Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)

[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">[email protected]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

[[Page 71094]]

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/.
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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\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

\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">[email protected]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.
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\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.
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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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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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]
BILLING CODE 3410-30-C