 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 (e.g., situations such as a lack of access to 
refrigeration). The proposed rule further clarifies that offering a 
participant substitutions in accordance with State agency policy and 
Federal regulations, is the first step before eliminating or reducing 
foods and must be based on their nutrition assessment.

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

    The Department is proposing to update the base year (from 2008 to 
2022) for the annual inflation adjustment to the CVV amounts primarily 
because the proposed rule establishes three different CVV amounts ($24, 
$43, and $47) compared to the two CVV amounts prescribed under current 
regulations ($9 and $11) making it impractical to base inflationary 
adjustments on the prior standard. Furthermore, the provision for the 
proposed CVV amounts was signed into law temporarily for fiscal year 
(FY) 2022 and adjusting the base year for the inflation adjustment to 
2022 will allow the Department to more accurately adjust for inflation 
by setting the base year to be the first year that these new amounts 
were provided to WIC participants. In addition, this proposed rule 
specifies the Consumer Price Index used in the inflation adjustment 
calculation. 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.

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

    The proposed rule includes conforming revisions and corrections to 
typographical and grammatical errors as well as to improve conciseness 
and clarity. These changes will have no substantive effect on the 
public.

V. Implementation

    The Department proposes that 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. During the 18-month 
phase-in period, State agencies would be required to issue food 
benefits based on either the revised food packages or current food 
packages but could not combine the two within any food package. For 
example, a State agency could not add canned fish to the current foods 
and quantities available in the child's food package. State agencies 
may, depending on their systems, phase-in the revised food packages on 
a participant category basis. To minimize

[[Page 71106]]

participant and vendor confusion, the Department proposes that once the 
State agency begins issuing each new food package, it must be done on a 
Statewide basis. The Department seeks comments from State agencies on 
the type and scope of administrative burden that may be associated with 
implementing the provisions in this proposed rule in this manner.

Procedural Matters

Executive Order 12866 and 13563

    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.
    This proposed rule has been determined to be economically 
significant and was reviewed by the Office of Management and Budget 
(OMB) in conformance with Executive Order 12866.

Regulatory Impact Analysis Summary

    As required for all rules that have been designated as economically 
significant by the Office of Management and Budget, a Regulatory Impact 
Analysis (RIA) was developed for this proposed rule. The complete RIA 
follows this proposed rule as an appendix. 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 proposed rule would revise regulations governing 
the WIC food packages to align with the Dietary Guidelines for 
Americans 2020-2025 (DGA) \38\ reflect recommendations made by the 
National Academies of Sciences, Engineering, and Medicine (NASEM),\39\ 
while promoting nutrition security and equity and taking into account 
program administration considerations.
---------------------------------------------------------------------------

    \38\ U.S. Department of Health and Human Services/U.S. 
Department of Agriculture, Dietary Guidelines for Americans, 2020-
2025. Available at internet site: Home [verbar] Dietary Guidelines 
for Americans.
    \39\ 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.
---------------------------------------------------------------------------

Benefits

    The proposed changes to the WIC food packages 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 proposed 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 \40\ 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.41 42
---------------------------------------------------------------------------

    \40\ 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.
    \41\ Ibid.
    \42\ 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 $25, $45, or $50 (adjusted for inflation to FY 2024), 
depending on participant category, to meet 50 percent of the 
recommended intakes for fruits and vegetables. This suggests that the 
current CVV levels of $9 for child participants and $11 for pregnant, 
postpartum, and breastfeeding participants only provide enough for 
around 19 percent and 12 percent of recommended fruit and vegetable 
intakes for child, pregnant, postpartum, and breastfeeding 
participants, 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 proposed 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 under this proposed rule, 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 highlight the importance of a healthy 
dietary pattern to help achieve a healthy body weight and reducing the 
risk of chronic disease. The DGA also emphasize 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 proposed 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 proposed 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 proposed rule to revise 
regulations governing the WIC food packages would result in a net 
increase in Federal WIC spending of $4.1 billion, in the form of 
Federal transfer payments for increased WIC food expenditures, over 
five years from FY 2024 through FY 2028. This increase in Federal WIC 
food expenditures is driven by the proposed increase in the CVV, which 
is estimated to increase WIC food expenditures by $4.9 billion over 
five years when compared to current CVV levels as outlined in 7 CFR 
246.10. However, the CVV levels proposed in this rule were recently 
enacted on a temporary basis for FY 2022. As a result, when compared to 
the FY 2022 WIC food

[[Page 71107]]

packages, the CVV increase proposed in this rule would not impact 
Federal WIC expenditures and would instead make permanent the CVV 
levels enacted in FY 2022. With the CVV impact zeroed out of the 
overall cost estimate for the proposed rule, the remaining provisions 
are expected to result in a net decrease in Federal WIC food spending 
of $821 million over five years when compared to the food packages as 
enacted in FY 2022. These estimates are summarized at the food category 
level in the attached RIA, where all changes proposed 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.
    These costs conservatively assume full implementation of the rule 
in all State agencies at the start of FY 2024 (i.e., the costs do not 
assume an incremental phase-in period). The estimates also assume 
annual increases in child participation at 2.08 percent between FY 2021 
and 2023 and 4.82 percent between 2023 and 2026 before leveling off at 
the higher participation level in 2027 and 2028. Participation among 
pregnant, postpartum, breastfeeding individuals and infants is held 
constant at current levels through FY 2028. In 2018, the most recent 
data available, only 44.2 percent of eligible children participated in 
WIC.\43\ The estimated increases in child participation used in this 
analysis reflect a projected narrowing of the large coverage gap among 
WIC-eligible children as a result of current efforts to improve child 
retention in the Program. While declining birth rates have contributed 
to a decrease in pregnant, postpartum, and breastfeeding individuals 
and infants participating in WIC each year since 2009, USDA projects 
participation among these groups to level off due to future outreach 
efforts to increase participation.
---------------------------------------------------------------------------

    \43\ Gray K., Meyers-Mathieu K., Johnson, P., and Giannarelli, 
L. (2021). National- and State-Level Estimates of WIC Eligibility 
and WIC Program Reach in 2018 With Updated Estimates for 2016 and 
2017. Prepared by Insight Policy Research, Contract No AG-3198-D-16-
0095. Alexandria, VA: U.S. Department of Agriculture, Food and 
Nutrition Service, Office of Policy Support, Project Officer: Grant 
Lovellette. Available online at: www.fns.usda.gov/research-analysis.
---------------------------------------------------------------------------

    The increase in value of the CVV accounts for most of the increased 
Federal spending, adding around $4.9 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 proposed change to add canned fish to 
most food packages is estimated to add around $171 million in 
additional spending over five years. The proposal to increase the 
amounts of jarred infant fruits and vegetables that can be substituted 
for CVV and the proposed expansion of the allowable age range to 
substitute CVV for jarred fruits and vegetables are estimated to 
increase redemptions for these items, adding $113 million in costs over 
five years, despite the proposed 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 $18 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 proposed reductions to the maximum monthly allowances issued are 
still expected to result in a net savings of $136 million for milk and 
$731 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 proposed rule would 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 $31 million on infant 
formula over five years. The proposed 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 2 of the 
attached RIA.
    In addition to the above impact on Federal transfer payments, the 
Department also estimates that WIC State agencies and local agencies 
will incur an in administrative burden associated with implementing and 
explaining the proposed changes to participants. This additional 
administrative burden is expected to account for about $171 million in 
State agency and local agency labor costs over five years. 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 proposed 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 proposed rule would not have a significant 
impact on a substantial number of small entities.
    This proposed rule would not have a significant economic impact on 
a substantial number of small entities. This proposed rule would not 
have an adverse impact of 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 update their 
approved foods lists.
    Factual Basis: The provisions of this proposed rule would 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 definitions of ``small governmental jurisdiction'' and ``small 
entity'' in the Regulatory Flexibility Act. These entities would not be 
negatively impacted by the changes and options proposed in this rule.

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 
proposed 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

[[Page 71108]]

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 proposed 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 proposed rule is not subject to the requirements of 
sections 202 and 205 of the UMRA.

Executive Order 12372

    This Special Supplemental Nutrition Program for Women Infants and 
Children 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.)

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 proposed rule on 
State and local governments and has determined this proposed 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 proposed 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 proposed rule is not intended to have 
retroactive effect unless so specified in the Effective Dates section 
of the final rule. Prior to any judicial challenge to the provisions of 
the final rule, all applicable administrative procedures must be 
exhausted.

Civil Rights Impact Analysis

    FNS has reviewed the proposed rule, in accordance with Department 
Regulation 4300-004, Civil Rights Impact Analysis, to identify and 
address any major civil rights impacts the proposed rule might have on 
minorities, women, and persons with disabilities. A comprehensive Civil 
Rights Impact Analysis (CRIA) was conducted on the proposed rule, 
including an analysis of participant data and provisions contained in 
the proposed 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 
proposed rule would impact WIC State Agencies, WIC vendors, Indian 
Tribal Organizations (ITOs), WIC Local Agencies and Clinic Sites, Food 
Producers and Manufacturers, and WIC participants. Specifically, WIC 
participants would 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 would be required to consistently stock 
three vegetable varieties. ITOs and State agencies would have to 
identify new foods and package sizes and update their WIC APLs 
consistent with the changes outlined in the proposed rule. WIC local 
agency and clinic staff would 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 
proposed 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 may lessen these impacts. If 
deemed necessary, FNS would 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 issue and received 
substantive feedback from several Tribal leaders which were taken into 
consideration during the development of this proposed rule, including 
support for more traditional native foods, consideration of impacts on 
small or tribal stores, and swift publication of the proposed updates. 
FNS will explore additional opportunities for engagement as needed. 
Once the proposed rule is published in the Federal Register, FNS will 
encourage stakeholders representing Indian Tribal Organizations to 
provide input on whether the proposed rule poses any adverse tribal 
implications. If a Tribe requests additional consultation in the 
future, FNS will work with the Office of Tribal Relations to ensure 
meaningful consultation is provided. We are unaware of any current 
Tribal laws that could be in conflict with this proposed rule.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; 5 CFR 
part 1320) requires the Office of Management and Budget (OMB) to 
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 
proposed rule contains existing information collections that are 
contained in OMB# 0584-0043 Special Supplemental Nutrition Program for 
Women, Infants, and Children (WIC) Program Regulations--Reporting and 
Recordkeeping (expiration date December 31, 2023) which are subject to 
review and approval by the Office of Management and Budget; therefore, 
FNS is submitting for public comment the changes to the existing 
information collection requirements and burden that would result from 
adoption of the proposals in the rule.
    Comments on information collection for this proposed rule must be 
received by January 20, 2023.
    Comments may be sent to: Allison Post, Food and Nutrition Service, 
U.S. Department of Agriculture, 1320

[[Page 71109]]

Braddock Place, 3rd Floor, Alexandria, VA 22314. Comments may also be 
submitted via email to usda.gov">Allison.Post@usda.gov. Comments will also be 
accepted through the Federal eRulemaking Portal. Go to https://www.regulations.gov, and follow the online instructions for submitting 
comments electronically.
    Comments are invited on: (a) whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    All responses to this document will be summarized and included in 
the request for OMB approval. All comments will also become a matter of 
public record.
    Title: Special Supplemental Nutrition Program for Women, Infants, 
and Children (WIC) Program Regulations--Reporting and Record-keeping 
Burden.
    OMB Number: 0584-0043.
    Expiration Date: 12/31/2023.
    Type of Request: Revision of a currently approved collection due to 
rulemaking.
    Abstract: This rulemaking proposes to revise regulations governing 
the WIC food packages to align them with the current Dietary Guidelines 
for Americans \44\ and reflect recommendations made by the National 
Academies of Sciences, Engineering and Medicine (NASEM) in its 2017 
report, ``Review of WIC Food Packages: Improving Balance and Choice,'' 
\45\ while promoting nutrition security and equity and taking into 
account program administration considerations. The proposed 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 food packages that accommodate 
participants' special dietary needs and personal and cultural food 
preferences; provide more equitable access to supplemental foods; and 
better promote and support individual breastfeeding goals of 
participants to help establish successful long-term breastfeeding. The 
average burden per respondent and the annual burden hours are 
summarized and explained below.
---------------------------------------------------------------------------

    \44\ U.S. Department of Agriculture and U.S. Department of 
Health and Human Services. Dietary Guidelines for Americans, 2020-
2025. 9th Edition. December 2020. Available at: Home [verbar] 
Dietary Guidelines for Americans.
    \45\ National Academies of Sciences, Engineering, and Medicine. 
``Review of WIC Food Packages: Improving Balance and Choice: Final 
Report,'' 2017. Available at internet site: https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice.
---------------------------------------------------------------------------

    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: 6,885,560.
    Estimated Number of Annual Responses Respondent: 4.98.
    Estimated Total Annual Responses: 34,314,693.
    Estimated Time Per Response: 0.16 hours.
    Estimated Total Annual Burden on Respondents: 5,637,114.77 hours.
    Current OMB Inventory: 3,469,735.53 hours related to the 
requirements for the identification of acceptable foods under Sec.  
246.10(b)(1), explanation of new food packages as part of the 
certification process under Sec.  246.7(i), and vendor applications and 
agreements under Sec.  246.12(h)(1)(i).
    Revised Annual Burden Due to the Proposed Rule: 5,637,114.77 hours 
related to the requirements for the identification of acceptable foods 
under Sec.  246.10(b)(1), training for State and local agencies on 
revised food lists under Sec.  246.10(b)(2)(i), review of food packages 
and explanation of proposed changes to food packages as part of the 
certification process under Sec.  246.7(i), and vendor applications and 
agreements under Sec.  246.12(h)(1)(i).
    Difference (Burden Revisions Requested): 2,167,379.24 additional 
hours.
    Summary:

