44784 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

DEPARTMENT OF AGRICULTURE 

Food and Nutrition Service 

7 CFR Part 246 

RIN 0584–AD77 

Special Supplemental Nutrition 

Program for Women, Infants and 

Children (WIC): Revisions in the WIC 

Food Packages 

AGENCY: Food and Nutrition Service 

(FNS), USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise regulations governing the WIC 

food packages to align the WIC food 

packages with the 2005 Dietary 

Guidelines for Americans and current 

infant feeding practice guidelines of the 

American Academy of Pediatrics, better 

promote and support the establishment 

of successful long-term breastfeeding, 

provide WIC participants with a wider 

variety of food, provide WIC State 

agencies with greater flexibility in 

prescribing food packages to 

accommodate participants with cultural 

food preferences, and serve participants 

with certain qualifying conditions under 

one food package to facilitate efficient 

management of medically fragile 

participants. The revisions largely 

reflect recommendations made by the 

Institute of Medicine of the National 

Academies in its Report ‘‘WIC Food 

Packages: Time for a Change,’’ with 

certain cost containment and 

administrative modifications found 

necessary by the Department to ensure 

cost neutrality. The proposed 

improvements to the WIC food packages 

can be made without increasing the 

projected costs. The proposed rule 

would revise the maximum monthly 

allowances and minimum requirements 

for certain supplemental foods; revise 

the substitution rates for certain 

supplemental foods and allow 

additional foods as alternatives; 

redesign WIC food packages to enhance 

breastfeeding promotion and support; 

revise age specifications for assignment 

to infant food packages; add fruits and 

vegetables for WIC participants 6 

months of age and older and eliminate 

juice from infants food packages; add 

whole grains to food packages for 

children and women and infant food 

meat for fully breastfed infants 6 

through 11 months of age; revise the 

purpose, content, and requirements for 

the Food Package for the Medically 

Fragile, and address general provisions 

that apply to all food packages. 

DATES: To be assured of consideration, 

comments must be postmarked on or 

before November 6, 2006. 

ADDRESSES: The Food and Nutrition 

Service invites interested persons to 

submit comments on this proposed rule. 

Comments may be submitted by any of 

the following methods: 

• Mail: Send comments to Patricia N. 

Daniels, Director, Supplemental Food 

Programs Division, Food and Nutrition 

Service, USDA, 3101 Park Center Drive, 

Room 528, Alexandria, Virginia 22302, 

(703) 305–2746. 

• Web site: Go to 

http://www.fns.usda.gov/wic. Follow 

the online instructions for submitting 

comments through the link at the 

Supplemental Food Programs Division 

Web site. 

• E-mail: Send comments to WICHQSFPD@fns.usda.gov. Include ‘‘Docket ID 

Number 0584–AD77, WIC Food 

Packages Rule,’’ in the subject line of 

the message. 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

All 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 

identities of the individuals or entities 

submitting the comments will be subject 

to public disclosure. All written 

submissions will be available for public 

inspection at the address above during 

regular business hours (8:30 a.m. to 5 

p.m.) Monday through Friday. FNS may 

also make the comments publicly 

available by posting a copy of all 

comments on the FNS Web site at 

http://www.fns.usda.gov/wic. 

A regulatory impact analysis has been 

prepared for this rule. It follows this 

regulation as an Appendix. 

FOR FURTHER INFORMATION CONTACT: 

Debra Whitford, Chief, Policy and 

Program Development Branch, 

Supplemental Food Programs Division, 

Food and Nutrition Service, USDA, 

3101 Park Center Drive, Room 528, 

Alexandria, Virginia 22302, (703) 305– 

2746, OR 

Debbie.Whitford@fns.usda.gov. A copy 

of the National Academies’ Institute of 

Medicine report, ‘‘WIC Food Packages: 

Time for a Change,’’ which provides the 

scientific backdrop for this proposed 

rule, is available on the FNS Web site 

at http://www.fns.usda.gov/oane/menu/ 

Published/WIC/FILES/ 

Time4AChange(mainrpt).pdf. 

SUPPLEMENTARY INFORMATION: 

I. Overview 

This proposed rule would implement 

the first comprehensive revisions to the 

WIC food packages since 1980. These 

revised food packages were developed 

to better reflect current nutrition science 

and dietary recommendations than do 

current food packages, within the 

parameters of current program costs. 

The proposal is based on the 

recommendations of the National 

Academies’ Institute of Medicine (IOM), 

which was commissioned by FNS in 

September 2003, to independently 

review the WIC food packages. The IOM 

used current scientific information to 

assess the nutrient adequacy of the diets 

of WIC participants; assess the 

supplemental nutrition needs of the 

population served by WIC; look at the 

nutrient contributions of the current 

packages; propose priority nutrients and 

general nutrition recommendations; and 

make recommendations for specific 

changes to the WIC food packages. The 

IOM used various data sources 

including the 2005 Dietary Guidelines 

for Americans, the Dietary Reference 

Intakes, WIC participant data, food 

consumption and intake data 

(Continuing Survey of Food Intakes by 

Individuals (CSFII); National Health and 

Nutrition Examination Survey 

(NHANES)) and examined nutritionrelated health risks to identify nutrients 

and food groups to try to increase or 

decrease in the food packages with the 

goal of improving the nutrition of WIC 

participants. The review of the WIC 

food packages was further informed by 

extensive comments made in response 

to an Advanced Notice of Proposed 

Rulemaking on revisions to the WIC 

food packages and by comments 

received by the IOM in public forums 

during its review. 

Compared to current WIC packages, 

the proposal: 

• Provides greater consistency with 

the Dietary Guidelines for Americans. 

The proposal adds fruits and vegetables, 

and whole grains to the packages for the 

first time. The revised packages include 

foods from each food group except oils 

and allow variety and choice within the 

groups. Reductions are made to the 

amounts provided for certain foods in 

the current packages in order to be more 

consistent with the amounts of these 

foods recommended in the 2005 Dietary 

Guidelines for Americans and WIC’s 

role as a supplemental nutrition 

program. 

• Supports improved nutrient 

intakes. The proposed additional foods 

and modified amounts of current foods 

support overall improvement in nutrient 

consumption and reduction in the 


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prevalence of inadequate or excessive 

nutrient intakes. Compared with the 

current food packages, the revised 

packages are estimated to provide 

greater amounts of nearly all the 

nutrients of concern with regard to 

inadequate intake identified by the IOM 

such as iron, fiber, and vitamin E. The 

revised food packages for women and 

children also provide less saturated fat, 

cholesterol, total fat and sodium than 

the current packages. 

• Provides greater consistency with 

established dietary recommendations 

for infants and children under 2, 

including encouragement and support 

for breastfeeding. The revised infant 

food packages improve overall nutrient 

density compared to current packages 

while keeping caloric content the same 

or slightly lower. The revised packages 

change age specification for assignment 

as well as establish three feeding 

categories to better address current 

dietary recommendations of the 

American Academy of Pediatrics (AAP) 

and promote breastfeeding. The 

packages for breastfeeding infant-mother 

pairs are revised to provide stronger 

incentives for continued breastfeeding, 

including providing less formula to 

partially breastfed infants than current 

packages, and providing additional 

quantities/types of food for 

breastfeeding mothers. For older infants, 

the proposal delays the introduction of 

complementary foods, consistent with 

AAP, from four to six months of age and 

modifies formula amounts. Infant foods 

are added and juice eliminated in the 

packages for older infants in order to 

promote healthy dietary patterns. 

• Addresses emerging public health 

nutrition-related issues. The 

prevalences of overweight and obesity 

in adults, adolescents, and children 

have increased dramatically, with direct 

implications for WIC participants. For 

example, childhood overweight has 

been linked to adverse health outcomes 

including elevated blood pressure, 

hyperinsulinemia, glucose intolerance, 

type 2 diabetes, dyslipidemia, and other 

early risks for chronic disease. The 

addition of fruits and vegetables and the 

emphasis on whole grains are consistent 

with recommendations for food patterns 

that may contribute to a health body 

weight. Compared to the current food 

packages, the revised food packages 

provide less saturated fat and 

cholesterol than the current packages for 

women and children. In addition, the 

revised food packages are designed to 

encourage breastfeeding and thus may 

contribute to a reduced risk of 

overweight in children. 

• Reinforces the nutrition education 

messages provided to participants. The 

proposed food package more closely 

mirrors the 2005 Dietary Guidelines for 

Americans and dietary 

recommendations for infants and 

children under two and is more 

consistent with the nutrition education 

provided to participants. 

• Provides wide appeal to diverse 

populations. The proposed additional 

foods are the foods most often requested 

over the years by a variety of 

stakeholders such as the National WIC 

Association, WIC participants, WIC 

State and local agencies, industry and 

health professionals, and would provide 

more participant choice and a wider 

variety of foods than the current food 

packages. The increased variety and 

choice will provide State agencies 

increased flexibility in prescribing 

culturally appropriate food packages. 

II. Background 

The WIC food packages provide 

supplemental foods designed to address 

the nutritional needs of low-income 

pregnant, breastfeeding, nonbreastfeeding postpartum women, 

infants and children up to five years of 

age who are at nutritional risk. WIC food 

packages and nutrition education are 

the chief means by which WIC affects 

the dietary quality and habits of 

participants. WIC is a unique nutrition 

assistance program in that it also serves 

as an adjunct to good health care during 

critical times of growth and 

development to prevent the occurrence 

of health problems and to improve the 

health status of Program participants. 

WIC was never intended to be a primary 

source of food, nor of general food 

assistance. Rather, WIC food benefits are 

scientifically-based and intended to 

address the supplemental nutritional 

needs of a specific population—low 

income pregnant, breastfeeding, nonbreastfeeding postpartum women, 

infants and children up to five years of 

age who are at nutritional risk. In 

addition to WIC, the Department 

administers a variety of other 

complementary nutrition assistance 

programs that work together to provide 

a more complete diet to low-income 

persons. Low-income families can, and 

frequently do, receive benefits from 

more than one of these programs. The 

largest of these programs, the Food 

Stamp Program, provides general food 

assistance intended to increase the food 

buying power of low-income 

households. 

The ability of the WIC food packages 

to reinforce nutrition education 

messages provided to participants is 

critical to affecting the dietary quality 

and habits of infants, children and 

mothers served by WIC. The nutrition 

education provided by WIC enables 

participants to make informed decisions 

in choosing foods that, together with the 

supplemental foods contained in the 

WIC food packages, can meet their total 

dietary needs. The intent is to help 

participants to continue healthful 

dietary practices after leaving the 

Program. 

Since the creation of the WIC Program 

in the 1970’s, and the last major revision 

of the WIC food packages in the early 

1980’s, much has been learned about the 

nutritional needs of Americans, 

including WIC’s target population of 

pregnant and postpartum women, 

infants, and preschool aged children. In 

recent years the ability of the WIC 

Program to address the supplemental 

nutritional needs of WIC participants 

through its food packages and nutrition 

education has received growing 

attention. Significant interest in 

updating the food packages based on 

new information about the needs of lowincome, culturally diverse women, 

infants, and children has been voiced by 

WIC Program administrators, the 

medical and scientific communities, 

advocacy groups, and Congress. 

A. Advanced Notice of Proposed 

Rulemaking (ANPRM) 

On September 15, 2003, FNS 

published an ANPRM at 68 FR 53903 

seeking comments on revisions to the 

food packages offered through the WIC 

Program. FNS solicited public 

comments to determine if the WIC food 

packages should be revised to better 

improve the nutritional intake, health 

and development of participants and, if 

so, what specific changes should be 

made to the food packages. In response 

to this ANPRM, the Department 

received 195 letters. Respondents 

represented the general public, State 

and local WIC agencies, the National 

WIC Association (NWA), State WIC 

associations, industry, independent 

health professionals, vendors, WIC 

participants, and others. Comments 

received from NWA included two 

published position papers (1, 2) that 

provided recommendations based on 

that organization’s analysis of the needs 

of WIC participants. 

B. Review of the WIC Food Packages by 

the Institute of Medicine 

In September 2003, FNS contracted 

with the National Academies’ Institute 

of Medicine (IOM) to independently 

review the WIC Food Packages in a 22- 

month study. FNS charged the IOM 

with reviewing the nutritional needs of 

the WIC population, and recommending 

changes to the WIC food packages. 

Recommendations were to be costVerDate Aug<31>2005 19:10 Aug 04, 2006 Jkt 208001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\07AUP2.SGM 07AUP2

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44786 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

neutral, efficient for nationwide 

distribution and vendor checkout, nonburdensome to administration, and 

culturally suitable. FNS asked IOM to 

consider the supplemental nature of the 

WIC Program, burdens/incentives for 

eligible families, the role of WIC food 

packages in reinforcing nutrition 

education, breastfeeding, and chronic 

disease prevention, and public 

comments received from FNS’ ANPRM. 

Under this contract, IOM selected a 

Committee of experts in nutrition, 

health, risk assessment and economics 

to conduct this study in two phases. 

During Phase I, the committee 

developed the following criteria to 

guide its work. It also used various data 

sources to identify nutrients and food 

groups to try to increase or decrease in 

the food packages (i.e., priority nutrients 

and priority food groups), with the goal 

of improving the nutrition of WIC 

participants. 

Criteria for a WIC Food Package 

FROM: ‘‘WIC Food Packages; Time For A Change.’’ The Institute of Medicine of the National Academies, The National Academies Press, 

2005, page 37 

1. The package reduces the prevalences of inadequate and excessive nutrient intakes in participants. 

2. The package contributes to an overall dietary pattern that is consistent with the Dietary Guidelines for Americans, for individuals two 

years of age and older. 

3. The package contributes to an overall diet that is consistent with established dietary recommendations for infants and children less 

than two years of age, including encouragement of and support for breastfeeding. 

4. Foods in the package are available in forms suitable for low-income persons who may have limited transportation, storage, and cooking facilities. 

5. Foods in the package are readily acceptable, widely available, and commonly consumed; take into account cultural food preferences; 

and provide incentives for families to participate in the WIC program. 

6. Foods will be proposed giving consideration to the impacts that changes in the package will have on vendors and WIC agencies. 

In Phase II, the Committee used these 

criteria and its review of the nutritional 

needs of WIC participants to develop 

recommendations for changing the WIC 

food packages. The IOM published these 

recommendations in a report, ‘‘WIC 

Food Packages: Time for a Change’’

(IOM Report), which was released on 

April 27, 2005). (3). 

C. Cost Neutrality 

Since the WIC Program receives a 

finite amount of funding annually to 

serve as many participants as this 

funding allows, it is important that 

revisions to the WIC food packages be 

cost neutral to protect the program’s 

ability to serve the greatest number of 

eligible women, infants, and children. 

The IOM conducted a cost analysis as 

part of its review and believes that its 

recommendations to revise the WIC 

food packages were relatively costneutral, given data available to the IOM 

at that time. However, based on updated 

data, the Department now estimates that 

implementing the IOM’s 

recommendations in full would cost 

$1.3 billion above the cost-neutral level 

over 5 years. Therefore, the Department 

has modified two of the IOM’s 

recommendations to achieve a cost 

neutral proposal consistent with 

statutory requirements. The Department 

carefully considered which of the IOM 

recommendations to modify to achieve 

cost neutrality, basing the decision on 3 

criteria—relative cost, nutritional 

impact, and overall context of the IOM 

recommendations. To achieve cost 

neutrality, the Department is proposing 

a cash-value fruit and vegetable voucher 

that is $2 less per month than that 

recommended by the IOM, and is not 

proposing yogurt as an authorized 

alternative to milk. 

The price of yogurt as compared to 

the price of milk would considerably 

increase the monthly cost of the food 

packages for children and women. Soy 

beverage and tofu also have higher per 

unit costs than milk; however, the 

estimated amount of tofu that would be 

purchased by WIC participants is 

substantially lower than that of yogurt. 

Soy beverage can serve as an alternative 

for all or part of the fluid milk for adult 

women, making it a more cost-effective 

substitute. For fruits and vegetables, the 

IOM’s intent was to move WIC 

participants towards some amount of 

increased fruit and vegetable 

consumption and, at the same time, 

reinforce the role of the WIC food 

packages in nutrition education. The 

proposed $2 reduction in the cash-value 

fruit and vegetable voucher fulfills this 

intent while ensuring cost neutrality. 

The Department believes that this 

proposed rule largely sets forth the 

scope of the IOM recommendations 

notwithstanding these necessary 

modifications. Commenters are 

encouraged to suggest alternative ways 

to achieve cost neutrality within the 

context of the overall IOM 

recommendations. State agencies will be 

responsible for determining how to fully 

implement the proposed provisions 

within their grants. Options available to 

State agencies include applying 

judicious use of currently authorized 

caseload management procedures, 

including the participant priority 

system in accordance with § 246.7(e)(4) 

of WIC regulations, or by implementing 

other cost containment measures. State 

agencies are also reminded that 

§ 246.16a(g) authorizes State agencies to 

implement a cost containment system 

for any WIC food other than infant 

formula. 

D. Stakeholder Comments 

The comments FNS received from its 

ANPRM represented a wide range of 

perspectives. A majority of those who 

commented expressed general support 

for foods currently offered, but also 

proposed at least one change. Nearly 

three-fourths of those responding to 

FNS stated that fruits and vegetables 

should be added to the packages. Other 

comments addressed topics including 

priority nutrients, design and structure 

of the food package, amount of juice, 

amount of milk, choices of milk 

products, alternative sources of calcium, 

cereal and grain choices, physical forms 

of legumes (i.e., dried or canned beans 

or peas), peanut butter, eggs, tuna, 

alternative sources of protein, infant 

formula, medical foods regulations, cost, 

incentives to breastfeed, flexibility at 

the State agency level, and more variety 

and choice at the participant level. 

Comments may be viewed at http:// 

www.fns.usda.gov/wic/ 

lawsandregulations/revfoodpkganprm.htm#publiccomments. Similar 

themes were addressed in over 70 

written and 30 oral public comments 

submitted directly to the IOM 

committee during its 22-month review 

of the WIC food packages. 

E. Legislative Requirements 

Sections 17(a) and (b)(14) of the Child 

Nutrition Act of 1966, as amended, 

(CNA) (42 U.S.C. 1786(a) and (b)(14)) 

clearly established the WIC Program as 


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1The IOM analyzed nutrient intake using 

nationally representative data for WIC children and 

for non-breastfed WIC infants. However, the IOM 

found that for breastfed infants 6 through 11 

months of age, and for the women’s groups, the 

nationally representative data did not provide 

adequate sample size of WIC participants for 

meaningful analysis. Consequently, the IOM used 

data for all infants 6 through 11 months and for all 

pregnant and lactating women. For nonbreastfeeding postpartum women categorically 

eligible for WIC (up to six months postpartum), the 

IOM used data for all women within one year 

postpartum. The Department would have preferred 

to have adequate sample size to limit all of these 

analyses to the WIC actual groups, so that the 

recommendations could be completely tailored to 

the WIC population. Prior research using data from 

the Continuing Survey of Food Intakes by 

Individuals indicates that there are statistically 

significant differences in dietary intake between 

low income and higher income adults. For example, 

when controlling for a wide variety of independent 

factors, those adults with incomes below 130 

percent of poverty have statistically lower usual 

mean intakes for food energy and almost all 

vitamins and minerals, and were less likely to meet 

either 70 percent or 100 percent of the RDA. (See 

Gleason P., A. Rangarajan and C. Olson. ‘‘Dietary 

Continued 

‘‘supplemental’’ in nature; that is, the 

WIC supplemental foods are not 

intended to provide a complete diet but 

are designed to provide nutrients 

determined by nutritional research to be 

lacking in the diets of the WIC 

population. The law also directs the 

Secretary in Section 17(f)(11) of the 

CNA (42 U.S.C. 1786(f)(11)) to assure 

that, to the degree possible, the fat, 

sugar, and salt content of supplemental 

foods is appropriate. Section 203(a)(2) of 

Public Law 108–265 amended Section 

17(b)(14) of the CNA by revising the 

definition of supplemental foods to 

include foods that promote health as 

indicated by relevant nutrition science, 

public health concerns, and cultural 

eating patterns. 

Early legislation for the WIC Program, 

Public Law 92–433 (1972) through 

Public Law 94–105 (1975), specifically 

identified protein, iron, calcium and 

vitamins A and C as nutrients of 

particular concern for WIC participants. 

Public Law 95–627, enacted in 

November 1976, deleted reference to 

specific nutrients; however, the 

Department retained high-quality 

protein, iron, calcium, and vitamins A 

and C as the targeted nutrients in the 

WIC Program. 

F. Current WIC Food Packages 

WIC food package requirements 

appear in § 246.10 of the WIC Program 

regulations. The last major revision of 

the WIC Food Packages was in 1980 (45 

FR 74854, November 12, 1980). The 

1980 rule established six different 

monthly packages—Food Package I for 

infants 0–3 months; Food Package II for 

infants 4–12 months; Food Package III 

for children and women with special 

dietary needs; Food Package IV for 

children 1–5 years of age; Food Package 

V for pregnant and breastfeeding 

women; and Food Package VI for 

nonbreastfeeding postpartum women. 

The Department created an additional 

food package in 1992 (57 FR 56231, 

November 27, 1992). This enhanced 

food package, Food Package VII, was 

designed for breastfeeding women who 

elect not to receive infant formula 

through WIC for their infants. 

Current WIC supplemental foods 

include iron-fortified infant formula, 

iron-fortified cereals, vitamin C-rich 100 

percent fruit and/or vegetable juice, 

calcium/protein-rich milk and cheese, 

protein/iron-rich eggs, protein-rich 

peanut butter or dried beans/peas, and 

physician-prescribed formula/medical 

foods for participants with certain 

special dietary needs. The enhanced 

package for breastfeeding women 

increases allowable amounts of juice, 

cheese, peanut butter and dry beans/ 

peas, and also allows protein-rich tuna 

fish and carrots that provide betacarotene (precursor to vitamin A) and 

dietary fiber. 

G. New Nutrient Recommendations 

Over the past decade, knowledge of 

nutrient requirements has increased 

substantially, resulting in a set of new 

dietary reference values called the 

Dietary Reference Intakes (DRIs).(4–9)

The DRIs replace the 1989 

Recommended Dietary Allowances 

(RDAs) as nutrient reference values for 

the United States population. Based on 

the DRIs, many of the recommendations 

for nutrient intakes for individuals 

(RDAs) have changed substantially since 

the WIC food packages were originally 

formulated. Although basic concepts of 

nutrition have not changed, there has 

been a substantial increase in 

knowledge of specific concepts such as 

bioavailability, nutrient-nutrient 

interactions, and the distribution of 

dietary intake of nutrients across 

subgroups of the population. In addition 

to recommended intakes, the DRIs 

include appropriate standards to use in 

determining whether diets are 

nutritionally adequate without being 

excessive. The DRIs encompass more 

aspects of nutrition that did the earlier 

RDAs, as follows: 

• DRIs consider reduction in the risk 

of chronic disease, as well as the 

absence of signs of deficiency. 

• For most nutrients, DRIs include 

both RDA and Estimated Average 

Requirement (EAR) values. 

• For some nutrients, insufficient 

data were available to set EAR and RDA 

values. For these nutrients, Adequate 

Intake (AI) values were estimated. 

• DRIs include Tolerable Upper 

Intake Levels (ULs), which are used in 

the evaluation of the risk of adverse 

effects from excess consumption. 

• DRIs specify appropriate ranges of 

macronutrient densities, which are 

called Acceptable Macronutrient 

Distribution Ranges (AMDRs). 

• When adequate data are available, 

DRIs provide reference values for food 

components other than nutrients. 

Assessing nutrient adequacy involves 

determining the extent to which the 

diets of WIC-income-eligible subgroups 

meet nutrient requirements without 

being excessive. In its Report, the IOM 

conducted analyses applying the DRIs 

and the recommended methods to 

assess the nutrient adequacy of the diets 

of WIC participants. 

III. Priority Nutrients, NutritionRelated Health Priorities, and Priority 

Food Groups Cited by the IOM 

Report (3)

The IOM Report cites fundamental 

changes that have occurred in the major 

health and nutrition risks faced by 

WIC’s target population. The 

prevalences of underweight and irondeficiency anemia have decreased. Diets 

have improved in many respects, and 

nutrients for which intakes often 

appeared to be low in the 1970s 

(calcium and vitamins A and C) are less 

problematic, particularly for children. 

Despite improved access to health care 

and health services, the prevalences of 

overweight and obesity in adults, 

adolescents, and children have 

increased dramatically, regardless of 

WIC participation. In addition, marked 

demographic changes have occurred, 

with both a dramatic increase in the 

number of persons served by WIC and 

a substantial shift in the ethnic 

composition of the WIC population. 

Hispanics now make up the largest 

share of WIC participants.(10)

A. Priority Nutrients 

IOM designated a nutrient as a 

priority nutrient if the prevalence of 

dietary inadequacy was non-trivial, or 

the mean intake is below the AI, or there 

is a recognized nutrition-related health 

priority (e.g., observable levels of iron 

deficiency anemia). The methodology 

used to identify nutrients at high risk of 

inadequacy is described by the IOM in 

‘‘Dietary Reference Intakes: 

Applications in Dietary 

Assessment.’’ (11) Based on detailed 

analyses,1 the IOM Report cites the 


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Intake and Dietary Attitudes Among Food Stamp 

Participants and Other Low-Income Individuals,’’

United States Department of Agriculture, Food and 

Nutrition Service, Office of Analysis, Nutrition and 

Evaluation FSP–00–DI, Project Officer Sharron 

Cristofar, Alexandria, Virginia 2002.) However, the 

pattern of which nutrients more frequently have 

low intakes is very similar for the high- and lowincome groups. For example, among the nine 

vitamins and five minerals studied, both the list 

and order of the six nutrients with the smallest 

portion of the population consuming 70% of the 

RDA is the same for the low- and high-income 

groups. Estimates based on too small a sample have 

an unacceptably high risk of inaccurately 

representing the true population mean and 

distribution. Therefore, for the purpose of 

comparing nutrient adequacy and excesses among 

a group of nutrients when the WIC sample is 

limited, use of the all-income sample is the best 

available alternative. 

following nutrients as high priority for 

WIC participants. 

• WIC infants under one year of age, 

non-breastfed: No nutrients were 

identified with a high risk of 

inadequacy. Priority nutrients related to 

risk of excessive intakes in nonbreastfed infants are zinc, preformed 

vitamin A, and food energy (calories). 

• Breastfed infants 6 through 11 

months: Priority nutrients identified as 

lacking in the diets of breastfed infants 

six months and older are iron and zinc. 

• WIC children 1 through 4 years of 

age: Priority nutrients identified as 

lacking in the diets of young children 

are vitamin E, fiber, and potassium, and 

iron. Nutrients that may be excessive in 

the diets of young children are zinc, 

preformed vitamin A, sodium, food 

energy (calories), and saturated fat. 

• Pregnant, lactating, and nonbreastfeeding postpartum women: 

Priority nutrients identified as lacking 

are calcium, iron, magnesium, vitamin 

E, potassium, and fiber. Nutrients with 

moderate, but still high, levels of 

inadequacy are vitamins A, C, and B6, 

and folate. Nutrients with lower levels 

of inadequacy are iron, zinc, thiamin, 

niacin, and protein. Sodium intakes and 

saturated fat intakes as a percentage of 

food energy intakes are excessive in the 

diets of pregnant, lactating, and nonbreastfeeding postpartum women. 

B. Nutrition-Related Health Priorities 

In addition to analyses of nutrient 

adequacy, the IOM reviewed 

epidemiological evidence on body 

weight status, micronutrients of special 

concern during reproduction and early 

childhood, food allergies, and selected 

environmental risks to the health of 

women, infants, and children. Several 

concerns were identified by the IOM for 

all WIC subgroups—obesity, poor iron 

status, and contamination of food with 

dioxin and methylmercury. The IOM 

also determined that low folate intake is 

a concern for all women during their 

reproductive years because of its 

importance in preventing neural tube 

defects; insufficient calcium intake for 

pregnant and breastfeeding women may 

be associated with potential lead 

toxicity for the fetus and infant; low 

intake of vitamin D is a potential 

concern for women of reproductive age 

because of its importance in bone 

health; and inadequate zinc intake is a 

concern for breastfed infants 6 through 

11 months of age because human milk 

does not provide recommended 

amounts of zinc for older infants. 

C. Priority Food Groups 

To determine whether specific foods 

or types of food should receive priority 

in the re-design of WIC food packages, 

the IOM reviewed information about 

dietary guidance, amounts of foods 

consumed by groups that potentially are 

eligible for the WIC Program, and the 

amounts of foods in current WIC food 

packages. The IOM’s assessment gave 

major consideration to the Dietary 

Guidelines for Americans (DGA), which 

form the basis of Federal food and 

nutrition programs (Pub. L. 101–445, 

U.S. Congress, 1990). To do this, the 

IOM used the DGA 2005 (12) as the 

source of dietary guidance for children 

ages two years and older and widely 

accepted dietary guidance from 

professional groups, such as the 

American Academy of Pediatrics, for 

children under two years of age. The 

IOM Report cites the following 

concerns: 

1. Children ages 2 through 4 years and 

women in the childbearing years: 

• Overall: Intakes of whole grains, 

vegetable subgroups excluding potatoes 

and other starchy vegetables, fruits, milk 

and milk products, and meats are all 

lower than recommended on average; 

• Children ages 2 through 4: Intakes 

tend to be low in whole grains and in 

dark green leafy vegetables, deep yellow 

vegetables, cooked dry beans and peas 

rather than vegetables in general; and 

• Women: Intakes tend to be low in 

whole grains, dark green leafy 

vegetables, deep yellow vegetables, 

cooked dry beans and peas, and fruit 

and milk groups. 

2. Infants and children younger than 

2 years of age: 

Dietary practices of most concern to 

the IOM include the short duration of 

breastfeeding, excessive consumption of 

fruit juice, early introduction of solid 

food and cow’s milk, low consumption 

of fruits (other than juice) and 

vegetables, and infrequent exposure to 

new foods. 

Exhibit A in this preamble, from the 

IOM Report,(3) summarizes nutrient and 

food group priorities that form the basis 

for the proposed revisions of the WIC 

food packages. 

EXHIBIT A.—NUTRIENT AND FOOD GROUP PRIORITIES FOR PROPOSED REVISED WIC FOOD PACKAGES

[FROM ‘‘WIC Food Packages; Time For A Change.’’ The Institute of Medicine of the National Academies, The National Academies Press, 2005, 

page 72] 

Participant 

category 

Nutrients of 

concern with 

regard to inadequate 

intake 

Priority food groups 

Nutrients of 

concern with regard to excessive intake 

Nutrients and ingredients 

to limit in the diet 

Infants, less than 1 y, nonbreastfed.No need identified to increase particular nutrients; maintain iron intakes and continue to 

provide a balanced set 

of essential nutrients.a.

na ...................................... Decrease intakes of Zinc, 

Vitamin A, preformed,b

and Food energy.

Infants, 6–11.9 mo, 

breastfed.

Increase intakes of Iron 

and Zinc.

na.

Children, 12–23.9 mo ........ Increase intakes of Iron, 

Potassium, Vitamin E, 

and Fiber.

Increase intakes of a variety of non-starchy vegetables.Decrease intakes of Zinc, 

Vitamin A, preformed, b

and Food energy.


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EXHIBIT A.—NUTRIENT AND FOOD GROUP PRIORITIES FOR PROPOSED REVISED WIC FOOD PACKAGES—Continued 

[FROM ‘‘WIC Food Packages; Time For A Change.’’ The Institute of Medicine of the National Academies, The National Academies Press, 2005, 

page 72] 

Participant 

category 

Nutrients of 

concern with 

regard to inadequate 

intake 

Priority food groups 

Nutrients of 

concern with regard to excessive intake 

Nutrients and ingredients 

to limit in the diet 

Children, 2–4.9 y ............... Increase intakes of Iron, 

Potassium, Vitamin E, 

and Fiber.

Increase intakes of whole 

grains, and a variety of 

non-starchy vegetables.

Decrease intakes of Zinc, 

Sodium, Vitamin A, 

preformed,b and Food 

energy.

Limit intakes of Saturated 

fat, Cholesterol, and 

Added sugars. 

Adolescent and adult 

women of reproductive 

age.

Give highest priority to increasing intakes of Calcium, Iron, Magnesium, 

Potassium, Vitamin E, 

and Fiber.

Also try to increase intakes 

of Vitamin A, Vitamin C, 

Vitamin D, Vitamin B6, 

and Folate].

Increase intakes of whole 

grains, a variety of nonstarchy vegetables, fruit, 

and fat-reduced milk 

products.

Decrease intakes of Sodium, Food energy, and 

Total fat.

Note: na = not applicable; UL = Tolerable Upper Intake Level. a Iron intakes are apparently adequate for non-breastfed infants, probably due in part to provision of iron-fortified formula in the current WIC 

food packages. bThe UL applies only to preformed vitamin A (i.e., retinol) ingested from the combined sources of animal-derived foods, fortified foods, and dietary supplements.(13)

cTrans fatty acids have not specifically been identified as a hazard for infants and children, and thus are shown in the table as nutrients to limit 

only in the diets of adolescents and adults.(8) However, the dietary guidance to limit trans fatty acids from processed foods in the diet is presumed to apply to all individuals regardless of age. 

D. Identifying Foods To Reduce or 

Eliminate 

Exhibit B in this preamble reflects the 

IOM’s recommendations and rationale 

regarding foods in the current WIC food 

packages to be deleted or reduced in the 

proposed revised food packages. 

EXHIBIT B.—FOODS IN THE CURRENT WIC FOOD PACKAGES TO BE DELETED OR REDUCED IN THE PROPOSED FOOD

PACKAGES

[FROM ‘‘WIC Food Packages; Time For A Change.’’ The Institute of Medicine of the National Academies, The National Academies Press, 2005, 

page 82] 

Food Change Rationale 

Infant formula ................ Reduce maximum amounts for partially 

breastfed infants.

The maximum amount provides approximately half the amount provided to fully formula fed infants to encourage the mother to 

breastfeed enough to provide at least half of the infant’s nutritional 

needs and to make possible other improvements in the WIC food 

packages. 

Infant formula ................ Reduce maximum amounts for fully formula 

fed infants ages 6–11.9 mo of age.

Since the food package for infants of this age provides greater 

amounts of nutrients through complementary foods, less formula is 

needed. 

Juice .............................. Delete juice for infants 4–11.9 mo of age; reduce amount of juice for children 1–4.9 y of 

age.

Meet AAP recommendations to delay introduction of juice for infants 

until after 6 mo of age; allow no more than 4–6 fl oz/day for infants 

above the age of 6 mo.(14) For infants age 6–11.9 mo, fruit juice 

has no nutritional benefit over whole fruit.(15)

Milk ................................ Decrease maximum amounts allowed for children and adults.Amounts provided need not exceed amounts recommended by DGA 

2005.(12)

Cheese .......................... Reduce maximum amount allowed in women’s and children’s packages.Meets recommendation from DGA 2005 (12) and recommendation 

from the IOM to reduce saturated fat and cholesterol intake.(8)

Eggs .............................. Reduce maximum amount allowed ................. Protein is no longer a priority nutrient. Reduction in amount provided 

is consistent with DGA 2005 (12) and with recommendation from 

the IOM to reduce cholesterol intake.(8)

Note: AAP = American Academy of Pediatrics; IOM = Institute of Medicine. 

The full context of IOM’s 

recommendations, including analyses, 

can be found in its report ‘‘WIC Food 

Packages: Time for a Change’’ (3)

available at http://www.fns.usda.gov/ 

oane/menu/Published/WIC/WIC.htm. 

E. The IOM’s Recommendations in the 

Context of this Proposed Rule 

The IOM Report considered current 

recommendations for nutrient intakes 

and dietary patterns, the major dietrelated health problems and risks faced 

by WIC’s target population, the 

characteristics of the WIC Program, and 

the diversity of its participants. IOM’s 

recommendations are intended to make 

the WIC food packages better meet the 

supplemental nutrition needs of 

participants and be more consistent 


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44790 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

with national and professional dietary 

guidance and more consistent with 

nutrition education messages that 

promote healthful diets for the WIC 

population. 

The IOM Report has provided FNS 

with a sound scientific basis for 

proposing a new set of food packages for 

the WIC Program. Except for certain cost 

containment and administrative 

modifications found necessary by the 

Department to ensure cost neutrality, 

FNS is largely setting forth IOM’s 

recommendations in this proposed rule 

for public comment. However, FNS is 

aware that these proposed revisions 

represent substantial changes for the 

WIC Program, its participants, and 

authorized vendors. Implementation 

procedures, staff and vendor training, 

and the nature of the nutrition 

education provided are likely to 

influence the effectiveness of the 

proposed revised food packages. 

Commenters are encouraged to provide 

input that would assist FNS in assessing 

the training and technical assistance 

needs of WIC State agencies and WICauthorized vendors in implementing 

these proposed changes. 

IV. Re-Design of WIC Food Packages To 

Enhance Breastfeeding Promotion and 

Support 

A. Current Breastfeeding Promotion and 

Support in WIC 

WIC has historically promoted 

breastfeeding to all pregnant women as 

the optimal infant feeding choice, 

unless medically contraindicated. 

Current federal WIC regulations 

(§§ 246.7(e)(1)(iii), 246.7(g)(1)(iii), 

246.10(c)(7), and 246.11(c)) contain 

provisions to encourage women to 

breastfeed and to provide appropriate 

nutritional support for breastfeeding 

participants, including: 

• Information provided to WIC 

mothers choosing to breastfeed through 

counseling and breastfeeding 

educational materials; 

• Follow-up support through peer 

counselors; 

• Eligibility to participate in WIC 

longer than non-breastfeeding mothers; 

• Enhanced food package for mothers 

who exclusively breastfeed their infants; 

and 

• Breast pumps, breast shells or 

supplemental nursing systems to help 

support the initiation and continuation 

of breastfeeding. 

In part as a result of strengthened WIC 

breastfeeding policy and program 

activities in the early 1990’s, WIC 

breastfeeding rates have increased at a 

faster rate than in the non-WIC 

population in the United States in the 

last decade. Despite these gains, WIC 

participants lag behind the general 

population in progress toward meeting 

the breastfeeding objectives of Healthy 

People 2010.(16)

B. The IOM’s Recommendations To 

Promote and Support Breastfeeding Via 

the WIC Food Packages 

As described in the IOM Report, the 

proposed revised food packages for 

infants and women are designed to 

strengthen WIC’s breastfeeding 

promotion efforts and provide 

additional incentives to assist mothers 

in making the decision to initiate and 

continue to breastfeed. Breastfeeding is 

the preferred method of infant feeding 

because of the nutritional value and 

health benefits of human milk.(15, 16, 17)

The IOM’s three-pronged approach to 

better promote and support 

breastfeeding through the WIC food 

packages is proposed. The proposed 

approach focuses on the market value of 

the package for the mother/infant pair 

for the first year after birth, addresses 

differences in supplementary nutrition 

needs of breastfed and formula fed 

infants, and considers how to minimize 

early supplementation with infant 

formula through continued or increased 

efforts to promote and support the 

breastfeeding dyad. 

Proposed changes to help support 

breastfeeding address packages for the 

infant as well as the mother since both 

are eligible to receive a WIC food 

package. According to the IOM, the 

perceived dollar value, from the 

mother’s point of view, of the current 

food packages provided for formulafeeding infant-mother pairs is 

substantially larger than that of the 

packages for the fully breastfeeding 

pairs, especially during the first six 

months postpartum. The IOM believes 

that attractive packages for fully 

breastfeeding mother/infant pairs might 

act as an incentive for breastfeeding. 

The proposed revised food packages 

increase the value of the contents of the 

food packages for the fully breastfeeding 

mother/infant pairs while decreasing 

the relative value to mothers of the food 

packages for partially breastfeeding 

pairs and fully formula-feeding pairs. 

As described by the IOM, the 

differences in the proposed packages for 

the mother-infant pairs are based on 

differences in nutritional needs. For 

example, fully breastfeeding women 

require additional calories per day 

during the first six months postpartum 

as well as higher levels of most vitamins 

and minerals. Thus, the package for 

fully breastfeeding women provides the 

most food energy and nutrients, and the 

package for fully formula-feeding 

women provides the least. Similarly, 

starting at age six months, the proposed 

package for fully breastfed infants 

includes commercial infant food meats 

to add a source of iron and zinc. 

Because early supplementation may 

contribute to the short duration of 

breastfeeding, only two infant feeding 

options were recommended initially 

after delivery—either full breastfeeding 

or full infant formula-feeding. The IOM 

recommended this approach because 

physiology provides a strong basis for 

avoiding supplemental formula. The 

amount of milk a breastfeeding woman 

produces depends directly on how often 

and how long she nurses. Providing 

supplemental formula to a new 

breastfeeding mother may interfere with 

her milk production and success at 

continued breastfeeding. 

These proposed food package 

changes, as recommended by the IOM, 

are intended to strengthen WIC’s efforts 

to promote and support breastfeeding as 

the optimal infant feeding choice for 

WIC mothers. 

V. Proposed Revisions to the WIC Food 

Packages 

A. Use of Terms 

For the purposes of discussion, this 

proposed rule uses the following terms. 

WIC food categories refers to WIC 

formula (infant formula, exempt infant 

formula and WIC-eligible medical 

foods); milk and milk alternatives; eggs; 

peanut butter; legumes (dried beans and 

peas); infant cereal; breakfast cereal; 

canned fish; whole wheat bread or other 

whole grains; infant fruits and 

vegetables; infant meat; cheese; juice; 

and fruits and vegetables. 

Food type refers to specific foods 

within a category, e.g., skim milk and 

soy-based beverages are types of food in 

the milk and milk alternatives category. 

Physical form refers to the way in 

which the food is manufactured and/or 

packaged, e.g., dried, frozen; fresh; 

powder; liquid concentrate; fluid; 

evaporated, canned. 

B. Revised Food Packages I and II for 

Infants 

As recommended by the IOM, this 

rule proposes the following changes in 

Food Packages I and II for infants 

(currently § 246.10(c)(1) and (c)(2)). 

• Revise age specifications for 

assignment to infant food packages; 

• Establish 3 feeding options within 

each infant food package—fully 

breastfed, partially breastfed, or fully 

formula fed; 

• Revise maximum monthly infant 

formula allowances; 

• Add infant food fruits and 

vegetables in Food Package II; 


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• Eliminate juice from both infant 

food packages; 

• Disallow provision of infant 

formula for breastfed infants during the 

first month after birth; 

• Disallow low iron infant formula; 

• Allow commercial infant food meat 

for fully breastfed infants in Food 

Package II; and 

• Reassign infants with a qualifying 

condition to proposed revised Food 

Package III—Participants With 

Qualifying Conditions—and authorize 

the issuance of exempt infant formulas 

only in Food Package III. 

The proposed revisions to Food 

Packages I and II for infants, as 

recommended by the IOM, are designed 

to better promote and support the 

establishment of successful long-term 

breastfeeding among women who 

choose that feeding method, address 

differences in nutritional needs of 

breastfed and formula fed infants, 

address developmental needs of infants, 

bring the infant food packages in line 

with current infant feeding practice 

guidelines from the AAP, and serve all 

participants with certain medical 

conditions under one food package to 

facilitate efficient management of 

medically fragile participants. 

1. Reassignment of Infants With 

Qualifying Conditions to Food Package 

III 

Medically fragile infants currently 

receive either Food Package I 

(§ 246.10(c)(1)) for infants 0–3 months of 

age or Food Package II (§ 246.10(c)(2)) 

for infants 4–12 months of age. The WIC 

formulas authorized for issuance to 

infants in Food Packages I and II 

include infant formula, exempt infant 

formula and WIC-eligible medical foods. 

This rule proposes to revise 

§ 246.10(c)(1) through (c)(3) of Program 

regulations for Food Packages I, II and 

III in order to develop a restructured 

Food Package III that would serve all 

categories of participants, including 

infants, who have certain diagnosed 

qualifying conditions. The revised title 

for this food package would be Food 

Package III—Participants with 

Qualifying Conditions. The rationale for 

including infants in Food Package III is 

to consolidate all medically fragile 

individuals with qualifying conditions 

into one package to facilitate efficient 

management and tracking of the benefits 

and costs of providing supplemental 

foods to these participants. Refer to 

section V.P. of this preamble, Revisions 

to Food Package III and their effect on 

Food Packages I and II, for further 

information. 

2. Change in Age Specifications for 

Assignment to Food Packages I and II 

As recommended by the IOM, this 

proposed rule would revise Food 

Package I to serve infants from birth 

through age 5 months and revise Food 

Package II to serve infants ages 6 months 

through 11 months. Currently, the 

assignment to Food Package II occurs at 

age four months. 

3. Establishment of Infant Feeding 

Options 

a. First Month After Birth. To support 

the successful establishment of 

breastfeeding, the proposed rule, as 

recommended by the IOM, would 

establish two infant feeding options for 

the first month after birth, either full 

breastfeeding or full formula-feeding. 

That is, formula would not be provided 

for fully or partially breastfeeding 

infants during the first month after 

birth. If a breastfeeding mother requests 

formula during the first month, the 

Department would advise WIC staff to 

continue to provide breastfeeding 

support for the mother, with special 

attention to the provision of peer 

counseling, breast pumps, consultation 

with lactation experts, and referrals to 

medical providers when appropriate. 

Anticipatory guidance for new mothers 

during the prenatal period would be 

important for the success of this 

approach. As is currently the case, the 

breastfeeding mother could ask to have 

the infant assigned to full formula 

feeding option at any time and WIC staff 

would reassign the infant’s and the 

mother’s food package accordingly. 

b. Second Month After Birth Through 

Month Eleven. Beginning the second 

month after birth, a third infant feeding 

option is proposed—partial 

breastfeeding. As recommended by the 

IOM, this rule proposes that, for the 

purposes of assigning WIC food 

packages, a partially breastfed infant be 

defined as an infant who is breastfed but 

also receives formula from the WIC 

Program in an amount not to exceed 

approximately half the amount of 

formula allowed for a fully formula fed 

infant. Currently, there is not a food 

package for partially breastfed infants. 

Instead, breastfeeding infants may 

receive up to the maximum amount of 

infant formula authorized in Food 

Packages I and II. State agencies are 

currently encouraged to tailor the 

amount of infant formula provided 

based on the assessed needs of the 

breastfeeding infant. Under this 

proposal, breastfeeding mothers who 

request more than the amount of 

formula allowed for partially breastfed 

infants could receive up to the 

maximum amount of formula for the 

fully formula fed infant. In such 

instances, the infant’s feeding option 

would be changed from partially 

breastfed to fully formula fed and the 

mother’s food package adjusted 

accordingly. 

4. Introduction of Complementary 

Foods at 6 Months of Age 

As recommended by the IOM, the 

proposed Food Package I would provide 

only iron-fortified infant formula for 

partially breastfed and fully formula fed 

infants until an infant is six months old. 

As cited by the IOM, this change is 

consistent with recent position 

statements from the American Academy 

of Pediatrics emphasizing that the 

introduction of complementary feedings 

before six months of age only substitutes 

foods that lack the protective 

components of human milk and that 

exclusive breastfeeding should be used 

as the reference or normative model for 

feeding infants. Six months is the age at 

which most healthy infants are 

developmentally ready to handle 

complementary foods. Infants do not 

need complementary foods for 

nutritional reasons at younger ages—

either breastmilk or iron-fortified infant 

formula would entirely meet the 

nutritional needs of most infants. 

Providing complementary foods 

beginning at age six months is 

consistent with common guidelines for 

clinical practice in the field of 

pediatrics. 

5. Disallowance of Low-Iron Infant 

Formula in Food Packages I, II and III 

It is well documented that ironfortified infant formulas play an 

essential role in providing iron in the 

diets of non-breastfed infants. 

According to AAP, there are no known 

medical conditions warranting the use 

of a low-iron infant formula during 

infancy. In addition, the IOM 

recommends that the WIC Program 

continue to provide iron-fortified infant 

formula to prevent iron-deficiency 

anemia in infants. This proposed rule 

would revise WIC food package 

regulations to prohibit the issuance of 

all low-iron infant formulas to any 

infants. 

6. Proposed Revisions and Maximum 

Monthly Allowances in Food Package 

I—Infants Less Than 6 Months of Age 

As recommended by the IOM, under 

this proposed rule, Food Package I 

would provide iron-fortified infant 

formula only. Infant formula would 

continue to be authorized in liquid 

concentrate, powder, and ready-to-feed 

(RTF) physical forms. However, powder 


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infant formula would be recommended 

in Food Package I for partially breastfed 

infants ages one month through three 

months due to its longer shelf life, less 

waste and capability to mix the small 

amounts needed for the partially 

breastfed infant. Powder and RTF 

physical forms are substitutes or 

alternatives to liquid concentrate and 

may be substituted at amounts that 

provide the approximate number of 

reconstituted fluid ounces as the liquid 

concentrate form of the same infant 

formula. Currently, in both Food 

Packages I and II, infant formula 

allowances are expressed in terms of 

fluid ounces of liquid concentrate, 

pounds of powder, and fluid ounces of 

RTF. WIC State agencies have suggested 

to FNS that maximum monthly formula 

allowances for liquid concentrate and 

powder physical forms be expressed in 

terms of reconstituted fluid ounces. The 

Infant Formula Act of 1980 and its 

amendments standardized the nutrient 

content of infant formulas ensuring that 

infant formulas distributed in the 

United States contain certain minimum 

levels of calories and nutrients per 

reconstituted fluid ounce. Therefore, the 

Department is proposing to express 

maximum monthly allowances of infant 

formula of liquid concentrate and 

powder physical forms in reconstituted 

fluid ounces according to the mixing 

directions on the container for 

preparation for consumption. RTF 

liquid will continue to be expressed in 

fluid ounces. 

a. Liquid Concentrate Infant Formula. 

