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

Federal RegisterNov 21, 2022

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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.

SUMMARY:

This rulemaking proposes to revise regulations governing the WIC food packages to align them with the current Dietary Guidelines for Americans and reflect recommendations made by the National Academies of Sciences, Engineering and Medicine (NASEM) in its 2017 report, “Review of WIC Food Packages: Improving Balance and Choice,” while promoting nutrition security and equity and taking into account program administration considerations. The proposed changes are intended to provide WIC participants with a wider variety of foods that align with the latest nutritional science; provide WIC State agencies with greater flexibility to prescribe and tailor food packages that accommodate participants' special dietary needs and personal and cultural food preferences; provide more equitable access to supplemental foods; and better promote and support individual breastfeeding goals of participants to help establish successful long-term breastfeeding.

DATES:

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

ADDRESSES:

The Food and Nutrition Service, USDA, invites interested persons to submit written comments on this proposed rule. USDA seeks comment on all aspects of this proposal. Comments may be submitted in writing by one of the following methods:

•

Federal eRulemaking Portal:

Go to

https://www.regulations.gov.

Follow the instructions for submitting comments.

•

Regular U.S. Mail:

WIC Administration, Benefits, and Certification Branch, Policy Division, Food and Nutrition Service, P.O. Box 2885, Fairfax, Virginia 22031-0885.

•

Overnight, Courier, or Hand Delivery:

Allison Post, WIC Administration, Benefits, and Certification Branch, Policy Division, Food and Nutrition Service, 1320 Braddock Place, 3rd Floor, Alexandria, Virginia 22314.

All written comments submitted in response to this proposed rule will be included in the record and will be made available to the public. Please be advised that the substance of the comments and the identity of the individuals or entities submitting the comments will be subject to public disclosure. FNS will make the written comments publicly available online at

https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Allison Post, Chief, Administration, Benefits, and Certification Branch, Policy Division, Food and Nutrition Service, USDA, 1320 Braddock Place, 3rd Floor, Alexandria, Virginia 22314, (703) 305-2746 OR

Allison.Post@usda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

This rulemaking proposes to revise regulations governing the WIC

food packages to align them with the Dietary Guidelines for Americans (DGA), 2020-2025

and reflect the National Academies of Sciences, Engineering and Medicine's (NASEM) recommendations,

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.

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.

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 | Dietary Guidelines for Americans. Referred to in this proposed rule as “2020-2025 DGA” or “DGA.”

National Academies of Sciences, Engineering, and Medicine. “Review of WIC Food Packages: Improving Balance and Choice: Final Report,” 2017. Available at internet site:

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

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;

milk; cheese; breakfast cereal; juice; fruits and vegetables; whole wheat/whole grain bread; eggs; legumes and peanut butter; and canned

fish. Food categories and quantities,

as well as minimum nutritional requirements, are established at the Federal level and outlined in WIC Program regulations at 7 CFR 246.10.

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.

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.

As part of the WIC certification process, a comprehensive nutrition assessment

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.

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).

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.

The report provided the scientific basis for the proposed rule that FNS published in August 2006.

This proposed rule garnered broad support from public commenters, the majority of whom were Program participants.

WIC Food Packages: Time for a Change | USDA-FNS.

Federal Register

: Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages (71 FR 44784).

Using the comments received, FNS published an interim rule in December 2007 that implemented revised food packages.

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.

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:

Interim Rule: Revisions in the WIC Food Packages | USDA-FNS (72 FR 68966).

Final Rule: Revisions in the WIC Food Packages | USDA-FNS (79 FR 12274).

• Introduction of the cash-value voucher (CVV)

for the purchase of fruits and vegetables.

(§ 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.

• Addition of whole grains (

e.g.,

bread, tortillas, brown rice, etc.).

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

• Reductions in some foods (

e.g.,

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

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

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

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

A. The 2017 NASEM Report

In 2014, FNS contracted with NASEM to conduct a second review of the WIC food packages, in accordance with the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, HHFKA), which required USDA to conduct a scientific review of the WIC food packages at least every ten years. FNS tasked NASEM with issuing both a set of cost-neutral recommendations and offering additional recommendations not constrained by cost-neutrality to identify and prioritize additional changes should a higher level of funding be appropriated. NASEM's process included a comprehensive review and analysis of available scientific evidence, including relevant published literature, National Health and Nutrition Examination Survey (NHANES 2005-2012) data, WIC benefit redemption

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,”

which informed many of the revisions in this proposed rule.

National Academies of Sciences, Engineering, and Medicine 2017.

Review of WIC Food Packages: Improving Balance and Choice: Final Report.

Washington, DC: The National Academies Press. Available at internet site:

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

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),

NASEM recommended reducing foods that provide more-than-supplemental amounts and increasing foods needed to improve intake of priority nutrients and food groups.

Zero refers to the lack of seafood in the majority of current WIC food packages.

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.

Mozaffarian D, Fleischhacker S, Andrés J. Prioritizing Nutrition Security in the US. JAMA. 2021;325(16):1605-1606. doi:

https://doi.org/10.1001/jama.2021.1915

USDA's nutrition programs are the most far-reaching tools available to support nutrition security. The proposed changes to the food packages were considered within the framework of enhancing WIC participants' equitable access to nutritious foods and better meeting their special dietary needs due to medical conditions (

e.g.,

allergies, intolerances) or limited cooking or storage facilities, cultural traditions, and personal preferences (

e.g.,

vegetarian diets).

Guided by the nutritional science presented in NASEM's report, the 2020-2025 DGA, and in recognition of the importance of nutrition security, FNS is proposing revisions to the food packages that prioritize WIC participants' supplemental nutrition needs over maintaining cost neutrality. The proposed changes (described below in part III, “Proposed Revisions to the WIC Food Packages”) are intended to achieve a better balance of nutrients and align with the supplemental nature of the Program.