[[Page 71110]]



                                                                   Estimated Annual Reporting & Recording Burden for 0584-0043 as a Result of the Proposed Rulemaking
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                                         Estimated       Estimated
                                                                                         Estimated        Annual                      Average burden     Estimated         Hours         change in       change in      Total estimated
               Regulation citation                     Description of activities         number of     responses per   Total annual      hours per     total annual      currently     burden hours    burden hours    change in burden
                                                                                        respondents     respondent       responses       response      burden hours   approved under      due to          due to             hours
                                                                                                                                                                      OMB #0584-0043    rulemaking      adjustments
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Reporting
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   State and Local Agencies (including Indian
   Tribal Organizations and U.S. Territories)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.7(i) Women..................................  Certification.....................        1,265.60        1,807.37    2,287,409.60           .2167      495,681.66      545,711.00     +114,446.73     -164,476.07          -50,029.34
246.7(i) Children...............................  Certification.....................        1,265.60        2,923.56    3,700,056.15           .2167      801,802.17      882,728.00     +185,126.14     -266,051.98          -80,925.83
246.7(i) Infants................................  Certification.....................        1,265.60          947.12    1,198,680.70           .2167      259,754.11      285,970.97      +59,973.99      -86,190.85          -26,216.86
246.7(i)........................................  Explaining food package updates...        1,265.60        3,799.85    4,809,089.60           .0833      400,597.16            0.00     +400,597.16            0.00         +400,597.16
246.10(b)(1)....................................  Identification of acceptable foods           89.00            1.00           89.00           43.00        3,827.00        3,560.00         +267.00            0.00             +267.00
246.10(b)(2)(i).................................  Attend, develop and provide                  89.00            1.00           89.00            5.00          445.00            0.00         +445.00            0.00             +445.00
                                                   training to local agencies on
                                                   revised food lists.
246.10(b)(2)(i).................................  Local agency training on revised          1,265.60            1.00        1,265.60            1.00        1,265.60            0.00       +1,265.60            0.00           +1,265.60
                                                   food lists.
246.12(h)(1)(i).................................  Vendor applications & agreements*.              89          152.07       13,534.62             .75       10,150.97       10,188.09          -37.13               0              -37.13
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Reporting
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
         Applicants for Program Benefits
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.7(i) Women..................................  Certification.....................    1,633,864.00            2.00    3,267,728.00           .2167      708,116.66      545,710.58     +162,406.08            0.00         +162,406.08
246.7(i) Children...............................  Certification.....................    3,523,863.00            1.50    5,285,794.50           .2167    1,145,431.67      882,727.68     +262,703.99            0.00         +262,703.99
246.7(i) Infants................................  Certification.....................    1,712,401.00            1.00    1,712,401.00           .2167      371,077.30      285,970.97      +85,106.33            0.00          +85,106.33
246.7(i)........................................  Explaining food package updates...    6,870,128.00            1.00    6,870,128.00          0.0833      572,281.66            0.00     +572,281.66            0.00         +572,281.66
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Reporting
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Retail Vendors (WIC-Authorized Food Stores) and
   Businesses (Non-Profit WIC Local Agencies)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.7(i) Women..................................  Certification.....................          542.40        1,807.37      980,318.40          0.2167      212,435.00            0.00      +49,048.60     +163,386.40         +212,435.00
246.7(i) Children...............................  Certification.....................          542.40        2,923.56    1,585,738.35          0.2167      343,629.50            0.00      +79,339.78     +264,289.73         +343,629.50
246.7(i) Infants................................  Certification.....................          542.40          947.12      513,720.30          0.2167      111,323.19            0.00      +25,703.14      +85,620.05         +111,323.19
246.7(i)........................................  Explaining food package updates...          542.40        3,799.85    2,061,038.40          0.0833      171,684.50            0.00     +171,684.50            0.00         +171,684.50
246.10(b)(2)(i).................................  Local agency training on revised            542.40            1.00          542.40            1.00          542.40            0.00         +542.40            0.00             +542.40
                                                   food lists.
246.12(h)(1)(i).................................  Vendor applications & agreements..       13,534.62            1.00       13,534.62            1.00       13,534.62       13,584.12          -49.50            0.00              -49.50
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 71111]]

 
                                                                                                              Recordkeeping
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
     State Agencies (including Indian Tribal
       Organizations and U.S. Territories)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
246.12(h)(1)(i).................................  Vendor applications & agreements..           89.00          152.07       13,534.62            1.00       13,534.62       13,584.12          -49.50            0.00              -49.50
                                                                                     ---------------------------------------------------------------------------------------------------------------------------------------------------
    Total.......................................  ..................................       6,885,560            4.98   34,314,692.86             .16    5,637,114.77   3,469,735,.53   +2,170,801.96       -3,422.72    +2,167,379,24.87
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* The baseline for the specific burden associated with this activity is not currently included in OMB Control #0584-0043 but can be referenced in the 60-day Notice published September 30, 2022 (87 FR 59392).


[[Page 71112]]


                            Estimated Annual Reporting and Recordkeeping Burden for OMB #0584-0043 Due to Proposed Rulemaking
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Projected
                                                                        Burden          respondents/       Difference in   Difference in   Difference in
                                                                       currently      responses/ burden     respondents      responses     burden hours
                                                                      approved *    due to proposed rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grand Total Respondents...........................................       6,913,189             6,913,039            -150  ..............  ..............
Grand Total Responses.............................................      48,812,384            62,554,388  ..............   ** 13,742,005  ..............
Grand Total Annual Burden Hours...................................       4,557,287             6,724,666  ..............  ..............       2,167,379
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The estimates shown above are the burden estimates for this proposed rule. The baseline estimates of 51,869.137 responses and 6,150,819 hours reported
  in the 60-Day Notice (87 FR 59392) include estimates for activities that are not associated with this proposed rule.
** Difference in total number due to rounding.

    Based on the proposals outlined in this rule, the Department 
estimates that the overall burden for OMB# 0584-0043 will increase by 
2,167,379 hours and 13,742,005 responses, while the respondents will 
decrease by 150. The decrease in the number of respondents is due to 
the decrease in number of vendor respondents as explained in the 
Reporting Burden for Vendors: Section 246.12(h)(1)(i).

Explanation

Reporting Burden (State and Local Agencies Including Indian Tribal 
Organizations and US Territories)
    Section 246.7(i) requires that pertinent certification data (income 
and nutrition risk assessment information) be collected and recorded by 
the local agency on computer software provided by the State agency. In 
addition, participants must be notified of their rights and 
responsibilities, including notification of termination for failure to 
pick up food instruments, notification of disqualification and 
notification of expiration of each certification period. During the 
certification process participants are assigned a food package based on 
their nutrition risk assessment and categorical eligibility. Due to the 
program (food package) changes in the proposed rule it is estimated 
that it will take an additional three minutes per participant during 
the certification (the current estimate is 10 minutes per participant) 
for clinic staff to review procedures to ensure that they prescribe the 
food package correctly with the proposed changes. FNS estimates that 
the collection of certification data, the provision of appropriate 
notifications, and reviewing the food packages require 13 minutes 
(0.2167 hours) per participant. Additionally, communicating the 
proposed food package changes to current participants would require an 
estimated one-time five-minute (0.0833 hours) explanation per 
participant.
    FNS estimates 495,681.66 annual burden hours for the certification 
of women (1,633,864 women x 2 certifications per year = 3,267,728 total 
annual responses / 1,808 = 1,807.37 certifications per local agency x 
1,265.60 local agencies = 2,287,409.60 total annual responses x 13 
minutes (0.2167 hours) per response = 495,681.66 hours). Note: A 
program adjustment was made to account for the fact that 30 percent of 
WIC local agencies are non-profits and are reflected in the 
``Business'' respondent category (see below). The number of government 
local agencies used in this calculation is 1,265.60 (1,808 x 0.70). 
Overall, the burden hours for the certification of women would decrease 
by 50,029.34, from 545,711.00 to 495,681.66 hours. The decrease is due 
to a program adjustment to account for non-profit local agencies, which 
is larger than the increase from a program change due to the proposed 
rule.
    FNS estimates 801,802.17 annual burden hours for the certification 
of children (3,523,863 children x 1.5 certifications per year = 
5,285,794.50 total annual responses / 1,808 = 2,923.56 certifications 
per local agency x 1,265.60 local agencies = 3,700,056.15 total annual 
responses x 13 minutes (0.2167 hours) per response = 801,802.17 hours). 
This is a decrease of 80,925.83 hours for the certification of 
children, from 882,728.00 to 801,802.17 hours. This decrease is due to 
an adjustment to account for non-profit local agencies, which is larger 
than the increase from a program change due to the proposed rule.
    FNS estimates 259,754.11 annual burden hours for the certification 
of infants (1,712,401 infants / 1,808 = 947.12 certifications per local 
agency x 1,265.60 local agencies = 1,198,680.70 total annual responses 
x 13 minutes (0.2167 hours) per response = 259,754.11 hours). This is a 
decrease of 26,216.86 hours for the certification of infants, from 
285,970.97 to 259,754.11 hours. This decrease is due to an adjustment 
to account for non-profit local agencies, which is larger than the 
increase from a program change due to the proposed rule.
    FNS estimates 400,597.16 burden hours to explain the changes to the 
food package proposed in this rule once to all current WIC participants 
(6,870,128 participants / 1,808 = 3,799.85 explanations per local 
agency x 1,265.60 local agencies = 4,809,089.60 total explanations x 5 
minutes (0.0833 hours) per explanation = 400,597.16 hours. This one-
time increase to the local agency reporting burden is due to a program 
change due to the proposed rule.
    Section 246.10(b)(1) requires each State agency to identify foods 
that are acceptable for use in the program in their State, in 
accordance with program regulations. This includes establishing 
criteria for and identifying foods, substitutions, brands and packaging 
the State will authorize for use in the Program. The proposed 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 soy-based yogurts and soy-based cheeses as 
substitution options for milk.
     Requiring the authorization of lactose-free milk.\46\
---------------------------------------------------------------------------

    \46\ 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.
    The Department estimates that on average it will take each State 
agency 43 hours annually to comply with this regulatory provision (to 
include the proposed changes), which is an increase

[[Page 71113]]

of 3 hours (based on an estimated range of 2 to 4 hours) per State 
agency. 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 total, from 3,560 to 3,827 
hours. This increase is due to a program change due to the proposed 
rule.
    Section 246.10(b)(2)(i) requires each State agency to provide to 
local agencies a list of foods that are acceptable for use in the 
Program in their jurisdiction. Due to the proposed 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 5 hours for each State agency (1 hour to 
attend the FNS training, 3 hours to develop State agency-specific 
trainings for local agencies, and 1 hour to provide training to local 
agencies). FNS estimates an additional one-time State agency reporting 
burden of 445 hours for these training activities (89 x 5 = 445). This 
addition is due to a program change due to the proposed rule.
    Section 246.10(b)(2)(i) requires each State agency to provide to 
local agencies a list of foods that are acceptable for use in the 
Program in their jurisdiction. Due to the proposed changes in the WIC 
food packages the food lists will be revised. Local agencies will need 
to attend a State agency training on the revised food lists, which FNS 
estimates will require one hour. FNS estimates an additional one-time 
burden of 1,265.60 hours for local agencies to attend the State agency 
training (1,265.60 x 1.00 = 1,265.60). This increase is due to a 
program change due to the proposed rule.
    Section 246.12(h)(1)(i) requires the State agency 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 45 minutes (.75 hours) to review 
the application and sign each vendor agreement. The Department 
estimates that the proposed 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, as the 
Department estimates particularly rural, remote, and/or small vendors 
with low WIC redemptions would be impacted by the small increase in the 
minimum stock requirement in the proposed rule (41,164 retail vendors - 
150 = 41,014). As such, each State agency is estimated to review 
approximately 152 vendor applications and agreements annually (41,014 x 
0.33/89 State agencies = 152.07). The Department estimates 10,150.97 
burden hours for State agencies to review applications and sign the 
agreements (89 State agencies x 152.07 vendor applications and 
agreements per State agency = 13,534.62 vendor applications and 
agreements x 45 minutes (.75 hour) per application and agreement = 
10,150.97 annual burden hours). With the expected decrease in the 
number of vendors filing applications and agreements, FNS estimates a 
decrease of 37.13 burden hours (10,188.09 \47\-10,150.97) for this 
provision. This decrease is due to a program change due to the proposed 
rule.
---------------------------------------------------------------------------

    \47\ These hours reflect hours identified as in use without OMB 
approval which FNS is currently seeking approval for through a 
revision to OMB Control Number 0584-0043.
---------------------------------------------------------------------------