All liquid concentrate infant formula 

currently marketed is packaged in 13 

fluid-ounce cans, is designed to be 

mixed with an equal quantity of water 

(i.e., has a 1:1 dilution ratio) and 

provides the standard dilution of 20 

kilocalories per fluid ounce 

reconstituted. Thus, 403 fluid ounces of 

liquid concentrate formula reconstitutes 

to 806 fluid ounces. The proposed 

maximum monthly formula allowances 

are evenly divisible by the 13-fluidounce cans of liquid concentrate infant 

formula. 

b. Powder Infant Formula. The 

reconstituted yields for powder 

formulas vary according to types and 

brands of products. Powder milk-based 

infant formulas designed for healthy, 

full-term infants have among the highest 

yields when compared to soy-based 

infant formulas and exempt infant 

formulas. This proposed rule would 

revise the substitution rate for powder 

infant formula since the current 

substitution rate of 8 pounds powder 

per 403 fluid ounces liquid concentrate 

is no longer appropriate and could 

result in providing excess amounts of 

formula in some cases. The IOM 

recommended rounding to whole cans 

in order to reach recommended amounts 

of infant formula. Therefore, the 

proposed maximum monthly 

allowances of liquid concentrate and 

RTF are evenly divisible by the whole 

can sizes of infant formula currently 

available. However, none of the whole 

container sizes of powder infant formula 

commonly issued by State agencies 

would provide the same number of 

reconstituted fluid ounces as the liquid 

concentrate form of the same product in 

whole containers. The Department 

recognizes that powder is the most 

economical form for State agencies to 

issue. Therefore, in order to provide a 

nutritional benefit amount 

recommended by the IOM and to 

provide administrative flexibility for the 

issuance of infant formula, this proposal 

would authorize an amount of powder 

infant formula that would provide at 

least the maximum monthly allowance 

as the reconstituted liquid concentrate 

form of the same infant formula in the 

same food package and infant feeding 

option (fully formula fed or partially 

breastfed). State agencies would be 

required to provide at least the number 

of fluid ounces as the same 

reconstituted liquid concentrate infant 

formula up to the maximum monthly 

allowance for reconstituted powder 

infant formula. This would ensure that 

participants receive comparable 

nutritional benefit no matter which 

physical form of infant formula they 

receive. The Department recognizes that 

participants issued powder infant 

formula may receive a slightly higher 

amount of reconstituted fluid ounces 

than the other forms due to the 

currently available container sizes and 

reconstitution rates. 

c. RTF Infant Formula. Proposed 

§ 246.10(e)(1)(iv) lists the reasons that 

RTF formula may be authorized as a 

substitute for liquid concentrate. The 

maximum monthly allowance of RTF 

formula provides about the same 

number of fluid ounces as the 

reconstituted liquid concentrate form of 

the same infant formula. The proposed 

maximum monthly allowances are 

evenly divisible by the 8 and 32-ounce 

whole containers of RTF infant formula. 

d. Maximum Monthly Allowances of 

Infant Formula. As recommended by the 

IOM, the maximum monthly allowance 

of infant formula would depend on the 

feeding option, physical form of infant 

formula provided (concentrated, 

powder, or ready-to-use), and the age of 

the infant, as summarized in Exhibit C 

of this preamble. 

• Fully formula fed infants would 

receive the equivalent of about 806 fluid 

ounces reconstituted infant formula per 

month from birth through 3 months of 

age; thus, Food Package I is unchanged 

for fully formula fed infants from birth 

through 3 months of age. Fully formula 

fed infants 4 months through 5 months 

of age would receive the equivalent of 

about 884 fluid ounces of reconstituted 

infant formula per month; 

• Juice and infant cereal would no 

longer be provided for infants ages 4 

months through 5 months. Compared 

with the current package, the amount of 

infant formula is increased slightly for 

infants ages 4 months through 5 months 

to compensate in part for the decrease 

in nutrients and calories that results 

from the omission of juice and infant 

cereal; 

• Partially breastfed infants ages 1 

month through 3 months would receive 

the equivalent of about 364 fluid ounces 

reconstituted infant formula per month. 

Powder infant formula is recommended 

until the partially breastfed infants 

reaches four months of age due to its 

longer shelf life and to minimize waste; 

and 

• Partially breastfed infants 4 months 

through 5 months of age would receive 

the equivalent of about 442 fluid ounces 

reconstituted infant formula per month. 

Since infant formula is supplemental 

to breast milk for partially breastfed 

infants, the maximum allowance of 

infant formula for partially breastfed 

infants is approximately 50 percent of 

the maximum allowance for fully 

formula fed infants. According to the 

IOM, this approach is designed to 

encourage mothers who are using the 

combination feeding method (feeding 

both breast milk and infant formula) to 

aim for a greater contribution of breast 

milk to the infant’s intake. 

By definition, fully breastfed infants 

would not receive infant formula from 

the WIC Program. Instead, they would 

receive the benefit of breast milk, which 

provides the nutrients they need and a 

wide array of protective and healthpromoting components in a safe form. 


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EXHIBIT C.—MAXIMUM MONTHLY ALLOWANCES FOR PROPOSED FOOD PACKAGE I FOR INFANTS AGES BIRTH TO 6 

MONTHS, BY FEEDING OPTION

WIC food 

Fully breastfed infants Partially breastfed infants Fully formula fed infants 

0 through 5 months 1 through 3 months 4 through 5 months 0 through 3 months 4 through 5 months 

Infant Formula ............ NA ............................. 364 fl oz reconstituted liquid concentrate *.442 fl. oz. reconstituted liquid concentrate.806 fl. oz. reconstituted liquid concentrate.884 fl. oz. reconstituted liquid concentrate. 

NA = not applicable. 

*The maximum monthly allowance is specified in the liquid concentrate form; however, powder and RTF are allowable substitutes and the 

powder form is recommended for partially breastfed infants, ages 1 through 3 months of age. 

7. Proposed Revisions and Maximum 

Monthly Allowances in Food Package 

II—Infants 6 Through 11 Months of Age 

As recommended by the IOM, this 

proposed rule would revise Food 

Package II to include the following 

changes: 

• Food Package II would be provided 

to infants from 6 through 11 months of 

age. This package would differ 

substantially by infant feeding option, 

as shown in Exhibit D in this preamble. 

Infant formula would be decreased for 

fully formula fed infants to 624 fluid 

ounces of reconstituted liquid 

concentrate infant formula per month 

and for partially breastfed infants to 312 

fluid ounces of reconstituted liquid 

concentrate infant formula per month; 

• Infant foods would be added to the 

food package to encourage healthy 

dietary patterns; and 

• Juice would be omitted to help 

make possible the addition of infant 

food fruits and vegetables. 

The amount of infant cereal in the 

package would be unchanged. The 

proposed decrease in the maximum 

allowance of infant formula is 

consistent with meeting nutritional 

requirements. The amount of infant 

formula proposed for partially breastfed 

infants reflects and encourages a greater 

contribution of breast milk to the 

infant’s diet. Decreasing the maximum 

amount of infant formula and omitting 

juice makes possible needed 

enhancements. For example, the 

addition of infant food fruits and 

vegetables in the second six months of 

infancy introduces infants to a variety of 

nutritious foods at an age when almost 

all infants are developmentally ready for 

semisolid foods. The infant food meat 

for fully breastfed infants provides 

needed iron and zinc in forms with high 

bioavailability, and the larger quantities 

of infant food for fully breastfed infants 

may encourage some mothers to 

continue fully breastfeeding. 

Long-standing WIC policy has not 

authorized infant cereals that included 

fruit or infant formula ingredients. 

However, this restriction was never 

incorporated into regulatory language. 

This proposed rule would clarify in WIC 

regulations that infant cereals with the 

added ingredients of infant formula, 

milk, fruit, or other non-cereal 

ingredients are not authorized based on 

recommendations of the AAP and cost 

concerns. The AAP recommends that 

single ingredient foods be introduced 

one at a time in an effort to isolate food 

sensitivities and possibly avert the 

development of food intolerances. 

Although cereal/fruit combinations may 

be appropriate once the risk of food 

sensitivity has diminished, these 

combination foods are more expensive 

than regular infant cereal. In reference 

to cereal/formula combinations, since 

infant formula is already provided in 

the food packages, it is not necessary to 

provide additional infant formula in 

combination with infant cereal. In 

addition, authorized infant cereals must 

continue to contain a minimum of 45 

milligrams of iron per 100 grams of dry 

cereal. 

a. Authorized Infant Foods. 

• Any variety of commercial infant 

food (fruit or vegetable) without added 

sugars, starches, or salt (i.e., sodium). 

Texture may range from strained 

through diced; and 

• Any variety, single ingredient, of 

commercial infant food meat with broth 

or with gravy. Texture may range from 

pureed through diced. 

b. Maximum Monthly Allowance of 

Infant Foods (Fruits, Vegetables, and 

Meats) for Infant 6 through 11 months 

of age: 

• For fully formula fed infants. 128 

ounces of fruits and vegetables (e.g., 32 

4-ounce jars); 

• For partially breastfed infants. 128 

ounces of fruits and vegetables (e.g., 32 

4-ounce jars); 

• For fully breastfed infants. 256 

ounces of fruits and vegetables (e.g., 64 

4-ounce jars); and 

• For fully breastfed infants. 77.5 

ounces of infant food meat (31 2.5- 

ounce jars. 

Fresh banana may replace up to 16 

ounces of infant food fruit at a rate of 

1 pound of bananas per 8 ounces of 

infant food fruit. Fresh bananas for 

infants in Food Package II would be 

issued via the standard food instrument 

system. 

As cited by the IOM Report, the 

rationale for providing a greater quantity 

of infant food fruits and vegetables in 

the package for fully breastfed infants is 

to provide added nutritional value to 

improve the parity with other infant 

packages, to provide sufficient fruits 

and vegetables to mix with infant food 

meats to increase the palatability of 

strained meats for older infants, and to 

encourage prolonged breastfeeding by 

adding to the convenience and 

monetary value of the food packages of 

the fully breastfeeding mother/infant 

pair. 

EXHIBIT D.—MAXIMUM MONTHLY ALLOWANCES FOR PROPOSED FOOD PACKAGE II FOR INFANTS AGES 6 MONTHS TO 1 

YEAR, BY FEEDING OPTION

Fully breastfed infants Partially breastfed 

infants 

Fully formula fed 

infants 

WIC Formula 

Infant Formula ........................ ....................................................... 312 fluid ounces of reconstituted 

liquid concentrate formula.

624 fluid ounces of reconstituted 

liquid concentrate formula. 

WIC Food 


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EXHIBIT D.—MAXIMUM MONTHLY ALLOWANCES FOR PROPOSED FOOD PACKAGE II FOR INFANTS AGES 6 MONTHS TO 1 

YEAR, BY FEEDING OPTION—Continued 

Fully breastfed infants Partially breastfed 

infants 

Fully formula fed 

infants 

Infant food (Fruits and Vegetables).256 ounces of infant food fruits 

and vegetables.

128 ounces of infant food fruits 

and vegetables.

128 of ounces infant food fruits 

and vegetables. 

Infant food (Cereal) ................ 24 ounces of iron-fortified infant 

cereal.

24 ounces of iron-fortified infant 

cereal.

24 ounces of iron-fortified infant 

cereal. 

Infant food (Meat) .................. 77.5 ounces of infant food meat.

c. Rounding Up of Infant Foods. 

• Infant Formula 

Public Law 108–265, the Child 

Nutrition and WIC Reauthorization Act 

of 2004, enacted on June 30, 2004, 

contains a provision that allows a State 

agency to round up to the next whole 

can of infant formula to allow all 

participants to receive the fullauthorized nutritional benefit specified 

by regulation. This provision only 

applies to infant formula (not exempt 

infant formula or WIC-eligible medical 

foods) issued as a result from a 

solicitation bid on or after October 1, 

2004. This proposal reflects this 

authority by calculating and dispersing 

the infant formula over the timeframe of 

the food package category and infant 

feeding option (fully formula fed or 

partially breastfed). This proposal 

would identify the full nutritional 

benefit (FNB) provided by infant 

formula as the maximum monthly 

allowance of reconstituted fluid ounces 

of liquid concentrate for the food 

package category and infant feeding 

option. This proposal would require 

State agencies to issue at least the FNB 

but not more than the maximum 

monthly allowance for the food package 

category and infant feeding option. This 

proposal would require State agencies 

that use the rounding up option to issue 

infant formula in whole containers of 

the same size for administrative ease 

and to use the methodology described 

herein to calculate the number of cans 

of infant formula for issuance to 

participants. 

This proposal would require 

calculating and dispersing the infant 

formula over the timeframe of the food 

package category and infant feeding 

option (fully formula fed or partially 

breastfed). For example, a fully formula 

fed infant who participates in WIC from 

birth through eleven months of age 

would be issued infant formula in 

amounts provided by Food Package IA–

FF from birth through 3 months of age, 

issued infant formula in amounts 

provided by Food Package IB–FF from 

four through five months of age, and 

issued infant formula in amounts 

provided by Food Package II–FF from 6 

through eleven months of age. The 

timeframe or the total number of months 

that the participant will receive each 

food package is shown in Exhibit E. 

EXHIBIT E.—FOOD PACKAGE

TIMEFRAME

Food package Maximum time frame 

I A–FF ....................... 4 months. 

I B–FF ....................... 2 months. 

II–FF .......................... 6 months. 

Exhibit F describes the methodology 

that State agencies must use to calculate 

the amount of infant formula dispersed 

over the timeframe of the food package 

category and infant feeding option, 

when using the rounding up option. 

EXHIBIT F.—ROUNDING UP INFANT FORMULA METHODOLOGY

1 ............. Multiply FNB by number of months in food package = Total amount of infant formula. 

2 ............. Determine yield (reconstituted fluid ounces) provided by the container issued by the State agency. 

3 ............. Divide total amount of infant formula by the container yield = total number of containers to issue. 

4 ............. Round up to the next whole same size container if the number of containers is not a whole number (e.g. 4.3 containers would round 

up to 5 containers). 

5 ............. Distribute the total containers across the food package timeframe as evenly as possible (e.g. 2,1,2,1). 

For example, a fully formula fed 

infant participant born January 1, 2006, 

would receive Food Package IA—FF 

issuance amount rounded over a 

4-month timeframe multiplied by the 

FNB (806 fluid ounces reconstituted) to 

equal 3224 fluid ounces reconstituted 

total amount of infant formula for the 

4-month timeframe. The total amount, 

3224 fluid ounces reconstituted, would 

then be divided by the yield of fluid 

ounces reconstituted provided by the 

authorized container to determine the 

total number of containers needed to 

provide 3224 fluid ounces reconstituted. 

The reconstituted fluid ounce yield 

provided by container varies depending 

on container size and the reconstitution 

rate. Currently, Enfamil Lipil infant 

formula in a 12.9 ounce can 

reconstitutes to about 94 fluid ounces 

per container, Similac Advance infant 

formula in a 12.9 ounce can 

reconstitutes to about 96 fluid ounces 

per container, and Nestle Good Start 

Supreme infant formula in a 12.0 ounce 

can reconstitutes to about 87 fluid 

ounces per container. Therefore, the 

3224 fluid ounces would be divided by 

either 94, 96 or 87 respectively, for a 

rounded up total of 35 12.9 ounce cans 

of Enfamil Lipil, or 34 12.9 ounce cans 

of Similac Advance, or 38 cans of 12 

ounce cans Nestle Good Start Supreme. 

Using Enfamil Lipil as the example, the 

35 cans would be dispersed over 4 

months as evenly as possible, such as 9 

cans the first month, 8 cans the second 

month, and 9 cans each for months 3 

and 4. 

Exhibit G shows the number of 

powder infant formula containers that 

would be issued to an infant participant 

born January 1, 2006, for the fully 

formula fed infant food packages, using 

the rounding up methodology, for 

Enfamil Lipil, Similac Advance, or 

Nestle Good Start Supreme infant 

formulas for a 1-year certification 

timeframe. 


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EXHIBIT G.—NUMBER OF POWDER INFANT FORMULA CONTAINERS ISSUED TO AN INFANT PARTICIPANT BORN 01/01/2006, 

FOR FOOD PACKAGES I & II FULLY FORMULA FED (FF) USING ROUNDING UP

Approximate reconstitution amount per container 

Mead Johnson’s 

Enfamil Lipil 

(number of 12.9 

oz. containers) 

94 fl. oz. 

Ross’ Similac 

Advance 

(number of 12.9 

oz. containers) 

96 fl. oz. 

Food Package I–FF A (FNB = 806 fl. oz. per month): 

January, age 0 months ............................................................................................. 9 .0 9 .0 10 .0 

February, age 1 month ............................................................................................. 8 .0 9 .0 10 .0 

March, age 2 months ............................................................................................... 9 .0 8 .0 9 .0 

April, age 3 months .................................................................................................. 9 .0 8 .0 9 .0 

Food Package I–FF A subtotal ......................................................................... 35 34 38 

Food Package I–FF B (FNB = 884 fl. oz. per month): 

May, age 4 months ................................................................................................... 10 .0 10 .0 11 .0 

June, age 5 months .................................................................................................. 9 .0 9 .0 10 .0 

Food Package I–FF B subtotal ......................................................................... 19 19 21 

Food Package II–FF (FNB = 624 fl. oz. per month): 

July, age 6 months ................................................................................................... 7 .0 7 .0 8 .0 

August, age 7 months .............................................................................................. 6 .0 6 .0 7 .0 

September, age 8 months ........................................................................................ 7 .0 7 .0 7 .0 

October, age 9 months ............................................................................................. 6 .0 6 .0 8 .0 

November, age 10 months ....................................................................................... 7 .0 7 .0 7 .0 

December, age 11 months ....................................................................................... 7 .0 6 .0 7 .0 

Food Package II–FF subtotal ............................................................................ 40 39 44 

Infant package total of formula issued .............................................................. 94 92 103 

• Infant Foods 

This proposed rule would allow State 

agencies to round up and disperse 

whole containers of infant foods (infant 

cereal, infant fruit and vegetables, and 

infant meat) over the timeframe of the 

food package category and infant 

feeding option (fully formula fed, fully 

breastfed or partially breastfed) to allow 

all participants to receive the maximum 

monthly allowance of infant foods as 

specified in regulations. This is 

consistent with the authority allowing 

State agencies to round up infant 

formula. Rounding up of infant foods 

provides administrative flexibility to 

State agencies since container sizes of 

infant foods vary and rounding ensures 

that infants would receive the full 

nutritional benefit recommended by the 

IOM. 

This proposal would require State 

agencies that use the rounding up 

option for infant foods to use the same 

methodology proposed to calculate and 

disperse infant formula over the 

timeframe of the food package category 

and infant feeding option. Exhibit H 

describes the methodology that State 

agencies must use to calculate and 

disperse infant foods over the timeframe 

of the food package category and infant 

feeding option. 

EXHIBIT H.—ROUNDING UP INFANT FOOD METHODOLOGY

1 ............. Multiply maximum monthly allowance by number of months in food package = Total amount of infant food in ounces. 

2 ............. Determine the container size (e.g., ounces) of infant food issued by the State agency. 

3 ............. Divide total amount of infant food by the container size = total number of containers to issue. 

4 ............. Round up to the next whole same size container if the number of containers is not a whole number (e.g. 54.3 containers would 

round up to 55 containers). 

5 ............. Distribute the total containers across the food package timeframe as evenly as possible (e.g.10, 9, 9, 9, 9, 9). 

For example, a fully formula fed 

infant participant born January 1, 2006, 

would receive Food Package II from July 

through December, for a 6-month total 

timeframe. The infant may receive 24 

ounces infant cereal per month, 

multiplied by 6 months, to equal a total 

of 144 ounces infant cereal. Currently, 

authorized infant cereal is packaged in 

8- and 16-ounce containers. Therefore, 

either 18 8-ounce containers or 9 16- 

ounce containers of infant cereal would 

be provided over the food package 

timeframe. The 18 8-ounce containers 

can be divided equally by the 6-month 

food package timeframe and results in 3 

8-ounce containers of infant cereal 

issued each month. The 9 16-ounce 

containers must be dispersed across the 

food package timeframe as evenly as 

possible, for example, two containers 

per month issued for three months and 

one container per month issued for 

three months on alternating months (e.g. 

2, 1, 2, 1, 2, 1) to equal the 9 total 

containers. 

The Department is seeking comments 

on the proposed methodology to round 

up and disperse infant formula and 

infant foods. 

d. Department Soliciting Input on 

changes to infant feeding packages. The 

proposed infant feeding options 

represent a dramatic change in infant 

food package issuance procedures. The 

procedural changes affect not only 

assignment to one of three feeding 

options but impact the delivery of other 

nutrition services as well. We are aware 


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that WIC State agencies will experience 

challenges in staff training, assessment 

of the mother-infant dyad, programming 

of management information systems, 

and the provision of participant 

nutrition education. Successful 

implementation of the infant feeding 

options may require enhanced nutrition 

education, peer counseling, and referral 

activities to support the successful 

establishment of breastfeeding. 

The Department is soliciting input on 

the potential impacts of the proposed 

changes to Food Package I and II, and 

any comments or suggestions on 

alternative options for FNS to consider. 

Specifically, FNS would like comments 

regarding the following: 

• The three infant feeding options; 

• Impact of proposed changes on 

breastfeeding rates; 

• Staff training and building support 

for proposed changes among WIC staff; 

• The expression of monthly 

maximum amounts of infant formula in 

reconstituted fluid ounces; 

• The methodology used to round up 

infant formula and infant foods; 

• Participant nutrition education; and 

• Administrative feasibility. 

C. Overview of Revised Food Package IV 

for Children 

Currently there is one package for 

children without special dietary needs, 

Food Package IV for children ages 1 to 

5 years (currently § 246.10(c)(4)). This 

proposed rule would continue to 

provide Food Package IV to children 

ages 1 through 4 years. However, as 

recommended by the IOM, only whole 

milk would be authorized for children 

age one year (12 through 23 months), 

and only milk with a fat content not to 

exceed two percent would be authorized 

for children 2 years of age and older. 

Compared with the current package, the 

revised food package, as recommended 

by the IOM, would include smaller 

amounts of milk and juice but would 

add fruits, vegetables, and whole grains. 

Cheese would continue to be allowed as 

a partial substitute for milk; however, 

the maximum cheese substitution 

would be reduced from current WIC 

regulations. As recommended by the 

IOM, with proper medical 

documentation, soy-based beverage and 

tofu would be authorized as substitutes 

for milk. As cited by the IOM Report, 

these changes would make the entire 

food package for children more 

consistent with the DGA 2005 (12) and 

help ensure a more balanced nutrient 

intake for WIC participants. 

D. Overview of Revised Food Packages 

V, VI, and VII for Women 

Currently, there are three food 

packages for women without special 

dietary needs. These are Food Package 

V for pregnant and breastfeeding 

women; Food Package VI for 

nonbreastfeeding postpartum women; 

and Food Package VII for breastfeeding 

women who do not receive infant 

formula for their infants from the WIC 

Program (currently § 246.10(c)(5) 

through (c)(7)). As recommended by the 

IOM, this proposed rule would retain 

these food packages, but as discussed in 

section V.B. of this preamble, would 

add for the purposes of assigning a food 

package, a definition of partially 

breastfeeding. Currently, a woman is 

certified to be eligible for the Program 

as a breastfeeding woman if she is 

breastfeeding on the average of at least 

once a day and meets other WIC 

eligibility criteria. Under this proposed 

rule, a woman would continue to be 

certified eligible as a breastfeeding 

woman if she is breastfeeding on the 

average of at least once a day. However, 

whether or not she receives a food 

package and which food package she is 

assigned would be based on the amount 

of infant formula she requests and 

receives from WIC for her infant and the 

age of the infant. 

Under this proposed rule, Food 

Package V would be provided for 

pregnant and partially breastfeeding 

woman (up to 1 year postpartum) whose 

infants participate in the WIC Program 

and receive infant formula in amounts 

that do not exceed the maximum 

allowances for the partially-breastfed 

infant food packages, as appropriate for 

the age of the infant. 

Food Package VI would continue to be 

provided for non-breastfeeding 

postpartum women (up to 6 months). 

Food Package VI would also be 

provided to partially breastfeeding 

postpartum women (up to 6 months) 

whose infants are receiving more than 

the maximum allowances for the 

partially breastfed infant food package, 

as appropriate for the age of the infant. 

In terms of the variety of foods and 

amounts offered, Food Package V for 

partially breastfeeding women is more 

desirable than Food Package VI. Food 

Package V provides whole wheat bread 

or other whole grains, peanut butter in 

addition to legumes, and more milk and 

juice than Food Package VI. Food 

Package VI does not provide whole 

wheat bread or other whole grains, and 

provides the option of peanut butter or 

legumes, but not both. The incentive 

value of Food Package V may encourage 

a higher level of breastfeeding among 

mothers who both breastfeed and 

formula-feed their infants. 

Food Package VII would continue to 

be provided to fully breastfeeding 

women whose infants do not receive 

infant formula from the WIC Program. In 

addition, based on estimates of 

increased nutrient and energy needs of 

women pregnant with more than one 

fetus, these women, as recommended by 

the IOM, would now receive Food 

Package VII rather than Food Package V. 

Women who are fully breastfeeding 

multiple infants would be prescribed 

1.5 times the maximum amounts of 

Food Package VII to cover their higher 

needs for energy and nutrients. Women 

partially breastfeeding multiple infants 

would receive also Food Package VII. 

Further, all breastfeeding women would 

be prescribed Food Package VII during 

the first month postpartum because 

their infants would not be receiving any 

infant formula from the WIC Program. 

As recommended by the IOM, under 

this proposed rule Food Package VII, for 

fully breastfeeding women, would 

provide the greatest variety and quantity 

of food; and Food Package VI for 

postpartum women, would provide the 

least. Compared with the current food 

packages, all 3 revised food packages for 

women would provide smaller amounts 

of milk products, eggs, and juice; the 

same amount of iron-fortified cereal; 

add a requirement that cereals be whole 

grain; and would add fruits and 

vegetables. Whole grain bread or other 

whole grains would be added to Food 

Packages V and VII. The food packages 

for women would no longer authorize 

whole milk, and would allow several 

alternatives to cow’s milk to address 

calcium needs. Canned light tuna would 

continue to be allowed in Food Package 

VII; canned salmon and sardines would 

be authorized as substitutes for light 

tuna. 

Women greater than 6 months 

postpartum whose infants do not meet 

the definition of a partially breastfed 

infant. The IOM recommends that a 

partially breastfeeding woman who 

requests, after the sixth month 

postpartum, more than the maximum 

amount of formula for a partially 

breastfed infant, no longer be certified 

for the WIC Program. However, FNS has 

determined that this approach is 

incongruous with the definition of 

breastfeeding in WIC regulations at 

§ 246.2—the practice of feeding a 

mother’s breastmilk to her infant(s) on 

the average of at least once per day. In 

WIC, this definition is used to 

determine Program eligibility, and 

allows all breastfeeding women, 

regardless of feeding pattern, to 

participate in the WIC Program, be 


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counted as a breastfeeding woman, and 

receive supplemental foods, 

breastfeeding promotion and support, 

and referrals to health care. The 

definition recognizes that any 

breastfeeding, even if only on an average 

of once a day, provides some 

immunological and nutritional benefits 

that would otherwise not be provided to 

an infant. 

As such, rather than adopt IOM’s 

recommendation in its entirety, FNS 

proposes to revise the definition for WIC 

‘‘participation’’ at § 246.2. The 

definition would now include the 

number of breastfeeding women who 

receive no supplemental foods or food 

instruments but whose breastfed 

infant(s) receives supplemental food or 

food instruments. Counting these 

women, although they are not receiving 

a food package, is consistent with the 

current practice of counting the infants 

of exclusively breastfeeding women. 

Therefore, a partially breastfeeding 

woman who requests, after the sixth 

month postpartum, more than the 

maximum amount of formula for a 

partially breastfed infant would no 

longer receive a food package but would 

continue to count as a WIC participant 

and receive other Program benefits 

(nutrition education, including 

breastfeeding promotion and support, 

and referrals to health and social 

services). This would serve to meet the 

intent of IOM’s recommendations 

within the context of WIC regulations. 

E. Inclusion of Fruits and Vegetables in 

Food Packages III through VII 

As recommended by the IOM, this 

proposed rule would add a variety of 

fruits and vegetables to Food Packages 

III, IV, V, VI, and VII (currently 

§ 246.10(c)(3) through (c)(7)). The IOM 

Report states that the addition of fruits 

and vegetables to WIC food packages is 

consistent with a major 

recommendation of the DGA 2005 (12)

—

namely, to increase daily intake of fruits 

and vegetables. The IOM’s basis for 

recommending the addition of fruits and 

vegetables was the substantial body of 

literature that supports the association 

of fruit and vegetable consumption with 

reduced risk of chronic disease 

including stroke and perhaps other 

cardiovascular diseases, some cancers, 

and type 2 diabetes. Evidence also 

suggests that increased fruit and 

vegetable consumption may be useful in 

programs to promote and sustain loss of 

body weight in overweight individuals. 

The IOM and FNS received many public 

comments from health professionals, 

consumers, WIC Program staff, WIC 

participants, and others, advocating for 

the inclusion of fruits and vegetables in 

the WIC food packages. 

1. Authorized Fruits and Vegetables 

As recommended by the IOM, this 

proposed rule would include fresh and 

processed (canned, frozen, and dried) 

fruits and vegetables. Fresh, canned, 

and frozen fruits and vegetables would 

be authorized for children and women 

in Food Packages III through VII. Dried 

fruits and dried vegetables would be 

authorized for women in Food Packages 

III and V through VII. As recommended 

by the IOM, dried fruit and dried 

vegetables would not be authorized for 

children in Food Packages III or IV to 

reduce the risk of choking. 

As recommended by the IOM, to 

improve the consumption of fresh fruits 

and vegetables and the appeal of this 

option, especially for people of different 

cultural backgrounds, this proposed rule 

would place minimal restrictions on 

participant choice of fresh produce. 

Because a fresh produce option might 

not be practical in some situations, a 

processed option and a combined fresh 

and processed option for fruits and 

vegetables are also proposed. 

As recommended by the IOM, for 

children and adults in Food Packages 

III–VII, different physical forms of fruit 

and vegetable offerings are proposed, as 

follows. 

a. Fresh fruits and vegetables. 

• Any variety of fresh whole or cut 

fruit without added sugars; and 

• Any variety of fresh whole or cut 

vegetable, except white potatoes, 

without added sugars, fats, or oils. 

b. Processed fruits and vegetables 

(canned, frozen, and dried). 

• Any variety of canned fruits, 

including applesauce; juice pack or 

water pack without added sugars, fats, 

oils, or salt (i.e., sodium); 

• Any variety of frozen fruits without 

added sugars; 

• Any dried fruit or vegetable without 

added sugars, fats, oils, or salt (i.e., 

sodium); and 

• Any variety of canned or frozen 

vegetables, except white potatoes 

(orange yams and sweet potatoes are 

allowed), without added sugars, fats, 

oils. 

2. Restrictions on Authorized Fruits and 

Vegetables 

This proposed rule would not 

authorize: 

• White potatoes (orange yams and 

sweet potatoes are allowed); 

• Catsup or other condiments; 

• Pickled vegetables and olives; or 

• Soups. 

IOM’s recommended restriction on 

white potatoes is based on the amounts 

suggested in DGA 2005 (12) for 

consumption of starchy vegetables; food 

intake data indicating that consumption 

of starchy vegetables meets or exceeds 

these suggested amounts; and food 

intake data showing that white potatoes 

are the most widely used vegetable. 

Although not addressed by IOM, the 

Department is proposing further 

restrictions on fruits and vegetables; and 

therefore this proposal would also not 

authorize: 

• Herbs or spices; 

• Edible blossoms and flowers, e.g., 

squash blossoms (broccoli, cauliflower 

and artichokes are allowed); 

• Creamed or sauced vegetables; 

• Vegetable-grain (pasta or rice) 

mixtures; 

• Fruit-nut mixtures; 

• Breaded vegetables; 

• Fruits and vegetables for purchase 

on salad bars; 

• Ornamental and decorative fruits 

and vegetables such as chili peppers on 

a string, garlic on a string; gourds, 

painted pumpkins; 

• Fruit baskets and party vegetable 

trays; 

• Fruit leathers and fruit roll-ups; 

• Peanuts; 

• Juices (juices are provided as a 

separate WIC food category); 

• Canned and dried mature legumes 

(these legumes are provided as a 

separate WIC food category); and 

• Items such as blueberry muffins and 

other baked goods. 

3. Maximum Monthly Allowances 

The IOM recommended that fruits 

and vegetables be provided at levels of 

$10 per month for women and $8 per 

month for children. However, as 

discussed earlier in this preamble, to 

achieve cost neutrality, the Department 

has reduced this recommendation by $2 

for both women and children. 

Therefore, this proposed rule establishes 

the value of fruit and vegetable vouchers 

at levels of $8 per month for women and 

$6 per month for children. The 

Department welcomes comments or 

suggestions from State agencies 

regarding cost-neutral options for 

providing vouchers at the IOMrecommended levels. 

a. Fresh produce option. Because few 

fresh fruits and vegetables are sold in 

uniform weight units with uniform bar 

codes, and their prices vary 

considerably across seasons, regions, 

and stores, they cannot be prescribed in 

quantity terms and still control the 

overall cost of the WIC food packages. 

Therefore, this proposal would include 

cash-value food instruments at the level 

of $8 per month for women and $6 per 

month for children for fresh fruits and 

vegetables. 


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Cash-value food instruments will be 

set at $6 for children and $8 for women 

in the year in which the proposed food 

package revisions take effect. FNS will 

adjust the maximum value of the 

vouchers in whole dollar increments to 

reflect the sum of annual, un-rounded 

increases in inflation using the Bureau 

of Labor Statistics’ Consumer Price 

Index for Fresh Fruits and Vegetables. In 

the fiscal year in which the whole dollar 

increment accrues, the Department 

would have the option to increase the 

value of the fruit and vegetable vouchers 

by the whole dollar increment. If the 

Department elects this option, it would 

request the funding necessary for the 

additional program costs. 

The recommendation to use cashvalue food instruments for fresh fruits 

and vegetables is based on input IOM 

received from vendors in public 

meetings. The IOM also cited two recent 

pilot studies in which cash-value 

vouchers for fresh fruits and vegetables 

were provided to WIC participants. (18,

19) The experience from both pilot 

studies, albeit unpublished at the 

present time, suggests that providing 

fresh produce to WIC participants using 

cash-value vouchers increased the 

intakes of fruits and vegetables, added 

variety to the diets of WIC participants, 

and was highly acceptable to WIC 

participants of various ethnic/cultural 

backgrounds. 

Because of greater participant choice, 

lower cost in many States, and 

potentially greater nutrient contribution 

from fresh produce, State agencies are 

encouraged to offer fresh produce to the 

extent possible. 

b. Processed fruit and vegetables 

option. As recommended by the IOM, 

this proposal would allow processed 

(canned, frozen, and dried) fruits and 

vegetables to be substituted when fresh 

produce is limited and to accommodate 

participant preference. The Department 

proposes to also provide the processed 

options via the $8 or $6 cash-value food 

instrument. State agencies would be 

authorized to allow the cash-value food 

instrument to be used to obtain any 

combination of fresh produce and 

processed fruits and vegetables, thereby 

providing maximum flexibility for the 

participant. In addition, the ability to 

combine all fruit and vegetable options 

on one type of cash-value food 

instrument should reduce the 

administrative complexity for State 

agencies and vendors. 

State agencies are encouraged to allow 

participants the wide variety of choices 

within the authorized fresh and 

processed options. To ensure 

participant choice among the fresh and 

processed fruit and vegetables 

authorized by the State agency, 

§ 246.12(g)(3)(i) would be revised to 

require that vendors authorized by the 

State agency carry a minimum of two 

varieties each of fruits and vegetables, in 

any combination of fresh and processed. 

However, it is the Department’s 

expectation that more than two varieties 

each of fruits and vegetables be 

authorized by State agencies. The 

Department welcomes comments or 

suggestions on ways to provide the 

widest variety of choice without 

introducing undue program complexity 

or administrative burden. 

4. Implementation of Fruit and 

Vegetable Options 

Under this proposed rule, State 

agencies would be encouraged to issue 

small denomination, such as $2, cashvalue fruit/vegetable food instruments. 

In consideration of the perishable nature 

of fresh fruits and vegetables, small 

denominations are needed so the 

participant can obtain small amounts of 

fresh product at various times during 

the month, lessening the chance of food 

spoilage and waste. Any combination of 

authorized fresh or processed fruit or 

vegetable would be allowed in 

quantities with a value up to the amount 

of the cash-value food instrument(s). 

The Department welcomes comments or 

suggestions on implementation of fresh 

fruit and vegetable options. 

a. Operational requirements for cashvalue fruits and vegetables food 

instruments. Under this proposed rule, 

cash-value food instruments for fruits 

and vegetables, as with any WIC food 

instrument, would be subject to the 

requirements in § 246.12—Food 

Delivery Systems. Section 246.12 sets 

forth design and operational 

requirements for food delivery systems, 

including vendor authorization, 

accountability, redemption and 

disposition of food instruments. 

b. Benefit delivery. While most of the 

proposed food package changes could 

be administered via existing State 

benefit delivery systems, the cash-value 

food instruments for the purchase of 

fruits and vegetables differs from other 

WIC benefits which provide specified 

quantities of approved food items. The 

fruit and vegetable benefit would 

require changes to WIC benefit delivery 

systems to accommodate a more openended benefit determined by a cash 

value rather than a fixed quantity of a 

specific food item. States and vendors 

would have to modify operations and 

procedures to issue, transact, and 

process the redemption of a cash value 

benefit. The implementation of a cash 

value paper voucher or check may prove 

administratively burdensome and 

prohibitively expensive given additional 

processing costs that may be applied to 

each transaction, depending on a State’s 

benefit processing arrangement. The 

cost and implications of these changes 

in the existing WIC benefit delivery 

system is an area that must be carefully 

considered. 

The fruit and vegetable benefit may 

lend itself to electronic benefit delivery 

in line with current trends in 

commercial retail transaction processing 

and consistent with the FNS 5–Year 

Plan for Electronic Benefit Transfer 

(EBT). While the majority of State WIC 

agencies deliver benefits via paper 

checks or vouchers, 5 States are testing 

the feasibility of EBT and an additional 

State has adopted EBT statewide. These 

pilots are testing and evaluating the 

feasibility of smartcard and online 

technologies. By 2008, FNS hopes to 

identify national model(s) that are 

technically and financially viable for 

retail transaction processing for WIC 

EBT. 

Although it will take a number of 

years to implement WIC EBT fully in all 

States, the fruit and vegetable benefit 

may provide opportunities for 

alternative forms of benefit delivery and 

allow some States to move toward 

limited electronic benefit processing 

prior to the implementation of EBT for 

all WIC purchases. These solutions 

could provide participants with greater 

flexibility in redeeming benefits by 

allowing them to spread their purchases 

out across the month, although some 

solutions will likely prove prohibitively 

costly in relation to the cash value of the 

proposed benefit. FNS will explore the 

range of possibilities for using existing 

commercial infrastructure to administer 

the fruit and vegetable benefit including 

WIC EBT smartcard and online 

solutions as well as commercial debit 

cards and other technologies. 

FNS will assess the administrative 

burden, technical feasibility, advantages 

and costs of alternative approaches to 

delivering the cash value benefit for 

fruits and vegetables. We recognize that 

this benefit will pose challenges and 

added costs for the existing paper 

voucher and check system and that 

various technical approaches may also 

be costly and complicated to develop, 

implement, and operate. Since the 

implications of alternative solutions are 

likely to vary across State WIC agencies 

depending on their current participating 

vendor characteristics and benefit 

delivery systems, several different 

options may be needed to deliver the 

cash value benefit throughout the 

Program. FNS seeks to minimize the 

complexity and cost associated with 

administering this benefit and invites 


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comments and suggestions on 

alternative approaches and 

considerations. 

c. Farmers’ markets. The Department 

proposes to allow the State agency to 

authorize farmers at farmers’ markets to 

accept the WIC cash-value food 

instrument for fruits and vegetables. 

Such markets would have to meet 

vendor selection criteria specified at 

§ 246.12(g)(3) and would be subject to 

the vendor agreement requirements 

outlined in § 246.12(h)(3). 

F. Addition of Peanut Butter in Food 

Package V 

As recommended by the IOM, this 

proposed rule would add 18 ounces of 

peanut butter in Food Package V 

(currently § 246.10(c)(5)) to improve the 

intake of several nutrients, including 

iron, folate, Vitamin E, and fiber, in the 

diets of pregnant and breastfeeding 

women. At present, Food Package V 

allows peanut butter only as an 

alternative to dry beans and peas. 

G. Addition of Legumes in Food Package 

VI 

As recommended by the IOM, this 

proposed rule would add 1 pound of 

dried beans or peas or, as an alternative, 

18 ounces of peanut butter, to Food 

Package VI for postpartum women 

(currently § 246.10(c)(6)). Currently 

Food Package VI does not provide 

legumes of any kind. This addition 

would improve the intake of several 

nutrients, including iron, folate, 

Vitamin E, and fiber, in the diets of 

these participants. 

H. Addition of Canned Mature Legumes 

as an Optional Substitute for Dry 

Legumes in Food Packages III–VII 

As recommended by the IOM, this 

proposed rule would allow the 

substitution of canned mature beans/ 

peas for dry mature beans/peas in Food 

Packages III, IV, V, VI and VII (currently 

§ 246.10(c)(3) through (c)(7)). This 

substitution, currently authorized for 

homeless persons, would be allowed 

under this proposed rule to increase 

flexibility and variety in food choices 

for participants receiving Food Packages 

III–VII. 

1. Authorized Types of Canned Beans 

This proposed rule would allow any 

type of mature dry beans in canned 

form. Examples include but are not 

limited to black beans (‘‘turtle beans’’), 

blackeye peas (cowpeas of the blackeye 

variety, ‘‘cow beans’’), garbanzo beans 

(chickpeas), great northern beans, 

kidney beans, lima beans (‘‘butter 

beans’’), pinto beans, navy beans, 

soybeans, split peas, and lentils. Baked 

beans may be provided for participants 

with limited cooking facilities, at the 

State agency’s discretion. 

2. Restrictions on Authorized Types of 

Canned Beans 

This proposed rule would not 

authorize the following forms of canned 

beans: 

• Soups; 

• With the exception of baked beans, 

those containing added sugars, fats, 

meat or oils as purchased; 

• Immature varieties of legumes, such 

as those used in canned green peas, 

green beans, snap beans, orange beans, 

and wax beans; or 

• Baked beans with meat, e.g., beans 

and franks. 

3. Maximum Monthly Substitution Rate 

As recommended the by the IOM, this 

proposed rule would allow the 

substitution of 64 ounces (e.g., four 16- 

ounce cans) of canned mature beans/ 

peas for 1 pound of dry mature legumes 

in Food Packages III–VII. 

Although not addressed by IOM, the 

Department proposes to allow the 

following additional substitutions in 

Food Package V and VII: 

• 1 pound dry and 64 ounces of 

canned beans/peas (and no peanut 

butter) 

Or 

• 2 pounds dry or 128 ounces of 

canned beans/peas (and no peanut 

butter) 

Or 

• 36 ounces of peanut butter (and no 

beans). 

I. Addition of Whole Wheat Bread or 

Other Whole Grains to Food Packages 

III, IV, V, VII 

As recommended by the IOM, this 

proposal would add whole wheat bread 

or other whole grains for children and 

pregnant and breastfeeding women in 

Food Packages III, IV, V and VII 

(currently § 246.10(c)(3) through (c)(5), 

and (c)(7)). This addition responds to 

recommendations of the DGA 2005 (12)

to consume at least 3 servings per day 

of whole grains to reduce the risk of 

coronary heart disease and type 2 

diabetes, to help with body weight 

maintenance, and to increase intake of 

dietary fiber. 

1. Authorized Whole Grains 

This proposed rule would include any 

bread that conforms to the Food and 

Drug Administration (FDA) standard of 

identity for whole grain bread as 

defined by 21 CFR 136.180 or that meets 

labeling requirements for making a 

health claim as a ‘‘whole grain food 

with moderate fat content’’ as defined 

by FDA in its December 9, 2003, Health 

Claim Notification for Whole Grain 

Foods with Moderate Fat Content at 

http://www.cfsan.fda.gov/~dms/ 

flgrain2.html (e.g., must contain a 

minimum of 51% whole grains). 

Proposed allowable substitutions for 

whole grain bread would include brown 

rice, bulgur, oatmeal, and whole-grain 

barley without added sugars, fats, oils, 

or salt (i.e., sodium). Under this 

proposed rule, soft corn or whole wheat 

tortillas without added fats or oils 

would be allowed at the State agency’s 

option. Using the minimum 

requirements and specifications in 

proposed § 246.10(e)(12), State agencies 

would determine which types and 

brands of whole grain products to allow 

on State food lists. 

2. Maximum Monthly Allowance 

As recommended by the IOM, this 

proposed rule would allow 2 pounds of 

whole grain bread or other whole grain 

options for children in Food Packages III 

and IV; and 1 pound of whole grain 

bread or other whole grain options for 

women in Food Packages III, V and VII. 

J. Milk and Milk Alternatives 

As recommended by the IOM, this 

proposed rule would continue to 

provide milk in food packages for 

children and women (currently 

§ 246.10(c)(4) through (c)(7)) as an 

important and concentrated source of 

vitamin D and calcium. This proposed 

rule would also authorize State agencies 

to provide alternatives for milk for 

individuals with lactose maldigestion 

and for those who avoid milk for 

cultural, religious, or other reasons. To 

maintain the nutritional content and 

cost neutrality of the food packages, 

some alternatives for milk (i.e., calciumset tofu and cheese) would be allowed 

in limited amounts. 

1. Nomenclature 

This proposed rule uses terminology 

for fat-reduced milk products as 

required by FDA on labeling for milk 

and milk products (21 CFR 101.62), i.e., 

‘‘reduced fat’’ has two percent milk fat, 

‘‘low fat’’ has one percent milk fat, and 

‘‘nonfat’’ is skim or fat-free. The term 

‘‘fat-reduced’’ is used in this proposal to 

refer to all varieties with two percent or 

less milk fat. 

2. Authorized Milks 

As long as a milk conforms to the 

FDA standard of identity for milk as 

defined by 21 CFR Part 131 and meets 

WIC Federal requirements, it is an 

authorized milk in Food Packages IV, V, 

VI, and VII (currently § 246.10(c)(4) 

through (c)(7)). WIC regulations also 


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require that all authorized milks must 

be pasteurized and contain at least 400 

International Units of vitamin D per 

quart (100 IU per cup) and 2000 

International Units of vitamin A per 

quart (500 IU per cup). 

As recommended by the IOM, under 

this proposed rule, only whole milk (not 

less than 3.25% milk fat) is authorized 

for children less than 2 years of age in 

Food Package IV (currently 

§ 246.10(c)(4)). For children two years of 

age and older and women (adolescent 

and adult) in Food Packages IV, V, VI, 

and VII (currently § 246.10(c)(4) through 

(c)(7)), this proposed rule would 

authorize only milk with no more than 

2% milk fat. 

3. Maximum Monthly Milk Allowances 

The current maximum monthly 

allowances provide about 3.2 cups of 

milk a day for children and postpartum 

women and about 3.7 cups a day for 

pregnant and all breastfeeding women. 

As recommended by the IOM, this 

proposed rule would decrease the 

maximum monthly allowances for milk 

in all food packages. Reducing the 

amount of milk provided through WIC 

is consistent with recommended limits 

on saturated fat, total fat, and 

cholesterol consumption put forth in the 

DGA 2005 (12). According to the IOM, 

amounts of milk provided by the WIC 

food packages need not exceed amounts 

recommended by DGA 2005 (12). 

Therefore, this proposed rule would 

reduce the maximum monthly milk 

allowances for children 1 through 5 

years and postpartum women from 24 

quarts to 16 quarts, which would 

provide 2.1 cups per day. This proposed 

rule would reduce the maximum 

monthly milk allowances for pregnant 

and partially breastfeeding women from 

28 to 22 quarts of milk (2.9 cups per 

day); and would reduce the maximum 

monthly milk allowances for fully 

breastfeeding women from 28 quarts to 

24 quarts of milk (3.2 cups per day). 

a. Substitution rates of evaporated 

milk. This proposed rule would change 

the substitution rate of evaporated milk 

for fluid milk in Food Packages IV, V, 

VI, and VII (currently § 246.10(c)(4) 

through (c)(7)). The current substitution 

rate is 13 fluid ounces of evaporated 

milk (or 26 fl. oz. reconstituted 

evaporated milk) per quart (or 32 fl. oz.) 

of fluid milk. This proposal would 

increase the substitution rate to 16 fluid 

ounces of evaporated milk per 32 fluid 

ounces of fluid milk or a 1:2 fluid ounce 

substitution ratio. This is based on a 

dilution rate of equal parts evaporated 

milk and water (i.e., 12 oz. can 

evaporated milk + 12 oz. water = 24 oz. 

reconstituted milk) and would ensure 

that participants issued evaporated milk 

would receive the same maximum 

monthly allowance of milk 

(reconstituted) as those issued fluid 

milk . The substitution rate is the same 

for both evaporated whole and 

evaporated fat reduced milks. When a 

combination of different milk physical 

forms (e.g., fluid plus evaporated) is 

provided, State agencies would have to 

ensure that the full maximum monthly 

allowances for milk are issued in Food 

Packages IV through VII. 

b. Substitution rates of dry milks. This 

proposed rule would change how the 

substitution rates of dry milks for fluid 

milk issued in Food Packages IV, V, VI, 

and VII (§ 246.10(c)(4) through (c)(7)) 

are expressed. Currently the rates are 

stated as: 

• 1 pound of nonfat or lowfat dry 

milk per 5 quarts of fluid whole milk; 

or 

• 1 pound of dry whole milk per 3 

quarts of fluid whole milk. 

The Department proposes to express 

the new substitution rates in terms of 

reconstituted fluid ounce yields of dry 

milk to make it easier for State agencies 

to calculate the amount of dry milk to 

substitute for fluid milk. Although the 

container sizes commonly available for 

dry milks vary in weight, the 

reconstituted yields are consistent with 

the substitution ratios of dry milk to 

fluid milk stated above. For example, a 

25.6 oz. box of nonfat dry milk 

reconstitutes to 8 quarts of fluid milk. 

This yield is consistent with the 1 

pound of nonfat dry milk per 5 quarts 

of fluid whole milk WIC substitution 

ratio. 

The proposed change will better 

accommodate the wide range of 

container sizes for dry milks now on the 

market and those that may be added in 

the future. When a combination of 

different milk physical forms (e.g., fluid 

plus nonfat dry) is provided, State 

agencies would have to ensure that the 

full maximum monthly milk allowances 

are issued in Food Packages IV–VII. 

4. Authorized Substitutions for Milk 

(Cheese, Tofu, Soy-Based Beverage) 

As recommended by the IOM to 

provide more flexibility for WIC State 

agencies and more variety and choice 

for WIC participants, this proposed rule 

would allow cheese to be substituted for 

milk for children at the rate of 1 pound 

of cheese per 3 quarts of milk. No more 

than 1 pound of cheese may be 

substituted for milk. State agencies 

could authorize, with medical 

documentation, amounts of cheese that 

exceed this substitution maximum for 

children in Food Package IV, up to the 

maximum allowance for fluid milk, in 

cases of lactose intolerance or other 

qualifying conditions. 