In addition, in developing the proposed changes, the Department considered the potential impact on program administration. Accordingly, the proposed changes reflect efforts to promote ease of implementation for State agencies, local agencies, vendors, and participants. These program administration considerations are discussed in Part III below.

D. Goals of the Proposed Changes to WIC Food Packages

The proposed changes are designed to achieve the following:

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

• Consider marketplace availability of supplemental foods.

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

• Improve equitable access to nutritious foods.

• Promote and support breastfeeding of all durations and intensities (

i.e.,

partially or fully).

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

• Provide a better balance of required nutrients and align with the 2020-2025 DGA, which emphasize nutrient-dense foods and beverages.

• Align with DGA guidance to consume a balanced diet that meets, but does not exceed, recommended food group and subgroup amounts and nutrients appropriate for an individual's life stage.

• Build on the 2014 changes to the WIC food packages and the positive impact those changes had on participant

diet quality and reduced prevalence of obesity among children.

15 16 17

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.

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.

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.

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.

Section

Summary of proposed change

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 Substitutions

1. Reduce maximum monthly allowances of 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 Flexibilities and Create a Separate Food Package for Partially (Mostly) Breastfeeding Participants

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

2. Allow all prescribed infant formula 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 Grain Bread, and other Whole Grain Options

1. Revise (reduce for children and increase for pregnant, postpartum, and 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).

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 (§ 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

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).

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):

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 (§ 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.

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 | WIC Works Resource System (

usda.gov

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.

https://www.usda.gov/foodwaste/.

Current regulations allow State agencies the option to provide a CVV for only fresh fruits and vegetables as a substitute for jarred infant fruits and vegetables. Consistent with the proposed change to the child, pregnant, postpartum, and breastfeeding food packages, this proposed rule would allow State agencies the option to provide a CVV for fresh and at least one other form of fruits and vegetables (frozen and/or canned; dried would not be authorized for infants) as a substitute for jarred infant fruits and vegetables (see section D below, “Infant Foods”). However, given potential concerns about sodium amounts in frozen and/or canned forms of vegetables exceeding infants' needs, the Department requests public comment to better understand the impact of, and potential barriers to, the proposed change to allow fresh and other forms (frozen and/or canned) of fruits and vegetables as an option in the infant food package.

The Department also requests public comment on the impact and feasibility of requiring State agencies to authorize all forms of fruits and vegetables (fresh, frozen, canned, and dried) for CVV redemption for pregnant, postpartum, breastfeeding, and child participants, specifically the potential burden on State agencies and vendors. The Department also seeks comment on the potential for confusion among households with infant participants whose benefits are aggregated with children and women participants who may receive dried forms.

3. Require Vendors To Stock at Least Three Varieties of Vegetables (§ 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.

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

redeem benefits, have access to a variety of vegetables.

Fruit and Vegetable Purchases and Consumption among WIC Participants after the 2009 WIC Food Package Revision: A Systematic Review—PMC (

nih.gov

The proposed change to the Federal minimum stocking requirement for vegetables may present a challenge for some vendors. Therefore, the Department requests public comment regarding the proposed increased vegetable stocking requirement on vendors, particularly remote and/or small vendors, to better understand the potential effects of this change.

4. Expand What Can Be Purchased With the CVV (§ 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 (§ 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 (§ 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,

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.

Eligibility of White Potatoes for Purchase with the Cash-Value Voucher | USDA-FNS.

c. Allow Larger Sizes of Packaged Fresh Fruits and Vegetables (§ 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 (§ 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 (§ 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.

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

The following are the proposed maximum monthly allowances for juice:

• Child, pregnant and breastfeeding participants: 64 fluid ounces.

• Postpartum participants: 0 fluid ounces.

2. Allow CVV as a Substitute for Juice (§ 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

WIC food packages, align with the DGA, and provide a better balance of foods, the Department proposes a variety of changes to milk and milk substitutions in the WIC food packages:

• Reduce the amount of milk provided in all child, pregnant, postpartum, and breastfeeding participant food packages.

• Require authorization of lactose-free milk.

• Permit only unflavored milk and reduce the total sugars allowed in yogurt and soy-based beverages.

• Add calcium specifications for tofu and vitamin D specifications for yogurt.

• Increase yogurt substitution amounts.

• Add substitution options for milk.

• Update the FDA standards of identity citations for yogurt.

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

• Remove cheese from the fully breastfeeding food package.

1. Reduce Maximum Monthly Allowances of Milk (§ 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.

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.

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:

Participant category

Proposed

MMA for

milk

(quarts)

Children 1 year (12 through 23 months)

Children 2 through 4 years

Pregnant

Partially (Mostly) & Fully Breastfeeding

Postpartum

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 (§ 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

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.

U.S. Department of Agriculture, Food and Nutrition Service, Office of Policy Support. WIC Food Packages Policy Options Study II, by B. Thorn, N. Huret, D. Bellows, E. Ayo, R. Myers, and E.Wilcox-Cook. Project Officer: Grant Lovellette. Alexandria, VA: October 2015. Available at:

https://www.fns.usda.gov/wic/wic-food-package-policy-options-ii.

3. Permit Only Unflavored Milk and Reduce Total Sugars Allowed in Yogurt and Soy-Based Beverages (§ 246.10(e)(12), Table 4)

As recommended by NASEM, this rule proposes to revise the total sugars requirements for milk, yogurt and soy-based beverages offered in WIC to align with the DGA, which emphasize nutrient dense foods and beverages—among other aspects, nutrient-dense foods and beverages include little or no added sugars. As noted in the DGA, nutrient dense foods and beverages are particularly important for toddlers since their relatively high nutrient needs leave virtually no room for added sugars in their diet. The DGA also recommend that beverages with no added sugars be the primary choice for children to assist in the establishment of healthy food choices early in life. The proposed changes are also consistent with the reduction in total sugars in the Child and Adult Care Food Program (CACFP). As a result, the Department proposes the following revisions that would limit total sugars:

• Unflavored milk only.