Reporting Burden (Applicants)
    Section 246.7(i) requires that certification data including income 
and nutritional risk be collected from all participants and recorded by 
the local agency on computer software provided by the State agency. In 
addition, participants must be notified of their rights and 
responsibilities, including notification of termination for failure to 
pick up food instruments, notification of disqualification and 
notification of expiration of each certification period. The income 
eligibility is established by applicants providing written 
documentation to the local agency. Applicants or certain family members 
that receive Medicaid, Supplemental Nutrition Assistance Program 
(SNAP), Temporary Assistance for Needy Families Program (TANF), or 
State-administered programs with income criteria at or below 185 
percent of the Federal poverty guidelines are not subject to the 
standard WIC income eligibility determination. Though some information 
is collected for the entire household, some documentation (such as 
nutrition risk) is required for each WIC applicant.
    Nutritional risk is determined by a competent professional 
authority on the staff of the local agency through a nutritional 
assessment. This determination may be based on referral data submitted 
by a competent professional authority not on the staff of the local 
agency. At a minimum, height or length and weight measurements and a 
hematological test for anemia such as a hemoglobin or hematocrit shall 
be performed and/or documented in the applicant's file at the time of 
certification. In addition, medical/health history, dietary intake and 
environmental (e.g., homelessness and migrancy) information is 
collected to determine all relevant nutrition risk(s). During the 
certification process participants are assigned a food package based on 
their nutrition risk assessment and categorical eligibility. Due to the 
program changes in the proposed rule it is estimated that the 
certification will take an additional three minutes (the current 
estimate is 10 minutes per participant) for clinic staff to communicate 
the food package changes to each participant. Additionally, 
communicating the proposed food package changes to current participants 
would require an estimated one-time five-minute (0.0833 hours) 
explanation per participant.
    FNS estimates that providing certification data to the local agency 
requires 13 minutes (0.2167 hours) on average per participant.
    Monthly WIC participation is 6,870,128 (1,633,864 women, 1,712,401 
infants and 3,523,863 children).
    Women are certified twice per year, thus FNS estimates 708,116.66 
hours for this provision (1,633,864 participants x 2 times per year = 
3,267,728 x 13 minutes (0.2167 hours) = 708,116.66 hours). This is an 
increase of 162,406.08 hours for the certification of women, from 
545,710.58 to 708,116.66 hours. This increase is due to a program 
change due to the proposed rule.
    Children may be certified once or twice per year. More than half of 
WIC State agencies certify children once per year. FNS estimates 
1,145,431.67 hours for this provision (3,523,863 participants x 1.5 
times per year = 5,285,794.5 x 13 minutes (0.2167 hours) = 1,145,431.67 
hours). This is an increase of 262,703.99 hours for the certification 
of children, from 882,727.68 to 1,145,431.67 hours. This increase is 
due to a program change due to the proposed rule.
    Infants are certified once per year, thus FNS estimates 371,077.30 
hours for this provision (1,712,401 participants x 1 time per year = 
1,712,401 x 13 minutes (0.2167 hours) = 371,077.30). This is an 
increase of 85,106.33 hours for the certification of infants, from 
285,970.97 to 371,077.30 hours. This

[[Page 71114]]

increase is due to a program change due to the proposed rule.
    FNS estimates 572,281.66 burden hours to explain the changes to the 
food package proposed in this rule once to all WIC participants 
(6,870,128 participants x 1 explanation = 6,870,128 total explanations 
x 5 minutes (0.0833) hours per explanation = 572,281.66 total hours. 
This one-time increase is due to a program change due to the proposed 
rule.
Reporting Burden (Businesses: Non-Profit WIC Local Agencies and 
Vendors)
    Section 246.7(i) requires that pertinent certification data (income 
and nutrition risk assessment information) be collected and recorded by 
the local agency on computer software provided by the State agency. In 
addition, participants must be notified of their rights and 
responsibilities, including notification of termination for failure to 
pick up food instruments, notification of disqualification and 
notification of expiration of each certification period. During the 
certification process participants are assigned a food package based on 
their nutrition risk assessment and categorical eligibility. Due to the 
program (food package) changes in the proposed rule it is estimated 
that it will take an additional three minutes per participant during 
the certification (the current estimate is 10 minutes per participant) 
for clinic staff to review procedures to ensure that they prescribe the 
food package correctly with the proposed changes. FNS estimates that 
the collection of certification data, the provision of appropriate 
notifications, and reviewing the food packages require 13 minutes 
(0.2167 hours) per participant. Additionally, communicating the 
proposed food package changes to current participants would require an 
estimated one-time five-minute explanation per participant.
    FNS estimates 212,435.00 annual burden hours for the certification 
of women (1,633,864 women x 2 certifications per year = 3,267,728 total 
annual responses / 1,808 = 1,807.37 certifications per local agency x 
542.40 non-profit local agencies = 980,318.40 total annual responses x 
13 minutes (0.2167 hours) per response = 212,435.00 hours). Note: Since 
30% of WIC local agencies are non-profits, the number of local agencies 
used in this calculation for the ``Business'' respondent category is 
542.40. Overall, the burden for the certification of women would 
increase by 212,435.00 hours. This increase is due to both an 
adjustment that separated non-profit businesses from government local 
agencies and a program change due to the proposed rule.
    FNS estimates 343,629.50 annual burden hours for the certification 
of children (3,523,863 children x 1.5 certifications per year = 
5,285,794.5 total annual responses / 1,808 = 2,923.56 certifications 
per local agency x 542.40 non-profit local agencies = 1,585,738.35 
total annual responses x 13 minutes (0.2167 hours) per response = 
343,629.50 hours). This is an addition of 343,629.50 hours for the 
certification of children. This increase is due to both an adjustment 
that separated non-profit businesses from government local agencies and 
a program change due to the proposed rule.
    FNS estimates 111,323.19 annual burden hours for the certification 
of infants (1,712,401 infants / 1,808 = 947.12 certifications per local 
agency x 542.40 non-profit local agencies = 513,720.30 total annual 
responses x 13 minutes (0.2167 hours) per response = 111,323.19 hours). 
This is an addition of 111,323.19 hours for the certification of 
infants. This increase is due to both an adjustment that separated non-
profit businesses from government local agencies and a program change 
due to the proposed rule.
    FNS estimates 171,684.50 burden hours to explain the changes to the 
food package proposed in this rule once to all current WIC participants 
(6,870,128 participants / 1,808 = 3,799.85 per local agency x 542.40 
non-profit local agencies = 2,061,038.40 total explanations x 5 minutes 
(0.0833 hours) per explanation = 171,684.50 hours. This one-time 
increase to the non-profit WIC local agency reporting burden is due to 
a program change due to the proposed rule.
    Section 246.10(b)(2)(i) requires each State agency to provide to 
local agencies a list of foods that are acceptable for use in the 
Program in their jurisdiction. Due to the proposed changes in the WIC 
food packages the food lists will be revised. Local agencies will need 
to attend a State agency training on the revised food lists, which FNS 
estimates will require one hour. FNS estimates an increase of 542.40 
burden hours for non-profit WIC local agencies to attend the State 
agency training (542.40 x 1.00 = 524.40 hours). This one-time increase 
is due to a program change due to the proposed rule.
    Section 246.12(h)(1)(i) requires the State agency to enter into 
written agreements with retail vendors. State agencies require the 
vendor to submit a signed vendor agreement with the completed 
application form. Retail vendor agreements can be for up to 3 years; 
therefore, the Department estimates that one-third of all retail 
vendors will submit applications each year. It is estimated that it 
requires one hour for the vendor to complete the application and sign 
the agreement. The Department further estimates that the proposed 
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, as the Department estimates particularly 
rural, remote, and/or small vendors with low WIC redemptions would be 
impacted by a small increase in minimum stock (41,164 retail vendors -
150 = 41,014). This proposed change results in a decrease of 150 vendor 
respondents reducing the total number of respondents to 6,913,039 from 
the current total of 6,913,189. In addition, the Department estimates 
13,534.62 burden hours for vendors to complete the applications and 
sign the agreements (41,014 retail vendors x 0.33 of all retail vendors 
submit applications per year = 13,534.62 x 1 per year = 13,534.62 x 1 
hour per application = 13,534.62 annual burden hours). This results in 
a decrease of 49.50 hours since the previous submission, from 13,584.12 
to 13,534.62 hours due to the decrease in the number of vendors. The 
decrease in the number of respondents and the burden hours is due to a 
program change due to the proposed rule.
Recordkeeping Burden (State Agencies)
    Section 246.12(h)(1)(i) requires the State agency to enter into 
written agreements with retail vendors. State agencies require the 
vendor to submit a signed vendor agreement with the completed 
application form. Retail vendor agreements can be for up to 3 years; 
therefore, the Department estimates that one-third of all retail 
vendors will submit applications each year. It is estimated that each 
application takes State agency staff one hour to collect and record the 
documents in the State agency's recordkeeping system; most State 
agencies use an electronic Management Information System (MIS) for this 
purpose. The Department further estimates that the proposed 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, as the Department estimates particularly 
rural, remote, and/or small vendors with low WIC redemptions would be

[[Page 71115]]

impacted by the small increase in the minimum stock requirement in the 
proposed rule (41,164 retail vendors--150 = 41,014). The Department 
estimates 13,534.62 annual burden hours for this provision for State 
agencies (41,014 vendor applications / 89 = 460.83 applications per 
State agency x 0.33 of all retail vendors will submit applications each 
year = 152.07 applications per State agency x 89 State agencies = 
13,534.62 x 1 burden hour = 13,534.62). This results in a decrease of 
49.50 hours since the previous submission, from 13,584.12 to 13,534.62 
hours due to the decrease in the number of vendors. This decrease is 
due to a program change due to the proposed rule.
    This rule proposes to include breast pumps as a Program benefit and 
add reference to the sale or offer to sell breast pumps to the 
definition of participant violation (Sec.  246.2). In addition, the 
proposed 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 
off-set 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.
    The change in burden hours is a best estimate. The Department 
requests comments on the burden and all proposed changes. Comments 
received in response to the proposed rule and burden estimates will 
inform the final burden estimates.

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 proposes to amend 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 adding the definition for ``Disability'' in 
alphabetical order, removing the definition for ``Individual with 
disabilities,'' and revising the definitions for ``Participant 
violation'' and ``WIC-eligible nutritionals for participants with 
qualifying conditions (hereafter referred to as `WIC-eligible 
nutritionals')'' to 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 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

[[Page 71116]]

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) of this section;
    (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. The 
full maximum monthly allowances of all supplemental foods in all food 
packages must be made available to participants if 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) of this section 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;
    (iii) Any exempt infant formula;
    (iv) Any WIC-eligible nutritional;
    (v) Any authorized supplemental food issued to participants who 
receive Food Package III;
    (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 program, 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 
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;

[[Page 71117]]

    (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, by facsimile or by 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. 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. The maximum monthly allowances, 
allowed options, and substitution rates of supplemental foods for 
infants in Food Packages I are stated 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.
    (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,

[[Page 71118]]

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-VII); 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 apparatus 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/lactose-free milk, cheese, eggs, canned fish, fresh and other 
State-authorized forms of fruits and vegetables, breakfast cereal, 
whole wheat/whole grain bread, juice, 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 and is divided into: IV-A 
for children 1 to less than 2 years of age (i.e., 12 through 23 
months), and IV-B for children 2 years through 4 years.
    (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, and legumes or peanut 
butter, and canned fish are the categories of supplemental foods 
authorized for both Food Package IV-A and IV-B. Canned fish is 
authorized for Food Package IV-B only. The maximum monthly allowances, 
canned fish varieties, allowed options and substitution rates of 
supplemental foods for children in Food Package IV 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 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 participants, whose partially (mostly) 
breastfed infants receive 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 participants 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

[[Page 71119]]

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.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, fresh and other State-authorized forms of fruits and 
vegetables, 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. This food 
package is also designed for issuance to women participants 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 participants 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, 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 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-                      Food Packages  IBF/
           Foods \1\              FF & III-FF  A: 0  Food Packages  II-    FF & III BF/FF    Food Packages II BF/ Food  Package I-BF   Food  Package II-
                                  through 3 months     FF & III-FF  6       A:0 through 3     FF & III BF/FF  6       0 through 5      BF  6 through 11
                                   B: 4 through 5     through 11 months     months  B: 4      through 11 months         months              months
                                       months                             through 5 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 oz
                                  fl oz               oz reconstituted    fl oz               reconstituted
                                  reconstituted       liquid              reconstituted       liquid concentrate
                                  liquid              concentrate or      liquid              or 338 fl oz RTF
                                  concentrate or      643 fl. oz RTF or   concentrate or      or 384 fl oz
                                  832 fl. oz. RTF     696 fl oz           384 fl oz RTF or    reconstituted
                                  or 870 fl oz        reconstituted       435 fl oz           powder.
                                  reconstituted       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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1 Footnotes (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.
\1\ Table 4 to paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. The competent
  professional authority (CPA) is authorized to determine nutritional risk and prescribe supplemental foods in Food Packages I, II and III (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.
\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\ 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.
\8\ State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the
  FNB. State agencies must use the methodology described in accordance with paragraph (h)(1) of this section.