For women, this proposed rule would 

allow cheese or calcium-set tofu to be 

substituted at the rate of 1 pound of 

cheese per 3 quarts of milk or 1 pound 

of tofu per 1 quart of milk. A maximum 

of 4 quarts of milk can be substituted in 

this manner in Food Packages V and VI; 

however, no more than 1 pound of 

cheese may be substituted for milk. A 

maximum of 6 quarts of milk can be 

substituted in this manner in Food 

Package VII; therefore, a maximum of 

two pounds of cheese may be 

substituted for milk in Food Package 

VII. State agencies could authorize, with 

medical documentation, amounts of 

cheese or calcium-set tofu that exceed 

these substitution maximums, up to the 

maximum allowance for fluid milk, in 

cases of lactose intolerance or other 

qualifying conditions. 

This proposed rule would authorize 

soy-based beverage to be substituted for 

milk for women in Food Packages V, VI 

and VII at the rate of 1 quart of soybased beverage for 1 quart of milk up to 

the total maximum allowance of milk. 

Under this proposed rule, soy-based 

beverage and tofu are not allowed as 

substitutes for milk for children in Food 

Package IV without medical 

documentation. The qualifying 

conditions may include, but are not 

limited to, milk allergy, severe lactose 

maldigestion, and vegan diets. 

Requiring medical documentation 

ensures that a child’s medical provider 

is aware that the child may be at 

nutritional risk when milk is replaced 

by other foods. State agencies could 

authorize, with medical documentation, 

soy-based beverages to be substituted for 

milk for children in Food Package IV on 

a quart for quart basis up to the total 

maximum allowance of milk. Tofu may 

be substituted, with medical 

documentation, for milk for children in 

Food Package IV at the rate of 1 pound 

of tofu per 1 quart of milk up to the total 

maximum allowance of milk. 

a. Authorized cheese. This proposed 

rule would clarify that a cheese that is 

a blend of authorized WIC cheeses (any 

combination of domestically produced, 

made with 100% pasteurized milk, 

Monterey Jack, Colby, natural Cheddar, 

Swiss, Brick, Muenster, Provolone, partskim or whole Mozzarella, pasteurized 

American processed) is a WIC-eligible 

food. This proposed rule would clarify 

that cheeses that are labeled low, free, 

reduced, less, or light in the nutrients 

sodium, fat, or cholesterol are WICeligible. 

b. Authorized tofu. To be authorized, 

the tofu must be calcium-set (prepared 

with only calcium salts, e.g., calcium 


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sulfate), and may not contain added fats, 

sugars, oils or sodium. Under this 

proposed rule, tofu is not allowed as a 

substitute for milk for children in Food 

Package IV without medical 

documentation. 

c. Authorized soy-based beverages. 

Section 102 of the Child Nutrition and 

WIC Reauthorization Act of 2004 

(Public Law 108–265) requires that 

nondairy beverages offered as an 

alternative to fluid milk in the National 

School Lunch Program and School 

Breakfast Program must be nutritionally 

equivalent to fluid milk and meet 

nutritional standards set by the 

Secretary of Agriculture. FNS believes 

that it is imperative for WIC and the 

school nutrition programs to use the 

same standards for defining allowable 

soy-based beverages as alternatives to 

fluid milk. In setting minimum 

nutritional standards for soy-based 

beverages, FNS considered the IOM 

recommendations and Food and Drug 

Administration (FDA) standards, and 

examined the nutrient levels found in 

various types of milk using the Nutrient 

Database for Dietary Studies. (20) IOM 

recommended allowing as milk 

alternatives only soy-based beverages 

that are fortified to contain nutrients in 

amounts similar to cow’s milk. The IOM 

also recommended minimum levels per 

cup of 300 mg calcium and 120 

International Units (IU) vitamin D. FDA, 

at 21 CFR Part 131, specifies that if 

added, milk should provide not less 

than 2000 IU vitamin A per quart (500 

IU per cup) and 400 IU vitamin D per 

quart (100 mg per cup.) Among the 

varieties of fluid milk, whole milk 

(3.25% milkfat) typically provides the 

lowest levels of several nutrients. Since 

soy beverage may be allowed as a 

substitute for milk over a variety of fat 

content levels, a single, broadly 

applicable standard is needed. Further, 

FNS believes that the statutory 

requirement of Public Law 108–265 for 

nutritional equivalency takes 

precedence over the IOM 

recommendations for WIC. Therefore, 

whole milk was used as a benchmark for 

all nutrients except vitamins A and D, 

which already have Federallyestablished standards for fortification of 

fluid milk. The chosen levels of 

vitamins A and D derive from the milk 

fortification levels required by the FDA. 

Based on the above, this rule proposes 

that authorized soy-based beverages 

provide, at a minimum, the following 

nutrients: 

Per cup 

Calcium ..................... 276 milligrams (mg). 

Protein ....................... 8 grams. 

Per cup 

Vitamin A ................... 500 International 

Units (IU). 

Vitamin D .................. 100 IU. 

Magnesium ................ 24 mg. 

Phosphorus ............... 222 mg. 

Potassium ................. 349 mg. 

Riboflavin .................. 0.44 mg. 

Vitamin B12 ............... 1.1 mcg. 

K. Cereal (for Women and Children) 

1. Nomenclature 

This proposed rule would adopt the 

term ‘‘breakfast cereal’’ as a substitute 

for the terms ‘‘cereal (hot or cold)’’ and 

‘‘adult cereal (hot or cold)’’ currently 

used in § 246.10(c). FDA regulations (21 

CFR 170.3(n)(4)) define breakfast cereals 

as those including ready-to-eat and 

instant and regular hot cereals. This 

term is consistent with USDA’s longstanding interpretation of WIC cereals 

(hot or cold) as meaning breakfast 

cereals that are either ready-to-eat or 

those cereals (e.g., oatmeal, grits, cream 

of wheat) that require the addition of a 

liquid (e.g., water or milk) and heating 

or cooking before being served. 

2. Authorized Cereals 

As recommended by the IOM, this 

proposal would add new minimum 

requirements for WIC breakfast cereals 

in Food Packages III, IV, V, VI, and VII 

(currently § 246.10(c)(3) through (c)(7)). 

To address current dietary guidance to 

increase whole grains and lower 

saturated fat and cholesterol, proposed 

authorized WIC breakfast cereals must 

meet labeling requirements for making a 

health claim as a ‘‘whole grain food 

with moderate fat content’’ as defined 

by FDA in its December 9, 2003, 

‘‘Health Claim Notification for Whole 

Grain Foods with Moderate Fat 

Content’’ at http://www.cfsan.fda.gov/ 

dms/flgrain2.html (e.g., must contain a 

minimum of 51% whole grains). In 

addition, all authorized WIC breakfast 

cereals must continue to contain a 

minimum of 28 mg per iron per 100 

grams of dry cereal and not more than 

21.2 grams of sucrose and other sugars 

per 100 grams of dry cereal (6 grams per 

dry ounce). In Food Package III, infant 

cereal may be substituted for breakfast 

cereal for children and women. 

L. Eggs 

This proposed rule would change the 

maximum monthly allowance for fresh 

shell eggs from the current 2 or 21⁄2 to 

1 dozen fresh shell eggs for children and 

women in Food Packages IV, V, and VI. 

This recommendation is consistent with 

recommendations of the IOM (8) and the 

DGA 2005 (12) to reduce cholesterol. In 

addition, the IOM determined that 

protein is no longer a priority nutrient 

for the WIC population. For fully 

breastfeeding women in Food Package 

VII, the maximum monthly allowance 

would be 2 dozen eggs. The quantity of 

eggs provided by the revised packages is 

comparable with the average amount of 

eggs consumed by children who are 

participating in the WIC Program. (21)

This proposed rule would allow the 

substitution of pasteurized liquid whole 

eggs, or dried egg mix for fresh shell 

eggs in these same food packages on an 

equivalent yield ready to eat versus 

weight or volume basis to accommodate 

differences among brands of these egg 

products. The proposed rule would 

authorize hard boiled eggs, where 

readily available for purchase in small 

quantities, for homeless participants. 

M. Canned Fish 

As recommended by the IOM, this 

proposed rule would authorize 30 

ounces of a variety of canned fish that 

do not pose a mercury hazard, as 

identified by federal advisories of the 

Food and Drug Administration and the 

U.S. Environmental Protection Agency, 

(22) in Food Package VII for fully 

breastfeeding women (currently 

§ 246.10(c)(7)). For ease of 

administration by State agencies, to 

accommodate participant preferences, 

and to minimize intake of mercury, this 

proposed rule would authorize the 

following varieties of canned fish—light 

tuna, salmon, and sardines. The 

Department seeks comments on 

additional canned fish to offer in Food 

Package VII. This proposed rule would 

clarify that fish packaged in foil bags 

(‘‘pouches’’) are WIC-eligible. 

N. Juice 

This proposed rule would clarify that 

authorized juices must be 100 percent 

unsweetened fruit/vegetable juice or 

blends of these juices, and contain a 

minimum of 30 milligrams of vitamin C 

per 100 milliliters of juice. This 

proposed rule would clarify that juices 

that are fortified with other nutrients 

may be allowed at the State agency’s 

option. This proposed rule would also 

require that juices be pasteurized. 

The Department acknowledges that 

100 percent citrus juices (i.e., orange, 

grapefruit, tangerine and blends of these 

juices) should naturally contain at least 

30 milligrams of vitamin C per 100 

milliliters of juice. To ease the 

administrative burden on State agencies 

in approving juices, this proposed rule 

would not require the verification of 

vitamin C content for 100 percent citrus 

juices. However, verification of vitamin 

C content for non-citrus juices would be 

a requirement. 


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44802 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

As recommended by the IOM, this 

proposed rule would change the 

maximum monthly allowance of juice 

for women and children in Food 

Packages IV, V, VI, and VII (currently 

§ 246.10(c)(4) through (c)(7)). For 

children in Food Packages III and IV, 

the proposed maximum monthly 

allowance of juice is 128 fluid ounces of 

single strength juice (4.3 fluid ounces 

per day). For pregnant and partially 

breastfeeding women in Food Package V 

and fully breastfeeding women in Food 

Package VII, the proposed maximum 

monthly allowance of juice is 144 fluid 

ounces (4.8 fluid ounces per day). For 

postpartum women in Food Package VI, 

the proposed maximum monthly 

allowance of juice is 96 fluid ounces 

(3.2 fluid ounces per day). 

In its Report, the IOM states that 

deleting or reducing the quantity of 

juice in the WIC food packages helps 

allow for the inclusion of whole fruits 

and vegetables while containing food 

costs. The reduction in the amount of 

juice provided for children to about 4 

ounces per day is consistent with the 

AAP recommendation for that age 

group. (14) The AAP also notes that juice 

does not provide any additional 

nutritional benefit beyond that of whole 

fruit. The reduced amount of juice for 

women is consistent with the 

recommendation of the DGA 2005 (12)

that whole fruits be used for a majority 

of the total daily amount of fruit. 

In Food Packages III, IV, V, VI and VII, 

this proposed rule would allow the 

substitution of shelf-stable and frozen 

concentrated juices for single strength 

juice. The proposed rule would allow 

combinations of single strength and 

concentrated juices provided that the 

total volume does not exceed the 

maximum monthly allowance for singlestrength juice. 

O. Peanut Butter 

This proposed rule clarifies that 

reduced fat peanut butter is an optional 

alternative for regular peanut butter in 

Food Packages III, IV, V, VI and VII 

(currently § 246.10(c)(3) through (c)(7)) 

provided that it meets the FDA standard 

of identity for peanut butter as defined 

by 21 CFR 164.150. That is, it must 

contain 90 percent peanuts by weight, 

contain no more than 10 percent by 

weight of seasonings and stabilizing 

ingredients, and contain no more than 

55 percent of fat by weight. 

P. Revisions in Food Package III and 

Their Effect on Food Packages I and II 

Food Package III (currently 

§ 246.10(c)(3)) was initially designed for 

women and children with special 

dietary needs. The IOM recommended 

that this unique aspect of Food Package 

III be retained; however, it 

recommended that infants with 

qualifying conditions be assigned to this 

food package to facilitate efficient 

management and tracking of the benefits 

and costs of providing supplemental 

foods to these participants. The IOM 

also recommended that the foods 

contained in Food Package III be 

restrictive only to the extent dictated by 

the participant?s health condition. This 

rule proposes these recommendations 

and, in addition, certain technical 

adjustments found necessary by the 

Department. 

This rule proposes the following 

changes in Food Package III: 

• Adds medically fragile infants to 

the population served; 

• Revises the maximum monthly 

allowances for WIC formulas; 

• Clarifies the purpose and the 

qualifying conditions that it serves; 

• Includes other WIC food(s), when 

not medically contraindicated, up to the 

same maximum monthly allowance 

authorized for Food Packages II, and IV 

through VII; and 

• Clarifies the physical forms of 

authorized WIC-eligible medical foods. 

Over the years the Department has 

received numerous requests from WIC 

State agencies, advocates and 

participants to revise this food package 

to better meet the needs of the medically 

fragile. The Department recognizes that 

this nutritionally vulnerable segment of 

the nation’s population has very special 

needs and WIC can assist in helping to 

address many of those nutritional needs. 

Some participants issued this food 

package may require a type of formula 

for which there is no substitute and 

their health would be seriously 

jeopardized if they did not receive this 

food package. 

The Department is proposing to revise 

Food Package III to serve all medically 

fragile WIC participants under the same 

food package and to include other 

supplemental foods when not medically 

contraindicated. The Department 

estimates that the current subgroup of 

participants who have medical 

conditions to receive Food Package III is 

only about 1–2 percent of the total WIC 

caseload. The inclusion of other 

supplemental foods in this food package 

would provide flexibility in 

accommodating the wide range of 

different nutritional needs of the 

participants served by this food 

package. 

1. Categories of Participants Served by 

Food Package III 

Food Package III (currently 

§ 246.10(c)(3)) serves only women and 

children who have a diagnosed medical 

condition when the use of conventional 

foods is precluded, restricted or 

inadequate to meet their nutritional 

needs. These medical conditions 

include, but are not limited to, 

metabolic disorders, inborn errors of 

amino acid metabolism, gastrointestinal 

disorders, malabsorption syndromes 

and food allergies. 

Infants with qualifying medical 

conditions currently receive either Food 

Package I, which serves infants 0–3 

months of age, or Food Package II for 

infants 4–12 months of age. These 

infants have the same diagnosed 

medical condition(s) cited for women 

and children who currently receive 

Food Package III. 

The Department is proposing to revise 

§ 246.10(c)(1) through (c)(3) of Program 

regulations for Food Packages I, II and 

III in order to serve all medically fragile 

participants with qualifying conditions, 

including infants, with Food Package III. 

The revised title for this food package 

would be ‘‘Food Package III—

Participants With Qualifying 

Conditions’’. Under revised Food 

Package III, infants would receive 

exempt infant formula and appropriate 

supplemental foods for the age and 

feeding option of the infant, when not 

medically contraindicated; children and 

adults would receive WIC formula 

(WIC-eligible infant formula, exempt 

infant formula, or WIC-eligible medical 

food) and appropriate supplemental 

foods, when not medically 

contraindicated. 

Infants who do not have a qualifying 

condition to receive exempt infant 

formula in Food Package III would 

continue to be served either under Food 

Package I or II, as deemed appropriate 

for their age and feeding option. Both 

Food Packages I and II would continue 

to authorize a variety of WIC-eligible 

infant formulas, consistent with Federal 

WIC regulations, State agency policies 

and authorization, and infant formula 

rebate contract agreements with 

manufacturers. 

2. Qualifying Conditions Under Food 

Package III 

The Department is aware that in the 

past some State agencies have 

experienced difficulty in determining 

which medical conditions qualify under 

Food Package III. For these reasons, this 

proposed rule would clarify the types of 

conditions that would qualify 

participants as medically fragile 

participants eligible to receive Food 

Package III. Food Package III would be 

reserved for participants who have one 

or more qualifying conditions and, as a 

result of the qualifying condition, 


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require a WIC formula (infant formula, 

exempt infant formula or WIC-eligible 

medical food) to supplement their 

nutrition needs as determined by the 

participant?s health care professional 

who is licensed to write medical 

prescriptions under State law. The WIC 

formulas prescribed in this food package 

provide nutritional support for specific 

conditions that are clinically serious or 

life-threatening and are generally 

required for long periods of time. The 

qualifying conditions include but are 

not limited to premature birth, low birth 

weight, failure to thrive, inborn errors of 

metabolism and metabolic disorders, 

gastrointestinal disorders, 

malabsorption syndromes, immune 

system disorders, severe food allergies 

that require an elemental formula, and 

life threatening disorders, diseases and 

medical conditions that impair 

ingestion, digestion, absorption or the 

utilization of nutrients that could 

adversely affect the participant?s 

nutrition status. 

3. Restricted Uses of Food Package III 

Under this proposed rule, Food 

Package III would not be authorized for 

infants whose only condition is: 

• A diagnosed formula intolerance or 

food allergy to lactose, sucrose, milk 

protein, or soy protein that does not 

require the use of an exempt infant 

formula; or 

• A non-specific formula or food 

intolerance. 

Infants with these infant formula 

intolerances or food allergies would not 

receive revised Food Package III but 

instead would receive either revised 

Food Package I or II based on age and 

feeding option, as described in section 

V.B. of this preamble. Food Package I 

and II have collectively provided infant 

formulas that are soy-based, lactose-free, 

or sucrose-free to accommodate most 

food intolerances or food allergies. 

While commercially available infant 

formulas in the United States may vary 

by containing different ingredients to 

address such intolerances and allergies, 

these infant formulas are still 

considered to be infant formulas (as 

opposed to exempt infant formulas) as 

long as the definition and requirements 

of § 246.2 are met. Therefore, Food 

Packages I and II would continue to 

authorize a variety of infant formulas, 

consistent with State agency policies 

and infant formula rebate contract 

agreements with manufacturers for 

infants with food intolerances and/or 

food allergies who do not have 

qualifying conditions in order to receive 

exempt infant formulas. 

Proposed Food Package III would not 

be authorized for a child or woman with 

a non-qualifying condition, such as a 

food dislike, or food intolerance (i.e. 

lactose intolerance) or a suspected but 

unconfirmed allergy (i.e. milk protein 

allergy). Currently other supplemental 

foods, such as cheese and lactose-free 

milk, are available and encouraged to 

address lactose intolerance. Proposed 

food packages IV–VII , described in 

sections V.C. and V.D. of this preamble, 

include new foods as substitutes or 

alternatives to milk, such as soy-based 

beverage and calcium-set tofu, that may 

provide more flexibility to the State and 

the participant, may be easier to obtain 

in retail establishments, and may be 

more appropriate to meet the nutritional 

needs of the participants who do not 

have a qualifying condition. The use of 

conventional foods when appropriate is 

important due to the additional 

nutrients, fiber and other benefits that 

conventional foods provide. WIC 

nutrition education supports the 

importance of obtaining nutrients from 

foods when appropriate and that a 

balanced diet remains the preferred 

overall source of nutrients. 

4. Authorized Foods in Food Package III 

Section 246.10(c)(3) of current 

regulations lists the authorized foods for 

children and women receiving Food 

Package III as WIC formula (infant 

formula, exempt infant formula and 

WIC-eligible medical foods), cereal and 

juice. As recommended by the IOM, this 

proposed rule would expand the WIC 

food categories offered in Food Package 

III of WIC formula, cereal and juice by 

adding milk and milk alternatives, fruits 

and vegetables, eggs, whole wheat 

bread, legumes and/or peanut butter, 

cheese, fish and infant foods, as 

medically appropriate and prescribed. 

Exempt infant formula would be the 

only WIC formula authorized for infants 

in revised Food Package III. Infant 

formula, exempt infant formula and 

WIC-eligible medical foods would be 

authorized for children and women in 

revised Food Package III. 

5. Authorized WIC Formulas 

Current authorized WIC formulas 

(infant formulas, exempt infant 

formulas, and WIC-eligible medical 

foods) are defined in § 246.2 of WIC 

regulations. 

WIC formulas are generally described 

as follows: 

• Infant formulas are food substitutes 

for human milk for generally healthy, 

full-term infants; 

• Exempt infant formulas are food 

substitutes for human milk for both preterm or full-term infants who have a 

nutritionally-related medical problem; 

and 

• WIC-eligible medical foods are 

specifically formulated to provide 

nutritional support for participants with 

a diagnosed medical condition. 

The Department proposes to revise 

the existing definition for ‘‘WIC-eligible 

medical foods’’ in § 246.2 to clarify that 

medical foods are designed for children 

(12 months and older) and adults. 

Infants served under Food Package III 

cannot receive WIC-eligible medical 

foods. 

6. Products Not Authorized as WIC 

Formulas 

Products not authorized as WIC 

formulas or foods in Food Package III or 

any other food package include, but are 

not limited to: 

• Medicines or drugs, as defined and 

regulated under the Food, Drug and 

Cosmetic Act (21 U.S.C. 301 et seq.), as 

amended; 

• Parenteral or intravenous nutrition 

products; 

• Enzymes; 

• Flavoring and thickening agents; 

• Oral rehydration fluids or 

electrolyte solutions; 

• Sports or breakfast drinks; and 

• Over-the-counter weight control/ 

loss products. 

In addition, all apparatus or devices 

(e.g., feeding tubes, bags and pumps) 

designed to administer WIC formulas 

are not WIC-allowable costs. 

7. Physical Forms of WIC Formulas 

a. Current Physical Forms. WIC 

regulations for Food Packages I, II and 

III (§ 246.10(c)(1) through (c)(3)) identify 

the three physical forms of WIC 

formulas as concentrated liquid, powder 

and ready-to-feed (RTF) in liquid form. 

b. Ready to Feed in Other Than Liquid 

Forms. New formulas and medical foods 

have been developed due to 

advancements in technology and these 

products do not strictly conform to the 

current physical form descriptions. 

While different forms of infant formula 

and exempt infant formula could be 

developed, it is anticipated that the 

largest variety of physical forms will be 

within the WIC-eligible medical foods 

category. The forms of WIC-eligible 

medical foods currently available 

include, but are not limited to, ready-tofeed bars, ready-to-eat puddings, and 

gels and capsules specifically designed 

for inborn errors of metabolism. The 

Department has determined that some of 

these products meet the minimum 

Federal WIC requirements for a WICeligible medical food, however the 

technical guidance regarding how to 

determine maximum monthly 

allowances is being considered in light 

of the IOM report recommendations that 


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powder and ready-to-feed forms may be 

substituted for liquid concentrate on an 

equivalent nutritional basis. Inclusion of 

these additional forms of WIC-eligible 

medical foods into Federal WIC 

regulations and their appropriate 

maximum monthly allowances would 

increase flexibility for State agencies to 

help meet the nutritional needs of the 

medically fragile participant. FNS is 

seeking comments on the appropriate 

equivalent standard to be used (e.g., 

protein equivalent, kilocalorie 

equivalent, volumetric or weight 

equivalent, number of serving 

equivalents, and/or other type of 

equivalent) to determine maximum 

monthly allowances for WIC-eligible 

medical foods in these new physical 

forms (e.g., bars, gels, and capsules) for 

those medically fragile participants 

served by Food Package III. Comments 

are also requested regarding how to 

determine maximum monthly 

allowances for WIC-eligible medical 

foods prescribed to children and women 

that are only available in ready-to-feed 

forms such as capsules or gels and 

therefore the liquid concentrate 

equivalent does not exist. 

c. Restrictions for Issuing RTF Forms 

of WIC Formulas. Current regulations 

(§ 246.10(c)(1)(ii)) governing Food 

Packages I and II restrict the issuance of 

WIC formulas in RTF liquid form to 

only the following conditions: 

• The participant’s household has an 

unsanitary or restricted water supply or 

poor refrigeration. 

• The participant or person caring for 

the participant may have difficulty in 

correctly diluting concentrated forms or 

reconstituting powder forms, or the WIC 

formula is only available in RTF form. 

This proposed rule would continue to 

include these same restrictions for 

issuing a WIC formula in a RTF form 

issued under revised Food Package III. 

However, recognizing the needs of 

participants with qualifying conditions, 

this proposed rule would expand upon 

these restrictions to also authorize a 

RTF form in Food Package III when the 

product: 

• Better accommodates the 

participant’s medical condition (e.g., 

RTF semi-solids for swallowing 

disorders and RTF forms to reduce the 

possibility of food contamination and 

risk of infection in cases of immune 

system disorders); or 

• Improves the participant’s 

compliance in consuming the 

prescribed formula (e.g., improved taste 

of RTF solid bars versus RTF liquid 

forms of WIC-eligible medical foods). 

This proposed rule would continue to 

authorize the WIC local agency 

competent professional authority, in 

consultation with the participant’s 

attending health care provider when 

appropriate, to determine and document 

if a WIC formula in a RTF form is 

required. 

8. Maximum Monthly Allowances for 

Food Package III 

As recommended by the IOM, this 

proposed rule would revise Food 

Package III to serve medically fragile 

women, infants and children with 

qualifying conditions. These 

participants would receive up to the 

same maximum monthly amounts of 

supplemental foods unless medically 

contraindicated, as those same 

participant categories (infants, children, 

pregnant or partially breastfeeding 

women, non-breastfeeding postpartum 

women, and fully breastfeeding women) 

who do not have a qualifying condition. 

a. Infants, ages birth through 11 

months. Infants with a qualifying 

condition would receive exempt infant 

formula and infant foods in up to the 

same maximum monthly allowances as 

infants of the same age and feeding 

option with no qualifying condition 

who are issued Food Packages I or II 

unless medically contraindicated. 

b. Children, ages 1 year through 4 

years. A child with a qualifying 

condition would receive up to 455 fluid 

ounces in liquid concentrate form of 

WIC Formula (infant formula, exempt 

infant formula, or WIC-eligible medical 

food). Formulas in other forms, such as 

powder or RTF could be substituted by 

providing nutritional equivalent 

amounts. Unless medically 

contraindicated, the participant may 

receive any or all of the following 

supplemental foods in up to the 

maximum monthly amounts with 

medical documentation—milk and milk 

alternatives, juice, breakfast cereal (hot 

or cold), eggs, fruits and vegetables, 

whole wheat bread or other whole 

grains, legumes, or peanut butter. 

c. Pregnant or partially breastfeeding. 

A pregnant, or partially breastfeeding 

woman, whose participating infant 

receives formula in amounts that do not 

exceed the maximum allowances 

provided by Food Packages I or II for 

partially breastfeeding infants, as 

appropriate for the age of the infant, and 

who has a documented qualifying 

condition would receive up to 455 fluid 

ounces in liquid concentrate form of 

WIC Formula (infant formula, exempt 

infant formula, or WIC-eligible medical 

food). Formulas in other forms, such as 

powder or RTF could be substituted by 

providing nutritional equivalent 

amounts. Unless medically 

contraindicated, the participant may 

receive any or all of the following 

supplemental foods up to the maximum 

monthly amounts with medical 

documentation—milk and milk 

alternatives, juice, breakfast cereal (hot 

or cold), eggs, fruits and vegetables, 

whole wheat bread or other whole 

grains, legumes, and peanut butter. 

d. Postpartum. A non-breastfeeding 

postpartum woman (up to 6 months 

postpartum) or a breastfeeding 

postpartum woman (up to 6 months 

postpartum) whose partially breastfed 

infant receives formula in amounts that 

exceed the maximum allowances 

provided by Food Packages I or II for 

partially breastfeeding infants, as 

appropriate for the age of the infant, and 

who has a documented qualifying 

condition would receive up to 455 fluid 

ounces in liquid concentrate form of 

WIC Formula (infant formula, exempt 

infant formula or WIC-eligible medical 

food). Formulas in other forms, such as 

powder or RTF, could be substituted by 

providing nutritional equivalent 

amounts. Unless medically 

contraindicated, the participant may 

receive any or all of the following 

supplemental foods up to the maximum 

monthly amounts with medical 

documentation—milk and milk 

alternatives, juice, breakfast cereal (hot 

or cold), eggs, fruits and vegetables, 

legumes, or peanut butter. 

e. Fully breastfeeding. A fully 

breastfeeding woman (up to 1 year 

postpartum) whose infant does not 

receive formula from WIC; all 

breastfeeding women during the first 

month postpartum; women pregnant 

with two or more fetuses; and women 

partially breastfeeding multiple infants 

(up to 1 year postpartum) with a 

qualifying condition would receive up 

to 455 fluid ounces in liquid 

concentrate form of WIC Formula 

(infant formula, exempt infant formula, 

or WIC-eligible medical food). Formulas 

in other forms, such as powder or RTF, 

could be substituted by providing 

nutritional equivalent amounts. Unless 

medically contraindicated, the 

participant may receive any or all of the 

following supplemental foods up to the 

maximum monthly amounts with 

medical documentation—milk and milk 

alternatives, juice, breakfast cereal (hot 

or cold), cheese, eggs, fruits and 

vegetables, whole wheat bread or other 

whole grains, fish (canned), legumes, 

and peanut butter. Women fully 

breastfeeding multiple infants (up to 1 

year postpartum) with a qualifying 

condition would be prescribed 1.5 times 

the maximum amounts of supplemental 

foods provided by Food Package III with 

medical documentation. 

The Department recognizes that the 

types of qualifying conditions 


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warranting Food Package III are varied 

and can impose different dietary 

restrictions on participants. For 

example, the presence of an inborn error 

of amino acid metabolism, such as 

phenylketonuria, known as PKU, would 

severely limit the types of traditional 

foods a participant could have, 

especially those high in protein. For 

these participants, the maximum 

monthly allowances of a WIC formula 

may be warranted to meet their special 

protein needs, but some of the food 

categories of the other allowable 

supplemental foods (e.g., eggs, legumes 

and fish) may be medically prohibited. 

The combination of WIC food options 

made available under revised Food 

Package III would provide flexibility in 

accommodating the wide range of 

different nutritional needs of the 

participants served by this food 

package. 

9. Coordination with Other Programs 

That Provide or Reimburse for Formulas 

This proposal would require WIC 

State agencies to coordinate with other 

Federal, State, or local government 

agencies or with private agencies that 

operate programs that also provide or 

reimburse, or could provide or 

reimburse, for exempt infant formula 

and WIC-eligible medical food benefits 

that may be authorized by WIC State 

agencies. 

Such coordination recognizes that 

WIC participants could fully participate 

in and benefit from other assistance 

programs. At a minimum, WIC State 

agencies would be required to 

coordinate with the Medicaid Program 

regarding the provision of exempt infant 

formulas and WIC-eligible medical 

foods prescribed for WIC participants 

who are also Medicaid recipients. The 

WIC State agency would be responsible 

for providing up to the maximum 

amount of exempt infant formulas and 

WIC-eligible medical foods under Food 

Package III in situations where 

reimbursement is not provided by 

another entity. 

In coordinating with programs on the 

provision of WIC-authorized exempt 

infant formulas and WIC-eligible 

medical foods, the Department strongly 

encourages WIC State agencies to: 

• Become knowledgeable of the 

participant eligibility criteria for 

receiving exempt infant formula and 

WIC-eligible medical foods benefits 

from other programs; 

• Implement a formula agreement or 

memorandum of understanding with 

these other programs to share the 

responsibility of meeting the exempt 

infant formula and WIC-eligible medical 

foods need of mutual participants; 

• Establish policies and procedures 

for issuing exempt infant formulas and 

WIC-eligible medical foods to WIC 

participants who are able to meet any 

portion of their exempt infant formula 

and WIC-eligible medical foods needs 

through these other programs; and 

• Assist WIC participants in quickly 

obtaining from the other programs any 

exempt infant formula and WIC-eligible 

medical foods needs beyond the 

maximum monthly allowances that may 

be needed to meet the amount 

prescribed. 

10. Infant Cereal in Food Package III 

Longstanding policy has allowed 

infant cereal to be substituted for hot or 

cold cereal intended for children and 

adults in Food Packages III whenever 

infant cereal was needed to better meet 

participants’ nutritional needs due to 

qualifying conditions. However, this 

provision was never incorporated into 

regulatory language for these food 

packages. 

The iron content of infant cereal is 

higher and in a form that is better 

absorbed than the iron in adult cereal. 

In addition, infant cereal has a finer 

texture than adult cereal for easier 

swallowing. Therefore, women and 

children who have increased iron 

requirements, developmental delays, or 

swallowing disorders may benefit from 

receiving infant cereal in lieu of adult 

cereal. 

This rule proposes to authorize only 

in Food Package III the substitution of 

32 dry ounces of infant cereal for 36 dry 

ounces of adult cereal for children and 

women when the WIC competent 

professional authority or the supporting 

medical prescription documents that 

this provision is necessary. The 

Department believes that the vast 

majority of children and women who 

would require this cereal substitution 

would be served in Food Package III 

rather than the other food packages. 

Q. Medical Documentation and 

Supervision Requirements for Food 

Packages I through VII 

1. Current Requirements 

Federal WIC regulations at 

§ 246.10(c)(1)(iii)(A) through 

(c)(1)(iii)(D) require medical 

documentation for the issuance of any 

contract brand infant formula that does 

not meet the requirements of an iron 

fortified infant formula; any noncontract brand infant formula; any 

exempt infant formula; or any WICeligible medical food. The medical 

documentation is intended to verify that 

the participant has a medical condition 

that dictates the use of a WIC formula 

(infant formula, exempt infant formula 

or WIC-eligible medical food). The 

current medical documentation 

technical requirements 

(§ 246.10(c)(1)(v)(B)) are: 

• The brand name of the WIC formula 

prescribed; 

• Medical diagnosis warranting the 

WIC formula; 

• Length of time the prescribed WIC 

formula is medically required by the 

participant; and 

• The signature (or name, if the initial 

documentation was received by 

telephone) of the requesting health care 

provider. 

Medical documentation may be 

provided as an original written 

document, electronically, by facsimile 

or by telephone to the competent 

professional authority who must 

promptly document the information. 

However, the receipt of medical 

documentation by telephone may only 

be used when absolutely necessary on 

an individual participant basis to 

prevent undue hardship to a participant 

or to prevent a delay in the provision of 

infant formula that would place the 

participant at increased nutritional risk. 

Section 246.10(c)(1)(v)(B) of current 

WIC regulations requires that this 

information be documented in writing 

and kept on file at the WIC local clinic. 

Therefore, receipt of medical 

documentation via the telephone must 

be followed by written documentation. 

2. Proposed Requirements 

This proposed rule would continue to 

require medical documentation for any 

contract brand infant formula that does 

not meet the requirements of an infant 

formula as specified in Table 4 of 

§ 246.10(e)(12) of the proposed rule, any 

non-contract brand infant formula, any 

exempt infant formula, or any WICeligible medical food. In addition, 

medical documentation would be 

required for certain milk alternatives for 

children and women as described in 

section V.J. of this preamble and for any 

supplemental foods authorized in 

proposed Food Package III for 

participant’s with certain qualifying 

conditions as described in section V.P. 

of this preamble. In addition to retaining 

all of the current medical 

documentation requirements, this 

proposed rule would add the following 

requirements to medical documentation: 

• Contact information for the 

participant’s healthcare provider who 

makes the medical determination; 

• Date of medical determination; 

• Name of specific supplemental 

food(s) to be prescribed; 

• Amount prescribed per day; 


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• Medical determination of a 

qualifying condition which warrants the 

issuance of the specific supplemental 

food(s); and 

• Length of time the specific 

supplemental food(s) is medically 

required. 

All required medical documentation 

necessary for the issuance of 

supplemental foods including WIC 

formulas would continue to be received 

as an original written document, an 

electronic document, or received by 

facsimile or telephone and kept on file. 

This proposed rule would broaden the 

file requirement to allow electronic 

medical documentation files. 

Medical documentation requirements 

for specific supplemental foods that do 

not usually require a prescription in 

order to obtain the food(s) are 

established to ensure that the 

participant’s healthcare professional, 

licensed in the State to write 

prescriptions, has determined that the 

supplemental foods are not medically 

contraindicated by the participant’s 

condition. 

3. Roles of the State-Licensed Health 

Care Provider and WIC Competent 

Professional 

Due to the nature of the health 

conditions of participants who would 

receive Food Package III, close medical 

supervision is essential for each 

participant’s overall dietary 

management. The Department considers 

it appropriate that the responsibility for 

this close medical supervision remain 

with the participant’s health care 

provider. This proposed rule would 

consider it the responsibility of the WIC 

competent professional authority to 

ensure that only the amounts of WIC 

formula and supplemental foods up to 

the regulatory maximum amounts 

prescribed by the participant’s health 

care provider are issued in the 

participant’s food package. 

4. State Agency Guidance to Local 

Agencies 

The Department encourages State 

agencies to develop guidance for their 

local agencies and clinic sites, including 

but not limited to guidance in the 

State’s procedure manual, to use in 

assisting the participant to obtain the 

required medical documentation for 

receiving Food Package III or the milk 

alternatives for children and women in 

Food Packages IV–VII and for health 

care professionals in local communities. 

Such guidance should assist local 

agencies in identifying and 

understanding: 

• Qualifying conditions; 

• Maximum monthly allowances of 

WIC formula (meaning infant formula, 

exempt infant formula and WIC-eligible 

medical foods) and specific 

supplemental food(s) authorized; and 

• Related State agency policies and 

procedures for issuing WIC formulas 

and specific supplemental foods(s) that 

require medical documentation. 

State agencies are encouraged to 

develop a standardized form for health 

care professionals to use in prescribing 

Food Package III to help ensure that the 

WIC local clinics obtain the required 

medical documentation. 

R. Flexibility and Variety 

As recommended by the IOM, WIC 

State agencies are encouraged to allow 

as much variety and choice from the 

proposed authorized foods as is feasible 

considering cost constraints and 

availability. Providing more variety and 

choice will facilitate the tailoring of 

food packages to specific situations, 

especially for different ethnic or cultural 

groups. 

This rule proposes that State agencies 

make available to participants at least 

two fruits and two vegetables from the 

category of fruits and vegetables (fresh 

or processed) in each authorized food 

package. However, it is the 

Department’s expectation that more 

than two varieties each of fruits and 

vegetables be authorized by State 

agencies and encourages States to offer 

participants the widest variety of fruit 

and vegetable options practicable. This 

rule also proposes that State agencies 

make available to participants more 

than one food type from each WIC food 

category in each authorized food 

package, except for the categories of 

peanut butter and eggs. 

S. Cultural Food Package Proposals 

The IOM was charged with 

considering the cultural needs of WIC 

participants and its recommendations 

for revisions to the WIC food packages 

reflect those considerations. The IOM’s 

recommendations, as put forth in this 

proposed rule, include allowing 

participants a broad selection of fruits 

and vegetables, tofu and soy-based 

beverages as substitutes for milk, 

participant choice for whole grains 

(including tortillas), and salmon and 

sardines as substitutions for tuna. 

IOM’s recommendations, as largely 

put forth in this proposed rule, include 

those foods that State agencies and 

participants have requested over the 

years to accommodate cultural needs of 

participants. In addition, the IOM 

recommendations reflect those put forth 

in NWA’s Position Paper—‘‘NWA WIC 

Culturally Sensitive Food Prescription 

Recommendations.’’ (2) Developing, 

reviewing, and analyzing cultural food 

package proposals is a time consuming 

process for WIC State agencies and the 

Department. Because the increased 

variety and choice in the supplemental 

foods proposed in this rule will provide 

State agencies increased flexibility in 

prescribing culturally appropriate 

packages for diverse groups, the 

Department proposes to no longer 

consider WIC State agency proposals for 

cultural accommodations. While we 

acknowledge that the future 

demographics of WIC participants may 

change, WIC is a supplemental program, 

and is not intended to provide all of the 

foods that may meet cultural food 

preferences. Future reviews of the WIC 

food packages by the Department will be 

used to determine the need for 

additional cultural accommodations. 

T. General Provisions That Affect All 

WIC Food Packages 

1. State Authority to Determine Brands 

This rule would clarify that State 

agencies have the authority to establish 

additional criteria for WIC-authorized 

foods that exceed Federal requirements. 

These State criteria could address, but 

not be limited to: 

• Other nutritional standards; 

• Competitive cost; 

• State-wide availability; and 

• Participant appeal. 

2. Nutrition Tailoring 

Nutrition tailoring is a process of 

modifying the standard food package to 

better meet the supplemental nutrition 

needs of participants. Nutrition tailoring 

entails making changes or substitutions 

to food types (e.g., dry beans vs. peanut 

butter), physical food forms (e.g. dry 

milk vs. fluid milk), and to quantities of 

foods. 

Current FNS policy allows both 

categorical and individual nutrition 

tailoring of WIC food packages. 

Individual nutrition tailoring is based 

on the Competent Professional 

Authority’s assessment of the 

participant’s supplemental nutrition 

needs. Categorical nutrition tailoring for 

participant groups or subgroups with 

similar supplemental nutrition needs is 

based on scientific nutrition rationale 

and State established policies. 

According to the IOM, the proposed 

revised food packages have the potential 

to address current nutrient inadequacies 

and excesses; discrepancies between 

dietary intake and dietary guidance; and 

current and future health-related 

problems in WIC’s target population. 

The IOM recommends that the revised 

food packages be provided to each 


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participant in full, except to the extent 

that the packages are tailored to the 

needs of individual WIC participants. 

Therefore, this proposed rule would 

prohibit categorical nutrition tailoring, 

but continue to allow individual 

nutrition tailoring based on the 

Competent Professional Authority’s 

assessment of a participant’s 

supplemental nutrition needs. 

Provisions of less than the maximum 

monthly allowances of supplemental 

foods to an individual WIC participant 

would be appropriate when: 

• Medically or nutritionally 

warranted (e.g., to eliminate a food due 

to a food allergy); 

• A participant refuses or cannot use 

the supplemental foods; or 

• The quantities necessary to 

supplement another program’s 

contribution to fill a medical 

prescription would be less than the 

maximum monthly allowances. 

Consistent with current FNS policy, 

reductions in amounts of supplemental 

foods could not be made for costsavings, administrative convenience, 

caseload management, or to control 

vendor abuse. However, State agencies 

could continue to make administrative 

adjustments for economic purposes. 

Acceptable administrative adjustments 

decrease cost while maintaining the 

nutrition integrity of the food packages 

and include such decisions as 

eliminating expensive brands, 

packaging or physical forms of WIC 

supplemental foods. 

3. Homeless Participants 

This proposal clarifies that State 

agencies would continue to have the 

authority to make food package 

adjustments to better accommodate 

homeless participants. 

4. Individual Use by Participants 

The WIC food packages are individual 

food prescriptions that, in order to have 

the full effect on improving a 

participant’s nutritional status, are 

intended to be consumed only by the 

participant and not by other family 

members. 

5. Settings for Participant Use of 

Supplemental Foods 

Under this proposal, State or local 

agencies would have to advise 

participants that the supplemental foods 

issued are only for their personal use. 

Supplemental foods would not be 

authorized for participant use while 

hospitalized on an in-patient basis. In 

addition, consistent with 

§ 246.7(n)(1)(i)(B), supplemental foods 

would not be authorized for use in the 

preparation of meals served in a 

communal food service. This restriction 

would not preclude the provision or use 

of supplemental foods for an individual 

participant in a: 

• Non-residential setting (e.g., child 

care facility, family day care home, 

school, or other educational program); 

• Homeless facility; or 

• At the State agency’s discretion, a 

residential institution (e.g., home for 

pregnant teens, prison, or residential 

drug treatment center) that meets the 

requirements currently set forth in 

§ 246.7(n)(1) and (n)(2). 

U. Implementation of Revised Food 

Packages 

The proposed revisions to the WIC 

food packages will result in substantial 

changes to all aspects of program 

operations including management 

information systems, nutrition 

education and counseling, vendor 

authorization, training and 

management, and, breastfeeding 

promotion and support. 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 its report, the IOM identified 

certain proposed changes that were so 

significant that it recommended pilot 

testing or limited application of the 

changes before full-scale 

implementation by all State agencies. As 

such, the Department seeks comments 

on the following proposed 

implementation plan that is designed to 

address the IOM recommendation for 

testing of certain provisions while 

allowing State agencies sufficient time 

and broad flexibility to implement the 

majority of the food packages. 

1. Pregnant Women—The most 

significant changes to the food package 

for pregnant women include the 

addition of the $8.00 cash value voucher 

for fresh fruits and vegetables and whole 

wheat bread (or other whole grain 

options). Also, pregnant women may 

receive soy-based beverage or tofu in 

addition to cheese as a substitute for 

milk. The Department is proposing a 

one-year implementation timeframe for 

these changes. 

2. Postpartum Women—The primary 

changes to the food package for 

postpartum women include the addition 

of the $8.00 cash value voucher for fresh 

fruits and vegetables and the option to 

receive soy-based beverage or tofu in 

addition to cheese as a substitute for 

milk. The Department is proposing a 

one-year implementation timeframe for 

these changes. 

3. Breastfeeding Women—The 

proposed food package changes 

subdivide breastfeeding women as 

either fully breastfeeding or partially 

breastfeeding. For fully and partially 

breastfeeding women, the most 

substantial food package changes 

include the addition of the $8.00 cash 

value voucher for fresh fruits and 

vegetables and whole wheat bread (or 

other whole grain options). Also, fully 

and partially breastfeeding women may 

receive soy-based beverage or tofu in 

addition to cheese as a substitute for 

milk. Recognizing that the ‘‘fully 

breastfeeding woman’’ is likely to be the 

same individual who under the current 

food package system receives Food 

Package VII, the enhanced breastfeeding 

package, the Department believes that a 

one-year implementation timeframe for 

these changes is appropriate. 

For partially breastfeeding women, 

the IOM recommends changes that 

strengthen and support breastfeeding as 

the optimal infant feeding choice and 

that support WIC’s breastfeeding 

promotion efforts. However, the IOM 

was concerned about the impact of the 

food package changes that support and 

promote breastfeeding on the mother/ 

infant dyad, particularly not allowing 

partially breastfeeding status during the 

infant’s first month of life. While there 

is empirical evidence that shows early 

supplementation with infant formula is 

associated with shorter duration of 

breastfeeding, particularly exclusive 

breastfeeding, some mothers who might 

otherwise try breastfeeding may choose 

formula feeding to be sure they can 

obtain formula from WIC if they run 

into breastfeeding difficulties. 

Recognizing the potential impacts 

associated with proposed changes to the 

partially breastfeeding woman’s 

package, the Department is proposing to 

analyze and assess the proposed 

changes before proceeding to full 

implementation. The Department 

believes that an experimental design 

with random assignment of motherinfant dyads is impractical. Therefore, 

the Department proposes to limit to not 

more than 4 sites within up to eight 

State agencies (32 total local sites) the 

ability to implement the partially 

breastfeeding food package changes. 

After the Department has had an 

opportunity to examine the effects of the 

revised changes on the initiation and 

duration of breastfeeding (based on a 

comparison of the experiences in the 

test sites to comparison sites in the 

selected State agencies), the Department 

will determine when all State agencies 

can implement the revised partially 

breastfeeding women’s food package. 

The State agencies will be selected 

based on willingness and ability to 


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cooperate with evaluation data 

collection and design protocols 

(including identification of appropriate 

comparison sites for the 4 test sites 

within the State), past breastfeeding 

rates in the State (the Department 

proposes to seek a range of high, 

medium and low past breastfeeding 

rates), adequacy of the infrastructure in 

place to provide the necessary support 

to breastfeeding mothers (the 

Department proposes to seek both ‘‘best 

case’’ and ‘‘average case’’ levels of 

infrastructure), ability of the 

management information system to 

provide requested data on the impact of 

the food package changes, and diversity 

of the population to receive the new 

food package. 

4. Infants—The proposed food 

package changes subdivide infants as 

fully formula fed, fully breastfed or 

partially breastfed. In addition, the food 

packages for fully formula fed infants 

are designated as birth through 3 

months; 4 through 5 months; and 6 

through 11 months. The food packages 

for partially breastfed infants are 

designated as 1 through 3 months, 4 

through 5 months, and 6 through 11 

months. The infant food packages for 

fully breastfed infants are designated as 

birth through 5 months, and 6 through 

11 months. 

For the fully formula fed infant, the 

amount of infant formula has been 

reduced for the 6 through 11 month old. 

This reduction has been offset by the 

addition of infant food fruits and 

vegetables. However, the amount of 

infant formula has been increased for 

the 4 through 5 month old. Also, juice 

has been eliminated. The Department 

proposes a six-month timeframe to 

implement the elimination of juice and 

a one-year timeframe to implement the 

remaining changes in the fully formula 

fed package. 

For the partially breastfed infant 

category, the most significant change is 

the inability to receive any WIC infant 

formula during the first month 

following birth. In the first month after 

birth there are only two feeding 

options—fully formula fed or fully 

breastfed. The other changes include a 

reduction of the amount of infant 

formula that can be received from WIC, 

elimination of juice and the addition of 

infant food fruits and vegetables. As 

noted above, the IOM was concerned 

about the impact of the recommended 

food package changes on the 

breastfeeding mother/infant dyad. 

Therefore, the Department proposes to 

limit the ability to implement the 

partially breastfed infant food packages 

changes to not more than 32 sites within 

up to eight State agencies selected to 

implement the partially breastfeeding 

woman’s food package. After the 

Department has had an opportunity to 

examine the effects of the revised 

changes on the initiation and duration 

of breastfeeding (based on a comparison 

of the experiences in the test sites to 

comparison sites in the eight State 

agencies), the Department will 

determine when all State agencies can 

implement the revised partially 

breastfed infant food package. The State 

agencies will be selected based on 

willingness and ability to cooperate 

with evaluation data collection and 

design protocols (including 

identification of appropriate comparison 

sites for the test sites), past 

breastfeeding rates in the State (the 

Department proposes to seek a range of 

high, medium and low past 

breastfeeding rates), adequacy of the 

infrastructure in place to provide the 

necessary support to breastfeeding 

mothers (the Department proposes to 

seek both ‘‘best case’’ and ‘‘average 

case’’ levels of infrastructure), ability of 

the management information system to 

provide requested data on the impact of 

the food package changes, and diversity 

of the population to receive the new 

food package. 

For the fully breastfed infant, the most 

significant change is the addition of 

infant fruits and vegetables, and infant 

meats. The Department believes that a 

one-year implementation timeframe for 

these changes is appropriate. 

5. Children—The most significant 

changes to the child’s food package 

include the addition of the $6.00 cash 

value voucher for fresh fruits and 

vegetables and whole wheat bread (or 

other whole grain options), and the 

reductions in the amounts of milk and 

juice. Also, children 2 years of age and 

older may no longer receive whole milk. 

Cheese remains a substitute for milk. 

The Department is proposing a one-year 

implementation timeframe for these 

changes. 

6. Participants with Qualifying 

Conditions—The most significant 

changes to the food package that address 

the dietary needs of participants’ with 

certain qualifying conditions is the 

addition of other supplemental food(s), 

when not medically contraindicated, 

and serving all medically fragile 

participants under one food package 

(Food Package III). Women, infants and 

children with qualifying conditions 

would receive the same maximum 

monthly amounts of supplemental 

foods, with medical documentation, as 

those same participant categories that 

do not have a qualifying condition. The 

Department is proposing a one-year 

implementation timeframe for these 

changes. 

