Proposed Rule2022-24705
Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages
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Published
November 21, 2022
Issuing agencies
Agriculture DepartmentFood and Nutrition Service
Abstract
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.
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: Go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the instructions for submitting comments.
<bullet> Regular U.S. Mail: WIC Administration, Benefits, and
Certification Branch, Policy Division, Food and Nutrition Service, P.O.
Box 2885, Fairfax, Virginia 22031-0885.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="/cdn-cgi/l/email-protection#b0f1dcdcd9c3dfde9ee0dfc3c4f08cd190d8c2d5d68d" http: usda.gov">usda.gov</a>">Allison.Post@<a href="http://usda.gov">usda.gov</a></a>.
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: <a href="https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice">https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice</a>.
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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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<bullet> 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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<bullet> Addition of whole grains (e.g., bread, tortillas, brown
rice, etc.).
<bullet> Addition of soy-based beverage and tofu as milk
alternatives.
<bullet> Reductions in some foods (e.g., milk, egg, and juice) to
better align with the supplemental nature of the Program.
<bullet> 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: <a href="https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice">https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice</a>.
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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: <a href="https://doi.org/10.1001/jama.2021.1915">https://doi.org/10.1001/jama.2021.1915</a>).
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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:
<bullet> 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.
<bullet> Consider marketplace availability of supplemental foods.
<bullet> Increase the actual and perceived value of the WIC food
packages to eligible populations.
<bullet> Improve equitable access to nutritious foods.
<bullet> Promote and support breastfeeding of all durations and
intensities (i.e., partially or fully).
<bullet> Provide foods in amounts that are more consistent with the
supplemental nature of the Program.
<bullet> Provide a better balance of required nutrients and align
with the 2020-2025 DGA, which emphasize nutrient-dense foods and
beverages.
<bullet> 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.
<bullet> 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.<SUP>15 16 17</SUP>
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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 (<a href="http://usda.gov">usda.gov</a>).
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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\ <a href="https://www.usda.gov/foodwaste/">https://www.usda.gov/foodwaste/</a>.
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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.
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\21\ Fruit and Vegetable Purchases and Consumption among WIC
Participants after the 2009 WIC Food Package Revision: A Systematic
Review--PMC (<a href="http://nih.gov">nih.gov</a>).
---------------------------------------------------------------------------
The proposed change to the Federal minimum stocking requirement for
vegetables may present a challenge for some vendors. Therefore, the
Department requests public comment regarding the proposed increased
vegetable stocking requirement on vendors, particularly remote and/or
small vendors, to better understand the potential effects of this
change.
4. Expand What Can Be Purchased With the CVV (Sec. 246.10(e)(12),
Table 4)
The Department proposes to allow fresh herbs, codify that State
agencies cannot exclude white potatoes from purchase with the CVV, and
allow larger sizes of packaged fresh fruits and vegetables.
a. Allow Fresh Herbs (Sec. 246.10(e)(12), Table 4)
The Department proposes to allow the purchase of fresh, cut herbs
with the CVV to increase participant choice in conjunction with the
proposed increase to the CVV value, accommodate cultural eating
patterns, and align with the DGA, which categorize herbs (e.g.,
cilantro and basil) as ``Dark-Green Vegetables.'' Additionally, herbs
can help enhance the flavor of foods as a strategy to reduce added
sugars, saturated fat, and/or sodium, as well as to potentially
increase consumption of other vegetables. Spices and dried herbs would
remain ineligible for purchase with the CVV.
b. Codify That White Potatoes Are WIC-Eligible (Sec. 246.10(e)(12),
Table 4)
The WIC food packages final rule, published in March 2014, excluded
the purchase of white potatoes with the CVV. This was an IOM
recommendation based on data indicating that starchy vegetable
consumption met or exceeded the recommended amounts. Subsequently, the
Consolidated and Further Continuing Appropriations Act, 2015 (the Act,
Pub. L. 113-235), enacted on December 16, 2014, precluded the exclusion
or restriction of the eligibility of any variety of fresh, whole, or
cut vegetables (except vegetables with added sugars, fats, or oils) in
the WIC Program. In response to the Act, FNS issued WIC Policy
Memorandum #2015-3: Eligibility of White Potatoes for Purchase with the
Cash-Value Voucher,\22\ allowing the purchase of white potatoes with
the CVV. Thus, the Department proposes to codify in regulations the
requirements of the Act by removing white potatoes as an excluded
vegetable. This would not be a change to current Program requirements.
---------------------------------------------------------------------------
\22\ Eligibility of White Potatoes for Purchase with the Cash-
Value Voucher [verbar] USDA-FNS.