[[Page 71120]]

 
\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 and disperse 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 greater 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 inflation adjustments made
  to women and children CVV values. State agencies must authorize fresh and one other form (frozen or canned). Dried fruits and vegetables are not
  authorized for infants.
\13\ State agencies may not categorically issue cash-value vouchers (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 
Package IV through VII 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:
                                   Food Package IV:     A: Pregnant  B:                        Food Package VII:
            Foods \1\              1 through 4 years       Partially       Food Package VI:          Fully
                                   A: 12 through 23        (mostly)       Postpartum  (up to  Breastfeeding  (up
                                     months  B: 2      breastfeeding (up        6months         to 1year post-
                                    through 4 years        to 1 year        postpartum) \3\       partum) 4 5
                                                        postpartum) \2\
----------------------------------------------------------------------------------------------------------------
Juice, single strength 6 7......  64 fl oz..........  64 fl oz..........  N/A...............  64 fl oz.
Milk, fluid 8 9 10 11 12 13 14    A: 12 qt 8 9 11 12  16 qt 8 10 11 12    16 qt 8 10 11 12    16 qt. 8 10 11 12
 15.                               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.
Fresh fruits and vegetables 18    $24.00 CVV........  A: $43.00 CVV.....  $43.00 CVV........  $47.00 CVV.
 19.                                                  B: $47.00 CVV.....
Whole wheat or whole grain bread  24 oz.............  48 oz.............  48 oz.............  48 oz.
 \20\.
Fish (canned) 21 22.............  A: N/A............  A: 10 oz..........  10 oz.............  20 oz.
                                  B: 5 oz...........  B: 15 oz..........
Legumes and/or Peanut butter      1 lb dry, or 64 oz  1 lb dry, or 64 oz  1 lb dry, or 64 oz  1 lb dry, or 64 oz
 \23\.                             canned Or 18 oz.    canned And 18 oz.   canned Or 18 oz.    canned And 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 2 Footnotes (abbreviations in order of appearance in table): N/A = 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 the
  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 (excluding WIC formula) 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 is issued to women participants with singleton pregnancies. Food Package V-B is issued to
  two categories of WIC participants: breastfeeding women whose partially (mostly) breastfed infants receive
  formula from the WIC Program 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, 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 the WIC Program; 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 maximum
  monthly allowances.
\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 pregnant, partially, and fully breastfeeding 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 inflation adjustments made to women and children CVV
  values. A partial CVV substitution for juice is not authorized.
\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).
\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 issued to 1-year-old children. At State agency option, 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.
\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, as established by
  State agency policy.
\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.

[[Page 71121]]

 
\12\ For children and women, 1 pound of cheese may substitute for 3 quarts of milk; 1 quart of yogurt may
  substitute 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 also have the option of 2 pounds of cheese substituting for 6 quarts of
  milk. For children and women in Food Packages IV-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. At State agency option, soy-based yogurt and/or soy-based cheese substitutes are
  authorized yogurt and cheese options for individuals who have a milk allergy, are lactose intolerant, or
  consume a vegan diet, as established by State agency policy.
\14\ For children, issuance of tofu and soy-based beverage as substitutes for milk must be based on an
  individual nutritional assessment and consultation with the participant's health care provider, if necessary,
  as established by State agency policy. Such determination can be made for situations that include, but are not
  limited to, milk allergy, lactose intolerance, and vegan diets. Soy-based beverage 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. Additional amounts of tofu may be substituted, up
  to the MMA for fluid milk for lactose intolerance or other reasons, as established by State agency policy.
\15\ For women, soy-based beverage 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; a maximum of 1
  pound of tofu can be substituted. Additional amounts of tofu may be substituted, up to the MMA for milk, for
  lactose intolerance or other reasons, as established by State agency policy.
\16\ All cereals authorized on a State agency's food list must meet whole grain criteria (refer to table 4 to
  paragraph (e)(12) of this section and its footnotes).
\17\ A substitution of dry legumes (1 pound) or canned legumes (64 ounces) or peanut butter (18 ounces) for each
  1 dozen eggs is permitted for individuals with an egg allergy or who consume a vegan diet or other reasons, as
  established by State agency policy. At State agency option, tofu (1 pound) may be substituted for each 1 dozen
  eggs for individuals with an egg allergy or who consume a vegan diet or other reasons, as established by State
  agency policy.
\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 as described in Sec.
  246.16(j).
\20\ Whole wheat and/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 weekly safe
  consumption level of methylmercury. The U.S. Food and Drug Administration (FDA) and the U.S. Environmental
  Protection Agency (EPA) provide joint advice regarding seafood consumption to limit methylmercury exposure for
  children. Depending on body weight, some women and many children should choose seafood lowest in methylmercury
  or eat less seafood than the amounts in the Healthy US-Style Dietary Pattern. More information is available on
  the FDA and EPA websites at FDA.gov/fishadviceandEPA.gov/fishadvice.
\22\ For children, salmon, sardines, and Atlantic mackerel are the only types of canned fish authorized.
\23\ State agencies are required to offer both mature dry and canned legumes: 1 pound dry or 64 ounces canned.
  In Food Packages V and VII, both legumes and peanut butter must be provided. However, when individually
  tailoring these food packages for nutritional reasons (e.g., food allergy, underweight, participant
  preference), State agencies have the option to authorize the following substitutions: 1 pound dry and 64 oz.
  canned legumes (and no peanut butter); or 2 pounds dry or 128 oz. canned legumes (and no peanut butter); or 36
  oz. peanut butter (and no legumes).

    (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:
                                                           Partially                                 Fully
            Foods \1\              A: 12 through 23        (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..........  N/A...............  64 fl oz.
WIC formula 8 9.................  Up to 455 fl        Up to 455 fl        Up to 455 fl        Up to 455 fl
                                   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 2 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.
Fresh fruits and vegetables 21    $24.00 CVV........  A: $43.00 CVV.....  $43.00 CVV........  47.00 CVV.
 22 23.                                               B: $47.00 CVV.....
Whole wheat or whole grain bread  24 oz.............  48 oz.............  48 oz.............  48 oz.
 \24\.
Fish (canned) 25 26.............  A: N/A............  A: 10 oz..........  10 oz.............  20 oz.
                                  B: 5 oz...........  B: 15 oz..........
Legumes and/or Peanut butter      1 lb dry, or 64 oz  1 lb dry, or 64 oz  1 lb dry, or 64 oz  1 lb dry, or 64 oz
 \27\.                             canned Or 18 oz.    canned And 18 oz.   canned Or 18 oz.    canned And 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 3 Footnotes (abbreviations in order of appearance in table): N/A = the supplemental food is not authorized
  in the corresponding food package; CVV= cash-value voucher.

[[Page 71122]]

 
\1\ Table 4 to paragraph (e)(12) of this section describes the minimum requirements and specifications for the
  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 as established by State agency policy.
\2\ Food Package III-A for women is issued to women participants with singleton pregnancies. Food Package III-B
  for women is issued to two categories of participants: breastfeeding women whose partially (mostly) breastfed
  infants receive formula from the WIC Program 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\ 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, 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 the WIC Program; 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\ As determined appropriate by the health care provider per medical documentation, children and pregnant,
  partially, and fully breastfeeding 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 ounce of jarred infant
  food fruits and vegetables.
\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).
\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 issued to 1-year-old children. 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 may substitute for 3 quarts of milk; 1 quart of yogurt may
  substitute for 1 quart of milk, with a maximum of 2 quarts of yogurt that may be substituted for 2 quarts of
  milk. Fully breastfeeding women may substitute 2 pounds of cheese for 6 quarts of milk. Children and other
  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 (Food Package IV-B) 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. At State agency option, soy-based yogurt and/or soy-based cheese substitutes are authorized
  yogurt and cheese options for individuals who have a milk allergy, are lactose intolerant, or consume a vegan
  diet as determined appropriate by the health care provider per medical documentation.
\16\ For children, issuance of tofu and soy-based beverage may be substituted for milk as determined appropriate
  by the health care provider per medical documentation. Soy-based beverage 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. Additional amounts of tofu may be substituted, up to the
  MMA of milk, as determined appropriate by the health care provider per medical documentation.
\17\ For women, soy-based beverage 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. Additional amounts
  of tofu may be substituted, 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\ All cereals authorized on a State agency's food list must meet whole grain criteria (refer to table 4 to
  paragraph (e)(12) of this section and its footnotes).
\20\ A substitution of dry legume (1 pound) or canned legumes (64 ounces) or peanut butter (18 ounces) for each
  1 dozen eggs is permitted for individuals with an egg allergy or who consume a vegan diet. At State agency
  option, tofu (1 pound) may be substituted for each 1 dozen eggs for individuals with an egg allergy or who
  consume a vegan diet.
\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 ounce
  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 and/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 weekly safe
  consumption level of methylmercury. The U.S. Food and Drug Administration (FDA) and the U.S. Environmental
  Protection Agency (EPA) provide joint advice regarding seafood consumption to limit methylmercury exposure for
  children. Depending on body weight, some women and many children should choose seafood lowest in methylmercury
  or eat less seafood than the amounts in the Healthy US-Style Dietary Pattern. More information is available on
  the FDA and EPA websites at FDA.gov/fishadviceandEPA.gov/fishadvice.
\26\ For children, salmon, sardines, and Atlantic mackerel are the only types of canned fish authorized.
\27\ State agencies are required to offer both mature dry and canned legumes: 1 pound dry or 64 ounces canned.
  In food packages where both beans and peanut butter are provided, when individually tailoring these food
  packages for nutritional reasons (e.g., food allergy, underweight, participant preference), State agencies
  have the option to authorize the following substitutions: 1 pound dry and 64 oz. canned legumes (and no peanut
  butter); or 2 pounds dry or 128 oz. canned legumes (and no peanut butter); or 36 oz. peanut butter (and no
  legumes).


[[Page 71123]]

    (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. (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:
    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).
    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.
    Yogurt (cow's milk)...........  Must be pasteurized, conform to FDA
                                     standard of identity (21 CFR
                                     131.200), and contain <=30 g of
                                     total sugars and 100 IU (2.5 mcg)
                                     of vitamin D per 8 ounces (227 g).
                                     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.
    Tofu..........................  Must contain a minimum of 200 mg of
                                     calcium per 100 g of tofu. May not
                                     contain added fats, sugars, oils,
                                     or sodium.
    Soy-based beverage............  Must contain <=12 g of total sugars
                                     per cup and be fortified to meet
                                     the following nutrient levels
                                     (amounts are provided per cup): 276
                                     mg calcium, 8 g protein, 500 IU
                                     vitamin A, 100 IU vitamin D, 24 mg
                                     magnesium, 222 mg phosphorus, 349
                                     mg potassium, 0.44 mg riboflavin,
                                     and 1.1 mcg vitamin B12, in
                                     accordance with fortification
                                     guidelines issued by FDA. May be
                                     flavored or unflavored.
    Soy-based cheese..............  Must contain 250 mg of calcium and
                                     6.5 g of protein per 1.5-oz. Soy
                                     curd cheeses are not authorized.
    Soy-based yogurt..............  Must contain <=30 g of total sugars,
                                     250 mg of calcium, 6.5 g of
                                     protein, and 100 IU (2.5 mcg)
                                     vitamin D per 8 ounces (227 g). May
                                     be plain or flavored. Soy-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.
JUICE.............................  Must be pasteurized 100% 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).
                                     With the exception of 100% 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 iron
 INSTANT AND REGULAR HOT CEREALS).   per 100 g dry cereal. Must contain
                                     <=21.2 g sucrose and other sugars
                                     per 100 g dry cereal (<=6 g per dry
                                     oz). All cereals on the State
                                     agency authorized food list must
                                     contain whole grain as the first
                                     ingredient.

[[Page 71124]]

 
FRUITS AND VEGETABLES (FRESH AND    Any variety of fresh (as defined by
 PROCESSED) 3 4 5 6 7.               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. Corn meal (including blue)
                                     must conform to FDA standard of
                                     identity 21 CFR 137.260. 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.
                                     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 authorized (e.g.,
                                     whole wheat rotini, and whole wheat
                                     penne).
FISH (CANNED) \5\.................  Canned only: 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\ For children
                                     (2 through 4 years of age), salmon,
                                     sardines, and Atlantic mackerel are
                                     the only types of canned fish
                                     authorized. 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....................  Any type of mature dry beans, peas,
(DRY BEANS AND PEAS) \10\.........   or lentils in dry-packaged or
                                     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.
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 fats, 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 fats, 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 fats, sugars, or
                                     salt (i.e., sodium) are not
                                     allowed. Texture may range from
                                     pureed through diced.\15\
------------------------------------------------------------------------
Table 4 Footnotes: FDA = Food and Drug Administration of the U.S.
  Department of Health and Human Services. Daily Value and Percent Daily
  Value: Changes on the New Nutrition and Supplement Facts Labels
  (fda.gov).
\1\ The following are not considered a WIC-eligible nutritional:
  Formulas used solely for the purpose of enhancing nutrient intake,
  managing body weight, 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,\4\ or dried.
\4\ Canned refers to processed food items in cans or other shelf-stable
  containers, e.g., jars, pouches.
\5\ Fresh cut herbs 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
  fruit and/or vegetable packaging with dips, sauces, or glazes; mixed
  vegetables containing noodles, nuts or sauce packets; vegetable-grain
  (pasta or 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 on a string; garlic on a string; gourds; painted pumpkins;
  fruit baskets; 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.

[[Page 71125]]

 
\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 product contains 50%
  or more whole grains by weight.
\9\ King mackerel is not authorized.
\10\ Mature legumes in dry or canned forms may be purchased with the WIC
  food instrument only. Immature varieties of fresh or canned beans and
  frozen beans of any type (immature or mature) may be purchased 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 (with the exception of 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\ No infant food combinations (e.g., meat and vegetables) or dinners
  (e.g., spaghetti and meatballs) are 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 
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 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 I A 
fully formula fed, IA-FF).
    (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. 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 I A fully formula fed, IA-FF) 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 substitutions. (1) The State agency may submit to FNS 
a plan for substitution of food(s) acceptable for use in the Program 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

[[Page 71126]]

the areas where the substitute is intended to be used.
    (iii) The cost of the substitute food must be equivalent to or less 
than 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 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)to read as follows:


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 20[22]. 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) 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

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)(C)). 
This rule proposes 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.