• Plain or flavored yogurt with ≤30 grams of total sugars per 8 ounces.

• Soy-based beverage with ≤12 grams of total sugars per 8 ounces.

For yogurt, the total sugars limit would be reduced from ≤40 grams per 8 ounces to ≤30 grams per 8 ounces. Since there are no total sugars limits for soy-based beverages, this proposed rule would require that a soy-based beverage not exceed 12 grams of total sugars per 8 fluid ounces. The Department requests public comment on the proposed limit on total sugars for yogurt and soy-based beverage, with specific interest in the use of an

added sugars

limit instead of a

total sugars

limit such as the suggested added sugars limits for yogurt provided in Table 6.5 (page 303) of the NASEM report

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.

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

To further accommodate special dietary needs and cultural and personal

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 (§ 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 (§ 246.10(e)(12), Table 4)

In accordance with NASEM recommendations, the proposed rule would add nutrient specifications for calcium for tofu and vitamin D for yogurt. Currently, tofu, a milk substitution option, is required to be calcium-set prepared with calcium salts with no minimum amount of calcium. Similarly, yogurt currently has no specifications for vitamin D. These nutrients are critical for healthy development, and the DGA identify vitamin D and calcium as nutrients of public health concern as well as highlight the importance of vitamin D for calcium absorption. The DGA also note that vitamin D recommendations are harder to achieve through natural sources from diet alone and would require consuming foods and beverages fortified with this nutrient. Therefore, the Department proposes changes to ensure that WIC milk substitutes provide an amount of calcium and vitamin D that is closer to milk. The proposed rule would add nutrient specifications for calcium for tofu and vitamin D for yogurt as follows:

• Tofu with a minimum of 200 milligrams of calcium per 100 grams.

• Plain or flavored yogurt with 100 IU (2.5 micrograms) of vitamin D per 8 ounces.

The calcium specification for tofu would ensure that those who do not consume milk or yogurt due to special dietary needs (

e.g.,

allergy, medical condition) or cultural or personal preferences could still obtain calcium through the tofu option. The Department requests public comment on the proposed vitamin D amount for yogurt and on the availability of yogurts and tofu meeting the proposed specifications.

5. Increase Yogurt Substitution Amounts for Milk (§ 246.10(e)(10) and (11), Tables 2 and 3)

As recommended by NASEM, the proposed rule would increase the amount of yogurt that can be substituted for milk. This change would maintain the ratio of 1 quart of yogurt for 1 quart of milk that is currently allowed but would increase the maximum substitution of yogurt for milk from 1 to 2 quarts. By providing additional flexibility and variety this change would better accommodate participant special dietary needs and cultural and personal preferences. The following proposed monthly maximum substitution amounts for child, pregnant, postpartum, and breastfeeding participants would allow:

• 2 quarts of yogurt for 2 quarts of milk.

To further increase participant variety and choice, as well as in consideration of the proposed additional nutrient specifications for yogurt and tofu, the Department proposes to remove the limitation that no more than a total of 4 quarts of milk (for participants in Food Packages IV-VI) or 6 quarts of milk (for participants in Food Package VII) may be substituted for a combination of cheese, yogurt, or tofu. Lifting this restriction would allow participants to substitute all three (cheese, yogurt, and tofu) in combination at their current substitution rates and current (1 pound of cheese; 1 pound of tofu) and proposed (2 quarts of yogurt) maximum substitution amounts.

Although NASEM recommended a maximum range (30 to 32 ounces) for yogurt, the Department is not proposing this change. This recommendation was intended to allow more flexibility in products' package sizes that equal or add up to the proposed range. The Department recognizes the value of increasing package size flexibility for participants; therefore, the Department is proposing to allow State agencies the option to authorize additional package sizes that may not equal or add up to the full maximum monthly amount (see section J “Maximum Monthly Allowances”) for all WIC allowable foods (excluding formula), thus allowing for greater overall flexibility and choice for participants that would apply to yogurt and other products. State agencies would continue to be required to authorize package sizes that add up to or provide the full amount. For example, State agencies would still be required to authorize packages sizes of yogurt that equal or add up to the maximum monthly allowance of 32 ounces (one quart) but may also authorize package sizes of yogurt that do not equal or add up to 32 ounces (

e.g.,

5.3-ounce containers). Therefore, the proposed flexibility related to maximum monthly allowances negates the need to implement a maximum range specific to yogurt.

NASEM also recommended that the partial substitution option of cheese for milk be revised to only allow 1 pound of cheese plus 1 quart of yogurt for 4 quarts of milk. This was intended to help alleviate the “dangling quart” that arises when cheese is substituted for milk given the current option of one pound of cheese for 3 quarts of milk. However, State agencies currently have the option to make available other authorized milk alternatives to fulfill the milk maximum allowance, such as a quart of yogurt or a 12-ounce can of evaporated milk. State agencies also currently have the option to prescribe half gallon containers of milk every other month for participants in lieu of the “dangling quart.” Only allowing cheese plus yogurt as a partial substitution for milk would limit this option to those State agencies that authorize yogurt and require issuing a food that participants may not want. Such a change would also require State agencies that currently do not authorize yogurt to do so for participants to be able to substitute cheese. Thus, the Department is not proposing to change the current cheese substitution option.

6. Add Soy-Based Yogurts and Soy-Based Cheeses as Substitution Options for Milk (§ 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-

based varieties of yogurts and cheeses are allowed.