The following chart summarizes the 

proposed implementation timeframes 

on which the Department is seeking 

comments. As noted, in most instances 

State agencies will have one year to 

implement the new food packages. 

During the one-year phase-in period, 

State agencies would be required to 

issue food benefits based on either the 

new food packages or current food 

packages but could not combine the 

two. For example, a State agency could 

not add whole wheat bread and fresh 

fruits and vegetables to the current 

foods and quantities available under the 

children’s food package. The State 

agency may, however, phase-in the new 

food packages on a participant category 

basis. To minimize participant and 

vendor confusion, the Department 

proposes that once the State agency 

begins issuing the new food packages, it 

must be done on a Statewide basis. 

PROPOSED TIMELINES FOR IMPLEMENTATION OF FOOD PACKAGE CHANGES

Food package category Who may implement Timeframe for implementation 

Pregnant Women ................................. All State Agencies .............................. One Year from Publication of Interim Rule. 

Postpartum Women ............................. All State Agencies .............................. One Year from Publication of Interim Rule. 

Fully Breastfeeding Women All State Agencies .............................. One Year from Publication of Interim Rule. 

Partially Breastfeeding Women Not More Than 32 sites (4 sites within 

each of up to 8 State agencies) 

One Year from Publication of Interim Rule (The selected sites 

will have authority to issue the revised packages for no more 

than 3 years.) 

Fully Formula fed Infants ..................... All State Agencies .............................. One Year from Publication of Interim Rule. 

Partially Breastfed Infants .................... The sites selected for the Partially 

Breastfeeding Women’s Package 

One Year from Publication of Interim Rule (The selected sites 

will have authority to issue the revised packages for no more 

than 3 years.) 


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PROPOSED TIMELINES FOR IMPLEMENTATION OF FOOD PACKAGE CHANGES—Continued 

Food package category Who may implement Timeframe for implementation 

Fully Breastfed Infants ......................... All State Agencies .............................. One Year from Publication of Interim Rule. 

Juice Elimination from Infant Food 

Packages.

All State Agencies .............................. Six months from Publication of Interim Rule. 

Children ................................................ All State Agencies .............................. One Year from Publication of Interim Rule. 

Participants with Certain Medical Conditions (Women, Infants and Children) All State Agencies .............................. One Year from Publication of Interim Rule. 

VI. Endnotes 

(1) NAWD (National Association of WIC 

Directors) 2000. ‘‘NAWD WIC Food 

Prescription Recommendations, 2000.’’

Copies may be purchased by telephoning the 

National WIC Association at (202) 232–5492. 

(2) NWA (National WIC Association). 2003. 

‘‘NWA WIC Culturally Sensitive Food 

Prescription Recommendations.’’ Position 

Paper No. 03–001. Copies may be purchased 

by telephoning the National WIC Association 

at (202) 232–5492. 

(3) Institute of Medicine, National 

Academy of Sciences. ‘‘WIC Food Packages: 

Time for a Change,’’ 2005. Available at 

Internet site: http://www.fns.usda.gov/oane/ 

menu/Published/WIC/FILES/ 

Time4AChange(mainrpt).pdf. 

(4) Institute of Medicine, National 

Academy of Sciences, 1997. Dietary 

Reference Intakes for Calcium, Phosphorus 

Magnesium, Vitamin D, and Fluoride. 

Washington, DC: National Academy Press. 

(5) Institute of Medicine, National 

Academy of Sciences, 1998. Dietary 

Reference Intakes for Thiamin, Riboflavin, 

Niacin, Vitamin B6, Folate, Vitamin B12, 

Pantothenic acid, Biotin and Choline. 

Washington, DC: National Academy Press, 

1998. 

(6) Institute of Medicine, National 

Academy of Sciences, 2000. Dietary 

Reference Intakes for Vitamin C, Vitamin E, 

Selenium, and Carotenoids. Washington, DC: 

National Academy Press. 

(7) Institute of Medicine, National 

Academy of Sciences, 2001. Dietary 

Reference Intakes for Vitamin A, Vitamin K, 

Arsenic, Boron, Chromium, Copper, Iodine, 

Iron, Manganese, Molybdenum, Nickel, 

Silicon, Vanadium, and Zinc. Washington, 

DC: National Academy Press. 

(8) Institute of Medicine, National 

Academy of Sciences, 2002a. Dietary 

Reference Intakes for Energy, Carbohydrate, 

Fiber, Fat, Fatty Acids, Cholesterol, Protein, 

and Amino Acids. Washington, DC: National 

Academy Press. 

(9) Institute of Medicine, National 

Academy of Sciences, 2004. Dietary 

Reference Intakes for Water, Potassium, 

Sodium, Chloride, and Sulfate. Washington, 

DC: National Academies Press. 

(10) USDA/FNS. WIC Participant and 

Program Characteristics, 2002. Executive 

Summary. Available at Internet site: http:// 

www.fns.usda.gov/oane/MENU/Published/ 

WIC/FILES/PC2002ExecSum.pdf. 

(11) Institute of Medicine, National 

Academy of Sciences, 2000. ‘‘Dietary 

Reference Intakes: Applications in Dietary 

Assessment.’’ National Academy Press. 

(12) U.S. Department of Health and Human 

Services/U.S. Department of Agriculture, 

Dietary Guidelines for Americans, 2005. 

Available at Internet site: http:// 

www.healthierus.gov/dietaryguidelines/. 

(13) Institute of Medicine, National 

Academy of Sciences, 2001. ‘‘Dietary 

Reference Intakes for Vitamin A, Vitamin K, 

Arsenic, Boron, Chromium, Cooper, Iodine, 

Iron, Manganese, Molybdenum, Nickel, 

Silicon, Vanadium, and Zinc.’’ National 

Academy Press. 

(14) American Academy of Pediatrics, 

Committee on Nutrition. ‘‘The use and 

misuse of fruit juice in pediatrics.’’

‘‘Pediatrics’’ 107(5):1210–1213, May 2001. 

Available at Internet site: http:// 

www.aap.org/policy/re0047.html. 

(15) American Academy of Pediatrics, 

Committee on Nutrition, 2004. ‘‘Pediatric 

Nutrition Handbook.’’ 5th edition. 

(16) U. S. Department of Health and 

Human Services, ‘‘Healthy People 2010: 

Understanding and Improving Health, 2nd 

edition.’’ U.S. Government Printing Office. 

Available at Internet site: http:// 

www.healthypeople.gov/document. 

(17) American Academy of Pediatrics, 

Section on Breastfeeding, 2005. 

‘‘Breastfeeding and the use of human milk.’’

‘‘Pediatrics’’ 115(2):496–596. Available at 

Internet site: http:// 

aappolicy.aappublications.org/cgi/content/ 

full/pediatrics;115/2/496. 

(18) Herman, DR. ‘‘Are economic 

incentives useful for improving dietary 

quality among WIC participants and their 

families’’ Presentation at the public forum on 

Impact of Changes in the WIC Food packages. 

Committee to Review the WIC Food 

Packages, Institute of Medicine,. Los Angeles, 

CA , July 22, 2004. 

(19) Runnings, S. ‘‘Mother Infant and Child 

Harvest (MICH): Fruit and Vegetable Pilot 

Program.’’ Presentation at the workshop on 

Impact of Changes in the WIC Food Packages. 

Committee to Review the WIC Food 

Packages, Institute of Medicine. Los Angeles, 

CA, July 22, 2004. 

(20) U.S. Department of Agriculture, 

Agricultural Research Service. USDA 

Nutrient Database for Standard Reference, 

Release 17, 2004. Nutrient Data Laboratory 

Home Page at http://www.nal.usda.gov/fnic/ 

foodcomp/. 

(21) Oliveira, V., Chandran, R. ‘‘Children’s 

Consumption of WIC-Approved Foods.’’

Food Assistance and Nutrition Research 

Report No. 44. Available at Internet site: 

http://www.ers.usda.gov/publications/ 

fanrr44/fanrr44.pdf. 

(22) Environmental Protection Agency/ 

Food and Drug Administration. ‘‘What You 

Need to Know About Mercury in Fish and 

Shellfish.’’ EPA and FDA Advice for: Women 

Who Might Become Pregnant, Women Who 

Are Pregnant, Nursing Mothers, and Young 

Children. 2004. Available at Internet site: 

http://www.cfsan.fda.gov/dms/ 

admehg3.html. 

VII. Procedural Matters 

Executive Order 12866 

This proposed rule has been 

determined to be economically 

significant and was reviewed by the 

Office Management and Budget in 

conformance with Executive Order 

12866. 

Regulatory Impact Analysis 

As required for all rules that have 

been designated as Significant by the 

Office of Management and Budget, a 

Regulatory Impact Analysis (RIA) was 

developed for this proposed rule. It 

follows this regulation as an Appendix. 

The conclusions of this analysis are 

summarized below. 

Need for Action. As the population 

served by WIC has grown and become 

more diverse over the last 20 years, the 

nutritional risks faced by participants 

have changed, and though nutrition 

science has advanced, the WIC 

supplemental food packages have 

remained largely unchanged. A rule is 

needed to implement recommended 

changes to the WIC food packages based 

on the current nutritional needs of WIC 

participants and advances in nutrition 

science. 

Benefits. Benefits of this rule include 

bringing the WIC food packages in line 

with the 2005 Dietary Guidelines for 

Americans and current infant feeding 

practice guidelines of the American 

Academy of Pediatrics, better promoting 

and supporting the establishment of 

successful long-term breastfeeding, 

providing WIC participants with a wider 

variety of food, providing WIC State 

agencies with greater flexibility in 

prescribing food packages to 

accommodate participants with cultural 

food preferences, and serving all 

participants with certain medical 

conditions under one food package to 

facilitate efficient management of 

medically fragile participants. 


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Costs. FNS estimates that the 

provisions in this proposed rule will 

have minimal impact on total costs over 

5 years. 

Regulatory Flexibility Act 

This proposed rule has been reviewed 

with regard to the requirements of the 

Regulatory Flexibility Act of 1980 (5 

U.S.C. 601–612). Pursuant to that 

review, Eric M. Bost, Under Secretary, 

Food, Nutrition and Consumer Services, 

has determined that this rule will not 

have a significant economic impact on 

a substantial number of small entities. 

State and local agencies and WIC 

recipients will be most affected by the 

rule and WIC authorized vendors and 

the food industry may be indirectly 

affected. The proposed rule would 

provide State and local agencies with 

increased flexibility in meeting food 

package requirements for the Program. 

Vendors and the food industry would 

realize increased sales of some foods 

and decreases in other foods, with an 

overall neutral effect on sales nationally. 

Although not required by the 

Regulatory Flexibility Act, FNS has 

prepared an Initial Regulatory 

Flexibility Analysis (IRFA) describing 

the impact of this proposed rule on 

small entities. Written public comments 

are requested on this IRFA. Comments 

must be identified as responses to the 

IRFA and must be filed by the deadline 

for comments as provided in the Dates 

section. Additional analysis of the 

regulatory flexibility considerations of 

this proposed rule may be found in the 

Regulatory Impact Analysis section of 

this preamble and the cited RIA itself. 

Need for, and Objectives of, the 

Proposed Rule 

This proposed rule would revise 

regulations governing the WIC food 

packages to change the maximum 

monthly allowances and minimum 

requirements for certain supplemental 

foods, and add new foods such as fruits, 

vegetables and whole grains. The 

revisions largely reflect 

recommendations made by the Institute 

of Medicine of the National Academies 

in its Report ‘‘WIC Food Packages: Time 

for a Change’’. These revisions would 

bring the WIC food packages in line 

with the 2005 Dietary Guidelines for 

Americans and current infant feeding 

practice guidelines of the American 

Academy of Pediatrics, better promote 

and support the establishment of 

successful long-term breastfeeding, 

provide WIC participants with a wider 

variety of food, and provide WIC State 

agencies with greater flexibility in 

prescribing food packages to 

accommodate participants with cultural 

food preferences. 

Description and Estimate of Number of 

Small Entities to Which the Proposed 

Rule Would Apply 

This proposed rule would have a 

direct application only to WIC State 

agencies with respect to their selection 

of foods to be included on their food 

lists. As a result, vendors and the food 

industry would realize increased sales 

of some foods and decreases in other 

foods, with an overall neutral effect on 

sales nationally. The rule may have an 

indirect economic affect on certain 

small businesses because they may have 

to carry a larger variety of certain foods 

to be eligible for authorization as a WIC 

vendor. Currently, approximately 

45,000 stores are authorized to accept 

WIC food instruments, some of which 

are small businesses. With the high 

degree of State flexibility allowable 

under this proposed rule, small vendors 

will be impacted differently in each 

State depending upon how that State 

chooses to meet the proposed 

requirements. It is therefore not feasible 

to accurately estimate the rule’s impact 

on small vendors. Since neither FNS nor 

the State agencies regulate food 

producers under the WIC program, it is 

not known how many small entities 

within that industry may be indirectly 

affected by the proposed rule. However, 

such entities are encouraged to 

comment on this IRFA and the proposed 

rule and their comments will be 

considered in the development of the 

final rule. 

Description of Projected Reporting, 

Recordkeeping, and Other Compliance 

Requirements 

This proposed rule provides State 

agencies with greater flexibility in 

prescribing food packages to WIC 

participants. The information collection 

burden estimated for this proposal is 

14,598 hours. The burden reflects 

requirements associated with medical 

documentation for the issuance of any 

supplemental foods issued to 

participants who receive Food Package 

III; any authorized soy-based beverage 

or tofu issued to children who receive 

Food Package IV; and, any additional 

authorized tofu and cheese issued to 

women who receive Food Packages V 

and VII that exceeds the maximum 

substitution rate. 

Steps Taken to Minimize Significant 

Economic Impact on Small Entities, and 

Significant Alternatives Considered 

FNS has considered significant 

alternatives in developing this proposed 

rule including those that may reduce 

impact on small business. These 

considerations include (among others) 

the establishment of differing 

compliance or reporting requirements or 

timetables that take into account the 

resources available to small entities; the 

clarification, consolidation, or 

simplification of compliance and 

reporting requirements under the rule 

for small entities; the use of 

performance, rather than design, 

standards; and an exemption from 

coverage of the rule, or any part thereof, 

for small entities. 

In general, the alternatives of 

exempting small entities from the 

requirements proposed in this rule or 

altering the requirements for small 

entities were rejected. The WIC food 

packages provide supplemental foods 

designed to address the nutritional 

needs of low-income pregnant, 

breastfeeding, non-breastfeeding 

postpartum women, infants and 

children up to age five who are at 

nutritional risk. Exempting small 

entities from providing the specific 

foods intended to address the 

nutritional needs of participants or 

altering the requirements for small 

entities would undermine the purpose 

of the WIC Program and endanger the 

health status of participants. 

FNS has, however, modified the new 

food provision in an effort to mitigate 

the impact on small entities. Currently, 

State agencies must establish minimum 

requirements for the variety and 

quantity of foods that a vendor must 

stock in order to receive WIC Program 

authorization. This proposal would add 

new food items, such as fruits and 

vegetables and whole grain breads, 

which may require some WIC vendors, 

particularly smaller stores, to expand 

the types and quantities of food items 

stocked in order to maintain their WIC 

authorization. In addition, vendors 

would also have to make available more 

than one food type from each WIC food 

category, except for the categories of 

peanut butter and eggs, which may be 

a change for some vendors. To mitigate 

the impact of the fruit and vegetable 

requirement, the proposal allows 

canned, frozen and dried fruits and 

vegetables to be substituted for fresh 

produce. 

Federal Rules That May Duplicate, 

Overlap, or Conflict With the Proposed 

Rule 

There are no federal rules that may 

duplicate, overlap, or conflict with the 

provisions of this proposed rule. 


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Public Law 104–4, Unfunded Mandates 

Reform Act of 1995 (UMRA) 

Title II of the UMRA 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 to State, local, or 

tribal governments, in the aggregate, or 

to the private sector, of $100 million or 

more 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 least costly, 

more cost-effective or least burdensome 

alternative that achieves the objectives 

of the rule. 

This proposed rule contains no 

Federal mandates (under the regulatory 

provisions of Title II of the UMRA) that 

impose costs on State, local, or tribal 

governments or to the private sector of 

$100 million or more in any one year. 

This rule is, therefore, not subject to the 

requirements of sections 202 and 205 of 

the UMRA. 

Executive Order 12372 

The Special Supplemental Nutrition 

Program for Women, Infants and 

Children (WIC) is listed in the Catalog 

of Federal Domestic Assistance under 

No. 10.557. For reasons set forth in the 

final rule in 7 CFR part 3015, Subpart 

V and related Notice (48 FR 29114, June 

24, 1983), this Program is included in 

the scope of Executive Order 12372, 

which requires intergovernmental 

consultation with State and local 

officials. 

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. 

Prior Consultation With WIC State and 

Local Agency Officials 

Over the years the Department has 

received numerous requests from WIC 

State and local agencies to modify the 

current food packages to permit greater 

substitution of foods or introduction of 

additional foods. These requests have 

come from formal and informal 

discussions and with State and local 

officials on an ongoing basis regarding 

program implementation and food 

package policy issues, and from written 

proposals and comments submitted to 

FNS by WIC State and local agencies to 

allow modifications and/or 

substitutions to the WIC food packages. 

Requests for revisions to the WIC food 

packages have also been received from 

Congress, participants, and 

organizations with interests in the 

welfare of WIC participants. 

Examples of the different forums and 

methods FNS has used over the years to 

solicit WIC State and local agency staff 

input on the WIC food packages include 

the following. 

• Publishing an advanced notice of 

public rulemaking (ANPRM) in 2003 to 

solicit comments to determine if the 

WIC food packages should be revised to 

better improve the nutritional intake, 

health and development of participants; 

and, if so, what specific changes should 

be made to the food packages. In 

response to the ANPRM, FNS received 

195 total comments; 

• Commissioning the National 

Academies’ Institute of Medicine (IOM) 

to independently review the WIC Food 

Packages. IOM solicited public 

comment on revisions to the WIC food 

packages, via 3 public hearings, letters 

and e-mail, throughout its 22-month 

study period. IOM considered these 

comments, as well as comments the 

Department received in response to the 

ANPRM, in developing 

recommendations to revise the WIC 

food packages. IOM published its 

reports of these recommendations on 

April 27, 2005: ‘‘WIC Food Packages: 

Time for a Change.’’ (3) This proposed 

rule incorporates IOM?s 

recommendations; 

• Holding nine public outreach 

sessions across the nation as part of 

FNS’ development of its 2004 

reauthorization proposals. Interested 

parties, including WIC State and local 

staff, offered oral testimony and written 

statements on the WIC food packages as 

well as on a variety of other WIC issues; 

• Hosting annual meetings (1977- 

present) of the National Advisory 

Council on Maternal, Infant and Fetal 

Nutrition that includes WIC staff as 

members of the Council; the Council 

develops recommendations for FNS on 

how to improve operations of the WIC 

and Commodity Supplemental Food 

Programs, including aspects related to 

the authorized foods and food packages; 

and 

• Consulting and collaborating with 

NWA on a wide variety of WIC issues, 

including those related to the WIC food 

packages (1983-present). NWA is a nonprofit organization that was founded in 

1983 by State and local agencies that 

administer the WIC Program. As of June 

1, 2005, its paid membership included 

73 of the 89 WIC State agencies, 675 

local agencies, 4 State WIC 

Associations, and 18 sustaining 

members (i.e., for-profit and non-profit 

businesses or organizations). 

Functioning as a coalition of WIC 

agencies, NWA is dedicated to 

maximizing WIC resources through 

effective management practices. NWA 

also serves in a leadership role for WIC 

agencies by developing position papers 

on issues of concern to the WIC 

community. 

Nature of Concerns and the Need To 

Issue This Rule 

• Congress has requested a WIC food 

package rule that includes fruits and 

vegetables and allows for cultural food 

accommodations. Starting in fiscal year 

2001, Congress has directed the 

Department, in language accompanying 

WIC appropriations bills, to move 

expeditiously to publish a proposed 

food package rule for public comment; 

• The National Advisory Council on 

Maternal, Infant, and Fetal Nutrition, in 

its 1992, 1996 and 2002 Reports to 

Congress, recommended better 

accommodation of the nutritional and 

cultural needs of WIC participants 

through the WIC food packages; and 

• In 1999, NWA (then the National 

Association of WIC Directors (NAWD)) 

published a position paper entitled 

‘‘NAWD WIC Food Prescription 

Recommendations’’ (1) and in 2003, 

NWA published a position paper 

entitled ‘‘NWA WIC Culturally Sensitive 

Food Prescription Recommendations.’’ (2) NWA’s major recommendations in 

these two reports were to reframe the 

WIC food packages to be consistent with 

the Dietary Guidelines for Americans 

and allow State agencies flexibility to 

accommodate cultural eating patterns. 

Based upon the need to address the 

nutritional needs of the WIC population 

given current scientific information and 

consumption patterns as exemplified by 

the concerns and recommendations of 

NWA, and others, FNS was aware of the 

need to revise the WIC food packages. 

Extent to Which We Meet Those 

Concerns 

FNS has considered the impact of the 

proposed rule on State and local 

agencies. FNS believes that the 

recommendations in the IOM Report, 

which are largely laid out in this 

proposed rule, are responsive to the 

expressed concerns and requests of 


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commenters representing State and local 

concerns. 

Executive Order 12988 

This 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 implementation. This 

rule is not intended to have retroactive 

effect unless so specified in the DATES 

paragraph of the preamble of the interim 

rule. Prior to any judicial challenge to 

the provisions of this rule or the 

application of its provisions, all 

applicable administrative procedures 

must be exhausted. 

Civil Rights Impact Analysis 

FNS has reviewed this proposed rule 

in accordance with the Department 

Regulation 4300–4, ‘‘Civil Rights Impact 

Analysis,’’ to identify and address any 

major civil rights impacts the rule might 

have on minorities, women, and persons 

with disabilities. After a careful review 

of the rule’s intent and provisions, and 

the characteristics of WIC Program 

applicants and participants, FNS has 

determined that it does not have a 

deleterious effect on the participation of 

protected individuals in the WIC 

Program. All data available to FNS 

indicate that protected individuals have 

the same opportunity to participate in 

the WIC Program as non-protected 

individuals. FNS specifically prohibits 

State and local agencies operating the 

WIC Program from discrimination based 

on race, color, national origin, sex, age, 

or disability. Section 246.8(a) of WIC 

regulations requires State agencies to 

ensure that no person will be excluded 

from participation based on race, color, 

national origin, age, sex or disability. 

Where State agencies have options, and 

they choose to implement a certain 

provision, they must implement it in 

such a way that it complies with the 

regulations at § 246.8. 

This rule merely addresses revisions 

to the WIC food packages to bring them 

into line with the DGA 2005 (12) and 

current infant feeding recommendations 

from the American Academy of 

Pediatrics. Several provisions are 

specifically designed to better 

accommodate WIC’s highly diverse 

population. This proposed rule provides 

WIC State agencies with greater 

flexibility in prescribing food packages 

to accommodate participants with 

cultural food preferences, including 

allowing participants a broad selection 

of fruits and vegetables; tofu and soybased beverages as substitutes for milk; 

participant choice for whole grains 

(including tortillas); and salmon and 

sardines as substitutions for tuna. This 

proposed rule also makes provisions to 

better accommodate the special dietary 

needs of high-risk participants served in 

Food Package III, helping to protect the 

health and well-being of this 

nutritionally vulnerable subset of WIC 

participants. 

Paperwork Reduction Act (60-Day 

Notice) 

The Paperwork Reduction Act of 1995 

(44 U.S.C. Chap. 35; see 5 CFR part 

1320) requires that OMB approve all 

collections of information by a Federal 

agency from the public 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. This 

proposed rule contains information 

collections that are subject to review 

and approval by OMB; therefore, FNS 

has submitted an information collection 

which contains the changes in burden 

from adoption of the proposals in the 

rule, for OMB’s review and approval. 

Comments on the information 

collection in this proposed rule must be 

received by October 6, 2006. 

Send comments to the Office of 

Information and Regulatory Affairs, 

OMB, Attention: Desk Officer for FNS, 

Washington, DC, 20503. Please also 

send a copy of your comments to 

Patricia N. Daniels, Director, 

Supplemental Food Programs Division, 

Food and Nutrition Service, U.S. 

Department of Agriculture, 3101 Park 

Center Drive, Room 528, Alexandria, 

Virginia 22302. For further information, 

or for copies of the information 

collection requirements, please contact 

Debra Whitford at the address indicated 

above. 

Comments are invited on (a) whether 

the proposed collection of information 

is necessary for the proper performance 

of the Agency’s functions, including 

whether the information will have 

practical utility; (b) the accuracy of the 

Agency’s estimate of the proposed 

information collection burden, 

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 request for 

comments will be summarized and 

included in the request for OMB 

approval. All comments will also 

become a matter of public record. 

Title: WIC Food Packages. 

OMB Number: Not Assigned. 

Expiration Date: Not Yet Determined. 

Type of Request: New. 

Abstract: This rule proposes revisions 

to the food packages to bring them in 

line with the 2005 Dietary Guidelines 

for Americans and current infant 

feeding practice guidelines of the 

American Academy of Pediatrics. The 

revisions would also: better promote 

and support the establishment of 

successful long-term breastfeeding, 

provide WIC participants with a wider 

variety of foods, provide WIC State 

agencies with greater flexibility in 

prescribing food packages to 

accommodate participants with cultural 

preferences, and serve participants with 

certain qualifying conditions under one 

food package to facilitate efficient 

management of medically fragile 

participants. 

The average burden per response and 

the annual burden hours are explained 

below and summarized in the chart 

which follows. 

Respondents for this Rule: Individuals 

or households and State, Local or Tribal 

Governments. 

Estimated Number of Respondents: 

152,783. 

Estimated Number of Responses per 

Respondent: 2. 

Estimate Average Hours per 

Response: 0.05. 

Estimated Total Annual Burden on 

Respondents: 14,598 Hours. 

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Section of regulations Annual number 

of respondents 

Number 

responses per 

respondent 

Average burden 

per response 

Annual burden 

hours 

Reporting Burden: 

§ 246.10(d) ................................................................................ 142,783 2 0.05 14,728 

Recordkeeping Burden: 


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ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued 

Section of regulations Annual number 

of respondents 

Number 

responses per 

respondent 

Average burden 

per response 

Annual burden 

hours 

§ 246.10(d) ................................................................................ 10,000 2 0.016 320 

Total Reporting and Recordkeeping Burden in the Proposed Rule ..................................................................... 152,783 2 0.05 14,598 

1. Reporting 

Sections 246.10(d) would require 

medical documentation for the issuance 

of any supplemental foods issued to 

participants who receive Food Package 

III; any authorized soy-based beverage 

or tofu issued to children who receive 

Food Package IV; and, any additional 

authorized tofu and cheese issued to 

women who receive Food Packages V 

and VII that exceeds the maximum 

substitution rate. 

In addition, the content of the medical 

documentation would be expanded to 

include: (1) Contact information for the 

participant’s healthcare provider 

making the medical determination; (2) 

date of medical determination; (3) the 

specific supplemental foods to be 

prescribed; (4) amount prescribed per 

day; (5) the medical determination of 

the qualifying conditions which 

warrants the supplemental foods; and 

(6) the length of time the supplemental 

foods is medically required. 

FNS estimates that approximately 1 

percent of participants (86,375) will be 

issued supplemental foods under Food 

Package III; 1 percent of children 

(42,408) will be authorized soy-based 

beverage or tofu under Food Package IV; 

and, 1 percent of women (14,000) will 

be authorized tofu and cheese in excess 

of the maximum substitution rate under 

Food Packages V and VII. Further, FNS 

estimates that it will take three minutes 

(0.05 person hours) for the 

documentation required to issue the 

authorized foods. Thus, the estimated 

reporting burden is 14,278 (142,783 

total participants × 0.05 person hours × 

2 certification periods per year). 

2. Recordkeeping 

FNS estimates that it will take one 

minute (0.016 per record) for each clinic 

(10,000 clinics) to file the required 

medical documentation provided by 

participants, for an estimated burden of 

320 hours (10,000 clinics × 0.016 hours 

per record × 2 times per year). 

E-Government Act Compliance 

The Food and Nutrition Service is 

committed to complying with the 

E-Government Act to promote the use of 

the Internet and other information 

technologies to provide increased 

opportunities for citizen access to 

Government information and services, 

and for other purposes. 

List of Subjects in 7 CFR Part 246 

Administrative practice and 

procedure, Civil rights, Food assistance 

programs, Grant programs—health, 

Grant programs—social programs, 

Indians, Infants and children, Maternal 

and child health, Nutrition, Penalties, 

Reporting and recordkeeping 

requirements, Women. 

For reasons set forth in the preamble, 

7 CFR part 246 is proposed to be 

amended as follows: 

PART 246—SPECIAL SUPPLEMENTAL 

NUTRITION PROGRAM FOR WOMEN, 

INFANTS AND CHILDREN 

1. The authority citation for part 246 

continues to read as follows: 

Authority: 42 U.S.C. 1786. 

2. In § 246.2: 

a. Revise the definition of 

‘‘Participation’’; and 

b. Amend the definition of ‘‘WICeligible medical foods’’ by removing the 

words ‘‘for individuals with a diagnosed 

medical condition’’ and adding in their 

place the words ‘‘for women or children 

with a qualifying condition’’, and by 

revising the second sentence. 

The revisions read as follows: 

§ 246.2 Definitions. 

* * * * * 

Participation means the sum of: 

(1) The number of persons who 

received supplemental foods or food 

instruments during the reporting period; 

(2) The number of infants who did not 

receive supplemental foods or food 

instruments but whose breastfeeding 

mother received supplemental foods or 

food instruments during the report 

period; and 

(3) The number of breastfeeding 

women who did not receive 

supplemental foods or food instruments 

but whose infant received supplemental 

foods or food instruments during the 

report period. 

* * * * * 

WIC-eligible medical foods * * * 

Such WIC-eligible medical foods must 

serve the purpose of a food, meal or diet 

(may be nutritionally complete or 

incomplete) and provide a source of 

calories and one or more nutrients; be 

designed for enteral digestion via an 

oral or tube feeding; and may not be a 

conventional food, drug, flavoring, or 

enzyme.* * * 

3. Revise § 246.10 to read as follows: 

§ 246.10 Supplemental foods. 

(a) General. This section prescribes 

the requirements for providing 

supplemental foods to participants. The 

State agency must ensure that local 

agencies comply with this section. 

(b) State agency responsibilities. (1) 

State agencies may: 

(i) Establish criteria in addition to the 

minimum Federal requirements in Table 

4 of paragraph (e)(12) of this section for 

the supplemental foods in their States. 

These State criteria could address, but 

not be limited to, other nutritional 

standards, competitive cost, State-wide 

availability, and participant appeal; and 

(ii) Make food package adjustments to 

better accommodate participants who 

are homeless. At the State agency’s 

option, these adjustments would 

include, but not be limited to, issuing 

authorized supplemental foods in 

individual serving-size containers to 

accommodate lack of food storage or 

preparation facilities. 

(2) State agencies must: 

(i) Identify the brands of foods and 

package sizes that are acceptable for use 

in the Program in their States in 

accordance with the requirements of 

this section. State agencies must also 

provide to local agencies a list of 

acceptable foods and their maximum 

monthly allowances as specified in 

Tables 1 through 3 of paragraphs (e)(9) 

through (e)(11) of this section; and 

(ii) Ensure that local agencies: 

(A) Make available to participants the 

maximum monthly allowances of 

authorized supplemental foods, except 

as noted in paragraph (c) of this section, 

and abide by the authorized substitution 

rates for WIC food substitutions as 

specified in Tables 1 through 3 of 

paragraphs (e)(9) through (e)(11) of this 

section; 

(B) Make available to participants 

more than one food from each WIC food 


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category except for the categories of 

peanut butter and eggs, and at least two 

fruits and two vegetables from the 

category of fruits and vegetables (fresh 

or processed) in each authorized food 

package as listed in paragraph (e) of this 

section; 

(C) Authorize only a competent 

professional authority to prescribe the 

categories of authorized supplemental 

foods in quantities that do not exceed 

the regulatory maximum and are 

appropriate for the participant, taking 

into consideration the participant’s age 

and nutritional needs; and 

(D) Advise participants or their 

caretaker, when appropriate, that the 

supplemental foods issued are only for 

their personal use. However, the 

supplemental foods are not authorized 

for participant use while hospitalized 

on an in-patient basis. In addition, 

consistent with § 246.7(n)(1)(i)(B), 

supplemental foods are not authorized 

for use in the preparation of meals 

served in a communal food service. This 

restriction does not preclude the 

provision or use of supplemental foods 

for individual participants in a 

nonresidential setting (e.g., child care 

facility, family day care home, school, 

or other educational program); a 

homeless facility that meets the 

requirements of § 246.7(n)(1); or, at the 

State agency’s discretion, a residential 

institution (e.g., home for pregnant 

teens, prison, or residential drug 

treatment center) that meets the 

requirements currently set forth in 

§ 246.7(n)(1) and (n)(2). 

(c) Nutrition tailoring. The full 

maximum monthly allowances of all 

supplemental foods in all food packages 

must be made available to participants 

if medically or nutritionally warranted. 

Reductions in these amounts cannot be 

made for cost-savings, administrative 

convenience, caseload management, or 

to control vendor abuse. Reductions in 

these amounts cannot be made for 

categories, groups or subgroups of WIC 

participants. The provision of less than 

the maximum monthly allowances of 

supplemental foods to an individual 

WIC participant in all food packages is 

appropriate only when: 

(1) Medically or nutritionally 

warranted (e.g., to eliminate a food due 

to a food allergy); 

(2) A participant refuses or cannot use 

the maximum monthly allowances; or 

(3) The quantities necessary to 

supplement another programs’

contribution to fill a medical 

prescription would be less than the 

maximum monthly allowances. 

(d) Medical documentation—(1) 

Supplemental foods requiring medical 

documentation. Medical documentation 

is required for the issuance of the 

following supplemental foods: 

(i) Any non-contract brand infant 

formula; 

(ii) Any infant formula prescribed to 

a child or adult who receives Food 

Package III; 

(iii) Any exempt infant formula; 

(iv) Any WIC-eligible medical food; 

(v) Any authorized supplemental food 

issued to participants who receive Food 

Package III; 

(vi) Any authorized soy-based 

beverage or tofu issued to children who 

receive Food Package IV; 

(vii) Any additional authorized cheese 

issued to children who receive Food 

Package IV that exceeds the maximum 

substitution rate; 

(viii) Any additional authorized tofu 

and cheese issued to women who 

receive Food Packages V and VII that 

exceeds the maximum substitution rate; 

and 

(ix) Any contract brand infant formula 

that does not meet the requirements in 

Table 4 of paragraph (e)(12) of this 

section. 

(2) Supplemental foods not requiring 

medical documentation. (i) State 

agencies may authorize local agencies to 

issue a non-contract brand infant 

formula that meets the requirements in 

Table 4 of paragraph (e)(12) of this 

section without medical documentation 

in order to meet religious eating 

patterns; and 

(ii) The State agency has the 

discretion to require medical 

documentation for any contract brand 

infant formula and may decide that 

some contract brand infant formula may 

not be issued under any circumstances. 

(3) Medical Determination. For 

purposes of this program, medical 

documentation means that a health care 

professional licensed to write medical 

prescriptions under State law has: 

(i) Made a medical determination that 

the participant has a qualifying 

condition as described in paragraphs 

(e)(3) through (e)(7) of this section that 

dictates the use of the supplemental 

foods, as described in paragraph (d)(1) 

of this section; and 

(ii) Provided the written 

documentation that meets the technical 

requirements described in paragraphs 

(d)(4)(ii) and (d)(4)(iii) of this section. 

(4) Technical Requirements—(i) 

Location. All medical documentation 

must be kept on file (electronic or hard 

copy) at the local clinic. The medical 

documentation kept on file must 

include the initial telephone 

documentation, when received as 

described in paragraph (d)(4)(iii)(B) of 

this section. 

(ii) Content. All medical 

documentation must include the 

following: 

(A) The name of the authorized WIC 

formula (infant formula, exempt infant 

formula, WIC-eligible medical food) 

prescribed, including amount needed 

per day; 

(B) The authorized supplemental 

food(s) appropriate for the qualifying 

condition(s) and their prescribed 

amounts; 

(C) Length of time the prescribed WIC 

formula and/or supplemental food is 

required by the participant; 

(D) The qualifying condition(s) for 

issuance of the authorized supplemental 

food(s) requiring medical 

documentation, as described in 

paragraphs (e)(3) through (e)(7) of this 

section; and 

(E) Signature, date and contact 

information (or name, date and contact 

information), if the initial medical 

documentation was received by 

telephone and the signed document is 

forthcoming, of the health care 

professional licensed by the State to 

write prescriptions in accordance with 

State laws. 

(iii) Written confirmation—(A) 

General. Medical documentation must 

be written and may be provided as an 

original written document, an electronic 

document, by facsimile or by telephone 

to a competent professional authority 

until written confirmation is received. 

(B) Medical documentation provided 

by telephone. Medical documentation 

may be provided by telephone to a 

competent professional authority who 

must promptly document the 

information. The collection of the 

required information by telephone for 

medical documentation purposes may 

only be used until written confirmation 

is received from a health care 

professional licensed to write medical 

prescriptions and used only when 

absolutely necessary on an individual 

participant basis. The local clinic must 

obtain written confirmation of the 

medical documentation within a 

reasonable amount of time (i.e., one or 

two week’s time) after accepting the 

initial medical documentation by 

telephone. 

(5) Medical supervision requirements. 

Due to the nature of the health 

conditions of participants who are 

issued supplemental foods that require 

medical documentation, close medical 

supervision is essential for each 

participant’s dietary management. The 

responsibility remains with the 

participant’s health care provider for 

this medical oversight and instruction. 

This responsibility cannot be assumed 

by personnel at the WIC State or local 


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agency. However, it would be the 

responsibility of the WIC competent 

professional authority to ensure that 

only the amounts of supplemental foods 

prescribed by the participant’s health 

care provider are issued in the 

participant?s food package. 

(e) Food packages. There are seven 

food packages available under the 

Program that may be provided to 

participants. The authorized 

supplemental foods must be prescribed 

from food packages according to the 

category and nutritional needs of the 

participant. The food packages are as 

follows: 

(1) Food Package I—Infants birth 

through 5 months—(i) Participant 

category served. This food package is 

designed for issuance to infant 

participants from birth through age 5 

months who do not have a condition 

qualifying them to receive Food Package 

III. 

(ii) Infant feeding categories—(A) 

Birth through one month. Two infant 

feeding options are available during the 

first month after birth—fully 

breastfeeding, i.e., the infant receives no 

infant formula from the WIC Program, or 

fully formula-feeding. Infant formula is 

not provided during the first month 

after birth to fully breastfed infants to 

support the successful establishment of 

breastfeeding. 

(B) Two through 5 months. Three 

infant feeding options are available from 

2 months through 5 months—fully 

breastfeeding, fully formula-feeding, or 

partially breastfeeding, i.e., the infant is 

breastfed but also receives infant 

formula from the WIC Program in an 

amount not to exceed approximately 

half the amount of infant formula 

allowed for a fully formula fed infant. 

(iii) Infant formula requirements. This 

food package provides iron-fortified 

infant formula that is not an exempt 

infant formula. The issuance of any 

contract brand or noncontract brand 

infant formula that contains less than 10 

milligrams of iron per liter at standard 

dilution (i.e., approximately 20 

kilocalories per fluid ounce of prepared 

formula) is prohibited. Except as 

specified in paragraph (d) of this 

section, local agencies must issue a 

contract brand infant formula that meets 

the requirements in Table 4 of 

paragraph (e)(12) of this section. 

(iv) Physical forms. Local agencies 

must issue all WIC formulas (WIC 

formulas mean all infant formula, 

exempt infant formula and WIC-eligible 

medical foods) in concentrated liquid or 

powder physical forms. Ready-to-feed 

WIC formulas may be authorized when 

the competent professional authority 

determines and documents that: 

(A) The participant’s household has 

an unsanitary or restricted water supply 

or poor refrigeration; 

(B) The person caring for the 

participant may have difficulty in 

correctly diluting concentrated or 

powder forms; or 

(C) The WIC infant formula is only 

available in ready-to-feed. 

(v) Authorized category of 

supplemental foods. Infant formula is 

the only category of supplemental foods 

authorized in this food package. Exempt 

infant formulas and WIC-eligible 

medical foods are authorized only in 

Food Package III. 

(2) Food Package II—Infants 6 

through 11 months—(i) Participant 

category served. This food package is 

designed for issuance to infant 

participants from 6 through 11 months 

of age who do not have a condition 

qualifying them to receive Food Package 

III. 

(ii) Infant feeding options. Three 

infant feeding options are available—

fully breastfeeding, fully formulafeeding, or partially breastfeeding. 

(iii) Infant formula requirements. The 

requirements for issuance of infant 

formula in Food Package I, specified in 

paragraphs (e)(1)(iii) and (e)(1)(iv) of 

this section, also apply to the issuance 

of infant formula in Food Package II. 

(iv) Authorized categories of 

supplemental foods. Infant formula, 

infant fruits and vegetables, infant meat, 

and infant cereal are the categories of 

supplemental foods authorized in this 

food package. 

(3) Food Package III—Participants 

with qualifying conditions—(i) 

Participant category served and 

qualifying conditions. This food package 

is reserved for issuance to women, 

infants and child participants who have 

a documented qualifying condition that 

requires the use of a WIC formula 

(infant formula, exempt infant formula 

or WIC-eligible medical food) because 

the use of conventional foods is 

precluded, restricted, or inadequate to 

address their special nutritional needs. 

Medical documentation must meet the 

requirements described in paragraph (d) 

of this section. Participants who are 

eligible to receive this food package 

must have one or more qualifying 

conditions, as determined by a health 

care professional licensed to write 

medical prescriptions under State law. 

The qualifying conditions include but 

are not limited to premature birth, low 

birth weight, failure to thrive, inborn 

errors of metabolism and metabolic 

disorders, gastrointestinal disorders, 

malabsorption syndromes, immune 

system disorders, severe food allergies 

that require an elemental formula, and 

life threatening disorders, diseases and 

medical conditions that impair 

ingestion, digestion, absorption or the 

utilization of nutrients that could 

adversely affect the participant’s 

nutrition status. This food package may 

not be issued solely for the purpose of 

enhancing nutrient intake or managing 

body weight. 

(ii) Non-authorized issuance of Food 

Package III. This food package is not 

authorized for: 

(A) Infants whose only condition is: 

(1) A diagnosed formula intolerance 

or food allergy to lactose, sucrose, milk 

protein or soy protein that does not 

require the use of an exempt infant 

formula ; or 

(2) A non-specific formula or food 

intolerance. 

(B) Women and children who have a 

food intolerance to lactose or milk 

protein that can be successfully 

managed with the use of one of the 

other WIC food packages (i.e., Food 

Packages IV–VII); or 

(C) Any participant solely for the 

purpose of enhancing nutrient intake or 

managing body weight without an 

underlying qualifying condition. 

(iii) Restrictions on the issuance of 

WIC formulas in ready-to-feed (RTF) 

forms. WIC State agencies must issue 

WIC formulas (infant formula, exempt 

infant formula and WIC-eligible medical 

foods) in concentrated liquid or powder 

physical forms unless the requirements 

for issuing RTF are met as described in 

paragraph (e)(1)(iv) of this section. In 

addition to those requirements, there are 

two additional conditions which may be 

used to issue RTF in Food Package III: 

(A) If a ready-to-feed form better 

accommodates the participant’s 

condition; or 

(B) If it improves the participant’s 

compliance in consuming the 

prescribed WIC formula. 

(iv) Unauthorized WIC costs. All 

apparatus or devices (e.g., enteral 

feeding tubes, bags and pumps) 

designed to administer WIC formulas 

are not allowable WIC costs. 

(v) Authorized categories of 

supplemental foods. The supplemental 

foods authorized in this food package 

require medical documentation for 

issuance and include infant formula (for 

children or women), exempt infant 

formula, WIC-eligible medical foods (for 

children and women), infant cereal, 

infant food fruits and vegetables, milk 

and milk alternatives, cheese, eggs, 

canned fish, fruits and vegetables, 

breakfast cereal, whole wheat bread or 

other whole grains, juice, legumes and/ 

or peanut butter. 

(vi) Coordination with medical payors 

and other programs that provide or 


jlentini on PROD1PC65 with PROPOSAL2
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reimburse for formulas. WIC State 

agencies must coordinate with other 

Federal, State or local government 

agencies or with private agencies that 

operate programs that also provide or 

could reimburse for exempt infant 

formulas and WIC-eligible medical 

foods benefits to mutual participants. At 

a minimum, a WIC State agency must 

coordinate with the State Medicaid 

Program for the provision of exempt 

infant formulas and WIC-eligible 

medical foods that are authorized or 

could be authorized under the State 

Medicaid Program for reimbursement 

and that are prescribed for WIC 

participants who are also Medicaid 

recipients. The WIC State agency is 

responsible for providing up to the 

maximum amount of exempt infant 

formulas and WIC-eligible medical 

foods under Food Package III in 

situations where reimbursement is not 

provided by another entity. 

(4) Food Package IV—Children 1 

through 4 years—(i) Participant category 

served. This food package is designed 

for issuance to participants 1 through 4 

years of age who do not have a 

condition qualifying them to receive 

Food Package III. 

(ii) Authorized categories of 

supplemental foods. Milk, breakfast 

cereal, juice, fruits and vegetables, 

whole wheat bread or other whole 

grains, eggs, and legumes or peanut 

butter are the categories of supplemental 

foods authorized in this food package. 

Cheese may be substituted for milk in 

amounts described in Table 2 of 

paragraph (e)(10) of this section. 

Substitutions exceeding the maximum 

substitution allowance of cheese, up to 

the maximum allowance for fluid milk, 

may be allowed with medical 

documentation of the qualifying 

condition. Soy-based beverages and tofu 

can be substituted for milk only with 

medical documentation in this food 

package, in amounts described in Table 

2 of paragraph (e)(10) of this section. A 

health care professional licensed by the 

State to write prescriptions must make 

a medical determination and provide 

medical documentation that a child 

cannot drink milk and requires soybased beverage, tofu, or additional 

cheese as a substitute for milk. Such 

determination can be made for 

situations that include, but are not 

limited to, milk allergy, severe lactose 

maldigestion, and vegan diets. Medical 

documentation must meet the 

requirements described in paragraph (d) 

of this section. 

(5) Food Package V—Pregnant and 

partially breastfeeding women—(i) 

Participant category served. This food 

package is designed for issuance to 

women participants with singleton 

pregnancies who do not have a 

condition qualifying them to receive 

Food Package III. This food package is 

also designed for issuance to 

breastfeeding women participants, up to 

1 year postpartum, who do not have a 

condition qualifying them to receive 

Food Package III and whose partially 

breastfed infants receive formula from 

the WIC program in amounts that do not 

exceed the maximum allowances 

described in Table 1 of paragraph (e)(9) 

of this section. Women participants 

breastfeeding more than one infant, and 

women participants pregnant with more 

than one fetus, are eligible to receive 

Food Package VII as described in 

paragraph (e)(7) of this section. 

(ii) Authorized categories of 

supplemental foods. Milk, breakfast 

cereal, juice, fruits and vegetables, 

whole wheat bread or other whole 

grains, eggs, legumes and peanut butter 

are the categories of supplemental foods 

authorized in this food package. Cheese 

or calcium-set tofu may be substituted 

for milk in amounts described in Table 

2 of paragraph (e)(10) of this section. 

Amounts of cheese or calcium-set tofu 

exceeding the maximum substitution 

allowances may be allowed with 

medical documentation of the 

qualifying condition, up to the 

maximum allowance for fluid milk. A 

health care professional licensed by the 

State to write prescriptions must make 

a medical determination and provide 

medical documentation that a woman 

cannot drink milk and requires 

additional cheese or calcium-set tofu. 

Such determination can be made for 

situations that include, but are not 

limited to, milk allergy or severe lactose 

maldigestion. Medical documentation 

must meet the requirements described 

in paragraph (d) of this section. 

(6) Food Package VI—Postpartum 

women—(i) Participant category served. 

This food package is designed for 

issuance to women up to 6 months 

postpartum who are not breastfeeding 

their infants, and to breastfeeding 

women up to 6 months postpartum 

whose participating infant receives 

more than the maximum amount of 

formula allowed for partially breastfed 

infants as described in Table 1 of 

paragraph (e)(9) of this section. 

(ii) Authorized categories of 

supplemental foods. Milk, breakfast 

cereal, juice, fruits and vegetables, eggs, 

and legumes or peanut butter are the 

categories of supplemental foods 

authorized in this food package. Cheese 

or calcium-set tofu may be substituted 

for milk in amounts described in Table 

2 of paragraph (e)(10) of this section. 

Amounts of cheese or calcium-set tofu 

exceeding the maximum substitution 

allowances may be allowed with 

medical documentation of the 

qualifying condition, up to the 

maximum allowance for fluid milk. A 

health care professional licensed by the 

State to write prescriptions must make 

a medical determination and provide 

medical documentation that a woman 

cannot drink milk and requires 

additional cheese or calcium-set tofu. 

Such determination can be made for 

situations that include, but are not 

limited to, milk allergy or severe lactose 

maldigestion. Medical documentation 

must meet the requirements described 

in paragraph (d) of this section. 

(7) Food Package VII—Fully 

breastfeeding (enhanced)—(i) 

Participant category served. This food 

package is designed for issuance to 

breastfeeding women up to 1 year 

postpartum whose infants do not 

receive infant formula from WIC (these 

breastfeeding women are assumed to be 

fully breastfeeding their infants), and to 

all breastfeeding women during the first 

month postpartum. This food package is 

also designed for issuance to women 

participants pregnant with two or more 

fetuses, and women participants 

partially breastfeeding multiple infants. 

Women participants fully breastfeeding 

multiple infants receive 1.5 times the 

supplemental foods provided in Food 

Package VII. 

(ii) Authorized categories of 

supplemental foods. Milk, cheese, 

breakfast cereal, juice, fruits and 

vegetables, whole wheat bread or other 

whole grains, eggs, legumes, peanut 

butter, and canned fish are the 

categories of supplemental foods 

authorized in this food package. Cheese 

or calcium-set tofu may be substituted 

for milk in amounts described in Table 

2 of paragraph (e)(10) of this section. 