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. WIC participation is also 
associated with improved diet quality.\1\ In Federal fiscal year 
(FY) 2020, WIC served an average of 6.25 million infants, children, 
and pregnant, breastfeeding and postpartum individuals per month.\2\
---------------------------------------------------------------------------

    \1\ 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.
    \2\ U.S. Department of Agriculture Food and Nutrition Service. 
WIC Data Tables, 2021. 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

[[Page 71127]]

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'').\3\ In its report, NASEM recommended modifications 
to the current WIC food packages to reduce foods provided in more 
than supplemental amounts and increase foods needed to improve 
intakes of priority nutrients and food groups. 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,\4\ which provide 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.\5\ The proposed revisions 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.
---------------------------------------------------------------------------

    \3\ 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.
    \4\ Referred to hereafter as ``2020-2025 DGA'' or ``DGA.''
    \5\ 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 proposed 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 President's Budget 
Request for FY 2023 included the same CVV increase, which would set 
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 temporarily increased the CVV on a year-to-year basis. This 
proposed rule would make permanent the CVV increase enacted in FY 
2022, and proposed in FY 2023, by revising the regulations governing 
the WIC food packages. Due to the temporary nature of the CVV 
increases in FY 2022 and as proposed for FY 2023, the following 
analysis presents both the total cost, in terms of increased Federal 
transfers, for the proposed rule as a whole (i.e., compared to 
current regulations and with the cost of CVV included) and also for 
the proposed 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).
    In its 2017 report, NASEM included a regulatory impact analysis 
of its recommended revisions. This impact analysis builds on NASEM's 
analysis to update cost estimates for the provisions outlined in the 
proposed rule and calculates 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.

III. Summary of Provisions

    Table 1 summarizes the proposed 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 under Public Law 117-103.
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IV. Impacts

A. Summary of Impacts

    The following analysis describes the estimated impacts of the 
proposed rule on the Federal WIC spending, accounted for in terms of 
Federal transfer payments projected between FY 2024 and 2028, as 
well as the key health and nutrition benefits for WIC participants 
expected as a result of the changes. The description of impacts on 
Federal transfers and participant health benefits is followed by a 
discussion of impacts on administrative burden and associated costs 
to State agencies, participation, and specific food markets.
    The Department estimates that the proposed rule to revise 
regulations governing the WIC food packages would result in a net 
increase in Federal WIC spending of $4.1 billion over five years 
from FY 2024 through FY 2028. This increase only reflects changes in 
overall Federal transfers for WIC food expenditures. 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 
2, where all changes proposed 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.
    This increase in Federal WIC food expenditures is driven by the 
proposed increase in the CVV, which is estimated to increase WIC 
food expenditures by $4.9 billion over five years when compared to 
current CVV levels as outlined in 7 CFR 246.10. However, as 
explained above, the CVV levels proposed in this rule were recently 
enacted on a temporary basis for FY 2022 and the increases are 
proposed to continue through FY 2023 in the President's Budget 
Request. As a result, when compared to the FY 2022 enacted food 
packages, the CVV increase proposed in this rule would not impact 
Federal WIC expenditures. With the CVV impact zeroed out of the 
overall cost estimate for the proposed rule, the remaining 
provisions are expected to result in a net decrease in Federal WIC 
food spending of $821 million over five years when compared to the 
food packages as enacted in FY 2022.

[[Page 71134]]



                                 Table 2--Summary of Estimated Food Costs and Savings of Proposed Rule by Food Category
                                                                [FY 2024 through FY 2028]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Fiscal year ($ millions)
                                                         -----------------------------------------------------------------------------------------------
                                                               2024            2025            2026            2027            2028        5 Year Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cash-Value Voucher (CVV)................................          $913.8          $949.8          $975.2        $1,029.2        $1,075.5        $4,943.5
Fish....................................................            31.6            33.1            34.8            35.6            36.4           171.4
Infant Fruits and Vegetables............................            21.6            22.1            22.6            23.1            23.6           113.0
Legumes.................................................             3.4             3.6             3.8             3.9             3.9            18.5
Infant Meats............................................            -2.9            -3.0            -3.0            -3.1            -3.2           -15.2
Breakfast Cereal........................................            -4.5            -4.8            -5.1            -5.2            -5.3           -24.8
Infant Formula \a\......................................             1.1            -7.8            -8.0            -8.2            -8.4           -31.3
Cheese..................................................            -7.3            -7.4            -7.6            -7.8            -8.0           -38.0
Whole Grains............................................            -8.3           -10.9           -13.6           -13.9           -14.3           -61.0
Infant Cereal...........................................           -18.1           -18.5           -18.9           -19.3           -19.8           -94.7
Milk....................................................           -25.2           -26.3           -27.5           -28.1           -28.7          -135.8
Juice...................................................          -133.6          -140.9          -148.7          -152.1          -155.5          -731.0
Interaction of Infant Formula Change Across Food                     0.0             2.0             2.0             1.9             1.9             7.8
 Packages \a\...........................................
Eggs....................................................            (**)            (**)            (**)            (**)            (**)            (**)
Fruit and Vegetables Forms and Varieties................            (**)            (**)            (**)            (**)            (**)            (**)
                                                         -----------------------------------------------------------------------------------------------
    Total projected cost: compared to food packages in             771.5           791.0           805.9           855.9           898.2         4,122.5
     current Federal Regulations (includes cost of CVV)
     \b\................................................
                                                         -----------------------------------------------------------------------------------------------
    Total projected cost: compared to food packages with          -142.3          -158.8          -169.3          -173.3          -177.3          -821.0
     CVV increase as enacted in FY 2022 (no cost impact
     of CVV) \b\........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
\a\ The proposed 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\ In FY 2022, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2022 (Pub. L. 117-103)
  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, which were also proposed in the President's Budget for FY 2023, are the same CVV values proposed in this proposed rule. This
  table provides overall cost estimates for the proposed 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 and proposed in FY
  2023 (i.e., cost of CVV excluded).
** Provisions not estimated to have a meaningful impact on overall food cost.

    The overall change in the 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 package to be $28.0 
billion from FY 2024 through 2028, this estimate does not include 
the cost of the temporary increase in the CVV authorized under 
Public Law 117-103 for FY 2022 (see Table 4 for comparisons to FY 
2022 enacted expenses). The additional food costs of $4.1 billion 
estimated under this proposed rule would bring total Federal WIC 
spending, in terms of Federal transfers, up to $32.2 billion in 
total from FY 2024 through 2028.

                                                    Table 3--Total Projected Federal WIC Expenditures
                                                                     [FY 2024-2028]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Fiscal year (millions)
                                                         --------------------------------------------------------------------------------      Total
                                                               2024            2025            2026            2027            2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Food Expenditures.................................        $3,840.7        $4,002.7        $4,168.8        $4,281.9        $4,388.9       $20,683.0
    Cost of Current Food Packages \a\...................         3,069.2         3,211.7         3,362.9         3,426.1         3,490.7        16,560.6
    Cost of CVV Increase \b\............................           913.8           949.8           975.2         1,029.2         1,075.5         4,943.5
    Incremental Cost of Proposed Rule Other than CVV              -142.3          -158.8          -169.3          -173.3          -177.3          -821.0
     Increase \c\.......................................
Total Nutrition Services & Administration Costs.........         2,157.6         2,224.5         2,293.4         2,364.5         2,437.8        11,477.8
                                                         -----------------------------------------------------------------------------------------------
    Total Federal Expenditures..........................         5,998.2         6,227.2         6,462.2         6,646.5         6,826.7        32,160.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 $9 for children and $12 for women in FY 2024.

[[Page 71135]]

 
\b\ Cost of CVV increase reflects the added cost of the CVV increase proposed in this rule, which is equal to the CVV increase temporarily enacted in FY
  2022 under Public Law 117-103.
\c\ Incremental cost of the proposed 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 when CVV was temporarily
  increased.

    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 the proposed 
changes (including estimated burden for State and local agency staff 
training) and explaining the revised food packages to participants. 
This additional administrative burden is expected to account for 
about $171 million in additional labor costs associated with the 
required State and local agency staff time over five years between 
FY 2024 and FY 2028. 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 proposed rule 
with current NSA funds.
    The proposed 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.\6\ 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.7 8 The proposed 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 individual's requirement for a nutrient or recommended amount 
of a food group.
---------------------------------------------------------------------------

    \6\ 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.
    \7\ Ibid.
    \8\ 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.
---------------------------------------------------------------------------

B. Baseline for Estimate of Program Expenditures

    The total projected baseline Federal cost of WIC under the 
current food package for FY 2024 through 2028 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 proposed 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 under Public Law 
117-103.
    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 2024 through 2028 in this 
analysis.

                                    Table 4--Total Projected Baseline Federal WIC Expenditures, Current Food Packages
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Fiscal year (millions)
                                                         -----------------------------------------------------------------------------------------------
                                                               2024            2025            2026            2027            2028            Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Food Cost.........................................        $3,982.9        $4,161.5        $4,338.1        $4,455.3        $4,566.2       $21,504.1
    Cost of Current Food Packages \a\...................         3,069.2         3,211.7         3,362.9         3,426.1         3,490.7        16,560.6
    Cost of CVV Increase \b\............................           913.8           949.8           975.2         1,029.2         1,075.5         4,943.5
Total Nutrition Services & Administration Costs.........         2,157.6         2,224.5         2,293.4         2,364.5         2,437.8        11,477.8
                                                         -----------------------------------------------------------------------------------------------
    Total Federal Cost..................................         6,140.5         6,386.0         6,631.5         6,819.8         7,004.0        32,981.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 $9 for children and $12 for women in FY 2024.
\b\ Cost of CVV increase reflects the added cost of the CVV increase proposed in this rule, which is equal to the CVV increase temporarily enacted in FY
  2022 under Public Law 117-103.

Participation

    This analysis bases WIC participation projections on 
participation changes observed during FY 2020 and FY 2021 (including 
when program flexibilities were implemented in response to the 
Coronavirus Disease 2019 (COVID-19) pandemic), specifically, a fixed 
level of participation among infants and pregnant, postpartum, and 
breastfeeding individuals and annual increases in participation 
among children. Accordingly, growth in child participation is 
estimated at 2.08 percent annually between FY 2021 and 2023 and to 
rise to 4.82 percent annual growth between 2023 and 2026 before 
leveling off at the higher participation level in 2027 and 2028. In 
2018, the most recent data available, only 44 percent of eligible 
children participated in WIC.\9\ The estimated increases in child 
participation used in this analysis reflect a projected narrowing of 
the coverage gap among WIC-eligible children as a result of current 
and future efforts to improve retention among children ages 1 to 4 
in WIC. While declining birth rates in the U.S. have contributed to 
a decrease in infants and pregnant, postpartum, and breastfeeding 
individuals participating in WIC each year since 2009, the 
Department projects
---------------------------------------------------------------------------

    \9\ Gray K., Meyers-Mathieu K., Johnson, P., and Giannarelli, L. 
(2021). National- and State-Level Estimates of WIC Eligibility and 
WIC Program Reach in 2018 With Updated Estimates for 2016 and 2017. 
Prepared by Insight Policy Research, Contract No AG-3198-D-16-0095. 
Alexandria, VA: U.S. Department of Agriculture, Food and Nutrition 
Service, Office of Policy Support, Project Officer: Grant 
Lovellette. Available online at: www.fns.usda.gov/research-analysis.

---------------------------------------------------------------------------

[[Page 71136]]

participation among these groups level off due to future outreach 
efforts to increase participation.\10\ 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.\11\
---------------------------------------------------------------------------

    \10\ The provisional number of U.S. births in 2020 declined 4 
percent compared to 2019. This is the lowest number of births since 
1979 and the sixth consecutive year of a decline. Source: Hamilton 
BE, Martin JA, Osterman MJK. Births: Provisional data for 2020. 
Vital Statistics Rapid Release; no 12. Hyattsville, MD: National 
Center for Health Statistics. May 2021. DOI: https://doi.org/10.15620/cdc:104993.
    \11\ 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: 
www.fns.usda.gov/research-and-analysis.