For participants who do not consume the current dairy-based WIC-eligible milk substitution options (yogurt and cheese) due to allergies, lactose intolerance, or a vegan diet, non-milk-based substitution options must still deliver important nutrients. As stated above (see section 3. “Add Nutrient Specifications for Tofu and Yogurt”), the DGA identify vitamin D and calcium as nutrients of public health concern. Therefore, in addition to the NASEM-recommended nutrient specifications for calcium and protein, the Department proposes to add a nutrient specification for vitamin D for soy-based yogurt, consistent with the proposed requirement in this rulemaking to add a vitamin D requirement for cow's milk-based yogurt. The proposed soy-based yogurt and cheese milk substitution options for child, pregnant, postpartum, and breastfeeding participant food packages would therefore include the following minimum nutrient specifications:

• Soy-based yogurts that contain ≤30 grams of total sugars and at least 250 milligrams of calcium, 6.5 grams of protein, and 100 International Units (2.5 micrograms) of vitamin D per 8-ounce serving.

• Soy-based cheeses that contain at least 250 milligram of calcium and 6.5 gram of protein per 1.5-ounce serving.

The Department requests public comment on this provision, particularly related to the marketplace availability of soy-based yogurts and cheeses meeting these proposed nutrient specifications. The Department is also requesting public comment on the possibility of a State agency option to allow, and the marketplace availability of, other plant-based yogurts that meet the proposed specifications for cow's milk-based yogurt.

As described above, the Department also requests public comment on the limit of total sugars in soy-based yogurts proposed provision with specific interest in the use of an

added sugars

limit instead of a

total sugars

limit such as the suggested added sugars limits for yogurt provided in Table 6.5 (page 303) of the NASEM report

or an alternative.

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

7. Update FDA Standard of Identity Citations for Yogurt (§ 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

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).

The FDA rule was effective July 12, 2021, with a compliance date of January 1, 2024.

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).

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-131/subpart-B/section%20-131.200.

8. Allow Reduced-Fat Yogurts for 1-Year-Old Children Without Restrictions (§ 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 (§ 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 (§ 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

vegetables per day, an amount difficult for 6 through 11-month-old infants to consume and with no apparent nutritional rationale (the DGA and AAP do not have specific recommendations for infant fruit and vegetable consumption for this age group). Further, fully breastfed infants do not have a greater need for fruits and vegetables compared to other infants. Therefore, the amount of infant fruits and vegetables for fully breastfed infants would be reduced (from 256 ounces per month) to the amount currently provided to partially (mostly) breastfed and fully formula fed infants (128 ounces per month, or a one-half-cup equivalent per day). There is no proposed change to the amount of infant fruits and vegetables for partially (mostly) breastfed or fully formula fed infants.

Infant meat, still limited to the fully breastfed infant food package, would be reduced from 77.5 to 40 ounces per month and provide approximately 65 percent of the AAP-recommended maximum amount. This reduction addresses NASEM's recommendation based on the finding that the current food package provides 130 percent of the amount of infant meat recommended by the AAP.

In summary, this proposed rule would provide the following maximum monthly amounts of infant cereal, infant fruits and vegetables, and infant meat:

• Fully breastfed infants:

○ 16 ounces infant cereal

○ 128 ounces infant fruits and vegetables

○ 40 ounces infant meat

• Partially (mostly) breastfed and fully formula fed infants:

○ 8 ounces infant cereal

○ 128 ounces infant fruits and vegetables (no change)

○ 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

) 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.

Advice about Eating Fish | 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.

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.

FoodKeeper App |

FoodSafety.gov

2. Increase CVV Substitution Amounts for Infant Fruits and Vegetables, Allow Forms Other Than Fresh, and Lower the Minimum Age for Infants To Receive a CVV (§ 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:

○ $10 CVV and 64 ounces of jarred infant fruits and vegetables, or

○ $20 CVV and no jarred infant fruits and vegetables.

3. Prohibit Added Fats in Infant Foods (§ 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

pattern includes nutrient-dense foods prepared with minimal added sugars, refined starches, or sodium as well as foods that are lean or in low-fat forms (with the exception of dairy for the 1-year-old). The recommendation to limit saturated fat to less than 10 percent of calories does not apply to children under age 2 years; however, healthy dietary patterns for 12 through 23 months have no remaining calories available for consuming additional added sugars, saturated fat, or more than the recommended amount of foods. As such, the Department proposes to exclude “added fats” from the ingredients authorized for infant foods. This proposed rule does not intend to imply that total fat should be restricted in this age group, rather excluding “added fats” from the ingredients authorized for infant foods aligns with a healthy eating pattern and anticipates the transition that will occur as children continue their eating trajectory to a healthy diet.

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

As recommended by NASEM, this proposed rule would add flexibilities to infant formula amounts and create a separate food package to support individual breastfeeding goals of participants and may lead to the establishment of successful long-term breastfeeding. The proposed changes would:

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

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

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

1. Increase Formula Amounts in the First Month for Partially (Mostly) Breastfed Infants (§ 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 (§ 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,”

(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.

Full nutrition benefit is defined in § 246.2: The minimum amount of reconstituted fluid ounces of liquid concentrate infant formula as specified in Table 1 of § 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 (§ 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

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 (§ 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 (§ 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 (§ 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.

The proposed revision would increase (from 16 to 48 ounces) the amount for pregnant, postpartum, and breastfeeding participants. This proposed increased

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.