Amounts of cheese or calcium-set tofu 

exceeding the maximum substitution 

allowances may be allowed with 

medical documentation of the 

qualifying condition, up to the 

maximum allowance for fluid milk. A 

health care professional licensed by the 

State to write prescriptions must make 

a medical determination and provide 

medical documentation that a woman 

cannot drink milk and requires 

additional cheese or calcium-set tofu. 

Such determination can be made for 

situations that include, but are not 

limited to, milk allergy or severe lactose 

maldigestion. Medical documentation 

must meet the requirements described 

in paragraph (d) of this section. 

(8) Supplemental Foods—Maximum 

monthly allowances, options and 

substitution rates, and minimum 

requirements. Tables 1 through 3 of 


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paragraphs (e)(9) through (e)(11) of this 

section specify the maximum monthly 

allowances of foods in WIC food 

packages and identify WIC food options 

and substitution rates. Table 4 of 

paragraph (e)(12) of this section 

describes the minimum requirements 

and specifications of supplemental 

foods in the WIC food packages. 

(9) Maximum monthly allowances of 

supplemental foods for infants. The 

maximum monthly allowances, options 

and substitution rates of supplemental 

foods for infants in Food Packages I, II 

and III are stated in Table 1 as follows: 

TABLE 1.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR INFANTS IN FOOD PACKAGES I, II AND III 

Foods 1

Fully formula fed (FF) Partially breastfed 

(BF/FF) 

Fully breastfed (BF) 

Food packages I–

FF & III–FF 

A: 0 through 3 

months 

B: 4 through 5 

months 

Food packages II–

FF & III–FF 

6 through 11 

months 

Food packages I–

BF/FF & III BF/FF 

A: 1 through 3 

months 2

B: 4 through 5 

months 

Food packages II–

BF/FF & III BF/FF 

6 through 11 

months 

Food package I–

BF 

0 through 5 

months 

Food package 

II–BF & III BF 

6 through 11 

months 

Infant formula 3456

and Exempt Infant formula.

A: 806 fl. oz. reconstituted liquid 

concentrate or 

800 fl. oz. RTF 

or 870 fl. oz. reconstituted powder.

624 fl. oz. reconstituted liquid concentrate or 640 

fl. oz. RTF or.

A: 364 fl. oz. reconstituted liquid 

concentrate or 

364 fl. oz. RTF 

or 435 fl. oz. reconstituted powder.

312 fl. oz. reconstituted liquid concentrate or 320 

fl. oz. RTF or.

B: 884 fl. oz. reconstituted liquid 

concentrate or 

896 fl. oz. RTF 

or 960 fl. oz. reconstituted powder.

696 fl. oz. reconstituted powder.B: 442 fl. oz. reconstituted liquid 

concentrate or 

448 fl. oz. RTF 

or 522 fl. oz. reconstituted powder.

384 fl. oz. reconstituted powder.

Infant cereal 7 ......... ............................... 24 oz ..................... ............................... 24 oz ..................... ........................... 24 oz. 

Infant food 7 8 fruits 

and vegetables 

Infant food meat.

............................... 128 oz ................... ............................... 128 oz ................... ........................... 256 oz. 

77.5 oz. 

Table 1 Footnotes: (abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially breastfed (i.e., the infant is 

breastfed but also receives formula from the WIC Program in an amount not to exceed approximately half the amount of formula allowed for a 

fully formula fed infant); BF = fully breastfed (i.e., the infant receives no formula through the WIC program). 1Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. 

2The powder form is the form recommended for partially breastfed infants, ages 1 through 3 months in Food Package I. 

3The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, ready-to-feed (RTF) liquid, and powder 

forms of infant formula and exempt infant formula. Reconstituted fluid ounce is the form prepared for consumption as directed on the container. 4Only infant formula may be issued for infants in Food Packages I and II. Exempt infant formula may only be issued for infants in Food Package III. 5 If powder infant formula is provided, State agencies must provide at least the number of reconstituted fluid ounces as the maximum allowance for the liquid concentrate form of the same product in the same Food Package up to the maximum monthly allowance for powder. State 

agencies must issue whole containers that are all the same size. 6State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the full authorized nutritional benefit (FNB). State agencies must use the methodology described in accordance with paragraph (h)(1) of 

this section. 7State agencies may round up and disperse whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the Food 

Package timeframe. .State agencies must use the methodology described in accordance with paragraph (h)(2) of this section. 8Fresh banana may replace up to 16 ounces of baby food fruit at a rate of 1 pound of bananas per 8 ounces of baby food fruit. 

(10) Maximum monthly allowances of 

supplemental foods in Food Packages 

IV through VII. The maximum monthly 

allowances, options and substitution 

rates of supplemental foods for children 

and women in Food Package IV through 

VII are stated in Table 2 as follows: 

TABLE 2.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES

IV, V, VI AND VII 

Foods 1

Children Women 

Food package IV: 1 

through 4 years 

Food package V: Pregnant 

and partially breastfeeding 

(up to 1 year postpartum) 2

Food package VI: 

Postpartum (up to 6 

months postpartum) 3

Food package VII: Fully 

breastfeeding (enhanced), 

(up to 1 year postpartum) 4 5

Juice, single strength 6 ...... 128 fl oz ............................ 144 fl oz ............................ 96 fl oz .............................. 144 fl oz. 

Milk, fluid ........................... 16 qt 7 8 9 10 ......................... 22 qt 7 8 11 12 ....................... 16 qt 7 8 11 12 ....................... 24 qt 7 8 11 12

Breakfast cereal ................ 36 oz ................................. 36 oz ................................. 36 oz ................................. 36 oz. 

Cheese .............................. N/A .................................... N/A .................................... N/A .................................... 1 lb. 

Eggs .................................. 1 dozen ............................. 1 dozen ............................. 1 dozen ............................. 2 dozen. 


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TABLE 2.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES

IV, V, VI AND VII—Continued 

Foods 1

Children Women 

Food package IV: 1 

through 4 years 

Food package V: Pregnant 

and partially breastfeeding 

(up to 1 year postpartum) 2

Food package VI: 

Postpartum (up to 6 

months postpartum) 3

Food package VII: Fully 

breastfeeding (enhanced), 

(up to 1 year postpartum) 4 5

Fruits and vegetables 13 14 $6.00 in cash value vouchers.$8.00 in cash value vouchers.$8.00 in cash value vouchers.$8.00 in cash value vouchers. 

Whole wheat bread or 

other whole grains 15.

2 lb .................................... 1 lb .................................... N/A .................................... 1 lb. 

Fish (canned) .................... N/A .................................... N/A .................................... N/A .................................... 30 oz. 

Legumes, dry 16 ................. 1 lb .................................... 1 lb .................................... 1 lb .................................... 1 lb. 

And/or Peanut butter ......... Or 18 oz ............................ And 18 oz .......................... Or 18 oz ............................ And 18 oz. 

Table 2 Footnotes: N/A = the supplemental food is not authorized in the corresponding food package. 

1Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. 

2Food Package V is issued to two categories of WIC participants: Women participants with singleton pregnancies and breastfeeding women 

whose partially breastfed infants receive formula from the WIC Program in amounts that do not exceed the maximum formula allowances for 

Food Packages I–BF/FF–A, I–BF/FF–B, or II–BF/FF, as appropriate for the age of the infant. 3Food Package VI is issued to two categories of WIC participants: Non-breastfeeding postpartum women and breastfeeding postpartum 

women whose partially breastfed infants receive more than the maximum infant formula allowances for Food Packages I–BF/FF–A, I–BF/FF–B, 

or II–BF/FF, as appropriate for the age of the infant. 4Food Package VII is issued to 4 categories of WIC participants: Fully breastfeeding women whose infants do not receive formula from the 

WIC Program; all breastfeeding women during the first month postpartum; women pregnant with two or more fetuses; and women fully or partially breastfeeding multiple infants. 5Women fully breastfeeding multiple infants are prescribed 1.5 times the maximum allowances. 

6 Combinations of single-strength and concentrated juices may be issued provided that the total volume does not exceed the maximum monthly allowance for single-strength juice. 7Whole milk, as specified in FDA standards, is the only type of milk allowed for 1-year-old children (12 through 23 months). Reduced fat milks, 

as specified in FDA standards, i.e., 2% milk fat, are the only types of milk allowed for children ≥ 24 months of age and women. 8Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate to fluid milk. When a combination of different milk forms is provided, the 

full maximum monthly fluid milk allowance must be provided. 9For children, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. No more than 1 lb. of cheese may be 

substituted for milk. With medical documentation, additional amounts of cheese may be substituted in cases of lactose intolerance or other qualifying conditions, up to the maximum allowance for fluid milk. 10For children, soy-based beverage and calcium-set tofu may be substituted for milk only with medical documentation for qualifying conditions. 

Soy-based beverages may be substituted for milk, with medical documentation, for children in Food Package IV on a quart for quart basis up to 

the total maximum allowance of milk. Tofu may be substituted for milk, with medical documentation, for children in Food Package IV at the rate 

of 1 pound of tofu per 1 quart of milk up to the total maximum allowance of milk. 11For women, cheese or calcium-set tofu may be substituted for milk at the rate of l pound of cheese per 3 quarts of milk or 1 pound of tofu 

per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in this manner in Food Packages V and VI; however, no more than 1 

pound of cheese may be substituted for milk. A maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, 

no more than 2 lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions. 12For women, soy-based beverage may be substituted for milk at the rate of 1 quart of soy-based beverage for 1 quart of milk up to the total 

maximum monthly allowance of milk. 13Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables. Dried fruit and dried vegetables 

are not authorized for children in Food Package IV. 14The maximum value of the vouchers may be adjusted in whole dollar increments to reflect accrued annual, un-rounded inflationary increases. 15Brown rice, bulgur, oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be substituted for whole wheat bread on an equal 

weight basis. 16 Canned legumes may be substituted for dried legumes at the rate of 64 oz of canned beans for 1 lb dried beans. Under Food Packages V 

and VII, two additional combinations of dry or canned beans/peas are authorized: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry or 128 oz. Canned beans/peas (and no peanut butter) or 36 oz. peanut butter (and no beans). 

(11) Maximum monthly allowances of 

supplemental foods for children and 

women with qualifying conditions in 

Food Package III. The maximum 

monthly allowances, options and 

substitution rates of supplemental foods 

for participants with qualifying 

conditions in Food Package III are stated 

in Table 3 as follows: 

TABLE 3.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGE

III 

Foods 1

Children Women 

1 through 4 years 

Pregnant and partially 

breastfeeding (up to 1 year 

postpartum) 2

Postpartum (up to 6 

months postpartum) 3

Fully breastfeeding (enhanced), (up to 1 year 

post-partum) 4 5

Juice, single strength 6 ...... 128 fl. oz ........................... 144 fl. oz ........................... 96 fl. oz ............................. 144 fl. oz. 

WIC Formula 7 8 ................. 455 fl. oz. liquid concentrate.455 fl. oz. liquid concentrate.455 fl. oz. liquid concentrate.455 fl. oz. liquid concentrate. 

Milk .................................... 16 qt 9 10 11 12 ...................... 22 qt 9 10 13 14 ...................... 16 qt 9 10 13 14 ...................... 24 qt. 9 10 13 14

Breakfast cereal 15 ............. 36 oz ................................. 36 oz ................................. 36 oz ................................. 36 oz. 


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TABLE 3.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGE

III—Continued 

Foods 1

Children Women 

1 through 4 years 

Pregnant and partially 

breastfeeding (up to 1 year 

postpartum) 2

Postpartum (up to 6 

months postpartum) 3

Fully breastfeeding (enhanced), (up to 1 year 

post-partum) 4 5

Cheese .............................. N/A .................................... N/A .................................... N/A .................................... 1 lb. 

Eggs .................................. 1 dozen ............................. 1 dozen ............................. 1 dozen ............................. 2 dozen. 

Fruits and vegetables 16 17 $6.00 in cash value voucher.$8.00 in cash value vouchers.$8.00 in cash value vouchers.$8.00 in cash value vouchers. 

Whole wheat bread 18 ....... 2 lb .................................... 1 lb .................................... N/A .................................... 1 lb. 

Fish (canned) .................... N/A .................................... N/A .................................... N/A .................................... 30 oz. 

Legumes, dry 19 ................. 1 lb .................................... 1 lb .................................... 1 lb .................................... 1 lb. 

And/or Peanut butter ......... Or 18 oz ............................ And 18 oz .......................... Or 18 oz ............................ And 18 oz. 

Table 3 Footnotes: N/A= the supplemental food is not authorized in the corresponding food package 

1Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. 

2 Issued to two categories of WIC participants—women participants with singleton pregnancies and breastfeeding women whose partially 

breastfed infants receive formula from the WIC Program in amounts that do not exceed the maximum formula allowances for Food Packages I–

BF/FF–A, I–BF/FF–B, or II–BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 3 Issued to two categories of WIC participants—non-breastfeeding postpartum women and breastfeeding postpartum women whose partially 

breastfed infants receive more than the maximum formula allowances for Food Packages I–BF/FF–A, I–BF/FF–B, or II–BF/FF, as appropriate for 

the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 4 Issued to 4 categories of WIC participants—fully breastfeeding women whose infants do not receive formula from the WIC Program; all 

breastfeeding women during the first month postpartum; women pregnant with two or more fetuses; and women fully or partially breastfeeding 

multiple infants. 5Women fully breastfeeding multiple infants are prescribed 1.5 times the maximum allowances. 

6 Combinations of single-strength and concentrated juices may be issued provided that the total volume does not exceed the maximum monthly allowance for single-strength juice. 7WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food. 

8Powder and Ready-to-Feed may be substituted at rates that provide comparable nutritive value. 

9Whole milk (not less than 3.25% milk fat) is the only type of milk allowed for 1-year-old children (12 through 23 months). Reduced fat milks 

(up to 2% milk fat) are the only types of milk allowed for children ≥24 months of age and women. 10Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce 

substitution ratio. Dry milk may be substituted at an equal reconstituted rate to fluid milk. When a combination of different milk forms is provided, 

the full maximum monthly fluid milk allowance must be provided. 11For children, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. No more than 1 lb. of cheese may be 

substituted for milk. With medical documentation, additional amounts of cheese may be substituted in cases of lactose intolerance or other qualifying conditions, up to the maximum allowance for fluid milk. 12For children, soy-based beverage and tofu may substituted for milk only with medical documentation for qualifying conditions. Soy-based 

beverages may be substituted for milk, with medical documentation, for children in Food Package IV on a quart for quart basis up to the total 

maximum allowance of milk. Tofu may be substituted for milk, with medical documentation, for children in Food Package IV at the rate of 1 

pound of tofu per 1 quart of milk up to the total maximum allowance of milk. 13For women, cheese or calcium-set tofu may be substituted for milk at the rate of l pound of cheese per 3 quarts of milk or 1 pound of tofu 

per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in this manner in Food Packages V and VI; however, no more than 1 

pound of cheese may be substituted for milk. A maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, 

no more than 2 lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions. 14For women, soy-based beverage may be substituted for milk at the rate of 1 quart of soy-based beverage for 1 quart of milk up to the total 

maximum monthly allowance of milk. 15 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal. 16Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables. Dried fruit and dried vegetables 

are not authorized for children. 17The maximum value of the vouchers may be adjusted in whole dollar increments to reflect accrued annual, un-rounded inflationary increases. 18Brown rice, bulgur, oatmeal, whole-grain barley barley, soft corn or whole wheat tortillas may be substituted for whole wheat bread on an 

equal weight basis. 19 Canned legumes may be substituted for dried legumes at the rate of 64 oz of canned beans for 1 lb dried beans. Issuance of two additional 

combinations of dry or canned beans/peas is authorized for the Pregnant and Partially Breastfeeding (up to 1 year postpartum) category and 

Fully Breastfeeding (Enhanced) (up to 1 year postpartum) category: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry 

or 128 oz. Canned beans/peas (and no peanut butter) or 36 oz. Peanut butter (and no beans). 

(12) Minimum requirements and 

specifications for supplemental foods. 

Table 4 describes the minimum 

requirements and specifications for 

supplemental foods in all food 

packages: 

TABLE 4.—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS

Categories/foods Minimum requirements and specifications 

WIC formula: 

Infant formula ............................................... All authorized infant formulas must (1) meet the definition for an infant formula in section 

201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic 

Act, as amended (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107; 

(2) be designed for enteral digestion via an oral or tube feeding; 

(3) provide at least 10 mg iron per liter (at least 1.8 mg iron/ 100 kilocalories) at standard dilution; 


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44820 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE 4.—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS—Continued 

Categories/foods Minimum requirements and specifications 

(4) provide at least 67 kilocalories per 100 milliliters (approximately 20 kilocalories per fluid 

ounce) at standard dilution. 

(5) not require the addition of any ingredients other than water prior to being served in a liquid 

state. 

Exempt infant formula ................................. All authorized exempt infant formula must (1) meet the definition and requirements for an exempt infant formula under section 412(h) of the Federal Food, Drug, and Cosmetic Act as 

amended (21 U.S.C. 350a(h)) and the regulations at 21 CFR parts 106 and 107; and 

(2) be designed for enteral digestion via an oral or tube feeding. 

WIC-eligible medical foods 1 ........................ Certain enteral products that (1) are specifically formulated to provide nutritional support for 

woman or children with a qualifying condition when the use of conventional food is precluded, restricted or inadequate; 

(2) must serve the purpose of a food, meal or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; 

(3) must be designed for enteral digestion via an oral or tube feeding; 

(4) may not be a conventional food, drug, flavoring or enzyme; and 

(5) include many but not all products that meet the definition of medical foods in Section 

5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). 

Milk and milk alternatives: 

Cow’s milk ................................................... Must conform to FDA standard of identity for whole, reduced fat, low-fat, or non-fat milks (21 

CFR 131.110). Must be pasteurized and contain at least 400 IU of vitamin D per quart (100 

IU per cup) and 2000 IU of vitamin A per quart (500 IU per cup). 

May be flavored or unflavored. May be fluid, shelf-stable, evaporated (21 CFR 131.130), or 

dried (i.e., powder) (21 CFR 131.147).2

Cultured Milks. Must conform to FDA standard of identity for cultured milk (21 CFR 131.112—

cultured buttermilk, kefir cultured milk, acidophilus cultured milk). 

Goat Milk ..................................................... Must conform to FDA standard of identity for whole, reduced fat, low-fat, or non-fat milks (21 

CFR 131.110). Must be pasteurized and contain at least 400 IU of vitamin D per quart (100 

IU per cup) and 2000 IU of vitamin A per quart (500 IU per cup) following FDA fortification 

standards (21 CFR 131). May be flavored or unflavored. May be fluid, shelf-stable, evaporated (21 CFR 131.130), or dried (i.e., powdered) (21 CFR 131.147).2

Cheese ........................................................ Domestic cheese made from 100 percent pasteurized milk. Must conform to FDA standard of 

identity (21 CFR 133); Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster, 

Provolone, part-skim or whole Mozzarella, pasteurized processed American, or blends of 

any of these cheeses are authorized. 

Cheeses that are labeled low, free, reduced, less or light in the nutrients of sodium, fat or cholesterol are WIC-eligible.3

Tofu .............................................................. Calcium-set tofu prepared with only calcium salts (e.g., calcium sulfate). May not contain 

added fats, sugars, oils, or sodium. 

Soy-based beverage ................................... Must be fortified to meet the following nutrient levels: 276 mg calcium per cup, 8 g protein per 

cup, 500 IU vitamin A per cup, 100 IU vitamin D per cup, 24 mg magnesium per cup, 222 

phosphorus per cup, 349 mg potassium per cup, 0.44 mg riboflavin per cup, and 1.1 mcg vitamin B12 per cup, in accordance with fortification guidelines issued by FDA. 

Juice .................................................................... Must be pasteurized 100% unsweetened fruit juice. Must conform to FDA standard of identity 

(21 CFR Part 146) or vegetable juice must conform to FDA standard of identity (21 CFR 

Part 156) and contain at least 30 mg of vitamin C per 100 mL of juice. With the exception of 

100 percent citrus juices, State agencies must verify the vitamin C content of all State-approved juices. Juices that are fortified with other nutrients may be allowed at the State agency’s option. Juice may be fresh, from concentrate, frozen, canned, or shelf-stable. 

Vegetable juice may be regular or lower in sodium.3

Breakfast cereal .................................................. Breakfast cereals as defined by FDA in 21 CFR 170.3(n)(4) for ready-to-eat and instant and 

regular hot cereals. 

Meet labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat 

content’’: 4

(1) contain a minimum of 51% whole grains (using dietary fiber as the indicator); 

(2) meet the regulatory definitions for ‘‘low saturated fat’’ at 21 CFR 101.62 (≤1 g saturated fat 

per RACC) and ‘‘low cholesterol’’ (≤20 mg cholesterol per RACC); 

(3) bear quantitative trans fat labeling; and 

(4) contain ≤6.5 g total fat per RACC and ≤0.5 g trans fat per RACC. 

Contain a minimum of 28 mg iron per 100 g dry cereal. 

Contain ≤21.2 g sucrose and other sugars per 100 g dry cereal (≤6 g per dry oz). 

Eggs .................................................................... Fresh shell domestic hens’ eggs or dried eggs mix. Must conform to FDA standard of identity 

in 21 CFR 160.105 or pasteurized liquid whole eggs (must conform to FDA standard of 

identity in 21 CFR 160.115). 

Hard boiled eggs, where readily available for purchase in small quantities, may be provided for 

homeless participants. 

Fruits and Vegetables (fresh and processed) .... Any variety of fresh whole or cut fruit without added sugars.5

Any variety of fresh whole or cut vegetable, except white potatoes, without added sugars, fats, 

or oils (orange yams and sweet potatoes are allowed).5

Any variety of canned 6 fruits (must conform to FDA standard of identity (21 CFR 145); including applesauce; juice pack or water pack without added sugars, fats, oils, or salt (i.e., sodium). Any variety of frozen fruits without added sugars.7


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TABLE 4.—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS—Continued 

Categories/foods Minimum requirements and specifications 

Any variety of canned 6 or frozen vegetables (must conform to FDA standard of identity (21 

CFR Part 155)) except white potatoes (orange yams and sweet potatoes are allowed); without added sugars, fats, or oils. May be regular or lower in sodium.3 7

Any type of dried fruits or dried vegetable without added sugars, fats, oils, or salt (i.e., sodium).5

Whole wheat bread or other whole grains ......... Whole wheat bread (must conform to FDA standard of identity (21 CFR 136.180)). 

OR 

Meet labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat 

content’’: 4

(1) contain a minimum of 51% whole grains (using dietary fiber as the indicator); 

(2) meet the regulatory definitions for ‘‘low saturated fat’’ at 21 CFR 101.62 (≤1 g saturated fat 

per RACC) and ‘‘low cholesterol’’(≤20 mg cholesterol per RACC); 

(3) bear quantitative trans fat labeling; and 

(4) contain ≤6.5 g total fat per RACC and ≤0.5 g trans fat per RACC. 

Brown rice, bulgur, oatmeal, whole-grain barley without added sugars, fats, oils, or salt (i.e., 

sodium). May be instant-, quick-, or regular-cooking. 

Soft corn or whole wheat tortillas without added fats or oils may be allowed at the State agency’s option. 

Canned fish 6 ...................................................... Canned only: light tuna (must conform to FDA standard of identity (21 CFR 161.190)); salmon 

(must conform to FDA standard of identity (21 CFR 161.170)); 

Sardines. 

May be packed in water or oil. Pack may include bones or skin. May be regular or lower in sodium content.3

Mature legumes (dry beans and peas) .............. Any type of mature dry beans, peas, or lentils in dry-packaged or canned 6 forms. Examples 

include but are not limited to black beans (‘‘turtle beans’’), blackeye peas (cowpeas of the 

blackeye variety, ‘‘cow beans’’), garbanzo beans (chickpeas), great northern beans, kidney 

beans, lima beans (‘‘butter beans’’), navy beans, pinto beans, soybeans, split peas, and lentils. All categories exclude soups. May not contain added sugars, fats, oils or meat as purchased. Canned legumes may be regular or lower in sodium content. 3 8

Baked beans may be provided for participants with limited cooking facilities.8

Peanut butter ...................................................... Peanut butter and reduced fat peanut butter (must conform to FDA Standard of Identity (21 

CFR 164.150)); creamy or chunky, regular or reduced fat, salted or unsalted 3 forms are allowed. 

Infant Foods: 

Infant cereal ................................................. Infant cereal, must contain a minimum of 45 mg of iron per 100 g of dry cereal.9

Infant fruits ................................................... Any variety of single ingredient commercial infant food fruit without added sugars, starches, or 

salt (i.e., sodium). Texture may range from strained through diced.10

Infant vegetables ......................................... Any variety of single ingredient commercial infant food vegetables without added sugars, 

starches, or salt (i.e., sodium). Texture may range from strained through diced.11

Infant meat ................................................... Any variety of single ingredient commercial infant food meat without added sugars, starches, 

vegetables or salt (i.e., sodium). Broth (unsalted, i.e., without added sodium) may be an ingredient. Texture may range from pureed through diced.12

Table 4 Footnotes: FDA = Food and Drug Administration of the U.S. Department of Health and Human Services; RACC = reference amount 

customarily consumed. 1The following are not considered a WIC eligible medical food: Formulas used solely for the purpose of enhancing nutrient intake, managing 

body weight, addressing picky eaters or used for a condition other than a qualifying condition (e.g., vitamin pills, weight control products, etc.); 

medicines or drugs, as defined by the Food, Drug and Cosmetic Act (21 U.S.C. 350a) as amended; enzymes, herbs, or botanicals; oral rehydration fluids or electrolyte solutions; flavoring or thickening agents; and feeding utensils or devices (e.g., feeding tubes, bags, pumps) designed to 

administer a WIC-eligible formula. 2All authorized milks must confirm to FDA, DHHS standards of identity for milks as defined by 21 CFR Part 131 and meet WIC’s requirements 

for vitamin fortification as stated above. Additional authorized milks include, but are not limited to: calcium-fortified, lactose-reduced and lactosefree, acidified, and UHT pasteurized milks. Other milks are permitted at the State agency’s discretion provided that the State agency determines 

that the milk meets the minimum requirements for an authorized milk. 3Any of the following lower sodium forms are allowable: Sodium-free—less than 5 mg sodium per serving; Very low sodium—35 mg sodium or 

less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 35 mg sodium or less per 50 g of the food; Low-sodium—140 mg sodium or less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 140 mg sodium or less per 50 g of the food; Light in sodium—

at least 50 percent less sodium per serving than average reference amount for same food with no sodium reduction; Lightly salted—at least 50 

percent less sodium per serving than reference amount (If the food is not ‘‘low in sodium,’’ the statement ‘‘not a low-sodium food’’ must appear 

on the same panel as the Nutrition Facts panel.); and Reduced or less sodium—at least 25 percent less sodium per serving than reference food. 4Food and Drug Administration (FDA), Health Claim Notification for Whole Grain Foods with Moderate Fat Content at http://www.cfsan.fda.gov/ 

dms/flgrain2.html 5 Herbs or spices; edible blossoms and flowers, e.g., squash blossoms (broccoli, cauliflower and artichokes are allowed); creamed or sauced 

vegetables; vegetable-grain (pasta or rice) mixtures; fruit-nut mixtures; breaded vegetables; fruits and vegetables for purchase on salad bars; 

peanuts; ornamental and decorative fruits and vegetables such as chili peppers on a string; garlic on a string; gourds; painted pumpkins; fruit 

baskets and party vegetable tray; and items such as blueberry muffins and other baked goods are not authorized. Mature legumes (dry beans 

and peas) and juices are provided as separate food WIC categories and are not authorized under the fruit and vegetable category. 6 ‘‘Canned’’ refers to processed food items in cans or other shelf-stable containers, e.g., jars, pouches. 7Excludes white potatoes; catsup or other condiments; pickled vegetables, olives; soups; juices; and fruit leathers and fruit roll-ups. 8The following canned mature legumes are not authorized: soups; immature varieties of legumes, such as those used in canned green peas, 

green beans, snap beans, orange beans, and wax beans; baked beans with meat; e.g., beans and franks; and beans containing added sugars 

(with the exception of baked beans), fats, meat, or oils. 9 Infant cereals containing infant formula, milk, fruit, or other non-cereal ingredients are not allowed. 

10 Mixtures with cereal or infant food desserts (e.g., peach cobbler) are not authorized; however, combinations of single ingredients (e.g., 

apple-banana) are allowed. 11 Combinations of single ingredients (e.g., peas and carrots) are allowed. 


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44822 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

12 No infant food combinations (e.g., meat and vegetables) or dinners (e.g., spaghetti and meatballs) are allowed. 

(f) USDA purchase of commodity 

foods. (1) At the request of a State 

agency, the Department may purchase 

commodity foods for the State agency 

using funds allocated to the State 

agency. The commodity foods 

purchased and made available to the 

State agency must be equivalent to the 

foods specified in Table 4 of paragraph 

(e)(12) of this section. 

(2) The State agency must: 

(i) Distribute the commodity foods to 

its local agencies or participants; and 

(ii) Ensure satisfactory storage 

facilities and conditions for the 

commodity foods, including 

documentation of proper insurance. 

(g) Infant formula manufacturer 

registration. Infant formula 

manufacturers supplying formula to the 

WIC Program must be registered with 

the Secretary of Health and Human 

Services under the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et 

seq.). Such manufacturers wishing to 

bid for a State contract to supply infant 

formula to the program must certify 

with the State health department that 

their formulas comply with the Federal 

Food, Drug, and Cosmetic Act and 

regulations issued pursuant to the Act. 

(h) Rounding up. State agencies may 

round up to the next whole container 

for either infant formula or infant foods 

(infant cereal, fruits, vegetables and 

meat). State agencies that use the 

rounding up option must calculate the 

amount of infant formula or infant foods 

provided according to the requirements 

and methodology as described in this 

section. 

(1) Infant Formula. State agencies 

must use the maximum monthly 

allowance of reconstituted fluid ounces 

of liquid concentrate infant formula as 

specified in Table 1 of paragraph (e)(9) 

of this section as the full nutritional 

benefit (FNB) provided by infant 

formula for each food package category 

and infant feeding option (e.g., Food 

Package I A fully formula fed, IA–FF). 

When using the rounding up option for 

infant formula, State agencies must 

issue whole containers that provide at 

least the FNB but not more than the 

maximum monthly allowances as 

specified in Table 1 of paragraph (e)(9) 

of this section. 

(i) State agencies that use rounding up 

of infant formula must: 

(A) Use the methodology described in 

paragraph (h)(1)(iii) of this section for 

calculating and dispersing the rounding 

up option; 

(B) Issue infant formula in whole 

containers that are all the same size; and 

(C) Disperse the number of whole 

containers as evenly as possible over the 

timeframe (the number of months the 

participant will receive the food 

package). 

(ii) The methodology to calculate 

rounding up and dispersing infant 

formula to the next whole container 

over the food package timeframe is as 

follows: 

(A) Multiply the FNB amount for the 

appropriate food package and feeding 

option (e.g. Food Package I A fully 

formula fed, IA–FF) by the timeframe 

the participant will receive the food 

package to determine the total amount 

of infant formula to be provided. The 

timeframe will vary depending on the 

food package category and infant 

feeding option. 

(B) Divide the total amount of infant 

formula provided by the yield of the 

container (in reconstituted fluid ounces) 

issued by the State agency to determine 

the total number of containers to be 

issued during the timeframe that the 

food package is prescribed. 

(C) If the number of containers to be 

issued does not result in a whole 

number of containers, the State agency 

must round up to the next whole 

container in order to issue whole 

containers. 

(2) Infant foods. (i) State agencies may 

use the rounding up option to the next 

whole container of infant food (infant 

cereal, fruits, vegetables and meats) 

when the maximum monthly allowance 

cannot be issued due to varying 

container sizes of authorized infant 

foods. 

(ii) State agencies that use the 

rounding up option for infant foods 

must: 

(A) Use the methodology described in 

paragraph (h)(2)(iii) of this section for 

calculating and dispersing the rounding 

up option; 

(B) Issue infant foods in whole 

containers; and 

(C) Disperse the number of whole 

containers as evenly as possible over the 

timeframe (the number of months the 

participant will receive the food 

package). 

(iii) The methodology to round up 

and disperse infant food is as follows: 

(A) Multiply the maximum monthly 

allowance for the infant food by the 

timeframe the participant will receive 

the food package to determine the total 

amount of food to be provided. 

(B) Divide the total amount of food 

provided by the container size issued by 

the State agency (e.g., ounces) to 

determine the total number of food 

containers to be issued during the 

timeframe that the food package is 

prescribed. 

(C) If the number of containers to be 

issued does not result in a whole 

number of containers, the State agency 

must round up to the next whole 

container in order to issue whole 

containers. 

In § 246.12, paragraph (g)(3)(i) is 

revised to read as follows: 

§ 246.12 Food delivery systems. 

* * * * * 

(g) * * * 

(3) * * * 

(i) Minimum variety and quantity of 

supplemental foods. The State agency 

must establish minimum requirements 

for the variety and quantity of 

supplemental foods that a vendor 

applicant must stock to be authorized. 

These requirements must include that 

the vendor stock at least two varieties of 

fruits and vegetables authorized by the 

State agency. The State agency may not 

authorize a vendor applicant unless it 

determines that the vendor applicant 

meets these minimums. The State 

agency may establish different 

minimums for different vendor peer 

groups. 

* * * * * 

Dated: July 20, 2006. 

Eric M. Bost, 

Under Secretary for Food, Nutrition and 

Consumer Services. 

Appendix 

Note: This appendix will not be published 

in the Code of Federal Regulations. 

Regulatory Impact Analysis 

7 CFR 246: Special Supplemental Nutrition 

Program for Women, Infants, and Children 

(WIC): Revisions in the WIC Food Packages 

Proposed Rule 

Executive Summary 

The WIC program addresses the 

supplemental nutritional needs of at-risk 

groups through the distribution of 

supplemental food packages, and a program 

of nutrition education that includes 

counseling, health and social service 

referrals, and breastfeeding promotion and 

support. WIC nutrition education provisions 

are governed by broad regulatory language 

that allows nutrition education provided to 

participants to respond to the supplemental 

nutrition needs of participants in light of 

changes in dietary and health research. In 

contrast, WIC supplemental food packages 

are defined very specifically in the regulatory 

language. Consequently, as the population 

served by WIC has grown and become more 

diverse over the last 20 years and as food 

consumption habits have changed, the 


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1 7 CFR 246.7(e). 

2 Id. 

3 7 CFR 246.11. 

nutritional risks faced by participants have 

changed. Also, though nutrition science has 

advanced, the WIC supplemental food 

packages have remained largely unchanged. 

A rule is needed to implement recommended 

changes to the WIC food packages based on 

the current supplemental nutritional needs of 

WIC participants and advances in nutrition 

science. 

The proposed rule would revise 

regulations governing the WIC food packages 

to revise the maximum monthly allowances 

and minimum requirements for certain 

supplemental foods; revise the substitution 

rates for certain supplemental foods and 

allow additional foods as alternatives; revise 

age specifications for assignment to infant 

food packages; add foods to children and 

women food packages; and address general 

provisions that apply to all food packages. 

The revisions reflect recommendations made 

by the Institute of Medicine of the National 

Academies in its Report ‘‘WIC Food 

Packages: Time for a Change,’’ and certain 

administrative revisions found necessary by 

the Department. 

The revisions would also bring the WIC 

food packages in line with the 2005 Dietary 

Guidelines for Americans and current infant 

feeding practice guidelines of the American 

Academy of Pediatrics: better promote and 

support the establishment of successful longterm breastfeeding; provide WIC participants 

with a wider variety of food; provide WIC 

State agencies with greater flexibility in 

prescribing food packages to accommodate 

participants with cultural food preferences; 

and, serve all participants with certain 

medical provisions under one food package 

to facilitate efficient management of 

participants with special dietary needs. 

Significant changes in the food packages 

include: the classification of infants in Food 

Packages I and II and mothers in Food 

Packages V, VI, and VII according to 

breastfeeding practice; eliminating juice from 

Food Packages I and II; adding infant foods 

and meat for fully breastfed infants in Food 

Package II; adding whole grains, and fruits 

and vegetables to food packages for children 

(IV) and women (V and VII only); and, 

revising the purpose, content and 

requirements for Food Package III, currently 

for children and women with special dietary 

needs. 

Under the proposed rule, revisions to the 

WIC food packages are cost-neutral to the 

Federal Government. Specifically, FNS 

estimates that the changes will result in a 

cost savings of $34 million dollars over five 

years, a negligible amount relative to the 

program’s annual cost of more than $5 

billion. 

Table of Contents 

Action 

Nature 

Need 

Affected Parties 

Effects 

Background 

Current WIC Food Packages and Changing 

Nutritional Priorities 

Changing Demographics of the WIC 

Population 

Institute of Medicine’s Recommendations 

Summary of Rule and Benefits 

Food Package I 

Package II 

Food Package III 

Food Package IV 

Food Package V 

Food Package VI 

Food Package VII 

Other Provisions 

Summary of Key Provisions 

Costs 

Proposed Rule 

Major Cost Drivers 

Fruit and Vegetables Option 

Cost Estimate Methodology 

Food Costs 

Prescriptions 

Infant Formula and Rounding 

Redemption Rates 

Food Prices 

Participant Projections 

Phased Implementation 

State Cost Variation 

Administrative Costs 

Uncertainties 

Price Volatility in the Dairy Market 

Reduce Assumed Preference for Soy 

Beverage 

Alternatives 

Include Yogurt as a Milk Substitute for 

Food Packages IV–VII 

More Restrictive Dark Green and Orange 

Vegetable Rule 

No Infant food Fruits, Vegetables or Meats 

for Infants 6 Mos and Older 

Drop the Whole Grain Requirement for 

Both Bread and Cereal 

Market Share Analysis 

Appendix: Additional Cost Estimate 

Assumptions 

Date: July 17, 2006. 

Agency: USDA, Food and Nutrition 

Service. 

Contact: Cindy Long. 

Phone: (703) 305–2340. 

Fax: (703) 305–2576. 

E-mail: cindy.long@fns.usda.gov. 

Title: 7 CFR 246: Special Supplemental 

Nutrition Program for Women, Infants, and 

Children (WIC): Revisions in the WIC Food 

Packages. 

Action 

A. Nature 

Proposed Rule. 

B. Need 

The WIC program addresses the 

supplemental nutritional needs of at-risk 

groups through the distribution of age and 

condition specific food packages, and a 

program of nutrition education that includes 

counseling, health and social service 

referrals, and breastfeeding promotion and 

support. WIC nutrition education provisions 

are governed by broad regulatory language 

that allows nutrition education provided to 

participants to respond to changes in dietary 

and health research. In contrast, WIC 

supplemental food packages are defined very 

specifically in the regulatory language. 

Consequently, as the population served by 

WIC has grown and become more diverse 

over the last 20 years, the nutritional risks 

faced by participants have changed, and 

though nutrition science has advanced, the 

WIC supplemental food packages have 

remained largely unchanged. This rule is 

needed to implement recommended changes 

to the WIC food packages based on the 

current supplemental nutritional needs of 

WIC participants and advances in nutrition 

science. 

C. Affected Parties 

The program affected by this rule is the 

Special Supplemental Nutrition Program for 

Women, Infants, and Children (WIC). The 

parties affected by this regulation are the 

USDA’s Food and Nutrition Service (FNS), 

State and local agencies that administer the 

WIC Program, retail vendors, and WIC 

participants. 

Effects 

The following analysis describes the 

potential economic impact of this proposed 

rule. This rule is needed due to changes in 

the population served by WIC, and advances 

in nutrition and knowledge about the 

supplemental nutritional needs of those 

served by WIC. The changes in this rule are 

significant to the costs or overall operations 

to the program. The potential effects of these 

changes are highlighted below. 

A. Background 

The WIC program was established in the 

1970s to address the special supplemental 

nutritional needs of low-income pregnant 

and postpartum women, infants, and 

children up to age five who are determined 

to be at nutritional risk. Regulations 

governing the WIC program recognize a broad 

range of nutritionally related medical 

conditions for purposes of establishing 

program eligibility. These include anemia, 

low birth weight, chronic infections, 

overweight, underweight, and similar 

manifestations of poor nutrition suitable for 

direct measurement or diagnosis.1 WIC 

regulations also recognize that personal 

medical histories, dietary patterns, and 

economic circumstances may put otherwise 

healthy women or children at nutritional 

risk. Certification may therefore be extended 

to women facing high-risk pregnancies, 

pregnant women or mothers who abuse 

alcohol or drugs, homeless women and 

children, and infants and children with 

congenital malformations that may interfere 

with adequate nutrient intake or absorption.2

WIC addresses the supplemental nutritional 

needs of at-risk groups through the 

distribution of age and condition-specific 

food packages, and a program of nutrition 

education that includes counseling, social 

service referrals, and breastfeeding 

promotion and support. 

WIC’s nutrition education provisions are 

governed by broad regulatory language that 

seeks to promote ‘‘proper nutrition,’’

‘‘optimal use’’ of WIC’s supplemental foods, 

and appropriate advice concerning non-WIC 

foods.3 Compliance with this regulatory 

mandate presumes that nutrition education 

will respond to the supplemental nutrition 

needs of participants based on advances in 


jlentini on PROD1PC65 with PROPOSAL2
44824 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

4See 42 USC 1786(a). 

5National Academies, Institute of Medicine 

(IOM). WIC Food Packages: Time for a Change, 

Washington, D.C.: The National Academies Press, 

2005. pp. 31, 64. 

6U.S. department of Agriculture, Food and 

Nutrition Web site, July 2005. www.fns.usda.gov/ 

wic/FAQs/FAQ.HTM. 

7See U.S. Department of Health and Human 

Services and U.S. Department of Agriculture, 

Dietary Guidelines for Americans, 2005, 6th edition, 

Washington D.C.: U.S. Government Printing Office, 

January 2005. (USDHHS/USDA, 2005). 

8 IOM, p.59. Note, however, that these 

conclusions are based on self-reported food 

consumption data from the Continuing Survey of 

Food Intakes by Individuals (1994–1996 and 1998.) 

Underreporting of food intakes is suspected by 

women involved in the survey. And, the data do not 

include nutrients consumed in the form of dietary 

supplements. These factors may overstate the 

problem of nutrient inadequacies, and may 

understate the problem of excessive intakes. 

9See IOM, p. 63; see also ‘‘High Costs of Poor 

Eating Patterns in the States,’’ Elizabeth Fraza ̃o, in 

America’s Eating Habits: Changes and 

Consequences, Elizabeth Fraza ̃o, ed., Economic 

Research Service, U.S. Department of Agriculture, 

Washington, D.C., 1999. 

10U.S. Department of Agriculture, Food and 

Nutrition Service, Office of Analysis, Nutrition and 

Evaluation, WIC Participant and Program 

Characteristics 1992, Abt. Associates. Alexandria, 

VA: 1994. 

U.S. Department of Agriculture, Food and 

Nutrition Service, Office of Analysis, Nutrition and 

Evaluation, WIC Participant and Program 

Characteristics 2004, Abt. Associates. Alexandria, 

VA: 2005. The program characteristics studies 

performed prior to 1992 did not include participant 

data from Alaska, Hawaii, Puerto Rico, or U.S. 

territories. The racial/ethnic breakdowns from those 

earlier reports should not be directly compared to 

the ones contained in reports from 1992 forward. 

dietary and health research. The U.S. 

Department of Agriculture’s (USDA) Food 

and Nutrition Service (FNS) provides 

provision of nutrition education to WIC 

participants that is consistent with the 2005 

Dietary Guidelines for Americans. 

WIC’s supplemental food packages, by 

contrast, are defined by regulation with 

specificity. The regulatory flexibility that 

characterizes WIC nutrition education does 

not extend to the prescription of individual 

food packages. The list of WIC-approved 

foods focused to provide select nutrient-rich 

foods; allowed substitutions provide only 

limited room for participant-specific food 

package tailoring. 

The population served by the WIC program 

has grown in size and diversity over time and 

the frequency of nutritional risks faced by 

WIC participants have changed. Most 

important, the content of existing WIC food 

packages no longer reflects the leading views 

of current nutrition science. 

1. Current WIC Food Packages and Changing 

Nutritional Priorities 

Supplemental foods are offered to WIC 

participants in one of seven packages 

designed for the special supplemental 

nutritional needs of the following subpopulations: 

I. Infants under four months old 

II. Infants from four to twelve months old 

III. Children and women with special dietary 

needs 

IV. Children from one to five years old 

V. Pregnant and breastfeeding women 

VI. Non-breastfeeding postpartum women 

VII. Exclusively breastfeeding women 

Inadequate nutrition was the prime 

motivating factor behind enactment of the 

WIC program.4 Nutrition research in the 

1970’s pointed to calcium, iron, high quality 

protein, and vitamins A and C as nutrients 

most likely to be lacking in the diets of lowincome women, infants, and children. 

Current WIC food packages reflect that early 

research. Today’s packages include some 

combination of: Iron-fortified infant 

formulas, iron-fortified cereals, vitamin C 

rich juice, vitamin A and D fortified milk, 

eggs, cheese, dried beans or peas, peanut 

butter, tuna, and carrots. Other factors that 

contributed to the selection of these foods are 

their nutrient density, modest cost, wide 

availability, and broad acceptance by the 

WIC-eligible population. 

The nutritional risks faced by the lowincome population of the 1970s have 

changed. Although inadequate intake of some 

nutrients remains a concern,5 improved diets 

have reduced the prevalence of once 

relatively common deficiency diseases and 

underweight in at-risk groups. A WIC 

program that now assists nearly eight million 

individuals monthly, including about half of 

the nation’s infants,6 supplements the diets 

of an at-risk population with the very types 

of iron-fortified, nutrient-dense foods 

associated with this changed health picture. 

WIC’s current food packages, little modified 

since the 1970s, were appropriately designed 

to address the recognized nutritional 

priorities of that time. But today’s WIC 

population, like the U.S. population as a 

whole, faces a reordered set of priorities. 

Excessive intakes of some nutrients, 

including saturated fat, and of food energy 

have taken a place among the nation’s top 

public health concerns.7 Other nutrients, 

including folate, vitamin E, and fiber, have 

since been identified as lacking in the diets 

of WIC-eligible sub-populations.8 While 

current WIC food packages continue to 

address important health risks of 

undernutrition, they do not target all 

identified inadequacies, and they may 

contribute to the risks associated with 

excessive intake of some nutrients. 

Medical consequences of improper diets 

include fetal or infant lead toxicity tied to 

low calcium intake by pregnant and 

breastfeeding women, birth defects caused by 

inadequate folate consumption during 

pregnancy, iron-deficiency anemia, and heart 

disease, diabetes, stroke, and cancer, all 

linked to obesity and excessive intake of 

saturated fat.9 Adjustments to the WIC food 

packages that move the levels of these 

priority nutrients closer to Recommended 

Dietary Allowances (RDAs) and Adequate 

Intake (AIs) levels of the Institute of 

Medicine’s Dietary Reference Intakes may 

reduce the nutrition-related medical health 

risks of WIC participants. 

2. Changing Demographics of the WIC 

Population 

The population served by WIC has grown 

more diverse over time. (See Figure 1.) White 

and Black participants represented 72% of 

the WIC population in 1992; by 2004, just 

56% of WIC participants fell into one of 

those two racial/ethnic groups.10 WIC’s 

Hispanic population, itself a diverse group, 

has grown from the third largest to the largest 

over the same period. Greater ethnic diversity 

increases the demand for additional food 

options consistent with cultural preferences. 

The introduction of new foods and 

substitution options should broaden the 

appeal of WIC food packages and increase the 

effectiveness of WIC’s educational message. 

Ultimately, wider acceptance of WICapproved diets should improve the nutrition 

of underserved at-risk groups. 


jlentini on PROD1PC65 with PROPOSAL2
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11See IOM, p. 46. IOM used CSFII data for infants 

and children enrolled WIC. To maintain a sufficient 

sample size, IOM used CSFII results for all 

pregnant, breastfeeding, and non-breastfeeding 

postpartum women. 

12Micro-nutrients are nutrients the body requires 

in small amounts, e.g. vitamins and minerals. 

Macro-nutrients are nutrients that constitute the 

majority of an individual’s diet, e.g. carbohydrates, 

proteins, and fats. 

13See IOM, pp. 46 through 60. 

14 IOM, p. 37. 

15 IOM, p. 153–154, 156–157. 

3. Institute of Medicine’s Recommendations 

FNS contracted with the National 

Academies’ Institute of Medicine (IOM) in 

2003 to assess the nutritional health profile 

of the current WIC population, and to 

recommend changes in the content of the 

program’s food packages. IOM examined the 

Continuing Survey of Food Intakes of 

Individuals (CSFII) food consumption survey 

data (see footnote 9) to evaluate the 

nutritional content of the diets of WICeligible and potentially WIC-eligible 

populations.11 IOM identified and prioritized 

a list of micro- and macro-nutrients 12 whose 

consumption by the targeted populations fell 

outside of acceptable ranges.13 (See Table 1.) 

TABLE 1.—PRIORITY NUTRIENTS IDENTIFIED BY THE INSTITUTE OF MEDICINE (IOM) AS POSSIBLY INADEQUATE OR

EXCESSIVE IN THE DIETS OF WIC SUB-POPULATIONS

WIC subpopulation 

Inadequate (grouped by relative levels of inadequacy) 

Excessive 

Highest High Moderate 

WIC infants: 

Non-breastfed under age one ................. .................................... .................................... .................................... Zinc, preformed vitamin A, food energy. 

Breastfed, 6 to 11 months ...................... Iron, zinc.

WIC children: 

Ages 1 to 4 ............................................. Vitamin E, fiber, potassium..................................... .................................... Zinc, preformed vitamin A, food energy, 

saturated fat. 

Women: 

Pregnant, breastfeeding, nonbreastfeeding postpartum.Calcium, magnesium, 

vitamin E, potassium, fiber.

Vitamins A, C, B6, and 

folate.

Iron, zinc, thiamin, 

niacin, protein.

Sodium and saturated 

fat (as a percent of 

food energy). 

IOM then recommended specific changes 

to the current WIC food packages to improve 

the nutritional balance of the diets of the WIC 

population. IOMs recommendations were 

guided by the following criteria: 14

1. Reducing the prevalence of inadequate 

or excessive nutrient intake by WIC 

participants, 

2. Helping WIC participants achieve 

dietary patterns consistent with the 2005 

Dietary Guidelines for Americans for 

individuals two years of age and older,15

3. Bringing the diets of infants and 

children under age two into closer 

conformity with accepted recommendations; 

encouraging and supporting breastfeeding, 

4. Including foods in the WIC packages that 

are available in forms suitable for individuals 

with limited means of transportation, storage, 

or cooking, 

5. Including foods in the WIC packages that 

are commonly consumed and widely 

available, accommodate cultural preferences, 

and encourage WIC participation, and 

6. Giving consideration to the impact that 

the proposed changes will have on vendors, 

and on state and local WIC agencies. 

