Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages, 44784-44855 [06-6627]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food and Nutrition Service

[Federal Register Volume 71, Number 151 (Monday, August 7, 2006)]
[Proposed Rules]
[Pages 44784-44855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6627]



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Part II





Department of Agriculture





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Food and Nutrition Service



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7 CFR Part 246



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

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

[[Page 44784]]


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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.

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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 https://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 WICHQ-SFPD@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 https://
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 https://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 https://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 nutrition-related 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, 
non-breastfeeding 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, non-breastfeeding 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 low-income, 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 cost-

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neutral, efficient for nationwide distribution and vendor checkout, 
non-burdensome 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.

 
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                     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
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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.
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    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 cost-neutral, 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 Sec.  246.7(e)(4) of WIC 
regulations, or by implementing other cost containment measures. State 
agencies are also reminded that Sec.  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 https://www.fns.usda.gov/
wic/lawsandregulations/revfoodpkg-anprm.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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``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 Sec.  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 beta-carotene (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, Nutrition-Related 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 iron-deficiency 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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following nutrients as high priority for WIC participants.
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    \1\ The 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 non-breastfeeding 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 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 low-income 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.
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     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 non-breastfed 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 non-breastfeeding 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 non-breastfeeding 
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]
----------------------------------------------------------------------------------------------------------------
                                     Nutrients of                            Nutrients of
                                     concern with        Priority food       concern with        Nutrients and
      Participant  category            regard to            groups             regard to        ingredients to
                                  inadequate  intake                       excessive intake    limit in the diet
----------------------------------------------------------------------------------------------------------------
Infants, less than 1 y, non-      No need identified  na................  Decrease intakes
 breastfed.                        to increase                             of Zinc, Vitamin
                                   particular                              A, preformed,b
                                   nutrients;                              and Food energy.
                                   maintain iron
                                   intakes and
                                   continue to
                                   provide a
                                   balanced set of
                                   essential
                                   nutrients.a.
Infants, 6-11.9 mo, breastfed...  Increase intakes    na................
                                   of Iron and Zinc.
Children, 12-23.9 mo............  Increase intakes    Increase intakes    Decrease intakes
                                   of Iron,            of a variety of     of Zinc, Vitamin
                                   Potassium,          non-starchy         A, preformed, b
                                   Vitamin E, and      vegetables.         and Food energy.
                                   Fiber.

[[Page 44789]]

 
Children, 2-4.9 y...............  Increase intakes    Increase intakes    Decrease intakes    Limit intakes of
                                   of Iron,            of whole grains,    of Zinc, Sodium,    Saturated fat,
                                   Potassium,          and a variety of    Vitamin A,          Cholesterol, and
                                   Vitamin E, and      non-starchy         preformed,b and     Added sugars.
                                   Fiber.              vegetables.         Food energy.
Adolescent and adult women of     Give highest        Increase intakes    Decrease intakes
 reproductive age.                 priority to         of whole grains,    of Sodium, Food
                                   increasing          a variety of non-   energy, and Total
                                   intakes of          starchy             fat .
                                   Calcium, Iron,      vegetables,
                                   Magnesium,          fruit, and fat-
                                   Potassium,          reduced milk
                                   Vitamin E, and      products.
                                   Fiber.
                                  Also try to
                                   increase intakes
                                   of Vitamin A,
                                   Vitamin C,
                                   Vitamin D,
                                   Vitamin B6, and
                                   Folate].
----------------------------------------------------------------------------------------------------------------
 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.
b The 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)
c Trans 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      The maximum amount provides
                                         partially breastfed infants.    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      Since the food package for infants of
                                         fully formula fed infants       this age provides greater amounts of
                                         ages 6-11.9 mo of age.          nutrients through complementary foods,
                                                                         less formula is needed.
Juice.................................  Delete juice for infants 4-     Meet AAP recommendations to delay
                                         11.9 mo of age; reduce amount   introduction of juice for infants until
                                         of juice for children 1-4.9 y   after 6 mo of age; allow no more than 4-
                                         of age.                         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        Amounts provided need not exceed amounts
                                         allowed for children and        recommended by DGA 2005.\(12)\
                                         adults.
Cheese................................  Reduce maximum amount allowed   Meets recommendation from DGA 2005
                                         in women's and children's       \(12)\ and recommendation from the IOM
                                         packages.                       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 https://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 diet-related 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

[[Page 44790]]

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 WIC-authorized 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 (Sec. Sec.  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 formula-feeding 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 Sec.  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;

[[Page 44791]]

     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 
(Sec.  246.10(c)(1)) for infants 0-3 months of age or Food Package II 
(Sec.  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 Sec.  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 iron-fortified 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

[[Page 44792]]

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-
fluid-ounce 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 Sec.  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 o