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

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

• Children 1 through 4 years: 24 ounces

• Pregnant, Postpartum, and Breastfeeding: 48 ounces

NASEM also recommended a range for whole grains; however, the Department is not proposing this change. To achieve NASEM's intent to provide greater flexibility, the Department instead proposes changes to requirements related to the maximum monthly amounts (see Section J: “Maximum Monthly Amounts”). The Department will maintain the requirement for State agencies to provide participants with the full amount by ensuring one or more State-authorized package sizes equal or add up to the full amount, while providing the flexibility to also authorize packages sizes that may not add up to full amount, if the participant chooses to take less. This proposed change could potentially ease the burden on small vendors who have expressed difficulty stocking the currently required package sizes.

The Department is not in support of NASEM's recommendation to limit bread options to 100 percent whole wheat as this would remove other whole grain breads from being WIC-eligible, thus limiting variety and choice for participants. Currently, State agencies can authorize whole wheat and/or whole grain bread such as whole grain rye, pumpernickel, oat, and honey wheat.

2. Change Criteria for Whole Grain Breads (§ 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 (§ 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 § 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 (§ 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

education would need to encourage parents/caretakers to select boneless canned fish or remove bones prior to consumption to prevent choking; choose lower sodium varieties; use the fish within 3 to 4 days of opening the can to ensure food safety; and serve fish varieties and amounts that limit the potential for methylmercury exposure. In addition, the Department would encourage WIC State agencies to authorize smaller package sizes whenever possible (

i.e.,

2.5 ounces).

The proposed monthly maximum amount of canned fish for children (2 through 4 years of age) would be as follows:

• Children 2 through 4 years: 5 ounces canned fish

Based on the FDA and Environmental Protection Agency (EPA) 2014 joint advice on eating fish for breastfeeding and pregnant individuals, individuals who might become pregnant, and children, NASEM also recommended canned fish for 1-year-old children and allowing fish to be substituted for infant meat. However, based on updated Federal guidance, the Department is not proposing these changes. Specifically, in 2021

34 35

the FDA and EPA updated their joint advice about eating fish, which incorporates 2020-2025 DGA recommendations; identifies fish types and serving sizes safe for consumption based on estimated methylmercury exposure; and newly includes advice for children age 1 year (previous advice included recommendations for children 2 to 11 years), including a subset list of “Best Choices” that contain lower methylmercury to support children age 1 year in consuming the quantities recommended in the Healthy U.S.-Style Dietary Pattern without exceeding limits for estimated methylmercury exposure. The advice also indicates that many commonly consumed fish types (including light canned tuna, a WIC-eligible variety) should be limited to the amounts in the FDA-EPA Fish Advice (footnote) due to their methylmercury content. To the Department's knowledge, other WIC-eligible fish varieties that are part of the “Best Choices” subset (

i.e.,

salmon, sardines, and Atlantic mackerel) are not widely available in the marketplace in sizes appropriate for infants or 1-year old children to meet the FDA-EPA guidance and DGA recommendations or to provide supplemental amounts. Therefore, it is not feasible to safely include fish in WIC food packages for infants or 1-year-old children.

https://www.epa.gov/fish-tech/epa-fda-advice-about-eating-fish-and-shellfish.

Advice about Eating Fish | 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

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.).

This list is not representative of all fish included in FDA's “Best Choices” category; the full list is available at:

https://www.fda.gov/food/metals-and-your-food/technical-information-development-fdaepa-advice-about-eating-fish-those-who-might-become-or-are.

2. Add Canned Fish in Food Packages for Pregnant, Postpartum, and Partially (Mostly) Breastfeeding Participants, Revise Amounts for Fully Breastfeeding Participants, and Revise WIC-Eligible Varieties (§ 246.10(e)(5)(ii), (e)(6)(ii), and (e)(10) Through (12), Tables 2 Through 4)

As recommended by NASEM, with modifications, this proposed rule would add canned fish to the pregnant, partially (mostly) breastfeeding, and postpartum participant food packages on a monthly basis. Currently, canned fish is included only in the fully breastfeeding food package and the proposed changes would decrease the monthly amount from 30 to 20 ounces. Proposed monthly fish amounts for these food packages align with NASEM's supplemental approach and DGA dietary patterns. In addition, the proposed monthly amounts of fish are consistent with NASEM's overall approach to enhancing the food package for partially (mostly) breastfeeding participants to promote breastfeeding.

The proposed monthly maximum amounts of canned fish for pregnant, postpartum, partially (mostly) and fully breastfeeding participants would be as follows:

• Pregnant and postpartum: 10 ounces canned fish

• Partially (mostly) breastfeeding: 15 ounces canned fish

• Fully breastfeeding: 20 ounces canned fish

Additionally, the FDA and EPA currently do not have methylmercury data on the commercial canned fish product “jack mackerel” and do not include this product in their joint advice about eating fish. Furthermore, the FDA guidance on defining jack mackerel species referenced in § 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 (§ 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

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 (§ 246.10(e)(10) Through (12), Tables 2 Through 4)

Based on NASEM's recommendations, with modification, the proposed changes would require that State agencies allow the substitution of eggs with legumes and peanut butter if a participant has an egg allergy, is vegan, or for other reasons (

e.g.,

cultural preferences) as determined by State agency policy and allow State agencies the option to authorize tofu as a substitute for eggs. Like eggs, legumes and peanut butter (to a lesser extent) are sources of choline, and both are sources of iron. Given iron's role in growth and development, the prevalence of inadequate intake among the WIC population, and the health consequences of inadequate intake, offering foods with iron is critical to WIC participants' health. In addition, peanut butter and legumes are required foods in the food packages, therefore the Department anticipates no additional administrative effort related to identifying and authorizing these foods as substitutes for eggs. For these reasons, the Department has determined that requiring peanut butter and legumes as substitutes for eggs is nutritionally appropriate, promotes equity, and will not increase administrative burden.