B. Summary of Rule and Benefits 

With few changes, the recommendations of 

the IOM have been adopted as this proposed 

rule. The provisions of the rule and the 

potential benefits of these changes are 

summarized below. 

1. Food Package I—Infants Under Six Months 

Proposed rule: Tie maximum infant 

formula prescriptions to breastfeeding 

practice. 

• Establish fully breastfed, partially 

breastfed, and fully formula-fed categories, 

and set maximum formula allowances for 

each. Food Package I currently specifies a 


jlentini on PROD1PC65 with PROPOSAL2EP07AU06.000</GPH>
44826 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

16 IOM, pp. 5, 6, 69. 

17 IOM, p. 69. 

18 IOM, pp. 94, 113. 

19 IOM, p. 100. 

20 Id. 

21 IOM, p. 103. 

22 IOM, p. 94. 

single maximum formula amount for all 

Package I recipients; local WIC staff may 

tailor the amount of formula to reflect with 

individual participant needs, based on 

frequency of breastfeeding. The new rule sets 

a maximum formula amount for partially 

breastfed infants that is roughly half the 

maximum provided to fully formula fed 

infants. 

• Powder formula alone is recommended 

for partially breastfed infants. Powder and 

non-powder options remain available for 

fully formula fed infants. 

Rationale and Benefits: 

• The infant breastfeeding categories are 

intended to promote breastfeeding. 

Breastfeeding provides important nutritional 

and health benefits beyond that provided by 

formula feeding; it is the AAPs recommended 

method of infant feeding.16 It is also 

proposed that the infants breastfeeding status 

be used to assign mothers to their own food 

packages. Mothers of fully formula fed 

infants under six months of age are assigned 

to Food Package VI; partially breastfeeding 

mothers of infants under six months are 

assigned to Package V which is relatively 

more attractive than Package VI for 

postpartum women due to the inclusion of 

additional foods and higher maximum 

allowances for the same foods that are 

provided in Package V. 

• Classification of infants by breastfeeding 

status makes it easier to ensure that partially 

breastfed infants are prescribed only powder 

formula, the option recommended by IOM to 

give parents greater control over the amount 

of formula prepared. This should reduce 

waste and contribute to safer formula use. 

Proposed rule: Delay introduction of 

complementary foods. Extend the age range 

of infants covered by Food Package I by two 

months. Currently, Food Package I 

supplements the diets of infants from birth 

through three months. Under the proposed 

rule, Food Package I would be provided to 

infants through five months of age. Under 

both the current and proposed rules, Food 

Package I contains no complementary foods. 

Extending the age range of infants served by 

Food Package I removes complementary 

foods (juice and infant cereal) from the food 

packages for four and five month old infants. 

Rationale and Benefits: Delaying the 

introduction of complementary foods until 

the infant reaches six months is consistent 

with the current recommendations of the 

American Academy of Pediatrics (AAP). 

Proposed rule: Increase maximum formula 

prescription at four months. Increase the 

maximum amount of formula allowed for 

four and five-month-old infants (relative to 

the amount allowed under current rules.) 

Rationale and Benefits: Calories lost 

through elimination of juice and infant cereal 

from Food Package I are replaced, in part, 

with increased formula prescription 

amounts. The package better meets the 

nutritional needs of the infant through to 

month 6. 

Proposed rule: No partially breastfed 

category for infants under one month. Do not 

provide formula to breastfed infants under 

one month old. Infants under one month will 

be recognized as either fully breastfed or 

fully formula-fed. No infant will be 

prescribed formula in the amount specified 

by Food Package I for partially breastfed 

infants until he or she reaches one month. 

Rationale and Benefits: By not offering a 

partially breastfed option for infants under 

one month old, the proposed rule intends to 

encourage mothers to continue a practice of 

breastfeeding that may have begun at the 

hospital. Additionally, the amount of milk a 

breastfeeding woman produces depends 

directly on how often and how long she 

nurses. Providing supplemental formula to a 

new mother may interfere with her milk 

production and success at continued 

breastfeeding. 

Proposed rule: No low iron formula. 

Discontinue the prescription of low iron 

infant formula for infants of all ages. 

Rationale and Benefits: Iron fortified 

formulas continue to play an important role 

in preventing iron deficiency in infants. The 

AAP recognizes no medical condition that 

would justify the feeding of low iron formula 

to infants. 

Proposed rule: Reclassify prescriptions of 

exempt infant formula under Package III. 

Administer exempt formulas, other than 

those prescribed for common food allergies, 

under Food Package III. Currently, all infants 

are classified as recipients of Food Packages 

I or II. This proposal would simply reclassify 

certain Package I (and II) recipients as 

Package III recipients; it is not intended to 

alter the types of foods prescribed to infants 

with qualifying conditions. 

Rationale and Benefits: Currently, only 

children and adults prescribed special 

medical foods are classified as Package III 

recipients. Grouping together all recipients of 

medical foods and exempt formulas is meant 

to increase management efficiency, and 

facilitate the tracking of the costs and 

benefits of medical and exempt food 

prescriptions. 

2. Food Package II—Infants 6 Through 11 

Months 

Proposed rule: Delay introduction of 

complementary foods. Delay the age at which 

infants become eligible for Food Package II. 

Infants are currently made eligible for Food 

Package II and its complementary foods at 

four months of age. The proposed rule would 

make infants eligible for Package II foods at 

six months of age. 

Rationale and Benefits: Delaying the 

introduction of complementary foods until 

the infant reaches six months is consistent 

with the current recommendations of the 

AAP. 

Proposed rule: Tie maximum formula 

prescription to breastfeeding practice. 

Establish fully breastfed, partially breastfed, 

and fully formula-fed categories, and set 

maximum formula allowances for each. The 

new rule sets a maximum formula amount for 

partially breastfed infants that is roughly half 

the maximum provided to fully formula-fed 

infants. 

Rationale and Benefits: Like the 

corresponding proposal under Food Package 

I, Package II breastfeeding categories will be 

used to assign mothers to their own food 

packages. However, once an infant reaches 

six months of age, the consequences of the 

infants breastfeeding status on the mothers 

food package eligibility are greater. Mothers 

whose infants are prescribed no more 

formula than the maximum allowed for a 

partially breastfed infant will remain eligible 

for Food Package V. Mothers who accept 

more formula will be considered nonbreastfeeding, and will be eligible for no food 

package at all. The proposed rule encourages 

mothers to continue breastfeeding beyond six 

months postpartum. Increasing the rate and 

duration of breastfeeding is a 

recommendation of the AAP.17

Proposed rule: Reduce maximum formula 

prescription amounts. Reduce the amount of 

formula, relative to current rules, for partially 

breastfed and fully formula-fed infants. 

Rationale and Benefits: With the addition 

of infant foods (see below), the revised 

Package II provides close to the 

recommended levels of priority nutrients 

without excess food energy. Reducing 

formula prescriptions should encourage 

parents to introduce complementary foods to 

their infants beginning at six months of age.18

Proposed rule: Replace juice with fruits 

and vegetables. 

• Eliminate juice from Food Package II. 

Add infant food fruits and vegetables to the 

package. Allow fresh bananas as a substitute 

for a portion of the infant food fruits and 

vegetables. 

• Provide more infant food fruits and 

vegetables to fully breastfed infants than to 

partially breastfed or fully formula-fed 

infants. 

Rationale and Benefits: 

• Increased fruit and vegetable 

consumption is among the major 

recommendations of the 2005 Dietary 

Guidelines for Americans; commonly 

consumed fruits and vegetables provide 

several of the priority nutrients identified by 

the IOM.19 The introduction of fruits and 

vegetables at an early age may promote 

acceptance and increased consumption.20

• Juice does not provide nutritional benefit 

beyond that available from whole fruits and 

vegetables.21

• Eliminating juice offsets the cost of 

providing infant food fruits and vegetables. 

• Providing more infant food fruits and 

vegetables to fully breastfed infants 

encourages the continuation of breastfeeding 

by increasing the value of the fully breastfed 

package.22 It also seeks to provide an amount 

sufficient to mix with infant food meat to 

improve palatability and acceptance of that 

food. (See below.) 

Proposed rule: Provide infant food meat to 

fully breastfed infants. Add infant food meat 

to Package II for fully breastfed infants. 

Rationale and Benefits: Infant food meat 

supplies iron and zinc for infants age six 

months and older, that breast milk alone does 

not supply. Increasing the value of the fully 

breastfed package is also intended to 

encourage continued breastfeeding. 


jlentini on PROD1PC65 with PROPOSAL2
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23November 12, 1980 final rule. 24USDHHS/USDA, 2005, p. 29. 

25 IOM, p. 153. 

26USDHHS/USDA, 2005, p. 24. 

Proposed rule: No low iron formula. 

Discontinue the prescription of low iron 

infant formula. 

Rationale and Benefits: Iron fortified 

formulas continue to play an important role 

in preventing iron deficiency in infants. The 

AAP recognizes no medical condition that 

would justify the feeding of low iron formula 

to infants. 

Proposed rule: Reclassify prescriptions of 

exempt infant formula under Package III. 

Administer exempt formulas to infants under 

Food Package III. 

Rationale and Benefits: Grouping together 

all recipients of medical foods and exempt 

formulas is meant to increase management 

efficiency, and facilitate the tracking of the 

costs and benefits of medical and exempt 

food prescriptions. 

Proposed rule: Disallow prescription of 

infant cereal with added ingredients. Infant 

cereal with added fruit, milk, formula, or 

other non-grain foods may not be prescribed 

under Food Package II. 

Rationale and Benefits: As recommended 

by IOM, the proposed rule formalizes federal 

policy 23 which states that cereal 

combinations are not allowed. The 

Department’s policy is based on 

recommendations of the American Academy 

of Pediatrics and costs concerns. The 

American Academy of Pediatrics 

recommends that single ingredient foods be 

introduced one at a time in an effort to isolate 

food sensitivities and possibly avert the 

development of food intolerances. Although 

cereal/fruit combinations may be appropriate 

once the risk of sensitivity has diminished, 

these combination foods are more expensive 

than regular infant cereal. Therefore, in an 

effort to contain the cost of the food 

packages, the Department has not authorized 

them. In reference to cereal/formula 

combinations, since infant formula is already 

provided in the food packages, the 

Department does not believe it is necessary 

to provide additional infant formula in 

combination with infant cereal. 

3. Food Package III—Medically Fragile 

Participants 

Proposed rule: Administer exempt 

formulas to infants with qualifying 

conditions under Package III. 

Infants with a qualifying condition (see 

below) who currently receive exempt infant 

formulas would be moved from Package I or 

Package II to Package III. 

Rationale and Benefits: The current 

system, which assigns infants with special 

dietary needs to either Packages I or II, while 

women and children with special dietary 

needs are placed in Package III, makes it 

difficult to track participation and costs 

associated with providing medical foods. 

Grouping infants with qualifying conditions 

with the category of women and children 

receiving medical foods is expected to 

increase management efficiency and facilitate 

the tracking of the costs and benefits of 

serving this segment of the WIC population. 

Proposal: Clarify language governing 

Package III’s purpose and scope. 

• The proposed rule would provide 

additional guidance to states on the nature of 

medical conditions that qualify a WIC 

participant for Package III medical foods. 

• Prescription of a medical food would 

also require additional justification and 

instructions by a licensed health care 

professional. 

• The proposal would also clarify the 

definition of WIC-eligible medical foods. 

Rationale and Benefits: The threshold of 

eligibility for Package III medical foods is 

currently unclear. The distinction between 

conventional foods marketed to the 

medically needy and WIC authorized 

medical foods can also be difficult to make. 

The proposed rule will provide guidance to 

state agencies that should promote efficiency 

and reduce the costs of restricting Package III 

to participants with qualifying medical 

conditions. 

Proposed rule: Make non-Package III foods 

available to Package III recipients. In 

addition to the medical foods and exempt 

formulas currently prescribed to Package III 

recipients, the proposed rule would offer 

these individuals all of the foods in the 

packages to which they would have been 

eligible in the absence of their special 

medical needs. 

Rationale and Benefits: Provides Package 

III recipients access to the same set of 

nutrients as other WIC recipients at the same 

life stage. An individual’s health constraints, 

not his or her administrative status as a 

Package III recipient, are all that should limit 

the prescription of foods from a standard 

WIC package. 

4. Food Package IV—Children From Age One 

Up to Age Five 

Proposed rule: Reduce the prescribed 

amount of milk; modify substitution options. 

• The amount of milk that may be 

prescribed to children would be reduced 

from 24 quarts to 16 quarts per month. 

• Under current rules, cheese may be 

prescribed as a substitute for up to 12 quarts 

of milk. The proposed rule would allow 

cheese to replace up to three quarts of milk. 

The substitution rate of one pound of cheese 

for three quarts of milk would remain 

unchanged. 

• Soy products will be allowed as a milk 

substitute on a restricted basis; soy may only 

be prescribed to children with a documented 

medical need. 

Rationale and Benefits: 

• Reducing the amount of milk provided to 

children brings the prescribed amounts into 

conformance with recommended limits on 

saturated fat and total fat consumption by 

children as a percent of food energy and with 

the 2005 Dietary Guidelines for Americans, 

and reduces the prevalence of inadequate 

and excessive nutrient intakes. Reduced 

intake of saturated fat is associated with 

decreased risk of coronary heart disease; total 

fat intake in excess of 35% of food energy 

makes it difficult to limit total calories to 

recommended levels.24 As noted by IOM, the 

revised amount of fat-reduced milk and milk 

products in Food Package IV are 

approximately the amount recommended in 

the 2005 Dietary Guidelines for Americans or 

other dietary guidance.25

• Reducing the amount of cheese that may 

be substituted for milk will reduce saturated 

fat and total fat intake by children age two 

and older. (See next proposal on fat reduced 

milk.) This proposal will also offset costs, 

allowing for the addition of other foods. 

• The 2005 Dietary Guidelines for 

Americans stresses the importance of milk 

consumption in the development of bone 

mass in children.26 While soy products may 

be an appropriate choice for children who 

cannot consume milk, the IOM does not 

believe that soy should be made available to 

satisfy participant preference in the absence 

of medical need. 

• IOM recommended yogurt as an 

alternative to fluid milk. To ensure cost 

neutrality yogurt was omitted as a fluid milk 

substitution. (See discussion of yogurt as a 

milk substitute on page 51.) 

Proposed rule: Provide only fat-reduced 

milk to older children. Prescribe only fatreduced milk to children age two and above. 

Prescribe only whole milk to children under 

age two. 

Rationale and Benefits: Increases the 

likelihood that the amount of total fat and 

saturated fat in the diets of children age two 

and over will be consistent with the 2005 

Dietary Guidelines for Americans. This is 

also consistent with the recommendations of 

the American Academy of Pediatrics. 

Proposed rule: Modify/clarify 

reconstitution rates for dry and evaporated 

milk. The reconstitution rate for evaporated 

milk is changed from 13 to 16 ounces of 

evaporated milk per reconstituted quart. The 

reconstitution rate for powdered milk is 

restated in terms of fluid ounces rather than 

quarts; this change does not alter the 

reconstitution rate itself. 

Rationale and Benefits: The proposed 

reconstitution rate for evaporated milk 

reflects its degree of concentration. 

Restatement of the reconstitution rate of 

powdered milk is intended to assist state 

agencies in making reconstitution 

calculations for a growing range of powdered 

milk container sizes. 

Proposed rule: Reduce juice prescriptions; 

add fruits and vegetables. 

• Reduce monthly maximum juice 

prescription from 288 fluid ounces to 128. 

Clarify that juice must be 100% unsweetened 

fruit or vegetable juice, that it contain a 

minimum of 30 milligrams of vitamin C per 

100 milliliters, and that it be pasteurized. 

• Add a $6 monthly voucher to the 

package for the purchase of any combination 

of fresh or processed fruits and vegetables. 

Rationale and Benefits: 

• Increased fruit and vegetable 

consumption is among the major 

recommendations of the 2005 Dietary 

Guidelines for Americans; commonly 

consumed fruits and vegetables provide 

several of the priority nutrients identified by 

the IOM. Evidence also suggests that fruit 

and vegetable consumption is associated 

with reduced incidence of some chronic 


jlentini on PROD1PC65 with PROPOSAL2
44828 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

27 IOM, p. 100. 

28Limited exceptions to individual choice 

include white potatoes, herbs, breaded vegetables, 

soups, salad bar items, pickles, juice, edible 

blossoms, decorative gourds and painted pumpkins. 

29See 21 CFR Part 136, Section 136.180, and 

FDA’s Health Claim Notification for Whole Grain 

Foods with Moderate Fat Content at 

www.cfsan.fda.gov/∼dms/flgrain2.html. 

30The proposed rule would also replace the 

existing terms ‘‘cereal (hot or cold)’’ and ‘‘adult 

cereal (hot or cold)’’ with ‘‘breakfast cereal’’ in 7 

CFR 246.10(c). 

31USDHHS/USDA, 2005, p. 25. 

32 Id. 

33Some states currently allow just two dozen as 

the monthly maximum. 

34 IOM, pp. 82, 108. 

35Tofu prepared with only calcium salts. 

36USDHHS/USDA, 2005, p. 29. 

37 IOM, p. 153. 

diseases.27 And the introduction of fruits and 

vegetables at an early age may promote 

acceptance and increased consumption. 

• Juice does not provide nutritional benefit 

beyond that available from whole fruits and 

vegetables. 

• A voucher, rather than a more narrowly 

defined fruit and vegetable option, offers 

flexibility, ensures participant access, and 

minimizes costs of compliance by 

administrative agencies and WIC-approved 

vendors. Allowing participants to choose any 

variety of fruits or vegetables 28 is intended 

to increase consumption by accommodating 

individual and culturally based preferences. 

The voucher form also ensures that some 

variety of fresh or processed fruits and 

vegetables will be available, year-round, at 

most food stores. And state and local WIC 

agencies need not tailor specific fruit and 

vegetable prescriptions to participants, nor 

will they be burdened with additional rules 

governing substitution between fresh and 

processed forms. 

• Reducing juice partially offsets the cost 

of providing fruit and vegetable vouchers. 

• IOM recommended cash-value food 

instruments for fruits and vegetables at the 

level of $8 per month for children. To ensure 

cost neutrality, cash-value food instruments 

for fruits and vegetables was decreased to $6 

per month. (See discussion of fruit and 

vegetable option on page 36.) 

Proposed rule: Add whole grain breads; 

add whole grain requirement to cereal. 

• Add two pounds of whole grain bread to 

the food package. Only bread meeting U.S. 

Food and Drug Administration (FDA) 

standards for whole grain labeling would be 

allowed.29

• Several whole grain products would be 

allowed as substitutions for bread. These 

include brown rice, bulgur, and whole grain 

barley without added sugar, fat, oil, or 

sodium. Soft corn or whole wheat tortillas 

would be allowed as an additional substitute 

at the option of state agencies. States may 

limit or completely eliminate substitutes if 

needed to control food costs. 

• Require that WIC authorized breakfast 

cereals 30 meet the same whole grain 

requirements as bread. 

Rationale and Benefits: 

• This proposal is consistent with current 

recommendations that Americans consume at 

least three ounce equivalents of whole grain 

foods daily as stated in the 2005 Dietary 

Guidelines for Americans.31 Whole grains 

provide dietary fiber, a priority nutrient 

identified by the IOM. Consumption of 

recommended amounts of whole grain foods 

can reduce the risk of chronic disease, and 

may help individuals control their weight.32

• Allowing a variety of substitutes for 

whole grain bread increases the likelihood of 

participant acceptance by accommodating 

individual taste and cultural preference. 

Proposed rule: Reduce maximum egg 

prescription. Reduce the maximum egg 

prescription from two and one-half dozen per 

month 33 to one dozen. 

Rationale and Benefits: This reduction is 

consistent with the 2005 Dietary Guidelines 

for Americans and with IOM’s 

recommendation that dietary levels of 

cholesterol be reduced, where possible, 

consistent with an adequate diet. Protein is 

no longer a priority nutrient for 

supplementation.34

Proposed rule: Allow canned beans as a 

substitute for dry beans. Allow canned beans 

as a substitute for dry at the rate of sixty-four 

ounces per pound. 

Rationale and Benefits: Accommodates 

participant preference and may encourage 

consumption because canned beans can be 

prepared more quickly than dried beans. 

5. Food Package V—Pregnant and Partially 

Breastfeeding Women Up to One Year 

Postpartum 

Proposed rule: Condition eligibility for 

Package V on breastfeeding practice. Mothers 

who request, and are prescribed, more than 

the maximum amount of formula allowed for 

partially breastfed infants will no longer be 

eligible for Food Package V. Currently, 

women who breastfeed at least once per day 

are eligible for this package. Reclassified as 

non-breastfeeding for purposes of WIC 

eligibility, these women will be assigned 

Food Package VI up to six months 

postpartum; they will receive no food 

package after six months. 

Rationale and Benefits: This is consistent 

with the proposed rule governing the 

breastfeeding status of infants (see 

explanation under sections 1 and 2). The rule 

provides an incentive for mothers to 

breastfeed their infants. This provision is 

designed to better promote and support the 

establishment of successful long-term 

breastfeeding among women and encourages 

a greater contribution of breast milk to the 

infant’s diet. 

Proposed rule: Reduce the prescribed 

amount of milk; introduce new substitution 

options. 

• The maximum amount of milk that may 

be prescribed to Package V recipients would 

be reduced from 28 quarts to 22 quarts per 

month. 

• Under current rules, cheese may be 

prescribed as a substitute for up to 12 quarts 

of milk. The proposed rule would allow 

cheese to replace just three quarts of milk. 

The substitution rate of one pound of cheese 

for three quarts of milk would remain 

unchanged. 

• Calcium-set tofu 35, and calcium and 

vitamin D fortified soy beverage would be 

introduced as new milk substitutes. Each 

pound of tofu would replace one quart of 

milk. For most women, cheese and tofu, 

combined, could replace no more than four 

quarts of milk; women with documented 

medical needs may be prescribed these 

substitutes in amounts that exceed the four 

quart maximum. No more than one pound of 

cheese may be substituted for milk. 

• Soy beverage would be allowed as a 

substitute for Package V’s entire milk 

allowance. 

• IOM recommended yogurt as an 

alternative to fluid milk. To ensure cost 

neutrality yogurt was omitted as a fluid milk 

substitution. (See discussion of yogurt as a 

milk substitute on page 51.) 

• States may limit allowable milk 

substitutes to soy beverage if needed to 

control food costs. 

Rationale and Benefits: 

• Reducing the amount of milk provided 

through WIC is consistent with 

recommended limits on saturated fat, total 

fat, and cholesterol consumption by 

American adults put forth in the 2005 Dietary 

Guidelines for Americans. Reduced intake of 

saturated fat is associated with decreased risk 

of coronary heart disease; and total fat intake 

in excess of 35% of food energy makes it 

difficult to limit total calories to 

recommended levels.36 As noted by IOM, the 

revised amount of fat-reduced milk and milk 

products in Food Package V are 

approximately the amount recommended in 

the 2005 Dietary Guidelines for Americans.37

• Reducing the amount of cheese that may 

be substituted for milk may reduce saturated 

fat and total fat intake by participants. 

Limiting substitutions of cheese and tofu to 

four quarts of milk will reduce costs. This 

permits the addition of other food and 

substitution options to the package. 

• Allowing tofu and soy beverage as 

substitutes for milk may help ensure 

adequate calcium intake by individuals who 

do not or cannot consume milk. These 

products are culturally preferable to milk 

within some groups, and may be consumed 

by individuals with lactose maldigestion. 

Proposed rule: Reduce maximum juice 

prescription; add fruits and vegetables. 

• Reduce monthly maximum juice 

prescription from 288 fluid ounces to 144. 

Clarify that juice must be 100% unsweetened 

fruit or vegetable juice, that it contain a 

minimum of 30 milligrams of vitamin C per 

100 milliliters, and that it be pasteurized. 

• Add an $8 monthly voucher to the 

package for the purchase of any combination 

of fresh or processed fruits and vegetables. 

Rationale and Benefits: 

• (The rationales and benefits for this 

proposal are the same as those for the 

introduction of fruits and vegetables to Food 

Package IV. See explanation under section 4.) 

• IOM recommended cash-value food 

instruments for fruits and vegetables at the 

level of $10 per month for women. To ensure 

cost neutrality, cash-value food instruments 

for fruits and vegetable was decreased to $8 

per month. (See discussion of fruit and 

vegetable option on page 36.) 

Proposed rule: Add whole grain breads. 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44829 

38 IOM, p. 153. 39 IOM, p. 153. 

• Add one pound of whole grain bread to 

the food package. Only bread meeting FDA 

standards for whole grain labeling would be 

allowed. 

• Several whole grain products would be 

allowed as substitutions for bread. These 

include brown rice, bulgur, and whole grain 

barley without added sugar, fat, oil, or 

sodium. Soft corn or whole wheat tortillas 

would be allowed as an additional substitute 

at the option of state agencies. States may 

limit or completely eliminate substitutes if 

needed to control food costs. 

Rationale and Benefits: (See discussion for 

comparable proposal under section 4.) 

Proposed rule: Reduce maximum egg 

prescription. Reduce the maximum egg 

prescription from two and one-half dozen per 

month to one dozen. 

Rationale and Benefits: This reduction is 

consistent with the 2005 Dietary Guidelines 

for Americans and with IOM’s 

recommendation that dietary levels of 

cholesterol be reduced, where possible, 

consistent with an adequate diet. In addition, 

the IOM determined that protein is no longer 

a priority nutrient for the WIC population. 

Proposed rule: Allow canned beans as a 

substitute for dry beans. Allow canned beans 

as a substitute for dry at the rate of sixty-four 

ounces per pound. 

Rationale and Benefits: Accommodates 

participant preference and may encourage 

consumption because canned beans can be 

prepared more quickly than dried beans. 

Proposed rule: Increase total amount of 

peanut butter and beans Peanut butter is 

currently offered as a substitute for dry 

beans. The proposal would provide both one 

pound of dry beans and 18 ounces of peanut 

butter to Package V recipients. The rule also 

clarifies that Package V recipients may 

replace both dry beans and peanut butter 

with canned beans. 

Rationale and Benefits: This adds food 

energy and priority nutrients to the diets of 

breastfeeding women, including iron, folate, 

Vitamin E, and fiber. 

6. Food Package VI—Postpartum Women (Up 

to Six Months Postpartum) 

Proposed rule: Reduce the prescribed 

amount of milk; introduce new substitution 

options. 

• The maximum amount of milk that may 

be prescribed to Package VI recipients would 

be reduced from 24 quarts to 16 quarts per 

month. 

• Under current rules, cheese may be 

prescribed as a substitute for up to 12 quarts 

of milk. The proposed rule would allow 

cheese to replace just three quarts of milk. 

The substitution rate of one pound of cheese 

for three quarts of milk would remain 

unchanged. Calcium-set tofu, and calcium 

and vitamin D fortified soy beverage would 

be introduced as new milk substitutes. Each 

pound of tofu would replace one quart of 

milk. For most women, cheese and tofu, 

combined, could replace no more than four 

quarts of milk; women with documented 

medical needs may be prescribed these 

substitutes in amounts that exceed the four 

quart maximum. No more than one pound of 

cheese may be substituted for milk. 

• Soy beverage would be allowed as a 

substitute for Package VI’s entire milk 

allowance. 

• IOM recommended yogurt as an 

alternative to fluid milk. To ensure cost 

neutrality yogurt was omitted as a fluid milk 

substitution. (See discussion of yogurt as a 

milk substitute on page 51.) 

• States may limit allowable milk 

substitutes to soy beverage if needed to 

control food costs. 

Rationale and Benefits: 

• As noted by IOM, the revised amount of 

fat-reduced milk and milk products in Food 

Package VI includes more than two thirds of 

the 2005 Dietary Guidelines for Americans 

recommended amounts.38

• (See the discussion for the comparable 

proposal under section 5.) 

Proposed rule: Reduce maximum juice 

prescription; add fruits and vegetables. 

• Reduce monthly maximum juice 

prescription from 192 fluid ounces to 96. 

Clarify that juice must be 100% unsweetened 

fruit or vegetable juice, that it contain a 

minimum of 30 milligrams of vitamin C per 

100 milliliters, and that it be pasteurized. 

• Add an $8 monthly voucher to the 

package for the purchase of any combination 

of fresh or processed fruits and vegetables. 

Rationale and Benefits: 

• (See the discussion for the comparable 

proposal under section 4.) 

• IOM recommended cash-value food 

instruments for fruits and vegetables at the 

level of $10 per month for women. To ensure 

cost neutrality, cash-value food instruments 

for fruits and vegetable was decreased to $8 

per month. (See discussion of fruit and 

vegetable option on page 36.) 

Proposed rule: Reduce maximum egg 

prescription. Reduce the maximum egg 

prescription from two and one-half dozen per 

month to one dozen. 

Rationale and Benefits: This reduction is 

consistent with the 2005 Dietary Guidelines 

for Americans and with IOM’s 

recommendation that dietary levels of 

cholesterol be reduced, where possible, 

consistent with an adequate diet. 

Proposed rule: Add beans and peanut 

butter to the food package. One pound of dry 

beans or 18 ounces of peanut butter would 

be added to Package VI. The same canned 

bean substitution option added to Packages 

IV, V, and VII would be extended to Package 

VI recipients as well. 

Rationale and Benefits: The proposal 

would supplement the diets of postpartum 

women with several priority nutrients, 

including iron, folate, Vitamin E, and fiber. 

7. Food Package VII—Exclusively 

Breastfeeding Women 

Proposed rule: Reduce the prescribed 

amount of milk; introduce new substitution 

options. 

• The maximum amount of milk that may 

be prescribed to Package VII recipients would 

be reduced from 28 quarts to 24 quarts per 

month. 

• Under current rules, cheese may be 

prescribed as a substitute for up to 12 quarts 

of milk. The proposed rule would allow 

cheese to replace just six quarts of milk. The 

substitution rate of one pound of cheese for 

three quarts of milk would remain 

unchanged. 

• Calcium-set tofu, and calcium and 

vitamin D fortified soy beverage would be 

introduced as new milk substitutes. Each 

pound of tofu would replace one quart of 

milk. For most women, cheese and tofu, 

combined, could replace no more than six 

quarts of milk; women with documented 

medical needs may be prescribed these 

substitutes in amounts that exceed the six 

quart maximum. No more than two pounds 

of cheese may be substituted for milk. 

• Soy beverage would be allowed as a 

substitute for Package VII’s entire milk 

allowance. 

• IOM recommended yogurt as an 

alternative to fluid milk. To ensure cost 

neutrality yogurt was omitted as a fluid milk 

substitution. (See discussion of yogurt as a 

milk substitute on page 51.) 

• States may limit allowable milk 

substitutes to soy beverage if needed to 

control food costs. 

Rationale and Benefits: 

• As noted by IOM, the revised amount of 

fat-reduced milk and milk products in Food 

Package VII approximately meets the 2005 

Dietary Guidelines for Americans 

recommended amount.39 The maximum milk 

prescription under Package VII is reduced by 

just 14%; the comparable reductions under 

Packages V and VI are 21% and 33%, 

respectively. In addition, Package VII 

recipients are permitted to substitute up to 

six quarts of milk with tofu and cheese; the 

other women’s packages limit milk 

substitutes to four quarts. Package VII, which 

currently provides more food energy and 

nutrients than do Packages V and VI, is made 

more attractive relative to these other 

packages as a result of this proposal. This is 

consistent with the general aim of the rule to 

encourage the incidence and duration of 

breastfeeding in the WIC population and to 

meet the supplemental nutritional needs of 

breastfeeding women. 

• (See the discussion for the comparable 

proposal under section 5.) 

Proposed rule: Reduce maximum juice 

prescription; add fruits and vegetables. 

• Reduce monthly maximum juice 

prescription from 336 fluid ounces to 144. 

Clarify that juice must be 100% unsweetened 

fruit or vegetable juice, that it contain a 

minimum of 30 milligrams of vitamin C per 

100 milliliters, and that it be pasteurized. 

• Add an $8 monthly voucher to the 

package for the purchase of any combination 

of fresh or processed fruits and vegetables. 

• Eliminate the separate prescription of 

carrots. 

Rationale and Benefits: 

• (See the discussion for the comparable 

proposal under section 4.) 

• IOM recommended cash-value food 

instruments for fruits and vegetables at the 

level of $10 per month for women. To ensure 

cost neutrality, cash-value food instruments 

for fruits and vegetable was decreased to $8 

per month. (See discussion of fruit and 

vegetable option on page 36.) 


jlentini on PROD1PC65 with PROPOSAL2
44830 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

Proposed rule: Add whole grain breads. 

• Add one pound of whole grain bread to 

the food package. Only bread meeting FDA 

standards for whole grain labeling would be 

allowed. 

• Several whole grain products would be 

allowed as substitutions for bread. These 

include brown rice, bulgur, and whole grain 

barley without added sugar, fat, oil, or 

sodium. Soft corn or whole wheat tortillas 

would be allowed as an additional substitute 

at the option of state agencies. States may 

limit substitutes if needed to control food 

costs. 

Rationale and Benefits: (See discussion for 

comparable proposal under section 4.) 

Proposed rule: Reduce maximum egg 

prescription. Reduce the maximum egg 

prescription from two and one-half dozen per 

month to one dozen. 

Rationale and Benefits: This reduction is 

consistent with the 2005 Dietary Guidelines 

for Americans and with IOM’s 

recommendation that dietary levels of 

cholesterol be reduced, where possible, 

consistent with an adequate diet. 

Proposed rule: Allow canned beans as a 

substitute for dry. Allow canned beans as a 

substitute for dry at the rate of sixty-four 

ounces per pound. Also clarifies that Package 

VII recipients may replace both dry beans 

and peanut butter with canned beans. 

Rationale and Benefits: Accommodates 

participant preference and may encourage 

consumption. 

Proposed rule: Modify Package VII’s 

canned fish provision. 

• Increase the maximum canned fish 

prescription to 30 ounces. Clarify that fish 

packaged in foil pouches meets WIC 

requirements. 

• Allow three varieties of canned fish that 

do not pose a mercury hazard as identified 

by federal advisories of the Food and Drug 

Administration and the U.S. Environmental 

Protection Agency for breastfeeding women. 

Rationale and Benefits: 

• For ease of administration by State 

agencies, to accommodate participant 

preferences, and to minimize intake of 

mercury, the proposed rule would allow only 

canned light tuna, salmon and sardines. 

• Increasing quantity provides 

breastfeeding women with more protein and 

omega-3 fatty acids. 

8. Other Provisions (Non Food-Package 

Specific) 

Proposed rule: Clarifies the right of states 

to impose restrictions on WIC foods. States 

retain the right to exclude particular 

products, by brand or variety, from the food 

packages distributed to their residents. States 

are authorized to set standards for WIC 

approval that are more restrictive than those 

set by the federal government; they may not 

authorize the prescription of foods that do 

not meet minimum WIC-eligibility 

requirements set forth in regulations. The 

states may take into account issues of cost, 

nutrition, statewide availability, and 

participant appeal in setting these 

restrictions. 

Rationale and Benefits: Federal 

specifications for WIC-approved foods are 

designed to ensure minimum standards of 

nutrition in food packages that appeal 

broadly to American consumers and can be 

provided at a reasonable cost. Permitting the 

states to set additional criteria consistent 

with their own market and population 

profiles encourages the development of stateapproved food lists that meet or exceed 

nutritional standards, maintain participant 

acceptance, and control costs. 

Proposed rule: Ends the state practice of 

categorical nutritional tailoring. States will 

no longer be permitted to construct their own 

standardized set of food packages for WIC 

subpopulations with common supplemental 

nutritional needs. The full maximum 

monthly allowances of all foods in all 

packages must be made available to 

participants if medically or nutritionally 

warranted. 

Rationale and Benefits: The IOM identified 

several nutrients, including saturated fat, and 

identified food energy, that are 

overconsumed by some WIC-eligible 

subpopulations. Long before the IOM report, 

however, overweight and obesity in the U.S. 

were recognized as public health issues. 

Categorical nutritional tailoring is the state 

practice of formalizing these modifications 

into a standard set of food packages that are 

prescribed in place of the USDA-designed 

packages. The revisions to the WIC packages 

proposed by this rule make categorical 

tailoring unnecessary and inappropriate. The 

revised packages are designed to deliver an 

appropriate set of nutrients when foods are 

prescribed at the specified maximums. 

Participants may still refuse amounts of or 

entire foods, and foods that pose a risk to the 

participant’s health (e.g., a food that causes 

an allergic reaction) should not be 

prescribed. Additionally, individual 

nutritional tailoring, based on the Competent 

Professional Authority’s assessment of a 

participant’s nutrition needs, is still allowed. 

This provision would not preclude state 

agencies from making administrative 

adjustments for economic and administrative 

convenience, i.e., requiring least expensive 

brands, packaging or physical forms of WIC 

supplemental foods. 

Proposed rule: Prohibit states from 

petitioning the USDA for new food package 

substitutions. A process is currently in place 

to accept and evaluate requests by state WIC 

agencies to add new foods to the program’s 

list of allowed substitutes. This process is 

designed to permit appropriate consideration 

of the cultural norms and preferences of the 

diverse client populations of the different 

state WIC agencies. 

Rationale and Benefits: Since 1980, the 

Department has only received 10 food 

package petitions. Developing, reviewing, 

and analyzing cultural food package 

proposals is a time consuming process for 

WIC State agencies and the Department. The 

increased variety and choice in the 

supplemental foods proposed in the rule will 

provide state agencies increased flexibility in 

prescribing culturally appropriate packages 

for diverse groups without the need to 

petition the Department for such changes. 

The IOM was charged with considering the 

cultural needs of WIC participants and its 

recommendations for revisions to the WIC 

food packages reflect those considerations. 

Proposed rule: Rounding up for infant food 

and infant cereal. A state agency would be 

allowed to round up to the next whole 

container of infant foods (i.e., infant cereal, 

fruits, vegetables and meats) if needed to 

provide at least the maximum authorized 

amount of these foods. The proposal requires 

calculating and dispersing the infant formula 

over the timeframe of the food package 

category and infant feeding option. 

Rationale and Benefits: This is consistent 

with the provision in Pub. L. 108–265 that 

allows states to round up to the next whole 

can of infant formula so that participants may 

receive the full authorized nutritional 

benefit. This proposal would require state 

agencies to issue at least the full nutritional 

benefit but not more than the maximum 

monthly allowance for the food package 

category and infant feeding option. 

C. Summary of Key Provisions 

The expected impact of the proposed rules 

on the Federal Government, state and local 

WIC agencies, vendors, manufacturers, and 

program participants is summarized in Table 

2. Overall economic effects are noted with a 

‘‘+$’’ for cost increases, and a ‘‘¥$’’ for cost 

savings. A more detailed examination of 

strictly economic effects follows Table 2. 

TABLE 2.—SUMMARY OF KEY PROVISIONS

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

Current rule: 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44831 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

1. Food Package I serves infants from 

birth through three months. Formula is 

the only food prescribed under Package I. 

Reduces cost of infant 

food packages. Proposed packages for 

four and five month 

old infants (which 

reduce calories 

slightly) are less expensive than current 

Food Package II. 

Changes to current 

rules will require the 

implementation of 

new state and local 

administrative procedures. 

May increase the sale 

of infant formula at 

the expense of juice 

and infant cereal. 

Provides a food package that conforms 

more closely to the 

diet recommended 

by health professionals for four and 

five month old infants. 

2. Infants from four through eleven 

months are eligible for juice and infant 

cereal, in addition to formula, under 

Package II. The maximum formula 

prescription in packages I and II are 

the same. 

Proposed rule: 

1. Expand Food Package I to serve infants up to six months. Delay the introduction of complementary foods by 

two months. 

2. Increase formula prescriptions at four 

months to offset lost food energy. 

¥$ 

Current rule: 

Under Food Package I, an infant can receive up to the maximum for the 

package. Since the rule does not separate partially and fully formula fed infants, a single package maximum applies to all partially and fully formulafed infants from birth through three 

months. 

May slightly reduce 

the costs of providing infant formula 

to mothers during 

their infants’ first 

month. However, a 

sustained increase 

in breastfeeding 

during an infant’s 

first year will affect 

the food package 

eligibility of both the 

mother and the infant. Although the 

economic effect of 

such a sustained increase is dependent 

on both 

breastfeeding duration and on the relative rates of partial 

and exclusive 

breastfeeding, the 

net economic effect 

is likely to be a reduction in cost. 

State and local agencies must develop 

new guidelines to 

implement and communicate this policy. 

Negligible effect on 

the sale of infant 

formula for newborn 

infants. But, the rule 

provides an incentive to breastfeed, 

which may ultimately reduce formula sales beyond 

the infants’ first 

month. But, the rule 

may slightly increase infant food 

sales to fully 

breastfed WIC infants 6 months of 

age and older, and 

may increase the 

sale of other WIC 

foods to 

breastfeeding mothers. 

Encourages 

breastfeeding. Additional support provided to new mothers by WIC staff 

may successfully increase 

breastfeeding rates. 

This is consistent 

with the recommendations of 

nutrition experts. 

However, it is uncertain whether this 

will have a significant impact on the 

number of WIC 

women who 

breastfeed. 

Proposed rule: 

Provide no infant formula to mothers 

who breastfeed during the infant’s first 

month. 

¥$ 

Current rule: 


jlentini on PROD1PC65 with PROPOSAL2
44832 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

The current infant food packages do not 

distinguish between fully and partially 

formula-fed infants. Infants receive infant formula based on an assessment 

of their supplemental nutritional 

needs, subject to a single package 

maximum.Food Package V is provided to pregnant women and to all 

new mothers, up to one year 

postpartum, if they breastfeed at least 

once per day. 

If the proposed rule 

has no effect on the 

initiation and duration of 

breastfeeding, the 

cost of providing 

food packages to 

women will drop; 

the cost of providing 

infant formula will 

remain unchanged. 

If breastfeeding increases enough to 

keep an infant classified as partially 

breastfed who 

would have been 

classified as fully 

formula fed otherwise, then formula 

costs are reduced 

and there is no 

change in the mother’s status. Both result in cost reductions. 

State and local agencies must conform 

to a new definition 

of breastfeeding for 

WIC food package 

purposes. Will also 

encourage changes 

in the approach to 

nutrition education; 

places greater emphasis on 

breastfeeding promotion. Implementing new procedures will initially increase administrative burden. 

Negligible effect in the 

absence of changes 

in breastfeeding behavior. Increased 

breastfeeding would 

reduce formula 

sales but might 

modestly increase 

the sale of infant 

food fruits, vegetables and meat to 

WIC’s fully 

breastfed population. 

Encourages 

breastfeeding consistent with the best 

advice of nutrition 

science. Will reduce 

the WIC benefit received by women 

who do not fully 

breastfeed. 

Proposed rule: 

Infants and mothers will be assigned 

food packages based on the mother’s 

reported breastfeeding practice. The 

corresponding amount of formula prescribed will distinguish infants between partially breastfed and fully formula-fed. The rule would provide a full 

formula-feeding package to some infants currently considered partially 

breastfed; it would move some mothers from Package V to Package VI, or 

to no package at all, depending on 

the amount of formula requested. 

¥$ 

Current rule: 

Currently, the definition of breastfeeding 

in WIC regulations allows women who 

breastfeed once a day to be eligible 

for the WIC program and receive supplemental foods. 

The net effect of this 

change is minimal. 

These women will 

be included in participation numbers 

and State agencies 

will be provided 

NSA funds, but 

there are very few 

of them and they 

will not be receiving 

food. 

State agencies will be 

provided NSA funds 

for a very small 

number of women 

who are receiving 

WIC benefits (nutrition education/ 

breastfeeding support and referrals to 

health and social 

services), but not 

receiving supplemental foods. 

Negligible effect because the few 

women who once 

received supplemental foods will no 

longer be eligible for 

these foods. 

Encourages more intensive 

breastfeeding for 

WIC women. 

Proposed rule: 

Revise the definition for WIC participation to include the number of 

breastfeeding women who receive no 

supplemental foods or food instruments but whose breastfed infant(s) 

receives supplemental foods or food 

instruments. 

¥$ 

Current rule: 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44833 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

Infants from 4–11 months are eligible for 

Food Package II. That food package 

includes juice and infant cereal, as 

well as formula. 

The net effect of these 

changes increases 

the cost of Food 

Package II. 

Implementing new 

procedures, such as 

setting state policy 

on allowed varieties 

of infant food, will 

increase short-term 

administrative burden. 

May increase sales of 

infant food and decrease sales of 

juice and formula if 

participants were 

not already using 

the quantities proposed in the rule. 

Some vendors may 

need to stock additional infant food varieties that meet the 

specific specifications set by the 

states. Vendors will 

need to train personnel to identify 

the newly WIC-eligible infant foods. 

Restructures the infant 

package according 

to the recommendations of current nutrition science. Encourages good infant feeding practices. Encourages 

consumption of 

fruits and vegetables. 

Proposed rule: 

The following changes are made to 

Food Package II: 

1. Change age eligibility to 6–11 

months. 

2. Eliminate juice. 

3. Add infant food fruits and vegetables. 

4. Reduce maximum formula 

amount. 

+$ 

Current rule: 

All infants are eligible for the same 

amounts of formula, juice, and infant 

cereal under Food Package II. 

The cost of the fully 

breastfed package 

for infants age six 

months and older is 

increased significantly. 

Implementing new 

procedures, such as 

setting state rules 

on permissible varieties of infant food 

meat, will increase 

short-term administrative burden. 

Increase in sales of 

infant food meat is 

likely to be negligible. The number 

of fully breastfed 

WIC infants age six 

months and over is 

small. Vendors will 

need to train personnel to identify 

the newly WIC-eligible infant foods. 

Provides added iron 

and zinc to the diet 

of fully breastfed infants age six 

months and older. 

Also encourages 

breastfeeding. Both 

are consistent with 

the recommendations of current nutrition science. 

Proposed rule: 

Provide relatively more infant food fruit 

and vegetables to fully breastfed infants at six months than to partially 

breastfed or fully formula-fed infants. 

Also provide infant food meat to this 

group. 

+$ 

Current rule: 

1. Low iron infant formula may be prescribed with medical documentation. These changes are 

expected to have little effect on the 

foods actually prescribed to WIC infants. The infant cereal rule simply formalizes what has 

been federal policy 

since 1980. 

The states will incur 

minimal short-term 

administrative burden as they implement these minor 

rule changes. 

Sales of low iron formula and certain infant cereal varieties 

will be reduced 

slightly, if at all, by 

these rules. 

Disallowing the prescription of low iron 

formula is supported 

by medical research. Disallowing 

infant cereal with 

added ingredients is 

consistent with current, though not formalized, federal policy. There should be 

little if any change 

in what participants 

can purchase. 

2. Infant cereal must be iron-fortified; 

WIC regulations contain no other 

specifications. 


jlentini on PROD1PC65 with PROPOSAL2
44834 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

Proposed rule: 

1. Disallow the prescription of low iron 

infant formula. 

2. Disallow the prescription of infant cereal with added ingredients. 

(minimal economic effect) 

Current rule: 

Children and women with special dietary 

needs are prescribed WIC-eligible 

medical foods under Food Package 

III. Infants with special dietary needs 

are provided exempt infant formula 

under Food Packages I or II. 

The rule is intended to 

reduce administrative costs and facilitate program management. 

The rule is intended to 

facilitate program 

management. It 

may also allow improved service to 

WIC beneficiaries. 

No impact. No direct impact. Improved service at 

the state and local 

level may result, to 

the benefit of WIC 

participants. 

Proposed rule: 

Serve infants with special dietary needs 

who receive exempt infant formulas 

under Food Package III. 

¥$ 

Current rule: 

Current practice allows some women 

and children with certain dietary restrictions, but without serious medical 

conditions, to be prescribed medical 

foods under Food Package III. 

Clarifies who is eligible for Food Package III and what 

foods may be distributed as part of 

that package. These 

clarifications are 

generally aimed at 

tightening these criteria. Will, if anything, reduce Package III costs by 

moving some participants to food 

packages more appropriate for their 

needs. But, given 

the size of the current Package III 

population (roughly 

1% of all WIC participants) these savings will be small. 

The rule may reduce 

administrative burden by eliminating 

Package III eligibility 

issues. But, it may 

require state efforts 

to develop educational materials 

for local WIC officials, WIC participants, and health 

care professionals 

on the eligibility criteria. Will require 

local agencies to 

assist WIC-eligible 

individuals in obtaining the necessary 

medical documentation for Package III. 

Possible minimal reduction in the sale 

of medical foods 

due to eligibility requirements. 

Some current participants receiving 

Package III may be 

served under food 

packages more appropriate to their 

needs. 

Proposed rule: 

Clarify language governing the purpose 

and scope of Package III eligibility. 

¥$ 

Current rule: 

Package III recipients are prescribed 

medical foods only; they do not receive any of the standard food package foods. 

This rule will increase 

costs in those cases 

where Food Package III recipients 

are able to consume the foods 

contained in the 

regular WIC food 

packages to which 

they would otherwise be eligible. 

But, the Package III 

population is small. 

The costs will be 

modest. 

Administrative burden 

of implementing the 

new rule will be incurred in the short 

run. 

May have a small 

positive effect on 

the sale of some 

secondary WIC 

foods. Will not affect 

sales of infant formula. 

For those Package III 

recipients able to 

consume at least 

some non-Package 

III WIC foods, this 

rule will provide 

them with additional 

food. 

Proposed rule: 

Make other WIC foods available to 

Package III recipients. 

+$ 

Current rule: 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44835 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

Food Packages IV through VII provide 

WIC beneficiaries with 24 to 28 quarts 

of milk per month. Cheese may be 

substituted for milk at a rate of one 

pound per three quarts; cheese may 

replace a total of 12 quarts of milk. 

The net effect of this 

provision will be a 

reduction in overall 

cost, due to the reduction in quantities 

allowed and reduced substitution 

amounts. 

The states will need to 

establish new specifications and restrictions for the new 

milk substitutes. 

They will also incur 

administrative burden in implementing 

changes to reflect 

reduced milk prescription maximums 

and substitution limits. 

The rule may result in 

reduced milk and 

cheese sales to 

WIC participants. It 

may lead to increased sales of 

tofu and soy beverage. Vendors may 

need to stock new 

items that match the 

specific product requirements set by 

the states. Rule proposes nutritional 

standards for soy 

milk that are currently not met by 

many products on 

the market. Because these standards will also apply 

to the school meals 

programs, vendors 

are likely to change 

fortification so that 

the variety of available soy beverages 

that can be authorized improves over 

time. 