                                    Table 5--WIC Participation Estimates by Category and Food Package[FY 2024--2028]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Fiscal year participants
                                                   Food package          -------------------------------------------------------------------------------
                                                                               2024            2025            2026            2027            2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants.................................  ..............................       1,468,664       1,468,664       1,468,664       1,468,664       1,468,664
    FF 0-4 months.......................  I-FF-A                                 223,294         223,294         223,294         223,294         223,294
    FF 4-6 months.......................  I-FF-B                                 158,365         158,365         158,365         158,365         158,365
    BF/FF 0-1 months....................  I-BF/FF-A                                7,918           7,918           7,918           7,918           7,918
    BF/FF 1-4 months....................  I-BF/FF-B                               68,097          68,097          68,097          68,097          68,097
    BF/FF 4-6 months....................  I-BF/FF-C                               42,759          42,759          42,759          42,759          42,759
    BF 0-4 months.......................  I-BF-A                                  60,179          60,179          60,179          60,179          60,179
    BF 4-6 months.......................  I-BF-B                                  31,673          31,673          31,673          31,673          31,673
    FF 6-11 months......................  II-FF                                  547,942         547,942         547,942         547,942         547,942
    BF/FF 6-11 months...................  II-BF/FF                               101,353         101,353         101,353         101,353         101,353
    BF 6-11 months......................  II-BF                                   93,435          93,435          93,435          93,435          93,435
    FP III..............................  III-I                                  133,648         133,648         133,648         133,648         133,648
Children................................  ..............................       3,714,820       3,894,002       4,081,826       4,081,826       4,081,826
    12-23 months........................  IV-A                                 1,066,153       1,117,579       1,171,484       1,171,484       1,171,484
    2-4 years...........................  IV-B                                 2,585,515       2,710,225       2,840,951       2,840,951       2,840,951
    FP III..............................  III-IV                                  63,152          66,198          69,391          69,391          69,391
Adults..................................  ..............................       1,381,305       1,381,305       1,381,305       1,381,305       1,381,305
    Pregnant............................  V-A *                                  494,645         494,645         494,645         494,645         494,645
    BF/FF...............................  V-B *                                  304,163         304,163         304,163         304,163         304,163
    Postpartum..........................  VI                                     399,750         399,750         399,750         399,750         399,750
    BF..................................  VII                                    180,260         180,260         180,260         180,260         180,260
    FP III..............................  III-V/VI/VII                             2,486           2,486           2,486           2,486           2,486
                                                                         -------------------------------------------------------------------------------
        Total Participants..............  ..............................       6,564,789       6,743,971       6,931,795       6,931,795       6,931,795
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.\12\ 
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 2022.\13\ 
Inflation for all food categories is estimated for FY 2023 through 
FY 2028 using the Office of Management and Budget's (OMB) food at 
home projections used in the most recent President's Budget 
request.\14\
---------------------------------------------------------------------------

    \12\ 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/.
    \13\ ERS food-specific inflation estimates are current as of 
June 26, 2022.
    \14\ As of March 2022, OMB projects annual food at home 
inflation to be around 2.26 percent annually for FY 2023-FY 2028. 
For more information, see https://www.whitehouse.gov/wp-content/uploads/2022/03/budget_fy2023.pdf.
---------------------------------------------------------------------------

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 proposed food package revisions use the MMAs defined under the 
proposed rule. Key changes to MMAs by food item under this proposed 
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 Appendix A-1, Tables A-1 
through A-12 for redemption rate estimates by food category).\15\
---------------------------------------------------------------------------

    \15\ 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 Proposed 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 
proposed 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 proposed 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 a number of 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

[[Page 71137]]

three State agencies (Kentucky, Michigan, and Nevada) for a 2014 
report by Altarum to understand three different types of WIC 
redemption patterns: (1) full redemption, (2) partial redemption, 
and (3) non-redemption.\16\ The effect of a decrease in the MMA for 
an item is not computed equally for all three groups, because we 
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 by Altarum 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. Beyond the implied redemption rates 
calculated based on changes to the MMA amounts, 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 redemption data NASEM 
collected directly from 6 State agencies to expand the 
representativeness of the estimates.
---------------------------------------------------------------------------

    \16\ 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/sites/default/files/uploaded-publication-files/Altarum_Transition%20to%20WIC%20EBT_Final%20Report_071614.pdf.
---------------------------------------------------------------------------

    NASEM's approach poses a number of limitations. Without much of 
a precedent for 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 proposed 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.
    Although the food costs presented here are updated with the best 
available information and to reflect the food package revisions as 
defined in this proposed rule, including where the Department's 
proposals 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)

    Summary of Proposed Change:
     Increase CVV maximum monthly allowances for child, 
pregnant, postpartum, and breastfeeding participants.
     Expand what can be purchased with CVV.
    The proposed 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. The proposed 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).
    Context, Behavior Change, and Benefits:
    Fruits and vegetables are nutrient dense and associated with a 
reduced risk of chronic diseases,\17\ including high blood 
pressure,18 19 stroke,\20\ heart disease,\21\ 
diabetes,\22\ and specific types of cancer.\23\ 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.\24\ 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.25 26 27 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.\28\ Among children participating in WIC, 
average intakes of fruits and vegetables are also below recommended 
levels.\29\ 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.
---------------------------------------------------------------------------

    \17\ 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.
    \18\ 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.
    \19\ Borgi L, Muraki I, Satija A, Willett WC, Rimm EB, Forman 
JP. Fruit and Vegetable Consumption and the Incidence of 
Hypertension in Three Prospective Cohort Studies. Hypertension. 2016 
Feb;67(2):288-93. doi: 10.1161/HYPERTENSIONAHA.115.06497. Epub 2015 
Dec 7. PMID: 26644239; PMCID: PMC5350612.
    \20\ Guo, N., Zhu, Y., Tian, D. et al. Role of diet in stroke 
incidence: an umbrella review of meta-analyses of prospective 
observational studies. BMC Med 20, 194 (2022). https://doi.org/10.1186/s12916-022-02381-6.
    \21\ 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.
    \22\ 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.
    \23\ 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.
    \24\ 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.
    \25\ 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.
    \26\ 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.
    \27\ 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.
    \28\ See 2020-2025 DGA, p. 30-32.
    \29\ 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.
---------------------------------------------------------------------------

    The proposed changes to regulations governing the CVV are likely 
to increase fruit and vegetable consumption among WIC participants. 
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 and

[[Page 71138]]

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.
    NASEM estimated that WIC participants would need to spend $25, 
$45, or $50 (adjusted for inflation to FY 2024), depending on 
participant category, to meet 50 percent of the DGA-recommended 
intakes for vegetables and fruits. This suggests that the current 
CVV levels of $9 for children and $11 for pregnant, postpartum, and 
breastfeeding individuals 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 
proposed 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.
    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 that see preparation time as a barrier to consumption.
    Federal Budgetary Costs:
    The increase in value of the CVV accounts for most of the 
increased Federal spending under the proposed rule, adding around 
$4.9 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. Table 6 compares the projected CVV values for 
the current food packages outlined in 7 CFR 246.10 and revised food 
packages under this proposed rule for child, pregnant, postpartum, 
and breastfeeding participants between FY 2024 through 2028, 
accounting for annual inflation and rounding down to the nearest 
whole dollar.\30\ As described earlier in this analysis, the CVV 
levels proposed in this rule were temporarily enacted in FY 2022 and 
have been proposed to continue through FY 2023 in the President's 
Budget Request. Therefore, compared to WIC food packages as enacted 
in FY 2022, the changes described in this section would have no 
impact on Federal spending, but would instead simply establish the 
FY 2022 CVV levels as the new permanent CVV levels in WIC 
regulations.
---------------------------------------------------------------------------

    \30\ 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 are 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--Changes to CVV Amount by Participant Category
                                                                [FY 2024 through FY 2028]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    2024                  2025                  2026                  2027                  2028
    Participant category (food package)    -------------------------------------------------------------------------------------------------------------
                                               Cur.       Rev.       Cur.       Rev.       Cur.       Rev.       Cur.       Rev.       Cur.       Rev.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (IV).............................         $9        $25         $9        $26        $10        $26        $10        $27        $10        $28
Pregnant (V-A)............................         12         45         12         46         12         47         13         49         13         50
Partially BF (V-B)........................         12         50         12         51         12         52         13         53         13         54
Postpartum (VI)...........................         12         45         12         46         12         47         13         49         13         50
Fully BF (VII)............................         12         50         12         51         12         52         13         53         13         54
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 proposed in this rule, which are equal to and make permanent the temporary levels enacted in FY 22, adjusted for inflation.

    To better understand how the proposed 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).\31\ 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.\32\ The Department assumes that this 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 proposed CVV levels in this rule.
---------------------------------------------------------------------------

    \31\ 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.
    \32\ 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.
---------------------------------------------------------------------------

Canned Fish

    Summary of Proposed Change:
     Add canned fish to food packages for children (ages 2 
through 4 years) and specify WIC-eligible varieties for children.
     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.
    In 2021, the FDA and EPA updated their joint advice about eating 
fish, which incorporates 2020-2025 DGA recommendations; identifies 
fish types and serving sizes safe for consumption based on estimated 
methylmercury exposure; and newly includes advice for children age 1 
year-11 years (previous advice included recommendations for children 
2 to 11 years). The advice includes a subset of ``Best Choices'' 
that contain lower methylmercury (as also noted in the DGA 2020-2025 
Table A3-1 (12-23 months) footnote (e)) to support children age 1 
year in consuming 3 ounces per week recommended in the Healthy U.S.-
Style Dietary Pattern without exceeding limits for estimated 
methylmercury exposure and indicates that many commonly consumed 
fish types, including light canned tuna, a WIC-eligible variety, 
should not be consumed in amounts of 3 ounces per week by this age 
group due to their methylmercury content. Therefore, the proposed 
changes for canned fish in the food packages does not include canned 
light tuna for children.
    Context, Behavior Change, and Benefits:
    The proposed revisions add select varieties of canned fish to 
food packages for children ages 2 through 4 years and for pregnant, 
postpartum and breastfeeding participants to

[[Page 71139]]

better align the WIC food packages with the DGA and generally follow 
NASEM recommendations. These revisions would greatly increase the 
number of WIC participants receiving fish (currently only 
breastfeeding participants receive fish), an important dietary 
source of polyunsaturated fatty acids and other key nutrients and 
would create more equitable access to this under-consumed food.
    The amount of fish offered in the revised food packages would 
provide a supplemental quantity of between 15 to 47 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.
    Federal Budgetary Costs:
    The proposed changes to the quantities of canned fish represent 
the second largest increase in cost under this proposed rule, 
accounting for an estimated $171 million increase 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 proposed revisions.

Infant Fruits and Vegetables

    Summary of Proposed Change:
     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 needed. Further, 
fully breastfed infants do not have a greater need for fruits and 
vegetables compared to other infants. Thus, the proposed reduced 
amounts of jarred fruits and vegetables for fully breastfed infant 
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) committee to 
promote full breastfeeding (2006 IOM report, page 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 to 6 months old) and increasing 
substitution amounts would provide additional choice to WIC 
participants to accommodate cultural 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.\33\ 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.
---------------------------------------------------------------------------

    \33\ 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 proposed rule would decrease the maximum monthly 
allowance of jarred infant fruits and vegetables issued to fully 
breastfed infants, the Department estimates that the proposed 
changes to infant fruits and vegetables under this rule would result 
in a net increase of $113 million in costs 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).\34\ 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 proposed rule.
---------------------------------------------------------------------------

    \34\ 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 Proposed Change:
     Change whole grain criteria for breakfast cereals.
     Require all breakfast cereals meet whole grain 
criteria.
    As recommended by NASEM, the proposed revisions would change the 
criteria for whole grain breakfast cereals and require that all 
breakfast cereals meet the criteria for whole grain. These changes 
are designed to increase the amount of whole grains in the food 
packages that provide whole grains and improve consistency with FNS 
Child Nutrition Programs (CACFP, the National School Lunch Program, 
and the National School Breakfast Program).
    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 National Health 
and Nutrition Examination Survey (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.\35\
---------------------------------------------------------------------------

    \35\ 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.
---------------------------------------------------------------------------

    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.
    Prior revisions to the WIC food package did not fully implement 
IOM's 2006 recommendation that all breakfast cereals meet the 
criteria for whole grain cereals due to concerns at the time that 
the recommendation would have eliminated corn- and rice-based 
cereals, which are alternatives for people with allergies or 
intolerances, and it would have limited participant choice due to a 
relatively lack of availability of whole-grain cereals in the 
marketplace when the prior rule was published.
    During its most recent review, the NASEM committee reviewed 
product information provided by two large national breakfast cereal 
manufacturers and found that manufacturers are now producing a 
sufficient number of different breakfast cereals across the country 
that meet the whole-grain rich criteria (including gluten-free 
varieties to address celiac disease, allergies, or intolerances) to 
provide sufficient choice to WIC participants; therefore, these 
requirements are expected to increase whole grain consumption and 
decrease refined grain consumption among WIC participants.
    Federal Budgetary Costs:
    While the maximum monthly allowances for breakfast cereal will 
not change under the proposed rule, the Department estimates that 
the revisions to whole grain requirements for cereal will decrease 
costs by approximately

[[Page 71140]]

$18 million over five years. The decrease in cost is driven by the 
estimated impact of these changes on redemption rates. While the 
changes to breakfast cereal requirements are expected to increase 
whole grain consumption overall amongst WIC participants, the 
Department, like NASEM, expects some participants will reduce cereal 
redemptions as a result of the changes in whole grain requirements. 
NASEM estimated that the changes will decrease redemption rates by 
10 percent, based on reduction in allowable cereal options and its 
analysis showing that whole grain cereals are less preferred by 
participants in some States.\36\ By applying NASEM's findings, the 
Department estimates that the redemption rates across all food 
packages for breakfast cereals will decrease from 48 to 43 percent. 
This estimate also accounts for a slight increase in unit costs. 
NASEM estimates that the proposed changes will increase the unit 
cost of breakfast cereals in the WIC food packages by about 9 
percent. The Department estimates that, starting in FY 2024, unit 
costs for cereal under the proposed rule will rise from $0.18 to 
$0.21 per ounce, after adjusting for inflation.
---------------------------------------------------------------------------

    \36\ 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 Proposed Change:
     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 proposed rule would increase 
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 would increase 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. Women 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.\37\
---------------------------------------------------------------------------

    \37\ 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 proposed change would 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 proposed increase to the infant 
formula amounts allowed during the first month of an infant's life 
would 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.
    The proposed 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.\38\ Because the partially 
breastfed infant food packages are less costly than the fully 
breastfed infant food packages, this shift would result in an 
estimated decrease of around $29 million in total Federal spending 
on infant formula in the WIC food packages over five years.
---------------------------------------------------------------------------

    \38\ 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 
proposed rule are also estimated to impact spending in other food 
categories. As described above, NASEM estimates these changes would 
result in a 5 percent shift of fully formula fed infants into the 
partially breastfed infant category. This would correspond 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 2 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 $8 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 Proposed Change:
     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 proposed revisions largely reflect NASEM's recommendations 
and would 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 would provide 27 to 
53 percent of DGA recommended amounts, better aligning the 
children's food packages with the concept of supplemental and 
offsetting cost increases elsewhere in the revised food packages.