The Department also proposes to allow State agencies the option to authorize tofu as a substitute for eggs. Like eggs, tofu is a source of choline and iron. Currently, State agencies have the option to authorize tofu as a milk substitute and as of publication of this proposed rule, 54 of the 89 State agencies permit this option. Allowing the option to authorize it as an egg substitute creates more State agency flexibility and would give participants more options, particularly for those participants with special dietary needs that preclude the ability to receive peanut butter or legumes in lieu of eggs.

Since eggs are a source of heme iron (more readily absorbed by the body) and legumes, peanut butter, and tofu are sources of non-heme iron (less readily absorbed), appropriate food package tailoring and nutrition education would need to address other food sources of iron, especially for participants determined to have low iron levels.

This change would allow children and all other participant categories (except infants) to substitute the following for one dozen eggs if a participant has an egg allergy or is vegan, or for other reasons (

e.g.,

cultural preferences) as determined by the State agency's policy:

• 1 pound dry or 64 ounces canned legumes

• 18 ounces peanut butter

• 1 pound tofu (at State agency option)

The Department recognizes that it is currently a State agency option to authorize tofu as a substitute for milk, therefore, not all State agencies authorize this food item. The Department requests public comment on the impact of requiring State agencies to authorize tofu as an egg substitute for participants who have an egg allergy or are vegan, or for other reasons (

e.g.,

cultural preferences) as determined by the State agency's policy.

The Department also requests public comment on allowing other nut and seed butters as a legume or peanut butter substitution option to further accommodate participants with food allergies. To be consistent with the scientifically based standards described in this proposed rule, the Department is especially interested in public comment on the commercial availability of nut and seed butters that are nutritionally equivalent (or close) to peanut butter/legumes in terms of the priority nutrients (

e.g.,

protein, iron).

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

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 § 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).

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 § 246.10(e)(9) and (11).

Additionally, to accommodate instances when there are two or more participants from the same household (

e.g.,

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

e.g.,

canned fish where certain types authorized for pregnant, postpartum, and breastfeeding participants are not authorized for child participants). Additionally, the requirement in § 246.10(b)(2)(ii)(D) that local agencies advise participants or their caretakers

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 § 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 (§ 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 (§§ 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

(§ 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 (§ 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 § 246.12(u)(2)(ii)). Additionally, the dollar threshold at § 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 (§ 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 § 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 (§ 246.10(c))

The proposed rule would add clarifying language to nutrition tailoring (§ 246.10(c)) that exists in current policy, as indicated in § 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 § 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 (§ 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 (§ 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

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)

reflect recommendations made by the National Academies of Sciences, Engineering, and Medicine (NASEM),

while promoting nutrition security and equity and taking into account program administration considerations.

U.S. Department of Health and Human Services/U.S. Department of Agriculture, Dietary Guidelines for Americans, 2020-2025. Available at internet site:

Home | Dietary Guidelines for Americans.

National Academies of Sciences, Engineering, and Medicine. “Review of WIC Food Packages: Improving Balance and Choice: Final Report,” 2017. Available online at:

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

Benefits

The proposed changes to the WIC food packages are intended to provide WIC participants with a wider variety of foods that align with the latest nutritional science, provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participant personal and cultural food preferences and special dietary needs, and better promote and support the establishment of successful long-term breastfeeding.

The proposed increases in the value of the cash value voucher (CVV) for fruits and vegetables, increases in canned fish, and changes to whole grain requirements will better align the WIC food packages with the 2020-2025 DGA. The DGA identified average daily food group intakes of fruits, vegetables, seafood, and whole grains as falling below the recommended intake ranges for adults and children

Increased consumption of these foods is expected to increase intakes of key nutrients, including dietary fiber, potassium, vitamin D, vitamin A, vitamin C, folate, and polyunsaturated fatty acids. Dietary fiber, potassium, and vitamin D, considered nutrients of public health concern in the general U.S. population, are currently also under-consumed by WIC participants.

41 42

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

www.fns.usda.gov/research-and-analysis.

Ibid.

Borger, C., Zimmerman, T., Vericker, T., et al. (2020). WIC Infant and Toddler Feeding Practices Study 2: Fourth Year Report. Prepared by Westat, Contract No. AG-3198-K-15-0033 and AG-3198-K-15-0050. Alexandria, VA: U.S. Department of Agriculture, Food and Nutrition Service, Office of Policy Support, Project Officer: Courtney Paolicelli. Available online at:

www.fns.usda.gov/research-and-analysis.

NASEM's analysis estimates that in order to meet half of the recommended intakes of fruits and vegetables, WIC participants would need to spend $25, $45, or $50 (adjusted for inflation to FY 2024), depending on participant category, to meet 50 percent of the recommended intakes for fruits and vegetables. This suggests that the current CVV levels of $9 for child participants and $11 for pregnant, postpartum, and breastfeeding participants only provide enough for around 19 percent and 12 percent of recommended fruit and vegetable intakes for child, pregnant, postpartum, and breastfeeding participants, respectively. By increasing the value of the CVV to the levels proposed by NASEM to meet 50 percent of the recommended fruit and vegetable intakes, the proposed rule is expected to significantly increase fruit and vegetable purchases and consumption among WIC participants.

While it is difficult to quantify the full extent of projected benefits associated with the revisions under this proposed rule, USDA's and NASEM's analyses find that the revisions better align the WIC food packages with the latest nutrition recommendations in the DGA and accordingly will support participants in achieving healthy dietary patterns. The 2020-2025 DGA highlight the importance of a healthy dietary pattern to help achieve a healthy body weight and reducing the risk of chronic disease. The DGA also emphasize the importance of exposing young children to nutrient-dense foods at an early age to support the establishment of healthy dietary patterns. By supporting healthy dietary patterns among pregnant women, the proposed changes to the WIC food packages will advance the Program's capacity to address nutrition-related causes of maternal and infant morbidity and mortality. The Department finds that this proposed rule presents an effective approach to supporting pregnant participants and families with infants and young children in achieving balanced, healthy diets and broadly promoting public health.