WIC participants with 

lactose maldigestion 

may benefit most by 

the addition of these 

new substitutes. 

Others with individual or cultural 

preferences will also 

benefit by the 

added choices. All 

WIC participants will 

benefit from a package lower in saturated and total fat, 

consistent with the 

recommendations of 

current nutrition 

science. 

Proposed rule: 

Reduce maximum milk prescription 

amounts to WIC children and women. 

Add new milk substitution options 

(tofu, cheese and soy beverage), but 

reduce the maximum amount of 

cheese substitution allowed. 

¥$ 

Current rule: 

Juice may be prescribed under Food 

Packages IV through VII at maximum 

levels that range from 192 to 336 fl. 

oz. per month. 

The fixed dollar values 

of the proposed fruit 

and vegetable 

vouchers are greater than the offsetting savings that will 

be realized through 

reduced juice 

amounts. 

States will need to authorize and develop 

a structure to distribute and redeem 

for fruit and vegetable vouchers, 

which will be a new 

component of the 

programs. This administrative burden 

will be on-going but 

part of the current 

banking and MIS 

systems. State and 

local agencies will 

incur administrative 

burden in developing educational 

messages for WIC 

participants concerning the selection of nutritious 

fruits and vegetables. 

Juice sales to WIC 

participants may decline. Sales of fruits 

and vegetables may 

increase. Costs will 

be incurred by vendors as they learn 

to accommodate the 

new WIC vouchers. 

Some WIC authorized vendors may 

need to add fruits 

and vegetables to 

their stocks in fresh, 

frozen, or canned 

form. Emphasis on 

fresh fruits and 

vegetables may encourage states to 

authorize and participants to shop at 

farmers markets 

more often. (See 

Market Analysis discussion on page 

57). 

The addition of fruits 

and vegetables to 

the WIC food packages responds to 

the recommendations of nutrition 

science. And the 

flexibility of a voucher will provide access to a variety of 

fruits and vegetables, in some form, 

year round, in all 

markets. 

Proposed rule: 


jlentini on PROD1PC65 with PROPOSAL2
44836 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

Reduce maximum juice prescription 

amounts in food packages for children 

and women. Add a voucher for fruits 

and vegetables to those packages. 

+$ 

Current rule: 

Eggs are provided under Food Packages IV through VII. States may set 

their monthly maximums at either 2 or 

21⁄2 dozen per month. 

Reducing the maximum egg prescription will produce a 

modest reduction in 

food package costs. 

That reduction is 

used to help offset 

costs of new foods 

and substitution options. 

State and local administrative burden will 

be incurred in the 

short term as new 

procedures are put 

in place. 

Market effects will be 

minimal. 

This proposal reduces 

both the food energy and fat content 

of the WIC food 

packages. The 

changes are consistent with the advice of current nutrition science. The 

reduction in food 

energy also makes 

room for the introduction of new 

foods that address 

priority nutrient 

needs. 

Proposed rule: 

1. Reduce maximum egg prescription in 

all food packages for women and children. 

¥$ 

Current rule: 

There are no restrictions on the fat content allowed in milk. Prescribing only fat reduced milk to 

women and children 

age two and older 

will have a negligible effect on 

cost. 

State and local administrative burden will 

be incurred in the 

short term as new 

procedures are put 

in place. 

Market effects will be 

minimal. Vendors 

will need to train 

personnel to identify 

the newly WIC-eligible foods. 

This proposal reduces 

fat content of the 

WIC food packages. 

The change is consistent with the advice of current nutrition science. 

Proposed rule: 

1. Provide only fat reduced milk to 

women as well as children age two 

and older. 

2. Provide only whole milk to children 

one year of age. 

¥$ 

Current rule: 

Grains are included in the current food 

packages for women and children in 

the form of breakfast cereal. Current 

regulations do not specify a minimum 

whole grain content for that product. 

The addition of whole 

grain bread to Packages IV, V, and VII 

increases the cost 

of those packages. 

The whole grain requirement for the 

existing cereal component of all food 

packages for children and women 

will have, at most, a 

minor effect on cost. 

State and local agencies will incur administrative burden 

to implement the 

new rules. States 

will incur administrative burden in establishing specifications and restrictions for the new 

foods and substitution options and 

local clinics will 

incur additional administrative burden 

to explain food options to participants. 

Manufacturers may respond by reformulating popular WICapproved cereals in 

whole grain form 

rather than forfeiting 

the WIC market. 

Smaller vendors 

may need to modify 

stocks to include 

whole grain bread 

and cereal varieties. 

All vendors will 

need to train personnel to readily 

identify WIC-eligible 

breads and grains. 

The addition of whole 

grains to the WIC 

packages is consistent with 2005 Dietary Guidelines for 

Americans that encourage increased 

consumption of 

these foods. 

Proposed rule: 

1. Add whole grain bread to Food Packages IV, V, and VII. Allow substitutions of other whole grain foods for 

bread. 

2. Require that breakfast cereal for children and women meet FDA standards 

for classification as whole grain food. 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44837 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

+$ 

Current rule: 

Dry beans are included in Food Packages IV, V, and VII. Canned beans 

may be prescribed, instead of dry, to 

WIC participants who lack cooking facilities. 

At the proposed rate 

of substitution between canned and 

dry beans, the new 

option will increase 

costs. However, the 

cost of beans in the 

food packages is 

relatively small and 

this change will 

have a relatively 

modest effect on 

overall program 

cost. 

The proposed option 

will prompt states to 

set specifications 

and restrictions. 

Other short-term administrative burden 

will be incurred as 

the new rule is put 

in place. 

Market effects will be 

minimal. But, as 

with the addition of 

any WIC substitution option, small 

vendors may need 

to add new items to 

their stocks, and all 

vendors will need to 

train personnel to 

identify the newlyeligible WIC foods. 

By adding variety and 

convenience, the 

canned bean option 

should increase the 

appeal of that food. 

It may also encourage greater consumption, replacing 

less healthy foods 

in the diets of WIC 

participants. 

Proposed rule: 

1. Allow canned beans as a substitute 

for dry in all food packages for children and women. 

2. Allow both Package V and Package 

VII recipients to replace both their dry 

bean and peanut butter allocations 

with canned beans. 

+$ 

Current rule: 

Beans and peanut butter are not included in Food Package VI. Package 

V currently provides a pound of dry 

beans; those can be replaced with 18 

oz of peanut butter. 

The costs of food 

packages V and VI 

are increased. 

Neither of these 

changes introduce 

foods not already 

included in other 

WIC packages. The 

administrative burden should be minimal. 

Minimal market impact. These changes supplement the diets of 

breastfeeding and 

postpartum women 

with several of the 

priority nutrients 

identified by the 

IOM. 

Proposed rule: 

1. Add one pound of beans, with an 18 

oz peanut butter substitution option, to 

Food Package VI. 

2. Increase the amount of beans and 

peanut butter allowed under Food 

Package V; allow the prescription of 

both one pound of beans and 18 oz of 

peanut butter. 

+$ 

Current rule: 

26 oz of tuna is made available to exclusively breastfeeding women in Food 

Package VII. White, light, or dark 

tuna, packed in water or oil, is allowed. 

Costs will increase 

slightly. While the 

new substitution option may increase 

the cost of individual prescriptions, 

the number of WIC 

participants eligible 

for Food Package 

VII is very small. 

States and local agencies will incur administrative burden 

in implementation. 

State agencies will 

adopt specifications 

and restrictions for 

the new substitution 

option. 

Minimal market impact. But, may force 

small vendors to 

stock additional 

types of canned fish 

and will require all 

vendors to train personnel to identify 

newly-eligible WIC 

foods. 

These changes add 

new choices that 

may encourage 

consumption. The 

rule also responds 

to medical advice 

that breastfeeding 

women avoid fish 

species that are 

high in mercury. 

Proposed rule: 

Authorize a variety of canned fish that 

do not pose a mercury hazard to fully 

breastfeeding women. Slightly increase the maximum amount allowed 

to 30 ounces. 

+$ 

Current rule: 


jlentini on PROD1PC65 with PROPOSAL2
44838 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

State WIC agencies impose restrictions 

on some foods by brand or variety in 

order to limit cost or ensure statewide 

product availability. The practice is accepted but not formally authorized by 

regulation. 

This simply clarifies 

what is already accepted policy. The 

policy is an effective 

way to control 

costs. Since the rule 

represents no 

change from current 

practice, it results in 

no economic impact. 

The states are given 

formal approval for 

current practice. 

The states should 

incur little or no administrative burden 

in implementation. 

If states adopt restrictions on the brands 

or varieties of foods 

newly added to the 

WIC food packages, 

then participants 

who already purchase those foods 

may switch their selection of brands or 

varieties to the 

WIC-approved 

choices. A measurable shift in consumption by brand 

or variety may result. 

WIC participants may 

need to switch 

brands or varieties 

of foods that they 

currently consume 

to brands and varieties consistent with 

those added to the 

WIC packages. 

Proposed rule: 

Clarifies the right of states to restrict 

WIC foods by variety or brand. 

(minimal economic impact) 

Current rule: 

States are permitted to prescribe foods 

to WIC participants in quantities that 

are less than the package maximums 

when nutritionally warranted. The 

states may also standardize these reductions and apply the reduced 

amounts consistently to like groups of 

WIC participants. Such categorical 

food package tailoring may be done 

for nutritional reasons, but not to 

achieve cost reductions. 

Assures more consistent WIC benefits 

are delivered across 

states. 

The rule reduces the 

level of work currently undertaken by 

state officials. Administrative burden 

will decrease to the 

extent that states 

will not undertake 

their own review of 

WIC prescription 

maximums in response to the federal revisions to the 

WIC food packages. 

In the absence of 

this rule, the states 

may have incurred 

administrative burden. 

Minimal effect on vendors and producers. Assures more consistent WIC benefits 

are delivered across 

states. IOM has 

based food prescription quantities 

on current nutritional science rendering food package 

tailoring unnecessary. 

Proposed rule: 

Ends the practice of categorical tailoring 

of WIC food packages by the states. 

Proposed rule: 

Allow state agencies to round up to the 

next whole container of infant foods if 

needed to provide the maximum authorized amount of these foods. 

Minimal cost given the 

small container 

sizes involved. 

Rounding up is likely to require the addition of little jarred 

infant food to the 

food packages; containers are typically 

just 4 oz. The current infant cereal 

maximum of 24 oz 

is a multiple of a 

commonly prescribed package 

size; 8 oz boxes are 

among the standard 

package sizes. 

States may incur 

some administrative 

burden to implement, particularly if 

manufacturers 

change container 

sizes in response to 

this rule. 

Unless manufacturers 

change container 

sizes to achieve 

greater product 

sales, no impact is 

expected. 

Will ensure WIC participants get the full 

nutritional benefit 

authorized. 

Proposed rule: 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44839 

TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued 

Current and proposed rules 

Effect of proposed rule on 

USDA/federal gov’t State/local agencies Vendors/industry WIC participants 

End state practice of requesting additional package substitutions. A process is currently in place to accept and 

evaluate requests by state WIC agencies to add new foods to the program’s list of allowed substitutes. 

Will reduce administrative costs of considering proposals 

but little affect on 

program costs since 

very few package 

substitutions have 

ever been approved. 

Because of the proposed rule’s flexibility in food offerings, states will no 

longer have as 

much, if any, need 

to request substitutions to meet cultural preferences. 

Administrative savings will accrue for 

those states that 

would have pursued 

substitutions in the 

absence of this rule. 

Minimal since very 

few food package 

substitutions have 

ever been permitted. 

Minimal since very 

few food package 

substitutions have 

ever been permitted. 

D. Costs 

1. Proposed Rule 

Under the proposed rule, FNS estimates 

that the revisions to the WIC food packages 

will be cost-neutral. Specifically, FNS 

estimates that the changes will result in a 

cost savings of $34 million dollars over five 

years. 

The economic effects of the proposed rule 

on the federal government over a five-year 

period are summarized in Table 3, which 

presents the impacts of the revisions by food 

package type. These figures are limited to 

food costs; no additional funds will be 

provided to states or local clinics to 

implement this rule. The costs have been 

adjusted for the rule’s phasedimplementation schedule. Current and 

proposed food package costs are provided in 

Tables A1–A3 in the appendix. 

TABLE 3.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS

[In millions] 

Food package FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2007–

FY 2011 

I ........................................................................................ ¥$15.1 ¥$31.6 ¥$33.2 ¥$34.7 ¥$36.3 ¥$150.9 

II ....................................................................................... 34.7 91.3 96.3 100.8 105.4 428.5 

III ...................................................................................... 8.1 18.6 19.6 20.5 21.5 88.3 

IV ...................................................................................... ¥47.9 ¥115.1 ¥128.0 ¥140.7 ¥154.3 ¥586.0 

V ....................................................................................... 15.7 32.9 32.0 30.8 43.8 155.3 

VI ...................................................................................... 2.5 4.5 3.4 2.1 8.1 20.6 

VII ..................................................................................... 1.1 2.1 1.9 1.7 3.1 10.0 

Total .......................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 

Negative values are cost reductions. 

Table 4 shows the major cost drivers for 

each food package; provisions listed do not 

reflect total food costs and savings. Total 

costs are for FY07–FY11 and have not been 

adjusted for the rule’s phased 

implementation. 

TABLE 4.—MAJOR COST DRIVERS OF WIC FOOD PACKAGES

Food package Major cost drivers 

I ....................................................... • Formula is reduced for partially breastfed infants and eliminated for fully breastfed infants (¥$367 million 

post rebate). 

II ...................................................... • Infants fruits, vegetables and meats is added for fully breastfed infants( + $1,033 million). 

• Formula is reduced for fully formula and partially breastfed infants and is eliminated for fully breastfed infants (¥$128 million post rebate). 

• Juice is eliminated for all infants (¥$164 million). 

III ..................................................... Package III recipients are eligible for foods in the other packages. Package III costs mirror the costs and 

savings reflected in other packages. 

IV ..................................................... • $6 cash-value instruments for fruits and vegetables is added (+ $1,372 million). 

• Milk is reduced (¥$956 million). 

• Juice is reduced (¥$948 million). 

• Whole grains added ( + $639 million). 

• Cheese is reduced (¥$638 million). 

• Eggs are reduced (¥$290 million). 

• Beans added (+ $130 million). 


jlentini on PROD1PC65 with PROPOSAL2
44840 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

40 40 IOM, p. 172. 

41The Participant Characteristics, ‘‘PC2002’’, 

dataset contains prescription data from 49 states, 

PR, D.C., several U.S. territories, and separately 

administered Native American WIC agencies. 

42The description that follows is a simplification 

of the process used to develop the estimated 

prescriptions. 

43Prescription rates for whole grain bread and 

bread substitutes are set to the observed 

prescription rates for cereal; the April 2002 Food 

Package IV cereal prescription rate was applied to 

Package IV bread prescriptions, the Package V 

cereal prescription rate was applied to Package V 

bread prescriptions, etc. 

44Market consumption data is based on 2003 AC 

Nielsen Homescan survey data. 

45This method of identifying general consumer 

preferences for particular items cannot be used to 

estimate the share of the infant population that 

consumes fresh bananas. It is assumed, then, that 

infants will be prescribed bananas as a substitute 

for jarred infant food fruits and vegetables at the 

average prescription rate for all foods across all food 

packages. 

TABLE 4.—MAJOR COST DRIVERS OF WIC FOOD PACKAGES—Continued 

Food package Major cost drivers 

V ...................................................... • $8 cash-value instruments for fruits and vegetables is added (+$556 million). 

• Juice is reduced (¥$333 million). 

• Cheese is reduced (¥$268 million). 

• Milk is reduced (¥$236 million). 

• Beans (+ $107 million). 

• Eggs are reduced (¥$102 million). 

VI ..................................................... • $8 cash-value instruments for fruits and vegetables is added (+$282 million). 

• Milk is reduced (¥$162 million). 

• Juice is reduced (¥$122 million). 

• Cheese is reduced (¥$109 million). 

VII .................................................... • Juice is reduced (¥$53 million). 

• $8 cash-value instruments for fruits and vegetables is added (+ $47 million). 

• Milk is reduced (¥$31 million). 

Negative values (¥) are cost reductions, positive values (+) are cost increases. 

2. Fruit and Vegetable Option 

Due to the seasonal fluctuation in price 

and availability of fresh fruits and vegetables, 

and the inability to purchase them in 

uniform weight units, it is difficult to set 

quantity terms for fruits and vegetables and 

still estimate the cost of the WIC food 

packages. In order to accurately capture the 

cost of providing fresh fruits and vegetables 

in WIC Food Packages III–VII, the proposed 

rule includes fruit and vegetable vouchers. 

Due to the administrative ease of 

implementation, the IOM recommended 

cash-value instruments be issued.40 The IOM 

also recommended that states provide fruit 

and vegetable vouchers at the level of $10 per 

month for women and $8 per month for 

children. However, to achieve cost neutrality 

with the proposed changes, FNS set the 

vouchers at the level of $8 per month for 

women and $6 per month for children in the 

year in which the proposed food package 

revisions take effect. The maximum amount 

of the vouchers would be adjusted to reflect 

inflation in whole dollar increments. 

3. Cost Estimate Methodology 

a. Food costs. i. Prescriptions. The states 

report participant-level food prescription 

data to FNS on a biennial basis. A statistical 

sample drawn from those state records was 

used in preparing this cost estimate. At the 

time of this analysis, the 2002 prescription 

dataset was the most current available. The 

dataset records the April, 2002 prescription 

of WIC foods to each participant who 

received a package that month.41 FNS used 

the 2002 prescription data to establish a 

baseline food cost and to estimate the costs 

of the proposed package revisions. Actual 

participant-level prescriptions provide a 

useful starting point for this analysis. Data at 

the participant level captures the preferences 

and dietary restrictions of the current WIC 

population. Assuming little change in the 

distribution of the WIC population by life 

stage, food preference, or supplemental 

dietary need over the short term, the 2002 

prescription data offers the best opportunity 

for estimating likely prescription amounts 

under the revised food package rules. FNS 

will use later year data to project cost 

changes if it becomes available before the 

final rule. FNS developed a micro-simulation 

program to model participant-specific 

prescription amounts for each of the foods in 

the proposed packages other than infant 

formula. The following assumptions guided 

this analysis :42

• For foods that are part of both the current 

WIC packages and the revised packages: 

• WIC participants currently prescribed 

none of that food will continue to be 

prescribed none. 

• If the participant’s current prescription 

exceeds the proposed maximum for the item, 

then the participant will be prescribed the 

new maximum amount. 

• If the participant’s current prescription is 

less than the proposed maximum, then the 

participant’s prescription will remain 

unchanged. 

• For foods newly added to the WIC 

packages by the proposed rule: 

• Generally, prescription rates are set to 

observed rates for comparable foods already 

contained in the WIC packages.43

• Foods newly added to the WIC packages 

as substitutes for standard WIC foods were 

prescribed to a subset of the WIC population 

equal to the percent of all low income U.S. 

households that currently purchase those 

items.44 For example, market consumption 

data indicates that about 3% of U.S. 

households with WIC-eligible incomes 

purchased tofu, so 3% of WIC participants 

are assumed to be prescribed tofu.45

Participants prescribed one of the new 

substitutes will be provided with the 

maximum allowed under the proposed rule 

given any other substitutions allowed. 

• Fruit and vegetable vouchers are 

assumed to be prescribed to all participants 

at the full amount. 

This methodology tends to produce 

prescription estimates that are at or near the 

maximum quantities allowed under the 

revised packages. (See Table 5.) That 

outcome is consistent with the proposed 

rule?s recommendation that participants be 

issued prescriptions at the package 

maximums. It is also consistent with the rule 

that would end categorical tailoring. 

ii. Infant Formula and Rounding. In this 

analysis, infant formula and infant foods 

were treated slightly differently than the 

other foods. Using a micro-simulation 

program with PC2002 data to model 

prescription amounts for infant formula and 

foods would not account for ‘‘rounding up’’. 

Rounding up refers to the ability of state 

agencies to round up to the next whole 

container to provide the maximum infant 

formula allowance. This option is only 

available for state agencies which renew its 

infant formula contract on or after October 1, 

2004. The proposed rule extends this 

rounding option to infant foods (cereal, fruit 

and vegetables, and meat). 

Since the PC2002 data do not reflect the 

costs of states rounding up, the cost estimates 

of the current and proposed packages use a 

different approach to factor in the cost of 

states rounding up. Given current container 

sizes, rounding up is only required when 

issuing powder infant formula and infant 

fruit and vegetables. The maximum 

allowances for liquid concentrate infant 

formula, ready-to-feed infant formula, infant 

cereal and infant meat are evenly divisible by 

whole containers. To capture the effect of 

rounding, the following assumptions have 

been made: 

• Current Food Packages I and II 

• Estimated prescription infant formula 

amounts for Packages I and II BF/FF 

(partially breastfed) and I and II BF 

(breastfed) do not incorporate rounding as 

the estimated amounts fall below the 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44841 

46The prescription rates for infant cereal, fruit 

and vegetables, and meat are set to the average 

prescription rate of juice across all of the women’s 

food packages. Only infant fruit and vegetables 

were subject to rounding up due to the current 

container sizes; that factor is reflected in the 

estimated prescribed amount. 

47Herman, Dena and Harrison, Gail, ‘‘Are 

Economic Incentives Useful for Improving Dietary 

Quality among WIC participants and their 

Families?’’ ERS, USDA, 2004. DRAFT. 

48Food and Nutrition Service, U.S. Department of 

Agriculture, ‘‘National Survey of WIC Participants’’, 

October 2001. 

maximum amounts. Estimated prescription 

amounts for Packages I and II FF (fully 

formula-fed) are set at the maximum amounts 

of 806 reconstituted liquid ounces for liquid 

concentrate and ready to feed infant 

formulas; for powder infant formula the 

current 8 pound limit is used. 

• The reconstituted fluid ounces from 

powder infant formula is a weighted average 

of the powder container yield for the three 

infant formula brands with which state 

agencies have rebate contracts: Mead 

Johnson, Ross and Nestle (as determined by 

state agency contracts as of January 2006). 

• Total infant formula allowance for each 

package is weighted by the percentage of 

infants receiving each of the three forms 

(liquid concentrate, ready to feed, and 

powder) as distributed in the PC2002 data. 

• Proposed Food Packages I and II 

• Infant Formula: 

• All packages are set at the maximum 

monthly allowance for liquid concentrate, 

ready to feed and powder infant formulas as 

detailed in the proposed rule. 

• Powder infant formula is rounded to 

meet the maximum monthly reconstituted 

liquid concentrate allowance, but to not 

exceed the maximum monthly powder infant 

formula limit. 

• The reconstituted fluid ounces from 

powder infant formula is a weighted average 

of the powder container yield for the three 

formula brands with which state agencies 

have rebate contracts: Mead Johnson, Ross 

and Nestle (as determined by state agency 

contracts as of January 2006). 

• Proposed Food Package I BF/FF–A 

assumes 100 percent powder infant formula. 

This is consistent with IOM 

recommendations. 

• Total infant formula allowance for each 

package is weighted by the percentage of 

infants receiving each of the three forms 

(liquid concentrate, ready to feed, and 

powder) as distributed in the PC 2002 data. 

• Infant Foods: 

• Only Package II has infant foods. 

Container sizes are based on IOM 

assumptions: infant fruits and vegetables 

amounts are determined using Gerber 

container sizes weighted over the 6 month 

package period; current infant cereal 

containers (8 oz) and infant meat containers 

(2.5 oz) meet maximum monthly allowance 

without the need to round up.46

• Bananas are allowed to be substituted for 

infant fruit at the rate of 2 pounds per 16 

ounces of fruit. The proposed packages cost 

estimate assumes 1.8 pounds of bananas as 

substitution. 

The proposed rule requires state agencies 

to issue at least the full nutritional benefit of 

infant formula but not more than the 

maximum monthly allowance for the food 

package category and infant feeding option. 

However, rounding up to the whole container 

to meet the maximum monthly allowance 

provides more containers per month, which 

in turn results in higher costs. In addition, 

under both the current and proposed 

packages, the roundup provision is assumed 

to apply in all states at full implementation 

beginning in FY07. Therefore, this analysis 

provides the most conservative estimate of 

the additional cost due to rounding, as there 

is no way to accurately determine which 

states will elect to include a roundup 

provision in their infant formula rebate 

contract. 

iii. Redemption rates. Tables 5 and 6 show 

the maximum amount per food category and 

estimated average prescribed amounts used 

to calculate costs for the food packages under 

the proposed rule and under the current rule, 

respectively. Each table includes the 

individual food package component and its 

corresponding unit of measurement. 

WIC foods are provided by quantity, except 

for the fruit and vegetable voucher. As stated 

in the proposed rule, participants will be 

given a fruit and vegetable voucher with a 

fixed dollar value which can be used to 

purchase fruit and vegetables. Because the 

proposed fruit and vegetable voucher 

provides WIC benefits in a different form 

than is currently used, different redemption 

behavior is to be expected. Therefore, in 

developing a cost estimate for the rule, it is 

assumed that these vouchers will be 

redeemed at a rate of 87.5 percent, which is 

consistent with an evaluation of a WIC fruit 

and vegetable intervention in Los Angeles in 

2004.47 Per participant, a redemption value 

of $5.25 for children and $7.00 for women 

was included in the cost of the respective 

food package. 

All other WIC foods are assumed to be 

redeemed at a 100% rate. The assumption of 

100% redemption rates for other WIC foods 

reflects research findings which indicate that 

redemption rates for current WIC foods are 

high and vary little by food item (ranging 

from 94–99 percent).48 Variation in the 

quantity of foods purchased by participants 

is reflected in the prescription rates. Thus a 

simplifying assumption of 100 percent 

redemption rates was used for WIC food 

prescribed by quantity. 

TABLE 5.—PRESCRIPTION ESTIMATES UNDER PROPOSED RULE 49

Food package Units 50

Maximum 

amount per 

food category 

Estimated 

average 

prescribed 

amount 

Infants: Food Package I 

I–FF–A (0–3.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 806 829.01 

I–FF–A (partially breastfed, 0–.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 96 0.00 

I–FF–B (4–5.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 884 917.10 

I–BF/FF–A (1–3.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 384 386.09 

I–BF/FF–B (4–5.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 442 461.57 

I–BF–A (0–3.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 0 0.00 

I–BF–B (4–5.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 0 0.00 

Infants: Food Package II 

II–FF (6–11.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 624 647.37 

Cereal .................................................................... oz ................................................................................ 24 20.10 


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44842 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE 5.—PRESCRIPTION ESTIMATES UNDER PROPOSED RULE 49—Continued 

Food package Units 50

Maximum 

amount per 

food category 

Estimated 

average 

prescribed 

amount 

Baby fruits & vegetables ....................................... oz ................................................................................ 128 108.21 

Bananas ......................................................... lb ................................................................................. .......................... 1.80 

II–BF/FF (6–11.9 mo): 

Formula (post-rebate) ........................................... reconstituted fluid oz ................................................... 312 344.04 

Cereal .................................................................... oz ................................................................................ 24 20.93 

Baby fruits & vegetables ....................................... oz ................................................................................ 128 108.21 

Bananas ......................................................... lb ................................................................................. .......................... 1.80 

II–BF (6–11.9 mo): 

Cereal .................................................................... oz ................................................................................ 24 22.27 

Baby fruits & vegetables ....................................... oz ................................................................................ 256 228.06 

Bananas ......................................................... lb ................................................................................. .......................... 1.80 

Infant food meat .................................................... oz ................................................................................ 77 .5 73.06 

Children: Food Package IV 

IV–A (1–1.9 yrs): 

Juice ...................................................................... oz ................................................................................ 128 127.59 

Milk (whole) ........................................................... qt ................................................................................. 16 13.01 

Cheese ........................................................... lb ................................................................................. .......................... 0.96 

Cereal .................................................................... oz ................................................................................ 36 34.39 

Eggs ...................................................................... oz ................................................................................ 1 1.00 

Whole grain bread ................................................. lb ................................................................................. 2 1.22 

Other grains ................................................... lb ................................................................................. .......................... 0.69 

Beans, dried .......................................................... lb ................................................................................. 1 0.30 

Beans, canned ............................................... oz ................................................................................ .......................... 19.54 

Peanut butter ................................................. oz ................................................................................ .......................... 6.27 

Fruit and vegetable voucher 51 ............................. voucher ($) .................................................................. 6 .00 6.00 

IV–B (2–4.9 yrs): 

Juice ...................................................................... oz ................................................................................ 128 127.59 

Milk, fat-reduced .................................................... qt ................................................................................. 16 13.01 

Cheese ........................................................... lb ................................................................................. .......................... 0.96 

Cereal .................................................................... oz ................................................................................ 36 34.39 

Eggs ...................................................................... doz .............................................................................. 1 1.00 

Whole grain bread ................................................. lb ................................................................................. 2 1.22 

Other grains ................................................... lb ................................................................................. .......................... 0.69 

Beans, dried .......................................................... lb ................................................................................. 1 0.30 

Beans, canned ............................................... oz ................................................................................ .......................... 19.54 

Peanut butter ................................................. oz ................................................................................ .......................... 6.27 

Fruit and vegetable voucher 51 ............................. voucher ($) .................................................................. 6 .00 6.00 

Women: Food Package V 

V: 

Juice ...................................................................... oz ................................................................................ 144 143.40 

Milk, fat-reduced .................................................... qt ................................................................................. 22 16.90 

Soy beverage ................................................. qt ................................................................................. .......................... 1.66 

Tofu ................................................................ lb ................................................................................. .......................... 0.05 

Cheese ........................................................... lb ................................................................................. .......................... 0.97 

Cereal .................................................................... oz ................................................................................ 36 35.09 

Eggs ...................................................................... doz .............................................................................. 1 1.00 

Whole grain bread ................................................. lb ................................................................................. 1 0.63 

Other grains ................................................... lb ................................................................................. .......................... 0.35 

Beans, dried .......................................................... lb ................................................................................. 1 0.56 

Beans, canned ............................................... oz ................................................................................ .......................... 36.06 

Peanut butter ......................................................... oz ................................................................................ 18 13.86 

Fruit and vegetable voucher 51 ............................. voucher ($) .................................................................. 8 .00 8.00 

Women: Food Package VI 

VI: 

Juice ...................................................................... oz ................................................................................ 96 95.54 

Milk, fat-reduced .................................................... qt ................................................................................. 16 11.68 

Soy beverage ................................................. qt ................................................................................. .......................... 1.29 

Tofu ................................................................ lb ................................................................................. .......................... 0.02 

Cheese ........................................................... lb ................................................................................. .......................... 0.95 

Cereal .................................................................... oz ................................................................................ 36 34.70 

Eggs ...................................................................... doz .............................................................................. 1 0.95 

Beans, dried .......................................................... lb ................................................................................. 1 0.23 

Beans, canned ............................................... oz ................................................................................ .......................... 14.69 

Peanut butter ................................................. oz ................................................................................ .......................... 9.06 


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TABLE 5.—PRESCRIPTION ESTIMATES UNDER PROPOSED RULE 49—Continued 

Food package Units 50

Maximum 

amount per 

food category 

Estimated 

average 

prescribed 

amount 

Fruit and vegetable voucher 51 ............................. voucher ($) .................................................................. 8 .00 8.00 

Women: Food Package VII 

VII: 

Juice ...................................................................... oz ................................................................................ 144 143.64 

Milk, fat-reduced .................................................... qt ................................................................................. 24 17.51 

Soy beverage ................................................. qt ................................................................................. .......................... 1.46 

Tofu ................................................................ lb ................................................................................. .......................... 0.01 

Cheese ........................................................... lb ................................................................................. .......................... 1.60 

Cheese .................................................................. lb ................................................................................. 1 1.00 

Cereal .................................................................... oz ................................................................................ 36 35.87 

Eggs ...................................................................... doz .............................................................................. 2 1.98 

Whole grain bread ................................................. lb ................................................................................. 1 0.63 

Other grains ................................................... lb ................................................................................. .......................... 0.35 

Canned fish ........................................................... oz ................................................................................ 30 ........................

Tuna ............................................................... oz ................................................................................ .......................... 22.44 

Salmon ........................................................... oz ................................................................................ .......................... 6.11 

Beans, dried .......................................................... lb ................................................................................. 1 0.60 

Beans, canned ............................................... oz ................................................................................ .......................... 38.63 

Peanut butter ................................................. oz ................................................................................ 18 13.41 

Fruit and vegetable voucher 51 ............................. voucher ($) .................................................................. 8 .00 8.00 

TABLE 6.—PRESCRIPTION ESTIMATES FOR CURRENT FOOD PACKAGES

Food package Units 52

Maximum 

amount per 

food category 

Estimated 

average 

prescribed 

amount 

Infants: Food Package I 

I—Fully breast-fed: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 49.08 

I—Partially breast-fed: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 479.75 

I—Fully formula-fed: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 876.99 

Infants: Food Package II 

II—Fully breast-fed 4–6 mo: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 42.17 

Juice ...................................................................... oz ................................................................................ 96 34.09 

Cereal .................................................................... oz ................................................................................ 24 20.63 

II—Partially breast-fed 4–6 mo: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 521.24 

Juice ...................................................................... oz ................................................................................ 96 53.80 

Cereal .................................................................... oz ................................................................................ 24 16.60 

II—Fully formula-fed 4–6 mo: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 876.99 

Juice ...................................................................... oz ................................................................................ 96 41.93 

Cereal .................................................................... oz ................................................................................ 24 16.99 

II—Fully breast-fed 7–12 mo: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 41.36 

Juice ...................................................................... oz ................................................................................ 96 81.15 

Cereal .................................................................... oz ................................................................................ 24 22.28 

II—Partially breast-fed 7–12 mo: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 596.89 

Juice ...................................................................... oz ................................................................................ 96 69.30 

Cereal .................................................................... oz ................................................................................ 24 21.08 

II—Fully formula-fed 7–12 mo: 

Formula ................................................................. reconstituted fluid oz ................................................... 806 876.99 

Juice ...................................................................... oz ................................................................................ 96 76.42 

Cereal .................................................................... oz ................................................................................ 24 20.27 

Children: Food Package IV 

IV: 


jlentini on PROD1PC65 with PROPOSAL2
44844 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

49The only significant change to Food Package III 

in the proposed rule is the proposed addition of 

foods to these recipients’ packages when their 

medical circumstances allow it. The PC2002 data 

set indicates that about 1 percent of WIC 

participants receive Food Package III. FNS assumes 

that half of them will be able to and will choose 

to receive all of the other foods available to them 

under the proposed rule. Therefore, we do not 

calculate prescription rates for Food Package III. 

50Units are expressed in: Fluid ounces (fluid oz); 

ounces (oz); pounds (lb); quarts (qt); and, dozens 

(doz). 

51Prescribed amount for fruit and vegetable 

vouchers is the redemption rate as discussed in 

4a(iii) within this section. 

52Units are expressed in fluid ounces (fluid oz), 

ounces (oz), pounds (lb), quarts (qt), and dozens 

(doz). 

53FNS computed average prices for all food items 

other than infant formula from calendar year 2003 

AC Nielsen Homescan data. A price for infant 

formula was estimated from FY 2004 Nielsen 

supermarket scanner data. Prices displayed below 

are inflated to FY 2004 levels using Bureau of Labor 

statistics CPI estimates. 

54 2004 price data became available in 2006 after 

this analysis was completed. 

TABLE 6.—PRESCRIPTION ESTIMATES FOR CURRENT FOOD PACKAGES—Continued 

Food package Units 52

Maximum 

amount per 

food category 

Estimated 

average 

prescribed 

amount 

Juice ...................................................................... oz ................................................................................ 288 232.77 

Milk ........................................................................ qt ................................................................................. 24 16.58 

Cheese .................................................................. lb ................................................................................. .......................... 1.57 

Cereal .................................................................... oz ................................................................................ 36 34.39 

Eggs ...................................................................... doz .............................................................................. 2 .5 1.83 

Beans, dried .......................................................... lb ................................................................................. 1 0.61 

Peanut butter ......................................................... oz ................................................................................ .......................... 6.27 

Women: Package V 

V: 

Juice ...................................................................... oz ................................................................................ 288 267.83 

Milk ........................................................................ qt ................................................................................. 28 20.94 

Cheese .................................................................. lb ................................................................................. .......................... 1.84 

Cereal .................................................................... oz ................................................................................ 36 35.09 

Eggs ...................................................................... doz .............................................................................. 2 .5 1.99 

Beans, dried .......................................................... lb ................................................................................. 1 0.55 

Peanut butter ......................................................... oz ................................................................................ .......................... 7.29 

Women: Package VI 

VI: 

Juice ...................................................................... oz ................................................................................ 192 185.54 

Milk ........................................................................ qt ................................................................................. 24 17.15 

Cheese .................................................................. lb ................................................................................. .......................... 1.65 

Cereal .................................................................... oz ................................................................................ 36 34.70 

Eggs ...................................................................... doz .............................................................................. 2 .5 1.78 

Women: Package VII 

VII: 

Juice ...................................................................... oz ................................................................................ 336 319.32 

Milk ........................................................................ qt ................................................................................. 28 22.28 

Cheese as milk substitute ..................................... lb ................................................................................. .......................... 1.65 

Cheese .................................................................. lb ................................................................................. 1 1.00 

Cereal .................................................................... oz ................................................................................ 36 35.87 

Eggs ...................................................................... doz .............................................................................. 2 .5 2.00 

Beans, dried .......................................................... lb ................................................................................. 1 1.20 

Peanut butter ......................................................... oz ................................................................................ 18 13.41 

Tuna ...................................................................... oz ................................................................................ 26 24.75 

Carrots ................................................................... lb ................................................................................. 2 1.99 

iv. Food prices. For each of the food items 

in the current or proposed packages, FNS 

estimated the average price paid by 

households with WIC-eligible incomes. 

These prices are based on 2003 retail sales 

data collected by AC Nielsen.53 All prices are 

averages weighted by the relative purchase 

volumes of the selected product varieties. 

Product descriptions captured by Nielsen 

sometimes lack the detail necessary to 

separate WIC-eligible items from non-eligible 

items. For this reason, the selection of 

products from the Nielsen datasets 

necessitates some compromise. The average 

prices computed by FNS and a brief 

description of FNS’ product selection criteria 

are shown in Table 7. 

Food prices obtained from AC Nielsen 

Homescan data are inflated to FY 2004 levels 

with CPI estimates published by Bureau of 

Labor statistics.54 Food item or category 

specific inflation estimates were used, when 

available. For years after FY 2004, food costs 

are inflated by the Office of Management and 

Budget’s June, 2005 Thrifty Food Plan (TFP) 

index except for the fruit and vegetable 

vouchers which are inflated by the USDA’s 

agricultural baseline projections for retail 

fruit and vegetable prices. (See Tables B and 

C in the Appendix for more detail.) 

In each case, prices are computed only for 

products in container sizes consistent with 

current WIC regulations, typical state agency 

requirements, or the proposed rule. Products 

identified as organic were excluded; states 

typically disallow organic varieties for cost 

reasons. FNS also adjusted the WIC food 

prices for fiscal years 2005 and 2006 to 

account for changes in the infant formula 

market (e.g., many State agencies are now 

prescribing infant formulas enhanced with 

DHA/ARA, which have tended to cost WIC 

more than non-enhanced infant formulas). 


jlentini on PROD1PC65 with PROPOSAL2
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55The term ‘‘standard infant formula’’ refers to 

both milk-based and soy-based infant formulas, 

excluding specialized infant formula (i.e. formula 

for infants or children with special dietary needs). 

‘‘Enhanced formula’’ are formulas that have been 

enhanced with two fatty acids, DHA and ARA. 56See IOM, p. 140. 

TABLE 7.—WIC FOODS: FOOD ITEM, SELECTION CRITERIA, UNITS, AND PRICES PER UNIT

Food item Retail sales database selection criteria Units 

Price per unit 

(inflated to FY 

04) 

Infant formula (post rebate): 

Powdered ............................................................... Standard and enhanced formula 55 in powdered, liquid concentrate, and ready-to-feed forms.oz .................... $0.026 

Weighted average of all forms .............................. ..................................................................................... oz .................... 0.031 

Infant cereal .................................................................. Dry grains without added fruit or other flavors ........... oz .................... 0.174 

Infant food fruit and vegetables .................................... Any texture; plain fruits or vegetables ........................ oz .................... 0.115 

Infant food meat .................................................... All plain meat varieties ............................................... oz .................... 0.319 

Bananas ................................................................. Fresh ........................................................................... lb ..................... 0.436 

Milk: 

Whole ..................................................................... Fresh dairy milk only, 1⁄2 gallon or gallon containers. 

Reduced fat includes skim milk and milk identified 

as 2% or lower milkfat.

qt ..................... 0.746 

Reduced fat ........................................................... ..................................................................................... qt ..................... 0.675 

Cheese .......................................................................... Processed American and domestic natural cheddar, 

colby, mozzarella, brick, Monterey jack. Sliced or 

unsliced varieties.

lb ..................... 3.557 

Tofu ............................................................................... Plain varieties ............................................................. lb ..................... 1.689 

Soy beverage ................................................................ Quart or larger sizes. Plain varieties .......................... qt ..................... 1.940 

Juice .............................................................................. Apple, grape, orange, grapefruit, tomato. Unsweetened 100% juice.oz .................... 0.031 

Adult cereal: 

Whole grain ........................................................... Name brands (and their generic versions) commonly 

prescribed by state WIC agencies.

oz .................... 0.151 

Current WIC cereals .............................................. Hot or ready-to-eat ..................................................... oz .................... 0.154 

Eggs .............................................................................. Large or medium, white. One doz containers only .... doz .................. 1.186 

Beans: 

Dry ......................................................................... Most varieties, excluding string beans and immature

peas. Not mixed with other foods.

lb ..................... 0.728 

Canned .................................................................. ..................................................................................... oz .................... 0.034 

Peanut butter ................................................................ All forms and varieties. Not mixed with jelly .............. oz .................... 0.094 

Whole grain bread ........................................................ Wheat or grain bread .................................................. lb ..................... 1.251 

Brown rice ..................................................................... Instant or regular ........................................................ lb ..................... 1.239 

Tuna .............................................................................. Chunk light, canned .................................................... oz .................... 0.090 

Salmon .......................................................................... Canned ....................................................................... oz .................... 0.102 

Carrots .......................................................................... Fresh, frozen, canned ................................................. lb ..................... 0.901 

v. Participant Projections. The estimated 

level of WIC participation through FY 2011 

are those used in developing WIC program 

costs for the President’s FY06 Midsession 

Budget. Those projections assume continued 

participant growth at the average rate 

observed over the past four years. Consistent 

with the IOM assumptions, we do not assume 

any changes in participation under the 

proposed rule due to potential participants 

finding the revised package more or less 

attractive. (For more detail on participation 

levels by food package see Tables D and E in 

the Appendix.) 

Many of the proposed package changes 

were intended to encourage breastfeeding. 

However, it is important to note that this 

analysis does not provide an estimate of the 

increase in the number infants or the 

additional length of time that infants will be 

breastfed. Due to the complex set of factors 

(demographic, clinical, etc.) that influence 

breastfeeding duration, we are unable to 

estimate the number of infants/mother pairs 

that will switch food packages as their 

feeding practices change. This is consistent 

with the analysis provided by IOM. 

The assumption of no change in 

breastfeeding patterns yield the most 

conservative cost estimate, as the net impact 

of increases in breastfed infants and 

breastfeeding women participants reduces 

the costs of this proposal. IOM conducted a 

sensitivity analysis by simulating possible 

shifts in participation rates. Shifting infant/ 

mother pairs from the fully formula-fed 

package to the breastfeeding packages has the 

effect of moving infant/mother pairs from the 

most expensive set of packages to less 

expensive ones. A constant shift of 30 

percent for one to 11 months of age from 

partial to full breastfeeding and a smaller 

range of shifts from full formula feeding to 

full breastfeeding (with an appropriate shift 

in the mother’s classification) decreased the 

average package cost by nearly two percent.56

vi. Phased implementation. The analysis 

assumes the rule takes effect on November, 

2006. State agencies would be required to 

issue food benefits based on either the new 

food packages or current food packages but 

could not combine the two. State agencies 

may also phase-in new food packages on a 

participant category basis. 

As shown in Table F in the Appendix, 

most of the rule’s provisions are phased-in 

over the course of a year. The elimination of 

juice from the infant food packages, however, 

is phased-in six months from publication of 

the rule. 

The IOM recommended pilot testing or 

limited application of certain changes before 

full scale implementation. The limited 

application option was chosen because FNS 

does not have the authority to conduct pilots 

that waive current regulations. The rule’s 

implementation plan addresses the IOM 

recommendation for testing of certain 

provisions while allowing State agencies 

sufficient time and broad flexibility to 

implement the majority of the food packages. 

Key provisions of the rule intended to 

promote breastfeeding will be implemented 

initially in no more than 32 local test sites 

in up to eight states. Those provisions will 

not be implemented nationwide until FNS 

has evaluated their effectiveness at the test 

sites. One such provision is that breastfed 

infants under one month old do not receive 

formula from the WIC Program. Another is 

the provision that conditions eligibility for 

Food Packages V and VI on the level of infant 

formula prescribed to the mother. However 

as noted, the breastfeeding promotion 

provisions of the rule cannot be estimated 

with confidence. Due to the indefinite 


jlentini on PROD1PC65 with PROPOSAL2
44846 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

57 If the phase-in rate increases linearly over the 

first year, the rule would not be fully effective until 

the second month of FY 2008. As a rough 

approximation, it is assumed that the effective rate 

of implementation throughout FY 2007 averages 

50%, and that the effective rate of implementation 

in the first month of FY 2008 (the last month of the 

phase-in period) is 11/12. 

timeline for full implementation for the test 

sites ensure that the near term cost of the 

breastfeeding promotion provisions will be 

minimal, the key provisions in the rule 

intended to promote breastfeeding have been 

factored into this rule with the same phasein schedule as the other provisions. 

All phase-in effects are reflected in the cost 

estimates contained in Table 3. Juice 

prescriptions under the revised infant food 

packages will be reduced linearly from 

current levels to zero in the six months 

following the rule’s effective date. 

Nationwide, the juice prescription over that 

six month period will average half the level 

that would have been forecast under existing 

WIC rules. Elimination of juice from the 

infant food packages would reduce program 

costs by $30.1 million in FY 2007 if the 

provision were made fully effective upon 

implementation of the rule. The six month 

phased elimination of juice will reduce those 

FY 2007 savings by an estimated $8.3 

million. 

This analysis assumes that the remaining 

provisions of the rule will be phased-in over 

the course of the year that begins November, 

2006. It is assumed, as above, that states will 

implement the provisions of the rule 

throughout the phase-in period; the effective 

rate of implementation is assumed to average 

50% over the year. 57 The rule’s phase-in 

schedule reduces these costs by half in FY 

2007 to $21.1 million. FY 2008 costs are 

reduced by an estimated $0.3 million. 

vii. State cost variation. This analysis is 

based on national average prescription and 

price data, which indicates that programwide, the proposed changes are cost neutral. 

States may vary somewhat in their 

implementation experiences, depending on 

how closely their prescription practices and 

prices correspond to the national averages. 

WIC funding rules help address these 

implementation issues. The food funding 

formula provides mechanisms for 

transferring funds from states which are not 

fully utilizing their grants to those with need 

for additional funding, and these 

mechanisms have been successfully used in 

the past to address variations in states’

funding needs. 

b. Administrative costs. WIC state agencies 

receive an annual nutrition services and 

administration (NSA) grant to help pay the 

administrative costs of operating the WIC 

program. Each state agency’s NSA grant is 

determined by a statutorily-defined formula 

that is adjusted annually for inflation and 

other factors. This rule does not propose any 

change to the NSA funding formula. FNS 

expects State and local agencies to 

implement this rule without receiving NSA 

funds beyond what they would have received 

in the absence of this rule. However, we 

believe that the administrative burden 

associated with implementing this rule can 

be absorbed within current funding 

constraints. 

As part of its analysis, IOM held open 

sessions to solicit State and local agencies, 

practitioners and experts for comment on the 

current and proposed packages. Participants 

supported the changes in the food packages, 

but also acknowledged the administrative 

burden that may arise. Specific 

administrative burden for each proposed 

revision is identified in the Summary of Key 

Provisions on page 23 of this analysis. 

FNS does not have data on the current 

administrative costs incurred by state and 

local agencies. Therefore, we are unable to 

quantify the potential increases in 

administrative burden due to the proposed 

revisions. The proposed rule asks for 

comments from State and local agencies on 

the scale of the administrative burden 

associated with implementation of the 

revisions. 

Generally, states and local clinics may 

need to reprioritize or postpone some 

initiatives to undertake some of the start-up 

activities associated with this rule, as well as 

adapt to certain ongoing administrative 

requirements resulting from the rule. 

Initially, State and local agencies will need 

to revise state lists of authorized foods and 

prescribed amounts, develop food package 

combinations, and create a fruit and 

vegetable cash-value voucher to accompany 

the standard WIC instruments. State agencies 

will need to review and update all of their 

guidance materials regarding authorized 

supplemental foods. Significant time during 

implementation will be required in order to 

train staff on the changes in the WIC food 

packages. Staff will need to work with 

manufacturers and vendors to evaluate 

newly-eligible foods for nutrient content, 

determine minimum stock requirements, 

identify any special needs for carrying foods, 

such as increased shelf space or refrigerator 

space, and ensure systems are in place to 

accept the fruit and vegetable vouchers. State 

and local agencies will need to modify their 

existing WIC food management information 

systems to allow the new foods to be 

prescribed and to process the fruit and 

vegetable vouchers. Expenditures related to 

management information systems, and the 

degree to which any this impact is one-time 

or ongoing, will vary based on the State and 

local agency’s current database structure. 

In addition to the administrative efforts 

associated with initial implementation of the 

rule, there may be some ongoing 

administrative requirements to ensure that 

WIC staff, vendors and participants 

understand and properly implement the 

changes. States will need to continuously 

review all of the food package changes and 

consider a broader range of issues in 

determining their strategies for containing 

costs. The increase in the number of food 

items and flexibility afforded to participants 

will impact time spent on providing 

education and support materials on food 

selection, storage and preparation. Many of 

the changes in this rule are designed to 

support breastfeeding and local clinics may 

make ongoing changes in staffing and 

materials to reinforce the changes in the food 

packages with breastfeeding counseling and 

support. In addition, time will be spent 

communicating with and monitoring vendors 

to ensure compliance may increase. 

WIC vendors will also be affected. Vendors 

will need to train their personnel to 

recognize the newly WIC-eligible foods and 

to handle the new fruit and vegetable 

vouchers. Training time may increase due to 

the expanded lists of foods, and management 

information system changes may be 

necessary. Vendors may also need to revise 

their practices to meet the stocking 

requirements dictated by the new food 

packages. Most large vendors already carry 

all of the newly-eligible foods; however, 

some smaller vendors may decide that it is 

not worth participation in WIC to stock the 

newer foods. We do not believe that these 

expenditures will be significant enough to 

cause many current vendors to discontinue 

their voluntary participation in the WIC 

program. 