---------------------------------------------------------------------------
c. Allow Larger Sizes of Packaged Fresh Fruits and Vegetables (Sec.
246.10(e)(12), Table 4)
The Department is proposing to permit larger sizes of packaged
fresh fruit and vegetables that are currently disallowed under the term
``party trays'' to provide additional variety and choice for
participants. Such food items may also increase consumption of fruits
and vegetables as they are already prepared and ready to eat. Eligible
products must meet current requirements in that they may not contain
added sugars, fats, or oils (which may appear in the form of dips,
sauces, or glazes). Nutrition education provided to participants may
address consideration of package size selections for individual
consumption to minimize food spoilage.
Regulations (Sec. 246.10(b)(1)(i)) only allow State agencies to
restrict container size of processed fruits and vegetables. Therefore,
the proposed change in this section would result in all packages of
fresh fruits and vegetables being WIC-eligible, regardless of package
size. As such, the Department is requesting public comments
specifically on any potential challenges to implementing the allowance
of larger sizes of packaged fresh fruits and vegetables for State
agencies, particularly related to managing approved product lists.
B. Juice
As recommended by NASEM and to align with the DGA, the Department
proposes to reduce juice in the child, pregnant and breastfeeding food
packages, eliminate juice for postpartum participants, and allow the
substitution of a $3 CVV for the full juice amount.
1. Reduce or Remove Maximum Monthly Allowance for Juice (Sec.
246.10(e)(10) and (11), Tables 2 and 3)
The proposed reduction of juice in the child, pregnant and
breastfeeding food packages would better provide supplemental
quantities of juice and align with the latest dietary guidance. The DGA
emphasize the consumption of whole forms of fruits and vegetables over
juice. While the DGA includes 100% juice as part of the fruit and
vegetable food groups, it emphasizes whole fruit and a variety of
vegetables from all subgroups, and places limits on fruit juice amounts
that should contribute toward an overall dietary pattern. Juice is not
a separate food subgroup (like dark-green vegetables) in the dietary
patterns that Americans should consume each day. Additionally, the DGA
recognizes juice as lower in dietary fiber than whole fruits or
vegetables. The DGA identify dietary fiber as a dietary component of
public health concern for the U.S. population due to underconsumption,
and these low intakes are associated with health concerns.
With this proposed change, the child, pregnant and breastfeeding
food packages would contain 64 fluid ounces of juice per month and
juice would be eliminated for postpartum participants, who have lower
caloric needs relative to those who are pregnant and lactating. The
current food packages provide between 96 and 144 fluid ounces
(depending on participant category), or 40 to 107 percent of DGA-
recommended limits for fruit juice. The reduced quantities would
provide approximately 27 to 53 percent of DGA-recommended limits for
children and most participants.\23\
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\23\ For children ages 12 to 23 months, the reduced juice
quantity provides 53% of the upper DGA limit based on 4 oz/day for
700-1000 kcal. For children 2 to 4 years, the reduced juice quantity
provides 36%-53% of the upper DGA limit based on 4-6 oz/day for
1000-1600 kcals. For all pregnant and breastfeeding food packages,
the reduced juice quantity provides 27% of the upper DGA limit based
on 8 oz/day for 2000-2400 kcals.
---------------------------------------------------------------------------
The following are the proposed maximum monthly allowances for
juice:
<bullet> Child, pregnant and breastfeeding participants: 64 fluid
ounces.
<bullet> 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:
<bullet> Reduce the amount of milk provided in all child, pregnant,
postpartum, and breastfeeding participant food packages.
<bullet> Require authorization of lactose-free milk.
<bullet> Permit only unflavored milk and reduce the total sugars
allowed in yogurt and soy-based beverages.
<bullet> Add calcium specifications for tofu and vitamin D
specifications for yogurt.
<bullet> Increase yogurt substitution amounts.
<bullet> Add substitution options for milk.
<bullet> Update the FDA standards of identity citations for yogurt.
<bullet> Allow reduced-fat yogurts for 1-year-old children without
restrictions.
<bullet> 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.
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\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: <a href="https://www.fns.usda.gov/wic/wic-food-package-policy-options-ii">https://www.fns.usda.gov/wic/wic-food-package-policy-options-ii</a>.
---------------------------------------------------------------------------
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:
<bullet> Unflavored milk only.
<bullet> Plain or flavored yogurt with <=30 grams of total sugars
per 8 ounces.
<bullet> Soy-based beverage with <=12 grams of total sugars per 8
ounces.