Costs

The Department estimates that the proposed rule to revise regulations governing the WIC food packages would result in a net increase in Federal WIC spending of $4.1 billion, in the form of Federal transfer payments for increased WIC food expenditures, over five years from FY 2024 through FY 2028. This increase in Federal WIC food expenditures is driven by the proposed increase in the CVV, which is estimated to increase WIC food expenditures by $4.9 billion over five years when compared to current CVV levels as outlined in 7 CFR 246.10. However, the CVV levels proposed in this rule were recently enacted on a temporary basis for FY 2022. As a result, when compared to the FY 2022 WIC food

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.

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.

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

www.fns.usda.gov/research-analysis.

The increase in value of the CVV accounts for most of the increased Federal spending, adding around $4.9 billion in costs over five years. This estimate assumes that the redemption rate of the increased CVV will continue at 2020 redemption levels (71.6 percent) and accounts for annual inflation adjustments. The proposed change to add canned fish to most food packages is estimated to add around $171 million in additional spending over five years. The proposal to increase the amounts of jarred infant fruits and vegetables that can be substituted for CVV and the proposed expansion of the allowable age range to substitute CVV for jarred fruits and vegetables are estimated to increase redemptions for these items, adding $113 million in costs over five years, despite the proposed reduction in the quantity of jarred fruits and vegetables issued to fully breastfed infants. Requiring all State agencies to authorize both dry and canned legumes is estimated to increase costs by $18 million over five years as some participants shift from purchasing dry legumes to more costly canned legumes.

The remaining provisions will either result in net savings at the food category level or are not estimated to have a significant impact on costs. Although the expanded substitution options for milk and juice are expected to increase redemption rates for these food categories, the proposed reductions to the maximum monthly allowances issued are still expected to result in a net savings of $136 million for milk and $731 million for juice over five years. The estimated savings associated with the reduction in the allowances for juice offset part of the costs of the increase to the CVV—encouraging greater consumption of whole fruits and vegetables as emphasized in the DGA. While the proposed rule would increase the amount of infant formula allowed in the first month for partially breastfed infants, this change is intended to support continued breastfeeding and is estimated to result in a shift of 5 percent of infant mother dyads from fully formula feeding food packages to partially breastfeeding food packages, which would ultimately lead to a net savings of $31 million on infant formula over five years. The proposed changes to infant meats, infant cereals, whole wheat/whole grains, breakfast cereal, and cheese are also expected to result in cost savings as summarized in Table 2 of the attached RIA.

In addition to the above impact on Federal transfer payments, the Department also estimates that WIC State agencies and local agencies will incur an in administrative burden associated with implementing and explaining the proposed changes to participants. This additional administrative burden is expected to account for about $171 million in State agency and local agency labor costs over five years. These administrative costs are considered allowable expenses for State agencies under their annually awarded Nutrition Services and Administration (NSA) grants. In general, the Department expects that State agencies will be able to absorb the costs associated with implementing the provisions under this proposed rule with current NSA funds.

Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies to analyze the impact of rulemaking on small entities and consider alternatives that would minimize any significant impacts on a substantial number of small entities. Pursuant to that review, it has been certified that this proposed rule would not have a significant impact on a substantial number of small entities.

This proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would not have an adverse impact of small entities in the Special Supplemental Nutrition Program for Women, Infants and Children; the impact is not significant as it allows for greater options and flexibilities within approved food lists for State and local agencies to offer participants. State agencies are already required on an annual basis to update their approved foods lists.

Factual Basis:

The provisions of this proposed rule would apply to small local agencies operating the Special Supplemental Nutrition Program for Women, Infants and Children, and to State agency staff who must monitor local agencies in remote locations. These entities meet the definitions of “small governmental jurisdiction” and “small entity” in the Regulatory Flexibility Act. These entities would not be negatively impacted by the changes and options proposed in this rule.

Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801

et seq.

), the Office of Information and Regulatory Affairs designated this proposed rule as a 'major rule', as defined by 5 U.S.C. 804(2).

Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and Tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with “Federal mandates” that may

result in expenditures by State, local or Tribal governments, in the aggregate, or the private sector, of $146 million or more (when adjusted for inflation; gross domestic product (GDP) deflator source: Table 1.1.9 at

https://www.bea.gov/iTable

) in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the most cost effective or least burdensome alternative that achieves the objectives of the rule.

This proposed rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments or the private sector of $146 million or more in any one year. Thus, the proposed rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 12372

This Special Supplemental Nutrition Program for Women Infants and Children is listed in the Catalog of Federal Domestic Assistance under Number 10.557 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

Federalism Summary Impact Statement

Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13132.

The Department has considered the impact of this proposed rule on State and local governments and has determined this proposed rule does not have federalism implications. Therefore, under section 6(b) of the Executive order, a federalism summary is not required.

Executive Order 12988, Civil Justice Reform

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

Civil Rights Impact Analysis

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

Executive Order 13175

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

Federal Register

, FNS will encourage stakeholders representing Indian Tribal Organizations to provide input on whether the proposed rule poses any adverse tribal implications. If a Tribe requests additional consultation in the future, FNS will work with the Office of Tribal Relations to ensure meaningful consultation is provided. We are unaware of any current Tribal laws that could be in conflict with this proposed rule.

Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; 5 CFR part 1320) requires the Office of Management and Budget (OMB) to approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number.