E. Uncertainties 

The estimate developed above is sensitive 

to changes in several key assumptions. A few 

of the most significant are discussed here. 

1. Price Volatility in the Dairy Market 

Instability in dairy prices over the last 

several years presents a major element of 

uncertainty in the cost estimate. However, 

the maximum amount of milk available in 

each of the food packages is reduced. The 

total amount of milk that can be replaced 

with more expensive substitutes has been 

reduced as well. These factors make the 

revised food packages less sensitive to dairy 

price fluctuations than the current WIC 

packages. A 10% increase in the price of milk 

and cheese would alter the cost of the revised 

food packages as follows: 

TABLE 8.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, ASSUMING A 10% INCREASE IN DAIRY PRICES

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 Total 

Total Cost of Rule with Alternate Assumption ......................................... ¥21.0 ¥42.9 ¥56.0 ¥69.7 ¥61.3 ¥250.9 

Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44847 

58 IOM, p. 119. 

TABLE 8.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, ASSUMING A 10% INCREASE IN DAIRY PRICES—

Continued 

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 Total 

Difference .......................................................................................... ¥20.2 ¥45.6 ¥48.1 ¥50.2 ¥52.6 ¥216.7 

Negative values are cost reductions. 

2. Reduce Assumed Preference for Soy 

Beverage 

FNS anticipates that 10% of women will 

request soy beverage in place of liquid milk, 

if provided the choice. AC Nielsen Homescan 

data indicate that approximately 10% of 

households with WIC-eligible incomes 

purchased some soy beverage during FY 

2003. The IOM cites high rates of lactose 

maldigestion and low rates of cultural 

acceptability of milk among African 

American and Asian women as important 

factors in its decision to introduce substitutes 

for milk.58 African American women are 

represented in the WIC population at a level 

disproportionate to their share of the general 

population. In part for that reason, it is 

appropriate to assume a WIC participant 

preference for soy beverage is at or near the 

upper range of estimates of soy beverage 

consumption in the U.S. as a whole. And 

because WIC participants may choose freely 

between milk and the more expensive soy 

substitute, without regard to cost, a natural 

response is consumption at a rate above the 

rate of those whose choice between the two 

products does not have personal cost impact. 

FNS identified each of the women on its 

2002 WIC prescription dataset who were 

provided neither milk nor cheese. Those 

individuals, as a group, are assumed to be the 

WIC participants most inclined to request a 

prescription of soy beverage in place of milk. 

FNS’ simulation model prescribes an amount 

of soy beverage to those individuals equal to 

the maximum allowed under their respective 

food packages. The program then substitutes 

soy beverage for the existing milk 

prescriptions of other WIC participants to the 

extent necessary to reach the 10% participant 

target. The program prescribes cheese and 

tofu before soy beverage; it does not replace 

the prescription of those milk substitutes 

with soy beverage. IOM took a similar 

approach in developing its cost estimate; it 

assumed that soy beverage would replace 

10% of liquid milk prescriptions. In IOM’s 

analysis, 8.7% of all milk and milk 

substitutes prescribed to women is in the 

form of soy beverage. FNS’ methodology, 

which incorporates the more detailed data 

available from PC2002, results in a somewhat 

lower 7.8% substitution rate for soy beverage. 

Adequate data on which to base a soy 

beverage consumption rate for adult women 

is not available; it is not known whether 

consumption is appreciably higher or lower 

among women than among the population 

generally. For these reasons, the cost of the 

proposed rule has been re-estimated using 

two alternate assumptions. If soy beverage is 

prescribed to only 5% of women, the average 

package V, VI, and VII soy beverage 

substitution rate is 3.9%. Conversely if soy 

beverage is prescribed to 15% of women, the 

average package V, VI, and VII soy beverage 

substitution rate is 11.5%. Given the high 

cost of soy beverage relative to milk, these 

alternate scenarios would have has cost 

implications. 

TABLE 9.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, ASSUMING A CHANGE IN THE PERCENTAGE OF WOMEN

PRESCRIBED SOY BEVERAGE

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 Total 

Total Cost of Rule with alternative 5% prescription rate ......................... ¥12.3 ¥23.4 ¥35.4 ¥48.3 ¥38.8 ¥158.3 

Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 

Total Cost of Rule with alternative 15% prescription rate ....................... 10.7 28.8 19.6 9.3 21.4 89.9 

Difference between rule and alternatives ......................................... +/¥11.5 +/¥26.1 +/¥27.5 +/¥28.8 +/¥30.2 +/¥124.1 

Negative values are cost reductions. 

F. Alternatives 

FNS considered several alternatives to the 

proposed rule. These alternatives are 

discussed below. Each of these alternatives 

was ultimately rejected because FNS believes 

that a food package which reflects the IOM 

recommendations as closely as possible 

within the constraint of cost neutrality best 

reflects current scientific consensus on how 

to best meet the dietary needs of WIC 

participants. 

1. Include Yogurt as a Milk Substitute for 

Food Packages IV–VII 

For Food Packages IV–VII, the IOM 

identified yogurt, tofu, and soy beverage as 

new milk substitutes to help ensure adequate 

calcium intake by those who cannot consume 

milk and to accommodate cultural 

preferences. Under the current rule cheese is 

also available as a milk substitute for up to 

three quarts of milk. IOM’s recommendation 

specifically called for limiting substitutions 

of cheese, yogurt, and tofu to four quarts of 

milk for Food Packages IV, V and VI, and six 

quarts of milk for Food Package VII. Soy 

beverage would be allowed for the entire 

milk allowance for Food Packages V, VI, and 

VII. 

In order to maintain cost-neutrality, the 

proposed rule eliminates yogurt as a milk 

substitute, but allows the substitution of tofu, 

cheese and soy beverages up to the IOM 

maximum substitution level. As shown in 

Table 10, the price of yogurt, $2.62 per quart, 

as compared to $.68 per quart for milk, 

considerably increases the monthly cost of 

Food Packages IV–VII. Soy beverage and tofu 

also have higher per unit costs than milk; 

however, the estimated amount of tofu 

purchased by WIC participants is 

substantially lower than that of yogurt, and 

soy beverage can serve as an alternative for 

all or part of the fluid milk for adult women 

making it a more cost-efficient substitute. 


jlentini on PROD1PC65 with PROPOSAL2
44848 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

59USDHHS/USDA, p. 4. 60 Id. 61USDHHS/USDA, p. 26. 62 Jane Reed, Elizabeth Fraza ̃o, Rachel Itskowitz, 

How Much Do Americans Pay for Fruits and 

Vegetables?, Economic Research Service, U.S. 

Department of Agriculture, July 2004, p. 33. 

63 Id. 

64ERS examined thirty common vegetables. The 

top ten by each measure (price and quantity), plus 

all of the dark green and orange vegetables are 

displayed. Prices are averages over all forms (fresh, 

frozen, canned, etc.) weighted by the number of 

servings purchased by form. 

TABLE 10.—PROJECTED COST OF YOGURT AS A MILK SUBSTITUTE

Food package 

Estimated 

average 

prescribed 

amount 

(qt.) 

Price per unit 

(inflated to 

FY04) 

Cost per food 

package 

IV .................................................................................................................................................. 0.86 $2.62 $2.25 

V ................................................................................................................................................... 0.84 2.62 2.21 

VI .................................................................................................................................................. 0.66 2.62 1.74 

VII ................................................................................................................................................. 0.83 2.62 2.17 

The economic impact of including yogurt 

as a milk substitute is shown in Table 11. 

The five year cost of the rule, as modified by 

this alternative, is $605.7 million. The cost of 

the proposed rule without yogurt is $¥34.2 

million (see Table 3.) 

TABLE 11.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, INCLUDING YOGURT AS A MILK SUBSTITUTE

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 Total 

Total Cost of Rule with Alternate Assumption ......................................... 58.6 137.4 134.0 129.0 146.6 605.7 

Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 

Difference .......................................................................................... 59.4 134.7 141.9 148.5 155.3 639.9 

2. Replace the Proposed Rule’s Fruit and 

Vegetable Provision With a More Restrictive 

Dark Green and Orange Vegetable Rule 

The 2005 Dietary Guidelines for Americans 

stresses the importance of consuming 

vegetables from each of five identified 

subgroups (dark green, orange, starchy, 

legumes, and ‘‘all other.’’) Overall 

consumption of vegetables by American 

adults tends to fall short of the levels 

recommended by the 2005 Dietary 

Guidelines for Americans.59 But inadequate 

consumption varies by vegetable subgroup. 

Consumption of vegetables from the dark 

green, orange, and legume groups fall farthest 

from recommended levels.60

The current WIC food packages address 

inadequate consumption of legumes through 

the prescription of dried beans and peanut 

butter and the proposed rule would increase 

the quantity of those items in two of the food 

packages. The rule also attempts to increase 

the appeal of the legume subgroup by 

providing a canned option in packages IV 

through VII. 

By contrast, the current WIC packages and 

the proposed revisions might appear to give 

too little attention to the lack of dark green 

and orange vegetables in the typical 

American diet. The current WIC food 

packages offer no vegetables from the dark 

green subgroup to any participant; carrots 

provided to breastfeeding women are the 

only vegetables from the orange subgroup 

currently offered through WIC. Development 

of the proposed rule presented the IOM and 

the USDA with an opportunity to add 

vegetables from these subgroups to the WIC 

packages. Perhaps surprisingly, the rule does 

not prescribe a specific quantity of vegetables 

from either of these subgroups. Despite 

recognizing potassium, folate, and vitamins 

A and C as priority nutrients lacking in the 

diets of some WIC subpopulations, the IOM 

chose not to emphasize the dark green and 

orange vegetable groups that tend to offer the 

highest concentrations of those nutrients.61

Instead, the IOM recommended a fruit and 

vegetable option with few restrictions. Under 

the proposed rule, nutrition education 

offered by local WIC agencies will remain the 

primary method of encouraging participants 

to the most nutritious fruit and vegetable 

varieties; participants remain largely free to 

choose the fruits and vegetables that they 

find most appealing. 

An alternative rule that excluded fruit from 

the WIC packages and limited vegetable 

choices to nutrient-dense dark green and 

orange varieties would increase the level of 

priority nutrients offered by the revised food 

packages. A restrictive vegetable rule might 

also reduce the inefficiency costs incurred by 

retailers as WIC participants mistakenly bring 

non-WIC items to the checkout counter. A 

small and definite list of WIC approved 

vegetables would allow retailers to affix 

labels to store shelves pointing WIC 

participants to each of their options. The 

same cannot be done as readily if the IOM 

recommended and USDA proposed approach 

is adopted. Although the rule offers 

substantial consumer choice, it also comes 

with significant restrictions on product form, 

especially for processed fruits and vegetables. 

Specifically, this alternative would 

provide, in Food Packages III–VII, 3.75 

pounds or 60 ounces of the following leafy 

green or dark orange vegetables: broccoli; 

carrots; leafy greens (kale, mustard, collard, 

turnip, spinach); sweet potatoes; and winter 

squash (i.e. Hubbard, acorn or butternut) in 

lieu of the fruit and vegetable voucher. Three 

and three quarters pounds of leafy greens or 

dark orange vegetables replace the current 

allowance of 2 pounds of carrots in Food 

Package VII. Allowable forms include fresh, 

canned, and frozen vegetables. This 

alternative allows substitution at a one-to-one 

rate, for example, one 16 ounce can per 1 

pound of fresh vegetables and 1 pound frozen 

for 1 pound fresh. In order to contain costs 

and administrative burden, as well as to 

maintain the nutrient density of the food 

packages, the following are disallowed: 

creamed or sauced vegetables; vegetablegrain (e.g. pasta/rice) mixtures; mixed 

vegetables that include non-authorized 

vegetables; breaded vegetables; fresh 

vegetables prepared for immediate 

consumption such as those cleaned and 

chopped on salad bars; baby vegetables; and, 

those packaged in individual servings except 

for homeless participants. These fruits and 

vegetables would only be prescribed to those 

Food Package III participants who do not 

have a medical condition that would 

preclude consumption of leafy green or dark 

orange vegetables. 

Cost is not an impediment to a limited, 

nutrient-dense vegetable option. Broccoli, 

carrots, mustard greens, kale, sweet potatoes, 

and spinach are among the least expensive 

fresh vegetables on a per serving basis, and 

are prime candidates for inclusion in any list 

of nutrient-dense, dark green and orange 

vegetables.62 Collard and turnip greens are 

among the least expensive vegetables 

available in frozen form.63

Table 12 summarizes price per serving, and 

the total number of servings purchased, for 

several common vegetables.64 Dark green 

leafy vegetables and deep orange vegetables 

are highlighted. 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44849 

65 IOM, p. 118. 

66 Id. 

TABLE 12.—COMMONLY CONSUMED VEGETABLES, 1999: PRICE PER SERVING AND SERVINGS PURCHASED

Price per serving Servings purchased 

Vegetable Dollars Rank 

(lowest = 1) Vegetable Billions Rank (most = 1) 

Cabbage .................................................... $0.05 1 Potatoes ................................................... 26.21 1 

Potatoes .................................................... 0.07 2 Tomatoes ................................................. 6.97 2 

Radishes ................................................... 0.11 3 Onions ...................................................... 6.01 3 

Onions ....................................................... 0.12 4 Carrots ..................................................... 5.67 4 

Cucumbers ................................................ 0.12 5 Green beans ............................................ 4.32 5 

Broccoli ...................................................... 0.13 6 Cabbage ................................................... 3.67 6 

Celery ........................................................ 0.13 7 Sweet corn ............................................... 3.43 7 

Green beans ............................................. 0.14 8 Broccoli .................................................... 3.33 8 

Carrots ....................................................... 0.14 9 Iceberg lettuce ......................................... 3.23 9 

Romaine lettuce ........................................ 0.15 10 Bell peppers ............................................. 2.52 10

Sweet potatoes ......................................... 0.19 14 Sweet potatoes ........................................ 0.94 16 

Kale ........................................................... 0.19 15 Spinach .................................................... 0.56 19 

Mustard greens ......................................... 0.19 16 Brussels sprouts ....................................... 0.16 22 

Brussels sprouts ........................................ 0.27 23 Collard greens .......................................... 0.06 26

Spinach ..................................................... 0.29 25 Mustard greens ........................................ 0.05 27 

Turnip greens ............................................ 0.30 27 Turnip greens ........................................... 0.04 28 

Collard greens ........................................... 0.32 29 Kale .......................................................... 0.02 30 

30 vegetable average ............................... 0.21 .................... 30 vegetable average .............................. 2.62 ....................

............................................................... .................... .................... Excluding potatoes ................................... 1.81 ....................

Source: Figures were compiled from data contained in Reed, Frazao, Itskowitz, How Much Do Americans Pay for Fruits and Vegetables?, 

ERS, USDA, July 2004. 

Averaged across all forms (fresh, frozen, 

and canned) five of the nine dark green and 

orange vegetables are available at prices 

below the 30 vegetable average. But just two 

of them are purchased at above average rates; 

the rest are purchased at rates well below 

average. 

The overall cost of the proposed rule 

would be significantly reduced if modified to 

restrict consumption of vegetables to dark 

green and orange vegetables with a 3.75 

pound maximum quantity. The five year cost 

of the rule, as modified by this alternative, 

is $¥702.4 million as shown in Table 13. 

The cost of the proposed rule, without 

modification or additional cost containment 

discussed above, is $¥34.2 million (see 

Table 3.) 

TABLE 13.—PROJECTED COST (+) / SAVINGS (¥) ASSOCIATED WITH REPLACING FRUIT AND VEGETABLE PROVISION WITH

MORE RESTRICTIVE DARK GREEN AND ORANGE VEGETABLES (3.75 LB MAXIMUM QUANTITY FOR PACKAGES III–VII) 

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 All 

Total Cost of Rule with Alternative .......................................................... ¥71.4 ¥146.7 ¥154.2 ¥161.3 ¥168.8 ¥702.4 

Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 

Difference .......................................................................................... ¥70.6 ¥149.4 ¥146.3 ¥141.8 ¥160.1 ¥668.2 

The relative lack of popularity of these 

vegetables raises two concerns. The first is 

whether vendors will be willing to stock 

vegetables with such limited appeal. 

Historically, WIC has included only 

commonly consumed and widely available 

items in its food packages. These 

considerations serve, in part, to limit the 

costs incurred by WIC-approved vendors. 

Requiring vendors to maintain fixed supplies 

of little-consumed foods may prove too 

expensive, especially for the smaller 

proprietors common in neighborhoods with 

significant WIC-eligible populations. Of 

course, high concentrations of WIC-eligible 

shoppers might allow smaller vendors to 

stock these foods profitably, however, that 

raises the second concern about whether 

such a narrow vegetable option will increase 

consumption. 

IOM and the USDA recognize the 

difference between a food package that 

simply offers needed nutrients to WIC 

participants, and one that encourages 

participants to increase their intake of those 

nutrients. IOM concluded that participant 

choice is among the keys to increased 

consumption of priority foods and 

nutrients.65 Concluding that food package 

options with limited choice fail to provide 

‘‘incentives for participation,’’ IOM suggests 

that poorly designed food packages may 

prevent WIC from reaching some at-risk 

populations at all.66

A rule that allows wide choice among 

vegetable varieties cannot guarantee delivery 

of priority nutrients at recommended levels. 

But, supported by local agency nutrition 

education, the proposed rule is expected to 

increase the intake of those nutrients. And to 

the extent that WIC participants, like 

Americans generally, consume too little from 

the fruit and vegetable groups overall, WICprovided fruits and vegetables may displace 

less healthy foods from the diet, and help 

reduce the excess intake of food energy and 

saturated fat. IOM and USDA propose a 

minimally restrictive fruit and vegetable 

option with the expectation that it will 

increase consumption of targeted nutrients, 

and improve the diets of WIC participants, 

more effectively than a limited vegetable 

option with less participant appeal. 

3. Do Not Offer Infant Food Fruits, 

Vegetables, or Meat to Infants Age Six 

Months and Older 

The proposed rule adds infant food fruits 

and vegetables to revised Package II in part 

as a preferred replacement for fruit juice. 

This alternative questions whether the fruit 

juice eliminated from the infant food 

packages needs to be replaced at all. 

With the exception of low iron and zinc 

intakes by the relatively small population of 

fully breastfed infants age six months and 

older, IOM identified no nutrient 

inadequacies among WIC infants. IOM 

understands that WIC foods are offered to 

supplement the diets of program 


jlentini on PROD1PC65 with PROPOSAL2
44850 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

67 IOM, p. 81. 

68 IOM, p. 103. 

69USDHHS/USDA, 2005, p. 5. 

70 Id., p. 25. 

71To estimate the cost of the alternative, AC 

Nielsen Homescan data were used. Prices paid by 

households with WIC-eligible incomes for whole 

wheat and multi-grain bread averaged $1.25 per lb 

in CY 2003. The comparable price for bread 

specified without the whole grain restriction was 

just $0.98. CY 2003 Homescan data suggest that low 

income households paid $1.17 per pound for brown 

rice, and just $1.05 for all varieties of rice. Selecting 

cereal brands representative of those allowed under 

current WIC rules produced an average CY 2003 

price per ounce of $0.155; restricting those brands 

to ones identified by FNS as whole grain produced 

an average price of $0.152. (Given the uncertainty 

of a price difference between whole grain WIC 

cereals and all WIC cereals, the whole grain price, 

adjusted for inflation, was used in both the current 

program cost estimate and the cost of the proposed 

rule.) 

beneficiaries. ‘‘Thus, food groups and 

nutrients that are lacking in the diet are to 

be emphasized, rather than staple foods that 

are already adequate in the diet.’’ 67

Accepting, for argument’s sake, that parents 

are likely to introduce complementary foods 

to their infants at six months of age, 

regardless of the content of the WIC food 

packages, it may make sense to eliminate 

juice from the infant food packages without 

offering jarred infant foods as a replacement. 

If this assumption about parents’ behavior 

could be substantiated, then elimination of 

jarred infant food from the proposed rule 

would reduce costs without placing infants at 

nutritional risk. Those savings could be used 

to allow for the full IOM-recommended level 

of fruits and vegetables or the savings could 

be redirected to other government priorities. 

The overall cost of the proposed rule 

would be significantly reduced if modified to 

eliminate both juice and infant foods from 

the infant food packages. The five year cost 

of the rule, as modified by this alternative, 

is $¥983.6 million. The cost of the proposed 

rule, without modification, is $¥34.2 million 

(see Table 3.) 

TABLE 14.—PROJECTED COST (+) / SAVINGS (¥) ASSOCIATED WITH ELIMINATING INFANT FOOD FRUITS, VEGETABLES, OR

MEAT FROM INFANT FOOD PACKAGES; REINSTATE CURRENT PACKAGE

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 All 

Total Cost of Rule with Alternative .......................................................... ¥89.0 ¥197.2 ¥218.5 ¥239.7 ¥239.2 ¥983.6 

Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 

Difference .......................................................................................... ¥88.2 ¥199.9 ¥210.6 ¥220.2 ¥230.5 ¥949.4 

The proposed infant food provision serves 

two of the broader goals of the WIC food 

package redesign effort. The first seeks to 

encourage WIC participants to increase their 

intake of fruits and vegetables. This effort, 

backed by the recommendations of current 

nutrition science, and reflected in the 2005 

Dietary Guidelines for Americans, is 

weakened by this alternative food package 

proposal. The proposed rule, unlike this 

alternative, sends a clear message that a 

variety of semi-solid fruits and vegetables is 

preferred to fruit juice as an early 

complementary food as baby food fruits and 

vegetables serve to introduce older infants to 

new flavors and textures.68

A second goal of food package redesign 

effort that is not met through this alternative 

proposal is the promotion of breastfeeding. 

The proposed rule offers twice the amount of 

infant food fruits and vegetables to fully 

breastfed infants that it offers to partially or 

fully formula-fed infants. IOM and the USDA 

are optimistic that increasing the value of the 

food package offered to fully breastfed infants 

will provide the type of economic support 

that will encourage mothers to continue 

breastfeeding beyond six months. The 

introduction of infant food meat to the fully 

breastfed package is intended to provide the 

same incentive; it extends economic 

assistance to parents, and helps ensure the 

health of their infants with foods that deliver 

the only two priority nutrients found lacking 

in WIC’s infant population. Because this 

alternative would undermine two the key 

goals of the WIC food package redesign effort, 

it was rejected. 

4. Drop the Whole Grain Requirement for 

Both Bread and Cereal 

The proposed rule requires that bread and 

the bread substitutes added to the children 

and women food packages meet FDA label 

standards for the health claim for whole grain 

foods with moderate fat content. In addition, 

the rule requires that cereal in all but the 

infant food packages meet the same whole 

grain standard. Relaxing the whole grain 

requirement is an alternative that may be 

supported with arguments similar to those 

behind the rule’s broad fruit and vegetable 

provision. IOM’s whole grain 

recommendation is motivated by nutrition 

research that recognizes low fiber intake as 

a health risk factor.69 Nevertheless, low fiber 

intake is a consequence of consumer choice. 

Simply mandating that WIC grain products 

meet the FDA’s whole grain standard may 

not increase whole grain consumption or 

fiber intake. Product variety is more limited, 

and cultural preferences may be difficult to 

meet, with a restrictive whole grain bread 

and cereal requirement. 

However, refined grains are not lacking in 

the American diet. The proposed rule’s fruit 

and vegetable provision encourages the 

consumption of foods that are 

underconsumed as a group. By contrast, the 

2005 Dietary Guidelines for Americans 

recommend that refined grains be replaced 

(not supplemented) with whole grains.70

Other arguments that might be raised 

against the whole grain requirement are 

possible limited availability of whole grain 

products at some WIC vendor sites, and 

higher food package costs. Although the need 

to stock additional whole grain items will be 

an economic burden to some WIC vendors, 

increased sales to WIC participants may 

justify the added vendor expense. 

Food package costs under the proposed 

rule will likely exceed the cost of otherwise 

equivalent packages that lack the whole grain 

requirement.71 The overall cost of the 

proposed rule would be significantly reduced 

if modified to eliminate the whole grain 

requirement. Because this alternative 

provides less nutritional benefit relative to 

the 2005 Dietary Guidelines for Americans 

recommendations and saves very little, it was 

rejected. 

TABLE 15.—PROJECTED COST (+) / SAVINGS (¥) ASSOCIATED WITH ELIMINATING THE WHOLE GRAIN REQUIREMENT FOR

BOTH BREAD AND CEREAL

[In $ millions] 

FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 All 

Total Cost of Rule with Alternative .......................................................... ¥$5.8 ¥$17.3 ¥$29.1 ¥$41.6 ¥$31.9 ¥$125.6 

Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2 

Difference .......................................................................................... ¥5.0 ¥20.0 ¥21.2 ¥22.1 ¥23.2 ¥91.4 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44851 

72Mary Kay Fox, William Hamilton, Biing-Hwan 

Lin, Effects of Food Assistance and Nutrition 

Programs on Nutrition and Health, Volume 3, 

Literature Review, Economic Research Service, U.S. 

Department of Agriculture, Food Assistance and 

Nutrition Research Report Number 19–3. October 

2004. 73WIC sales refer only to sales produced by the 

use of WIC vouchers, not the total sales from all 

purchases made by WIC participants. 74Prescription amounts used in this market share 

analysis are the same as those used in the cost 

analysis. 

75Total annual sales include foods that fit in the 

category of food product, but may not be WIC 

eligible (i.e., within cereal, total sales include 

cereals of any sugar content and cereals without 

whole grains). This was done to accurately portray 

the impact of the proposed food package on the 

whole market and not just the narrow sub-market 

of ‘‘WIC eligible’’ food. Because AC Nielsen 

Productscan data covers approximately 70% of the 

total grocery market, total annual sales were 

adjusted by dividing by 70%. 

76Total WIC sales reported here are less than the 

$5.2 billion dollars (pre-rebate) reported in WIC 

2004 food costs. The estimates of total WIC food 

sales for the current and proposed packages are 

likely to be lower than actual WIC food 

expenditures because the AC Nielsen Productscan 

and Homescan data used to estimate food prices 

may not fully capture the higher prices charged by 

WIC vendors such as small, non-chair, convenience 

and ‘‘WIC-Only’’ stores. 

77 ‘‘WIC % of Market’’ estimates are calculated 

only for items for which we have both a numerator 

and denominator. 

78We were unable to assess the market impact of 

four items in the WIC food package; tofu, soy 

beverage, baby food, and infant cereal. These items 

are not included in the Productscan data; however, 

we are able to estimate WIC sales because these 

items are part of the Homescan data, which is our 

source for item price data. 

79Total ‘‘WIC % of Market’’ estimates are 

calculated only for items for which we have both 

a numerator and denominator. 

G. Market Analysis 

The proposed changes in the quantities 

and types of foods provided by the WIC 

program should result in changes in the 

quantities and types of foods that WIC 

participants buy with their WIC vouchers. 

The complete market impact of this rule is 

difficult to accurately quantify, because we 

do not know the extent to which WIC foods 

substitute for purchases WIC participants 

would have otherwise made with their own 

funds. Empirical research on this issue is 

inconclusive.72 Because of this uncertainty, 

we present two scenarios. In the first (Table 

16), we assume full substitution—that is, all 

foods purchased with WIC vouchers under 

the current packages would otherwise be 

purchased with the participants’ own funds 

under the proposed rule. In the second (Table 

17), we assume the alternate—that none of 

the foods purchased with WIC vouchers 

would otherwise be purchased with the 

participants’ own funds. In both scenarios, 

the potential impact of the proposed rule on 

the total market size for most foods is 

relatively modest, as is the impact on WIC’s 

share of the total market. 

We estimated the total value of WIC 

sales 73 for each food item and the total 

annual U.S. retail sales for each WIC food 

item. To estimate WIC sales, we multiplied 

the average unit price per food item by an 

estimate of the quantity of food purchased by 

WIC participants (the average estimated 

participation multiplied by the amount of 

food prescribed to a participant throughout 

the course of a year).74 To estimate total 

annual sales, 2004 AC Nielsen Productscan 

data was used to calculate total volume and 

annual grocery store sales of the different 

categories of food products.75 We used 

calendar year (CY) 2004 participation, cost 

and sales estimates for our market share 

analysis. Although the rule does not take 

effect until FY2007, we cannot reliably make 

projections about the overall sales of WIC 

food items for the next three years; we 

believe the CY2004 data provides a good 

indication of the relative impact of the rule’s 

changes on each food item. 

It is important to note that this approach 

understates the size of the total markets for 

WIC food items (and thus overstates both 

WIC’s market share and the potential impact 

of the proposed change on WIC food 

markets), because the data used to estimate 

total market size is limited to grocery store 

sales. Data on sales through other outlets was 

not available, but would likely significantly 

increase the estimated size of the total market 

for WIC foods. 

TABLE 16.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD PACKAGE AND PROPOSED FOOD PACKAGE, ASSUMING FULL SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES, 

CY2004 

WIC food item 

Current food package Proposed food package 

Estimated total 

annual sales 

($) 

Estimated total WIC 

sales 

($) 76

WIC % of 

market 77

Estimated total 

annual sales 

($) 

Estimated total WIC 

sales 

($) 

WIC % of 

market 77

Formula ............................ 3,827,207,300 2,218,376,592 58.0 3,827,207,300 1,861,708,927 48.6 

Beans ............................... 1,594,508,550 28,452,447 1.8 1,594,508,550 74,093,164 4.6 

Peanut butter ................... 1,220,294,910 40,124,965 3.3 1,220,294,910 55,178,642 4.5 

Milk ................................... 15,079,942,711 906,058,003 6.0 15,079,942,711 677,234,215 4.5 

Adult cereal ...................... 10,659,174,187 371,248,425 3.5 10,659,174,187 371,248,425 3.5 

Juice ................................. 9,054,815,014 554,654,178 6.1 9,054,815,014 281,605,147 3.1 

Rice .................................. 1,555,487,249 .................................. 0.0 1,555,487,249 47,771,371 3.1 

Fruit and vegetables ........ 20,885,553,820 3,257,252 0.0 20,885,553,820 423,909,963 2.0 

Eggs ................................. 4,565,261,316 157,506,055 3.5 4,565,261,316 85,613,782 1.9 

Cheese ............................. 14,115,201,047 420,378,841 3.0 14,115,201,047 252,558,109 1.8 

Bread ................................ 9,639,041,0346 .................................. 0.0 9,639,041,0346 85,756,306 0.9 

Canned fish ...................... 1,876,855,676 3,635,931 0.2 1,876,855,676 4,313,082 0.2 

Infant cereal 78 ................. .................................. 37,109,290 ................ .................................. 27,928,716 ................

Baby food 78 ..................... .................................. .................................. ................ .................................. 181,459,935 ................

Tofu 78 .............................. .................................. .................................. ................ .................................. 1,354,354 ................

Soy beverage 78 ............... .................................. .................................. ................ .................................. 69,438,663 ................

Total79 ....................... 94,073,343,126 4,740,801,978 5.7 94,073,343,126 4,501,172,621 4.5 


jlentini on PROD1PC65 with PROPOSAL2
44852 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

80Total WIC sales reported here are less than the 

$5.2 billion dollars (pre-rebate) reported in WIC 

2004 food costs. The estimate of total WIC food 

sales for the current and proposed packages are 

likely to be lower than actual WIC food 

expenditures because the AC Nielsen Productscan 

and Homescan data used to estimate food prices 

may not fully capture the higher prices charged by 

WIC vendors such as small, non-chain, convenience 

and ‘‘WIC-Only’’ stores. 81 ‘‘WIC % of Market’’ estimates are calculated 

only for items for which we have both a numerator 

and denominator. 82We were unable to assess the market impact of 

four items in the WIC food package: tofu, soy 

beverage, baby food, and infant cereal. These items 

are not included in the Productscan data; however, 

we are able to estimate WIC sales because these 

items are part of the Homescan data, which is our 

source for item price data. 83Total ‘‘WIC % of Market’’ estimates are 

calculated only for items for which we have both 

a numerator and denominator. 

84 Victor Olivera, Mark Prell, David Smallwood, 

Elizabeth Fraza ̃o, WIC and the Retail Price of Infant 

Formula, Economic Research Service, U.S. 

Department of Agriculture, May 2004, p. 60. 

TABLE 17.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD PACKAGE AND PROPOSED FOOD PACKAGE, ASSUMING NO SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES, 

CY2004 

WIC food item 

Current food package Proposed food package 

Estimated proposed total annual 

sales 

Estimated total 

WIC sales 

($) 80

WIC % of 

market 81

Estimated total 

WIC sales 

($) 

Estimated total 

WIC sales 

($) 

WIC % of 

market 81

Formula ........................................... 3,827,207,300 2,218,376,592 58.0 3,470,539,636 1,861,708,927 53.6 

Beans .............................................. 1,594,508,550 28,452,447 1.8 1,640,149,267 74,093,164 4.5 

Peanut butter ................................... 1,220,294,910 40,124,965 3.3 1,235,348,407 55,178,642 4.5 

Milk .................................................. 15,079,942,711 906,058,003 6.0 14,851,118,924 677,234,215 4.6 

Adult cereal ..................................... 10,659,174,187 371,248,425 3.5 10,659,174,187 371,248,425 3.5 

Juice ................................................ 9,054,815,014 554,654,178 6.1 8,781,765,983 281,605,147 3.2 

Rice ................................................. 1,555,487,249 .............................. 0.0 1,603,258,620 47,771,371 3.0 

Fruit and vegetables ........................ 20,885,553,820 3,257,252 0.0 21,306,206,531 423,909,963 2.0 

Eggs ................................................ 4,565,261,316 157,506,055 3.5 4,493,369,043 85,613,782 1.9 

Cheese ............................................ 14,115,201,047 420,378,841 3.0 13,947,380,315 252,558,109 1.8 

Bread ............................................... 9,639,041,346 .............................. 0.0 9,724,797,652 85,756,306 0.9 

Canned fish ..................................... 1,876,855,676 3,635,931 0.2 1,877,532,826 4,313,082 0.2 

Infant cereal 82 ................................. .............................. 37,109,290 ................ .............................. 27,928,716 ................

Baby food 82 .................................... .............................. .............................. ................ .............................. 181,459,935 ................

Tofu 82 .............................................. .............................. .............................. ................ .............................. 1,354,354 ................

Soy beverage 82 .............................. .............................. .............................. ................ .............................. 69,438,663 ................

Total 83 ...................................... 94,073,343,126 4,740,801,978 5.7 93,590,641,391 4,501,172,621 4.5 

It is important to note that current and 

proposed estimated WIC sales differ from the 

costs reported in Table 3 mainly because the 

market analysis uses pre-rebate formula costs 

as compared to the cost estimate which 

factors in the post-rebate savings. In addition, 

the data in the market impact analysis is 

based on CY2004 participation whereas the 

cost estimate uses the projected participation 

estimates for 2007 and beyond. Finally, the 

market analysis does not take into account 

any phase-in period. 

Overall, the changes in the WIC food 

package will have a modest impact on WIC 

sales as a percentage of total annual sales of 

these food item categories. Market shares are 

slightly higher under the no substitution 

scenario. (See Table 17). For the foods that 

are currently part of the food package, the 

proposed food package has the largest dollar 

impact on the infant formula market. Under 

the proposed food package, the market share 

of WIC sales for infant formula is less than 

with the current food package. The decline 

is mostly due to a reduction in the maximum 

allowance of infant formula for partially 

breastfed and fully formula-fed infants 6 

through 11 months of age (Food Package II 

FF). 

The other markets that will be impacted 

and are currently part of the food package are 

the milk, juice, eggs, bean, cheese, peanut 

butter, and fruit and vegetable markets. The 

market share of these items will change 

slightly. The items that will have decreases 

are milk, juice, eggs, and cheese, while the 

items that will have increases are beans, 

peanut butter, and fruits and vegetables. The 

WIC market share of milk will change from 

6% to 4.5%–4.6% due to lower prescription 

amounts and the ability of participants to 

substitute tofu, and soy beverage for fluid 

milk. The decline in cheese is also due to 

these reasons. The share of the juice market 

shifts from 6.1% to 3.1%–3.2%, while the 

share of the egg market shifts from 3.5% to 

1.9%. Both of these declines stem from 

changes in the package that are designed to 

improve the overall nutritional benefit of the 

package. Participants will be receiving less 

juice, but more fruits and vegetables. The 

amount of eggs will be lowered consistent 

with recommendations of the IOM on 

cholesterol intake and to permit a wider 

variety of foods to be included in the WIC 

food packages. The market share of beans 

will increase from 1.8% to 4.5%–4.6%. The 

majority of this impact stems from the fact 

that participants can now substitute canned 

beans, which are more expensive, for dried 

beans. The market share of peanut butter will 

increase from 3.3% to 4.5%. Lastly, the WIC 

percent of the fruit and vegetable market will 

increase from 0% to 2.0%–3.1%. This is due 

to the fact that the only fruit or vegetable that 

WIC participants currently receive are carrots 

and only exclusively breastfeeding mothers 

receive them. Under the new rule, the fruit 

and vegetable vouchers will provide WIC’s 

women and children participants with much 

greater access to these foods. 

For the foods being added to the WIC food 

package, the WIC market share percentages 

are, for the most part, small, 0.9% and 3.0%–

3.1%, for bread and rice, respectively. We 

were unable to assess the market impact of 

four items in the food package: tofu, soy 

beverage, baby food, and infant cereal. These 

items are not included in the Productscan 

data; however we are able to estimate WIC 

sales because these items are part of the 

Homescan data, which is our source for item 

price data. 

Given the changes in market share and 

potential changes in total market demand, 

changes in the purchases of WIC-provided 

foods could theoretically have an impact on 

prices for WIC foods. However, because the 

demand impacts for most foods are small and 

impossible to estimate precisely, we are 

unable to determine the potential price 

effects. 

WIC purchases of infant formula represent 

a larger share of the total market of WICprovided foods than do WIC purchases of the 

other WIC foods. The Economic Research 

Service (ERS) recently studied the 

relationship between retail prices of infant 

formula and demand for WIC-provided 

formula. ERS findings suggest that the 

amount of WIC-provided formula purchased 

has an effect on retail prices; specifically, 

larger WIC demand leads to higher retail 

prices for non-WIC consumers who purchase 

the state’s contract brand of formula.84 ERS 

found that the larger the relative size of the 

WIC program, the greater the retail price of 

the contract brand of infant formula, ranging 

from 8 to 14 cents across brands of milkbased powder infant formula and from 3 to 


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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44853 

85Current Food Package III is $0 because the 

analysis only considers the incremental costs 

associated with the proposal. Proposed Food 

Package III represents the incremental costs as a 

result of the changes in the proposed rule. FNS does 

not have comprehensive data on the current cost of 

medical foods provided in Food Package III. 

However, the medical foods associated with this 

package stay the same under the current and 

proposed rules. The incremental cost is extending 

foods from other packages to food package III 

recipients. All other food package costs reflect the 

full package costs. 

86FY 07 is multiplied by 11 months. 

11 cents across brands of non-contract 

powder infant formula for a one-unit change 

in relative size of WIC (e.g., WIC’s share of 

all formula-fed infants increase from one-half 

to two-thirds of all formula-fed infants). 

However, it is difficult to project the exact 

impact of the reduction in WIC demand for 

infant formula under the proposed rule based 

on this study. The ERS analysis was limited 

to formulas sold in supermarkets, whereas 

projecting the impact of the rule on overall 

demand would require an analysis of the 

behavior of non-WIC consumers, which have 

more diverse purchasing habits. For instance, 

many non-WIC formula purchases are at 

prices below that of supermarkets from mass 

merchandisers that do not participate in the 

WIC Program. In addition, the change in WIC 

formula sales as a percentage of retail grocery 

sales due to this proposed rule (from 58% to 

49%–54%) is smaller than the changes in 

WIC sales examined in the ERS report (from 

50% to 66%). We invite comment on the 

impact of the proposed revisions to the WIC 

packages on food prices. 

Appendix: Additional Cost Estimate 

Assumptions 

TABLE A1.—FY 07 FOOD PACKAGE COSTS

[Post-rebate] 

Food package Current Proposed 

I—0 to 3 month infants ............................................................................................................................................................ $25.41 $22.91 

II—6 to 11.9 month infants ...................................................................................................................................................... 30.62 38.74 

III—Participants with special medical needs 85 ....................................................................................................................... 0.00 34.36 

IV—Children 1 to 4.9 years ..................................................................................................................................................... 35.60 33.54 

V—Women: pregnant and partially breastfeeding .................................................................................................................. 40.02 42.28 

VI—Women: postpartum ......................................................................................................................................................... 32.41 33.14 

VII—Women: fully breastfeeding ............................................................................................................................................. 51.25 52.62 

TABLE A2.—ANNUAL CURRENT FOOD PACKAGE COSTS (POST-REBATE) FY 07–FY 11 

[In $ millions] 

Food package FY 07 86 FY 08 FY 09 FY 10 FY 11 

I ................................................................................................................ $282.08 $321.87 $336.70 $352.19 $368.52 

II ............................................................................................................... 304.34 347.27 363.27 379.97 397.60 

III 85 .......................................................................................................... 0.00 0.00 0.00 0.00 0.00 

IV .............................................................................................................. 1,660.65 1,894.92 1,982.24 2,073.38 2,169.55 

V ............................................................................................................... 554.12 632.28 661.42 691.83 723.92 

VI .............................................................................................................. 227.20 259.26 271.20 283.67 296.83 

VII ............................................................................................................. 79.57 90.80 94.98 99.35 103.96 

TABLE A3.—ANNUAL PROPOSED FOOD PACKAGE COSTS (POST-REBATE) FY 07–FY 11 

[In $ millions] 

Food package FY 07 86 FY 08 FY 09 FY 10 FY 11 

I ................................................................................................................ $267.02 $290.30 $303.49 $317.45 $332.17 

II ............................................................................................................... 339.08 438.53 459.61 480.74 503.04 

III 85 .......................................................................................................... 8.15 18.56 19.58 20.50 21.48 

IV .............................................................................................................. 1,612.74 1,779.82 1,854.27 1,932.70 2,015.25 

V ............................................................................................................... 569.79 665.23 693.47 722.65 767.75 

VI .............................................................................................................. 229.75 263.72 274.56 285.81 304.93 

VII ............................................................................................................. 80.64 92.92 96.92 101.07 107.06 

TABLE B.—FY 04 PRICE INFLATION

ASSUMPTIONS USING FY 04 FOOD

SPECIFIC CPIS

Food item Inflation rate 

(percent) 

Infant cereal .............................. ¥0.8 

Infant food fruit and vegetables: 

Infant food meat ................ 2.6 

Bananas ............................ ¥1.0 

Milk: 

Whole ................................ 11.0 

Reduced fat ....................... 9.1 

Cheese ..................................... 5.2 

Tofu ........................................... 3.0 

TABLE B.—FY 04 PRICE INFLATION

ASSUMPTIONS USING FY 04 FOOD

SPECIFIC CPIS—Continued 

Food item Inflation rate 

(percent) 

Soy beverage ........................... 3.0 

Juice ......................................... ¥1.4 

Adult cereal: 

Whole grain ....................... ¥0.8 

Current WIC cereals .......... ¥0.8 

Eggs .......................................... 11.3 

Beans: 

Dry ..................................... 0.4 

Canned .............................. 0.4 

TABLE B.—FY 04 PRICE INFLATION

ASSUMPTIONS USING FY 04 FOOD

SPECIFIC CPIS—Continued 

Food item Inflation rate 

(percent) 

Peanut butter ............................ 0.6 

Whole grain bread .................... 0.4 

Brown rice ................................. 5.7 

Tuna .......................................... 0.1 

Salmon ...................................... 0.1 

Carrots ...................................... 1.3 


jlentini on PROD1PC65 with PROPOSAL2
44854 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 

TABLE C.—INFLATION ASSUMPTIONS, 

FY 04–FY 11 

Year 

Thrifty food 

plan 

(% change) 

CPI: Fruit 

and vegetables 

(% change) 

FY 04 ................ n/a 3.01 

FY 05 ................ 2.46 3.22 

FY 06 ................ 2.33 3.29 

TABLE C.—INFLATION ASSUMPTIONS, 

FY 04–FY 11—Continued 

Year 

Thrifty food 

plan 

(% change) 

CPI: Fruit 

and vegetables 

(% change) 

FY 07 ................ 2.40 3.26 

FY 08 ................ 2.40 3.32 

FY 09 ................ 2.41 3.29 

TABLE C.—INFLATION ASSUMPTIONS, 

FY 04–FY 11—Continued 

Year 

Thrifty food 

plan 

(% change) 

CPI: Fruit 

and vegetables 

(% change) 

FY 10 ................ 2.40 3.29 

FY 11 ................ 2.44 3.33 

TABLE D.—PROJECTED PARTICIPATION IN THE WIC PROGRAM, BY FOOD PACKAGE TYPE: CURRENT PACKAGES

Food package FY07 FY08 FY09 FY10 FY11 

I 0–3 month Infants: 

Fully formula-fed ............................................................................... 510,062 521,009 532,192 543,614 555,282 

Partially breast-fed ............................................................................ 78,699 80,388 82,113 83,876 85,676 

Fully breast-fed ................................................................................. 83,033 84,815 86,635 88,495 90,394 

671,794 686,212 700,941 715,985 731,352 

II 4–6 month Infants: 

Fully formula-fed ............................................................................... 418,052 427,025 436,190 445,552 455,115 

Partially breast-fed ............................................................................ 38,534 39,361 40,205 41,068 41,950 

Fully breast-fed ................................................................................. 54,361 55,528 56,719 57,937 59,180 

7–12 month Infants: 

Fully formula-fed ............................................................................... 609,727 622,813 636,181 649,835 663,783 

Partially breast-fed ............................................................................ 55,529 56,721 57,938 59,182 60,452 

Fully breast-fed ................................................................................. 64,501 65,885 67,299 68,744 70,219 

1,240,703 1,267,332 1,294,532 1,322,317 1,350,698 

III Participants with special medical needs ........................................... 86,375 88,229 90,123 92,057 94,033 

IV Children: 1–4.9 years ........................................................................ 4,240,829 4,331,850 4,424,825 4,519,794 4,616,803 

V Women: 

Pregnant ........................................................................................... 1,138,091 1,162,518 1,187,469 1,212,955 1,238,989 

Partially breastfeeding ...................................................................... 120,786 123,378 126,026 128,731 131,494 

1,258,877 1,285,896 1,313,495 1,341,686 1,370,483 

VI Women: Postpartum ......................................................................... 637,268 650,946 664,917 679,188 693,766 

VII Women: Fully breastfeeding ............................................................ 141,155 144,184 147,279 150,440 153,669 

Total ........................................................................................... 8,277,000 8,454,649 8,636,111 8,821,468 9,010,803 

TABLE E.—PROJECTED PARTICIPATION IN THE WIC PROGRAM, BY FOOD PACKAGE TYPE: PROPOSED RULE

Food package FY07 FY08 FY09 FY10 FY11 

I 0–3 month Infants: 

Fully formula-fed ............................................................................... 510,062 521,009 532,192 543,614 555,282 

Partially breast-fed ............................................................................ 78,699 80,388 82,113 83,876 85,676 

Fully breast-fed ................................................................................. 83,033 84,815 86,635 88,495 90,394 

4–5 month Infants: 

Fully formula-fed ............................................................................... 275,914 281,836 287,885 294,064 300,376 

Partially breast-fed ............................................................................ 25,432 25,978 26,536 27,105 27,687 

Fully breast-fed ................................................................................. 35,878 36,648 37,434 38,238 39,059 

1,009,018 1,030,674 1,052,796 1,075,392 1,098,473 

II 6–12 month Infants: 

Fully formula-fed ............................................................................... 751,865 768,002 784,486 801,323 818,522 

Partially breast-fed ............................................................................ 68,630 70,103 71,608 73,145 74,715 

Fully breast-fed ................................................................................. 82,983 84,764 86,583 88,442 90,340 

903,478 922,870 942,677 962,910 983,577 

III Participants with special medical needs ........................................... 86,375 88,229 90,123 92,057 94,033 

IV Children: 

1–1.9 years ....................................................................................... 1,400,314 1,430,369 1,461,069 1,492,427 1,524,459 

2–4.9 years ....................................................................................... 2,840,515 2,901,481 2,963,756 3,027,367 3,092,343 

4,240,829 4,331,850 4,424,825 4,519,794 4,616,803 

V Women: 

Pregnant ........................................................................................... 1,138,091 1,162,518 1,187,469 1,212,955 1,238,989 

Partially breastfeeding ...................................................................... 120,786 123,378 126,026 128,731 131,494 

1,258,877 1,285,896 1,313,495 1,341,686 1,370,483 

VI Women: Postpartum ......................................................................... 637,268 650,946 664,917 679,188 693,766 

VII Women: Fully breastfeeding ............................................................ 141,155 144,184 147,279 150,440 153,669 

Total ........................................................................................... 8,277,000 8,454,649 8,636,111 8,821,468 9,010,803 


jlentini on PROD1PC65 with PROPOSAL2
Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44855 

TABLE F.—TIMEFRAME FOR IMPLEMENTATION

Food package category Who may implement Timeframe for implementation 

Pregnant Women ............................................... All State Agencies ............................................ One Year from Publication of Interim Rule. 

Postpartum Women ............................................ All State Agencies ............................................ One Year from Publication of Interim Rule. 

Full Breastfeeding Women ................................. All State Agencies ............................................ One Year from Publication of Interim Rule. 

Partially Breastfeeding Women .......................... Not More Than 32 sites (4 sites within each of 

up to 8 state agencies).

One Year from Publication of Interim Rule 

(The selected sites will have authority to 

issue the revised packages for no more 

than 3 years.). 

Fully Formula-Fed Infants .................................. All State Agencies ............................................ One Year from Publication of Interim Rule. 

Partially Breastfed Infants .................................. The sites selected for Partially Breastfeeding 

Women’s Package.

One Year from Publication of Interim Rule 

(The selected sites will have authority to 

issue the revised packages for no more 

than 3 years.). 

Fully Breastfed Infants ....................................... All State Agencies ............................................ One Year from Publication of Interim Rule. 

Juice Elimination from Infant Food Packages .... All State Agencies ............................................ Six months from Publication of Interim Rule. 

Children .............................................................. All State Agencies ............................................ One Year from Publication of Interim Rule. 

Participants with Certain Medical Conditions 

(Women, Infants and Children).

All State Agencies ............................................ One Year from Publication of Interim Rule 

[FR Doc. 06–6627 Filed 8–4–06; 8:45 am] 

BILLING CODE 3410–30–P 


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