For yogurt, the total sugars limit would be reduced from <=40 grams
per 8 ounces to <=30 grams per 8 ounces. Since there are no total
sugars limits for soy-based beverages, this proposed rule would require
that a soy-based beverage not exceed 12 grams of total sugars per 8
fluid ounces. The Department requests public comment on the proposed
limit on total sugars for yogurt and soy-based beverage, with specific
interest in the use of an added sugars limit instead of a total sugars
limit such as the suggested added sugars limits for yogurt provided in
Table 6.5 (page 303) of the NASEM report \26\ or an alternative. While
NASEM provided an added sugars limit for yogurt in its 2017 report, the
final recommendation was for a total sugars limit given that FDA's
regulation to include added sugars on food labels was not yet
implemented. Thus, NASEM could not review and compare the suggested
added sugars limits against marketplace availability, a core tenet of
their charge in this report. USDA recognizes there is value in aligning
with the DGA recommendation to reduce added sugars while maintaining
consistency with other Federal Child Nutrition Programs. With FDA's
labeling requirement for added sugars now in place, USDA seeks
additional information on the marketplace availability, administrative
burden, and nutritional impacts of implementing an added sugar
requirement.
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\26\ <a href="https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice">https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice</a>.
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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:
<bullet> Tofu with a minimum of 200 milligrams of calcium per 100
grams.
<bullet> 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:
<bullet> 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:
<bullet> 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.
<bullet> 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.
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\27\ <a href="https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice">https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice</a>.
---------------------------------------------------------------------------
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.
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\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\ <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-131/subpart-B/section%20-131.200">https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-131/subpart-B/section%20-131.200</a>.
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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:
<bullet> Fully breastfed infants:
[cir] 16 ounces infant cereal
[cir] 128 ounces infant fruits and vegetables
[cir] 40 ounces infant meat
<bullet> 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.
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\31\ FoodKeeper App [verbar] <a href="http://FoodSafety.gov">FoodSafety.gov</a>.
---------------------------------------------------------------------------
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:
<bullet> Increase formula amounts in the first month for partially
(mostly) breastfed infants.
<bullet> Allow all prescribed infant formula quantities to be
considered ``up to'' amounts.
<bullet> 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.
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\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:
<bullet> Children 1 through 4 years: 24 ounces
<bullet> 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:
<bullet> 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 <SUP>34 35</SUP> 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.
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\34\ <a href="https://www.epa.gov/fish-tech/epa-fda-advice-about-eating-fish-and-shellfish">https://www.epa.gov/fish-tech/epa-fda-advice-about-eating-fish-and-shellfish</a>.
\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.).
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\36\ This list is not representative of all fish included in
FDA's ``Best Choices'' category; the full list is available at:
<a href="https://www.fda.gov/food/metals-and-your-food/technical-information-development-fdaepa-advice-about-eating-fish-those-who-might-become-or-are">https://www.fda.gov/food/metals-and-your-food/technical-information-development-fdaepa-advice-about-eating-fish-those-who-might-become-or-are</a>.
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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:
<bullet> Pregnant and postpartum: 10 ounces canned fish
<bullet> Partially (mostly) breastfeeding: 15 ounces canned fish
<bullet> 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:
<bullet> 1 pound dry or 64 ounces canned legumes
<bullet> 18 ounces peanut butter
<bullet> 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).
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\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).
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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.
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\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: <a href="https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice">https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice</a>.
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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.<SUP>41 42</SUP>
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\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. <a href="http://www.fns.usda.gov/research-and-analysis">www.fns.usda.gov/research-and-analysis</a>.
\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: <a href="http://www.fns.usda.gov/research-and-analysis">www.fns.usda.gov/research-and-analysis</a>.
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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.
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\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: <a href="http://www.fns.usda.gov/research-analysis">www.fns.usda.gov/research-analysis</a>.
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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 <a href="https://www.bea.gov/iTable">https://www.bea.gov/iTable</a>) 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 <a href="/cdn-cgi/l/email-protection#d998b5b5b0aab6b7f789b6aaad99e5b8f9b1abbcbfe4" http: usda.gov">usda.gov</a>">Allison.Post@<a href="http://usda.gov">usda.gov</a></a>. Comments will also be
accepted through the Federal eRulemaking Portal. Go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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: <a href="https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice">https://www.fns.usda.gov/wic/review-wic-food-packages-improving-balance-and-choice</a>.
---------------------------------------------------------------------------
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:
<bullet> Requiring one other form of fruits and vegetables in
addition to fresh.
<bullet> Allowing greater flexibility to authorize additional
package sizes (e.g., fresh fruits and vegetables, yogurt, bread).
<bullet> Allowing soy-based yogurts and soy-based cheeses as
substitution options for milk.
<bullet> 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.
---------------------------------------------------------------------------
<bullet> Allowing additional whole grain options as substitutes for
bread.
<bullet> 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
[…truncated; see source link]Indexed from Federal Register on November 21, 2022.
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