[[Page 71141]]

    The proposed increased amount for pregnant, postpartum and 
breastfeeding participants exceeds NASEM's recommended amount (24 
ounces). Specifically, the Department's proposed amount for would 
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 would provide and encourage 
consumption of whole grains, consistent with the DGA and in 
quantities closer to NASEM's definition of a supplemental amount. 
The proposed 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.\39\ 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.
---------------------------------------------------------------------------

    \39\ 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 proposed 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 proposed rule. Overall, these changes result in an 
estimated decrease of about $61 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 proposed rule differs from NASEM's 
recommendation to allow a specific range of package sizes under this 
category, and instead proposes to allow 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 proposed rule would 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 proposed 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 proposed 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 that 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 package.\40\ 
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).
---------------------------------------------------------------------------

    \40\ 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 Proposed Change:
     Remove cheese as a food category for fully 
breastfeeding participants.
    As recommended by NASEM, this proposed rule would remove 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 $38 million over five years.

Infant Meats

    Summary of Proposed Change:
     Reduce infant meats amounts.
    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 proposed 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 $15 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 proposed rule.

Infant Cereal

    Summary of Proposed Change:
     Reduce infant cereal amounts for all infants.
    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 proposed 
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 would 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 would provide 50 percent of the AAP 
recommended amount for partially (mostly) breastfed and fully 
formula fed infants.

[[Page 71142]]

    Federal Budgetary Costs:
    Reducing infant cereals in all infant food packages is estimated 
to reduce WIC food costs by around $95 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 proposed rule.

Milk

    Summary of Proposed Change:
     Reduce milk amounts for child, pregnant, postpartum, 
and breastfeeding participants.
     Require authorization of lactose-free milk.
     No longer allow the option for flavored milk.
     Increase amount of yogurt available to substitute for 
milk and revise specifications for package sizes.
     Add milk substitution options and milk substitution 
specifications.
    The proposed 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 proposed revisions to reduce the amount of milk prescribed 
to WIC participants would better align the amount given to 
participants to the Program's intent to provide a supplemental 
amount of food. The current food packages provide 85 to 128 percent 
of the DGA recommendations for dairy products. The revision 
recommended by NASEM and proposed by the Department would 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 proposed rule allows only unflavored milk and specifies 
limits on sugar for milk substitutions 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 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 proposed revisions align the 
milk offering with CACFP provision of milks to children less than 5 
years of age.
    The proposed option for substitution of two quarts of yogurt in 
place of two quarts of milk may improve intakes for participants who 
prefer dairy in this form. In addition, the proposed rule would 
allow fortified soy cheese and beverage options as well as require 
authorization of lactose-free milk for participants with lactose 
intolerance, a milk allergy, and those who consume a vegan diet.\41\ 
The options are intended to provide participants with flexibility to 
select substitutions that better meet cultural needs and personal 
preferences while still providing critical nutrients to WIC 
participants.
---------------------------------------------------------------------------

    \41\ Although, currently an option (not a requirement) all 
States and most ITOs already authorize some kind of lactose-free 
milk, and therefore, USDA does not estimate an additional cost 
attributable to this requirement.
---------------------------------------------------------------------------

    The revised specifications for yogurt and other dairy 
substitutions will help ensure that WIC participants receive the 
most nutritionally dense dairy or dairy substitute products without 
unnecessary added sugars.
    Federal Budgetary Costs:
    Reducing the maximum monthly allowance of milk as described is 
estimated to reduce WIC food costs by $136 million over five years. 
This large cost savings contributes to improving the balance and 
supplemental nature of the WIC food packages by offsetting some of 
the costs associated with increased amounts provided in other food 
categories.
    The decrease in costs is driven by the decrease in the maximum 
monthly allowance for milk in most food packages under the proposed 
rule. The savings associated with the reduction in milk quantities 
are expected to be partially offset by the proposed changes to milk 
substitution options, 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 soy 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 proposed rule are expected to increase 
the composite unit cost for milk across almost 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 participants are allowed to 
substitute for milk, and (3) increased flexibility in allowable 
yogurt package sizes.

        Table 7--Composite Unit Price for Milk and Milk Alternatives in Current and Revised Food Packages
----------------------------------------------------------------------------------------------------------------
                                               Current                                   Revised
                             -----------------------------------------------------------------------------------
        Food package                     Substitution   Composite cost             Substitution   Composite cost
                                MMA         scheme          ($/qt)        MMA         scheme          ($/qt)
----------------------------------------------------------------------------------------------------------------
IV-A........................       16  12 qt milk + 1           1.1240       12  8 qt milk + 1            1.2021
                                        lb cheese + 1                             lb cheese + 1
                                        qt yogurt.                                qt yogurt.
IV-B........................       16  12 qt milk + 1           1.0709       14  11 qt milk +             1.0977
                                        lb cheese + 1                             0.5 lb cheese
                                        qt yogurt.                                + 1.5 qt
                                                                                  yogurt.
V-A.........................       22  18 qt milk + 1           0.9900       16  13 qt milk +             1.0605
                                        lb cheese + 1                             0.5 lb cheese
                                        qt yogurt.                                + 1.5 qt
                                                                                  yogurt.
V-B.........................       22  18 qt milk + 1           0.9900       16  13 qt milk +             1.0605
                                        lb cheese + 1                             0.5 lb cheese
                                        qt yogurt.                                + 1.5 qt
                                                                                  yogurt.
VI..........................       16  12 qt milk + 1           1.0709       16  13 qt milk +             1.0605
                                        lb cheese + 1                             0.5 lb cheese
                                        qt yogurt.                                + 1.5 qt
                                                                                  yogurt.
VII.........................       24  19 qt milk + 1           0.9856       16  12 qt milk + 1           1.0709
                                        lb cheese + 1                             lb cheese + 1
                                        qt yogurt.                                qt yogurt.
----------------------------------------------------------------------------------------------------------------
Notes:

[[Page 71143]]

 
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 applying weights of 0.992 to whole milk and 0.008 to soy beverages for food package IV-A and weights
  of 0.989 to reduced-fat milk and 0.011 to soy beverages for all other food packages. 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).
Table adapted from NASEM Report (Appendix U, p. 950-955).

    Cost estimates for milk also apply NASEM's assumptions about the 
impact of the revisions on redemption rates. NASEM estimates that 
the revisions under the proposed rule, particularly the additional 
amount of yogurt authorized for substitution, is expected to 
increase redemption rates across all food packages (see Appendix A-
1, Table A-10 for detailed redemption rates). 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 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.

Juice

    Summary of Proposed Change:
     Reduce juice amounts for child, pregnant, and 
breastfeeding participants and eliminate juice for postpartum 
participants.
     Allow CVV juice substitution.
    Context, Behavior Change, and Benefits:
    The proposed reduction of juice in food packages for child, 
pregnant, 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 would provide 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, and 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 cultural needs and personal preferences. These 
proposed 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 program (across food packages) 
would be 64 fluid ounces, potentially decreasing vendor burden by 
streamlining options across food packages.
    Finally, the cost savings from the reduction of juice partially 
offsets the cost of increasing the value of the CVV.
    Federal Budgetary Costs:
    The reduction of juice in all food packages represents the 
largest source of cost savings under the proposed rule--accounting 
for an estimated net decrease of $731 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 proposed 
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

    Summary of Proposed Change:
     Require both dry and canned legumes be allowed.
    As recommended by NASEM, this proposed change would 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.
    Context, Behavior Change, and Benefits:
    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 proposed 
provision will require State agencies to authorize both dried and 
canned legumes for WIC participants. States are currently only 
required to authorize dried legumes, and allowing canned legumes is 
a State option.\42\ Requiring canned legumes would 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.
---------------------------------------------------------------------------

    \42\ 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: 
www.fns.usda.gov/research-analysis.
---------------------------------------------------------------------------

    Federal Budgetary Costs:
    Requiring all State agencies to authorize canned legumes is 
expected to increase food costs by around $18 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 
proposed 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.\43\ 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 proposed rule as canned legumes are generally more 
expensive than dry legumes.\44\
---------------------------------------------------------------------------

    \43\ 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: www.fns.usda.gov/research-analysis.
    \44\ 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.
---------------------------------------------------------------------------

Eggs

    Summary of Proposed Change:
     Add required and optional substitution options for 
eggs.
    Context, Behavior Change, and Benefits:
    Based on NASEM's recommendations, with modification, the 
proposed changes would require that State agencies allow the 
substitution of eggs with legumes or peanut butter if a participant 
has an egg allergy, is vegan, or for other reasons (e.g., cultural 
preferences) as determined by State agency policy. The changes would 
also allow 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,

[[Page 71144]]

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 Department also proposes to allow State agencies the option 
to authorize tofu as a substitute for eggs. Similar to eggs, tofu is 
a source of choline. If implemented, appropriate food package 
tailoring and nutrition education would need to address other food 
sources of iron, especially for participants determined to have low 
iron levels.
    Federal Budgetary Costs:
    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. The substitution is limited to participants 
with an egg allergy, are vegan, or for reasons defined 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.\45\ 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 less 
common than vegetarian diets.\46\ Therefore, while this policy 
change provides an important substitution option, its use is 
expected to be rare as it will likely only apply to a small number 
of participants.
---------------------------------------------------------------------------

    \45\ This information is not yet published. Data will be 
publicly available in the forthcoming report from the WIC Food Cost-
Containment Practices Study, expected to be published in early-2022.
    \46\ Gallup. ``Snapshot: Few Americans Vegetarian or Vegan.'' 
August 1, 2018. Available at: https://news.gallup.com/poll/238328/snapshot-few-americans-vegetarian-vegan.aspx.
---------------------------------------------------------------------------

Fruit and Vegetables Forms and Varieties

    Summary of Proposed Change:
     State agencies required to authorize an additional form 
of fruits and vegetables.
     Require vendors to stock at least 3 different 
vegetables.
    Context, Behavior Change, and Benefits:
    As recommended by NASEM, the proposed rule would require 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 proposed change would 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 proposed 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.
    As recommended by NASEM, the proposed rule would also require 
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.\47\ 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.
---------------------------------------------------------------------------

    \47\ 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 proposed change is intended to increase the purchase 
and consumption of vegetables among WIC participants, particularly 
given the proposed 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 proposed 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 proposed revision could also increase general availability 
of different types of vegetables in areas served by small WIC 
vendors, as those additional vegetable types would be available for 
retail purchase by the general public.
    Federal Budgetary Costs:
    The requirement for State agencies to authorize at least one 
additional form of fruits and vegetables other than fresh and the 
requirement that vendors stock at least three varieties of 
vegetables are not expected to increase the 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. Further, because only 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 proposed 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 
proposed 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 proposed 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 \48\ also emphasize the consumption 
of whole fruits and vegetables over juice. A recent FNS study using 
2011-2016 National Health and Nutrition Examination Survey (NHANES) 
data found that children participating in WIC under the current food 
package report overall inadequate intake levels for vegetables, 
seafood, and whole grains.\49\ 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 proposed rule will help WIC participants narrow 
these gaps in intake by increasing the amounts of whole grains, 
fish, and whole fruits and vegetables available in the WIC food 
packages.
---------------------------------------------------------------------------

    \48\ 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.
    \49\ 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.
---------------------------------------------------------------------------

    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 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

[[Page 71145]]

this proposed rule.\50\ 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.
---------------------------------------------------------------------------

    \50\ 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 proposed 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                                        % of DGA
                                                                                                  \b\      % of DGA     WIC MMA    % of DGA     met \c\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total fruit..........................  Total Fruit............  c-eq                    1.25        0.86          72        0.99          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        0.60          27         -17
    Breakfast cereal.................  Whole grains...........  oz-eq                   2.25        0.23          58        0.60          62           5
    Bread............................  Whole grains...........  oz-eq             ..........        1.07  ..........        0.80  ..........  ..........
Total protein foods..................  Total protein foods....  oz-eq                   3.50        1.00          28        1.16          33           5
    Peanut butter....................     Nuts, seeds, and soy  oz-eq                   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        0.17          23          23
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                                        % of DGA
                                                                                                  \b\      % of DGA     WIC MMA    % of DGA     met \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        0.60          17         -11
    Breakfast cereal.................  Whole grains...........  oz-eq                   3.50        0.23          22        0.60          63          41
    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
    Peanut butter....................     Nuts, seeds,and soy.  oz-eq                   0.71        1.20         168        1.20         168           0
    Eggs.............................     Meat, poultry, eggs.  oz-eq                   4.43        0.40           9        0.40           9           0
    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.


[[Page 71146]]

E. Administrative Impacts

Participant Burden

    The proposed 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 
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 proposed 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 2024). 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 is seeking comments from local agencies on 
the type and scope of administrative burden that may be associated 
with implementing the provisions in this proposed rule in this 
manner to better estimate the burden in the final rule.

WIC State Agency Burden

    The general benefits and requirements of the Program are not 
changing. However, the proposed 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 small 
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 is seeking comments from State agencies on the type and 
scope of administrative burden that may be associated with 
implementing the provisions in this proposed rule in this manner.

Vendor Burden

    The proposed 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 proposed 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 150 small vendors 
will decide to discontinue participation in the Program (out of more 
than 41,000 total vendors) as a result of the implementation of this 
rule. The Department is seeking public comment from vendors to 
better understand the impact of and potential barriers to 
implementing the proposed changes.

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 
is seeking comments from food manufacturers on the type and scope of 
burden that may be associated with implementing the provisions in 
this proposed rule in this manner.