In accordance with the Paperwork Reduction Act of 1995, this proposed rule contains existing information collections that are contained in OMB# 0584-0043 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program Regulations—Reporting and Recordkeeping (expiration date December 31, 2023) which are subject to review and approval by the Office of Management and Budget; therefore, FNS is submitting for public comment the changes to the existing information collection requirements and burden that would result from adoption of the proposals in the rule.

Comments on information collection for this proposed rule must be received by January 20, 2023.

Comments may be sent to:

Allison Post, Food and Nutrition Service, U.S. Department of Agriculture, 1320

Braddock Place, 3rd Floor, Alexandria, VA 22314. Comments may also be submitted via email to

Allison.Post@usda.gov.

Comments will also be accepted through the Federal eRulemaking Portal. Go to

https://www.regulations.gov,

and follow the online instructions for submitting comments electronically.

Comments are invited on:

(a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All responses to this document will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title:

Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program Regulations—Reporting and Record-keeping Burden.

OMB Number:

0584-0043.

Expiration Date:

12/31/2023.

Type of Request:

Revision of a currently approved collection due to rulemaking.

Abstract:

This rulemaking proposes to revise regulations governing the WIC food packages to align them with the current Dietary Guidelines for Americans

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 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.

National Academies of Sciences, Engineering, and Medicine. “Review of WIC Food Packages: Improving Balance and Choice: Final Report,” 2017. Available at internet site:

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

Respondents:

Businesses or Other For-Profit Organizations, non-profit WIC local agencies, State, Local, or Tribal Government, and Individuals and Households. Respondent groups identified include State Agencies (including Indian Tribal Organizations and U.S. Territories), applicants for Program benefits, and retail vendors.

Estimated Number of Respondents:

6,885,560.

Estimated Number of Annual Responses Respondent:

4.98.

Estimated Total Annual Responses:

34,314,693.

Estimated Time Per Response:

0.16 hours.

Estimated Total Annual Burden on Respondents:

5,637,114.77 hours.

Current OMB Inventory:

3,469,735.53 hours related to the requirements for the identification of acceptable foods under § 246.10(b)(1), explanation of new food packages as part of the certification process under § 246.7(i), and vendor applications and agreements under § 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 § 246.10(b)(1), training for State and local agencies on revised food lists under § 246.10(b)(2)(i), review of food packages and explanation of proposed changes to food packages as part of the certification process under § 246.7(i), and vendor applications and agreements under § 246.12(h)(1)(i).

Difference (Burden Revisions Requested):

2,167,379.24 additional hours.

Summary:

Estimated Annual Reporting & Recording Burden for 0584-0043 as a Result of the Proposed Rulemaking

Regulation citation

Description

of activities

Estimated

number of

respondents

Annual

responses per

respondent

Total

annual

responses

Average

burden hours

per response

Estimated

total

annual

burden hours

Hours

currently

approved

under

OMB #0584-0043

Estimated

change in

burden hours

due to

rulemaking

Estimated

change in

burden hours

due to

adjustments

Total

estimated

change in

burden hours

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 training to local agencies on revised food lists

89.00

1.00

89.00

5.00

445.00

0.00

+445.00

0.00

+445.00

246.10(b)(2)(i)

Local agency training on revised food lists

1,265.60

1.00

1,265.60

1.00

1,265.60

0.00

+1,265.60

0.00

+1,265.60

246.12(h)(1)(i)

Vendor applications & agreements*

152.07

13,534.62

.75

10,150.97

10,188.09

−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 food lists

542.40

1.00

542.40

1.00

542.40

0.00

+542.40

0.00

+542.40

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

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).

Estimated Annual Reporting and Recordkeeping Burden for OMB #0584-0043 Due to Proposed Rulemaking

Burden

currently

approved *

Projected

respondents/

responses/

burden

due to proposed rule

Difference in

respondents

Difference in

responses

Difference in

burden hours

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 × 2 certifications per year = 3,267,728 total annual responses ÷ 1,808 = 1,807.37 certifications per local agency × 1,265.60 local agencies = 2,287,409.60 total annual responses × 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 × 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 × 1.5 certifications per year = 5,285,794.50 total annual responses ÷ 1,808 = 2,923.56 certifications per local agency × 1,265.60 local agencies = 3,700,056.15 total annual responses × 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 × 1,265.60 local agencies = 1,198,680.70 total annual responses × 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 × 1,265.60 local agencies = 4,809,089.60 total explanations × 5 minutes (0.0833 hours) per explanation = 400,597.16 hours. This one-time increase to the local agency reporting burden is due to a program change due to the proposed rule.

Section 246.10(b)(1)

requires each State agency to identify foods that are acceptable for use in the program in their State, in accordance with program regulations. This includes establishing criteria for and identifying foods, substitutions, brands and packaging the State will authorize for use in the Program. The proposed rule includes additional requirements and options for WIC-authorized foods that will impact State agencies' identification of foods, substitutions, brands, and packaging acceptable for use in the Program to include:

• Requiring one other form of fruits and vegetables in addition to fresh.

• Allowing greater flexibility to authorize additional package sizes (

e.g.,

fresh fruits and vegetables, yogurt, bread).

• Allowing soy-based yogurts and soy-based cheeses as substitution options for milk.

• Requiring the authorization of lactose-free milk.

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

• Allowing additional whole grain options as substitutes for bread.

• Requiring the authorization of canned legumes in addition to dry legumes.

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

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 × 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 × 5 = 445). This addition is due to a program change due to the proposed rule.

Section 246.10(b)(2)(i)

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 × 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 × 152.07 vendor applications and agreements per State agency = 13,534.62 vendor applications and agreements × 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

−10,150.97) for this provision. This decrease is due to a program change due to the proposed rule.

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 × 2 times per year = 3,267,728 × 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 × 1.5 times per year = 5,285,794.5 × 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 es

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