Administrative Costs

    As described above, USDA expects any administrative burden and 
costs associated with this rule to be highly localized, most will be 
one-time and minimal, and/or to be absorbed within current 
programmatic overhead. Specifically, USDA only expects slight 
measurable administrative costs for State agencies and local 
agencies to account for the added time for the identification of 
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 
$17.9 million in FY 2024.
    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 2024. As 
described above, State and local WIC agencies are also expected to 
incur some burden for training activities related to the proposed 
changes. The 5 hours estimated for State agency training activities 
is estimated to increase administrative costs by around $26,000 
while the 1 hour of training for each of the 1,808 local agencies is 
estimated to increase administrative costs by around $94,000. 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 $29.9 million in FY 2024. 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 $141 
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 $171 million over 
five years from FY 2024 through FY 2028.

[[Page 71147]]



                           Table 10--Administrative Costs Associated With Staff Burden
----------------------------------------------------------------------------------------------------------------
                                                                     Fiscal year
                                  Additional   -------------------------------------------------------   Total
                                 burden hours      2024       2025       2026       2027       2028
----------------------------------------------------------------------------------------------------------------
                                ..............                  Annual cost (millions)
----------------------------------------------------------------------------------------------------------------
State Agency Staff Burden:
    Identifying acceptable                 267     $0.016        n/a        n/a        n/a        n/a     $0.016
     foods....................
    State agency training                  445      0.026        n/a        n/a        n/a        n/a      0.026
     activities...............
Local Agency Staff Burden:
    Local agency training                1,808      0.094        n/a        n/a        n/a        n/a      0.094
     activities...............
    Explaining food package            572,282     29.855        n/a        n/a        n/a        n/a     29.855
     changes (one-time).......
    Explaining revised food            510,216     26.618    $27.416    $28.239    $29.086    $29.958    141.316
     package options (ongoing)
                               ---------------------------------------------------------------------------------
        Total.................       1,085,018     56.609     27.416     28.239     29.086     29.958    171.308
----------------------------------------------------------------------------------------------------------------
Notes:
Hourly labor costs are based on Bureau of Labor and Statistics (BLS) estimates for total compensation and
  inflated to FY 2024-FY 2028 according to the CPI-W projections in OMB's economic assumptions for the FY2023
  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

    The baseline and revised costs presented in this analysis both 
assume a change in WIC participation from historical participation 
trends as a result of 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 efforts to increase participation and redemption of 
benefits. Implementation of projects made possible by this ARPA 
funding assume a leveling-off of infant, pregnant, postpartum, and 
breastfeeding participants and an eventual increase in participation 
among children followed by a leveling off at the higher rate of 
child participation.
    As noted in the above analysis, the Department's primary 
estimate does include 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 the food package changes will not have a meaningful impact on 
participation. However, because the proposed rule goes beyond 
NASEM's cost neutral recommendations (particularly in the proposed 
increases to the CVV), the rule may be more likely to have an impact 
on participation. However, given planned efforts to increase 
participation and retention under ARPA, as described above, USDA is 
uncertain at this time how much of an increase in participation may 
be attributable solely to the proposed rule. To better understand 
how the proposed rule, and specifically the increase to the CVV 
benefit, will impact participation, USDA is tracking WIC 
participation trends under the temporary CVV increase recently 
extended under the Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies Appropriations Act, 2022 (Pub. 
L. 117-103). As described in WIC Policy Memorandum #2022-3, the 
current WIC CVV levels will be set at $24 for child participants, 
$43 for pregnant and postpartum participants, and $47 for fully and 
partially breastfeeding participants until September 30, 2022.\51\ 
As FY 2022 participation data become available, USDA will analyze 
changes in participation trends to better project the potential 
impact of the proposed changes on participation and will incorporate 
this, as well as public comment, into the estimates in the final 
rule. USDA presents additional cost estimates in the Uncertainties 
section below, which demonstrate how the cost of the rule would be 
affected if participation remains flat compared to our primary 
estimate.
---------------------------------------------------------------------------

    \51\ WIC Policy Memorandum #2022-3: Implementation of the 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 2022 (Pub. L. 117-103), 
Extending the Temporary Increase in the Cash-Value Voucher/Benefit 
for Fruit and Vegetable Purchases. March 18, 2022. Available online 
at: https://www.fns.usda.gov/wic/wpm-2022-3.
---------------------------------------------------------------------------

G. Market Impacts

    Generally, the changes proposed 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 
proposed 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 proposed rule on the 
wider U.S. food market will be small and easily absorbed by the 
competitive marketplace. Nevertheless, the Department is seeking 
public comment from U.S. food market suppliers and participants on 
the type and scope of market impacts that may be associated with 
implementing the provisions in this proposed rule.
    The dollar impacts of the proposed rule on the different food 
categories are presented in our primary estimate in Table 2. 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,\52\ so the changes represent less than 0.2% 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 proposed increase in fish represents approximately 
one-half percentage point of the total U.S. canned fished market. 
The proposed changes would cause even smaller impacts to the 
breakfast cereal, grain, and dairy markets. 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.
---------------------------------------------------------------------------

    \52\ For more information, see https://www.alliedmarketresearch.com/us-baby-food-market.
---------------------------------------------------------------------------

    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.\53\ Even though the decrease 
in juice attributable to WIC may seem substantial, it accounts for 
only 0.5% of the total U.S. juice market over the estimate period. 
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

[[Page 71148]]

decrease in spending on their juice products with increased spending 
on other products.
---------------------------------------------------------------------------

    \53\ For more information, see https://www.statista.com/outlook/cmo/non-alcoholic-drinks/juices/united-states.
---------------------------------------------------------------------------

    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 disruptions. The total size 
of the U.S. fruit and vegetable market is 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.\54\ The value of the processed fruit and 
vegetable market in North America may have been approximately $90 
billion in 2020.\55\ Just as examples, the increase in the CVV value 
would account, separately, for less than 2% of the value of farm 
cash receipts, and for less than 1% of the processed fruit and 
vegetable market.
---------------------------------------------------------------------------

    \54\ See https://data.ers.usda.gov/reports.aspx?ID=17845.
    \55\ For more information, see https://www.gminsights.com/industry-analysis/processed-fruits-and-vegetables-market.
---------------------------------------------------------------------------

    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 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, the primary analysis assumes WIC participation 
growth is consistent with current projections. These estimates 
assume a fixed level of infant, pregnant, postpartum, and 
breastfeeding participants and annual increases in child 
participants through FY 2026. Growth in child participation is 
estimated at 2.08 percent annually between FY 2021 and FY 2023 and 
rises to 4.82 percent annual growth between FY 2023 and FY 2026 
before leveling off at the higher participation rate in FY 2026 and 
FY 2028. WIC participation declined each year between 2009 and 2020. 
There was an increase in participation among children in 2020 during 
the COVID-19 pandemic; however, participation among adults and 
infants continued to decline. Table 11, below, compares the cost of 
the proposed rule under current participation projections compared 
to a model that assumes flat WIC participation across all categories 
between FY 2021 to FY 2028. As shown below, the projected increase 
in participation accounts for $297.0 million of the food cost of the 
proposed rule over five years.

                                         Table 11--Projected Food Cost of Proposed Rule by Participation Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Fiscal year (millions)
                                                         --------------------------------------------------------------------------------      Total
                                                               2024            2025            2026            2027            2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
Primary Analysis: No growth among pregnant, postpartum           $771.48         $791.00         $805.88         $855.86         $898.25        $4,122.5
 and breastfeeding individuals and children, annual
 growth among children of 2.1 percent, FYs 2021-2023,
 4.82 percent FYs 2023-2026, and flat participation FYs
 2026-2028..............................................
No Growth: Flat WIC participation among all participant           740.07          742.06          738.84          783.64          820.85         3,825.5
 categories, FYs 2021-2028..............................
                                                         -----------------------------------------------------------------------------------------------
Difference..............................................            31.4            48.9            67.0            72.2            77.4           297.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

Cash-Value Voucher Redemption Rate

    Compared to the current food packages outlined in 7 CFR 246.10, 
the proposed increase to the CVV accounts for the largest share of 
the costs associated with the proposed 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.\56\ USDA does not 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 2 percentage points higher or 2 
percentage points lower than the current projections. A 2-percentage 
point change in the CVV redemption rate under this model is 
estimated to account for a $138 million change in the cost of the 
revised CVV benefit amounts under this proposed rule.
---------------------------------------------------------------------------

    \56\ 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.

                                       Table 12--Projected Food Cost of CVV Increase at Different Redemption Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Fiscal year (millions)
                                                         --------------------------------------------------------------------------------      Total
                                                               2024            2025            2026            2027            2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
Higher (+2): 73.6 percent...............................          $797.0          $817.6          $833.1          $884.6          $928.3        $4,260.6
Current: 71.6 percent...................................           771.5           791.0           805.9           855.9           898.2         4,122.5
Lower (-2): 69.6 percent................................           746.0           764.4           778.6           827.1           868.2         3,984.3
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 71149]]

V. Alternatives

Different CVV Values

    The Department considered permanently implementing ARPA's 
temporary increase of the WIC CVV to $35 for all participant 
categories instead of NASEM's proposed values.\57\ State agencies 
and participants are already familiar with the $35 benefit value, 
and $35 CVV benefit is much closer to NASEM's recommendations than 
the pre-ARPA CVV benefit.
---------------------------------------------------------------------------

    \57\ See WIC Policy Memorandum #2021-3, ``State Agency Option to 
Temporarily Increase the Cash-Value Voucher/Benefit for Fruit and 
Vegetable Purchases,'' available online at https://www.fns.usda.gov/wic/policy-memorandum-2021-3.
---------------------------------------------------------------------------

    The Department decided to reject this alternative for both 
nutrition security and cost reasons. A permanent $35 benefit would 
provide approximately 75 percent of the DGA recommended quantity of 
fruits and vegetables for children, while at the same time providing 
only 36 to 39 percent of the DGA recommended quantity of fruits and 
vegetables for women. A $35 CVV benefit to all participants would 
also be more expensive than the proposed rule, costing approximately 
$6.1 billion over 5 years compared to the proposed rule's CVV cost 
of $4.9 billion because of the high number of child participants who 
would receive the higher amount of CVV.

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.

VI. Accounting Statement

    As required by OMB Circular A-4, we have prepared an accounting 
statement summarizing the annualized estimates of benefits, costs 
and transfers associated with the provisions of this rule.
    The benefits of the rule include 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. Health benefits are not specifically quantified in 
this analysis but were considered upfront in the detailed nutrient 
gap analysis conducted to develop the recommendations for the food 
package.
    The net transfers associated with provisions of the rule are 
incurred by the Federal government. These include the following:

 Increasing the value of the CVV
 Increasing the amount of fish prescribed to WIC 
participants
 Decreasing the amount of juice prescribed to WIC 
participants
 Other changes as noted in the above analysis

                             Table 13--Undiscounted Cost and Transfer Payment Stream
----------------------------------------------------------------------------------------------------------------
                                                       Fiscal year  ($ millions)
                                   -----------------------------------------------------------------    Total
                                        2024         2025         2026         2027         2028
----------------------------------------------------------------------------------------------------------------
Nominal Federal Transfer Payment         $771.5       $791.0       $805.9       $855.9       $898.2     $4,122.5
 Stream...........................
Nominal State Agency Cost Stream..         56.6         27.4         28.2         29.1         30.0        171.3
----------------------------------------------------------------------------------------------------------------

    Applying 3 percent and 7 percent discount rates (plus our annual 
assumed inflation factor) to these nominal streams gives present 
values (in 2023 dollars):

                                        Table 14--Discounted Cost Streams
----------------------------------------------------------------------------------------------------------------
                                                Fiscal year  ($ millions, 2023 dollars)
                                   -----------------------------------------------------------------    Total
                                        2024         2025         2026         2027         2028
----------------------------------------------------------------------------------------------------------------
Discounted Federal Transfer
 Payment Stream:
    3 percent.....................       $732.8       $714.0       $690.9       $697.1       $695.2     $3,530.0
    7 percent.....................        706.0        662.7        617.7        600.5        576.9      3,163.8
Discounted State Agency Cost
 Stream:
    3 percent.....................         53.8         25.8         25.8         25.8         25.8        157.1
    7 percent.....................         51.8         23.9         23.1         22.2         21.4        142.4
----------------------------------------------------------------------------------------------------------------

    Table 15 takes the discounted streams from Table 14 and computes 
annualized values in FY 2023 dollars.

                                                             Table 15--Accounting Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Discount rate
                    Benefits                          Range         Estimate       Year dollar         (%)                    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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 71150]]

 
                                    Program participants, farmers, food processors, food distributors, food retailers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized ($ millions/year).........            n.a.            n.a.            n.a.            n.a.  FY 2024-2028.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs                                                     Range        Estimate            Year   Discount rate  Period
                                                                                         dollar             (%)  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quantitative: Net increase in State agency administrative costs associated with increased State agency and local agency administrative burden required
 to implement proposed changes to the food packages. Administrative cost increases are only expected to be one-time costs in the first year the changes
 are implemented (estimate for FY 2024).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     State Agencies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized ($ millions/year).........            n.a.          $136.0            2023               7  FY 2024.
                                                                          158.3            2023               3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers                                                 Range        Estimate            Year   Discount rate  Period
                                                                                         dollar             (%)  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quantitative: Net increase in WIC food expenditures associated with proposed changes to the food packages.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Federal Government
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized ($ millions/year).........            n.a.          $749.4            2023               7  FY 2024-2028.
                                                                          780.1            2023               3
--------------------------------------------------------------------------------------------------------------------------------------------------------

Appendix A-1: Detailed Cost Estimates

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[FR Doc. 2022-24705 Filed 11-18-22; 8:45 am]
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